Self-Administered Drug Exclusion 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 that the drugs are not "usually self-administered" by the
patient. Section 112 of the Benefits, Improvements & Protection Act of 2000
(BIPA), amended 1861(s)(2)(A) and 1861(s)(2)(B) of the Social Security Act
(SSA) 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.  
  
CMS has defined "not usually self-administered" by the patient, according to
how the Medicare population as a whole uses the drug, not how an individual
patient or physician may choose to use a particular drug. This is defined in
the CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual,
Chapter 15, 50.2, Determining Self-Administration of Drug or Biological.  
  
For purpose of this exclusion, the term 'usually' means more than 50% of the
time for all Medicare beneficiaries who use the drug. Therefore, if a drug is
self-administered by more than 50% of Medicare beneficiaries, the drug is
excluded from coverage and this A/B MAC may not make any Medicare payment for
it.  
  
The term 'administered' refers only to the physical process by which the drug
enters the patient's body. Injectable drugs, including intravenously
administered drugs, are typically eligible for inclusion under the 'incident
to' benefit. With limited exceptions, other routes of administration
including, but not limited to, oral drugs, suppositories, topical medications
are considered to be usually self-administered by the patient.  
  
The term 'by the patient' means Medicare beneficiaries as a collective whole.
The determination is based on whether the drug is self-administered by the
patient the majority of the time. This determination is made on a drug-by-drug
basis, not on a beneficiary-by-beneficiary basis.  
  
This A/B MAC is committed to assuring appropriate coverage for those drugs
that meet Medicare statute requirements for drugs, "not usually self-
administered by the patient".  
  
In the absence of objective data specific to the Medicare beneficiary
population who are capable of self-administration of an injectable drug, this
A/B MAC will consider the following factors listed below, weighted on a per
indication basis, to estimate, whether an injectable drug in the outpatient
setting is "usually or not usually self-administered":  
  
1\. **Route** : _Intravenous (IV) route_ and _Intramuscular (IM) route_ of
administration will be presumed to meet "not usually self-administered"
requirements and therefore meets Medicare benefit category requirements.
Palmetto GBA may consider the depth and nature of the particular injection in
applying this presumption. _Subcutaneous (SQ) route_ of administration will
not be presumed to meet the "not usually self-administered by the patient."  
  
2\. **Acuity of condition being treated** : In accordance with CMS
instructions, if the condition being treated is for a short-term acute basis
(e.g., less than 2 weeks), the drug for this indication is considered "not
usually self-administered". If the condition being treated is for a longer
term (e.g., more than 2 weeks), the drug for this indication is considered
"usually self-administered by the patient".  
  
3\. **Setting of condition being treated** : To the extent an injectable drug
for a particular indication is given (e.g., only in an emergency department
setting, pre-operative outpatient setting, or in the context of chemotherapy
administration), the drug for that indication would be presumed to be for an
acute situation and therefore "not usually self-administered".  
  
4\. **Frequency of administration** : In accordance with CMS instructions, if
a drug is administered once per month, it is less likely to be self-
administered by the patient. If a drug is administered once or more per week,
it is likely that the drug is administered by the patient.  
  
 **Process For Determining Benefit Category**  
  
To determine if a drug meets the definition of "usually self-administered" on
a Medicare population basis, as required by CMS instructions, this A/B MAC
will use the following process:  
  
 **Self-Administered Drug Process Flow**  
  
The process steps to determine whether a drug is self-administered are as
follows:

    * Determine if the drug is produced in parenteral form. 
    * Determine the route of administration. If the drug is only administered IV, the drug is a covered benefit. 
    * Determine if the route of administration is IM or SQ, and if the drug is administered in the outpatient setting, list the clinical indications and determine the percent of utilization by clinical indication. 
    * Review claims data and check a variety of sources/factors to arrive at the preliminary recommendation: 
      * Acute/chronic setting 
      * Clinical indication 
      * FDA/drug package inserts 
      * Provider specialty 
    * Estimate the percent self-administered (greater than or less than 50%) by indication.
    * Assess all information to determine whether the drug is covered under the benefit category and notify providers via the Palmetto GBA website.

If a drug meets the definition of "usually self-administered", this A/B MAC
will determine that the drug does not meet a Medicare benefit category. In
this instance when the drug is administered "incident-to" the physician
service, the provider may bill the beneficiary for the drug without an Advance
Beneficiary Notice.

**Route of Administration Modifier**

The use of the JA and JB modifiers is required for drugs which have 1 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 IV infusion of the drug or billed with the JB
modifier for the SQ injection form of administration. Claims billed with the
JA modifier are not part of the SAD exclusion. The Contractor will process
claims with the JA modifier applying the policy that not only the drug is
medically reasonable and necessary, but also that the route of administration
is medically reasonable and necessary. 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.

**Consideration of Objective Evidence**  
  
In accordance with CMS instructions, this A/B MAC will consider objective
evidence, when available, to determine utilization of a particular drug.  
  
 **Evidence**  
  
This A/B MAC welcomes any data and evidence that describes utilization of
injectable drugs in the outpatient setting, specific to the Medicare
beneficiary population as outlined above.  
  
This A/B MAC is only required to consider the following types of evidence:

      * Peer reviewed medical literature,



      * Standards of medical practice,



      * Evidence-based practice guidelines,



      * FDA approved label, and package inserts.

This A/B MAC may also consider other evidence submitted by interested
individuals or groups subject to their judgment.  
  
This A/B MAC will consider all of the information it receives in order to make
a balanced and considered determination of benefit category meeting "not
usually self-administered" injectable drugs. The information will be weighted
according to the strength of the evidence.  
  
 **General Information**  
  
These drugs have been deemed by this A/B MAC to be excluded from payment
"incident-to" a physician's service because they are usually self-administered
by the patients who take them.  
  
The publication of this list begins a 45-day notice period. After the 45-day
notice, this A/B MAC will deny payment for drugs subject to this notice. This
list will be reviewed on a rolling basis and will be periodically updated as
needed. Therefore, the absence of any particular drug on the exclusion list
should not be taken to mean that at some later date the drug might be deemed
excluded through application of the criteria referenced above.  
  
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 (chronic vs acute), they are, or are not, usually self-
administered. For example, a course of treatment consisting of scheduled
injections lasting less than 2 weeks, regardless of frequency or route of
administration, is considered by CMS as acute, and it would be unlikely that a
patient would self-administer the drug in those circumstances [CMS Internet-
Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, 50.2]  



Basis for Non-Coverage  
  
A. Apparent due to the nature of the condition(s) for which they are
administered,  
  
B. Presumption: Long-Term Non-Acute Administration,  
  
C. Acceptable Evidentiary Criteria Available

  
 **Coding of Unclassified Drugs**  
  
Many of the drugs listed below do not have a unique HCPCS code. It may still
be considered correct coding to list these drugs under a "not otherwise
classified" or "unclassified" HCPCS code (i.e., J3490, J3590, C9399; J9999)
other than the one designated in this table. Regardless of which HCPCS code is
reported with that listed drug, the drug remains non-covered.