CMS Pub. 100-02, ch. 15, § 50.4.1

B3-2049.4

Use of the drug or biological must be safe and effective and otherwise reasonable and necessary. (See the

Medicare Benefit Policy Manual, Chapter 16, “General Exclusions from Coverage,” §20.) Drugs or

biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and

effective for purposes of this requirement when used for indications specified on the labeling. Therefore, the

program may pay for the use of an FDA approved drug or biological, if:

• It was injected on or after the date of the FDA’s approval;

• It is reasonable and necessary for the individual patient; and

• All other applicable coverage requirements are met.

The A/B MAC (A), (B), or (HHH), or DME MAC will deny coverage for drugs and biologicals, which have

not received final marketing approval by the FDA unless it receives instructions from CMS to the contrary.

For specific guidelines on coverage of Group C cancer drugs, see the Medicare National Coverage

Determinations Manual.

If there is reason to question whether the FDA has approved a drug or biological for marketing, the MAC

must obtain satisfactory evidence of FDA’s approval. Acceptable evidence includes:

• A copy of the FDA’s letter to the drug’s manufacturer approving the new drug application (NDA);

• A listing of the drug or biological in the FDA’s “Approved Drug Products” or “FDA Drug and

Device Product Approvals”;

• A copy of the manufacturer’s package insert, approved by the FDA as part of the labeling of the

drug, containing its recommended uses and dosage, as well as possible adverse reactions and

recommended precautions in using it; or

• Information from the FDA’s Web site.

When necessary, the regional office (RO) may be able to help in obtaining information.