VYALEV® (foscarbidopa and foslevodopa), the VYAFUSER Pump, and Related Infusion Supplies - Correct Coding and Billing - Revised

Joint DME MAC Publication

VYALEV® (foscarbidopa and foslevodopa, AbbVie Inc. Chicago, IL, U.S.A) is a medication approved by the U.S. Food and Drug Administration on October 17, 2024 and is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. Administration of VYALEV® is via subcutaneous administration only, preferably in the abdomen, via the VYAFUSER pump. Per the FDA prescribing information, the maximum recommended daily dosage of VYALEV is 3,525 mg of foslevodopa (approximately 2,500 mg levodopa).

Questions have arisen about the proper coding and billing of VYALEV® and the VYAFUSER pump and related infusion supplies. For dates of service on or after October 17, 2024, claims for VYALEV® 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

Claims for the VYAFUSER pump and administration supplies for dates of service before January 24, 2025 must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS) for the pump and A9999 (MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED) for the administration supplies. Code E1399 is the proper code to use if a unique pump is FDA approved and does not fall under any existing pump HCPCS codes. Suppliers must include the following information on each claim when submitting claims for items coded E1399 or A9999:

• Description of the item
• Manufacturer name
• Product name and number
• Supplier price list
• HCPCS of related item

This additional information for the drugs, supplies, and pump (if applicable) 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. Since these miscellaneous codes are individually adjudicated, use of the KX, GA and GZ modifiers are not required.

Claims for the VYAFUSER pump and related administration supplies for dates of service on or after January 24, 2025 must be coded as follows:

*A9900 (MISCELLANEOUS DME SUPPLY, ACCESSORY, AND/OR SERVICE COMPONENT OF ANOTHER HCPCS CODE) for the vial adapter is not separately payable as it is included in the payment for the K0552 (SUPPLIES FOR EXTERNAL NON-INSULIN DRUG INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH).

Suppliers must use the KX modifier on claims for the VYAFUSER pump and related infusion supplies billed under HCPCS E0781, A4222, K0552 and K0604. In this situation, application of the KX modifier attests that a Standard Written Order (SWO) is on file and the medical record supports the item is reasonable and necessary. Use of the KX modifier is not required for NOC-coded pumps, supplies, and drugs.

For questions about correct coding or products not listed on the DMECS Product Classification List,, contact the Pricing, Data Analysis and Coding (PDAC) HCPCS Helpline at (877) 735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday. You may also visit the PDAC website to chat with a representative or select the Contact Us button at the top of the PDAC website for email, FAX, or postal mail information.