We’ve previously written about Medically Unlikely Edits (MUE) published by CMS and how to appeal them on an individual patient case basis. This article also pertains to MUE values but outlines a different process to ensure that clinically appropriate drugs are reimbursed for Medicare outpatients and uses a new dosing regimen for Cetuximab (Erbitux®) as an example.
Cetuximab is a chemotherapy agent approved for patients with K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN).
On April 6, 2021, the FDA approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for ERBITUX (cetuximab). This approval provides a biweekly dosage regimen option in addition to the previously approved weekly (QW) dosage regimen (initial dose of 400 mg/m2 as a 120-minute intravenous infusion, and subsequent doses of 250 mg/m2 infused over 60 minutes once weekly) as a single agent or in combination with other chemotherapy.
The HCPCS code for cetuximab is J9055-injection, cetuximab, 10 mg and currently has an MUE in the April 2021 and July 2021 tables of “120”.
After publication of the July 2021 MUE tables on the CMS website, we corresponded with the NCCI Coordinator to request that the MUE value be raised from “120” to “150” to accommodate this new dosing regimen. In addition to convenience for the patient, the new dosing regimen may also decrease the amount of drug wasted. A copy of our letter is here.
We are pleased to have received a response on June 28th indicating that they have reviewed and accepted our request and will be increasing the MUE to “150” in a future quarterly update.
Until that update is finalized, we recommend that all claims for J9055-injection, cetuximab, 10 mg be reviewed and when the current MUE of “120” is appropriately exceeded, that pertinent information from the patient’s medical record (e.g. physician diagnosis, drug order, BSA calculation, MAR, documentation of discarded waste (if any)) be included with the original claim submission to ensure a medical review at the MAC to avoid a denial. A template letter that can be included with your submission is here..
What can you do if dosing regimens for other drugs also change the MUE in the future?
Contact us through the CONTACT US page of the website and we’ll send the letter to the NCCI contractor for review.
You can also submit a letter to NCCI asking for a review.
Pharmacy should identify trends when new dosing regimens are used to ensure that MUE values are not appropriately exceeded.
Pharmacy and Revenue Integrity should collaborate when FDA labeling changes occur to ensure that MUEs are not exceeded. If they are, the initial claim submission for the full amount of drug utilized should be billed and a copy of pertinent portions of the medical record submitted with the claim submission.
When new dosing regimens are exceeded, Pharmacy and Revenue Integrity should consider submitting a requester to the NCCI contractor to increase the MUE, or contact PHARMACY REVENUE CYCLE to submit the letter to request the increase.