Local Coverage Article Self-Administered Drug Exclusion List

Self-Administered Drug Exclusion List:

A53066

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General Information

Article ID
A53066
Article Title
Self-Administered Drug Exclusion List:
Article Type
SAD Exclusion Article
Original Effective Date
10/01/2015
Revision Effective Date
11/19/2022
Revision Ending Date
N/A
Retirement Date
N/A
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Article Guidance

Article Text

The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished "incident-to" a physician's service provided that the drugs are not “usually self-administered” by the patient. Section 112 of the Benefits, Improvements & Protection Act of 2000 (BIPA), amended §§1861(s)(2)(A) and 1861(s)(2)(B) of the Social Security Act (SSA) to redefine this exclusion. The prior statutory language referred to those drugs "which cannot be self-administered”. Implementation of the BIPA provision requires interpretation of the phrase "not usually self-administered” by the patient.

CMS has defined "not usually self-administered" by the patient, according to how the Medicare population as a whole uses the drug, not how an individual patient or physician may choose to use a particular drug. This is defined in the CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2, Determining Self-Administration of Drug or Biological.

For purpose of this exclusion, the term 'usually' means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage and this A/B MAC may not make any Medicare payment for it.

The term 'administered' refers only to the physical process by which the drug enters the patient's body. Injectable drugs, including intravenously administered drugs, are typically eligible for inclusion under the 'incident to' benefit. With limited exceptions, other routes of administration including, but not limited to, oral drugs, suppositories, topical medications are considered to be usually self-administered by the patient.

The term 'by the patient' means Medicare beneficiaries as a collective whole. The determination is based on whether the drug is self-administered by the patient the majority of the time. This determination is made on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis.

This A/B MAC is committed to assuring appropriate coverage for those drugs that meet Medicare statute requirements for drugs, "not usually self-administered by the patient".

In the absence of objective data specific to the Medicare beneficiary population who are capable of self-administration of an injectable drug, this A/B MAC will consider the following factors listed below, weighted on a per indication basis, to estimate, whether an injectable drug in the outpatient setting is "usually or not usually self-administered":

1. Route: Intravenous (IV) route and Intramuscular (IM) route of administration will be presumed to meet "not usually self-administered" requirements and therefore meets Medicare benefit category requirements. Palmetto GBA may consider the depth and nature of the particular injection in applying this presumption. Subcutaneous (SQ) route of administration will not be presumed to meet the "not usually self-administered by the patient."

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

3. Setting of condition being treated: To the extent an injectable drug for a particular indication is given e.g. only in an emergency department setting, pre-operative outpatient setting, or in the context of chemotherapy administration, the drug for that indication would be presumed to be for an acute situation and therefore "not usually self-administered".

4. Frequency of administration: In accordance with CMS instructions, if a drug is administered once per month, it is less likely to be self-administered by the patient. If a drug is administered once or more per week, it is likely that the drug is administered by the patient.

Process For Determining Benefit Category

To determine if a drug meets the definition of “usually self-administered” on a Medicare population basis, as required by CMS instructions, this A/B MAC will use the following process:

Self-Administered Drug Process Flow

The process steps to determine whether a drug is self-administered are as follows: 

    • Determine if the drug is produced in parenteral form. 
    • Determine the route of administration. If the drug is only administered IV, the drug is a covered benefit. 
    • Determine if the route of administration is IM or SQ, and if the drug is administered in the outpatient setting, list the clinical indications and determine the percent of utilization by clinical indication. 
    • Review claims data and check a variety of sources/factors to arrive at the preliminary recommendation: 
      • Acute/chronic setting 
      • Clinical indication 
      • FDA/drug package inserts 
      • Provider specialty 
    • Estimate the percent self administered (greater than or less than 50 percent) by indication.
    • Assess all information to determine whether the drug is covered under the benefit category and notify providers via the Palmetto GBA website.

If a drug meets the definition of "usually self-administered", this A/B MAC will determine that the drug does not meet a Medicare benefit category. In this instance when the drug is administered "incident-to" the physician service, the provider may bill the beneficiary for the drug without an Advance Beneficiary Notice.

Route of Administration Modifier

The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection form of administration. Claims billed with the JA modifier are not part of the SAD exclusion. The Contractor will process claims with the JA modifier applying the policy that not only the drug is medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary. Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied.

Consideration of Objective Evidence

In accordance with CMS instructions, this A/B MAC will consider objective evidence, when available, to determine utilization of a particular drug.

Evidence

This A/B MAC welcomes any data and evidence that describes utilization of injectable drugs in the outpatient setting, specific to the Medicare beneficiary population as outlined above.

This A/B MAC is only required to consider the following types of evidence: 

      • Peer reviewed medical literature,

         

      • Standards of medical practice,

         

      • Evidence-based practice guidelines,

         

      • FDA approved label, and package inserts.

This A/B MAC may also consider other evidence submitted by interested individuals or groups subject to their judgment.

This A/B MAC will consider all of the information it receives in order to make a balanced and considered determination of benefit category meeting “not usually self-administered” injectable drugs. The information will be weighted according to the strength of the evidence.

General Information

These drugs have been deemed by this A/B MAC to be excluded from payment "incident-to" a physician's service because they are usually self-administered by the patients who take them.

The publication of this list begins a 45-day notice period. After the 45-day notice, this A/B MAC will deny payment for drugs subject to this notice. This list will be reviewed on a rolling basis and will be periodically updated as needed. Therefore, the absence of any particular drug on the exclusion list should not be taken to mean that at some later date the drug might be deemed excluded through application of the criteria referenced above.

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 (chronic vs acute), they are, or are not, usually self-administered. For example, a course of treatment consisting of scheduled injections lasting less than two weeks, regardless of frequency or route of administration, is considered by CMS as acute, and it would be unlikely that a patient would self-administer the drug in those circumstances [CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2]

 

Basis for Non-Coverage

A. Apparent due to the nature of the condition(s) for which they are administered

B. Presumption: Long-Term Non-Acute Administration

C. Acceptable Evidentiary Criteria Available

 
Coding of Unclassified Drugs

Many of the drugs listed below do not have a unique HCPCS code. It may still be considered correct coding to list these drugs under a “not otherwise classified “ or “unclassified” HCPCS code (i.e. J3490, J3590, C9399; J9999) other than the one designated in this table. Regardless of which HCPCS code is reported with that listed drug, the drug remains non-covered.

Coding Information

ICD-10-CM Codes that Support Medical Necessity

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
XX000 Not Applicable

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

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
XX000 Not Applicable

Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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.

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Skyrizi™ (risankizumab-rzaa) subcutaneous use* 05/15/2022 N/A Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kesimpta® (ofatumumab) subcutaneous use* 07/01/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adbry™ (tralokinumab-Idrm) 11/01/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS All insulin products 11/19/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Mounjaro™ (Tirzepatide) 11/19/2022 N/A Apparent on its Face
J0129 INJECTION, ABATACEPT, 10 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) Abatacept, Orencia®, subcutaneous use* 10/03/2013 N/A Presumption of Long-Term Non-Acute Administration
J0135 INJECTION, ADALIMUMAB, 20 MG Humira® 05/01/2003 N/A Presumption of Long-Term Non-Acute Administration
J0270 INJECTION, ALPROSTADIL, 1.25 MCG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) Caverjet®, Edex®, Prostin VR® 12/01/2002 N/A Acceptable Evidentiary Criteria Available
J0490 INJECTION, BELIMUMAB, 10 MG Benlysta® subcutaneous use* 07/20/2019 N/A Acceptable Evidentiary Criteria Available
J0599 INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA), 10 UNITS Haegarda 01/01/2019 N/A Acceptable Evidentiary Criteria Available
J0800 INJECTION, CORTICOTROPIN, UP TO 40 UNITS H.P. Acthar® Gel 09/03/2013 N/A Acceptable Evidentiary Criteria Available
J1324 INJECTION, ENFUVIRTIDE, 1 MG Fuzeon® 12/01/2002 N/A Acceptable Evidentiary Criteria Available
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® 12/01/2002 N/A Presumption of Long-Term Non-Acute Administration
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone®, Glatopa® 09/15/2003 N/A Acceptable Evidentiary Criteria Available
J1628 INJECTION, GUSELKUMAB, 1 MG Tremfya 1 mg 01/01/2019 N/A Apparent on its Face
J1675 INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS Supprelin LA® 01/01/2006 N/A Acceptable Evidentiary Criteria Available
J1744 INJECTION, ICATIBANT, 1 MG Firazyr® 06/18/2012 N/A Acceptable Evidentiary Criteria Available
J1815 INJECTION, INSULIN, PER 5 UNITS All insulin products 01/01/2004 N/A Acceptable Evidentiary Criteria Available
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS All insulin products 01/01/2004 N/A Acceptable Evidentiary Criteria Available
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® 12/01/2002 N/A Acceptable Evidentiary Criteria Available
J2170 INJECTION, MECASERMIN, 1 MG Increlex® 07/16/2007 N/A Acceptable Evidentiary Criteria Available
J2212 INJECTION, METHYLNALTREXONE, 0.1 MG Relistor® 09/03/2013 N/A Acceptable Evidentiary Criteria Available
J2354 INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Sandostatin® subcutaneous use* 05/01/2003 N/A Presumption of Long-Term Non-Acute Administration
J2440 INJECTION, PAPAVERINE HCL, UP TO 60 MG Papaverine (generic) 09/03/2013 N/A Acceptable Evidentiary Criteria Available
J2941 INJECTION, SOMATROPIN, 1 MG Biotropin®, Genotropin® Nutropin®, Humatrope®, Genotropin®, Genotropin Miniquick®, Norditropin®, Nutropin®, Nutropin AQ®, Omnitrope®, Saizen®, Saizen Somatropin RDNA Origin®, Serostim RDNA Origin®, Zorbtive®, Serostim®, Accretropin™ 12/01/2002 N/A Presumption of Long-Term Non-Acute Administration
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®, Imitrex Statdose Pen®, Zembrace™- SymTouch™, Alsuma™, Sumavel® DosePro® 12/01/2002 N/A Presumption of Long-Term Non-Acute Administration
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® 10/01/2019 N/A Apparent on its Face
J3355 INJECTION, UROFOLLITROPIN, 75 IU Bravelle®, Fertinex®, Metrodin® 01/01/2006 N/A Acceptable Evidentiary Criteria Available
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara® 10/15/2021 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Liraglutide-GLP-1, Victoza® 09/03/2013 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Tesamorelin, Egrifta® 09/03/2013 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Mipomersen sodium, Kynamro® 09/03/2013 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS TriMix 09/03/2013 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Peginterferon Alfa 2-b, Peg-Intron®, Peg-Intron Redipen®, Sylatron® 05/01/2003 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Pramlintide acetate, Symlin®, SymlinPen 60®, SymlinPen 120® 07/16/2007 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Exenatide, Byetta®, Bydureon® 07/16/2007 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Anakinra, Kineret® 09/15/2003 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Albiglutide, Tanzeum® 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Dulaglutide, Trulicity® 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Methotrexate - Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Pasireotide, Signifor® 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Cosentyx ®, secukinumab 10/01/2015 N/A Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS QuadMix (tri-mix+atropine) 07/17/2017 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS All insulin products 07/20/2019 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Cyltezo® (Adalimumab-adbm) 07/20/2019 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Skyrizi™ (risankizumab-rzaa) subcutaneous use* 05/15/2022 N/A Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Kesimpta® (ofatumumab) subcutaneous use* 07/01/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Adbry™ (tralokinumab-Idrm) 11/01/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Mounjaro™ (Tirzepatide) 11/19/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Mounjaro™ (Tirzepatide) 11/19/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adbry™ (tralokinumab-Idrm) 11/01/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Kesimpta® (ofatumumab) subcutaneous use* 07/01/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Skyrizi™ (risankizumab-rzaa) subcutaneous use* 05/15/2022 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Emgality® (Galcanezumab-gnlm) 07/20/2019 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Tymlos® (abaloparatide) 07/20/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Kevzara® (Sarilumab) 07/20/2019 N/A Acceptable Evidentiary Criteria Available
J3590 UNCLASSIFIED BIOLOGICS Ozempic® (semaglutide) 07/20/2019 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Aimovig™ (erenumab-aooe) 07/20/2019 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Dupixent® 07/17/2017 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Siliq™ 07/17/2017 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Erelzi™ 07/17/2017 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Ixekizumab, Taltz® 11/14/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Liraglutide, Saxenda®, Victoza® 11/14/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Metreleptin, Myalept® 11/14/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Alirocumab, Praluent® 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Evolcumab, Repatha® 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS All insulin products 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Parathyroid Hormone, Natpara® 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Peginterferon beta-1a, Plegridy® 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Golimumab, Simponi® 10/22/2012 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Pegvisomant, Somavert® 07/16/2007 N/A Acceptable Evidentiary Criteria Available
J3590 UNCLASSIFIED BIOLOGICS Pegylated Interferon Alfa-2a,
Pegasys® , Pegasys ProClick™
10/03/2013 N/A Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Sogroya (somapacitan-beco) 04/05/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS BESREMi® (ropeginterferon alfa-2b-njft) 04/24/2022 N/A Presumption of Long-Term Non-Acute Administration
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune® 05/01/2003 N/A Acceptable Evidentiary Criteria Available
J9218 LEUPROLIDE ACETATE, PER 1 MG Eligard® 12/01/2002 N/A Presumption of Long-Term Non-Acute Administration
Q3027 INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE Avonex Pen® 07/17/2017 N/A Presumption of Long-Term Non-Acute Administration
Q3028 INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE Rebif®, Rebif®Rebidose 05/16/2016 N/A Presumption of Long-Term Non-Acute Administration
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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® 10/29/2010 07/17/2017 Acceptable Evidentiary Criteria Available
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG Apokyn 10/22/2012 09/03/2013
J0604 CINACALCET, ORAL, 1 MG, (FOR ESRD ON DIALYSIS) Sensipar® 01/01/2018 08/06/2018 Presumption of Long-Term Non-Acute Administration
J0630 INJECTION, CALCITONIN SALMON, UP TO 400 UNITS Calcimar®, Miacalcin® 12/01/2002 07/17/2017 Acceptable Evidentiary Criteria Available
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Hizentra® 11/18/2013 12/31/2020 Acceptable Evidentiary Criteria Available
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Immune globulin
Hizentra
09/03/2013 09/03/2013
J1562 INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG Vivaglobin® 09/03/2013 03/23/2017 Acceptable Evidentiary Criteria Available
J1575 INJECTION, IMMUNE GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN HyQvia 11/14/2016 08/06/2018 Presumption of Long-Term Non-Acute Administration
J2760 INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG Regitine® 09/03/2013 07/17/2017 Acceptable Evidentiary Criteria Available
J2940 INJECTION, SOMATREM, 1 MG Protropin® 12/01/2002 07/17/2017 Presumption of Long-Term Non-Acute Administration
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo® 05/01/2003 07/17/2017 Acceptable Evidentiary Criteria Available
J3262 INJECTION, TOCILIZUMAB, 1 MG Actemra® 07/17/2017 07/03/2017 Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Nitroglycerine Lingual spray, Nitrolingual®, Nitromist® 05/16/2016 07/17/2017 Apparent on its Face|Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Haegarda® 10/02/2017 02/09/2019 Acceptable Evidentiary Criteria Available
J3590 UNCLASSIFIED BIOLOGICS Zinbryta® 07/17/2017 07/15/2020 Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Efalizumab, Raptiva® 07/16/2007 04/08/2009
J3590 UNCLASSIFIED BIOLOGICS Actemra® 07/03/2017 07/15/2020 Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Tezspire™ (tezepelumab-ekko). 07/01/2022 07/01/2022 Apparent on its Face
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Infergen® 05/01/2003 09/01/2013
J9213 INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS Roferon-A® 06/18/2012 03/23/2016
Q0515 INJECTION, SERMORELIN ACETATE, 1 MICROGRAM Sermorelin 07/16/2007 03/23/2017 Acceptable Evidentiary Criteria Available
XX000 Not Applicable XX000 01/01/2014 01/01/2014
XX000 Not Applicable XX000 01/01/2014 01/01/2014
XX000 Not Applicable XX000 01/01/2014 01/01/2014
XX000 Not Applicable xx000 11/19/2012 11/29/2012

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
11/19/2022 R36

Under Excluded CPT/HCPCS Codes – Table Format added the medication Mounjaro™ (Tirzepatide), and under Descriptor Brand Names for insulin products, the verbiage been revised to read “All insulin products” for HCPCS codes C9399, J1815, J1817, J3490 and J3590.

11/01/2022 R35

Under Excluded CPT/HCPCS Codes – Table Format added the medication Adbry™ (tralokinumab-Idrm), and added an asterisk (*) to Skyrizi™ (risankizumab-rzaa) to indicate subcutaneous use.

07/01/2022 R34

Under Excluded CPT/HCPCS Codes – Table Format removed code J3590 for Tezspire™ (tezepelumab-ekko) effective 7/1/22.

07/01/2022 R33

Under Excluded CPT/HCPCS Codes – Table Format added code J3590 for Tezspire™ (tezepelumab-ekko), and added codes J3490, J3590 and C9399 for Kesimpta® (ofatumumab) subcutaneous use*.

05/15/2022 R32

Under Excluded CPT/HCPCS Codes – Table Format added the drug Skyrizi™ (risankizumab-rzaa).

04/24/2022 R31

Under Excluded CPT/HCPCS Codes – Table Format added code J3590 BESREMi® (ropeginterferon alfa-2b-njft).

02/17/2022 R30

Under Associated Documents repaired the Rules and Regulations URL broken hyperlink.

10/15/2021 R29

Under Excluded CPT/HCPCS Codes - Table Format as indicated in the previous revision, code J3357 Stelara® (Ustekinumab) has an effective date of 10/15/21. The date has now been revised to reflect that change. 

10/15/2021 R28

Under Article Text Route of Administration Modifier verbiage was revised for clarity. Under Excluded CPT/HCPCS Codes – Table Format code J3357 Stelara® (Ustekinumab) has been added effective 10/15/21. Formatting was revised throughout the article.

07/05/2021 R27

Under Excluded CPT/HCPCS Codes – Table Format changed the description for code J2354 to read “Sandostatin® subcutaneous use*” and removed the word “ClickJet™” from the description for code J0129. Formatting was corrected throughout the article.

04/05/2021 R26

Under Article Text replaced the verbiage regarding JA and JB modifiers to cover all applicable medications. The revised language is now under the heading “Route of Administration Modifier”. The verbiage regarding J3590- Ajovy® (Injection, fremanezumab-vfrm) was deleted. Under Excluded CPT/HCPCS Codes – Table Format code J3590 was changed to code J3031 for Ajovy® (fremanezumab-vfrm), code J3590 was changed to code *J0129 for Orencia® (Abatacept), subcutaneous use* and code J3590 Sogroya (somapacitan-beco) was added.

01/01/2021 R25

Based on Transmittal 10463 (CR11880) (Billing for Home Infusion Therapy Services On or After January 1, 2021), which includes changes to the Medicare home infusion therapy services benefit, the article has been updated to move Hizentra® (J1559) to the Non-Excluded CPT/HCPCS Codes-Table with an Exclusion End Date of 12/31/2020.

07/15/2020 R24

Under Excluded CPT/HCPCS Codes – Table Format J3590 Zinbryta® was removed. This medication was taken off the worldwide market due to safety concerns. J3590 Actemra® was removed. This medication was taken off the list due to home administration is at the discretion of the provider and can be returned to office administration at any time. Additionally, the codes for the drug do not differentiate between the subq and IV formulations.

04/20/2020 R23

Under Excluded CPT/HCPCS Codes – Table Format the previous revision (R22) that added HCPCS code J3358 - Stelara®, ustekinumab for intravenous injection, 1 mg should be disregarded as this code was inadvertently added. HCPCS code J3357 - Stelara®, ustekinumab for subcutaneous injection, 1 mg has been added.

04/20/2020 R22

Under Excluded CPT/HCPCS Codes – Table Format added HCPCS code J3358 - Stelara®, ustekinumab for intravenous injection, 1 mg.

10/01/2019 R21

Under Article Text – General Information added “*NOTE: HCPCS code J3590- Ajovy® (Injection, fremanezumab-vfrm) is to be used when this drug is self-administered.”

Under Excluded CPT/HCPCS Codes – Table Format HCPCS code C9040 was deleted and J3590 was added for Ajovy® (Injection, fremanezumab-vfrm). This revision is due to the 4th quarter HCPCS Code update is effective on 10/1/2019.

07/20/2019 R20

Under Article Text – General Information added the verbiage “*NOTE: HCPCS code J0490 - Benlysta® (belimumab) must be billed with modifier JA for the intravenous form or billed with modifier JB for the subcutaneous form of the drug. The subcutaneous form is considered a self-administered drug and is therefore excluded from Medicare Part B coverage” after the third paragraph. Under Excluded CPT/HCPCS Codes – Table Format added J0490-JB Benlysta® (Belimumab*), J3490 Lantus Solostar® (Insulin glargine), J3490 Cyltezo® (Adalimumab-adbm), J3590 Emgality® (Galcanezumab-gnlm), J3590 Tymlos® (abaloparatide), J3590 Kevzara® (Sarilumab), J3590 Ozempic® (semaglutide), and J3590 Aimovig™ (erenumab-aooe).

05/16/2019 R19

Under Associated Documents – SAD Process URL 1 and 2 added links to the contractor's website.

04/01/2019 R18

Under Excluded CPT/HCPCS Codes – Table Format added C9040 Ajovy® (Injection, fremanezumab-vfrm, 1mg). This revision is due to the 2Q19 CPT®/HCPCS Code Update and is effective on 4/1/2019.

01/01/2019 R17

Under Excluded CPT/HCPCS Codes - Table Format CPT code J3490 has been deleted for Haegarda. The exclusion end date is 01/01/19. Under Excluded CPT/HCPCS Codes - Table Format, CPT codes J1628 Guselkumab (Tremfya) and J0599 (Haegarda) have been added. The exclusion effective date is 01/01/19. This revision is due to the Annual CPT/HCPCS Code Update and will become effective on 01/01/19.

 

 

08/06/2018 R16

Under Excluded CPT/HCPCS Codes – Table Format – Code, Row 3 HCPCS code J0604 – Sensipar® (cinacalcet) was deleted as it was inadvertently added to this section, effective 5/9/2018.

08/06/2018 R15

Under Excluded CPT/HCPCS Codes – Table Format – Code, Row 8 deleted HCPCS code J1575 – HyQvia.

05/09/2018 R14

Under Excluded CPT/HCPCS Codes-Table Format added J0604 Sensipar® (cinacalcet).

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

02/26/2018 R13 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
01/29/2018 R12 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
10/02/2017 R11

Under Excluded CPT/HCPCS Codes-Table Format added J3490 Haegarda®.

08/17/2017 R10

Under Excluded CPT/HCPCS Codes - Table Format deleted J3262 Actemra® and added J3590 Actemra®.

07/17/2017 R9 Under Excluded CPT/HCPCS Codes – Table Format – deleted J0275, J0630, J2760, J2940, J3110, J3490 (Nitroglycerine Lingual Spray, Nitrolingual®, Nitromist®) and added J3590 Etanercept-SZZS (biosimilar to entanercept), J3262, J3490 QuadMix (tri-mix + Atropine), Q3027, J3590 Dupilimab, J3590 Daclizumab, J3590 Broadalumab, J3590 HyQvia changed to J1575. Under Descriptor Brand Name under J1595 added Glatopa® , added (generic) to J2440, added to J3030 Imitrex Statdose Pen®, Zembrace™, SymTouch™, Alsuma, Sumavel® DosePro, under J3490 Peginterferon added Peg-Intron®, Peg-Intron®, Redipen®, under J3590 Abatacept added Orencia® and ClickJect™ , under J3590 Pegylated added Pegasys ProClick™, under J3590 Liraglutide added Victoza® and under Q3028 added Rebif®Rebidose.

05/07/2017 R8 The Exclusion End Date for Sermorelin Acetate, 1mcg and Injection, Immune Globulin (Vivaglobin), 100mg should read 05/07/2017.
05/07/2017 R7 Under Article Guidance-Article Text – revised direct quote from the first paragraph, removed “…by the patient” from sentence, “The prior statutory language referred to those drugs…” In the third paragraph replaced “will” with “may not”, “no” with “any Medicare” and “the drug” for “it”. Revised wording under Self-Administered Drug Process Flow, the sixth bullet. Changed the hyperlink to “Palmetto GBA website”. Under Excluded CPT/HCPCS Codes – Table Format – added exclusion end date to J1562 Injection, Immune Globulin (Vivaglobin), 100mg as this medication is off the market for use in the United States. Added Lantus ® and changed U-50 to U500 under Descriptor Brand Name for code J1815. Added “Protropin” to Descriptor Brand Name for J2940. Added Biotropin ® and corrected spelling of Zorbtive® under Descriptor Brand Name for J2941. Corrected spelling to “Tesamorelin” under Descriptor Brand Name for J3490. Added registered trademark symbol to “SymlinPen 60®” and “SymlinPen 120®” under Descriptor Brand Name for J3490. Corrected spelling of “Alirocumab” under Descriptor Brand Name for J3590. Changed trademark symbol to Registered Trademark symbol on Repatha® for J3590. Deleted Lantus® from Descriptor Brand Name for J3590. Removed Lupron® from Descriptor Brand Name for J9218, this medication is administered by physician. Added exclusion end date for Q0515 Injection, Sermorelin Acetate, 1 mcg, as this medication is off the market for use in the United States.
11/14/2016 R6 Under Coding Table Information-Excluded CPT/HCPCS Codes for J3590 added Toujeo® SoloSTAR®, Lantus® and Lantus® SoloSTAR® all with the effective date of 5/16/16. For J3590 added HyQvia, Ixekizumab/Taltz®, Liraglutide/Saxenda® and Metreleptin/Myalept® all with the effective date of 11/14/16.
05/16/2016 R5 Under Article Text language quoted from the Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized. CMS Manual System was revised X2 to now read CMS Internet-Only Manual. Under Excluded CPT/HCPCS Codes added Tanzeum®, Praluent®, Trulicity®, Repatha™, Toujeo®, Rebif®, Otrexup™ and Rasuvo®, Nitrolingual® and Nitromist®, Natpara®, Signifor®, and Plegridy® all with the effective date of 05/16/2016. Exclusion end dates were added for Raptiva®, Infergen®, and Roferon-A® and the brand names Protropin® and Bio-Tropin® were deleted from the list under J2940 and J2941 as these drugs are off the market and no longer available. The drug brand name Accretropin™ was added for J2941.
02/19/2016 R4 Under Associated Documents deleted the "url" under SAD Process URL 1.
10/01/2015 R3 Updated website address for Self-Administered Drug Exclusion List due to JM web site has changed.
07/16/2015 R2 J11 reference was removed from the Palmetto GBA website.
10/01/2015 R1 Under Article Text took out "we" and corrected to read as "Palmetto GBA" under #1, added "requirements" to the first sentence. Under General Information, removed "on its face" and "in and of itself dictate the mode of usual administration" and corrected the sentence to read" they are, or are not, usually self-administered." Under Basis for Non-coverage, removed "on its face" and added "due to the nature of the condition(s) for which they are administered".
Under CPT/HCPCS Codes - Table Format number 28, corrected the drug name "Victorz" to read "Victoza".
Added Cosentyx® with an effective date of 10/01/2015.


NOTE: 1/16/15 Annual Validation will be completed awaiting a decision from all contractor CMD's-All CMD Call related to addition of Cosentyx.

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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Updated On Effective Dates Status
09/29/2022 11/19/2022 - N/A Currently in Effect You are here
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03/25/2022 05/15/2022 - 06/30/2022 Superseded View
03/01/2022 04/24/2022 - 05/14/2022 Superseded View
02/07/2022 02/17/2022 - 04/23/2022 Superseded View
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Keywords

  • SAD
  • Self Administered Drugs