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Self Administered Drug Exclusions
Reference: AR – LSB 081408
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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. Included in this article is a list of injectable drugs
that Pinnacle Business Solutions, Inc. (PBSI), has determined to be usually
self-administered by the patient and are, therefore, not reimbursable by
Medicare.
For the purposes of this article, the term "administered" refers only to the
physical process by which the drug enters the patient’s body. It does not refer
to whether the process is supervised by a medical professional. Only injectable
(including intravenous) drugs are eligible for inclusion under the "incident to"
benefit.
Additionally, 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 and the contractor
may not make any Medicare payment for it.
In making a determination for exclusion (non-coverage) of injectable drugs
"incident to" a physician’s service, the following criteria will be considered.
If a drug has multiple indications, then the final determination will be based
on the weighted average of the determination for each indication:
- Nature of the Condition
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.
Administration
If it is not apparent on its face that a drug is or is not
self-administered, the following presumptions will be made, absence evidence
to the contrary:
- Drugs delivered intravenously are not usually self-administered by
the patient
- Drugs delivered by intramuscular injection are not usually
self-administered by the patient
- Drugs delivered by subcutaneous injection are usually
self-administered by the patient
Duration of Treatment
A course of treatment consisting of scheduled injections lasting less
than two weeks, regardless of frequency or route of administration, is
considered acute and would usually be covered.
Frequency of Administration
Drugs administered once or more per week are more likely to be
self-administered by the patient.
Evidentiary Criteria
Peer reviewed medical literature, standards of medical practice,
evidence-based practice guidelines, the FDA approved label, and package
inserts will be considered when determining if a drug is self-administered.
The following codes are determined to be self-administered, and are not
covered. Please note the exclusion effective date. Several codes have been
added to the list with an exclusion effective date of October 15, 2008. This
article is providing the required notice period that these codes will no
longer by covered.
|
Code |
Descriptor Generic Name |
Descriptor Brand Name |
Exclusion Effective Date |
Exclusion End Date |
Comments |
|
J0270 |
Injection, alprostadil, 1.25 mcg (code
may be used for Medicare when drug administered under direct supervision
of a physician, not for use when drug is self administered) |
Caverjet, Edex |
02/17/2003 |
N/A |
Rationale for Determination-
Intracavernosal injection by patient on an as needed basis up to 3 times
per week. |
|
J0275 |
Alprostadil urethral suppository (code
may be used for Medicare when drug administered under direct supervision
of a physician, not for use when drug is self administered) |
Muse |
02/17/2003 |
N/A |
Rationale for Determination- Apparent
on its face |
|
J0630 |
Injection, calcitonin salmon, up to 400
units |
Calcimar, Miacalcin |
02/17/2003 |
N/A |
Rationale for Determination -
Subcutaneous injection by patient every day or every other day for a
prolonged period of time. |
|
J0945 |
Injection, brompheniramine maleate, per
10 mg |
Bromph-eniramine maleate, injection, per 10 mg |
10/15/2008 |
N/A |
Rationale for Determination - Apparent
on its face; injectable form rarely medically necessary. |
|
J1817 |
Insulin for administration through DME
(i.e., insulin pump) per 50 units |
Insulin |
10/15/2008 |
N/A |
Rationale for Determination - Apparent
on its face; subcutaneous administration by the patient daily for more
than two weeks. |
|
J3420 |
Injection, vitamin b-12 cyanocobalamin,
up to 1000 mcg |
Vitamin B-12 |
02/17/2003 |
N/A |
Rationale for Determination- Apparent
on its face |
|
J1438 |
Injection, etanercept, 25 mg (code may
be used for Medicare when drug administered under direct supervision of
a physician, not for use when drug is self administered) |
Enbrel |
02/17/2003 |
N/A |
Rationale for Determination -
Subcutaneous injection by patient twice per week for a prolonged period
of time. |
|
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 |
02/17/2003 |
N/A |
Rationale for Determination -
Subcutaneous injection by patient every other day for a prolonged period
of time. |
|
J9216 |
Interferon, gamma 1-b, 3 million units |
Actimmune |
02/17/2003 |
N/A |
Rationale for Determination -
Subcutaneous injection by patient every other day for a prolonged period
of time. |
|
J9218 |
Leuprolide acetate, per 1 mg |
Lupron |
02/17/2003 |
N/A |
Rationale for Determination - Dose form
for daily subcutaneous injection by patient for a prolonged period of
time; apparent on its face |
|
J2940 |
Injection, Somatrem, 1mg |
Protopin |
02/17/2003 |
N/A |
Rationale for Determination -
Subcutaneous injection by patient several times per week for a prolonged
period of time; apparent on its face |
|
J2941 |
Injection, Somatropin, 1mg |
Genotropin, Humatrope, Norditropin,Nutropin, Saizen,
Serostim |
02/17/2003 |
N/A |
Rationale for Determination -
Subcutaneous injection by patient several times per week for a prolonged
period of time; apparent on its face |
|
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 |
02/17/2003 |
N/A |
Rationale for Determination -
Subcutaneous injection by patient at onset of symptoms up to two times
in a 24hr. Period PRN; apparent on its face |
|
J9213 |
Interferon alfa-2a, recombinant, 3
million units |
Roferon-A |
10/15/2008 |
N/A |
Rationale for Determination - Apparent
on its face; subcutaneous administration by the patient three times per
week for more than two weeks. |
Sources:
- CMS Manual System, Pub 100-02 Medicare Benefit Policy Manual, Chapter
15, section 50.2, Change Request 5988 dated June 20, 2008.
- CMS Manual System, Pub 100-04 Medicare Claims Processing Manual, Chapter
17, section 80.5, Change Request 5988 dated June 20, 2008.
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