RAC Region B contractor CGI posted a semi-automated review on March 26, 2014, for outpatient providers regarding the medical necessity for the drug Cetuximab. Per the contractor’s description of this issue, clinical editing to identify potential incorrect billing occurring for Cetuximab claims billed with an ICD-9-CM code that does not support medical necessity, according to existing Medicare policy, FDA labeling, accepted guidelines, approved compendia, or other Medicare rules and regulations.

Payment will be recouped when no additional documentation is received from the provider for complex review within the 45-day response period. Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of metastatic colorectal cancer and head and neck cancer.

The issue references Wisconsin Physicians Service Insurance Corporation’s Local Coverage Determination (LCD): Chemotherapy Drugs and their Adjuncts (L28576) which specifically lists the ICD codes for Cetuximab:

ICD codes for Cetuximab:
Cetuximab (Erbitux TM) (J9055) 10 mg
Colorectal Cancer 153.0-154.8
Head and Neck Cancer 140.0-149.9, 160.0-161.9, 195.0, 196.0
Non-Small cell lung cancer 162.2-162.9
Squamous Cell Skin Cancer of the head and neck 173.02, 173.12, 173.22, 173.32, 173.42
Squamous Cell Skin Cancer for Regional Recurrences or Distal Metastases 239.2 or V10.83.

{{cta('eeb9343e-b646-424a-8f66-561f696cd1ce')}}

Cetuximab is covered when:

• Used in combination with irinotecan, is indicated for the treatment of metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy.
• Administered as a single agent for the treatment of patients with metastatic colorectal carcinoma in patients who are intolerant to irinotecan based chemotherapy.
• The patient must not have K-RAS mutation when using this drug for the treatment of colorectal cancer.
• As a single agent or in combination with irinotecan after first progression except in patients receiving capecitabine or fluorouracil and leucovorin with bevacizumab.

Other sources referenced by the contractor for this issue include the Centers for Medicare & Medicaid Services (CMS) publications: CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15, Section 50 – Drugs and Biologicals and CMS Pub 100-04 Chapter 17 Section 90.2 – Drugs, Biological, and Radiopharmaceuticals.

* This article by Margaret Klasa, DC, APN, Bc, was originally published in the online version of the RACmonitor.