CMS Pub. 100-02, ch. 15, § 50.5.4

Effective January 1, 1998, Medicare also covers self-administered anti-emetics, which are necessary for the

administration and absorption of the anti-neoplastic chemotherapeutic agents when a high likelihood of

vomiting exists. The anti-emetic drug is covered as a necessary means for administration of the anti-neoplastic chemotherapeutic agents. Oral drugs prescribed for use with the primary drug, which enhance the

anti-neoplastic effect of the primary drug or permit the patient to tolerate the primary anti-neoplastic drug in

higher doses for longer periods, are not covered. Self-administered anti-emetics to reduce the side effects of

nausea and vomiting brought on by the primary drug are not included beyond the administration necessary

to achieve drug absorption.

Section 1861(s)(2) of the Social Security Act extends coverage to oral anti-emetic drugs that are used as full

replacement for intravenous dosage forms of a cancer regimen under the following conditions:

• Coverage is provided only for oral drugs approved by the Food and Drug Administration (FDA) for

use as anti-emetics;

• The oral anti-emetic must either be administered by the treating physician or in accordance with a

written order from the physician as part of a cancer chemotherapy regimen;

• Oral anti-emetic drugs administered with a particular chemotherapy treatment must be initiated

within 2 hours of the administration of the chemotherapeutic agent and may be continued for a

period not to exceed 48 hours from that time;

• The oral anti-emetic drugs provided must be used as a full therapeutic replacement for the

intravenous anti-emetic drugs that would have otherwise been administered at the time of the

chemotherapy treatment.

Only drugs pursuant to a physician’s order at the time of the chemotherapy treatment qualify for this benefit.

The dispensed number of dosage units may not exceed a loading dose administered within two hours of the

treatment, plus a supply of additional dosage units not to exceed 48 hours of therapy.

Oral drugs that are not approved by the FDA for use as anti-emetics and which are used by treating

physicians adjunctively in a manner incidental to cancer chemotherapy are not covered by this benefit and

are not reimbursable within the scope of this benefit.

It is recognized that a limited number of patients will fail on oral anti-emetic drugs. Intravenous anti-emetics

may be covered (subject to the rules of medical necessity) when furnished to patients who fail on oral anti-emetic therapy.

More than one oral anti emetic drug may be prescribed and may be covered for concurrent use if needed to

fully replace the intravenous drugs that otherwise would be given. See the Medicare National Coverage

Determinations Manual, Publication 100-03, Chapter 1, Section 110.18, for detailed coverage criteria.