On March 6, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application updating the nivolumab (Opdivo®) dosing schedule to include 480 mg infused every four weeks (Q4W).
If you are using the new Q4W dosing schedule be aware that HCPCS J9299 nivolumab, 1 mg has a current Medically Unlikely Edit (MUE) value of 440 units. An MUE for a HCPCS/CPT code is the maximum units of service that a provider would report under most circumstances for a single beneficiary on a single date of service. MUEs are designed to prevent billing errors by denying items billed above the established number of units. In this case, J9299 would deny for units billed over the established MUE value of 440 (based on previous prescribing information).
The MUE files are updated quarterly, in the meantime, MUE denials for J9299 claims of more than 440mgs should be appealed to your Medicare Administrative Contractor (MAC). The MUE for J9299 has a MUE Adjudication Indicator (MAI) of “3” indicating this is a date of service edit based on clinical benchmarks. If you receive a MUE denial on HCPCS J9299 your appeal should include documentation of the updated prescribing information and the new Q4W dosing of 480mgs to support medical necessity.
CMS states that MUEs for HCPCS codes with a MAI of “3” may be bypassed by the MAC if they have pre-payment evidence that the units of service were actually provided, were correctly coded, and were medically necessary.
Until the MUE file is updated, you should monitor your claims for J9299 when billing for more than 440mgs and be prepared to appeal with supporting documentation.
CMS Medically Unlikely Edit webpage:
Providers may request a re-evaluation of an MUE by contacting the CMS National Correct Coding Initiative (NCCI) contractor in writing:
National Correct Coding Initiative
Correct Coding Solutions LLC
P.O. Box 907
Carmel, IN 46082-0907
Attention: Niles R. Rosen, M.D., Medical Director and Linda S. Dietz, RHIA, CCS, CCS-P, Coding Specialist
Fax #: 317-571-1745