Nebulizers, External Infusion Pumps and Related Drugs

Joint DME MAC Publication

Recently, the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have received questions about coverage of drugs under the Nebulizers (NEB) and External Infusion Pumps (EIP) Local Coverage Determinations (LCDs) (L33370 and L33794, respectively). Suppliers are reminded that while these LCDs are often thought of as a drug coverage policy, the benefit is durable medical equipment, and the inhaled or infused drug is considered as a supply to the DME. Consequently, the overarching coverage requirement is that administration of the drug via a nebulizer or external infusion pump must be reasonable and necessary.

The NEB and EIP LCDs outline the coverage criteria for specific drugs or classes of drugs that meet the requirements for coverage. Coverage details for newly approved drugs will not initially be available within the LCDs until a reconsideration is completed and evaluated by the DME MACs. In such situations, claims for 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 J7699 (NOC DRUGS, INHALATION SOLUTION ADMINISTERED THROUGH DME) for drugs administered by a nebulizer or J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME) for drugs used in an EIP. Codes J7699 or J7799 are the proper codes 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 J7699 or 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 (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.

Manufacturers are encouraged to apply for a new HCPCS code for their drug and/or external infusion pump (if applicable) as soon as possible following FDA approval. The CMS HCPCS Level II Modification to Code Set Form can be accessed at: https://mearis.cms.gov/public/home.

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) or the Nebulizer LCD (L33370) for an inhalation drug. Information for submitting an LCD reconsideration request may be found here.

Refer to the External Infusion Pump LCD and related Policy Article or the Nebulizer 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.