Page 51 - Medicare Benefit Policy Manual

• They are reasonable and necessary for the diagnosis or treatment of the illness or
injury for which they are administered according to accepted standards of
medical practice (see §50.4);

• They are not excluded as noncovered immunizations (see §50.4.4.2); and

• They have not been determined by the FDA to be less than effective. (See
§§50.4.4).

Medicare Part B does generally not cover drugs that can be self-administered, such as
those in pill form, or are used for self-injection. However, the statute provides for the
coverage of some self-administered drugs. Examples of self-administered drugs that are
covered include blood-clotting factors, drugs used in immunosuppressive therapy,
erythropoietin for dialysis patients, osteoporosis drugs for certain homebound patients,
and certain oral cancer drugs. (See §110.3 for coverage of drugs, which are necessary to
the effective use of Durable Medical Equipment (DME) or prosthetic devices.)

50.1 - Definition of Drug or Biological
(Rev. 1, 10-01-03)
B3-2049.1

Drugs and biologicals must be determined to meet the statutory definition. Under the
statute §1861(t)(1), payment may be made for a drug or biological only where it is
included, or approved for inclusion, in the latest official edition of the United States
Pharmacopoeia National Formulary (USP-NF), the United States Pharmacopoeia-Drug
Information (USD-DI), or the American Dental Association (AOA) Guide to Dental
Therapeutics, except for those drugs and biologicals unfavorably evaluated in the ADA
Guide to Dental Therapeutics. The inclusion of an item in the USP DI does not
necessarily mean that the item is a drug or biological. The USP DI is a database of drug
information developed by the U.S. Pharmacopoeia but maintained by Micromedex,
which contains medically accepted uses for generic and brand name drug products.
Inclusion in such reference (or approval by a hospital committee) is a necessary condition
for a product to be considered a drug or biological under the Medicare program, however,
it is not enough. Rather, the product must also meet all other program requirements to be
determined to be a drug or biological. Combination drugs are also included in the
definition of drugs if the combination itself or all of the therapeutic ingredients of the
combination are included, or approved for inclusion, in any of the above drug compendia.

Drugs and biologicals are considered approved for inclusion in a compendium if
approved under the established procedure by the professional organization responsible for
revision of the compendium.

50.2 - Determining Self-Administration of Drug or Biological
(Rev. 157, Issued: 06-08-12, Effective: 07-01-12, Implementation: 07-02-12)