Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic
Regimen

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.

The general utilization of any cancer chemotherapy drug or biological will be
covered for use that is not FDA approved (unlabeled) if used for anti-
neoplastic conditions, and if the use is listed as acceptable in one of the
Medicare-approved drug compendia and the use is not listed as "not indicated"
or unfavorably evaluated in any of the compendia per CMS Internet-Only Manual
(IOM), Pub 100-02, Chapter 15, 50.4.5 Off Label Use of Anti-Cancer Drugs and
Biologicals.

Although NCCN Category 2B is not included in the IOM, NCCN 2B indications are
supported by evidence and require a consensus of the NCCN expert panel. For
this reason, CGS Administrators considers any off label/drug or biological
with a NCCN Category 2B indication to meet the benefit category requirements.

CGS Administrators may also identify off-label uses for Anti-Cancer Drugs and
Biologicals as part of anti-cancer chemotherapeutic regimen that are not
listed as supported/recommended in medically accepted compendia (NCCN,
Micromedex Drug DEX, Lexi-Drugs, AHFS or Clinical Pharmacology). Coverage will
be determined for off-label use if supported by clinical research under the
conditions identified in CMS Internet-Only Manual, Pub 100-02, Chapter 15,
Section 50.4.5 Off-Label Use of Anti-Cancer Drugs and Biologicals. For a
review of medications under ths process, please submit full articles, not
abstracts, for consideration. CGS will communicate our decisions for off-label
uses for Anti-Cancer Drugs and Biologicals an article published on our
website.

Consistent with CMS Internet-Only Manual, Pub 100-02, Chapter 15, Section
50.4.5 D 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 use is specifically identified as not indicated in one or more of the
compendia listed in Pub 100-02, Chapter 15, Section 50.4.5 B, 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>).