Off-Label Use of Chemotherapeutic Drugs and Biologicals for Non-Cancer
Indications

Off-label (unlabeled) drug is defined as a use for a non-FDA approved
indication that is not listed on the drug's official label/prescribing
information. Off-label use is further defined as giving the drug in a way that
deviates significantly from the labeled prescribing information for a
particular indication. This includes but is not necessarily limited to,
dosage, route of administration, duration, and frequency of administration,
and population to whom the drug would be administered.

Indication is defined as a diagnosis, illness, injury, syndrome, condition, or
other clinical parameter for which a drug may be given.

For the off-label (unlabeled) use of drugs and biologicals for indications
that are not part of an anti-cancer chemotherapeutic regime CGS will consider
coverage on case to case basis per CMS IOM 100-02, Chapter 15, 50.4.2
Unlabeled Use of Drugs. Inclusion of these drugs and biologicals in a
compendium does not guarantee coverage, but the compendium recommendation will
be considered as part of the review.

The following may be submitted to support the coverage with the claim:

  * Submission of compendium reference if available
  * Full text support articles for use of the agent for the indication
  * Societal recommendations

The medical records must document the rationale for the off-label use of the
agent.

If a cancer chemotherapy drug /biologic use is identified as not indicated by
the Centers for Medicare and Medicaid Services (CMS) or the FDA or if CGS
determines that peer-reviewed medical literature does not support the off-
label usage, the drug/biologic is not covered.

List the appropriate J or Q to indicate the drug name. When a specific HCPCS
code does not exist, list the appropriate NOC code J3490, J3590, or J9999 with
the drug name, and dose in the remarks field of the claim Item 19 of the
CMS-1500 form for claims billed to the Part B MAC.

For Part A, claims with C9399 are suspended, and remarks should be placed on
the claim in field locator 80 for the UB04 claim form or SV202-7 for 837I
electronic claim.

Facilities under the hospital OPPS may use code C9399, billed as one unit, if
it does not have an assigned HCPCS or the assigned HCPCS is not yet effective.

**Note:** Claims billed to the Part B MAC with C9399 will be rejected.

Claims billed with a NOC drug code are suspended and the following should be
provided on the claim in the following fields:

  * Field locator 80 for paper claims /line SV202-7 for electronic claims for Part A.
  * Box 19 for paper claims/loop 2400 or SV101-7 for Part B.

Claims billed for Not Otherwise Classified (NOC) codes need to include the
following information in the fields listed above:

  * Name of the drug
  * Dose administered (mg, cc, etc.)
  * Route of administration (IV, IM, SC, PO, etc.)
  * NDC number if available
  * The invoice price (for new drugs if the wholesale acquisition cost (WAC) is unavailable, or for compounded drugs).

The JW modifier is required for wastage in single-dose vials; this modifier
does not apply to multi-dose vials per CMS Internet-Only Manual, Pub 100-04,
Chapter 17, Section 40 Discarded Drugs and Biologicals (
<https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/clm104c17.pdf>).