Page 80 - Medicare Benefit Policy Manual

“Approved Drug Products” (Orange Book), “Physician’s Desk Reference” (PDR),
or an authoritative drug compendium;

• Be used for the same indications, including unlabeled uses, as the non-self-
administrable version of the drug; and

• Be reasonable and necessary for the individual patient.

50.5.4 - Oral Anti-Nausea (Anti-Emetic) Drugs
(Rev. 185, Issued: 04-15-14, Effective: 05-29-13, Implementation: 07-07-14)

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.