SUPERSEDED LCD Reference Article Self-Administered Drug Exclusion List Article

Self-Administered Drug Exclusion List:

A52571

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NOT AN LCD REFERENCE ARTICLE
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Document Note

Posted: 2/8/2024
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). Q5132 is a new code for Abrilada, which has been on the list with HCPCS codes C9399, J3490 and J3590. This code was formally added to the Coding Information Table section in the version of this article to be effective 03/17/2024.

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A52571
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
10/01/2023
Revision Ending Date
01/13/2024
Retirement Date
N/A
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CMS National Coverage Policy

N/A

Article Guidance

Article Text

Background

The Social Security Act does not provide a comprehensive drug benefit for Medicare beneficiaries. For Part A (inpatient), drugs provided during acute inpatient stays and qualified skilled nursing facility stays are generally covered if Medicare requirements are met. For Part B (outpatient, including outpatient hospital such as the emergency room), drugs and biological coverage is generally limited to the type of drugs that cannot be self-administered (SA), are medically necessary and reasonable, are Food and Drug Administration (FDA) approved, and are incident to the services of physicians in the treatment of patients as defined in the Carrier, Intermediary and Hospital manuals. Payment for drugs and supplies used in the performance of procedures is included in the fee for the procedure and are not separately billable to Medicare or the beneficiary.

Congress changed the Medicare definition of the type of drugs that cannot be self-administered with passage of the Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP) Benefits Improvement and Protection Act (BIPA) of 2000 to usually not self-administered. As a result of this benefit structure, SA drugs and biologicals (pill form or injection form) in the outpatient setting are usually not covered except where Congress has provided for additional coverage. Examples of such coverage include specific blood clotting factors, drugs used in immunosuppressive therapy, renal dialysis related erythropoietin, osteoporosis drugs for certain homebound patients, some oral anti-cancer drugs, and some anti-nausea drugs in combination with oral or intravenous chemotherapy.

The Centers for Medicare and Medicaid Services (CMS) has published two Program Memorandums on this issue. Transmittal AB-02-072, Change Request 2200, which was released on May 15, 2002, provides clarification of Section 112 of the BIPA. Change Request 2200 supersedes the following program instructions:

- Medicare Carriers Manual, Section 2049.2
- Intermediary Manual, Sections 3112.4B & 3660.11
- Hospital Manual, Sections 230.4, E205 & 422.

This transmittal instructs contractors to define usually not self-administered as more than 50 percent of the time for all Medicare beneficiaries who use the drug. A drug self-administered by more than 50 percent of Medicare beneficiaries is excluded from coverage. This definition and other criteria in the transmittal will necessitate an evaluation process by Carriers and Intermediaries prior to applying the exclusion. Transmittal AB-02-139 Change Request 2311, which was released on 10/11/2002, provided additional guidance for applying the Medicare Self-Administered Drug Exclusion.

The Medicare exclusion is clear for oral drugs, suppositories and topical medications. For drugs that have previously been covered as an integral part of the procedure, (e.g., a topical ophthalmic anesthetic is not separately reimbursed but is considered part of the fee for the procedure), there is no change. The issues arise with the drugs that are given by intravenous (IV), intramuscular (IM), subcutaneous (SQ) or multiple routes of administration.

These transmittals instruct each individual contractor to develop a process for the determination on each drug. For drugs that have multiple indications and routes of administration, contractors will consider all of the indications and routes of administration when making a single determination for a drug.

Contractors must continue to apply the policy that not only is the drug medically reasonable and necessary for any individual claim, but also that the route of administration is medically reasonable and necessary. In making the determination, the contractor must use the guidelines in the transmittals, as well as to the extent available, any peer reviewed medical literature; standards of medical practice; FDA approval language, package inserts, other drug compendia as appropriate; evidence-based practice guidelines; and other information submitted by interested individuals or groups.

Terms Defined by the CMS

Acute Condition: a condition that is likely to be of short duration and/or the expected course of treatment is for a short, finite interval (usually less than 2 weeks).

Chronic Condition: a condition that is expected to last longer than 2 weeks.

Infrequent Use: less than once per week (e.g., once per month).

Frequent Use: once or more per week (e. g., once per week).

Administered: the term administered refers to the physical process by which the drug enters the patient’s body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). Only injectable (including intravenous) drugs are eligible for inclusion under the “incident to” benefit.

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.

By the Patient: the term “by the patient” means Medicare beneficiaries as a collective whole, which includes the patients themselves, and not other individuals who may assist with the administration of the drug. The contractor is not to consider individual beneficiaries who do not have the capacity to SA any drug due to a condition other than the condition for which they are taking the drug in question.

Frequency: to determine frequency, consider how often the drug is administered. For example, if the drug is administered once per month, it is less likely to be SA. If the drug is administered once or more per week, it is likely that the drug is SA.

Usually: 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, regardless of the indication or route of administration.

Process For Determining List of Excluded Injectable Drugs

During the implementation of this new process for determining coverage of drugs and biologicals, First Coast Service Options (FCSO), Inc.’s current medical review and payment policies will continue to be in effect. Providers will be given a 45-day notice period if a previously covered drug is determined to be non-covered. Also, providers and beneficiaries will have the usual and customary appeal rights for denied coverage. Interested parties who wish to comment on the list should address their comments to First Coast Service Options Medical Affairs, 2020 Technology Parkway, Suite 100, Mechanicsburg, PA 17050-9419 or you may email the comments to MedicalAffairs@guidewellsource.com.

The Process for Determining the List of Excluded Injectable Drugs involves a 10 step process.

Step 1 represents the Apparent on its Face Determination

  1. Is it apparent on its face that the drug is self-administrable?

    Yes Presumed to be usually self-administered (USA), non-covered.

    No Go to Steps 2-6.

    Steps 2-6 represent the Presumptive Factors for the Determination of Self-Administration

  2. Is the drug administered orally, topically, or by suppository?

    Yes Presumed to be usually self-administered (USA), non-covered.

    No Go to question #3.

  3. Is it always administered IV? Absent evidence to the contrary, drugs delivered IV are presumed to not usually be self-administered (NUSA).

    Yes Presumed to be NUSA, covered, if other requirements are met.

    No Go to question #4.

  4. Is it always administered IM? Absent evidence to the contrary, drugs delivered IM are presumed to not usually be self-administered (NUSA).

    Yes Presumed to be NUSA, covered, if other requirements are met.

    No Go to question #5.

  5. Is it always administered SQ? Absent evidence to the contrary, drugs delivered SQ are presumed to be self-administered (SA) by the patient.

    Yes Presumed to be SA, excluded from coverage.

    No Go to steps 6-10.

    Steps 6-10 represents the Evidentiary Factors in the Determination Process (These steps are to be used when data exists to support the coverage determination of a drug.)

  6. List the outpatient clinical indication(s) (frequency, chronic/acute conditions as listed in the package insert).

  7. Determine % utilization by clinical indication and route of administration.

    Estimate the % SA

    (> or < 50%) by indication. Use a variety of sources/factors which include: acute/chronic, setting, clinical parameter, FDA/drug inserts, pharmacy data, hospital data, health plan data, formulary data, etc.

  8. Review claims data for setting, specialty, provider, clinical indication, etc.

  9. Review information from interested parties and prioritize all available levels of evidence and make the final determination.

  10. Was drug determined to be USA by more than 50% of Medicare beneficiaries?

        Yes Non-covered service, 45-day notice period if previously covered, notify via web site.

        No Covered service.

 

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 form of administration. Absent evidence 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.

Response To Comments

Number Comment Response
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Coding Information

Bill Type Codes

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Revenue Codes

Code Description
99999 Not Applicable
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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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ICD-10-CM Codes that Support Medical Necessity

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

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ICD-10-PCS 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.

Code Description
N/A

Revenue Codes

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

Code Description
99999 Not Applicable
N/A

Other Coding Information

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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 Exenatide extended release for injectable suspension (Bydureon™) 08/06/2012 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Liraglutide (VICTOZA®) 05/01/2010 N/A Acceptable Evidentiary Criteria Available
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Golimumab (SIMPONI ®) 05/01/2010 N/A Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tesamorelin (Egrifta ™) 06/04/2011 N/A Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Anakinra (Kineret ™) 100 mg 04/13/2003 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Exenatide injection (Byetta®) 01/19/2006 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Peginterferon alpha 2a (Pegasys® Pegasys® Proclick™) 03/05/2006 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Peginterferon alfa-2b (Sylatron™) 05/19/2012 N/A Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Pasireotide (SIGNIFOR®) 06/17/2013 N/A Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Dulaglutide (Trulicity™) 09/28/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Methotrexate Injection (Otrexup™) 09/28/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Peginterferon beta-1a (PLEGRIDY®) 09/28/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Secukinumab (Cosentyx™) 09/28/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Albiglutide for SQ injection (Tanzeum™) 30mg 12/01/2014 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Interferon beta 1a, 1 mcg (Rebif®) 01/01/2014 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Myalept® Metreleptin for injection 11 mg 10/13/2014 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Alirocumab (Praluent®) 01/18/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Evolocumab (Repatha™) 01/18/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Parathyroid hormone (Natpara®) 01/18/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Asfotase alfa (Strensiq™) 05/23/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS TriMix 10/31/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS pegylated interferon alfa-2b) (PegIntron®) 10/31/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Saxenda® (Liraglutide) 10/31/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Somavert® (Pegvisomant) 10/31/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Symlin® (Pramlintide Acetate Injection) 10/31/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Toujeo® (Insulin glargine injection) 10/31/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Taltz™ (Ixekizumab) 10/31/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Siliq™ (brodalumab) 11/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Amjevita™ (adalimumab-atto) 11/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Dupixent® (dupilumab) 11/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Erelzi™ (etanercept-SZZS) 11/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kynamro®, (Mipomersen sodium) 11/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Quad-Mix 11/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Rasuvo® (methotrexate, injection for subcutaneous use) 11/16/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tymlos™ (abaloparatide) 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kevzara® (sarilumab) 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ozempic® (semaglutide) 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Aimovig® (erenumab-aooe) 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Lantus® SoloStar® (insulin glargine injection) 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Emgality® (galcanezumab-gnlm) 12/02/2019 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Cyltezo™ (adalimumab-adbm) 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
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* 11/16/2017 N/A Apparent on its Face
J0135 INJECTION, ADALIMUMAB, 20 MG Humira® 09/20/2005 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) Caverject, Prostaglandin E1 11/29/2002 N/A Presumption of Long-Term Non-Acute Administration
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™ 10/31/2016 N/A Apparent on its Face
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG Apokyn 11/16/2017 N/A Apparent on its Face
J0490 INJECTION, BELIMUMAB, 10 MG Benlysta (belimumab) subcutaneous use* 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® (lanadelumab-flyo) 12/02/2019 N/A Apparent on its Face
J0599 INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA), 10 UNITS HAEGARDA, subcutaneous use 01/01/2019 N/A Apparent on its Face
J0630 INJECTION, CALCITONIN SALMON, UP TO 400 UNITS Miacalcin, Calcimar, Calcitonin-salmon 12/26/2011 N/A Apparent on its Face
J0801 INJECTION, CORTICOTROPIN (ACTHAR GEL), UP TO 40 UNITS 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 ™ 11/26/2004 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® 12/20/1999 N/A Apparent on its Face
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone®, Glatopa® 04/12/2003 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 Icatibant (Firazyr®) 05/19/2012 N/A Apparent on its Face
J1811 INSULIN (FIASP) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Fiasp® for insulin pump 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 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®, Levemir®, Novolin®, Novolog® 08/01/2002 N/A Apparent on its Face
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Humalog®, Humulin®, Novolin®, Novolog®, Insulin Lispro®, Apidra Solostar® 04/30/2009 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® 04/19/1999 N/A Apparent on its Face
J1941 INJECTION, FUROSEMIDE (FUROSCIX), 20 MG Furoscix® injection 09/03/2023 N/A Apparent on its Face
J2170 INJECTION, MECASERMIN, 1 MG Increlex 10/31/2016 N/A Apparent on its Face
J2212 INJECTION, METHYLNALTREXONE, 0.1 MG Relistor® 04/20/2009 N/A Apparent on its Face
J2354 INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Sandostatin, subcutaneous use* 10/31/2016 N/A Apparent on its Face
J2940 INJECTION, SOMATREM, 1 MG Protropin 11/29/2002 N/A Presumption of Long-Term Non-Acute Administration
J2941 INJECTION, SOMATROPIN, 1 MG Genotropin®, Humatrope®, Norditropin®, Nutropin®, Omnitrope®, Saizen®, Serostim®, Zomacton™, Zorbtive® 12/20/1999 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™ 11/29/2002 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™ (fremanezumab-vfrm) 12/02/2019 N/A Apparent on its Face
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo® 09/01/2006 N/A Apparent on its Face
J3355 INJECTION, UROFOLLITROPIN, 75 IU Bravelle® 10/31/2016 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 pegylated interferon alfa-2b) (PegIntron®) 10/31/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Symlin® (Pramlintide Acetate Injection) 10/31/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Somavert® (Pegvisomant) 10/31/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS TriMix 10/31/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Saxenda® (Liraglutide) 10/31/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Exenatide extended release for injectable suspension Bydureon(™) 08/06/2012 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Anakinra (Kineret (™) 100 mg 04/13/2003 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Exenatide injection (Byetta®) 01/19/2006 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Golimumab (SIMPONI®) 05/01/2010 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Tesamorelin (Egrifta ™) 06/04/2011 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Peginterferon alfa-2b(Sylatron ™) 05/19/2012 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Pasireotide (SIGNIFOR®) 06/17/2013 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Parathyroid hormone (Natpara®) 01/18/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Evolocumab (Repatha™) 01/18/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Alirocumab (Praluent®) 01/18/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS albiglutide for SQ injection (Tanzeum™) 30mg 12/01/2014 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Interferon beta 1a, 1 mcg (Rebif®) 01/01/2014 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Liraglutide (VICTOZA®) 05/01/2010 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Peginterferon alpha 2a (Pegasys®), Pegasys® Proclick™) 03/05/2006 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Dulaglutide (Trulicity™) 09/28/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Methotrexate Injection (Otrexup™) 09/28/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Secukinumab (Cosentyx™) 09/28/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Asfotase alfa (Strensiq™) 05/23/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Myalept® Metreleptin for injection 11 mg 10/13/2014 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Toujeo® (Insulin glargine injection) 10/31/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Plegridy® 09/28/2015 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Taltz™ (Ixekizumab) 10/31/2016 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Amjevita™ (adalimumab-atto) 11/16/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Dupixent® (dupilumab) 11/16/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Erelzi™ (etanercept-SZZS) 11/16/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Kynamro®, (Mipomersen sodium) 11/16/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Tymlos™ (abaloparatide) 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Kevzara® (sarilumab) 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Ozempic® (semaglutide) 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Aimovig® (erenumab-aooe) 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Lantus® SoloStar® (insulin glargine injection) 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Emgality® (galcanezumab-gnlm) 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Cyltezo™ (adalimumab-adbm) 12/02/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Quad-Mix 11/16/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Rasuvo® (methotrexate, injection for subcutaneous use) 11/16/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Siliq™ (brodalumab) 11/16/2017 N/A Apparent on its Face
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 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
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 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
J3590 UNCLASSIFIED BIOLOGICS Amjevita™ (adalimumab-atto) 11/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Dupixent® (dupilumab) 11/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Erelzi™ (etanercept-SZZS) 11/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Kynamro®, (Mipomersen sodium) 11/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Quad-Mix 11/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Rasuvo® (methotrexate, injection for subcutaneous use) 11/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Siliq™ (brodalumab) 11/16/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Taltz™ (Ixekizumab) 10/31/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Toujeo® (Insulin glargine injection) 10/31/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Myalept® Metreleptin for injection 11 mg 10/13/2014 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS albiglutide for SQ injection (Tanzeum™) 30mg 12/01/2014 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Interferon beta 1a, 1 mcg (Rebif®) 01/01/2014 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Asfotase alfa (Strensiq™) 05/23/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Anakinra (Kineret ™) 100 mg 04/13/2003 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Exenatide Injection (Byetta®) 01/19/2006 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Golimumab (SIMPONI®) 05/10/2010 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Dulaglutide (Trulicity™) 09/28/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Methotrexate Injection (Otrexup™) 09/28/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon beta-1a (PLEGRIDY®) 09/28/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Secukinumab (Cosentyx™) 09/28/2015 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Tesamorelin (Egrifta ™) 06/04/2011 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Pasireotide (SIGNIFOR®) 06/17/2013 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Alirocumab (Praluent®) 01/16/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Evolocumab (Repatha™) 01/18/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Parathyroid hormone (Natpara®) 01/18/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Exenatide extended release for injectable suspension [Bydureon(™)]

08/06/2012 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon alpha 2a (Pegasys®), Pegasys® Proclick™) 03/05/2006 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Liraglutide (VICTOZA®) 05/01/2010 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon alfa-2b(Sylatron ™) 05/19/2012 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Saxenda® (Liraglutide) 10/31/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS TriMix 10/31/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Somavert® (Pegvisomant) 10/31/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Symlin® (Pramlintide Acetate Injection) 10/31/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS pegylated interferon alfa-2b) (PegIntron®) 10/31/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Tymlos™ (abaloparatide) 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Kevzara® (sarilumab) 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Ozempic® (semaglutide) 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Aimovig® (erenumab-aooe) 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Lantus® SoloStar® (insulin glargine injection) 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Emgality® (galcanezumab-gnlm) 12/02/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Cyltezo™ (adalimumab-adbm) 12/02/2019 N/A Apparent on its Face
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Infergen® 10/31/2016 N/A Apparent on its Face
J9213 INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS N/A 10/31/2016 N/A Apparent on its Face
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune 10/31/2016 N/A Apparent on its Face
J9218 LEUPROLIDE ACETATE, PER 1 MG Lupron®, Eligard® 12/20/1999 N/A Apparent on its Face
Q0515 INJECTION, SERMORELIN ACETATE, 1 MICROGRAM N/A 10/23/2016 N/A Apparent on its Face
Q5131 INJECTION, ADALIMUMAB-AACF (IDACIO), BIOSIMILAR, 20 MG Idacio® injection 09/03/2023 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
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS methylnatrexone bromide (Relistor®) 04/20/2009 12/31/2012
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Icatibant
(Firazyr ®)
05/19/2012 12/31/2012
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Daclizumab (Zinbryta™) 10/31/2016 01/01/2021 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Orencia®, subcutaneous only 11/16/2017 12/02/2019 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® 06/18/2011 01/01/2021 Presumption of Long-Term Non-Acute Administration
J2502 INJECTION, PASIREOTIDE LONG ACTING, 1 MG Injection Pasireotide long acting 1 mg 10/31/2016 04/05/2021 Apparent on its Face
J3262 INJECTION, TOCILIZUMAB, 1 MG Actemra® (tocilizumab) subcutaneous use* 12/02/2019 01/01/2021 Apparent on its Face
J3490 UNCLASSIFIED DRUGS methylnatrexone bromide (Relistor®) 04/20/2009 12/31/2012
J3490 UNCLASSIFIED DRUGS Icatibant
(Firazyr ®)
05/19/2012 12/31/2012
J3490 UNCLASSIFIED DRUGS Daclizumab (Zinbryta™) 10/31/2016 01/01/2021 Apparent on its Face
J3490 UNCLASSIFIED DRUGS Haegarda® (C1 Esterase Inhibitor Subcutaneous [Human]) 04/02/2018 12/31/2018 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Haegarda® (C1 Esterase Inhibitor Subcutaneous [Human]) 04/02/2018 12/31/2018 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Orencia®, subcutaneous only 11/16/2017 12/02/2019 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Daclizumab (Zinbryta™) 10/31/2016 01/01/2021 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Icatibant
(Firazyr ®)
05/19/2012 12/31/2012
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
10/01/2023 R22

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 R21

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

06/25/2023 R20

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 R19

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 R18

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 R17

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 R16

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 R15

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 First Coast Service Options, Inc. 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 (SAD) Exclusion List:  Xembify® (Injection, immune globulin) (J1558), Avonex® (interferon beta-1a) (J1826), Besremi® (ropeginterferon alfa-2b) (J3490, J3590, C9399), Skyrizi™ (risankizumab-rzaa) (J3490, J3590, C9399) and Sogroya®(Somapacitan-beco) (J3490, J3590, C9399).

Also, the drugs Tremfya® (guselkumab) (J1628) and Stelara® (ustekinumab) subcutaneous (J3357) that were added to the SAD Exclusion List published on 05/03/2020 will also be effective for services on and after 06/06/2022.

10/21/2021 R14

Article revised and published on 01/27/2022 to update the physical and e-mail address for submitting comments in the article.

10/21/2021 R13

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

04/05/2021 R12

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 modifier 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. HCPCS code J2502 has been removed from the article as it is IM administration and therefore is not considered self-administered.

01/01/2021 R11

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.

05/03/2020 R10

The following drugs have been evaluated by First Coast Service Options, Inc. 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 Medicare administrative contractor (MAC) Jurisdiction N (JN) self-administered drug (SAD) list: Tremfya® (guselkumab) (J1628) and Stelara® (ustekinumab) subcutaneous (J3357). The effective date of this revision is for dates of service on or after May 3, 2020.

12/02/2019 R9

12/02/2019 - The following drugs have been evaluated by First Coast Service Options, Inc. and have been determined to be usually self-administered drugs: Actemra® (tocilizumab) subcutaneous (J3262), Aimovig® (erenumab-aooe) (C9399/J3490/J3590), Ajovy™ (fremanezumab-vfrm) (J3031), Benlysta (belimumab) subcutaneous (J0490), Cyltezo™ (adalimumab-adbm) (C9399/J3490/J3590), Emgality® (galcanezumab-gnlm) (C9399/J3490/J3590), Kevzara® (sarilumab) (C9399/J3490/J3590), Lantus® SoloStar® (insulin glargine injection) (C9399/J3490/J3590), Ozempic® (semaglutide) (C9399/J3490/J3590), Takhzyro® (lanadelumab-flyo) (J0593), Tymlos™ (abaloparatide) (C9399/J3490/J3590). In addition, a “Route of Administration Modifier” section has been added with an asterisk statement for drugs that have multiple routes of administration. The JB modifier must be billed for the subcutaneous form of the drug. Drugs that require the JB modifier have been listed with an asterisk in the coding table. The following drugs require the JB modifier when the subcutaneous form of the drug is administered: Actemra® (J3262), Benlysta (J0490), Orencia® (J0129), and Sandostatin (J2354). Also, “subcutaneous” has been added to the descriptor for Sandostatin (J2354) and HAEGARDA (J0599) and any typographical errors that were identified were corrected. Furthermore, the unlisted HCPCS codes (C9399, J3490, and J3590) have been removed and replaced with HCPCS code J0129 for Orencia®. The effective date of these revisions is for dates of service on or after December 2, 2019.

01/01/2019 R8

01/01/2019 - Based on the Annual 2019 HCPCS Update, HCPCS codes J3490 and J3590 were removed and replaced with HCPCS code J0599. The effective date of this revision is based on date of service.

04/02/2018 R7

04/02/2018 - Article revised and posted for notice on 02/08/2018 to add Haegarda® (C1 Esterase Inhibitor Subcutaneous [Human]) (J3490/J3590) effective for dates of service on or after 04/02/2018.

11/16/2017 R6

11/16/2017 - The following drugs have been evaluated by First Coast Service Options, Inc. and have been determined to be usually self-administered drugs: J0364: Apokyn; J0800: H.P. Acthar Gel; C9399/J3490/J3590: Amjevita, Dupixent, Erelzi, Kynamro, Orencia, Quad-Mix, Rasuvo, and Siliq. The following brand name drugs were added: J1595: Glatopa; J1830: Extavia; J2941: Norditropin and Zomacton; J3030: Sumavel, Dosepro, and Zembrace; C9399, J3490, J3590: Pegasys Proclick. The effective date of this revision is based on date of service.

10/31/2016 R5 10/31/2016 - The following drugs have been evaluated by First Coast Service Options, Inc. and have been determined to be usually self-administered drugs: Alprostadil Urethral Suppository (MUSE), Mecasermin (Increlex), Octreotide Non-Depot form (Sandostatin), Urofollitropin (Bravelle), Interferon Alfacon-1, Recombinant 1 Microgram, Interferon, Alfa-2A, Recombinant 3 million units, Interferon, GAMMA 1-B, 3 Million units, Actimmune Pegylated Interferon Alfa-2A (Peglntron), Pramlintide Acetate (Symlin), TriMix, Liraglutide (Saxenda), Pegvisomant (Somavert), Daclizumab (Zinbryta), Insulin glargine (Toujeo) Sermorelin Acetate, Pasireotide Long Acting 1 mg-J2502 and Taltz (Ixekizumab). The effective date of this revision is based on date of service.
10/31/2016 R4 10/31/2016 - The following drugs have been evaluated by First Coast Service Options, Inc. and have been determined to be usually self-administered drugs: Alprostadil Urethral Suppository (MUSE), Mecasermin (Increlex), Octreotide Non-Depot form (Sandostatin), Urofollitropin (Bravelle), Interferon Alfacon-1, Recombinant 1 Microgram, Interferon, Alfa-2A, Recombinant 3 million units, Interferon, GAMMA 1-B, 3 Million units, Actimmune Pegylated Interferon Alfa-2A (Peglntron), Pramlintide Acetate (Symlin), TriMix, Liraglutide (Saxenda), Pegvisomant (Somavert), Daclizumab (Zinbryta), Insulin glargine (Toujeo) Sermorelin Acetate, and Taltz (Ixekizumab). The effective date of this revision is based on date of service.
05/23/2016 R3 5/23/2016 -STRENSIQ™ (asfotase alfa) has been evaluated by First Coast Service Options, Inc. and was determined it is apparent on its face that this drug is usually self-administered. The effective date of this revision is based on date of service.
01/18/2016 R2 01/18/2016 - The following drugs have been evaluated by First Coast Service Options, Inc. and have been determined to be usually self-administered drugs: Praluent (alirocumab), Repatha (evolocumab), and Natpara (parathyroid hormone) The effective date of this revision is based on date of service.
10/01/2015 R1 08/21/15 - The language and content updated to be consistent with the current list .
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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