Contents Please refer to Medical Policy I-4, Hemophilia Treatment for additional information.

Transcription

1 August 2018 In This Issue Coverage Guidelines Updated for Hemophilia Treatment... 2 Coverage Criteria Revised for Nusinersen (Spinraza)... 6 Coverage Guidelines Developed for Vestronidase Alpha (Mepsevii)... 7 Contents Policy Coverage Guidelines Updated for Hemophilia Treatment Highmark Delaware has updated coverage guidelines for hemophilia treatment to include coverage for Hemlibra and Rebinyn for their Food and Drug Administration (FDA) approved indications, allow for Feiba to treat bleeding episodes in hemophilia A, allow Humate-P to be given in severe von Willebrand disease and allow for use of Wilate for treatment of spontaneous and trauma-induced bleeding episodes. This updated criteria will apply to both professional provider and facility claims. The effective date is August 6, Please refer to Medical Policy I-4, Hemophilia Treatment for additional information. Place of Service: Outpatient Highmark Delaware 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 insurance companies.

2 Coverage Guidelines Updated for Hemophilia Treatment Highmark Delaware has updated coverage guidelines for hemophilia treatment to remove coverage for NovoSeven as used in prophylaxis, indicate that Rixibus is not utilized in induction of immune tolerance, and mandate that individuals with immune tolerance induction for six (6) months or more must have a documented referral to a hemophilia treatment center. This updated criteria will apply to both professional provider and facility claims. The effective date is October 29, Please refer to Medical Policy I-4, Hemophilia Treatment for additional information. Place of Service: Outpatient Coverage Guidelines Revised for Ipilimumab (Yervoy) Highmark Delaware has revised the coverage guidelines for Ipilimumab (Yervoy ). Ipilimumab (Yervoy) may be considered medically necessary for the following: For individuals with intermediate or poor risk as first line treatment in combination with nivolumab (Opdivo) in advanced renal cell carcinoma For use in combination with nivolumab (Opdivo) for relapsed or surgically unresectable stage IV clear cell disease as first-line therapy for predominant clear cell histology or as subsequent therapy for predominant clear cell histology For treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dmmr) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab. This Medical Policy will apply to both professional provider and facility claims. The effective date is August 20, Please refer to Medical Policy I-34, Ipilimumab (Yervoy) and I-120, Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies for additional information. 2

3 Coverage Criteria Revised for Erythropoiesis Stimulating Agents Highmark Delaware has revised the coverage criteria and added a new medication, epoetin alfa-epbx (Retacrit ) to Erythropoiesis Stimulating Agents (ESA). Coverage criteria added: The use of darbepoetin alfa (Aranesp) and epoetin alfa (Procrit, Epogen) may be considered medically necessary for the treatment of anemia in the following: Treatment of anemia in individuals with cancer who have ANY of the following: o Have moderate to severe chronic kidney disease; or o Are undergoing palliative treatment; or o Are receiving myelosuppressive chemotherapy and have no other identifiable cause of anemia; or o Refuse blood transfusions in select cases; or Management of myelofibrosis-associated anemia with serum erythropoietin (EPO) less than 500 mu/ml; or Individuals with anemia secondary to combination of ribavirin and interferonalfa therapy in patients with hepatitis C; or For the treatment of neonates with hypoxic-ischemic encephalopathy (HIE). The use of epoetin beta-methoxy polyethylene glyol (Mircera) may be considered medically necessary in the following: For pediatric individuals age 5 to 17 years on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA Epoetin alfa-epbx (Retacrit) may be considered medically necessary for the treatment of anemia associated with ANY of the following conditions when reversible causes of anemia are identified and managed: Chronic kidney disease, whether or not on dialysis, to decrease the need for red blood cell transfusion; or HIV infection or AIDS-related Complex (ARC) receiving Azidothymidine (AZT) therapy. ALL of the following patient indications should apply: o AZT doses of 4200 mg or less/week; and o Endogenous levels of erythropoietin of 500 MU/ml or less; and o Treatment lasting no longer than three months following the discontinuation of the AZT; or Treatment of anemia in individuals with nonmyeloid malignancies when: o Anemia is due to the effect of concomitant myelosuppressive chemotherapy; and o Upon initiation, there is a minimum of two additional months of planned chemotherapy; and o Myelosuppressive therapy is not for curative intent; or o Individual is undergoing palliative treatment; or Reduction of allogeneic red blood cell transfusions in individuals when ALL of the following apply: o Individual is undergoing elective noncardiac/nonvascular surgery; and o Individual is not a candidate for autologous blood transfusion preoperatively; and o Individual is expected to lose two or more units of blood during 3

4 surgery; and o Individual presents with perioperative hemoglobin levels of greater than 10 g/dl up to 13 g/dl; and o Antithrombotic prophylaxis should be strongly considered for concurrent use; AND ESAs may be initiated when ONE of the following criteria is met: The hematocrit (HCT) is less than or equal to 30%; or The hemoglobin (Hgb) is less than or equal to 10g/dL plus adequate iron supplementation/replacement. Treatment should be stopped when the hematocrit is greater than or equal to 34% or the hemoglobin is greater than or equal to 11.5g/dL. ESAs will be considered not medically necessary when the hematocrit or hemoglobin are greater than or equal to these stated levels. This Medical Policy will apply to both professional provider and facility claims. The effective date is August 20, Please refer to Medical Policy I-7, Erythropoiesis Stimulating Agents, for additional information. Coverage Guidelines Revised for Granulocyte Colony Stimulating Factors (G- CSF) Highmark Delaware has revised the coverage guidelines for Granulocyte Colony Stimulating Factors (G-CSF) and added Filgrastim-aafi (Nivestym ) and Pegfilgrastim-jmdb (Fulphila ). G-CSF may be considered medically necessary for the following indications for their respective medications: Filgrastim (Neupogen ) Acute Myeloid Leukemia (AML) o As treatment induction in individuals less than 60 years in age in combination with fludarabine, high-dose cytarabine, and idarubicin; or o As a component of repeating the initial successful induction regimen if late relapse occurs (greater than or equal to 12 months); or o For relapsed or refractory disease in combination with ONE of the following: Cladribine and cytarabine, with or without mitoxantrone or idarubicin: or Fludarabine and cytarabine, with or without idarubicin; or Clofarabine and cytarabine, with or without idarubicin Filgrastim-sndz (Zarxio ) Used in hematopoietic cell transplant for: o Mobilization of donor hematopoietic progenitor cells or for granulocyte transfusion in the allogenic setting Addition of biosimilar Filgrastim-aafi (Nivestym) to policy: Filgrastim-aafi (Nivestym ) may be considered medically necessary for ANY of the 4

5 following: Individuals with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia (FN) to decrease the incidence of infection; or Individuals with AML following induction or consolidation chemotherapy to reduce the time to neutrophil recovery and duration of fever following treatments; or Individuals with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) to reduce duration of neutropenia and neutropenia-related clinical sequalae; or Individuals undergoing autologous peripheral blood progenitor cell collection and therapy for mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis; or Reduce the incidence and duration of sequealae of severe neutropenia in symptomatic individuals with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia. Addition of biosimilar Pegfilgrastim-jmdb (Fulphila) to policy: Pegfilgrastim-jmdb (Fulphila ) may be considered medically necessary for the following: Individuals with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of FN to decrease the incidence of infection. Sargramostim (Leukine ) Sargramostim (Leukine) may be considered medically necessary for ANY of the following indications: Adult individuals undergoing mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation; or Individuals 2 years of age or older for the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation; or Individuals 2 years or age or older for the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation; or Individuals 2 years or age or older for treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation; or Individuals acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) to increase survival. This Medical Policy will apply to both professional provider and facility claims. The effective date is August 20, Please refer to Medical Policy I-88, Granulocyte Colony Stimulating Factor (G-CSF) for additional information. 5

6 Coverage Criteria Revised for Blinatumomab (Blincyto) Highmark Delaware has revised the coverage criteria for Blinatumomab (Blincyto ) according to a recent FDA update. Blinatumomab (Blincyto) may be medically necessary for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. This Medical Policy will apply to both professional provider and facility claims. The effective date is August 20, Please refer to Medical Policy I-127, Blinatumomab (Blincyto), for additional information. Coverage Criteria Revised for Nusinersen (Spinraza) Highmark Delaware has revised coverage criteria for nusinersen (Spinraza ). The Medical Policy will apply to both professional provider and facility claims. The effective date is October 29, Coverage criteria revised to expand coverage to spinal muscular atrophy (SMA) types II and III, to require that individuals be 15 years of age or younger at initiation of treatment, expanding clinician consultation to include neuromuscular specialist, and requiring at least 2 survival motor neuron 2 (SMN2) genes to initiate therapy. Please refer to Medical Policy I-157, Nusinersen (Spinraza) for additional information. 6

7 Coverage Guidelines Developed for Vestronidase Alpha (Mepsevii) Highmark Delaware has developed coverage guidelines for Vestronidase Alpha (Mepsevii TM ) for FDA approved indication of Mucopolysaccharidosis VII (e.g. MPS VII, Sly syndrome). The coverage criteria will be based on clinical signs and symptoms and decreased level of beta-glucuronidase activity in blood or as confirmed by genetic testing showing mutations in the glucuronidase beta (GUSB) gene. This new coverage will apply to both professional provider and facility claims. The effective date is August 6, Please refer to Medical Policy I-188, Vestronidase Alpha (Mepsevii) for additional information. Place of Service: Outpatient Coverage Guidelines Established for Daunorubicin and Cytarabine Liposomal (Vyxeos) Highmark Delaware has established coverage guidelines for daunorubicin and cytarabine liposomal (Vyxeos TM ) to include coverage for AML and AML with myelodysplasia-related changes per FDA approved indications and NCCN guidelines. The effective date is August 20, Please refer to Medical Policy I-193, Daunorubicin and Cytarabine Liposomal (Vyxeos), for additional information. Place of Service: Outpatient 7

8 Coverage Guidelines Established for Burosumab (Crysvita) Highmark Delaware has established coverage guidelines for burosumab (Crysvita ) for the FDA approved indication of X-linked hypophosphatemia for individuals aged one (1) year of age and older. The effective date is August 20, Please refer to Medical Policy I-198, Burosumab (Crysvita), for additional information. Place of Service: Outpatient Coverage Established for Electroencephalogram (EEG) for Headache Highmark Delaware has established coverage criteria for electroencephalogram (EEG) when used for headache. This Medical Policy will apply to both professional provider and facility claims. The effective date is October 29, Coverage criteria for EEG for headache include: Use of EEG in the evaluation of headache is considered not medically necessary. Please refer to Medical Policy M-80, EEG for Headache, for additional information. 8

9 Recommendations Established for Evidence-Based Practice Highmark Delaware has established coverage guidelines for evidence-based practice. The effective date is October 29, Recommendations for evidence-based practice include: Annual electrocardiogram testing in adults (greater than or equal to 18 years of age) is not recommended when ALL of the following indications are present: o Individual has no known signs or symptoms of heart disease; and o Individual has no family history of sudden cardiac death; and o Individual is at low risk for coronary heart disease event, where low risk is defined as a 10-year risk less than 10%. Imaging tests for eye disease are not recommended for individuals who have no signs or symptoms of significant eye disease (e.g. visual-field testing; optical coherence tomography (OCT) testing; retinal imaging of patients with diabetes; and neuroimaging or fundus photography). Needle lavage to treat individuals with symptomatic osteoarthritis of the knee for long-term relief is not recommended. Performing unproven diagnostic tests (i.e. immunoglobulin G (IgG) testing, indiscriminate battery of immunoglobulin E (IgE) tests) in the evaluation of allergy is not recommended. Don t routinely perform diagnostic testing in patients with chronic urticaria (i.e. skin testing, IgE testing for inhalants or foods). Please refer to Medical Policy G-45, Recommendations for Evidence-Based Practice, for additional information. 9

10 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 Contents Coverage Guidelines Updated for Hemophilia Treatment... 1 Coverage Guidelines Updated for Hemophilia Treatment... 2 Coverage Guidelines Revised for Ipilimumab (Yervoy)... 2 Coverage Criteria Revised for Erythropoiesis Stimulating Agents... 3 Coverage Guidelines Revised for Granulocyte Colony Stimulating Factors (G-CSF).4 Coverage Criteria Revised for Blinatumomab (Blincyto)... 6 Coverage Criteria Revised for Nusinersen (Spinraza)... 6 Coverage Guidelines Developed for Vestronidase Alpha (Mepsevii)... 7 Coverage Guidelines Established for Daunorubicin and Cytarabine Liposomal (Vyxeos)... 7 Coverage Guidelines Established for Burosumab (Crysvita)... 8 Coverage Established for Electroencephalogram (EEG) for Headache... 8 Recommendations Established for Evidence-Based Practice... 9 Comments on these new medical policies? Contents 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. 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 Delaware 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- 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