Retired - Coverage and Correct Coding of HYQVIA (Immune Globulin Infusion (Human) 10%, with Recombinant Human Hyaluronidase) – Revised

Joint DME MAC Publication

This is a revision to previous version published on December 29, 2014.

On September 12, 2014, HYQVIA (Baxter Healthcare) was approved by the FDA. HYQVIA is a subcutaneously administered immune globulin 10% (Human) with recombinant human hyaluronidase, and is indicated for the treatment of Primary Immunodeficiency (PI) in adults.

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have evaluated HYQVIA and determined that it is eligible for inclusion in the Durable Medical Equipment (DME) External Infusion Pump Local Coverage Determination (LCD).

HYQVIA is administered using a programmable variable infusion pump (HCPCS code E0781), that is capable of infusing a patient's therapeutic dose at infusion rates of up to 300 mL/hr/site.

Coverage is available for claims with dates of service on or after September 12, 2014 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
• HYQVIA is administered subcutaneously through an E0781 pump that is pre-programmed, and
• The E0781 pump is delivered to the Medicare beneficiary in a “locked mode” i.e., the patient is unable to self-adjust the infusion rate.

The medical record must contain sufficient information to clearly demonstrate that the beneficiary meets all of the requirements specified above.

Administration of HYQVIA requires a gradual increase in the infusion rate at the beginning of each infusion. This infusion rate ramp-up is patient-specific and must be determined under medical supervision over the course of several infusions of HYQVIA. Once the infusion rate ramp-up specification(s) have been determined, they can be programmed into an appropriate E0781 pump. 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 as incident to the required professional supervision.

Claims to the DME MAC for the pump, drugs and supplies administered in this scenario will be denied as wrong jurisdiction.

Claims for HYQVIA 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
• Manufacturer's Suggested retail price (MSRP)

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.

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 PDAC 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.