CMS Pub. 100-02, ch. 15, § 50.1

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.