Retired - KF Modifier Use - Correct Coding
Suppliers are reminded that devices classified by the Food & Drug Administration (FDA) as Class III devices must be billed using the KF modifier (ITEM DESIGNATED BY FDA AS CLASS III DEVICE). The following HCPCS codes and their associated Local Coverage Determinations (LCD) have devices where the KF modifier is applicable:
| HCPCS Code | Descriptor | LCD |
|---|---|---|
| E0617 | EXTERNAL DEFIBRILLATOR WITH INTEGRATED ELECTROCARDIOGRAM ANALYSIS | Automatic External Defibrillators |
| E0747 | OSTEOGENESIS STIMULATOR, ELECTRICAL, NON-INVASIVE, OTHER THAN SPINAL APPLICATIONS | Osteogenesis Stimulators |
| E0748 | OSTEOGENESIS STIMULATOR, ELECTRICAL, NON-INVASIVE, SPINAL APPLICATIONS | Osteogenesis Stimulators |
| E0760 | OSTEOGENESIS STIMULATOR, LOW INTENSITY ULTRASOUND, NON-INVASIVE | Osteogenesis Stimulators |
| E0766 | ELECTRICAL STIMULATION DEVICE USED FOR CANCER TREATMENT, INCLUDES ALL ACCESSORIES, ANY TYPE | Tumor Treatment Field Therapy |
| K0553 | SUPPLY ALLOWANCE FOR THERAPEUTIC CONTINUOUS GLUCOSE MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE | Glucose Monitors |
| K0554 | RECEIVER (MONITOR), DEDICATED, FOR USE WITH THERAPEUTIC GLUCOSE CONTINUOUS MONITOR SYSTEM | Glucose Monitors |
| K0606 | AUTOMATIC EXTERNAL DEFIBRILLATOR, WITH INTEGRATED ELECTROCARDIOGRAM ANALYSIS, GARMENT TYPE | Automatic External Defibrillators |
| K0607 | REPLACEMENT BATTERY FOR AUTOMATED EXTERNAL DEFIBRILLATOR, GARMENT TYPE ONLY, EACH | Automatic External Defibrillators |
| K0608 | REPLACEMENT GARMENT FOR USE WITH AUTOMATED EXTERNAL DEFIBRILLATOR, EACH | Automatic External Defibrillators |
| K0609 | REPLACEMENT ELECTRODES FOR USE WITH AUTOMATED EXTERNAL DEFIBRILLATOR, GARMENT TYPE ONLY, EACH | Automatic External Defibrillators |
For items classified by the FDA as a Class III device that do not have a specific HCPCS code assigned, use HCPCS code E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS) with the KF modifier appended.
The following HCPCS code also has products which are classified by the FDA as Class III devices. Although not associated with a specific LCD, the KF modifier is required for claim submission of this HCPCS code as well.
| HCPCS Code | Descriptor | LCD |
|---|---|---|
| E0764 | FUNCTIONAL NEUROMUSCULAR STIMULATION, TRANSCUTANEOUS STIMULATION OF SEQUENTIAL MUSCLE GROUPS OF AMBULATION WITH COMPUTER CONTROL, USED FOR WALKING BY SPINAL CORD INJURED, ENTIRE SYSTEM, AFTER COMPLETION OF TRAINING PROGRAM |
None (see National Coverage Determination 160.12 at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part2.pdf) |
This information will be added to the applicable LCD-related Policy Articles in an upcoming revision. Please see the applicable Policy Articles for specific information.
| Date | Revision |
|---|---|
| 10/21/2019 | Published on PDAC website |
| 05/19/2026 | Revised to (1) clarify that classification of a device as Class III is specific to the device and is not specific to the HCPCS code that describes the device; (2) clarify that a claim submitted with the KF modifier for a device that is not Class III is subject to overpayment; (3) clarify that if, upon review of the LCD-related Policy Article(s) or other article(s), the supplier is uncertain whether the device is Class III, then to confirm classification of the device with the FDA or manufacturer; (4) remove osteogenesis stimulators (E0747, E0748, and E0760) from the table due to the FDA’s reclassification of the devices from Class III to Class II (effective for dates of service on or after May 18, 2026); and, (5) clarify information in the table by adding references to LCD-related Policy Articles and other article(s), by removing K0553 and K0554, and by adding E2102, E2103, A4238, and A4239 |