Self-Administered Drug Exclusion List Article

Self-Administered Drug Exclusion List: Medical Policy Article

A53021

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
National Government Services, Inc.	A and B and HHH MAC	14111 - MAC A	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14112 - MAC B	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14211 - MAC A	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14212 - MAC B	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14311 - MAC A	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14312 - MAC B	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14411 - MAC A	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14412 - MAC B	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14511 - MAC A	J - K	Vermont
National Government Services, Inc.	A and B and HHH MAC	14512 - MAC B	J - K	Vermont

Article Information

General Information

Article ID
A53021

Article Title
Self-Administered Drug Exclusion List: Medical Policy Article

Article Type
SAD Exclusion Article

Original Effective Date
10/01/2015

Revision Effective Date
10/03/2024

Revision Ending Date
N/A

Retirement Date
N/A

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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Article Guidance

Article Text

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.

Response To Comments

Number	Comment	Response
1

Coding Information

Bill Type Codes

Code	Description
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Revenue Codes

Code	Description
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ICD-10-CM Codes that Support Medical Necessity

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

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.

Code	Description
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N/A

Revenue Codes

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.

Code	Description
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N/A

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	Asfotase-alfa (Strensiq™)	02/15/2016	N/A	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Tesamorelin (Egrifta®)	10/25/2013	N/A	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Pramlintide (Symlin)	10/25/2013	N/A	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Liraglutide (Victoza®, Saxenda®)	10/25/2013	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	Tanzeum (albiglutide)	09/15/2014	N/A	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Pegvisomant (Somavert®)	10/25/2013	N/A	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Peginterferon alfa-2b (Pegintron)	10/25/2013	N/A	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Golimumab (Simponi®)	10/25/2013	N/A	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Exenatide,(Byetta)	10/25/2013	N/A	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Anakinra (Kineret®)	10/25/2013	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	Abaloparatide (Tymlos™)	12/01/2019	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	Semaglutide (Ozempic®, Wegovy®)	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	Galcanezumab-gnlm (Emgality®)	12/01/2019	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	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™)	11/19/2022	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®	10/25/2013	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	10/25/2013	N/A	Apparent on its Face
J0364	INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG	Apokyn®	10/25/2013	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	10/25/2013	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®	10/25/2013	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®	10/25/2013	N/A	Apparent on its Face
J1562	INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG	Vivaglobulin	10/25/2013	N/A	Apparent on its Face
J1595	INJECTION, GLATIRAMER ACETATE, 20 MG	Copaxone®	10/25/2013	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	10/25/2013	N/A	Apparent on its Face
J1744	INJECTION, ICATIBANT, 1 MG	Firazyr®	10/25/2013	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®	10/25/2013	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	10/25/2013	N/A	Apparent on its Face
J2212	INJECTION, METHYLNALTREXONE, 0.1 MG	Relistor	10/25/2013	N/A	Apparent on its Face
J2267	INJECTION, MIRIKIZUMAB-MRKZ, 1 MG	Mirikizumab-mMirikizumab-mrkz (Omvoh™)	07/01/2024	N/A	Apparent on its Face
J2354	INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG	Sandostatin LAR Depot, subcutaneous use*	10/25/2013	N/A	Apparent on its Face
J2440	INJECTION, PAPAVERINE HCL, UP TO 60 MG	N/A	10/25/2013	N/A	Apparent on its Face
J2760	INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG	Regitine	10/25/2013	N/A	Apparent on its Face
J2940	INJECTION, SOMATREM, 1 MG	N/A	10/25/2013	N/A	Apparent on its Face
J2941	INJECTION, SOMATROPIN, 1 MG	Genotropin, Humatrope, Nutropin, Omnitrope, Saizen, Serostim, Zorbtive	10/25/2013	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	10/25/2013	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®	10/25/2013	N/A	Apparent on its Face
J3355	INJECTION, UROFOLLITROPIN, 75 IU	Bravelle®, Metrodin®	10/25/2013	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	Tesamorelin (Egrifta®)	10/25/2013	N/A	Apparent on its Face
J3490	UNCLASSIFIED DRUGS	Pramlintide (Symlin)	10/25/2013	N/A	Apparent on its Face
J3490	UNCLASSIFIED DRUGS	Liraglutide (Victoza®, Saxenda®)	10/25/2013	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	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™)	11/19/2022	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™)	11/19/2022	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	Erenumab-aooe (Aimovig®)	12/01/2019	N/A	Apparent on its Face
J3590	UNCLASSIFIED BIOLOGICS	Semaglutide (Ozempic®, Wegovy®)	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	Abaloparatide (Tymlos™)	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 (Victoza®, Saxenda®)	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	Peginterferon alfa-2b (Pegintron)	10/25/2013	N/A	Apparent on its Face
J3590	UNCLASSIFIED BIOLOGICS	Golimumab (Simponi®)	10/25/2013	N/A	Apparent on its Face
J3590	UNCLASSIFIED BIOLOGICS	Exenatide,(Byetta)	10/25/2013	N/A	Apparent on its Face
J3590	UNCLASSIFIED BIOLOGICS	Anakinra (Kineret®)	10/25/2013	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	Pegvisomant (Somavert®)	10/25/2013	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	10/25/2013	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®	10/25/2013	N/A	Apparent on its Face
J9213	INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS	Roferon®-A	10/25/2013	N/A	Apparent on its Face
J9216	INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS	Actimmune®	10/25/2013	N/A	Apparent on its Face
J9218	LEUPROLIDE ACETATE, PER 1 MG	Lupron	10/25/2013	N/A	Apparent on its Face
Q0515	INJECTION, SERMORELIN ACETATE, 1 MICROGRAM	Geref Diagnostic	10/25/2013	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)	07/01/2024	N/A	Apparent on its Face

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)	10/25/2013	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*	01/14/2024	07/01/2024	Apparent on its Face
C9399	UNCLASSIFIED DRUGS OR BIOLOGICALS	Ustekinumab-auub (Wezlana™)	03/16/2024	07/01/2024	Apparent on its Face
J1559	INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG	Hizentra®	10/25/2013	12/31/2020	Apparent on its Face
J2502	INJECTION, PASIREOTIDE LONG ACTING, 1 MG	Pasireotide (Signifor®)	10/25/2013	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*	01/14/2024	07/01/2024	Apparent on its Face
J3490	UNCLASSIFIED DRUGS	Ustekinumab-auub (Wezlana™)	03/16/2024	07/01/2024	Apparent on its Face
J3590	UNCLASSIFIED BIOLOGICS	Ustekinumab-auub (Wezlana™)	03/16/2024	07/01/2024	Apparent on its Face
J3590	UNCLASSIFIED BIOLOGICS	Mirikizumab-mrkz (Omvoh™) subcutaneous use*	01/14/2024	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)	10/25/2013	03/17/2017	Apparent on its Face

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation
10/03/2024	R39	We added a JA/JB modifier for Tremfya (J1628) following a revised FDA approval effective on or after 10/3/2024. We also removed JA/JB modifiers for Secukinumab (Cosentyx™) as the drug has distinct codes for each route of administration. We also added a JB modifier to Zymfentra (J1748) which was inadvertently not added during the 7/4/2024 update.
07/01/2024	R38	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	R37	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). Effective for dates of service on or after May 16, 2024.
02/01/2024	R36	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	R35	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	R34	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	R33	Based on CRs 13316 and 13339, HCPCS code J0800 has been deleted and replaced with J0801 and J0802.
07/06/2023	R32	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	R31	The article has been updated to add: Adalimumab-aacf (Idacio®), Adalimumab-afzb (Abrilada™), Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio®), Adalimumab-adaz (Hyrimoz), Adalimumab-aqvh (Yusimry) (C9399, J3490, J3590) effective for dates of service on or after 07/01/2023.
10/06/2022	R30	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	R29	The article has been updated to add: Tralokinumab-Idrm (Adbry™) effective for dates of service on or after 11/01/2022.
08/11/2022	R28	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	R27	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	R26	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	R25	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	R24	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	R23	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	R22	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	R21	The article has been updated to add an effective date of 05/15/2021 for J1628 (Guselkumab, Tremfya®).
02/18/2021	R20	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	R19	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	R18	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	R17	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	R16	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	R15	The article has been updated to correct the SAD Process URL.
01/01/2018	R14	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	R13	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	R12	Added Metreleptin (Myalept®) (C9399, J3590) and Mipomersen Sodium (Kynamro®) (C9399, J3590) effective 01/15/2017.
11/01/2016	R11	Added Adalimumab-atto (Amjevita™) (C9399, J3590) effective 12/15/2016
10/01/2016	R10	Added Etanercept-SZZS (Erelzi™) (C9399, J3590) effective 11/15/2016
06/01/2016	R9	Added ixekizumab (Taltz™) (C9399, J3590) effective 07/15/2016
05/01/2016	R8	Added peginterferon beta-1a (Plegridy™) (C9399, J3590) effective 06/15/2016.
01/01/2016	R7	The article has been updated to correct the SAD Process URL.
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.
10/01/2015	R1	The following drugs have been added: Tanzeum (albiglutide) effective 09/15/2014, parathyroid hormone (Natpara®) (J3590) and secukinumab (Cosentyx™) (J3590) effective 04/26/2015 and liraglutide (Saxenda®) (J3590) and insulin glargine injection (Toujeo®) (J3590) effective 06/15/2015.

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2

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09/26/2024	10/03/2024 - N/A	Currently in Effect	You are here
06/26/2024	07/04/2024 - 10/02/2024	Superseded	View
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12/21/2023	01/01/2024 - 01/31/2024	Superseded	View
11/21/2023	11/30/2023 - 12/31/2023	Superseded	View
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Self-Administered Drug Exclusion List: Medical Policy Article

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