Policy

Self-Administered Drug Exclusion List (SAD List)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation

Contractor Number
00951, 00952, 00953, 00954

Contractor Type
Carrier

Article Information

General Information

Article ID Number
A49372

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
12/01/2011

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

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date
J0135	INJECTION, ADALIMUMAB, 20 MG	Humira	08/17/2003	N/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, Edex	10/15/2002	N/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)	Muse	01/15/2003	N/A
J0630	INJECTION, CALCITONIN SALMON, UP TO 400 UNITS	Calcimar, Miacalcin	11/29/2002	N/A
J1324	INJECTION, ENFUVIRTIDE, 1 MG	Fuzeon	05/16/2006	N/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)	Enbrel	04/15/2003	N/A
J1559	INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG	Hizentra	01/15/2011	N/A
J1562	INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG	Vivaglobulin	02/15/2007	N/A
J1595	INJECTION, GLATIRAMER ACETATE, 20 MG	Copaxone	05/16/2006	N/A
J1675	INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS	Supprelin LA	03/18/2006	N/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-500	01/01/2003	N/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 Novolin	10/17/2008	N/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	11/29/2002	N/A
J2170	INJECTION, MECASERMIN, 1 MG	Iplex, Increlex	02/15/2007	N/A
J2354	INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG	Sandostatin	11/29/2002	N/A
J2440	INJECTION, PAPAVERINE HCL, UP TO 60 MG	NA	01/15/2003	N/A
J2760	INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG	NA	01/15/2003	N/A
J2940	INJECTION, SOMATREM, 1 MG	Protropin	11/29/2002	N/A
J2941	INJECTION, SOMATROPIN, 1 MG	Genotropin	11/29/2002	N/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)	Imitrex	11/29/2002	N/A
J3110	INJECTION, TERIPARATIDE, 10 MCG	Forteo	12/15/2003	N/A
J3140	INJECTION, TESTOSTERONE SUSPENSION, UP TO 50 MG	NA	10/16/2010	N/A
J3150	INJECTION, TESTOSTERONE PROPIONATE, UP TO 100 MG	NA	10/16/2010	N/A
J3355	INJECTION, UROFOLLITROPIN, 75 IU	Metrodin, Bravelle, Fertinex	10/16/2008	N/A
J3490	UNCLASSIFIED DRUGS	TriMix„¢	10/16/2011	N/A
J3490	UNCLASSIFIED DRUGS	Tesamorelin (Egrifta„¢)	10/16/2011	N/A
J3490	UNCLASSIFIED DRUGS	Liraglutide (Victoza„¢)	10/16/2011	N/A
J3490	UNCLASSIFIED DRUGS	Pramlintide,(Symlin„¢)	08/15/2005	N/A
J3490	UNCLASSIFIED DRUGS	Nitroglycerin lingual spray	05/15/2003	N/A
J3490	UNCLASSIFIED DRUGS	Icatibant (Firazyr„¢)	11/15/2011	N/A
J3590	UNCLASSIFIED BIOLOGICS	Pegvisomant, (Somavert„¢)	10/16/2008	N/A
J3590	UNCLASSIFIED BIOLOGICS	Peginterferon alfa-2b,(Pegintron„¢)	12/15/2003	N/A
J3590	UNCLASSIFIED BIOLOGICS	Peginterferon alfa-2a, (Pegasys„¢)	08/15/2005	N/A
J3590	UNCLASSIFIED BIOLOGICS	Exenatide,(Byetta„¢)	08/15/2005	N/A
J3590	UNCLASSIFIED BIOLOGICS	Efalizumab,(Raptiva„¢)	05/16/2006	N/A
J3590	UNCLASSIFIED BIOLOGICS	Anakinra (Kineret„¢)	05/16/2006	N/A
J9212	INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM	Infergen	04/15/2003	N/A
J9216	INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS	Actimmune	04/15/2003	N/A
J9218	LEUPROLIDE ACETATE, PER 1 MG	Lupron	11/29/2002	N/A
Q0515	INJECTION, SERMORELIN ACETATE, 1 MICROGRAM	Geref	02/15/2006	N/A

Other Information

SAD Exclusion Article URL

http://www.wpsmedicare.com/part_b/

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

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

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

12/01/2011-Typo Corrected- Exclusion effective date for J3490 TriMix and J3490-Tesamorelin (Egrifta) is 10/16/2011;

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