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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). Only injectable (including
intravenous) drugs are eligible for inclusion under the "incident
to" benefit. Other routes of administration including, but not limited
to, oral drugs, suppositories, topical medications are all 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 may opt to adopt the
determinations of the carrier(s) within their jurisdiction(s). In the
interest of providing consistent coverage for all providers within each
state, the National Government Services fiscal intermediaries will adopt the
coverage decisions for injectable drugs subject to the self-administered
drug exclusion as determined by the carrier in each respective state. HCPCS
codes for the same drugs that apply only to providers that bill the fiscal
intermediary (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.NGSMedicare.com. It
can also be found on the Medicare Coverage Database at www.cms.hhs.gov/mcd.
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