Process for Determining Self-Administered Drug Exclusions  Medical Policy
Article

The Centers for Medicare and Medicaid Services (CMS) published guidelines
instructing contractors to develop a process to determine whether a drug or
biological is usually self-administered and excluded from payment. (See CMS
Publication 100-02, _Medicare Benefit Policy Manual_ , Chapter 15, Section
50.2). These instructions include the following:  
  
 _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. Section 112 of the Benefits, Improvements & Protection
Act of 2000 ( BIPA) amended sections 1861 (s)(2)(A) and 1861 (s)(2)(B) of the_
[Social Security] _Act 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."  
  
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 (for example, to observe proper technique
or side-effects of the drug). 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. For the purpose
of applying this exclusion, the term "usually" means more than 50 percent of
the time for all Medicare beneficiaries who use the drug. _  
  
Contractors are further instructed to make this determination on a drug-by-
drug basis, not on a beneficiary-by-beneficiary basis.  
  
**"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. 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._  
  
 **Evidence Criteria for applying the Medicare Self-Administered Drug
Exclusion:**  
  

  * Peer reviewed medical literature
  * Standards of medical practice
  * Evidence-based practice guidelines
  * FDA approved label
  * Package insert
  * Drug compendia references
  * Self-administration utilization statistics  
  
 **_Acute:_** _For the purpose of determining whether a drug is usually self-
administered, an acute condition means a condition that begins over a short
time period, is likely to be of short duration and/or the expected course of
treatment is for a short, finite interval. A course of treatment consisting of
scheduled injections lasting less than two weeks, regardless of frequency or
route of administration, is considered acute.  
  
 **Usually:** 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 you may not
make any Medicare payment for it._  
  
 **Drugs NOT Usually Self-administered:**  
  

  * Drugs delivered intravenously may usually be presumed not usually self-administered
  * Drugs delivered intramuscularly may usually be presumed not usually self-administered

  
  
**Drug Usually Self-administered:**  
  

  * Drugs delivered subcutaneously may be usually presumed self-administered
  * Drugs delivered by other routes of administration such as oral, suppositories, and topical medications are all considered to be usually self-administered  
  
 **Notice of Non-Covered Drugs**  
  
 _Contractors must provide notice 45 days prior to the date that these drugs
will not be covered. During the 45-day time period, contractors will maintain
existing medical review and payment procedures. After the 45-day notice,
contractors may deny payment for the drugs subject to the notice._  
  
CMS further provided that Part A intermediaries or Part A MACs may opt to
adopt the determinations of the Part B MACs within their jurisdiction(s). In
the interest of providing consistent coverage for all providers within each
state, the CGS Administrators, LLC Part A MACs will adopt the coverage
decisions for injectable drugs subject to the self-administered drug exclusion
as determined by the Part B MAC in each respective state. HCPCS codes for the
same drugs that apply only to providers that bill the Part A MAC (e.g., HCPCS
codes used for drugs billable under the Outpatient Prospective Payment System
[OPPS]) are included when applicable. The list of drugs excluded from Medicare
coverage as self-administered drugs can be accessed on our contractor Web site
at www.cgsmedicare.com. It can also be found on the Medicare Coverage Database
at www.cms.gov/mcd.