Self-Administered Drug Exclusion List (SAD List)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation		 Contractor Number
52280		 Contractor Type
FI

Article Information

General Information
Article ID Number
A49338

Article Type
SAD Exclusion Article

Key Article
Yes

Article Title
Self-Administered Drug Exclusion List (SAD List)

AMA CPT / ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction

Original Article Effective Date
09/01/2009

Article Revision Effective Date
10/01/2011

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

Evidentiary Criteria

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

Presumptions

Because reliable statistical information on the extent of self-administration by the patient may not always be available, the following considerations will be used:
1. Absent evidence to the contrary, drugs delivered intravenously should be presumed to be not usually self-administered by the patient.
2. Absent evidence to the contrary, drugs delivered by intramuscular injection should be presumed to be not usually self-administered by the patient.
3. Absent evidence to the contrary, drugs delivered by subcutaneous injection should be presumed to be usually self-administered by the patient.
4. Absent evidence to the contrary, oral drugs, suppositories, topical medications and inhaled medications are considered to be usually self-administered by the patient.

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

Apparent on its Face

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

The list of drugs identified below have been determined, following the above guidelines, to be usually self-administered by the patients who use them and are excluded from payment. Publication on this list begins a 45 day notice period whereby existing medical review and payment procedures will remain in effect. After the 45 day notice period ends, payment will be denied. The list will be reviewed periodically and updated as further determinations are made.

Therefore, the absence of any particular drug on the exclusion list does not mean, at some later date, the drug might be deemed excluded based on the guidelines listed above.

Coding Information

No Coding Information has been entered in this section of the article.

Coding Table Information

CPT/HCPCS Codes - Table Format
CodeDescriptor Generic NameDescriptor Brand NameExclusion Effective DateExclusion End DateComments
J0135 INJECTION, ADALIMUMAB, 20 MG Humira05/16/2003N/A
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, Edex05/16/2003N/A
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) Muse05/16/2003N/A
J0630 INJECTION, CALCITONIN SALMON, UP TO 400 UNITS Calcimar, Miacalcin05/16/2003N/A
J1324 INJECTION, ENFUVIRTIDE, 1 MG Fuzeon05/16/2003N/A
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) Enbrel05/16/2003N/A
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Hizentra01/15/2011N/A
J1562 INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG Vivaglobulin06/26/2008N/A
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone05/16/2003N/A
J1675 INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS Supprelin LA05/16/2003N/A
J1815 INJECTION, INSULIN, PER 5 UNITS Humalog, Humulin, Iletin, Insulin Lispro, Novo Nordisk, NPH, Pork Insulin, Regular Insulin, Ultralente, Velosulin, Humulin R, Iletin II Regular Port, Insulin Purified Pork, ReliOn, Lente Iletin I, Novolin R, Humulin R U-50005/16/2003N/A
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS Humalog, Humulin, Vesolin BR, Iletin II NPH Pork, Lantus, Lispro-PFC, Novolin, Novolog, Novolog Flexpen, Novolog Mix, ReliOn Novolin06/26/2008N/A
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) Actimmune, Betaseron
05/16/2003N/A
J2170 INJECTION, MECASERMIN, 1 MG Iplex, Increlex
06/26/2008N/A
J2354 INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Sandostatin05/16/2003N/A
J2440 INJECTION, PAPAVERINE HCL, UP TO 60 MG NA05/16/2003N/A
J2760 INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG NA10/16/2010N/A
J2940 INJECTION, SOMATREM, 1 MG Protropin05/16/2003N/A
J2941 INJECTION, SOMATROPIN, 1 MG Genotropin05/16/2003N/A
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) Imitrex05/16/2003N/A
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo05/16/2003N/A
J3140 INJECTION, TESTOSTERONE SUSPENSION, UP TO 50 MG NA06/26/2008N/A
J3150 INJECTION, TESTOSTERONE PROPIONATE, UP TO 100 MG NA05/16/2003N/A
J3355 INJECTION, UROFOLLITROPIN, 75 IU Metrodin, Bravelle, Fertinex
06/26/2008N/A
J3490 UNCLASSIFIED DRUGS Nitroglycerin lingual spray 09/01/2008N/A
J3490 UNCLASSIFIED DRUGS Liraglutide (Victoza TM)
10/16/2011N/A
J3490 UNCLASSIFIED DRUGS (Pramlintide) Symlin05/16/2003N/A
J3490 UNCLASSIFIED DRUGS Tesamorelin (Egrifta TM)
10/16/2011N/A
J3490 UNCLASSIFIED DRUGS TriMix TM10/16/2011N/A
J3490 UNCLASSIFIED DRUGS Icatibant (Firazyr TM)11/15/2011N/A
J3590 UNCLASSIFIED BIOLOGICS Anakinra(Kineret TM)
05/16/2003N/A
J3590 UNCLASSIFIED BIOLOGICS Exanatide (Byetta TM)
06/26/2008N/A
J3590 UNCLASSIFIED BIOLOGICS Efalizumab (Raptiva TM)
05/16/2003N/A
J3590 UNCLASSIFIED BIOLOGICS Peginterferon alfa-2a(Pegasys TM)
05/16/2003N/A
J3590 UNCLASSIFIED BIOLOGICS Peginterferon alfa-2b(Pegintron TM)
05/16/2003N/A
J3590 UNCLASSIFIED BIOLOGICS Pegvisomant (Somavert TM)
05/16/2003N/A
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Infergen05/16/2003N/A
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune05/16/2003N/A
J9218 LEUPROLIDE ACETATE, PER 1 MG Lupron09/01/2008N/A
Q0515 INJECTION, SERMORELIN ACETATE, 1 MICROGRAM Geref06/26/2008N/A

Other Information

SAD Exclusion Article URL


Revision History Explanation
08/21/2009: Article A47498 for 2008 SAD drug list retired with effective date 09/01/2009 and replaced with A49338. Correction made to original effective date of article as no new drugs were added from year 2008.

04/19/2010: In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this article because claims processing for those states are transitioning from FI Contractor Wisconsin Physician Services (WPS) to MAC - Part A Contractor Palmetto.

09/02/2009: Typographical spelling change of Exenatide HCPCS code J3590. No change in effective date, No notice required, none given.

08/21/2009: Article A47498 for 2008 SAD drug list retired with effective date 09/01/2009 and replaced with A49338. Correction made to original effective date of article as no new drugs were added from year 2008.

08/07/2009: Article A47498 for 2008 SAD drug list retired with effective date 10/16/2009 and replaced with A49338. Article A49338 replaces the previous SAD article, no new drugs added to article, title change for year 2009 and statements removed from the HCPCS code section, added notice dates in the comment section, added more brand name drugs to drug name section, provider notification on 09/01/2009 per Communique' and eNews Listserv for article effective date 10/16/2009.

10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Trailblazers (04901).

12/01/2010 - Added J1559 to the listing with an effective date of 01/15/2011

02/21/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).

09/01/2011- Added J3490-Liraglutide (Victoza), J3490 TriMix TM, J3490-Tesamorelin (Egrifta TM), Reformatted to be consistent among WPS contracts.


10/01/2011- Added J3490 Icatibant (Firazyr TM)

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Page Last Updated: Tuesday, 04-Oct-2011 12:20:23 CDT