11/08/2018

Dosing changes for BAVENCIO® (avelumab) Injection 20mg/mL and four new ICD-10-CM diagnosis codes issued by CMS for Merkel Cell Carcinoma.

Revised Dosage and Administration Schedule
On October 19, 2018, the FDA approved modification to the Recommended Dosage section of the PI for BAVENCIO as follows:

“The recommended dosage of BAVENCIO is 800mg administered as an intravenous infusion over 60 minutes every 2 weeks until diseases progression or unacceptable toxicity.”

Please  refer to the Full Prescribing Information for BAVENCIO  for complete Dosage and Administration information.

NOTE:   There is no change to how BAVENCIO is supplied.  BAVENCIO is supplied as a single-dose vial of 200mg/10mL (20mg/mL) individually packed (11-digit NDC is 44087-3535-01). 

Additionally, the national Level II Healthcare Common Procedure Coding System (HCPCS) J-code for BAVENCIO is J9023 (injection, avelumab, 10mg).

Four New ICD-10-CM Diagnosis Codes for Merkel Cell Carcinoma
Separately, CMS has revised the C4A range of ICD-10-CM diagnosis codes to add the following four new codes effective for dates of service on or after October 1, 2018.  

The full range of C4A ICD-10-CM diagnosis codes is included in the 2019 ICD-10-CM files at the following link: https://www.cms.gov/Medicare/Coding/ICD10/2019-ICD-10-CM.html

We respectfully request your immediate review of the enclosed information and that you update any applicable local coverage determinations or coverage articles to reflect the revised dosing requirements, and add the four new codes in the C4A range of ICD-10-CM codes referenced above.