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LCD Reference Article Self-Administered Drug Exclusion List Article

Self-Administered Drug Exclusion List:

A53127

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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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General Information

Source Article ID
N/A
Article ID
A53127
Original ICD-9 Article ID
Not Applicable
Article Title
Self-Administered Drug Exclusion 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

Medicare provides only limited benefits for outpatient prescription drugs. The program covers drugs that are furnished “incident to” a physician’s service provided that the drugs are medically reasonable and necessary, approved by the Food and Drug Administration (FDA) and are not usually administered by the patients who take them. Each Medicare Administrative Contractor (MAC) as well as fiscal intermediary and carrier must make its own determinations for determining which drugs will be excluded from coverage. The detailed process for this determination is available in the CMS Internet-Only Manual (IOM) Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.2.

DEFINITIONS
In making these determinations, Novitas Solutions used the following definitions:

Self-administered—administered by the patient to him or herself. This does NOT include administration by spouses, nursing aides, allied health professionals, or physicians. Therefore, oral medications are considered self-administered drugs. However, payment for an oral drug is made as a rare exception when the drug is an oral anti-cancer drug or an oral antiemetic that is given with chemotherapy treatments (See CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.5.3 and 50.5.4).

Usually self-administered—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 and the contractor may not make any Medicare payment for it. In other words, this determination is made by evaluating beneficiaries as a collective whole rather than basing it on an individual drug or individual beneficiary.

Acute condition—any condition that the expected course of treatment is less than two weeks.

Chronic condition—any condition that requires treatment for more than two weeks.

PROCESS OF DETERMINATION
In making these determinations, Novitas Solutions uses the process prescribed by CMS. The process is summarized as follows.

Statistical information is used to make the required decisions. However, when this data is not available the following factors are considered: route of administration, status of the condition, frequency of drug administration.

Route of Administration

  • Drugs delivered intravenously are presumed to be NOT usually self-administered.
  • Drugs injected intramuscularly are presumed to be NOT usually self-administered, although depth and nature of the drug may be considered.
  • Drugs administered subcutaneously are considered to be usually self-administered.

Status of the Condition

  • Acute: any condition that the expected course of treatment is less than two weeks.
  • Chronic condition: any condition that requires treatment for more than two weeks.

Frequency of Administration

  • Infrequent injection: e.g., drug given monthly or less than once per month.
  • Frequent injections: e.g., drug given one or more times per week or more than once per month.

Novitas Solutions arrived at a single determination for each drug listed in this article by reviewing each indication and route of administration for that indication. The relative contribution for each indication to the total use of that drug (i.e., weighted average) was obtained to determine the overall status of administration. For example, if a drug has three indications where the first indication makes up 40% of its use and is usually self-administered, the second and third indications make up 60% of its use and the drug is not usually self-administered for these indications, then the overall determination of that drug is that it is not usually self-administered. Conversely, if the first indication makes up 60% of its use and the drug is usually self-administered, and the second indication makes up 40% of its use and the drug is not usually self-administered, the overall determination made is that the drug is usually self-administered. After the route of administration is determined, the status of the condition and the frequency of administration are assessed. If the condition is acute or if the drug is given less frequently than one time per week, the drug is determined to be not usually self-administered.

For certain injectable drugs, it is apparent that due to the nature of the condition(s) for which they are self-administered or the usual course of treatment for those conditions, the drugs are, or are NOT, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. For these drugs, the rationale for the determination is “apparent on its face value.”

BENEFICIARY APPEALS
A beneficiary may appeal the denial if a claim for a particular drug is denied because the drug is subject to the self-administered drug exclusion. Because it is a benefit category denial and not a denial based on medical necessity, an Advance Beneficiary Notice (ABN) is not required. A benefit category denial (i.e., a denial based on the fact that there is no benefit category under which the drug may be covered) does not trigger the financial liability protection provisions of limitation on liability (under Section 1879 of the Act). Therefore, physicians or providers may charge the beneficiary for an excluded drug.

PROVIDER AND PHYSICIAN APPEALS
A physician accepting assignment may appeal a denial under the provisions found in Chapter 29 of the CMS IOM Publication 100-04, Medicare Claims Processing Manual.

For complete information on Medicare Regulations regarding Drugs and Biologicals, please refer to the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.

Coding Information

Drugs and Biologicals furnished incident to a physician's service are subject to the Medicare self-administration drug exclusion.

The evaluation of drugs for addition to the self-administered drug (SAD) list is an ongoing process. This list contains only those drugs and biologicals that are determined to be “usually self-administered by the patients” and therefore not eligible for Medicare coverage.

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 form of administration. Absent to the contrary, the Contractor presumes that drugs delivered intravenously are not usually self-administered by the patient. The contractor will process claims with the JA modifier still applying the policy as stated in the Medicare Benefit Policy Manual, Chapter 15, Section 50.2 that not only must the drug be 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.

The drugs represented by HCPCS codes J0801 and J0802 are administered by IM or SQ, therefore they require the JB modifier to be reported for SQ administration and they should not have any modifier reported for the IM administration.

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Coding Information

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ICD-10-CM Codes that Support Medical Necessity

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XX000 Not Applicable
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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XX000 Not Applicable
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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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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 Amjevita™ (adalimumab-atto) 08/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Pegasys®, Pegasys®, Proclick™ (injection, pegylated interferon alfa-2a) 03/17/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Sylatron™ (Peginterferon alfa-2b) 03/17/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS TriMix 03/17/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Bydureon® (Exenatide extended release for injectable suspension) 10/01/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Byetta® (exenatide injection) 10/01/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tanzeum™ (albiglutide 30mg) 10/01/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Victoza® (Liraglutide) 10/01/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Signifor® (Pasireotide) 10/01/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Myalept™ (Metreleptin for injection 11mg) 10/01/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kineret (Anakinra) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Symlin® (Pramlintide Acetate Injection) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS PEG-Intron (Peginterferon alfa-2b) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Somavert® (Pegvisomant for injection) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Cosentyx® (secukinumab) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Otrexup™ (methotrexate, injection) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Saxenda® (Liraglutide) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Toujeo® (Insulin glargine injection) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Trulicity® (dulaglutide) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Plegridy® (Peginterferon beta-1a) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Egrifta® (Tesamorelin) 10/24/2016 N/A Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Strensiq® (Asfotase alfa) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Simponi® (golimumab) 10/24/2016 N/A Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Praluent® (Alirocumab) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Repatha™ (Evolocumab) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Natpara® (Parathyroid hormone) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Rebif® (Interferon beta 1a, 11 mcg) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Taltz® (ixekizumab) 10/24/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Dupixent® (dupilumab) 08/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Erelzi™ (etanercept-SZZS) 08/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kynamro® (Mipomersen sodium) 08/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Orencia®, subcutaneous* 08/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Quad-Mix 08/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Rasuvo® (methotrexate, injection) 08/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Siliq™ (brodalumab) 08/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Aimovig™ 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Emgality® 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kevzara 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ozempic 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tymlos 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Lantus® (Insulin glargine) 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Cyltezo® 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Besremi® (ropeginterferon alfa-2b, injection for subcutaneous use) 06/06/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Skyrizi™ (risankizumab-rzaa, injection for subcutaneous use)* 06/06/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Sogroya® (Somapacitan-beco, injection for subcutaneous use) 06/06/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kesimpta* (ofatumumab, injection for subcutaneous use) 09/19/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adbry™ (tralokinumab-Idrm) 11/14/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Mounjaro™ (tirzepatide) 03/27/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS IDACIO® (adalimumab-aacf) 06/25/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS ABRILADA (adalimumab-afzb) is biosimilar to HUMIRA (adalimumab). 06/25/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS HADLIMA (adalimumab-bwwd) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS HULIO® (adalimumab-fkjp) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS HYRIMOZ (adalimumab-adaz) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS YUSIMRY (adalimumab-aqvh) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Entyvio (vedolizumab) 01/14/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS YUFLYMA (adalimumab-aaty) 01/14/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Wegovy (Semaglutide) 06/30/2024 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Zepbound (Tirzepatide) 06/30/2024 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* 12/02/2019 N/A Apparent on its Face
J0135 INJECTION, ADALIMUMAB, 20 MG Humira® 08/13/2012 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, Prostaglandin E1 08/13/2012 N/A 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 08/13/2012 N/A Apparent on its Face
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG Apokyn 08/28/2017 N/A Apparent on its Face
J0490 INJECTION, BELIMUMAB, 10 MG Benlysta®, subcutaneous* 12/02/2019 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 Miacalcin, Fortical 08/13/2012 N/A Apparent on its Face
J0801 INJECTION, CORTICOTROPIN (ACTHAR GEL), UP TO 40 UNITS Acthar Gel, subcutaneous* 10/01/2023 N/A Apparent on its Face
J0802 INJECTION, CORTICOTROPIN (ANI), UP TO 40 UNITS Purified Cortrophin Gel, subcutaneous* 10/01/2023 N/A Apparent on its Face
J1324 INJECTION, ENFUVIRTIDE, 1 MG Fuzeon® 08/13/2012 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® 08/13/2012 N/A Apparent on its Face
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone®, Glatopa 08/13/2012 N/A Apparent on its Face
J1628 INJECTION, GUSELKUMAB, 1 MG Tremfya® (guselkumab)* 06/06/2022 N/A Acceptable Evidentiary Criteria Available
J1744 INJECTION, ICATIBANT, 1 MG Firazyr® (Icatibant) 10/01/2015 N/A Apparent on its Face
J1748 INJECTION, INFLIXIMAB-DYYB (ZYMFENTRA), 10 MG ZymfentraTM (infliximab-dyyb) 09/01/2024 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®, Lantus®, Novolin, Novolog®, etc. 08/13/2012 N/A Apparent on its Face
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Lispro, Humalog, etc. 08/13/2012 N/A Apparent on its Face
J1826 INJECTION, INTERFERON BETA-1A, 30 MCG Avonex® 06/06/2022 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 08/13/2012 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 Increlex 08/13/2012 N/A Apparent on its Face
J2212 INJECTION, METHYLNALTREXONE, 0.1 MG Relistor® (methylnaltrexone bromide) 10/01/2015 N/A Apparent on its Face
J2267 INJECTION, MIRIKIZUMAB-MRKZ, 1 MG OmvohTM (mirikizumab-mrkz)* 07/01/2024 N/A Apparent on its Face
J2354 INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Sandostatin®, subcutaneous* 08/13/2012 N/A Apparent on its Face
J2940 INJECTION, SOMATREM, 1 MG N/A 08/13/2012 N/A Apparent on its Face
J2941 INJECTION, SOMATROPIN, 1 MG Genotropin®, Humatrope, Norditropin®, Nutropin, Omnitrope, Saizen, Serostim®, Zomacton™, Zorbtive 08/13/2012 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®, Zembrace 08/13/2012 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® 12/02/2019 N/A Apparent on its Face
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo® 08/13/2012 N/A Apparent on its Face
J3355 INJECTION, UROFOLLITROPIN, 75 IU Bravelle® 08/13/2012 N/A Apparent on its Face
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara® (ustekinumab) Subcutaneous 06/06/2022 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Besremi® (ropeginterferon alfa-2b, injection for subcutaneous use) 06/06/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Skyrizi™ (risankizumab-rzaa, injection for subcutaneous use)* 06/06/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Sogroya® (Somapacitan-beco, injection for subcutaneous use) 06/06/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Kineret (Anakinra) 08/13/2012 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Symlin® (Pramlintide Acetate Injection) 08/13/2012 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Pegasys®, Pegasys® Proclick™ (injection, pegylated interferon alfa-2a) 08/13/2012 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS PEG-Intron (injection, pegylated interferon alfa-2b) 08/13/2012 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Byetta® (Exenatide Injection) 08/13/2012 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Myalept™ (Metreleptin for injection, 11mg) 10/01/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Signifor® (Pasireotide) 10/01/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Victoza® (Liraglutide-GLP-1) 10/01/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Cosentyx® (secukinumab) 03/17/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Otrexup™ (methotrexate, injection) 03/17/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Sylatron™ (Peginterferon alfa-2b) 03/17/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS TriMix 03/17/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tanzeum™ (albiglutide 30mg) 10/01/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Bydureon® (Exenatide extended release for injectable suspension) 10/01/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Somavert® (Pegvisomant for injection) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Rebif® (Interferon beta 1a, 11 mcg) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Natpara® (Parathyroid hormone) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Repatha™ (Evolocumab) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Praluent® (Alirocumab) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Simponi® (golimumab) 10/24/2016 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Strensiq® (Asfotase alfa) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Egrifta® (Tesamorelin) 10/24/2016 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Plegridy® (Peginterferon beta-1a) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Trulicity® (dulaglutide) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Saxenda® (Liraglutide) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Toujeo® (Insulin glargine injection) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Taltz® (ixekizumab) 10/24/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Amjevita™ (adalimumab-atto) 08/28/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Dupixent® (dupilumab) 08/28/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Erelzi™ (etanercept-SZZS) 08/28/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Kynamro® (Mipomersen sodium) 08/28/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Orencia®, subcutaneous* 08/28/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Quad-Mix 08/28/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Rasuvo® (methotrexate, injection) 08/28/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Siliq™ (brodalumab) 08/28/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Haegarda® (Injection, c-1 esterase inhibitor [human]) 03/15/2018 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Aimovig™ 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Emgality® 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Kevzara 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Lantus® (Insulin glargine) 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Ozempic 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tymlos 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Cyltezo® 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Kesimpta* (ofatumumab, injection for subcutaneous use) 09/19/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Adbry™ (tralokinumab-Idrm) 11/14/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Mounjaro™ (tirzepatide) 03/27/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS IDACIO® (adalimumab-aacf) 06/25/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS ABRILADA (adalimumab-afzb) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS HADLIMA (adalimumab-bwwd) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS HULIO® (adalimumab-fkjp) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS HYRIMOZ (adalimumab-adaz) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS YUSIMRY (adalimumab-aqvh) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Entyvio (vedolizumab) 01/14/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS YUFLYMA (adalimumab-aaty) 01/14/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Wegovy (Semaglutide) 06/30/2024 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Zepbound (Tirzepatide) 06/30/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Wegovy (Semaglutide) 06/30/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Zepbound (Tirzepatide) 06/30/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Entyvio (vedolizumab) 01/14/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS YUFLYMA (adalimumab-aaty) 01/14/2024 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS IDACIO® (adalimumab-aacf) 06/25/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS ABRILADA (adalimumab-afzb) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS HADLIMA (adalimumab-bwwd) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS HULIO® (adalimumab-fkjp) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS HYRIMOZ (adalimumab-adaz) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS YUSIMRY (adalimumab-aqvh) is biosimilar to HUMIRA (adalimumab) 06/25/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Mounjaro™ (tirzepatide) 03/27/2023 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adbry™ (tralokinumab-Idrm) 11/14/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Kesimpta* (ofatumumab, injection for subcutaneous use) 09/19/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Aimovig™ 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Emgality® 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Kevzara 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Lantus® (Insulin glargine) 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Ozempic 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Tymlos 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Amjevita™ (adalimumab-atto) 08/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Dupixent® (dupilumab) 08/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Erelzi™ (etanercept-SZZS) 08/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Kynamro® (Mipomersen sodium) 08/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Orencia®, subcutaneous* 08/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Quad-Mix 08/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Rasuvo® (methotrexate, injection) 08/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Siliq™ (brodalumab) 08/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Taltz® (ixekizumab) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Otrexup™ (methotrexate, injection) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS TriMix 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Plegridy® (Peginterferon beta-1a) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Egrifta® (Tesamorelin) 10/24/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Strensiq® (Asfotase alfa) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Simponi® (golimumab) 10/24/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Praluent® (Alirocumab) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Repatha™ (Evolocumab) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Natpara® (Parathyroid hormone) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Rebif® (Interferon beta 1a, 11 mcg) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS PEG-Intron (Peginterferon alfa-2b) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Symlin® (Pramlintide Acetate Injection) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Kineret (Anakinra) 10/24/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Bydureon® (Exenatide extended release for injectable suspension) 10/01/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Saxenda® (Liraglutide) 10/01/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Tanzeum™ (albiglutide 30mg) 10/01/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Victoza® (Liraglutide) 10/01/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Signifor® (Pasireotide) 10/01/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Myalept™ (Metreleptin for injection, 11mg) 10/01/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Byetta® (Exenatide) 10/01/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Cosentyx® (secukinumab) 03/17/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Pegasys®, Pegasys® Proclick™ (injection, pegylated interferon alfa-2a) 03/17/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Sylatron™ (Peginterferon alfa-2b) 03/17/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Toujeo® (Insulin glargine injection) 03/17/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Trulicity® (dulaglutide) 03/17/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Somavert® (Pegvisomant for injection) 08/13/2012 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Haegarda® (Injection, c-1 esterase inhibitor [human]) 03/15/2018 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Cyltezo 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Besremi® (ropeginterferon alfa-2b, injection for subcutaneous use) 06/06/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Skyrizi™ (risankizumab-rzaa, injection for subcutaneous use)* 06/06/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Sogroya® (Somapacitan-beco, injection for subcutaneous use) 06/06/2022 N/A Apparent on its Face
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM N/A 08/13/2012 N/A Apparent on its Face
J9213 INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS N/A 08/13/2012 N/A Apparent on its Face
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune
 08/13/2012 N/A Apparent on its Face
J9218 LEUPROLIDE ACETATE, PER 1 MG Lupron 08/13/2012 N/A Presumption of Long-Term Non-Acute Administration
Q0515 INJECTION, SERMORELIN ACETATE, 1 MICROGRAM N/A 08/13/2012 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 01/01/2024 N/A Apparent on its Face
Q5137 INJECTION, USTEKINUMAB-AUUB (WEZLANA), BIOSIMILAR, SUBCUTANEOUS, 1 MG WEZLANATM (ustekinumab-auub) 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 Zinbryta™ (Daclizumab) 10/24/2016 01/01/2021 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Omvoh (mirikizumab-mrkz)* EFFECTIVE 7/1/2024 REPLACED BY CODE J2267 (SEE EXCLUDED CPT/HCPCS Codes TABLE ABOVE) 01/14/2024 07/01/2024 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS WEZLANA (ustekinumab-auub)* EFFECTIVE 7/1/2024, REPLACED BY CODE Q5137 (SEE EXCLUDED CPT/HCPCS Codes TABLE ABOVE) 03/17/2024 07/01/2024 Apparent on its Face
J1558 INJECTION, IMMUNE GLOBULIN (XEMBIFY), 100 MG Xembify® 06/06/2022 06/06/2022 Apparent on its Face
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Hizentra® 10/24/2016 01/01/2021 Presumption of Long-Term Non-Acute Administration
J3262 INJECTION, TOCILIZUMAB, 1 MG Actemra®, subcutaneous* 12/02/2019 01/01/2021 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Zinbryta™ (Daclizumab) 10/24/2016 01/01/2021 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Omvoh (mirikizumab-mrkz)* EFFECTIVE 7/1/2024 REPLACED BY CODE J2267 (SEE EXCLUDED CPT/HCPCS Codes TABLE ABOVE) 01/14/2024 07/01/2024 Apparent on its Face
J3490 UNCLASSIFIED DRUGS WEZLANA (ustekinumab-auub)* EFFECTIVE 7/1/2024, REPLACED BY CODE Q5137 (SEE EXCLUDED CPT/HCPCS Codes TABLE ABOVE) 03/17/2024 07/01/2024 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS WEZLANA (ustekinumab-auub)* EFFECTIVE 7/1/2024, REPLACED BY CODE Q5137 (SEE EXCLUDED CPT/HCPCS Codes TABLE ABOVE) 03/17/2024 07/01/2024 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Omvoh (mirikizumab-mrkz)* EFFECTIVE 7/1/2024 REPLACED BY CODE J2267 (SEE EXCLUDED CPT/HCPCS Codes TABLE ABOVE) 01/14/2024 07/01/2024 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Simponi (Injection, golimumab) 08/13/2012 08/13/2012
J3590 UNCLASSIFIED BIOLOGICS Raptiva (Efalizumab) *discontinued drug 08/13/2012 10/01/2015
J3590 UNCLASSIFIED BIOLOGICS Zinbryta™ (Daclizumab) 10/24/2016 01/01/2021 Apparent on its Face
XX000 Not Applicable Not Applicable 08/13/2012 08/13/2012
XX000 Not Applicable N/A 08/13/2012 08/13/2012
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
09/11/2024 R25

Article revised and published on 10/31/2024 effective for dates of service on and after 09/11/2024. An asterisk has been added to J1628 Tremfya® (guselkumab)* to indicate the requirement of the JA or JB modifier in response to the IV formulation FDA approval.
09/01/2024 R24

Article revised and published on 07/18/2024 effective for dates of service on and after 07/01/2024. The codes C9399, J3490, and J3590 for WezlanaTM (ustekinumab-auub) and OmvohTM (mirikizumab-mrkz) were removed from the Excluded CPT/HCPCS Codes Table and replaced with J2267 (OmvohTM) and Q5137 (WezlanaTM). The asterisk has been removed from Cosentyx® (secukinumab), listed with C9399, J3490 and J3590, because it no longer requires JA or JB modifiers.

Effective for dates of service on and after 09/01/2024, the code J1748 for drug ZymfentraTM (infliximab-dyyb) has been added to the Excluded CPT/HCPCS Codes Table.

Minor formatting changes have been made throughout the article. These revisions are in response to the July Quarterly CPT/HCPCS update.
06/30/2024 R23

Article revised and published on 05/16/2024 effective for dates of service on and after 06/30/2024. Drugs Wegovy (Semaglutide) and Zepbound (Tirzepatide) have been added to the Excluded CPT/HPCPCS Codes table for codes C9399, J3490, and J3590. 
03/17/2024 R22

Article revised and published on 02/01/2024 effective for dates of service on and after 01/01/2024. The code Q5132 has been added for drug Abrilada (INJECTION, ADALIMUMAB-AFZB (ABRILADA), BIOSIMILAR, 10 MG).

Effective for dates of service on and after 03/17/2024, the drug WEZLANA (ustekinumab-auub)* has been added for codes C9399, J3490, and J3590.

The asterisk has been removed for the following drugs for CPT/HCPCS Codes C9399, J3490, and J3590: ABRILADA, HADLIMA, HULIO, HYRIMOZ, YUSIMRY. These drugs do not require the JA or JB modifier.
01/14/2024 R21

Article revised and published on 11/30/2023 effective for dates of service on and after 01/14/2024. An asterisk was added for Cosentyx® (secukinumab)* (HCPCS codes C9399, J3490 and J3590) to indicate that this drug must be billed with either the JA or JB modifier. The SQ form of Entyvio (vedolizumab) (HCPCS codes C9399, J3490 and J3590) was added to the article. The JA and JB modifiers do not apply to this drug because the IV form has a specific HCPCS code. YUFLYMA (adalimumab-aaty) (HCPCS codes C9399, J3490 and J3590) was added to the article. The JA and JB modifiers do not apply to this drug because it is for SQ use. The SQ form of Omvoh (mirikizumab-mrkz)* (HCPCS codes C9399, J3490 and J3590) was added to the article with an asterisk to indicate that this drug must be billed with either the JA or JB modifier. Language was added to the ‘Route of Administration Modifier’ section to indicate that the drugs represented by HCPCS codes J0801 and J0802 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.
10/01/2023 R20

Article revised and published on 10/05/2023 effective for dates of service on and after 10/01/2023 to reflect the CPT/HCPCS Code Updates. The following HCPCS code has been deleted and therefore has been removed from the article: J0800 in the Excluded CPT/HCPCS Codes Table. The following HCPCS codes have been added to the article: J0801 and J0802 in the Excluded CPT/HCPCS Codes Table.

HCPCS codes J0801 and J0802 require a Route of Administration Modifier as identified by an asterisk.
09/03/2023 R19

Article revised and published on 07/20/2023 effective for dates of service on and after 09/03/2023 to add the following drugs and associated HCPCS codes: Fiasp® (insulin aspart) for administration through DME using code J1811 , Fiasp® (insulin aspart) injection using code J1812, Lyumjev® (insulin lispro-aabc) for administration through DME using code J1813, Lyumjev® (insulin lispro-aabc) injection using code J1814, Furoscix (furosemide) injection using code J1941, and Idacio® (adalimumab-aacf) injection using code Q5131.

HCPCS codes J1812 and J1814 require a Route of Administration Modifier as identified by an asterisk.

06/25/2023 R18

Article revised and published on 05/11/2023 effective for dates of service on and after 06/25/2023 to add IDACIO® (adalimumab-aacf), 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), and YUSIMRY (adalimumab-aqvh) is biosimilar* to HUMIRA (adalimumab) using the NOC codes C9399, J3490, and J3590.
03/27/2023 R17

Article revised and published on 02/09/2023 effective for dates of service on and after 03/27/2023 to add Mounjaro™ (tirzepatide) using the NOC codes C9399, J3490 and J3590.
11/14/2022 R16

Article revised and published on 09/29/2022 effective for dates of service on and after 11/14/2022 to add Adbry™ (tralokinumab-Idrm) using the NOC codes C9399, J3490 and J3590 and to add an * next to Skyrizi to indicate need for JA or JB modifier.
09/19/2022 R15

Article revised and posted for notice on 08/04/2022 effective for dates of service on and after 09/19/2022. Kesimpta* (ofatumumab, injection for subcutaneous use) (C9399, J3490, J3590) has been added to the Self-Administered Drug Exclusion List in response to the July Quarterly CPT/HCPCS code update. An asterisk (*) has been added on all three HCPCS codes to indicate this drug has multiple routes of administration and must be billed with the appropriate modifier.
06/06/2022 R14

Article revised and posted for notice on 06/02/2022 effective for dates of service on and after 06/06/2022. Xembify® (Injection, immune globulin) (J1558) has been removed from the Self-Administered Drug (SAD) Exclusion List table and added to the ‘Non-Excluded CPT/HCPCS Ended Codes’ table related to Change Request 11880 which includes changes to the Medicare home infusion therapy services benefit. This drug is not included on the list of self-administered drugs.
06/06/2022 R13

Article revised and posted for notice on 04/21/2022 effective for dates of service on and after 06/06/2022. The following drugs have been evaluated by Novitas and have been determined to be usually self-administered drugs. Medicare data supports that these drugs are self-administered by more than 50 percent of Medicare beneficiaries; therefore, the following drugs have been added to the Self-Administered Drug Exclusion List: Xembify® (Injection, immune globulin) (J1558), Tremfya® (guselkumab) (J1628), Avonex® (interferon beta-1a) (J1826), Stelara® (ustekinumab) subcutaneous (J3357) Besremi® (ropeginterferon alfa-2b) (J3490, J3590, C9399), Skyrizi™ (risankizumab-rzaa) (J3490, J3590, C9399) and Sogroya®(Somapacitan-beco) (J3490, J3590, C9399).
10/21/2021 R12

Article revised and published on 10/21/2021 to update the JA and JB modifier wording.
04/05/2021 R11

Article revised and published on 02/18/2021 effective for dates of service on and after 04/05/2021. The Route of Administration Modifier note has been revised to add new language regarding the use of the JA and JB modifiers for drugs with multiple routes of administration. An asterisk (*) has been added to J0129, J0490 and J2354 to indicate these drugs have multiple routes of administration and must be billed with the appropriate modifier.
01/01/2021 R10

Article, revised and published on 01/07/2021 and effective for dates of service on and after 01/01/2021. Hizentra (J1559) has been removed from this Self-Administered Drug (SAD) List Article in response to CR11880 which includes changes to the Medicare home infusion therapy services benefit. Zinbryta (C9399, J3490 and J3590) has been taken off of the Worldwide market due to safety concerns. Therefore, Zinbryta will be removed from the article. After review of the current list it has been determined that Actemra (J3262) will be removed from the SAD list.
12/02/2019 R9

Article revised and posted for notice on 10/17/2019 to add the following drugs effective for dates of service on and after 12/02/2019: J3262 Actemra®; C9399, J3490, J3590 Aimovig™; J3031 Ajovy®; J0490 Benlysta®; C9399, J3490, J3590 Cyltezo®; C9399, J3490, J3590 Emgality®; C9399, J3490, J3590 Kevzara; C9399, J3490, J3590 Lantus Solostar®; J0129 Orencia; C9399, J3490, J3590 Ozempic; J0593 Takhzyro®; C9399, J3490, J3590 Tymlos. The following drugs have more than one method of administration available; the subcutaneous route is the route of administration being added to the SAD list for the following drugs: Actemra®; Benlysta®; Sandostatin®; Orencia®. Provider education has been added to the Article text regarding the JB modifier and the SAD list drug codes that require the application of the JB modifier to indicate subcutaneous route of administration; those drugs are indicated with an asterisk in the Coding Table. Removed sticky note dated 2016 which remains accessible on previous versions.
01/01/2019 R8

Article revised and published on 02/14/2019 effective for dates of service on and after 01/01/2019 to reflect the annual CPT/HCPCS code updates. The following CPT/HCPCS code(s) have been added to the SAD list: J0599: Haegarda®.
03/15/2018 R7

Article revised and posted for notice on 01/25/2018 to add the following drugs effective for dates of service on and after 03/15/2018: J3490, J3590: Haegarda ®.
08/28/2017 R6

Article revised and posted for notice on 07/13/2017 to add the following drugs effective for dates of service on and after 08/28/2017: J0800: H.P. Acthar® Gel; J0364: Apokyn;  C9399, J3490, J3590: Amjevita™; C9399, J3490, J3590: Dupixent®; C9399, J3490, J3590: Erelzi™; C9399, J3490, J3590: Kynamro®;  C9399, J3490, J3590: Orencia®; C9399, J3490, J3590: Quad-Mix; C9399, J3490, J3590: Rasuvo®; C9399, J3490, J3590: Siliq™. The following brand name drugs were added for the following CPT/HCPCS codes: J1595: Glatopa; J1830: Extavia; J2941: Omnitrope, Zomacton™, Zorbtive; J3030: Sumavel® Dosepro®, Zembrace; C9399, J3490, J3590: Pegasys® Proclick™.
10/24/2016 R5 Article revised and posted for notice on 09/08/2016 to create a uniform Article with other MAC Jurisdiction and to add the following drugs effective for dates of service on and after 10/24/16: J1559: Hizentra®; C9399, J3590: Kineret; C9399: Cosentyx®; C9399, J3590: Otrexup™; C9399, J3490: Trulicity®; C9399, J3490, J3590: Egrifta®; C9399, J3490, J3590: Plegridy®; C9399, J3490, J3590: Rebif®; C9399, J3490, J3590: Praluent®; C9399, J3490, J3590: Repatha™; C9399, J3490, J3590: Natpara®; C9399, J3590: Symlin®; C9399, J3590: PEG-Intron®; C9399, J3490: Somavert®; J3590: TriMix; C9399, J3490: Saxenda; C9399, J3490 Toujeo®; C9399, J3490, J3590: Simponi®; C9399, J3490, J3590: Strensiq®; C9399, J3490, J3590: Zinbryta™; C9399, J3490, J3590: Taltz ®.
10/24/2016 R4 Article revised and posted for notice on 09/08/2016 to create a uniform Article with other MAC Jurisdiction and to add the following drugs effective for dates of service on and after 10/24/16: J1559: Hizentra®; C9399, J3590: Kineret; C9399: Cosentyx®; C9399, J3590: Otrexup™; C9399, J3490: Trulicity®; C9399, J3490, J3590: Egrifta®; C9399, J3490, J3590: Plegridy®; C9399, J3490, J3590: Rebif®; C9399, J3490, J3590: Praluent®; C9399, J3490, J3590: Repatha™; C9399, J3490, J3590: Natpara®; C9399, J3590: Symlin®; C9399, J3590: PEG-Intron®; C9399, J3490: Somavert®; J3590: TriMix; C9399, J3490: Saxenda; C9399, J3490 Toujeo®; C9399, J3490, J3590: Simponi®; C9399, J3490, J3590: Strensiq®; C9399, J3490, J3590: Zinbryta™
03/17/2016 R3 Article revised and posted for notice on 01/28/2016 effective for dates of service on and after 03/17/2016 to add the following drugs: J3490, J3590 Cosentyx; J3490 Otrexup; C9399, J3590 Interferon, alfa-2a, Pegasys; C9399, J3490, J3590 Interferon, alfa-2b, Sylatron; J3590 Toujeo; C9399, J3490 Trimix; J3590 Trulicity.
10/01/2015 R2 Article revised and posted for notice 8/13/2015 effective for 10/01/2015 to create a uniform Article with other MAC jurisdictions and to add the following drugs: C9399, J3590 Byetta (exanatide); C9399, J3490, J3590 Bydureon (exenatide); J3590 Saxenda (liraglutide); C9399, J3490, J3590 Tanzeum (albiglutide); C9399, J3490, J3590 Victoza (liraglutide); J1744 Firazyr (icatibant); J2212, Relistor (methylnaltrexone bromide); C9399, J3490, J3590 Pasireotide (SIGNIFOR®); C9399, J3490, J3590 Metreleptin for injection, (Myalept™).

The following drugs are new for the JL states (Pennsylvania, Maryland, Delaware, District of Columbia, New Jersey): J3355 Injection, Urofollitropin, 75 IU, Bravelle; J3490 Unclassified Drugs, Byetta (Exenatide Injection).

The following drugs have been removed from the Descriptor Brand Name column because they have been discontinued by the FDA: J0630 (Calcimar); J1815 (Regular, NPH, Lente, Ultralente); J2170 (Iplex); J2940 (Protropin); J3355 (Metrodin, Fertinex); J9212 (Infergen); J9213 (Roferon-A); Q0515 (Geref).

The following codes have been end dated for the JH states (Arkansas, Louisiana, Mississippi, Colorado, Texas, Oklahoma, New Mexico) due to the drug listed for that code has been discontinued by the FDA: J3590, UNCLASSIFIED BIOLOGICS (Raptiva).
10/01/2015 R1 Article updated on 8/18/2014 to remove the following states which were incorrectly applied to this article: Pennsylvania, Maryland, Delaware, New Jersey and the District of Columbia. This article never became effective for these states. SAD Process URL 1 also updated. Article published on 08/28/2014.
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Medicare BPM Ch 15.50.2 SAD Determinations
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