Self-Administered Drugs - Process To Determine Which Drugs Are Usually Self-
Administered by the Patient This process applies only to medications described
in the program instructions of the Internet Only Manual (IOM) _Medicare
Benefit Policy Manual_ , Chapter 15, Section 50.2 at  
 _http://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/bp102c15.pdf._  
  
 **Introduction**  
This process applies only to **injectable drugs** used in an **outpatient
setting** for **Medicare beneficiaries** for **reasonable and necessary
indications.** Generic or otherwise equivalent drugs with separate "J" codes
may be treated separately or as one drug.  
  
**CMS Instructions to Each Contractor**  
 _"Contractors must describe the process they will use to determine whether a
drug is usually self-administered by the patient and as such cannot be covered
as "incident to" a physician's service. Contractors must continue to assure
that not only is the drug medically reasonable and necessary for any
individual claim, but also that the route of administration is medically
reasonable and necessary."_  
  
The words **_"by the patient"**_ mean for Medicare beneficiaries as a
collective whole. If the drug is not covered, it is not covered for _all_
patients and for _all_ routes of administration. For example, if a drug is
usually self-administered based on the frequency of its subcutaneous
injections, and therefore is not covered, the less-frequent intravenous form
of the drug also will not be covered, even when administered by a physician
(e.g. insulin, even if for an "emergency" indication). Even if a specific
patient could _never_ self-administer _any_ injectable drug (because of
cognitive impairment, blindness, paralysis, other mental or physical
disability, etc.) if a particular drug is usually self-administered by most of
the Medicare population, the drug would not be covered for this individual. If
a drug has multiple uses and the drug is self-administered more than 50% of
the time for the total of all uses, then the drug would not be covered even
for uses that require physician administration.  
  
When a drug is usually self-administered, and therefore not covered, no
payment may be made even when the drug is given incident to a physician's
service for reasons such as:  

  

  * Teaching self-administration,
  
  

  * Adjusting or titrating the dose,
  
  

  * Monitoring for immediate side effects, and
  
  

  * Emergency use.
  

  
If a drug has multiple uses, and the drug is administered "incident to" a
physician's service for its most frequent uses, and therefore covered, then
the drug is covered even for uses that can be self-administered. However, when
a drug is thereby covered, payment still requires that the drug is actually
administered incident to a physician's service and is reasonable and necessary
for the condition treated.  
  
No payment may be made for an otherwise-covered drug that is self-
administered.  
  
**Noridian will use the following process to determine coverage:  
  
Step 1  
  
Determination of Self-Administration: _"Apparent on its face"**_  
For certain injectable drugs, the nature of the condition(s) for which it is
administered will be sufficient to determine that the drug is or is not
usually self-administered.  
  
When the predominant use is for a condition that is recurrent, identifiable by
the patient, given for an immediate effect and provided with self-
administration instructions in the drug's package insert approved by the
United States Food and Drug Administration (FDA), the drug is usually self-
administered. Examples include sumatriptan to treat migraine headaches,
insulin to treat diabetes and alprostadil to treat erectile dysfunction.  
  
On the other hand, a drug that a reasonably prudent patient would not be
expected to self-administer is not usually self-administered, and is therefore
covered. Examples include a drug usually requiring clinical expertise to
administer (e.g. a drug given intravenously or for use in an implanted
intravenous or intrathecal pump), a drug usually administered during a
procedure (e.g. a local anesthetic or an injected releasing hormone to measure
a hormonal response) and a drug usually requiring a physician to titrate the
next dose (e.g. erythropoietin alfa for chemotherapy support).  
  
Further, a drug generally used only for an acute condition such that the
course of scheduled injections lasts less than two weeks, is not usually self-
administered.  
  
**If, and only if, you are unable to make a determination from step 1, go to
step 2.  
  
Step 2  
  
If there are _not_ multiple indications for a drug or there is no reliable
usable data, skip directly to step 3.  
  
Using _Presumptive Evidence_ to Combine Information When a Drug Has Multiple
Indications and there is Reliable Usable Data:**  
  
1\. Select beginning and end dates for the analysis. For consistency  
try to use the same dates for all calculations.  
  
2\. Calculate the total injections during this period, including any  
intravenous or intramuscular injections. This total will be 100%.  
  
3\. Drug indications will be sorted by diagnoses and where similar  
will be combined to facilitate analysis.  
  
4\. Calculate the number of subcutaneous injections, but do not  
include those for courses of treatment consisting of scheduled  
injections lasting less than two weeks. (Any indication with  
scheduled injections lasting less than two weeks is weighted as  
not usually self-administered, even if administered  
subcutaneously.)  
  
5\. Add to this number (from # 4) those injections for courses of  
treatment lasting two weeks or longer and with injections at least  
weekly (i.e. those that are both "chronic" and "frequent")  
  
6\. If this sum is equal to or less than 50% of the total injections  
during the period, the drug is not usually self administered and  
is covered.  
  
7\. If this sum is more than 50% of the total injections during the  
period, proceed to Step 3.  
  
**Step 3  
Determination of Self-Administration using _Evidentiary  
Criteria:**_  
When available, evidence of the following types must be considered:  

  

  * Peer-reviewed medical literature
  

  * Standards of medical practice
  

  * Evidence-based practice guidelines
  

  * FDA approved indications
  

  * FDA approved package insert (which is not to be used _by  
itself as the only_ determining factor)

  

  

  
  
Further, evidence of the following types _may_ be considered:  

  * Drug compendia references
  

  * Reliable patient use data
  

  * The need for physician monitoring to determine each dose
  

  * Other relevant parameters according to contractor discretion
  

  
The above data will be used for each indication to supplement available
utilization data on the percentage of self-administered injections. Where it
appears more reliably available, utilization data on the percent of
beneficiaries receiving a drug by self-administration may be used as an
alternative to percent of injections.  
  
**Provider Notice of Non-Covered Drugs**  
After making determinations by the above three-step process, Noridian will
provide notice on our web site, _http://www.noridianmedicare.com,_ 45 days
prior to the date that any drug will change from current covered status to
being not covered. During the 45-day period, the Noridian existing medical
review and payment procedures will remain in effect. After the 45-day period,
we may deny payment for the drug(s) subject to the notice.  
  
**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 of Noncoverage (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**  
A physician accepting assignment and the hospital may appeal a denial under
the provisions found in the IOM _Medicare Claims Processing Manual,_
Publication 100-04, Chapter 29, Appeals of Claims Decisions at
_http://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/clm104c29.pdf_  
  
 **Reasonable and Necessary**  
Noridian will make the determination of reasonable and necessary with respect
to the medical appropriateness of a 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 _Medicare Benefit Policy Manual,_ Publication 100-02, Chapter
15, Covered Medical and Other Health Services, Section 50.2, Determining Self-
Administration of Drug or Biological; IOM _Medicare Claims Processing Manual,_
Publication 100-04, Chapter 29, Appeals of Claims Decisions.**