ARTICLE : Self-Administered Drugs and Biologicals Excluded from Coverage - Medical Policy Article (formerly Self-Administered Drug Exclusion Directive - Medical Policy Article)

Self-Administered Drugs and Biologicals Excluded from Coverage - Medical Policy Article (formerly Self-Administered Drug Exclusion Directive - Medical Policy Article) - R3 (A23213)

Contractor Information

Contractor Name

National Government Services, Inc.

Contractor Number

Number	Type	State(s)
00308	FI	CT, DE, NY

Contractor Type

Article Information

Article ID Number

A23213

Article Type

SAD Exclusion Article

Key Article

Yes

Article Title

Self-Administered Drugs and Biologicals Excluded from Coverage - Medical Policy Article (formerly Self-Administered Drug Exclusion Directive - Medical Policy Article) - R3

Primary Geographic Jurisdiction

Number	Type	State(s)
00308	FI	CT, DE, NY

Secondary Geographic Jurisdiction

Connecticut
Delaware
New York

Original Article Effective Date

09/01/2004

Article Revision Effective Date

07/01/2008

Article Text

The table below lists drugs that are not covered by Medicare, the effective date of non-coverage, and the rationale. (Please see Process for Determining Self-Administered Drug Exclusions – Medical Policy Article). The column, “Brand Names,” provides one or more examples but not all. Information about drugs not separately reimbursed or not covered for reasons other than “usually self-administered,” is found in other carrier and fiscal intermediary publications and sites.

In the interest of consistent Medicare coverage, the National Government Services fiscal intermediary will follow the coverage decision for self-administered drugs as determined by the carrier in each respective state. HCPCS codes for the same drugs that apply only to providers that bill the fiscal intermediary ( e.g., HCPCS codes used for drugs billable under the Outpatient Prospective Payment System [OPPS]) are included when applicable.

Coverage Topic

Outpatient Hospital Services
Prescription Drugs

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	Comments
J0135	INJECTION, ADALIMUMAB, 20 MG	Humira	06/02/2004	N/A	Non-acute subcutaneous (SC) injection by patient, weekly or every other week.
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	06/02/2004	N/A	Usually self-injected by patient on an "as needed basis".
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	06/02/2004	N/A	Supposistory.
J0630	INJECTION, CALCITONIN SALMON, UP TO 400 UNITS	Calcimar, Miacalcin	06/02/2004	N/A	Non-acute subcutaneous (SC) injection by patient, daily or every other day.
J1324	INJECTION, ENFUVIRTIDE, 1 MG	Fuzeon	12/28/2007	N/A	Non-acute subcutaneous (SC) injection by patient, twice daily.
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	06/02/2004	N/A	Non-acute subcutaneous (SC) injection by patient, usually twice a week.
J1595	INJECTION, GLATIRAMER ACETATE, 20 MG	Copaxone	06/02/2004	N/A	Self-administration; subcutaneous 20 mg/day.
J1675	INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS	Supprelin	12/28/2007	N/A	Non-acute subcutaneous administration, usually once daily by patient.
J1815	INJECTION, INSULIN, PER 5 UNITS	Humalog, Humulin, Iletin, Insulin Lispo, 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	06/02/2004	N/A	Non-acute subcutaneous (SC) injection by patient, every day.
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	06/02/2004	N/A	Non-acute chronic filling of pump by patient.
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	06/02/2004	N/A	Non-acute subcutaneous (SC) injection by patient, usually every other day.
J2170	INJECTION, MECASERMIN, 1 MG	Increlex, Iplex	06/02/2004	N/A	Non-acute subcutaneous injection twice daily by patient.
J2354	INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG	Sandostatin	06/02/2004	N/A	Usually self-administered injections two to four times daily, depending on the indication.
J2940	INJECTION, SOMATREM, 1 MG	Protropin	06/02/2004	N/A	Non-acute subcutaneous (SC) injection by patient, several time a week.
J2941	INJECTION, SOMATROPIN, 1 MG	Genotropin	06/02/2004	N/A	Non-acute subcutaneous (SC) injection by patient, several time a week.
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	06/02/2004	N/A	Subcutaneous (SC) injection by patient at onset of symptoms (up to two times in a 24-hour period).
J3110	INJECTION, TERIPARATIDE, 10 MCG	Forteo	12/28/2007	N/A	Non-acute, subcutaneous (SC) injection into thigh or abdomen (lower stomach area) once a day by patient using multidose prefilled delivery device (FORTEO pen - contains 28 daily doses).
J3490	UNCLASSIFIED DRUGS	Byetta (exenatide)	12/28/2007	N/A	Non-acute subcutaneous (SC) injection by patient, within the 60-minute period before morning and evening meals.
J3490	UNCLASSIFIED DRUGS	Symlin (Pramlintide acetate)	12/28/2007	N/A	Non-acute subcutaneous (SC) injection by patient, immediately prior to major meals.
J3590	UNCLASSIFIED BIOLOGICS	Kineret	12/28/2007	N/A	Non-acute subcutaneous (SC) injection by patient, every day.
J3590	UNCLASSIFIED BIOLOGICS	Peg-Intron	06/02/2004	N/A	Subcutaneous weekly administration for one year by patient.
J3590	UNCLASSIFIED BIOLOGICS	Pegasys	06/02/2004	N/A	Subcutaneous weekly administration for 48 weeks by patient.
J3590	UNCLASSIFIED BIOLOGICS	Raptiva	06/02/2004	N/A	Non-acute subcutaneous weekly injection by patient.
J3590	UNCLASSIFIED BIOLOGICS	Somavert	12/28/2007	N/A	Non-acute subcutaneous injection daily, by patient.
J9212	INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MCG	Infergen	12/06/2003	N/A	Subcutaneous administration three times per week for 24-48 weeks, by patient.
J9213	INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS	Roferon A	12/06/2003	N/A	Hepatitis C: Subcutaneous administration three times per week for 12 months by patient. Hairy cell leukemia: Subcutaneous administration daily for 16 - 24 weeks and three times per week by patient. CML: Subcutaneous daily.
J9216	INTERFERON, GAMMA 1-B, 3 MILLION UNITS	Actimmune	12/06/2003	N/A	Non-acute subcutaneous administration usually three times per week by patient.
J9218	LEUPROLIDE ACETATE, PER 1 MG	Lupron	11/14/2002	N/A	Non-acute, usually daily subcutaneous (SC) injection by patient.
Q0515	INJECTION, SERMORELIN ACETATE, 1 MICROGRAM	Geref	12/28/2007	N/A	Non-acute subcutaneous daily administration by patient.

Other Information

Other Comments
Not applicable.
Revision History Explanation
Article published June 2008 (R3): The article text paragraph has been revised to remove information found in the article titled "Self-Administered Drug Exclusion Directive - Medical Policy Article". As part of the National Government Services consolidation process, the title has also been revised. Article published November 14, 2007 (R2): The following HCPCS were previously listed as unclassified drugs (J3490) for this contractor: J0135 Humira J3590 Peg-Intron J3590 Pegasys J3590 Raptiva The following HCPCS are additions to the prior list for this contractor and are effective 12/28/2007: J1324 Fuzeon J1675 Supprelin J2170 Increlex, Iplex J3490 Byetta (exenatide) J3490 Symlin (Pramlintide) J3590 Kineret J9212 Infergen Article Published July 25, 2007 (R1): Title Revison By MPU.

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Article(s) A47521 - Process for Determining Self-Administered Drug Exclusions – Medical Policy Article