Billing and Coding: Chemotherapy

The purpose of this article is to provide billing guidance for
chemotherapeutic agents, that are usually billed as "incident to" medications
under Part B. This article provides the information which must be included in
box 19 of the CMS-1500 Claim Form or the electronic equivalent for Part B or
in the remarks field (Field Locator 80) of the CMS- 1450 (UB-04) Claim Form or
the electronic equivalent for Part A in order to process the claim.

Palmetto GBA expects that providers identify off-label uses by the use of the
"KX" modifier appended to the CPT/HCPCS code for the drug. These off-label
uses must be supported by clinical research under the conditions identified in
this section. Peer-reviewed medical literature may appear in scientific,
medical, and pharmaceutical publications in which original manuscripts are
published, only after having been critically reviewed for scientific accuracy,
validity, and reliability by unbiased, independent experts prior to
publication. In-house publications of entities whose business relates to the
manufacture, sale, or distribution of pharmaceutical products are excluded
from consideration. Abstracts (including meeting abstracts) are excluded from
consideration. Such usages will be subject to review at the discretion of
Palmetto GBA. For review of medications under these considerations, please
submit full articles, not abstracts, for consideration.

The JW modifier is required for wastage in single dose vials; this modifier
does not apply to multidose vials.

This article applies only to those medications that have designated "J" codes.
For those medications that have not been provided "J" codes use CPT C9399
using the instructions found in the published article A55913 Correct Billing
and Coding for Hospital Outpatient Drugs and Biologicals Under the Outpatient
Prospective Payment System (OPPS). For those medications that have not been
provided "J" codes and are being billed under Part B use the appropriate NOC
code (J9999 Not otherwise classified, antineoplastic drugs; J3490 Unclassified
drugs; J3590 Unclassified biologics). Administration coding for these drugs is
addressed in the Billing and Coding of Drug and Biological Infusions A55297
article.

It is noted that some drugs have approvals for specific forms of the cancers,
such as estrogen receptor positivity in breast cancers. If the approved
indications require that level of specificity, it is expected that the coded
diagnosis will include the additional codes (Z codes on occasion) that improve
the specificity to the level shown in the FDA (or other) approval.

Per the manual, Medicare limits coverage to those indications listed in the
FDA label as approved, or in the NCCN Guidelines listing as category 2B or
higher or in the additional approved compendia listed in the manual per the
rating or recommendation level assigned for each of those compendia. As new
agents and indications are approved, general coverage guidelines are found in
the CMS Internet-Only Manual, Pub 100-02, Chapter 15, 50.4.1 Approved Use of
Drug and  50.4.5 Off Label Use of Anti-Cancer Drugs and Biologicals. **Other
off-label indications may be approved as noted above with the KX modifier.**