LCD Reference Article Self-Administered Drug Exclusion List Article

Self-Administered Drug Exclusion List: Medical Policy Article

A53022

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
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Article ID
A53022
Original ICD-9 Article ID
Not Applicable
Article Title
Self-Administered Drug Exclusion List: Medical Policy Article
Article Type
SAD Exclusion Article
Original Effective Date
10/01/2015
Revision Effective Date
07/04/2024
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Coverage for self-administered drugs for both Part A and Part B is determined by the MAC Contractor in each jurisdiction. HCPCS codes used under Outpatient Prospective Payment System (OPPS) are included, in addition to the codes used for Part B claims, when appropriate.

The table below lists drugs that are not covered by Medicare, the effective date of non-coverage, and the rationale. (Please see “Process for Determining Self-Administered Drug Exclusions – Medical Policy Article”). The column, “Brand Names,” provides one or more examples but may not include all brand names.

Information about drugs not separately reimbursed or not covered for reasons other than “usually self-administered,” is detailed in Part A and Part B MAC publications and postings available elsewhere.

Route of Administration Modifier

The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection form of administration. Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied.

NOTE: The drugs represented by HCPCS codes J0801 and J0802 (marked with a double asterisk **) are administered by IM or SQ, therefore they require the JB modifier to be reported for SQ administration and they should not have any modifier reported for the IM administration.

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Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Brodalumab (Siliq™) 02/15/2018 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Dupilumab (Dupixent®) 02/15/2018 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Praluent (alirocumab) 11/15/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Exenatide, (Bydureon - extended-release formulation) 02/23/2014 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Liraglutide (Saxenda®, Victoza®) 05/16/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Pramlintide (Symlin) 09/07/2013 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tesamorelin (Egrifta®) 09/07/2013 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Asfotase-alfa (Strensiq™) 02/15/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Anakinra (Kineret®) 09/07/2013 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Exenatide (Byetta) 09/07/2013 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Golimumab (Simponi®) 09/07/2013 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Peginterferon alfa-2b (Pegintron) 09/07/2013 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Pegvisomant (Somavert®) 09/07/2013 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tanzeum (albiglutide) 09/15/2014 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Parathyroid hormone (Natpara®) 04/26/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Secukinumab (Cosentyx™) subcutaneous use* 04/26/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Liraglutide (Saxenda®) 05/16/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS All insulin products 11/19/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Dulaglutide (Trulicity™) 08/15/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Methotrexate (Otrexup™) 08/15/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Evolocumab (Repatha™) 01/15/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Peginterferon beta-1a (Plegridy™) 06/15/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ixekizumab (Taltz™) 07/15/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Etanercept-SZZS (Erelzi™) 11/15/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adalimumab-atto (Amjevita™) 12/15/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Metreleptin (Myalept®) 01/15/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Mipomersen Sodium (Kynamro®) 01/15/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adalimumab-adbm (Cyltezo®) 12/01/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Galcanezumab-gnlm (Emgality®) 12/01/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Erenumab-aooe (Aimovig®) 12/01/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Semaglutide (Ozempic®, Wegovy®) 05/16/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Sarilumab (Kevzara®) 12/01/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Abaloparatide (Tymlos™) 12/01/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Abatacept (Orencia®) 12/01/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Pasireotide (Signifor®) 04/05/2021 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Somapacitan-beco (Sogroya®) 04/05/2021 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Peginterferon Alfa-2a (Pegasys®) 10/15/2021 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ropeginterferon alfa-2b-njft (Besremi®) 04/24/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 05/15/2022 N/A Acceptable Evidentiary Criteria Available
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ofatumumab (Kesimpta®) 07/10/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tralokinumab-Idrm (Adbry™) 11/01/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tirzepatide (Mounjaro™, Zepbound™) 05/16/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio®), Adalimumab-adaz (Hyrimoz), Adalimumab-aqvh (Yusimry) 07/01/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Vedolizumab (Entyvio®) subcutaneous use* 01/14/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adalimumab-aaty (Yuflyma) 01/14/2024 N/A Apparent on its Face
J0129 INJECTION, ABATACEPT, 10 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) Orencia®, subcutaneous use* 04/05/2021 N/A Apparent on its Face
J0135 INJECTION, ADALIMUMAB, 20 MG Humira® 09/07/2013 N/A Apparent on its Face
J0270 INJECTION, ALPROSTADIL, 1.25 MCG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) Prostaglandin E1 09/07/2013 N/A Apparent on its Face
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG Apokyn® 09/07/2013 N/A Apparent on its Face
J0593 INJECTION, LANADELUMAB-FLYO, 1 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF-ADMINISTERED) Takhzyro™ 12/01/2019 N/A Apparent on its Face
J0599 INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA), 10 UNITS Haegarda® 01/01/2019 N/A Apparent on its Face
J0630 INJECTION, CALCITONIN SALMON, UP TO 400 UNITS Calcimar, Calcitonin-salmon, Miacalcin 09/07/2013 N/A Apparent on its Face
J0801 INJECTION, CORTICOTROPIN (ACTHAR GEL), UP TO 40 UNITS H.P. Acthar® Gel subcutaneous use** 10/01/2023 N/A Apparent on its Face
J0802 INJECTION, CORTICOTROPIN (ANI), UP TO 40 UNITS Purified Cortrophin Gel® manufactured by ANI subcutaneous use** 10/01/2023 N/A Apparent on its Face
J1324 INJECTION, ENFUVIRTIDE, 1 MG Fuzeon® 09/07/2013 N/A Apparent on its Face
J1438 INJECTION, ETANERCEPT, 25 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) Enbrel® 09/07/2013 N/A Apparent on its Face
J1562 INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG Vivaglobulin 09/07/2013 N/A Apparent on its Face
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone® 09/07/2013 N/A Apparent on its Face
J1628 INJECTION, GUSELKUMAB, 1 MG Tremfya® 05/15/2021 N/A Acceptable Evidentiary Criteria Available
J1675 INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS N/A 09/07/2013 N/A Apparent on its Face
J1744 INJECTION, ICATIBANT, 1 MG Firazyr® 09/07/2013 N/A Apparent on its Face
J1748 INJECTION, INFLIXIMAB-DYYB (ZYMFENTRA), 10 MG Infliximab-dyyb (Zymfentra™) 08/18/2024 N/A Apparent on its Face
J1811 INSULIN (FIASP) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Fiasp® 07/01/2023 N/A Apparent on its Face
J1812 INSULIN (FIASP), PER 5 UNITS Fiasp® 07/01/2023 N/A Apparent on its Face
J1813 INSULIN (LYUMJEV) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Lyumjev® 07/01/2023 N/A Apparent on its Face
J1814 INSULIN (LYUMJEV), PER 5 UNITS Lyumjev® 100 IU* 07/01/2023 N/A Apparent on its Face
J1814 INSULIN (LYUMJEV), PER 5 UNITS Lyumjev® 200 IU 07/01/2023 N/A Apparent on its Face
J1815 INJECTION, INSULIN, PER 5 UNITS All insulin products 11/19/2022 N/A Apparent on its Face
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS All insulin products 11/19/2022 N/A Apparent on its Face
J1826 INJECTION, INTERFERON BETA-1A, 30 MCG Avonex Pen®, Rebif®, Rebif® Rebidose® 09/01/2021 N/A Apparent on its Face
J1830 INJECTION, INTERFERON BETA-1B, 0.25 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) Betaseron® 09/07/2013 N/A Apparent on its Face
J1941 INJECTION, FUROSEMIDE (FUROSCIX), 20 MG Furoscix® 08/20/2023 N/A Apparent on its Face
J2170 INJECTION, MECASERMIN, 1 MG Increlex 09/07/2013 N/A Apparent on its Face
J2212 INJECTION, METHYLNALTREXONE, 0.1 MG Relistor 09/07/2013 N/A Apparent on its Face
J2267 INJECTION, MIRIKIZUMAB-MRKZ, 1 MG Mirikizumab-mrkz (Omvoh™) subcutaneous use* 07/18/2024 N/A Apparent on its Face
J2354 INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Sandostatin LAR Depot, subcutaneous use* 09/07/2013 N/A Apparent on its Face
J2440 INJECTION, PAPAVERINE HCL, UP TO 60 MG N/A 09/07/2013 N/A Apparent on its Face
J2760 INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG Regitine 09/07/2013 N/A Apparent on its Face
J2940 INJECTION, SOMATREM, 1 MG N/A 09/07/2013 N/A Apparent on its Face
J2941 INJECTION, SOMATROPIN, 1 MG Genotropin, Humatrope, Nutropin, Omnitrope, Saizen, Serostim, Zorbtive 09/07/2013 N/A Apparent on its Face
J3030 INJECTION, SUMATRIPTAN SUCCINATE, 6 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) Imitrex, Sumavel Dosepro 09/07/2013 N/A Apparent on its Face
J3031 INJECTION, FREMANEZUMAB-VFRM, 1 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF-ADMINISTERED) Ajovy™ 12/01/2019 N/A Apparent on its Face
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo® 09/07/2013 N/A Apparent on its Face
J3355 INJECTION, UROFOLLITROPIN, 75 IU Bravelle®, Metrodin® 09/07/2013 N/A Apparent on its Face
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara® 10/15/2021 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Pasireotide (Signifor®) 04/05/2021 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Exenatide, (Bydureon - extended-release formulation) 02/23/2014 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Liraglutide (Saxenda®, Victoza®) 05/16/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Pramlintide (Symlin) 09/07/2013 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tesamorelin (Egrifta®) 09/07/2013 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tanzeum (albiglutide) 09/15/2014 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Praluent (alirocumab) 11/15/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Adalimumab-adbm (Cyltezo®) 12/01/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS All insulin products 11/19/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Somapacitan-beco (Sogroya®) 04/05/2021 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Peginterferon Alfa-2a (Pegasys®) 10/15/2021 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Ropeginterferon alfa-2b-njft (Besremi®) 04/24/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 05/15/2022 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Ofatumumab (Kesimpta®) 07/10/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tralokinumab-Idrm (Adbry™) 11/01/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tirzepatide (Mounjaro™, Zepbound™) 05/16/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio®), Adalimumab-adaz (Hyrimoz), Adalimumab-aqvh (Yusimry) 07/01/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Adalimumab-aaty (Yuflyma) 01/14/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Vedolizumab (Entyvio®) subcutaneous use* 01/14/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Vedolizumab (Entyvio®) subcutaneous use* 01/14/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-aaty (Yuflyma) 01/14/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio®), Adalimumab-adaz (Hyrimoz), Adalimumab-aqvh (Yusimry) 07/01/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Tirzepatide (Mounjaro™,Zepbound™) 05/16/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Tralokinumab-Idrm (Adbry™) 11/01/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Ofatumumab (Kesimpta®) 07/10/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 05/15/2022 N/A Acceptable Evidentiary Criteria Available
J3590 UNCLASSIFIED BIOLOGICS Ropeginterferon alfa-2b-njft (Besremi®) 04/24/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon Alfa-2a (Pegasys®) 10/15/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Somapacitan-beco (Sogroya®) 04/05/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Galcanezumab-gnlm (Emgality®) 12/01/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Abaloparatide (Tymlos™) 12/01/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Sarilumab (Kevzara®) 12/01/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Semaglutide (Ozempic®, Wegovy®) 05/16/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Erenumab-aooe (Aimovig®) 12/01/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Abatacept (Orencia®) 12/01/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Parathyroid hormone (Natpara®) 04/26/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Secukinumab (Cosentyx™) subcutaneous use* 04/26/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Liraglutide (Saxenda®,Victoza®) 06/15/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS All insulin products 11/19/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Dulaglutide (Trulicity™) 08/15/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Methotrexate (Otrexup™) 08/15/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Exenatide (Byetta) 09/07/2013 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Golimumab (Simponi®) 09/07/2013 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon alfa-2b (Pegintron) 09/07/2013 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Pegvisomant (Somavert®) 09/07/2013 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Evolocumab (Repatha™) 01/15/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Asfotase-alfa (Strensiq™) 02/15/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon beta-1a (Plegridy™) 06/15/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Ixekizumab (Taltz™) 07/15/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Anakinra (Kineret®) 09/07/2013 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Etanercept-SZZS (Erelzi™) 11/15/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-atto (Amjevita™) 12/15/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Mipomersen Sodium (Kynamro®) 01/15/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Metreleptin (Myalept®) 01/15/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Brodalumab (Siliq™) 02/15/2018 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Dupilumab (Dupixent®) 02/15/2018 N/A Apparent on its Face
J7999 COMPOUNDED DRUG, NOT OTHERWISE CLASSIFIED TriMix 09/07/2013 N/A Apparent on its Face
J7999 COMPOUNDED DRUG, NOT OTHERWISE CLASSIFIED Quad-Mix 03/17/2017 N/A Apparent on its Face
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Infergen® 09/07/2013 N/A Apparent on its Face
J9213 INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS Roferon®-A 09/07/2013 N/A Apparent on its Face
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune® 09/07/2013 N/A Apparent on its Face
J9218 LEUPROLIDE ACETATE, PER 1 MG Lupron 09/07/2013 N/A Apparent on its Face
Q0515 INJECTION, SERMORELIN ACETATE, 1 MICROGRAM Geref Diagnostic 09/07/2013 N/A Apparent on its Face
Q3027 INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE Avonex® 09/01/2021 N/A Apparent on its Face
Q3028 INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE Rebif® 09/01/2021 N/A Apparent on its Face
Q5131 INJECTION, ADALIMUMAB-AACF (IDACIO), BIOSIMILAR, 20 MG Idacio® 07/01/2023 N/A Apparent on its Face
Q5132 INJECTION, ADALIMUMAB-AFZB (ABRILADA), BIOSIMILAR, 10 MG Abrilada™ 07/01/2023 N/A Apparent on its Face
Q5137 INJECTION, USTEKINUMAB-AUUB (WEZLANA), BIOSIMILAR, SUBCUTANEOUS, 1 MG Ustekinumab-auub (Wezlana™) 07/04/2024 N/A Apparent on its Face
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Efalizumab (Raptiva) 09/07/2013 03/17/2017 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Insulin Glargine (Lantas Solostar®) 12/01/2019 11/19/2022 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tezepelumab-ekko (Tezspire™) 07/10/2022 07/10/2022 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Mirikizumab-mrkz (Omvoh™) subcutaneous use* 06/20/2024 07/01/2024 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ustekinumab-auub (Wezlana™) 06/20/2024 07/01/2024 Apparent on its Face
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Hizentra® 09/07/2013 12/31/2020 Apparent on its Face
J2502 INJECTION, PASIREOTIDE LONG ACTING, 1 MG Pasireotide (Signifor®) 09/07/2013 12/01/2019 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tezepelumab-ekko (Tezspire™) 07/10/2022 07/10/2022 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Mirikizumab-mrkz (Omvoh™) subcutaneous use* 06/20/2024 07/01/2024 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Ustekinumab-auub (Wezlana™) 06/20/2024 07/01/2024 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Ustekinumab-auub (Wezlana™) 06/20/2024 07/01/2024 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Mirikizumab-mrkz (Omvoh™) subcutaneous use* 06/20/2024 07/01/2024 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Tezepelumab-ekko (Tezspire™) 07/10/2022 07/10/2022 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Efalizumab (Raptiva) 09/07/2013 03/17/2017 Apparent on its Face
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
07/01/2024 R37

The article has been updated to add a new code for Ustekinumab-auub (Wezlana) (Q5137) effective for dates of service on or after 7/4/2024. The previous miscellaneous codes C9399, J3490, and J3590 have been deleted. A new code for Mirikizumab-mMirikizumab-mrkz (Omvoh™) subcutaneous use* has been added (J2267) effective for dates of service on or after 7/4/2024. The previous miscellaneous codes C9399, J3490, and J3590 have been deleted. The new drug Infliximab-dyyb (Zymfentra) subcutaneous use* has been added to SAD list with the code J1748 effective for dates of service on or after 8/18/2024.

05/16/2024 R36

The article has been updated to add: Semaglutide (Wegovy®) (C9399, J3590), Tirzepatide (Zepbound®) (C9399, J3490, J3590), and moved Liraglutide (Saxenda®) to be on the same rows as Liraglutide (Victoza®) (C9399, J3490, J3590).

 

02/01/2024 R35

The article has been updated to add Ustekinumab-auub (Wezlana™) (C9399, J3490, J3590) effective for dates of service on or after 03/16/2024.

01/01/2024 R34

Based on Transmittal 12233 (CR 13356) - Instructions for Retrieving the January 2024 Medicare Physician Fee Schedule Database (MPFSDB) Files Through the CMS Mainframe Telecommunications System HCPCS code Q5132 has been added for Adalimumab-afzb (Abrilada™)

11/30/2023 R33

The article has been updated to add “subcutaneous use*” for HCPCS codes J0801, J0802 and for Secukinumab (Cosentyx™) (C9399, J3590). The following new drugs have been added: Vedolizumab (Entyvio®) subcutaneous use* (C9399, J3490, J3590), Adalimumab-aaty (Yuflyma) (C9399, J3490, J3590) and Mirikizumab-mrkz (Omvoh™) subcutaneous use* (C9399, J3490, J3590) effective for dates of service on or after 1/14/2024.

10/01/2023 R32

Based on CRs 13316 and 13339, HCPCS code J0800 has been deleted and replaced with J0801 and J0802.

07/06/2023 R31

The article has been updated to add:J1811, J1812- insulin Fiasp®, J1813, J1814- insulin Lyumjev® and Q5131 and Adalimumab-aacf (Idacio) effective 7/1/2023 and J1941 - furosemide (Furoscix), effective for dates of service on or after 08/20/2023.

05/18/2023 R30

The article has been updated to add: Adalimumab-aacf (Idacio®), Adalimumab-afzb (Abrilada™), Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio®), adalimumab-adaz (Hyrimoz) and Adalimumab-aqvh (Yusimry) (C9399, J3490, J3590) effective for dates of service on or after 07/01/2023.

10/06/2022 R29

The article has been updated to add: “All insulin products” in the “Descriptor Brand Name” column for HCPCS codes C9399, J1815, J1817, J3490 and J3590 effective 11/19/2022. A duplicate row for C9399 Insulin Glargine (Lantas Solostar®) has been end-dated. Tirepatide (Mounjaro™) (C9399, J3490, J3590) has been added effective for dates of service on or after 11/19/2022.

09/15/2022 R28

The article has been updated to add: Tralokinumab-Idrm (Adbry™) effective for dates of service on or after 11/01/2022.

08/11/2022 R27

The article has been updated to remove Tezepelumab-ekko (Tezspire™) (C9399, J3490, J3590) effective for dates of service on or after 07/10/2022. 

08/04/2022 R26

The article has been updated to add an asterisk for Risankizumab-rzaa (Skyrizi™) subcutaneous use* (C9399, J3490, J3590) on all three HCPCS codes to indicate this drug has multiple routes of administration and must be billed with the appropriate modifier.

05/26/2022 R25

The article has been updated to add: Ofatumumab (Kesimpta®) (C9399, J3490, J3590) and Tezepelumab-ekko (Tezspire™) (C9399, J3490, J3590) effective for dates of service on or after 07/10/2022. 

04/01/2022 R24

The article has been updated to add: Risankizumab-rzaa (Skyrizi™) (C9399, J3490, J3590) effective for dates of service on or after 05/15/2022.

03/10/2022 R23

The article has been updated to add: Ropeginterferon alfa-2b-njft (Besremi®) (C9399, J3490, J3590) effective for dates of service on or after 04/24/2022.

08/26/2021 R22

The article has been updated to add: Peginterferon Alfa-2a (Pegasys®) (C9399, J3490, J3590) effective for dates of service on or after 10/15/2021. An effective date of 10/15/2021 has been added for J3357 (Ustekinumab, Stelara®. The JA/JB modifier paragraph has been revised to the following:

The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection form of administration. Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied.

07/15/2021 R21

The article has been updated to add: J1826 (Avonex Pen®, Rebif®, Rebif® Rebidose®), Q3027 (Avonex®) and Q3028 (Rebif®) effective for dates of service on or after 09/01/2021,

04/01/2021 R20

The article has been updated to add an effective date of 05/15/2021 for J1628 (Guselkumab, Tremfya®).

02/18/2021 R19

The article has been updated to add: J0129 (Orencia®, subcutaneous use*), J0800 (H.P. Acthar® Gel) and Somapacitan-beco (Sogroya®) (C9399, J3490, J3590) effective for dates of service on or after 04/05/2021. The effective date for Pasireotide (Signifor®) (C9399, J3490) has been revised to 04/05/2021. HCPCS code J2354 has been updated to add asterisk criteria in the “Descriptor Brand Name” section. The following paragraph regarding use of JA/JB modifiers has been added to “Article Text” section of the article:

Route of Administration Modifier

The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with JA modifier for the intravenous infusion of the drug or billed with the JB modifier for subcutaneous injection of the drug. Claims billed with the JA modifier are not part of the SAD exclusion. The Contractor will process claims with the JA modifier applying the policy that not only the drug is medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary. Claims for drugs marked with an asterisk (*) billed without a JA or JB modifier will be denied.

01/01/2021 R18

Based on Transmittal 10463 (CR11880) (Billing for Home Infusion Therapy Services On or After January 1, 2021), which includes changes to the Medicare home infusion therapy services benefit, the article has been updated to move Hizentra® (J1559) to the Non-Excluded CPT/HCPCS Codes-Table with an Exclusion End Date of 12/31/2020.

03/19/2020 R17

The article has been updated to add: Guselkumab (Tremfya®) (J1628) and Ustekinumab (Stelara®) (J3357) effective for dates of service on or after 05/03/2020. Medicare data supports greater than 50% is self-administered. Pasireotide (Signifor®) (C9399, J3490) has been added and is effective for dates of service on or after 05/03/2020.

10/17/2019 R16

The article has been updated to add: Abaloparatide (Tymlos™) (C9399, J3590), Sarilumab (Kevzara®)(C9399, J3590), Semaglutide (Ozempic®) (C9399, J3590), Fremanezumab-vfrm (Ajovy™) (J3031), Erenumab-aoooe (Aimovig®) (C9399, J3590), Insulin Glargine (Lantas Solostar®) (C9399, J3490), Galcanezumab-gnlm (Emgality®) (C9399, J3590), Adalimumab-adbm (Cyltezo®) (C9399, J3490), lanadelumab (Takhzyro™) (J0593), Abatacept (Orencia®) (C9399, J3590) effective for dates of service on or after 12/01/2019. An end-date of 12/01/2019 has been added for Pasireotide LA (J2502).

01/01/2019 R15

Based on the 2019 annual HCPCS update, HCPCS code C9015 has been deleted and replaced with HCPCS code J0599, Injection, c-1 esterase inhibitor (human), (haegarda), 10 units.

01/01/2018 R14

The article has been updated to correct the SAD Process URL.

01/01/2018 R13

Added (C9015) Injection, C1 Esterase Inhibitor Subcutaneous (Human) (Haegarda®),  Brodalumab (Siliq™) (C9399, J3590) and Dupilumab (Dupixent®) (C9399, J3590) effective 02/15/2018.

02/01/2017 R12 Added Quad-Mix (J7999) effective 03/17/2017. The brand name, Supprelin® LA, has been removed from HCPCS code J1675. Efalizumab (Raptiva) (C9399, J3590) has been end-dated effective 03/17/2017.
12/01/2016 R11 Added Metreleptin (Myalept®) (C9399, J3590) and Mipomersen Sodium (Kynamro®) (C9399, J3590) effective 01/15/2017.
11/01/2016 R10 Added Adalimumab-atto (Amjevita™) (C9399, J3590) effective 12/15/2016
10/01/2016 R9 Added Etanercept-SZZS (Erelzi™) (C9399, J3590) effective 11/15/2016
06/01/2016 R8 Added ixekizumab (Taltz™) (C9399, J3590) effective 07/15/2016
05/01/2016 R7 Added peginterferon beta-1a (Plegridy™) (C9399, J3590) effective 06/15/2016.
01/01/2016 R6 The article has been updated to correct the SAD Process URL.
01/01/2016 R5 The article has been updated to correct the SAD Process URL.
01/01/2016 R4 HCPCS code C9454 has been deleted and replaced with J2502 for Pasireotide (Signifor®) for the A and B MACS. HCPCS code J7999 has been added for TriMix. Asfotase-alfa (Strensiq™) (C9399, J3590) has been added effective 02/15/2016.
12/01/2015 R3 Added evolocumab (Repatha™) (C9399, J3590) effective 01/15/2016.
10/01/2015 R2 Added Praluent (alirocumab) (J3490, C9399) effective 11/15/2015.
Added code C9454 for Pasireotide (Signifor®) for Part A claims, effective 07/01/2015.
Added dulaglutide (Trulicity™) (J3590, C9399) and methotrexate (Otrexup™) (J3590, C9399) effective 08/15/2015.
Added NOC code C9399 for Part A claims for all drugs that are already listed under NOC codes J3490 or J3590.

The following drugs have been added: Tanzeum (albiglutide) effective 09/15/2014, parathyroid hormone (Natpara®) (J3590) and secukinumab (Cosentyx™) (J3590) effective 04/26/2015.
05/01/2015 R1 Added liraglutide (Saxenda®) (J3590) and insulin glargine injection (Toujeo®) (J3590) effective 06/15/2015.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
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Related National Coverage Documents
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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