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.
