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Self Administered Drug Exclusion List
(Medicare Payment for Drugs and Biologicals Furnished Incident to a Physician's Service)
BlueCross BlueShield of Tennessee (Riverbend Government Benefits Administrator)

Contractor Information

Contractor Name

BlueCross BlueShield of Tennessee (Riverbend Government Benefits Administrator)

Contractor Number

00390

Contractor Type

Article Information

Article Database ID Number

A2341

Article Type

SAD Exclusion Article

Key Article

Article Version Number

Article Title

Self Administered Drug Exclusion List (Medicare Payment for Drugs and Biologicals Furnished Incident to a Physician's Service

Is the AMA CPT / ADA CDT Copyright Statement Required?

Yes
CPT codes, descriptions and other data only are copyright 2004 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

NJ
TN

Secondary Geographic Jurisdiction

AK
AL
AR
AZ
CA
CO
CT
FL
GA
HI
IA
ID
IL
IN
KS
KY
LA
MA
MD
ME
MI
MN
MO
MS
NC
ND
NE
NJ
NM
NV
NY
OH
OK
OR
PA
RI
SC
TN
TX
UT
VA
VT
WA
WI
WV
WY

Original Article Effective Date

06/03/2003

Article Revision Effective Date

06/03/2003

Article Ending Effective Date

Article Text

Summary

In BIPA section 112, Congress set forth a new operational definition for self-administered drugs, i.e. those that CANNOT be provided incident to a physician's service due to exclusion under the Medicare benefit structure.

At this time, drugs that are administered orally, topically, or through an existing orifice (e.g. rectally) are presumed to be self-administered and are therefore excluded from coverage under the "incident to" benefit. Conversely, drugs that are administered in a manner that almost always requires medical skills (intramuscularly, intravenously, and intrathecally, for example) are presumed to be non self-administered and are therefore covered under the "incident to" benefit when all other conditions of coverage (such as medical necessity) exist.

Drugs administered sub-cutaneously may be considered either "self-administered" or "non self-administered," depending upon the outcome of an analysis of current patterns of usage. This page defines those sub-cutaneous drugs that Riverbend considers to be "self-administered" (excluded from coverage), and delineates the basis for that determination.

Regulatory Definition

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 patients who take them. Section 112 of BIPA amended sections 1861(s)(2)(A) and 1861(s)(2)(B) of the Social Security Act 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."

Route of Administration

Only injectable (including intravenous) drugs are eligible for inclusion under the "incident to" benefit. Other routes of administration including, but not limited to, oral drugs, suppositories, and topical medications are all considered to be usually self-administered by the patient.

The determination of "usually self-administered" is made on a drug by drug basis, not a case by case basis. Thus a drug that is excluded from coverage under this rule is always excluded from coverage: the individual clinical circumstances of a specific case are never relevant. This is a requirement of the regulations that implement BIPA, so there is no contractor discretion in this matter.

In the past, Riverbend has provided payment for one or more doses of a drug in circumstances where the specific dose would not be self-administered. Riverbend used this discretion for limited coverage, for example, during a brief time when the patient was being trained under the supervision of a physician in the proper technique for self-administration. Medicare will no longer pay for such doses.
Medicare may no longer pay for any drug, even when it is administered on an outpatient emergency basis, if the drug is excluded because it is usually self-administered by the patient.

Implementation

Medicare carriers and intermediaries are charged with applying certain criteria in their local jurisdictions in order to create a list of injectable drugs that are considered self-administered and therefore excluded from coverage in all instances. Intermediaries, however, are allowed to follow the lead of their local carrier. In the interest of improving consistency, Riverbend will be using the list generated by one of its local carriers and applying that list to all of its providers in all 46 states.

Beneficiary Appeals

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 (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 §1879 of the Act]. Therefore, physicians or providers may charge the beneficiary for an excluded drug.

Provider and Physician Appeals

A facility that bills Riverbend may appeal a denial under §3781.2 of the Medicare Intermediary Manual.

Reasonable and Necessary

Contractors will continue to review claims to ascertain a determination of reasonable and necessary with respect to the medical appropriateness of a drug to treat the patient’s condition, and will simultaneously verify that the intravenous or injectable form of the drug is appropriate as opposed to the oral form. They will also look at whether an office or outpatient visit was reasonable and necessary. However, if an injectable drug is not listed as self-administered, the injection service itself will always be considered reasonable and necessary even if an associated physician’s office visit is not. Thus a provider administering a (medically necessary) non-self administered drug should bill Medicare for the injection service, although they should not bill Medicare for a visit (E&M service) unless that medical evaluation was also reasonable and necessary.

This notification is based on instructions in PMs AB-02-139 and AB-02-072.

Coverage Topic

Prescription Drugs

Coding Information

Bill Type Codes

Revenue Codes

ICD-9 Codes that are Covered

ICD-9 Codes that are Not Covered

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	Adalimumab (Humira) Previous billed under J3490, as of 1-1-05 new code for the billing of this drug.	10/21/2003	N/A	Apparent on its face/USA/SC 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, Prostaglandins, MUSE	01/16/2003	N/A	Apparent on its face/USA/ Intracavernosal or Intraurethral/ Use as Needed
J0630	INJECTION, CALCITONIN SALMON, UP TO 400 UNITS	Miacalcin	01/16/2003	N/A	Frequency/USA/ SC as needed
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	01/16/2003	N/A	Apparent on its face/Provided as Kit for Self Admin/USA/SC twice a week
J1595	INJECTION, GLATIRAMER ACETATE, 20 MG	Copaxone (inj glatiramer Acetate per dose)	01/16/2003	N/A	Apparent on it face/USA/SC daily
J1815	INJECTION, INSULIN, PER 5 UNITS		01/16/2003	N/A	Frequency/Apparent on its face/USA/ SC/Daily
J1817	INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS		01/16/2003	N/A	Frequency/Apparent on its face/USA/ SC/Daily
J2940	INJECTION, SOMATREM, 1 MG	Somatrem	01/16/2003	N/A	Frequency/Apparent on its face/USA/ SC or IM Daily
J2941	INJECTION, SOMATROPIN, 1 MG	(Genotropin, Humatrope, Norditropin, Nutropin AQ, Saizen, Serostim are all SC {Daily or 3 times weekly} and Nutropin Depot once monthly or twice monthly on same days {i.e., 1st & 15th})	01/16/2003	N/A	Apparent on its face/Frequency/USA/SC Daily/SC or IM 3 times weekly
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	01/16/2003	N/A	Apparent on its face/USA/SC as needed
J3490	UNCLASSIFIED DRUGS	Kutapressin(previously billed under code 1910 this code was deleted)	01/01/2003	N/A	Frequency /USA?SC or Im daily
J3490	UNCLASSIFIED DRUGS	Pegvisomant for injection (Somavert)	07/17/2003	N/A	Frequency/Apparent on it face/USA/SC Daily
J3490	UNCLASSIFIED DRUGS	Teriparatide (Forteo)	07/17/2003	N/A	Frequency/Apparent on it face/USA/SC Daily
Q2020	INJECTION, HISTRELIN ACETATE, 10 MCG	Histrelin Acetate	01/16/2003	N/A	Frequency/Apparent on its face/USA/ SC Daily
				N/A

Other Information

SAD Exclusion Article URL

Other Comments

J1645 Dalteparin (Fragmin) [Included in the Excluded List 01/16/2003] [Removed from Excluded List 02/26/03]

J1650 Enoxaparin Sodium (Lovenox) [Included in the Excluded List 01/16/2003] [Removed from Excluded List 02/26/03]

J1655 Tinzaparin Sodium, Inj. [Included in the Excluded List 01/16/200] [Removed from Excluded List 02/26/03]

J1820 Injection Insulin, up to 100 units. (Removed due to code being invalid as of 4/01/2003)

01/29/2005 - CPT/HCPCS code J1910 was deleted from the Code Table
01/29/2005 - CPT/HCPCS code Q2010 was deleted from the Code Table
01/01/2005 J3490 replaced with J0135 for Humira(Adalimumab)

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Approval Notes

Revision History Explanation

Riverbend

Publications

LCDs