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LCD Reference Article Self-Administered Drug Exclusion List Article

Self-Administered Drug Exclusion List: (SAD List)

A52800

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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
A52800
Original ICD-9 Article ID
Not Applicable
Article Title
Self-Administered Drug Exclusion List: (SAD List)
Article Type
SAD Exclusion Article
Original Effective Date
10/01/2015
Revision Effective Date
09/11/2024
Revision Ending Date
N/A
Retirement Date
N/A

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CMS National Coverage Policy

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Article Text

The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished "incident to" a physician's service provided the drugs are not usually self-administered by the patients who take them. On May 15, 2002, the Centers for Medicare and Medicaid Services (CMS) issued Program Memorandum AB-02-072/Change Request 2200 which contains guidelines to be used by contractors to determine whether a drug or biological is usually self-administered and excluded from payment. For the purposes of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage.

Please note: some drugs may be listed more than once, using a different code, on the CPT/HCPCS coding table.

The following guidelines are to be used for the process of determining whether a drug is usually self-administered:

Evidentiary Criteria

Only evidence of the following types will be considered: peer reviewed medical literature, standards of medical practice, evidence based practice guidelines, FDA approved labeling information and package inserts.

Presumptions

Because reliable statistical information on the extent of self-administration by the patient may not always be available, the following considerations will be used:

  1. Absent evidence to the contrary, drugs delivered intravenously should be presumed to be not usually self-administered by the patient. 
  2. Absent evidence to the contrary, drugs delivered by intramuscular injection should be presumed to be not usually self-administered by the patient. 
  3. Absent evidence to the contrary, drugs delivered by subcutaneous injection should be presumed to be usually self-administered by the patient. 
  4. Absent evidence to the contrary, oral drugs, suppositories, topical medications and inhaled medications are considered to be usually self-administered by the patient.

Additional consideration will be given to whether the condition being treated by the drug is acute or chronic and the frequency of administration.

Basis for Non-Coverage

  1. Apparent on its Face
    For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are not, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered.

    The list of drugs identified below have been determined, following the above guidelines, to be usually self-administered by the patients who use them and are excluded from payment. Publication on this list begins a 45-day notice period whereby existing medical review and payment procedures will remain in effect. After the 45-day notice period ends, payment will be denied. The list will be reviewed periodically and updated as further determinations are made. Therefore, the absence of any particular drug on the exclusion list does not mean, at some later date, the drug might be deemed excluded based on the guidelines listed above.

  2. Presumption: Long-Term Non-Acute Administration
    In accordance with CMS instructions, if the condition being treated is for a short term acute basis (e.g. less than two weeks), the drug for this indication is considered "not usually self-administered." If the condition being treated is for a longer term (more than two weeks), the drug for this indication is considered "usually self-administered by the patient."

  3. Acceptable Evidentiary Criteria Available
    - Peer reviewed medical literature,
    - Standards of medical practice,
    - Evidence-based practice guidelines,
    - FDA approved label, and
    - Package inserts

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.

CPT/HCPCS Modifiers
Group 1 Paragraph: Claim denials may occur when the appropriate modifier is not applied to a J code/medication, which has more than one route of administration.
Group 1 Codes:

JA Intravenous administration
JB Subcutaneous administration

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Coding Information

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 Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

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 Group 1 Codes

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

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 Group 1 Codes

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ICD-10-PCS Codes

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 Group 1 Codes

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Additional ICD-10 Information

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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.

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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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 Group 1 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 Rebif® (Interferon Beta–1A, 1 mcg) 07/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tesamorelin (Egrifta ™) 07/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Sogroya® (somapacitan-beco) 11/15/2021 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Pasireotide (Signifor®) 11/15/2021 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 01/12/2020 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS ofatumumab (Kesimpta®) subcutaneous use* 07/24/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS tralokinumab-idrm (Adbry™) 11/13/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS All insulin products 12/11/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS tirzepatide (Mounjaro™) 12/11/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adalimumab-aacf (Idacio®), Adalimumab-afzb (Abrilada™), Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio®), Adalimumab-adaz (Hyrimoz), Adalimumab-aqvh (Yusimry) 06/25/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS secukinumab (Cosentyx™) 06/15/2015 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
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Semaglutide (Wegovy®) 06/30/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Semaglutide (Ozempic®) 04/01/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tirzepatide (Zepbound™) 06/30/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Liraglutide (Saxenda®) 06/15/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Liraglutide (Victoza®) 10/16/2011 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* 04/01/2021 N/A Apparent on its Face
J0135 INJECTION, ADALIMUMAB, 20 MG Humira 02/01/2008 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) Caverject, Edex 02/01/2008 N/A Apparent on its Face
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG Apokyn® 04/01/2021 N/A Apparent on its Face
J0490 INJECTION, BELIMUMAB, 10 MG Benlysta®, subcutaneous use* 04/01/2021 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® 12/02/2019 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, Miacalcin 02/01/2008 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® subcutaneous use** 10/01/2023 N/A Apparent on its Face
J1324 INJECTION, ENFUVIRTIDE, 1 MG Fuzeon 02/01/2008 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 02/01/2008 N/A Apparent on its Face
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone™ 02/01/2008 N/A Apparent on its Face
J1628 INJECTION, GUSELKUMAB, 1 MG Tremfya® (guselkumab)* 04/01/2021 N/A Apparent on its Face
J1675 INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS Supprelin LA™ 02/01/2008 N/A Apparent on its Face
J1744 INJECTION, ICATIBANT, 1 MG Firazyr™ 11/15/2011 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® for insulin pump use 09/03/2023 N/A Apparent on its Face
J1812 INSULIN (FIASP), PER 5 UNITS Fiasp® injection* 09/03/2023 N/A Apparent on its Face
J1813 INSULIN (LYUMJEV) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Lyumjev® for insulin pump use 09/03/2023 N/A Apparent on its Face
J1814 INSULIN (LYUMJEV), PER 5 UNITS Lyumjev® injection* 09/03/2023 N/A Apparent on its Face
J1815 INJECTION, INSULIN, PER 5 UNITS Humalog, Humulin, Iletin, Insulin Lispro, Novo Nordisk, NPH, Pork Insulin, Regular Insulin, Ultralente, Velosulin, Humulin R, Iletin II Regular Port, Insulin Purified Pork, ReliOn, Lente Iletin I, Novolin R, Humulin R U-500 02/01/2008 N/A Apparent on its Face
J1815 INJECTION, INSULIN, PER 5 UNITS All insulin products 12/11/2022 N/A Apparent on its Face
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS All insulin products 12/11/2022 N/A Apparent on its Face
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Humalog, Humulin, Vesolin BR, Iletin II NPH Pork, Lantus, Lispro-PFC, Novolin, Novolog, Novolog Flexpen, Novolog Mix, ReliOn Novolin 02/01/2008 N/A Apparent on its Face
J1826 INJECTION, INTERFERON BETA-1A, 30 MCG Avonex Pen®, Rebif®, Rebif® Rebidose® 11/15/2021 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™ 02/01/2008 N/A Apparent on its Face
J1941 INJECTION, FUROSEMIDE (FUROSCIX), 20 MG Furoscix® 09/03/2023 N/A Apparent on its Face
J2170 INJECTION, MECASERMIN, 1 MG Iplex ™ Increlex™ 02/01/2008 N/A Apparent on its Face
J2212 INJECTION, METHYLNALTREXONE, 0.1 MG Relistor ™ 02/15/2013 N/A Apparent on its Face
J2267 INJECTION, MIRIKIZUMAB-MRKZ, 1 MG mirikizumab-mrkz (Omvoh™) subcutaneous use* 07/01/2024 N/A Apparent on its Face
J2354 INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Sandostatin™, subcutaneous use* 02/01/2008 N/A Apparent on its Face
J2440 INJECTION, PAPAVERINE HCL, UP TO 60 MG Papaverine HCL 02/01/2008 N/A Apparent on its Face
J2940 INJECTION, SOMATREM, 1 MG Protropin™ 02/01/2008 N/A Apparent on its Face
J2941 INJECTION, SOMATROPIN, 1 MG Genotropin™ 02/01/2008 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™ 02/01/2008 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™ 04/01/2021 N/A Apparent on its Face
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo™ 02/01/2008 N/A Apparent on its Face
J3355 INJECTION, UROFOLLITROPIN, 75 IU Metrodin, Bravelle, Fertinex 02/01/2008 N/A Apparent on its Face
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara® 11/15/2021 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tirzepatide (Zepbound™) 06/30/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Sogroya® (somapacitan-beco) 11/15/2021 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Abaloparatide (Tymlos™) 07/16/2018 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Albiglutide (Tanzeum™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Alirocumab (Praulent™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Dulaglutide (Trulicity™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS etanercept-szzs (Erelzi) 11/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Evolocumab (Repatha™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Insulin Glargine (Toujeo SoloStar™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Insulin Glargine (Lantus SoloStar™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Sarilumab (Kevzara™) 04/01/2021 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Ixekizumab (Taltz™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Liraglutide (Victoza™) 10/16/2011 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Liraglutide (Saxenda™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Methotrexate (Rasuvo™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Methotrexate (Otrexup™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Metreleptin (Myalept™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Mipomersen sodium (Kynamro™) 09/15/2013 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Parathyroid hormone (Natpara™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Pasireotide (Signifor™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Peginterferon beta-1a (Plegridy™) 06/15/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Pramlintide (Symlin™) 02/01/2008 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Rebif® (Interferon Beta–1A, 1 mcg) 07/16/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tesamorelin (Egrifta™) 10/16/2011 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS TriMix™ 10/16/2011 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Quadmix (+ Atropine) 07/16/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Adalimumab-atto (AMJEVITA™) 02/15/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Golimumab (SIMPONI) 02/15/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 01/12/2020 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS ofatumumab (Kesimpta®) subcutaneous use* 07/24/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS tralokinumab-idrm (Adbry™) 11/13/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS All insulin products 12/11/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS tirzepatide (Mounjaro™) 12/11/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Adalimumab-aacf (Idacio®), Adalimumab-afzb (Abrilada™), Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio®), Adalimumab-adaz (Hyrimoz), Adalimumab-aqvh (Yusimry) 06/25/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS secukinumab (Cosentyx™) 06/15/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Vedolizumab (Entyvio ®) subcutaneous use* 01/14/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS adalimumab-aaty (Yuflyma ®) 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 Vedolizumab (Entyvio ®) subcutaneous use* 01/14/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-aacf (Idacio®), Adalimumab-afzb (Abrilada™), Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio®), Adalimumab-adaz (Hyrimoz), Adalimumab-aqvh (Yusimry) 06/25/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS All insulin products 12/11/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS tirzepatide (Mounjaro™) 12/11/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS tralokinumab-idrm (Adbry™) 11/13/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS ofatumumab (Kesimpta®) subcutaneous use* 07/24/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS adalimumab-adbm (Cyltezo™ ) 04/01/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Anakinra (Kineret ™) 02/01/2008 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Asfotase-alfa (Strensiq®) 04/01/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Brodalumab (Siliq) 07/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Dupilumab (Dupixent) 07/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS erenumab-aooe (Aimovig™) 04/01/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Exenatide,(Byetta ™) 10/16/2008 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Exenatide (Bydureon™) 06/15/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Galcenezumab-gnlm (Emgality™) 04/01/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon alfa-2b, (Pegintron™ Sylatron™) 02/01/2008 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Pegvisomant, (Somavert™ ) 02/01/2008 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Rebif® (Interferon Beta–1A, 1 mcg) 07/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Sarilumab (Kevzara®) 04/01/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS secukinumab (Cosentyx™) 06/15/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Semaglutide (Ozempic®) 04/01/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 01/12/2020 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Sogroya® (somapacitan-beco) 11/15/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Ropeginterferon alfa-2b-njft (BESREMI®) 04/24/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Semaglutide (Wegovy®) 06/30/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Tirzepatide (Zepbound™) 06/30/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Liraglutide (Saxenda®) 06/15/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Liraglutide (Victoza®) 10/16/2011 N/A Apparent on its Face
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Infergen 02/01/2008 N/A Apparent on its Face
J9213 INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS Peginterferon alfa-2a, (Pegasys ®, Pegasys ® Proclick™) 02/15/2013 N/A Apparent on its Face
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune™ 02/01/2008 N/A Apparent on its Face
J9218 LEUPROLIDE ACETATE, PER 1 MG Lupron™ 02/01/2008 N/A Apparent on its Face
Q3027 INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE Avonex™ 01/01/2014 N/A Apparent on its Face
Q3028 INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE Rebif™ 01/01/2014 N/A Apparent on its Face
Q5131 INJECTION, ADALIMUMAB-AACF (IDACIO), BIOSIMILAR, 20 MG Idacio® 09/03/2023 N/A Apparent on its Face
Q5132 INJECTION, ADALIMUMAB-AFZB (ABRILADA), BIOSIMILAR, 10 MG ABRILADA™ 06/25/2023 N/A Apparent on its Face
Q5137 INJECTION, USTEKINUMAB-AUUB (WEZLANA), BIOSIMILAR, SUBCUTANEOUS, 1 MG ustekinumab-auub (Wezlana™) subcutaneous use* 07/01/2024 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
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™) subcutaneous use* 03/16/2024 07/01/2024 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS tezepelumab-ekko (Tezspire™) 07/10/2022 07/10/2022 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 11/15/2013 11/15/2013
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Hizentra 01/15/2011 01/01/2021 Apparent on its Face
J1814 INSULIN (LYUMJEV), PER 5 UNITS Lyumjev® 200 IU 09/03/2023 09/03/2023 Apparent on its Face
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara™ 09/15/2013 06/01/2014
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™) subcutaneous use* 03/16/2024 07/01/2024 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS ustekinumab-auub (Wezlana™) subcutaneous use* 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
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
09/11/2024 R37

Posted 10/10/2024: Under CPT/HCPCS Codes Table, added an asterisk after Tremfya®. This change is effective 09/11/2024.
08/18/2024 R36

Posted 08/29/2024: Removed asterisk after CPT/HCPCS codes for secukinumab Cosentyx™. This change is effective 07/01/2024.
06/30/2024 R35

Posted 07/04/2024: Added C9399, J3490, J3590 Ustekinumab-auub (Wezlana) to Non-Excluded CPT/HCPCS Ended Codes and replaced with Q5137. Added C9399, J3490, J3590 Mirikizumab-mrkz to Non-Excluded CPT/HCPCS Ended Codes and replaced with J2267. These changes are effective 07/01/2024. Added J1748 Infliximab-dyyb (Zymfentra), effective 08/18/2024.
06/30/2024 R34

Posted 05/16/2024 The article has been updated to add: Semaglutide (Wegovy®) (C9399, J3590), Semaglutide (Ozempic®) (C9399), Tirzepatide (Zepbound™) (C9399, J3490, J3590) effective 06/30/2024.

Formatting update only to Liraglutide (Victoza®, Saxenda®) (C9399, J3590). The formatting update does not change any coverage or guidance.
04/25/2024 R33

Posted 04/25/2024 Under Article Guidance Route of Administration Modifier added: 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. J0801 H.P. Acthar® Gel subcutaneous use** and J0802 Purified Cortrophin Gel® subcutaneous use** was updated to a double asterisk.
03/16/2024 R32

Posted 02/01/2024 Added Q5132 INJECTION, ADALIMUMAB-AFZB (ABRILADA), BIOSIMILAR, 10 MG (Abrilada™) to the CPT/HCPCS Codes-Table effective 06/25/2023. Added C9399, J3490, and J3590 ustekinumab-auub (Wezlana™) subcutaneous use* effective 03/16/2024.
11/30/2023 R31

Posted 11/30/2023 Under CPT/HCPCS Codes secukinumab (Cosentyx ™)* was updated to include codes C9399 and J3490. The asterisk was added for subcutaneous use.

The following codes were updated to add subcutaneous use*: J0801 Acthar® Gel and J0802 Purified Cortrophin Gel® .

Under CPT/HCPCS codes C9399, J3490, and J3590 added the following effective 01/14/2024:
Vedolizumab (Entyvio ®) subcutaneous use*
adalimumab-aaty (Yuflyma ®)
mirikizumab-mrkz (Omvoh™) subcutaneous use*
10/01/2023 R30

Posted 09/28/2023 Deleted J0800 Acthar® Gel which will be replaced by J0801 and J0802 effective 10/01/2023.
09/03/2023 R29

Posted 08/31/2023 Minor corrections made to last revision. J1811does not require an *as noted in revision history. J1813 removed *. J1814 updated to remove 100IU & 200IU language.
09/03/2023 R28

Posted 06/29/2023 Added J1811 Fiasp®*, J1812 Fiasp®*, J1813 Lyumjev® 50 IU*, J1814 Lyumjev® 100 IU* & 200 IU, J1941 Furoscix®, and Q5131 Idacio® effective for dates of service on or after 09/03/2023. Review completed 06/01/2023.
06/25/2023 R27

Posted 05/11/2023 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 06/25/2023.
10/27/2022 R26

Posted 10/27/2022 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 12/11/2022. tirzepatide (Mounjaro™) (C9399, J3490, J3590) has been added effective for dates of service on or after 12/11/2022.
09/29/2022 R25

Posted 09/29/2022 Added C9399, J3490, and J3590 tralokinumab-idrm (Adbry™) effective for dates of service on or after 11/13/2022. Review completed 08/25/2022.
08/11/2022 R24

Posted 08/11/2022 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. Tezepelumab-ekko (Tezspire™) C9399, J3490, and J3590 have been removed from SAD List.
07/24/2022 R23

Posted 06/09/2022 Added C9399, J3490, and J3590 ofatumumab (Kesimpta®) subcutaneous use* to the CPT/HCPCS Codes-Table effective 07/24/2022.
07/10/2022 R22

Posted 05/26/2022: Added C9399, J3490, and J3590 tezepelumab-ekko (Tezspire™) to the CPT/HCPCS Codes-Table effective 07/10/2022.
04/28/2022 R21

Posted 04/28/2022 Additional codes C9399 and J3490 added to Risankizumab-rzaa (Skyrizi™) which was added to this list on 01/12/2020. These codes will be effective with the same date of 01/12/2020.
04/24/2022 R20

Posts 03/10/2022 Added J3590 Ropeginterferon alfa-2b-njft (BESREMI®) to the CPT/HCPCS Codes – Table effective 04/24/2022.
11/15/2021 R19

09/30/2021 The "Route of Administrative Modifier" paragraph is revised. Added the following to C9399: Sogroya® (somapacitan-beco) and Pasireotide (Signifor®). Added J1826 Interferon Beta-1A (Avonex Pen®, Rebif®, Rebif® Rebidose®), J3357 Ustekinumab (Stelara®), J3490 Sogroya® (somapacitan-beco), and J3590 Sogroya® (somapacitan-beco) with effective dates of 11/15/2021. Minor spelling errors corrected. Review completed 09/09/2021.
04/01/2021 R18

02/15/2021 Added the following: J0364 Apomorphine (Apokyn®); J0490 Belimumab (Benlysta®, subcutaneous use*); J0129 abatacept 10 mg (Orencia®, subcutaneous use*); J1628 Guselkumab (Tremfya®); J3031 fremanezumab-vfrm, (Ajovy™); J3490 Sarilumab (Kevzara™); J3590 adalimumab-adbm (Cyltezo™); J3590 Asfotase-alfa (Strensiq®); J3590 erenumab-aoooe (Aimovig™) J3590 Galcenezumab-gnlm (EmgalityTM); J3590 Sarilumab (Kevzara®); and J3590 Semaglutide (Ozempic®); and added Peginterferon alfa-2a, (Pegasys ®, Pegasys® Proclick™) to J9213 effective 04/01/2021.

Added Subcutaneous use* to J2354 Octreotide (Sandostatin ™).

Removed the following: J3490 Daclizumab (ZINBRYTA™) (taken off the worldwide market due to safety concerns); J3590 Abatacept (Orencia)(has true code) ; J3590 Peginterferon alfa-2a, (Pegasys™)(has true code); removed Roferon A™ from J9213 (no longer available); and Q0515 Injection, Sermorelin Acetate, 1 Microgram (Geref™) (discontinued drug product).

Added the following in Article Guidance:
Basis for Non-Coverage

B. Presumption: Long-Term Non-Acute Administration
In accordance with CMS instructions, if the condition being treated is for a short term acute basis (e.g. less than two weeks), the drug for this indication is considered "not usually self-administered." If the condition being treated is for a longer term (more than two weeks), the drug for this indication is considered "usually self-administered by the patient."

C. Acceptable Evidentiary Criteria Available
- Peer reviewed medical literature,
- Standards of medical practice,
- Evidence-based practice guidelines,
- FDA approved label, and
- Package inserts

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.

CPT/HCPCS Modifiers
Group 1 Paragraph: Claim denials may occur when the appropriate modifier is not applied to a J code/medication, which has more than one route of administration.
Group 1 Codes:

JA Intravenous administration
JB Subcutaneous administration

Format revisions completed.
01/01/2021 R17

01/07/2021 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 01/01/2021.
08/27/2020 R16

08/27/2020 Review completed 08/04/2020 with no change in coverage. Format revision completed.
01/12/2020 R15

11/28/2019 Added J3590 risankizumabrzaa (Skyrizi™) to the CPT/HCPCS Coding Table effective 01/12/2020.
12/02/2019 R14

10/17/2019 Added J0593 lanadelumab-flyo (Takhzyro®) to the CPT/HCPCS Coding table effective 12/02/2019. Review completed 09/04/2019.
01/01/2019 R13

01/01/2019 CPT/HCPCS Code updates: deleted code C9015 and added code J0599. Also removed code J3590 for C1 Esterase Inhibitor, Human (Haegarda®) since it got a true code J0599.
12/01/2018 R12

12/01/2018 Annual review done 11/02/2018.
07/16/2018 R11

06/01/2018 Added J3490 Abaloparatide (TymlosTM) to the CPT/HCPCS Coding table, effective 07/16/2018.
 
01/01/2018 R10

05/01/2018 Code update: added C9015 for C1 Esterase Inhibitor, Human (Haegarda®) to the CPT/HCPCS Coding table, effective 01/01/2018. In the Revision History for 06/01/2017 J0272 is a typographical error; it should be J0275 for Alprostadil urethral suppository.
12/16/2017 R9

12/01/2017 Annual review done 11/03/2017. No change in coverage.

 
12/16/2017 R8

11/01/2017 Added J3590 C1 Esterase Inhibitor, Human (Haegarda®) to the CPT/HCPCS Coding table, effective 12/16/2017.
07/16/2017 R7 06/01/2017 Added the following sentence to the article text: Please note: some drugs may be listed more than once, using a different code, on the CPT/HCPCS coding table. Added J3590 Dupilumab (Dupixent); J3590 Brodalumab (Siliq); C9399 to code J3490 Tesamorelin (Egrifta®); C9399, J3490, and J3590 to code Q3028 for Interferon Beta-1A 1 mcg (Rebif®); J3490 Quadmix (+Atropine); and descriptor brand name of Papaverine HCL to J2440; all effective 07/16/2017. Removed J0272 Alprostadil urethral suppository (Muse®) (since it is a suppository); J2760 Phentolamine mesylate up to 5mg (Regitine) (since not self administered); J3310 Perphenazine up to 5mg (Perphenazine) (since it is no longer available in the US); J3590 Efalizumab (Raptiva®) (since it is off the US market) ; J1562 Immune Globulin (Vivaglobin®) (since it is not being manufactured anymore); and J3490 Nitroglycerine Lingual spray (Nitrolingual, Nitromist) (since it is not an injection); all effective 07/16/2017.
02/15/2017 R6 01/20/2017 - Replaced "SAD Process URL 1" directing to wpsmedicare.com with URL directing to new WPS GHA website wpsgha.com
02/15/2017 R5 01/01/2017- Code updates-description change to J3357& J1830 effective 01/01/2017; added J3490 for Daclizumab (ZINBRYTA™), Adalimumab-atto (AMJEVITA™) and Golimumab (SIMPONI)-effective 02/15/2017. Annual review completed 11/23/2016.
11/15/2016 R4 10/01/2016- Added etanercept-szzs (Erelzi) (J3490)-effective 11/15/2016.
05/01/2016 R3 05/01/2016- Annual review completed 04/06/2016. Removed J3490 for use as H.P. Acthar gel & added J0800. Added J3310. Added J3490 for the following drugs Albiglutide (Tanzeum™), Alirocumab (Praulent™), Dulaglutide (Trulicity™), Evolocumab (Repatha™), Insulin Glargine (Toujeo SoloStar™), Insulin Glargine (Lantus SoloStar™), Ixekizumab (Taltz™), Liraglutide (Saxenda™), Methotrexate (Rasuvo™), Methotrexate (Otrexup™), Metreleptin (Myalept™), Parathyroid hormone (Natpara™), Pasireotide (Signifor™), Peginterferon beta-1a (Plegridy™). Added J3590 for Exenatide (Bydureon™), Removed Actimmune from brand name for J1830 & put the NOC drugs in alphabetical order.
10/01/2015 R2 05/01/2015- added J3590-secukinumab (Cosentyx); annual review 04/07/2015.
10/01/2015 R1 06/01/2014- Moved J3357 Ustekinumab from the list of excluded codes to the Non-Excluded list, Annual Review;
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 1
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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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