External Infusion Pumps and Related Drugs - Revised - JA DME

Joint DME MAC Publication
Posted February 22, 2024

Recently, the DME MACs have received questions about coverage of drugs under the External Infusion Pumps (EIP) Local Coverage Determination (LCD) (L33794). Suppliers are reminded that while it is often thought of as a drug coverage policy, the benefit is durable medical equipment, and the infused drug is considered as a supply to the DME. Consequently, the overarching coverage requirement is that administration of the drug via a durable external infusion pump must be reasonable and necessary.

The EIP LCD outlines the coverage criteria for specific drugs or classes of drugs that meet the requirements for coverage. Coverage details for newly approved drugs or external infusion pumps will not initially be available within the LCD until a reconsideration is completed and evaluated by the DME MACs. In such situations, claims for pumps and/or drugs are processed on a claim-by-claim basis. "Clean" claims for miscellaneous codes or not otherwise classified codes are subject to the same claim processing timeliness standards as other HCPCS codes (30 day ceiling).

Drugs that do not have a specific healthcare common procedure coding system (HCPCS) code may be billed using code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME). Code J7799 is the proper code to use until a product-specific code is assigned through the formal HCPCS coding process. 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

External infusion pumps that do not fall under an existing HCPCS code, may be billed using code E1399 (DURABLE MEDICAL EQUIPMENT, MICSCELLANEOUS). 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:

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

This additional information for the drugs and pump 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 is not required.

Manufacturers are encouraged to apply for a new HCPCS code for their drug and/or external infusion pump as soon as possible following FDA approval. The CMS HCPCS Level II Modification to Code Set Form can be accessed from the MEARiS website.

Providers and suppliers, in addition to submitting a timely application for a new HCPCS code, are encouraged to engage the DME MAC contractors early in their drug development process to discuss their product, the clinical evidence underpinning potential indications and the process for requesting an LCD reconsideration. The LCD reconsideration process is the mechanism for potentially incorporating a new drug and/or pump into the External Infusion Pumps LCD (L33794). Information for submitting an LCD reconsideration request may be found on the LCD Reconsideration Process website.

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) HCPCS Helpline at (877) 735-1326 from 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.

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