Exclusion Reasons Presumption of Long- Term Non-Acute Administration C9399 Unclassified Drugs or

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1 Noridian Healthcare Solutions, LLC Jurisdiction F Part B Self-Administered Drug (SAD) Exclusion List (A53033); Effective 8/7/2017 The following medications are considered self-administered and are not payable under Medicare Part B. Coverage may be provided under Medicare Part D. The most current version of this list may be accessed at med.noridianmedicare.com under Policies. The Noridian Contractor Medical Directors (CMDs) review the list on an ongoing basis and may update and republish at their discretion. Code Generic Name Brand Name Effective Date Apparent On Its Face Exclusion Reasons Presumption of Long- Term Non-Acute Administration Tanzeum (albiglutide SQ) 6/4/2015 X X Myalept (metreleptin) 6/4/2015 X X Signifor (pasireotide) 6/4/2015 X X Rebif (interferon beta 1a) 6/4/2015 X X Bydureon (exanatide XR) 6/4/2015 X X Cosentyx (secukinumab) 6/4/2015 X X Praluent (alirocumab) 11/24/2015 X Repatha (evolucumab) 11/24/2015 X Trulicity (dulaglutide) Acceptable Evidentiary Criteria Available

2 C9399 Unclassified Drugs or Otrexup, Rasuvo (methotrexate solution auto-injector nonchemotherapeutic) Natpara (parathyroid hormone) Plegridy (pedinterferon beta-1a) Toujeo (insulin glargine injection) Byetta (exenatide) Erelzi (etanercept-szzs) 12/6/2016 X Strensiq (asfotase-alfa) 2/28/2017 X Zinbryta (daclizumab) 2/28/2017 X Taltz (ixekizumab) 2/28/2017 X Amjevita (adalimumab-atto) 2/28/2017 X Dupixent (dupilumab) 8/7/2017 X Siliq (brodalumab) 8/7/2017 X J0135 Injection, Adalimumab, 20 Mg Humira 11/1/2003 X X J0270 Injection, Alprostadil, 1.25 Alprostadil, Caverject, Edex, 1/15/2003 X X Mcg (Code May Be Used For Prostin VR Pediatric Medicare When Drug Administered Under The

3 J0364 J0630 Injection, Apomorphine Hydrochloride, 1 Mg Injection, Calcitonin Salmon, Up To 400 Units Apokyn 6/4/2015 X X Calcimar, Miacalcin, Osteocalcin, Salmonine, Fortical 1/15/2003 X X H. P. Acthar 6/26/2013 X X J0800 Injection, Corticotropin, Up To 40 Units J1324 Injection, Enfuvirtide, 1 Mg Fuzeon 5/1/2004 X X J1438 Injection, Etanercept, 25 Mg Enbrel 1/15/2003 X X (Code May Be Used For Medicare When Drug Administered Under The J1559 Injection, Immune Globulin Hizentra 2/15/2011 X X (Hizentra), 100 Mg J1595 Injection, Glatiramer Acetate, Copaxone 5/1/2004 X X 20 Mg J1675 Injection, Histrelin Acetate, 10 Supprelin LA 7/15/2006 X X Micrograms J1744 Injection, Icatibant, 1 Mg Firazyr 7/31/2012 X X J1815 Injection, Insulin, Per 5 Units Humalog, Humalog Mix 11/1/2003 X X 50/50, Humulin N. Humulin R, Lantus, Levemir, Novolin 70/30, Novolin N. Novolin R. Novolog, Novolog Flexpen, Novolog Penfill J1817 Insulin For Administration Through Dme (I.E., Insulin Pump) Per 50 Units Humalog, Humulin R, Novolin R, Novolog, Novolog Flexpen, Novolog Penfill 1/15/2003 X X J1830 Injection, Interferon Beta-1b, 0.25 Mg (Code May Be Used Betaseron 1/15/2003 X X

4 For Medicare When Drug Administered Under The J2170 Injection, Mecasermin, 1 Mg Increlex, Iplex 4/15/2007 X X J2212 Injection, Methylnaltrexone, Relistor 9/30/2013 X X J Mg Injection, Octreotide, Non- Depot Form For Subcutaneous Or Intravenous Injection, 25 Mcg Sandostatin, Ocreotide Acetate 10/15/2005 X J2440 Injection, Papaverine Hcl, Up Papaverine HCL 11/1/2003 X X To 60 Mg J2940 Injection, Somatrem, 1 Mg Protropin 1/15/2003 X X J2941 Injection, Somatropin, 1 Mg Humatrope, Genotropin, Omnitrope, Saizen, Zorbtive, Zomacton, Norditropin, Nutropin 1/15/2003 X X J3030 Injection, Sumatriptan Succinate, 6 Mg (Code May Be Used For Medicare When Drug Administered Under The Imitrex 1/15/2003 X X J3110 Injection, Teriparatide, 10 Mcg Forteo 11/1/2003 X J3355 Injection, Urofollitropin, 75 Iu Metrodin, Bravelle, Fertinex 4/15/2007 X X J3490 Unclassified Drugs Peginterferon Alfa 2-b, 6/26/2013 X X Sylatron, Pegintron J3490 Unclassified Drugs Kynamro (mipomersen 6/26/2016 X X sodium) J3490 Unclassified Drugs Pramlintide acetate, Symlin, SymlinPen 60, SymlinPen 4/1/2006 X X

5 120 J3490 Unclassified Drugs Byetta (exenatide) 4/1/2006 X X J3490 Unclassified Drugs Egrifta, Tesamorelin Acetate 9/30/2013 X X J3490 Unclassified Drugs Trimix 9/30/2013 X X J3490 Unclassified Drugs Victoza, Saxenda, Liraglutide 9/30/13 X X GLP-1 J3490 Unclassified Drugs Tanzeum (albiglutide SQ) 6/4/2015 X X J3490 Unclassified Drugs Myalept (metreleptin) 6/4/2015 X X J3490 Unclassified Drugs Signifor (pasireotide) 6/4/2015 X X J3490 Unclassified Drugs Rebif (interferon beta 1a) 6/4/2015 X X J3490 Unclassified Drugs Bydureon (exanatide XR) 6/4/2015 X X J3490 Unclassified Drugs Cosentyx (secukinumab) 6/4/2015 X X J3590 Unclassified Biologics Praluent (alirocumab) 11/24/2015 X J3590 Unclassified Biologics Repatha (evolucumab) 11/24/2015 X J3590 Unclassified Biologics Trulicity (dulaglutide) J3590 Unclassified Biologics Otrexup, Rasuvo (methotrexate solution auto-injector nonchemotherapeutic) J3590 Unclassified Biologics Natpara (parathyroid hormone) J3590 Unclassified Biologics Plegridy (pedinterferon beta-1a) J3590 Unclassified Biologics Toujeo (insulin glargine injection) J3590 Unclassified Biologics Pegvisomant Somavert 5/1/2004 X X J3590 Unclassified Biologics Pegasys, Roferon-A 5/1/2005 X X (peginterferon Alfa-2a) J3590 Unclassified Biologics Kineret (anakinra) 10/15/2005 X X J3590 Unclassified Biologics Simponi (golimumab) 9/30/2013 X X J3590 Unclassified Biologics Orencia (abatacept) 9/30/2013 X X J3590 Unclassified Biologics Erelzi (etanercept-szzs) 12/6/2016 X J3590 Unclassified Biologics Strensiq (asfotase-alfa) 2/28/2017 X

6 J3590 Unclassified Biologics Zinbryta (daclizumab) 2/28/2017 X J3590 Unclassified Biologics Taltz (ixekizumab) 2/28/2017 X J3590 Unclassified Biologics Amjevita (adalimumab-atto) 2/28/2017 X J3590 Unclassified Biologics Dupixent (dupilumab) 8/7/2017 X J3590 Unclassified Biologics Siliq (brodalumab) 8/7/2017 X J9212 Injection, Interferon Alfacon- Infergen 11/1/2003 X X 1, Recombinant, 1 Microgram J9213 Injection, Interferon, Alfa-2a, Roferon-A 11/1/2003 X X Recombinant, 3 Million Units J9216 Injection, Interferon, Gamma 1-B, 3 Million Units Actimmune 1/15/2003 X X J9218 Leuprolide Acetate, Per 1 Mg Leuprolide Acetate inj 1/15/2003 X X Q0515 Injection, Sermorelin Acetate, Geref 4/15/2007 X X 1 Microgram Q3027 Injection, Interferon Beta-1a, Avonex, Avonex Pen 6/4/2015 X X 1 Mcg For Intramuscular Use Q3028 Injection, Interferon Beta-1a, 1 Mcg For Subcutaneous Use N/A 6/4/2015 X X Visiant conducts organization determinations and reconsiderations on behalf of Premera Blue Cross.