Joint DME MAC Publication
On July 3, 2019, Xembify® (Grifols USA, LLC) was approved by the Food & Drug Administration (FDA). Xembify® is a 20% immune globulin solution for subcutaneous infusion through an external infusion pump for the treatment of primary immunodeficiencies (PI) in patients 2 years of age and older. Xembify® is included in the External Infusion Pumps Local Coverage Determination (LCD L33794).
Coverage for Xembify® is available for claims with dates of service on or after July 3, 2019 when all of the following requirements have been met:
- The criteria for subcutaneous immune globulin as specified in the External Infusion Pumps LCD are met; and,
- Xembify® is administered subcutaneously through an E0779 or E0781 infusion pump.
Medical records must contain sufficient information to clearly demonstrate that the beneficiary meets all of the requirements specified above.
Claims for Xembify® for dates of service on or after July 3, 2019 through June 30, 2020 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 Xembify® for dates of service on or after July 1, 2020 must be submitted using the HCPCS code J1558 (INJECTION, IMMUNE GLOBULIN (XEMBIFY), 100 MG).
Refer to the External Infusion Pumps LCD and LCD-related Policy Article, and Standard Documentation Article for additional coverage, coding and documentation requirements.
For questions about correct coding, contact the PDAC Contact Center at 877-735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday, or email the PDAC by completing the DME PDAC Contact Form located on the PDAC Website.
||Published on PDAC website
||Retired due to content incorporation into the applicable Local Coverage Determination and/or related Policy Article