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LCD Reference Article Self-Administered Drug Exclusion List Article

Self-Administered Drug Exclusion List: and Biologicals Excluded from Coverage - Medical Policy Article

A52527

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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.
NOT AN LCD REFERENCE ARTICLE
This article is not in direct support of an LCD.

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Source Article ID
N/A
Article ID
A52527
Original ICD-9 Article ID
Not Applicable
Article Title
Self-Administered Drug Exclusion List: and Biologicals Excluded from Coverage - Medical Policy Article
Article Type
SAD Exclusion Article
Original Effective Date
10/01/2015
Revision Effective Date
01/13/2024
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

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Article Text

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 not all. Information about drugs not separately reimbursed or not covered for reasons other than "usually self-administered," is found in other Part A and Part B MAC publications and sites.

In the interest of consistent Medicare, the CGS Administrators Part A MAC will follow the coverage decision for self-administered drugs as determined by the Part B MAC in each respective state. HCPCS codes for the same drugs that apply only to providers that bill the Part A MAC (e.g., HCPCS codes used for drugs billable under the Outpatient Prospective Payment System [OPPS]) are included when applicable.

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. 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. 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.

And mark all applicable drugs with *.

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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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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.

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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 Besremi (ropeginterferon alfa-2b-njft) 04/24/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kesimpta® (ofatumumab) Can be billed under J3490, J3590 as well 11/19/2022 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) Abatacept* Orencia* Orencia Clickjet* Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 03/27/2021 N/A Acceptable Evidentiary Criteria Available
J0135 INJECTION, ADALIMUMAB, 20 MG Humira Note: Adalimumab 09/15/2005 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) Caverjet®,
Edex®		 03/15/2003 N/A Apparent on its Face
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG Apokyn 05/31/2017 N/A Apparent on its Face
J0490 INJECTION, BELIMUMAB, 10 MG Belimumab* Benlysta* Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 03/27/2021 N/A Acceptable Evidentiary Criteria Available
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) LANADELUMAB-FYO (Takhzyro) 10/01/2019 N/A Apparent on its Face
J0599 INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA), 10 UNITS C1 Inhibitor (Human) Berinert Cinryze Haegarda Note: Prior to 01/01/2019 billed under J3490 09/25/2017 N/A Apparent on its Face
J0630 INJECTION, CALCITONIN SALMON, UP TO 400 UNITS Calcimar Fortical-DSC Miacalcin Osteocalcin Salmonine 03/15/2003 N/A Apparent on its Face
J0801 INJECTION, CORTICOTROPIN (ACTHAR GEL), UP TO 40 UNITS Acthar® Gel* (use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 10/01/2023 N/A Apparent on its Face
J0802 INJECTION, CORTICOTROPIN (ANI), UP TO 40 UNITS Purified Cortrophin Gel ®*(use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 10/01/2023 N/A Apparent on its Face
J1324 INJECTION, ENFUVIRTIDE, 1 MG Fuzeon 05/16/2007 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® Enbrel Mini Enbrel Sure Click Brenzys Also see J3590 Etanercept-szzs (Erelzi) 03/15/2003 N/A Apparent on its Face
J1562 INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG Vivaglobin 10/23/2013 N/A Apparent on its Face
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone Glatopa 05/16/2007 N/A Apparent on its Face
J1628 INJECTION, GUSELKUMAB, 1 MG Guselkumab Tremfya 05/15/2021 N/A Acceptable Evidentiary Criteria Available
J1675 INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS Supprelin 05/16/2007 N/A Apparent on its Face
J1744 INJECTION, ICATIBANT, 1 MG Firazyr 10/23/2013 N/A Apparent on its Face
J1811 INSULIN (FIASP) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Insulin via insulin pump (fiasp) 08/20/2023 N/A Apparent on its Face
J1812 INSULIN (FIASP), PER 5 UNITS Inj. Insulin (fiasp) *Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 08/13/2023 N/A Apparent on its Face
J1813 INSULIN (LYUMJEV) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Insulin via insulin pump (lyumjev) 08/20/2023 N/A Apparent on its Face
J1814 INSULIN (LYUMJEV), PER 5 UNITS Inj. insulin (lyumjev) U-100 and U-200 *Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 08/13/2023 N/A Apparent on its Face
J1815 INJECTION, INSULIN, PER 5 UNITS Humalog®,
Humulin® R,
Humalin® 50/50,
Lente® Iletin® II,
Novolin® 		03/15/2003 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
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Humalog,
Humulin,
Iletin etc.		 05/16/2007 N/A Apparent on its Face
J1826 INJECTION, INTERFERON BETA-1A, 30 MCG Avonex Pen Rebif Rebif Rebidose 05/31/2017 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® Extavia 03/15/2003 N/A Apparent on its Face
J1941 INJECTION, FUROSEMIDE (FUROSCIX), 20 MG furosemide (Furoscix) 08/20/2023 N/A Apparent on its Face
J2170 INJECTION, MECASERMIN, 1 MG Increlex 05/16/2007 N/A Apparent on its Face
J2212 INJECTION, METHYLNALTREXONE, 0.1 MG Relistor 10/23/2013 N/A Apparent on its Face
J2354 INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Sandostatin* Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 08/15/2005 N/A Apparent on its Face
J2440 INJECTION, PAPAVERINE HCL, UP TO 60 MG Papaverine Hydrochloride 10/23/2013 N/A Apparent on its Face
J2941 INJECTION, SOMATROPIN, 1 MG Genotropin®
Humatrope®
Norditropin®
Nutropin® Omnitrope Saizen Serostim Tev-Tropin DSC Zomacton Zorbtive		 03/15/2003 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® Alsuma DSC Imitrex STATdose Refill Imitrex STATdose System Onzetra Xsail Sumavel DosePro Zecuity DSC Zembrace SymTouch 03/15/2003 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) Fremanezumab-vfrm AJOVY 09/09/2019 N/A Apparent on its Face
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo® 10/15/2006 N/A Apparent on its Face
J3355 INJECTION, UROFOLLITROPIN, 75 IU Bravelle . 10/23/2013 N/A Apparent on its Face
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG 11/01/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Mipomersen Sodium Kynamro Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. 10/23/2013 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Pasireotide Diaspartate SIGNIFOR Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. (J2502 is only to be used when the LAR form is administered IM under the direct supervision of a physician) 10/23/2013 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Liraglutide-GLP-1 agonist DM Victoza Saxenda Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. 10/23/2013 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Exenatide Byetta Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. 08/15/2005 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Pramlintide Acetate SymlinPen 60 or 120 Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. 08/15/2005 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Trimix (alprostadil, papaverine and phentolamine) Quadramix (alprostadil, papaverine, phentolamine and atropine) Note: If billed under any other miscellaneous code (i.e., J3590, J7999, J9999, or C9399) same rules apply. . 08/15/2010 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Methotrexate - Solution Auto-injector Non Chemotherapeutic Otrexup Rasuvo Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. 10/01/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Secukinumab* Cosentyx* Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. (use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 10/01/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Dulaglutide Trulicity Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. 10/01/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Alirocumib Praluent Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 10/17/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Albiglutide, SQ Tanzeum Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 05/31/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Metreleptin Myalept Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 05/31/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tesamorelin Egrifta Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 05/31/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Asfotase-alfa Strensiq Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 05/31/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Dupilumab Dupixent Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 09/28/2018 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Evolocumab Repatha Repatha Pushtronex System Repatha SureClick Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 05/31/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Exenatide XR Bydureon Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 05/31/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Ixekizumab Taltz Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Golimumab - Non-IV Form Simponi - Non-IV Form Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply 10/17/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tralokinumab-Idrm (Adbry™) This can also be billed with J3590 and C9399 11/01/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tirepatide (Mounjaro) Also billed under: J3590 and C9399 11/19/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS All Insulin Products Also can be billed under J3590 and C9399 11/19/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. ABRILADA (adalimumab-afzb) is biosimilar* to HUMIRA (adalimumab). HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab) HULIO® (adalimumab-fkjp) is biosimilar* to HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) is biosimilar* to HUMIRA (adalimumab) YUSIMRY (adalimumab-aqvh) is biosimilar* to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Vedolizumab* Entyvio* (J3490, J3590, C9399) (use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 01/13/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Yuflyma (J3490, J3590, C9399) 01/13/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Omvoh mirikizumab-mrkz (J3490, J3590, C9399) (use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 01/13/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-atto Amjevita Biosimilar to Adalimumab (Humira) Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Brodalumab Siliq Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Abaloparatide Tymlos Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Sarilumab Kevzara Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Semaglutide Ozempic Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Erenumab-aoooe Aimovig Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Galcanezumab-gnlm Emgality Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-adbm Cyltezo Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/28/2018 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-bwwd (Hadlima) biosimilar to Adalimumab Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-adaz (Hyrimoz) Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 09/09/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Etanercept-SZZS Erelzi Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 10/17/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Parathyroid Hormone Natpara Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 04/15/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Anakinra Kineret Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 05/16/2007 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peg-interferon Alfa 2B Pegintron Sylantra Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 05/16/2007 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon Alpha-2A Pegasys Pegasys Proclick Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 05/16/2007 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Pegvisomant Somavert Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply 05/16/2007 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Somapacitan-beco Sogroya 03/27/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Risankizumab-rzaa (Skyrizi™) *Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) This can also be beill with J3490 or C9399 as well as J3590. 05/15/2022 N/A Apparent on its Face
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Pegasys Pegasys ProClick 05/16/2007 N/A Apparent on its Face
J9213 INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS Peginterferon Alpha 2A Roferon A Pegasys Proclick 05/16/2007 N/A Apparent on its Face
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune 05/16/2007 N/A Apparent on its Face
J9218 LEUPROLIDE ACETATE, PER 1 MG Lupron® Eligard® 03/15/2003 N/A Apparent on its Face
Q3027 INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE Injection, INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE Avonex 06/04/2021 N/A Acceptable Evidentiary Criteria Available
Q3028 INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE Rebif 06/04/2021 N/A Acceptable Evidentiary Criteria Available
Q5131 INJECTION, ADALIMUMAB-AACF (IDACIO), BIOSIMILAR, 20 MG Idacio (adalimumab-aacf) 08/20/2023 N/A Apparent on its Face
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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) Abatacept (Orencia) 10/17/2016 04/17/2017 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) Abatacept; Orencia when self administered Note: J0129 Abatacept should only be used for Medicare when administered under the direct supervision of a physician, not for use when drug is self administered. If filing for self-administered form for Medicare denial, use J3490, J3590, or C9399 listed within this document. 10/17/2016 01/23/2020 Apparent on its Face
J0275 ALPROSTADIL URETHRAL SUPPOSITORY (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) Muse 03/15/2003 04/17/2017 Apparent on its Face
J1555 INJECTION, IMMUNE GLOBULIN (CUVITRU), 100 MG Immune Globulin Cuvitru 03/27/2021 03/27/2021 Apparent on its Face
J1558 INJECTION, IMMUNE GLOBULIN (XEMBIFY), 100 MG Immune Globulin-klhw Xemblify 03/27/2021 03/27/2021 Apparent on its Face
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Hizentra 10/23/2013 12/31/2020 Apparent on its Face
J1602 INJECTION, GOLIMUMAB, 1 MG, FOR INTRAVENOUS USE Simponi Note: If billing for any other form of this drug, use J3490. Removing J1602 from list as code is for IV form only and references Simponi Aria. 10/17/2016 10/17/2016 Apparent on its Face
J1628 INJECTION, GUSELKUMAB, 1 MG Tremfya 05/01/2020 05/01/2020 Acceptable Evidentiary Criteria Available
J2760 INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG Regitine 10/23/2013 07/24/2019 Apparent on its Face
J2940 INJECTION, SOMATREM, 1 MG Protropin®,
Genotropin®,
Humatrope®,
Norditropin®,
Nutropin®,S
Saizen®,
Serostim® No longer available		 03/15/2003 04/17/2017 Apparent on its Face
J3310 INJECTION, PERPHENAZINE, UP TO 5 MG Trilafon 10/01/2015 07/24/2019 Apparent on its Face
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara 05/01/2020 05/01/2020 Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Otrexup (Methotrexate - Solution Auto-injector Non Chemotherapeutic) See under J3490 Methotrexate Solution Auto-injector Non Chemotherapeutic 10/01/2015 04/18/2017 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Insulin Glargine (pen injector) Toujeo SoloStar Lantus Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. 10/01/2015 11/19/2022 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Abatacept, SQ Orencia Orencia Prefilled Syringe Orencia Clickjet Note: Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules applySpecial Instruction: (Note: J0129 Abatacept is only to be used when administered by IV infusion under direct supervision of a physician) Note: End dating and adding code J0129 with additional information 05/31/2017 03/27/2021 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Quadmix (alprostadil, atropine, papaverine, phentolamine) Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply Note End dating as this is a duplicate entry see under J3490 with Timix and Quadramix 05/31/2017 02/10/2021 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tezspire (Tezepelumab-Ekko) CUrrently billed with unlisted codes J34490, J3590 or C9399 for ASC and facility POS Effective 07/01/2022 use J2356 Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) 07/10/2022 07/10/2022 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Etanercept-szzs Erelzi Biosimilar to Etanercept (Enbrel) under J1438 Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply **End dating 09/09/2019 entry only as this is already listed under J3490 effective 10/17/2016 which still applies. 09/09/2019 09/09/2019 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon Beta-1A Plegridy Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply Note: End dating as this is listed under J9213 10/17/2016 03/27/2021 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Raptiva removing no longer available 05/16/2007 04/18/2017 Apparent on its Face
Q0515 INJECTION, SERMORELIN ACETATE, 1 MICROGRAM Geref 05/16/2007 04/18/2017 Apparent on its Face
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
01/13/2024 R51

Revision Effective: 1/13/2024

Revision Explanation: Added asterisk to J0801, J0802 and 5. Secukinumab Cosentyx™ to use JA or JB modifier depending on how the drug was given. Added new drugs 1. Vedolizumab/Entyvio , Yuflyma, and Omvoh/ mirikizumab-mrkz  to the SAD drug list.
10/05/2023 R50

Revision Effective: 10/05/2023

Revision Explanation: Annual review, no changes.
10/01/2023 R49

Revision Effective: 10/01/2023

Revision Explanation: Code J0800 is end dated effective 09/30/2023 and replaced with codes J0801 and J0802.
08/20/2023 R48

Revision Effective: 08/20/2023

Revision Explanation: Added J1811, J1813, Q5131, and J1941 to SAD article.
08/13/2023 R47

Revision Effective: 08/13/2023

Revision Explanation: Added J1812 - Inj. Insulin (fiasp) and J1814 - Inj. insulin (lyumjev).
06/25/2023 R46

Revision Effective: 06/25/2023

Revision Explanation: added the following as self administered effective 06/15/2023:

ABRILADA (adalimumab-afzb) is biosimilar* to HUMIRA (adalimumab).

HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab)

HULIO® (adalimumab-fkjp) is biosimilar* to HUMIRA (adalimumab)

HYRIMOZ (adalimumab-adaz) is biosimilar* to HUMIRA (adalimumab)

YUSIMRY (adalimumab-aqvh) is biosimilar* to HUMIRA (adalimumab
11/19/2022 R45

Revision Effective: 11/19/2022

Revision Explanation: Corrected the spelling for Stelara for J3357.
11/19/2022 R44

Revision Effective: 11/19/2022

Revision Explanation: 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.
11/19/2022 R43

Revision Effective: 11/19/2022

Revision Explanation: Added Tirepatide (Mounjaro) to SAD list.
11/01/2022 R42

Revision Effective: 10/06/2022

Revision Explanation: Annual review, no changes
11/01/2022 R41

Revision Effective: 11/01/022

Revision Explanation: Added Tralokinumab-Idrm (Adbry™) and Stelera to self administered list.
08/04/2022 R40

Revision Effective: 08/04/022

Revision Explanation: Removed Tezspire from Self administered article effective 07/10/2022.
07/28/2022 R39

Revision Effective: 07/28/2022

Revision Explanation: Added the JA and JB information note for Risankizumab-rzaa (Skyrizi™).
07/10/2022 R38

Revision Effective: 07/01/022

Revision Explanation: Added Tezspire (Tezepelumab-Ekko) 
05/19/2022 R37

Revision Effective: 05/19/2022

Revision Explanation: Drugs J1555 and J1558 were added to the SAD list in error. These codes are being enddated 03/27/2021 for this list.
05/15/2022 R36

Revision Effective: 05/15/2022

Revision Explanation: Added Risankizumab-rzaa (Skyrizi™)  as this is a self administered drug that can be billed under J3590, J3490, or C9399.
04/24/2022 R35

Revision Effective: 04/24/2022

Revision Explanation: Added new drug Besremi (ropeginterferon alfa-2b-njft) to the SAD article.
10/15/2021 R34

Revision Effective: N/A

Revision Explanation: Annual review, no changes were made.
10/15/2021 R33

Revision Effective: 10/15/2021

Revision Explanation: Updated the paragraph concerning JA and JB modifier for clarity.
04/01/2021 R32

Revision Effective: 04/01/2021

Revision Explanation: Added asterisk for J2354 as it was left off in error from previous update. Added in article text information concerning JA and JB modifiers. 
04/01/2021 R31

Revision Effective: 04/01/2021

Revision Explanation: Added in article text information concerning JA and JB modifiers. Also added asterisk after drugs these modifiers will apply.
12/30/2020 R30

Adding Q3027 and Q3028 to the list.
12/30/2020 R29

Code J1628 removing note regarding use of modifiers as modifiers will not be acceptable, all other information remains the same.
12/30/2020 R28

Adding J1628 Guselkumab effective 05/15/2021
12/30/2020 R27

Adding: J0129 Abatacept; J0490 Belimumab; J1553 Immune Globulin, SC; J1558 Immune Globulin-klhw; J3590 Somapacitan-beco  (effective 03/27/2021). End Dating effective 03/27/2021: J3490 Abatacept and use J0129; J3490 Peginterferon Alpha 2A see info under J9213/27/2021); End dating effective 02/10/2021 J3490 Quadmix as this is a duplicate of Trimix/Quadramix already on list; J3490 Methotrexate Solution Auto-injector Non Chemotherapeutic was entered as non-excluded in error on 04/18/2017 ( it was still left as excluded in the list and should be).
12/30/2020 R26

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.
05/01/2020 R25

Revision effective: N/A
Revision Explanation: Annual review no changes made.
05/01/2020 R24

Revision Effective:05/01/2020

Revision Explanation: J3357 and J1628 were added effective 05/01/2020 but CGS is end dating the same as the effective date as we are removing these 2 drugs at this time.
05/01/2020 R23

Revision effective: 5-1-2020
Revision Explanation: Removed J1628 Generic name: Guselkumab and J3357 generic name: Ustekinumab.
05/01/2020 R22

Revision effective: 5-1-2020
Revision Explanation: Correction to the Revision #21 notation.

Added J1628 Generic name: Guselkumab – Brand name: Tremfya. Also, added an exclusion date and reason for exclusion for J3357 Ustekinumab.
05/01/2020 R21

Revision effective: 5-1-2020
Revision Explanation: Added J1628 Generic name: Guselkumab – Brand name: Tremfya. Also, updated revised the exclusion effective date and change the reason for exclusion.
01/30/2020 R20

Revision effective 02/20/2020: 02/10/2020 added J3357 Ustekinumab, subcutaneous inj., 1 mg - editing will not begin until 03/26/2020 due to 45 day rule;; End dated entry for J3590 Etanercept-szzs Erelzi 09/09/2019 as this is already listed under J3590 effective 10/17/2016 and this date will still apply. 
01/30/2020 R19

Revision effective: 01/30/2020 - 01/23/2020 Added Lanadelumab-flyo J0593 and is retroactive to 10/01/2019 (since this is new addition 45 day rule applies this will begin editing on 03/09/2020 for DOS 10/01/2019 forward); Removed J0129 and left subQ form under J3490 per all contractor CMD decision; J3490 Pasireotide Diaspartate added note regarding J2502; J3590 Fremanezumab-vfrm changed to new code J3031 effective 10/01/2019 original effective date of exclusion does not change; and corrected typo.
10/31/2019 R18

Revision effective: 10/31/2019
Revision Explanation: Code for Hizentra was listed as J1599 which was a typographical error. The correct code for this drug is J1559.
09/26/2019 R17

Revision effective: N/A
Revision Explanation: Annual review no changes made.
09/09/2019 R16

Removing J1602 as this code is the IV form of the drug (Simponi Aria) and moving back to J3490 for non-IV form.
09/09/2019 R15

Based on joint decision between the MACs, added J0129 back to list with note and added drugs effective 9/9/2019 Ixekizumab, Adalimumab-atto, Brodalumab, Abaloparatide, Sarilumab, Semaglutide, Fremanezumab-vfrm, Erenumab-aoooe, Galcanezumab-gnlm, Etanercept-szzs; Also added Adalimumab-adaz and Adalimumab=bwwd effective 9/9/2019; Changed C-1 Esterase Inhibitor (Haegarda from J3490 to J0599; Under Trimix added Quadramix; Removed J2760 Phentolamine as not administered in the office and J3310 Perphanzine; J1830added Extavia brand name; J1826 added Avonex pen; J9213 added drug names Pegasys, Pegasys ProClick & removed Infergen; Golimumab moved from J3490 to J1602; Under J1438 added Enbrel Mini, Enbrel Sure Click, Brenzys and a note Also see J3590 Etanercept-szzs (Erelzi); J0135 added Note: If filing for biosimilars under J3590, J3490, or C9399 same rules apply; changed Corticotropin from J3490 to J0800; Under all J3490 codes added Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply and under a J3590 codes added Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply.
09/28/2018 R14

Revision effective: N/A
Revision Explanation: Annual review no changes made.
09/28/2018 R13

08/16/2018 Added  Adalimumab (Cyltezo) and Dupilumab (Dupixent)/ Added note: if billed under J3590 or J9999, the same rules apply
09/25/2017 R12

10/01/2017-Annual review no changes made

 

08/09/2017 Added J3490 C1 Inhibitor; Human Injection; Berinert; Cinryze; Haegarda Note: If billed under J3590 or C9399, the same rules apply.
05/31/2017 R11

J3490 Abatacept Added Orencia prefilled syringe and Orencia Clickjet to the list of brand RX; added note: If billed under J3590 or C9399 dame rules apply; added special instruction Note: J0129 is only to be used when administered by IV infusion under direct supervision of a physician.
05/31/2017 R10 Added the following with effective dates of 05/31/2017: J0364 Apomorphine Hcl (Apokyn); J1826 Interferon Beta 1A; J3490/J3590/C9399 ABATACEPT, SQ (Orencia); J3490/J3590/C9399 Albiglutide, SQ; J3490 Asfotase-alfa; Cotocotropin; J3490 Evolocumab; J3490 Exenatide XR; J3490 Metreleptin; J3490 Tesamorelin; J3490 Quadrmix.. End dated the following effective 04/17/2017: J0275 Alprostadil Urethral Suppository; end dated J0129 see subcutaneous form under J3490; Endated the following effective 04/18/2017 J2940 Somatrem no longer available; J3590 Efalizumab; and Q0515 Semorelin no longer available..
10/17/2016 R9 Correction to history explanation for 10/17/2016 under revision 8 - this is the information that was added to be effective 10/17/2016 J3490 Golimumab; J3490 Alirocumib; J3590 Etanercept-SZZS; J3590 Peginterferon Beta-1A (the information under revision 8 goes with effective dates of 05/31/2017)
10/17/2016 R8 End dated J0275 Alprostadil Urethral Suppository; end dated J0129 see subcutaneous form under J3490; added J3490/J3590/C9399 ABATACEPT, SQ (Orencia); added J3490/J3590/C9399 Albiglutide, SQ; added J3490/J3590/C9399 Alirocumib (Praleunt); added J0364 Apomorphine Hcl (Apokyn)
10/01/2015 R7 Revision effective: N/A
Revision Explanation: Annual review
10/17/2016 R6 Added Etanercept-SZZS (Erelzi); Peginterferon Beta-1A (Plegridy); Alirocumib (Praluent); Abatacept (Orencia); and Golimumab (Simponi) subcutaneous form effective 10/17/2016.
10/01/2015 R5 Secukinumab was determined to be self-administered effective 04/14/2015
10/01/2015 R4 01/01/2016 Added drug names peg-interferon alfa 2B and sylantra to miscellaneous code for Peg-Intron effective date has not changed.
10/01/2015 R3 Revision effective: N/A
Revision Explanation: Annual review
10/01/2015 R2 Added the following drugs: Trulicity (Dulaglutide), Insuline Glargine , Otrexup, and Rasuvo. Also added Saxenda as a brand name for liraglutide.
04/15/2015 R1 Revision effective: 04/15/2015
Revision Explanation: Added natpara to self administered list.
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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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SAD Process URL 1
http://www.cgsmedicare.com/partb/medicalpolicy/sad/self_admin_process.html N/A
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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