Page 66 - Medicare Benefit Policy Manual

recognized and paid for administration of the vaccine to ESRD
patients.

C. Influenza Virus Vaccine

Effective for services furnished on or after May 1, 1993, the Medicare Part B program
covers influenza virus vaccine and its administration when furnished in compliance with
any applicable State law by any provider of services or any entity or individual with a
supplier number. Typically, these vaccines are administered once a flu season. Medicare
does not require, for coverage purposes, that a doctor of medicine or osteopathy order the
vaccine. Therefore, the beneficiary may receive the vaccine upon request without a
physician’s order and without physician supervision.

50.4.5 - Off-Label Use of Drugs and Biologicals in an Anti-Cancer
Chemotherapeutic Regimen
(Rev. 212, Issued: 11-06-15, Effective: 08-12-15, Implementation: 02-10-16)

A. Overview

Effective January 1, 1994, off-label, medically accepted indications of Food and Drug
Administration-(FDA) approved drugs and biologicals used in an anti-cancer
chemotherapeutic regimen are identified under the conditions described below. A regimen is
a combination of anti-cancer agents clinically recognized for the treatment of a specific type
of cancer. Off-label, medically accepted indications are supported in either one or more of
the compendia or in peer-reviewed medical literature. The contractor may maintain its own
subscriptions to the listed compendia or peer-reviewed publications to determine the
medically accepted indication of drugs or biologicals used off-label in an anti-cancer
chemotherapeutic regimen. Compendia documentation or peer-reviewed literature
supporting off-label use by the treating physician may also be requested of the physician by
the contractor.

B. Recent Revisions to the Compendia List

Do not deny coverage based solely on the absence of FDA-approved labeling for the use, if
the use is supported by any of the following compendia and the use is not listed as
unsupported, not indicated, not recommended, or equivalent terms, in any of the following
compendia:

Existing - American Hospital Formulary Service-Drug Information (AHFS-DI)

Effective June 5, 2008 - National Comprehensive Cancer Network (NCCN) Drugs and
Biologics Compendium

Effective June 10, 2008 - Micromedex DrugDex

Effective July 2, 2008 - Clinical Pharmacology