Self-Administered Drug Exclusion List:

The following SAD list is current as of 11/30/2023. However, the Noridian
Contractor Medical Directors (CMDs) review the list on an ongoing basis and
may update and republish at their discretion.  
  
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 by the patient." 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 Manual System, 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 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 this A/B MAC will make no payment for
the drug.  
  
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.  
  
Noridian 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. We 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 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\. **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, Noridian 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 percent) by indication.

    * Assess all information to determine whether the drug is covered under the benefit category and notify providers.

  
If a drug meets the definition of "usually self-administered," Noridian 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.  
  
 **Consideration of Objective Evidence**  
  
In accordance with CMS instructions, Noridian will consider objective evidence
when available to determine utilization of a particular drug.  
  
 **Evidence**  
  
Noridian welcomes any data and evidence that describes utilization of
injectable drugs in the outpatient setting, specific to the Medicare
beneficiary population as outlined above.  
  
Noridian 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.

  
Noridian may also consider other evidence submitted by interested individuals
or groups subject to their judgment.  
  
Noridian 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.  
  
Any miscellaneous HCPCS codes (J3490, J3590 and C9399) billed to Medicare for
drugs that are listed in the Coding Table Information below will be denied.  
  
For certain injectable drugs, it will be "apparent on its face" that the
nature of the condition(s) for which they are administered, or the usual
course of treatment for those conditions (chronic vs acute), in and of itself
dictate the mode of usual administration. For example, a course of treatment
consisting of scheduled injections lasting less than two 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 Manual System, Pub 100-02, Medicare Benefit Policy Manual,
Chapter 15, 50.2]  
  
 **Basis for Non-Coverage**  
  
A. Apparent on its Face  
  
B. Presumption: Long-Term Non-Acute Administration  
  
C. Acceptable Evidentiary Criteria Available

**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. Absent
evidence to the contrary, the Contractor presumes that drugs delivered
intravenously are not usually self-administered by the patient. The Contractor
will process claims with the JA modifier still applying the policy as stated
in Medicare Benefit Policy Manual Chapter 15, section 50.2 that not only must
the drug be 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.

**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  
  
Providers are reminded that no form of insulin, regardless of route of
administration including intravenous, intramuscular, subcutaneous, or
inhalation, is reimbursable by Medicare. [This includes J8499: Insulin,
inhaled (Exubera), variable.]  
  
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 of Non-coverage (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 Section 1879 of the Act]. Therefore, physicians or providers
may charge the beneficiary for such an excluded drug.  
  
 **Provider and Physician Appeals**  
  
The hospital and a physician accepting assignment may appeal a denial under
the provisions found in the IOM, Publication 100-04, Medicare Claims
Processing Manual, Chapter 29, Section 200.  
  
 **Reasonable and Necessary**  
  
Noridian will make the determination of reasonable and necessary with respect
to the medical appropriateness of the drug to treat the patient's condition
and will continue to make the determination of whether the intravenous or
injection form of a drug is appropriate, as opposed to the oral form. We will
also continue to make the determination as to whether a physician's office
visit was reasonable and necessary. However, while a physician's office visit
may not be reasonable and necessary in a specific situation, the medical
necessity of the injection will still be determined on its own merits based on
this process for determining which drugs are usually self-administered.  
  
 **Sources  
**  IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15,
Covered Medical and Other Health Services, Section 50.2, Determining Self-
Administration of Drug or Biological  
 Transmittal 123, CR 6950 dated April 30, 2010 **  
**