Correct Coding of CUVITRU™ - Revised

Joint DME MAC Publication

On September 13, 2016, CUVITRU™ (Shire) was approved by the FDA.  CUVITRU is a 20% solution of human immune globulin, which is administered subcutaneously, and is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults. The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have evaluated CUVITRU™ and determined that it is eligible for inclusion in the Durable Medical Equipment (DME) External Infusion Pump Local Coverage Determination (LCD).

CUVITRU™ is administered using a mechanical infusion pump (HCPCS code E0779).

Coverage is available for claims with dates of service on or after September 13, 2016 when all of the following requirements have been met:

  • The criteria for subcutaneous immune globulin as specified in the External Infusion Pump LCD are met, and
  • CUVITRU™ is administered subcutaneously through an E0779 infusion pump.
    The medical record must contain sufficient information to clearly demonstrate that the beneficiary meets all of the requirements specified above.

Several of the initial doses of CUVITRU™ are administered under the supervision of a healthcare professional. There is no coverage under the Durable Medical Equipment Benefit for equipment, drugs and infusions supplies used during these initial doses as they are considered to be incident to the required professional supervision.  Claims to the DME MAC for the pump, drugs and supplies administered in this scenario will be rejected as wrong jurisdiction.

Claims for CUVITRU™ for dates of service on or after September 13, 2016 through December 31, 2017 must be submitted using the HCPCS code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME).  Suppliers are reminded that when submitting claims for items coded J7799, the supplier must include the following information on each claim:

  • Name of Drug
  • Manufacturer name
  • Dosage Strength

This information must be entered in the narrative field of an electronic claim (NTE 2300 or NTE 2400 of an electronic claim) or Item 19 of a paper claim.

Claims for CUVITRU™ for dates of service on or after January 01, 2018 must be submitted using the HCPCS code J1555 (INJECTION, IMMUNE GLOBULIN (CUVITRU), 100 MG)

Refer to the External Infusion Pump LCD and related Policy Article for additional coverage, coding and documentation requirements.
For questions about correct coding, contact the Pricing, Data Analysis and Coding (PDAC) contractor Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the
DME PDAC Contact Form.


Revision History

Date Update
11/15/2016 Published on PDAC website
12/12/2017 Revised - to reflect 2018 Annual HCPCS Updates 


Last Updated: 12/12/2017