Self-Administered Drug Exclusion List: (SAD List)

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.

Please note: some drugs may be listed more than once, using a different code,
on the CPT/HCPCS coding table.

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.

**Basis for Non-Coverage**

  1. **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.

  2. **Presumption: Long-Term Non-Acute Administration**   
In accordance with CMS instructions, if the condition being treated is for a
short term acute basis (e.g. less than two weeks), the drug for this
indication is considered "not usually self-administered." If the condition
being treated is for a longer term (more than two weeks), the drug for this
indication is considered "usually self-administered by the patient."

  3. **Acceptable Evidentiary Criteria Available**  
\- Peer reviewed medical literature,  
\- Standards of medical practice,  
\- Evidence-based practice guidelines,  
\- FDA approved label, and  
\- Package inserts

**Route of Administration Modifier**

The use of the JA and JB modifiers is required for drugs which have one HCPCS
Level II (J or Q) code but multiple routes of administration. Drugs that fall
under this category will be marked with an asterisk (*) and must be billed
with the JA modifier for the intravenous infusion of the drug or billed with
the JB modifier for the subcutaneous injection form of administration.
Subcutaneously administered drugs listed on the Usually Self-Administered list
will be denied as a benefit exclusion. Claims for drugs marked with an
asterisk (*) billed without either a JA or JB modifier will also be denied.

**CPT/HCPCS Modifiers**  
**Group 1 Paragraph:** Claim denials may occur when the appropriate modifier
is not applied to a J code/medication, which has more than one route of
administration.  
 **Group 1 Codes:**

JA | Intravenous administration  
---|---  
JB | Subcutaneous administration