2025 HCPCS code KF
(Active) Effective Date: N/A Revision Date: N/A Durable Medical Equipment (DME) - Modifiers for HCPCS codes Feed
Modifier KF is appended to a HCPCS code to indicate that the device has been designated as a Class III device by the FDA.
Modifier KF can be used with other applicable modifiers if they further describe the service provided. However, ensure that modifiers used together are not contradictory or redundant.
Medical necessity must be established for the Class III device. Justification for its use should be thoroughly documented in the patient's medical record, especially for high-risk devices, and may include supporting evidence from peer-reviewed literature, clinical practice guidelines, and the patient's specific condition.
The clinician is responsible for ensuring the proper use of the Class III device and for appropriately appending modifier KF to the HCPCS code when billing for it. They should also be prepared to provide documentation if requested by the payer, especially if the device is part of an IDE trial.It is crucial for clinicians to understand the distinction between Category A and Category B investigational devices under the Class III designation, as this will impact Medicare coverage.
In simple words: Modifier KF is used with a code for medical equipment that is considered high risk by the FDA and is still being studied in clinical trials.This helps track these special devices.
This modifier is used for durable medical equipment (DME) that the Food and Drug Administration (FDA) has designated as a Class III device.Class III devices are generally considered high risk, as they are often used to sustain or support life, are implantable, or present a potential for unreasonable risk of illness or injury. These devices require premarket approval (PMA) from the FDA before they can be marketed.The KF modifier helps identify these Class III devices on DME claims for billing and reimbursement purposes. It is important to note that Class III devices can be categorized by the FDA as either Category A or Category B. Category A devices are those for which initial questions of safety and effectiveness have not been resolved, while Category B devices are those for which the FDA believes underlying safety and effectiveness questions have been resolved, often because similar devices have already obtained FDA approval. Medicare does not generally cover Category A investigational devices. For Category B devices participating in an FDA-approved investigational device exemption (IDE) clinical trial, participating providers must furnish the necessary documentation for the DME contractor to make coverage and claims processing determinations.
Example 1: A patient receives an implantable intraspinal catheter with an infusion pump (a Class III device) for pain management. The provider uses the appropriate HCPCS code for the device and appends modifier KF to indicate it's a Class III device., A patient is fitted with a new type of stair-climbing power wheelchair that is currently in clinical trials under an IDE (and designated as a Class III, Category B device).The supplier bills for the wheelchair using the HCPCS code with modifier KF., A patient receives replacement electrodes for an external defibrillator. The defibrillator itself is a Class III device; therefore, modifier KF is applied.
Documentation should include the device's FDA classification, the specific type of device used, and any relevant information about its investigational status (e.g., IDE number, clinical trial information). In cases where the device is being used as part of a clinical trial, comprehensive documentation of the patient's participation and the device's usage within the trial should be maintained.
** Modifier KF should not be used for devices not officially designated as Class III by the FDA. It's important to maintain clear documentation supporting the medical necessity of the Class III device.Providers should confirm payer-specific coverage policies for Class III devices, particularly for Category A devices, as coverage may vary or require pre-authorization.
- Payment Status: Active
- Specialties:Modifier KF can apply across various specialties utilizing DME designated as Class III devices, such as cardiology (e.g., pacemakers), orthopedics (e.g., implanted prosthetics), audiology (e.g., cochlear implants), neurology (e.g., intraspinal catheters and infusion pumps), physical medicine and rehabilitation (e.g., advanced power wheelchairs), and others.
- Place of Service:"Ambulatory Surgical Center", "Home", "Hospice", "Independent Clinic", "Inpatient Hospital", "Nursing Facility", "Office", "Outpatient Hospital", "Physician's Office", "Skilled Nursing Facility", "Telehealth Provided in Patient’s Home".