Local Coverage Article Self-Administered Drug Exclusion List

Self-Administered Drug Exclusion List:

A53033

Expand All | Collapse All

Contractor Information

Article Information

General Information

Article ID
A53033
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
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2022, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

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

Article Guidance

Article Text

The following SAD list is current as of 11/19/2022. However, the Noridian Contractor Medical Directors (CMDs) review the list on an ongoing basis and may update and republish at their discretion.

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 by the patient.” 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 Manual System, 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 will make no payment for the drug.

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.

Noridian 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. We 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, Noridian 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.


If a drug meets the definition of "usually self-administered," Noridian 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.

Consideration of Objective Evidence

In accordance with CMS instructions, Noridian will consider objective evidence when available to determine utilization of a particular drug.

Evidence

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

Noridian 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.


Noridian may also consider other evidence submitted by interested individuals or groups subject to their judgment.

Noridian 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.

Any miscellaneous HCPCS codes (J3490, J3590 and C9399) billed to Medicare for drugs that are listed in the Coding Table Information below will be denied.

For certain injectable drugs, it will be "apparent on its face" that the nature of the condition(s) for which they are administered, or the usual course of treatment for those conditions (chronic vs acute), in and of itself dictate the mode of usual administration. 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 Manual System, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2]

Basis for Non-Coverage

A. Apparent on its Face

B. Presumption: Long-Term Non-Acute Administration

C. Acceptable Evidentiary Criteria Available

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. 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 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.

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

JA

Intravenous administration

JB

Subcutaneous administration

Providers are reminded that no form of insulin, regardless of route of administration including intravenous, intramuscular, subcutaneous, or inhalation, is reimbursable by Medicare. [This includes J8499: Insulin, inhaled (Exubera®), variable.]

If a beneficiary's claim for a particular drug is denied because the drug is subject to the "self-administered drug exclusion," the beneficiary may appeal the denial. Because it is a "benefit category" denial and not a denial based on medical necessity, an Advance Beneficiary Notice of Non-coverage (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 such an excluded drug.

Provider and Physician Appeals

The hospital and a physician accepting assignment may appeal a denial under the provisions found in the IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 29, Section 200.

Reasonable and Necessary

Noridian will make the determination of reasonable and necessary with respect to the medical appropriateness of the drug to treat the patient's condition and will continue to make the determination of whether the intravenous or injection form of a drug is appropriate, as opposed to the oral form. We will also continue to make the determination as to whether a physician's office visit was reasonable and necessary. However, while a physician's office visit may not be reasonable and necessary in a specific situation, the medical necessity of the injection will still be determined on its own merits based on this process for determining which drugs are usually self-administered.

Sources
• IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, Section 50.2, Determining Self-Administration of Drug or Biological
• Transmittal 123, CR 6950 dated April 30, 2010

Coding Information

ICD-10-CM Codes that Support Medical Necessity

N/A

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

N/A

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 Albiglutide for SQ injection (Tanzeum™) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Metreleptin for injection (Myalept ™) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Pasireotide (Signifor®) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Interferon beta 1a, Rebif ® 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Exenatide XR, Bydureon® 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Cosentyx (Secukinumab) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Praluent® (Alirocumab) 11/24/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Repatha™ (Evolucumab) 11/24/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Dulaglutide, Trulicity® 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Methotrexate - Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Parathyroid Hormone, Natpara® 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Peginterferon beta-1a, Plegridy™ 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS All insulin products 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Exenatide Byetta® 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Etanercept-SZZS (Erelzi™) 12/06/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Asfotase-alfa (Strensiq™) 02/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ixekizumab (Taltz™) 02/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adalimumab-atto (Amjevita™) 02/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Dupilumab (Dupixent) 08/07/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Brodalumab (Siliq) 08/07/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Sogroya® (somapacitan-beco) 04/05/2021 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ropeginterferon alfa-2b-njft (Besremi®) 04/24/2022 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 05/15/2022 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Kesimpta® (ofatumumab) subcutaneous use* 07/17/2022 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adbry™ (tralokinumab-ldrm) 11/01/2022 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
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) Orencia® subcutaneous use* 04/05/2021 N/A Apparent on its Face
J0135 INJECTION, ADALIMUMAB, 20 MG Humira® 11/01/2003 N/A Apparent on its Face|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) Alprostadil®, Caverject®, Edex®, Prostin VR Pediatric® 01/15/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG Apokyn® 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J0593 INJECTION, LANADELUMAB-FLYO, 1 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF-ADMINISTERED) lanadelumab-flyo (TAKHZYRO) 12/02/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J0599 INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA), 10 UNITS HAEGARDA® 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J0630 INJECTION, CALCITONIN SALMON, UP TO 400 UNITS Calcimar®, Miacalcin, Osteocalcin, Salmonine, Fortical 01/15/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J0800 INJECTION, CORTICOTROPIN, UP TO 40 UNITS H.P. ACTHAR® 06/26/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1324 INJECTION, ENFUVIRTIDE, 1 MG Fuzeon® 05/01/2004 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
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® 01/15/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone® 05/01/2004 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1628 INJECTION, GUSELKUMAB, 1 MG Tremfya® (guselkumab) 05/15/2021 N/A Acceptable Evidentiary Criteria Available
J1675 INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS Supprelin LA® 07/15/2006 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1744 INJECTION, ICATIBANT, 1 MG Icatibant (Firazyr®) 07/31/2012 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1815 INJECTION, INSULIN, PER 5 UNITS All insulin products 11/01/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS All insulin products 01/15/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
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® 01/15/2003 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
J2170 INJECTION, MECASERMIN, 1 MG Increlex®, Iplex 04/15/2007 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J2212 INJECTION, METHYLNALTREXONE, 0.1 MG Relistor® 09/30/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J2354 INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Octreotide Acetate, Sandostatin* 10/15/2005 N/A Presumption of Long-Term Non-Acute Administration
J2440 INJECTION, PAPAVERINE HCL, UP TO 60 MG Papaverine HCL 11/01/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J2940 INJECTION, SOMATREM, 1 MG Protropin® 01/15/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J2941 INJECTION, SOMATROPIN, 1 MG Humatrope, Genotropin, Omnitrope, Saizen, Zorbtive, Zomacton, Norditropin, Nutropin 01/15/2003 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
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® 01/15/2003 N/A Apparent on its Face|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) Fremanezumab-vfrm (Ajovy) 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo® 11/01/2003 N/A Presumption of Long-Term Non-Acute Administration
J3355 INJECTION, UROFOLLITROPIN, 75 IU Metrodin®, Bravelle®, Fertinex® 04/15/2007 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara® 10/15/2021 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Peginterferon Alfa 2-b, Sylatron, Pegintron 06/26/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Kynamro® (mipomersen sodium) 06/26/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Pramlintide acetate, Symlin®, SymlinPen 60, SymlinPen 120 04/01/2006 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Exenatide Byetta® 04/01/2006 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Tesamorelin Acetate, Egrifta® 09/30/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Trimix
09/30/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Liraglutide GLP-1, Victoza®
, Saxenda®
09/30/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Albiglutide for SQ injection (Tanzeum™) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Metreleptin for injection (Myalept™) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Pasireotide (Signifor®) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Interferon beta 1a, (Rebif®) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Exenatide XR, Bydureon® 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Cosentyx (Secukinumab) 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS All insulin products 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Adalimumab-adbm (Cyltezo) 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Sogroya® (somapacitan-beco) 04/05/2021 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Ropeginterferon alfa-2b-njft (Besremi®) 04/24/2022 N/A Apparent on its Face
J3490 UNCLASSIFIED DRUGS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 05/15/2022 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Kesimpta® (ofatumumab) subcutaneous use* 07/17/2022 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Adbry™ (tralokinumab-ldrm) 11/01/2022 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Mounjaro™ (Tirzepatide) 11/01/2022 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-ldrm) 11/01/2022 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
J3590 UNCLASSIFIED BIOLOGICS Kesimpta® (ofatumumab) subcutaneous use* 07/17/2022 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Risankizumab-rzaa (Skyrizi™) subcutaneous use* 05/15/2022 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
J3590 UNCLASSIFIED BIOLOGICS Ropeginterferon alfa-2b-njft (Besremi®) 04/24/2022 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Sogroya® (somapacitan-beco) 04/05/2021 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Abaloparatide (Tymlos) 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Sarilumab (Kevzara) 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Semaglutide (Ozempic) 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Erenumab-aoooe (Aimovig) 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Alcanezumab-gnlm (Emgality) 09/18/2019 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Praluent® (Alirocumab) 11/24/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Repatha™ (Evolucumab) 11/24/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Dulaglutide, Trulicity® 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Methotrexate - Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Parathyroid Hormone, Natpara® 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon beta-1a, Plegridy™ 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS All insulin products 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Pegvisomant Somavert®, variable 05/01/2004 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Peginterferon Alfa-2a, Pegasys™, Roferon®-A 05/01/2005 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Anakinra (Kineret®) 10/15/2005 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Golimumab, Simponi® 09/30/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Abatacept Orencia® 09/30/2013 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Etanercept-SZZS (Erelzi™) 12/06/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Asfotase-alfa (Strensiq™) 02/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Ixekizumab (Taltz™) 02/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-atto (Amjevita™) 02/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Dupilumab (Dupixent) 08/07/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Brodalumab (Siliq) 08/07/2017 N/A Apparent on its Face
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Infergen® 11/01/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J9213 INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS Roferon-A® 11/01/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune® 01/15/2003 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J9218 LEUPROLIDE ACETATE, PER 1 MG Leuprolide Acetate, Leuprolide Acetate Inj 01/15/2003 N/A Presumption of Long-Term Non-Acute Administration|Acceptable Evidentiary Criteria Available
Q0515 INJECTION, SERMORELIN ACETATE, 1 MICROGRAM Geref® 04/15/2007 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
Q3027 INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE Avonex®, Avonex Pen® 06/04/2015 N/A Apparent on its Face|Presumption of Long-Term Non-Acute Administration
Q3028 INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE Rebif® 06/04/2015 N/A Apparent on its Face|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
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Daclizumab (Zinbryta™) 02/28/2017 02/18/2021 Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Tezspire™ (tezepelumab-ekko) 07/17/2022 07/17/2022 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
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 (Abatacept)
09/30/2013 09/30/2013
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® 01/15/2003 07/14/2017 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Hizentra® 02/15/2011 12/31/2020 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1562 INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG Vivaglobin® 04/15/2007 07/14/2017 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J1575 INJECTION, IMMUNE GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN Immune globulin 02/11/2016 07/25/2016
J1628 INJECTION, GUSELKUMAB, 1 MG Tremfya® 05/03/2020 05/03/2020 Acceptable Evidentiary Criteria Available
J2502 INJECTION, PASIREOTIDE LONG ACTING, 1 MG Pasireotide long acting 02/11/2016 10/01/2016 Apparent on its Face
J2760 INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG Regitine® 09/30/2013 07/14/2017 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3357 USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG Stelara® subcutaneous 05/03/2020 05/03/2020 Acceptable Evidentiary Criteria Available
J3490 UNCLASSIFIED DRUGS Methylnaltrexone bromide
09/30/2013 07/14/2017 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Tezspire™ (tezepelumab-ekko) 07/17/2022 07/17/2022 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Tezspire™ (tezepelumab-ekko) 07/17/2022 07/17/2022 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Peginterferon Alfa 2-b, Sylatron, Pegintron 11/01/2003 06/06/2017 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS efalizumab (Raptiva®), variable 05/01/2004 07/14/2017 Apparent on its Face|Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Daclizumab (Zinbryta™) 02/28/2017 02/18/2021 Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS risankizumab-rzaa (Skyrizi™) 12/02/2019 12/02/2019 Apparent on its Face|Presumption of Long-Term Non-Acute Administration

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
11/19/2022 R30

Under Excluded CPT/HCPCS Codes added: Mounjaro™ (Tirzepatide) - C9399, J3490, J3590 effective 11/19/2022.

Under Excluded CPT/HCPCS Codes updated: Descriptor Brand Names for insulin products, the verbiage has been revised to read "All insulin products" for HCPCS codes C9399, J1815, J1817, J3490 and J3590.

11/01/2022 R29

The article is updated to add: Adbry™ (tralokinumab-ldrm) - C9399, J3490, J3590 effective 11/01/2022. 

08/11/2022 R28

The article is updated to remove: Tezspire™ (tezepelumab-ekko) - C9399, J3490, J3590 effective 07/17/2022.

*Note: J2356 assigned to Tezspire™ (tezepelumab-ekko) was also not added due to the removal.

The article is updated to add an asterisk to Skyrizi™ - C9399, J3490, J3590 as this drug has multiple routes of administration and must be billed with the appropriate modifier. - Effective 06/17/2022.

 

07/17/2022 R27

The article is updated to add: Kesimpta® (ofatumumab) subcutaneous use* - C9399, J3490, J3590 effective 07/17/2022.

The article is updated to add: Tezspire™ (tezepelumab-ekko) - C9399, J3490, J3590 effective 07/17/2022.

Note: Effective July 1, 2022 - J2356 will be established and added to this article for Tezspire™ (tezepelumab-ekko) and should be used in place of the 3 miscellaneous codes in this revision.

05/15/2022 R26

The article is updated to add: Risankizumab-rzaa (Skyrizi™) - C9399, J3490, J3590 effective 05/15/2022. 

04/24/2022 R25

The article updated to add: Ropeginterferon alfa-2b-njft (Besremi®) (C9399, J3490, J3590) effective 04/24/2022.

10/15/2021 R24

The "Route of Administrative Modifier" paragraph is revised.

The drug J3357 Ustekinumab, for subcutaneous injection, 1 mg is added with an effective date of 10/15/2021.

05/15/2021 R23

The article is updated to add: J1628, Injection, Guselkumab, (Tremfya®)1mg, effective 5/15/2021.

The asterisk does not apply to J3357 and therefore has been removed.

04/05/2021 R22

The article is revised to correct version 21. The asterisk criteria added in the "Descriptor Brand Name" section for J2354. Effective date remains 4/5/2021.

04/05/2021 R21

The article is updated to add: J0129 (Orencia®, subcutaneous use*), C9399, J3490 and J3590 Sogroya® (somapacitan-beco), effective 4/5/2021.

Removed the following drug to the Non-Excluded CPT/HCPCS Codes - Table Format: C9399 and J3590, Zinbryta (daclizumab), effective 2/18/2021. This drug was taken off the market.

J2354 has been updated to add asterisk criteria in the "Descriptor Brand Name" section.

Added the following in Article Guidance:

Route of Administration Modifier

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

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

JA

Intravenous administration

JB

Subcutaneous administration

01/01/2021 R20

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

05/03/2020 R19

The effective date of 5/3/2020 for Guselkumab (Tremfya®) (J1628) and Ustekinumab (Stelara®) (J3357) will be deferred to 45 days after the public health emergency ends. A notice article will be posted to Latest Update for the new effective date.

05/03/2020 R18

The following drugs are added to the SAD list with an effective date of 05/03/2020:

J1628 - Injection, Guselkumba, 1mg, (Tremfya®)

J3357 - Ustekinumab, for subcutaneous injection, 1 mg (Stelara®)

12/02/2019 R17

Due to the receipt of additional information and evidence-based literature, at this time the status of risankizumab-rzaa (Skyrizi) placement on the SAD List will be held pending further review.

12/02/2019 R16

This revision changes fremanezumab-vfrm (Ajovy) from code J3590 to code J3031, effective 10/01/2019. Code J3590 is effective from 09/18/2019 to 09/30/2019.

This revision also adds the following drug to the SAD exclusion list with an effective date of 12/2/2019:

J0593 - lanadelumab-flyo (TAKHZYRO)

J3590 - risankizumab-rzaa (Skyrizi™)

 

Also, Rebif® was added to the Descriptor Brand Name field for Q3028 and the spelling of Exenatide was corrected from Exanatide.

09/18/2019 R15

This revision updates the effective date of the drugs listed in Revision 14 from 09/09/2019 to 09/18/2019 to give providers the 45-day notice.

09/09/2019 R14

The following drugs are added to the SAD list with an effective date of 09/09/2019:

J0599 – HAEGARDA

J3490 – Insulin Glargin (recombinant), Lantus Solostar, Adalimumab-adbm (Cyltezo)

J3590 - Abaloparatide (Tymlos), Sarilumab (Kevzara), Semaglutide (Ozempic), Fremanezumab-vfrm (Ajovy), Erenumab-aoooe (Aimovig), Alcanezumab-gnlm (Emgality)

08/07/2017 R13

The article is revised to correct the drug code J2075 to J0275 from Revision 12.  Effective date remains the same.

08/07/2017 R12

The article is revised to remove the following drugs from the SAD list effective 7/14/2017: J2075, J1562, J2760 and J3590 (Efalizumab (Raptiva).


J3490 - UNCLASSIFIED DRUGS, Methylnaltrexone bromide is removed effective 7/14/17.  This is duplicate to J2212.


The following drugs added with an effective date of August 7, 2017.


J3590, C9399 - Dupilumab (Dupixent)


J3590, C9399 - Brodalumab (Siliq)


 

02/28/2017 R11 The article is revised to change the effective date of service from 2/6/2017 to 2/28/2017 for the following drugs:
Asfotase-alfa (Strensiq™), Daclizumab (ZINBRYTA™), Ixekizumab (Taltz™), Adalimumab-atto (Amjevita™)

02/06/2017 R10 The article is revised to add the HCPCS codes J3590 and C9399 for the following drugs effective 2/6/2017.
Asfotase-alfa (Strensiq™), Daclizumab (ZINBRYTA™), Ixekizumab (Taltz™), Adalimumab-atto (Amjevita™)
12/06/2016 R9 J2502 removed from the SAD list with an exclusion end date of 10/1/2016.
12/06/2016 R8 Added HCPCS Codes J3590, C9399 for Etanercept-SZZS (Erelzi™) effective 12/6/2016.
Added Saxenda® brand name to include in HCPCS code J3490 Liraglutide GLP-1, Victoza®. The effective date remains 09/30/2013.
07/25/2016 R7 The article revised to remove HCPCS code J1575 from the excluded table with an effective date 7/25/2016.
06/27/2016 R6 The article is revised to add the following drugs effective 6/27/2016:
Dulaglutide, Trulicity® (C9399, J3590), Methotrexate - Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® (C9399, J3590), Parathyroid Hormone, Natpara® (C9399, J3590), Peginterferon beta-1a, Plegridy™ (C9399, J3590), Insulin glargine injection, Toujeo® (C9399, J3590) and exanatide (Byetta®), variable (C9399).

The sentence "Any miscellaneous HCPCS codes (J3490, J3590 and C9399) billed to Medicare for drugs that are listed in the Coding Table Information below will be denied" is added under the "General Information" in the Article Text section.

This revised article, effective 6/27/2016 combines JF A A53035 into the JF B article so that both JFA and JFB contract numbers will have the same final Article number.
02/11/2016 R5 The article is revised to add J2502 and J1575 effective 2/11/2016.
11/24/2015 R4 The article is revised only to correct the effective date noted in R3 with effective date 11/18/2014. The correct effective date to deny J3590 or C9399 - Praluent® (Alirocumab) and J3590 or C9399 - Repatha™ (Evolucumab) is 11/24/2015.
11/24/2015 R3 The article is revised to add the following drugs to the SAD Exclusion List:
J3590 or C9399 - Praluent® (Alirocumab)
J3590 or C9399 - Repatha™ (Evolucumab)
Effective 11/18/2015.
10/01/2015 R2 This article is revised with an effective date of 06/04/2015 for the HCPCS code J0364, and the following miscellaneous C9399 and J3490 for Albiglutide for SQ injection (Tanseum™), C9399 and J3490 for Metreleptin for injection, (Myalept™), C9399 and J3490 for Pasireotide (Signifor®), C9399 and J3490 for Interferon beta 1a, (Rebif®), C9399 and J3490 for Exenatide extended release (Bydureon ™) and C9399 and J3490 for Cosentyx (Secukinumab). For HCPCS codes Q3027 and Q3028, the correct effective date of service is also June 4, 2015.

J3140 and J3150 were deleted from the Code Table due to the 2015 CPT/HCPCS Updates.
10/01/2015 R1 The article is revised to add the correct URL link to the Self Administered Drug Process.

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
N/A
Related National Coverage Documents
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Public Versions
Updated On Effective Dates Status
09/30/2022 11/19/2022 - N/A Currently in Effect You are here
09/06/2022 11/01/2022 - 11/18/2022 Superseded View
08/05/2022 08/11/2022 - 10/31/2022 Superseded View
05/27/2022 07/17/2022 - 08/10/2022 Superseded View
03/25/2022 05/15/2022 - 07/16/2022 Superseded View
03/03/2022 04/24/2022 - 05/14/2022 Superseded View
08/19/2021 10/15/2021 - 04/23/2022 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • SAD
  • Self Administered Drugs Exclusion List
  • Self-Administered