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Modifier KF: Item designated by FDA as class iii device

Modifier KF is a HCPCS Level II modifier that CMS describes as "Item designated by FDA as class iii device", in effect since April 1, 2004. 38 DMEPOS fee schedule rows carry it.

Compiled from CMS files by the QuickIntell RCM Editorial Team · Data effective · Method: reference methodology · Report a data correction

Data currency: HCPCS Level II file: October 2026 (effective October 1, 2026); Medicare Coverage Database billing and coding articles: MCD release October 8, 2026 (effective October 4, 2026); DMEPOS fee schedule: DME26-D (October 2026) (effective October 1, 2026). Next CMS release: January 1, 2027 (quarterly update) for the HCPCS Level II file and DMEPOS fee schedule; weekly, every Thursday for the Medicare Coverage Database billing and coding articles.

Modifier
KF
Code set
HCPCS Level II
CMS October 2026 HCPCS file
In effect since
April 1, 2004
Group
Durable medical equipment
Medicare coverage articles
None
current MCD billing and coding articles that list it
DMEPOS fee schedule rows
38
DME26-D

CMS descriptor for modifier KF

Item designated by fda as class iii device

CMS HCPCS Level II file, October 2026 (short descriptor: Fda class iii device)

When modifier KF is used

KF identifies an item the FDA designates as a class III device. Class III DMEPOS items carry their own prices on the fee schedule, separate from the class I and II versions of the same code.

Modifier KF on the DMEPOS fee schedule

38 rows across 20 HCPCS codes on the DME26-D DMEPOS fee schedule carry modifier KF, so the fee Medicare pays for those items depends on it.

Denials when modifier KF is wrong or missing

A modifier that does not fit the procedure code comes back with claim adjustment reason code 4 (the procedure code is inconsistent with the modifier used, or a required modifier is missing). When a coverage article requires the modifier and it is absent, the line is usually returned as unprocessable with reason code 16 and a remark code naming the missing information, which is fixed with a corrected claim rather than an appeal. The denial code lookup explains each code.

For teams evaluating QuickIntell software

Where QuickIntell fits with modifiers

QuickCode supports qualified coder review, documentation clarification and the billing handoff, where each modifier is matched to what the record supports. QuickRCM carries claim readiness and the modifier-related denials with configurable automation and human review.

See QuickCode for modifier reviewSee QuickRCM for modifier denials
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Optional software evaluation, not payer support or help with an individual claim. For coverage or payment decisions, use the official sources on this page. Do not include patient information in a demo booking or inquiry.

Frequently asked questions

What does modifier KF mean?

CMS describes modifier KF as "Item designated by FDA as class iii device" in the HCPCS Level II file. KF identifies an item the FDA designates as a class III device.

Is modifier KF still valid?

Yes. Modifier KF is active in the CMS October 2026 HCPCS file; CMS added it on April 1, 2004. Payers can still decline to accept it, so check the payer's modifier policy.

Does modifier KF change the DMEPOS fee?

Yes. 38 rows across 20 HCPCS codes on the DME26-D DMEPOS fee schedule carry KF, and the fee for those items is listed separately for it.

Sources

Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-10. Verify against the primary file before billing or contracting decisions. The reference methodology explains how each figure is computed from these files.

Disclaimer

The descriptor is reproduced from the CMS HCPCS file; the note on when the modifier is used is our own summary of the Medicare rule. Medicaid and commercial plans publish their own modifier policies. Not legal, clinical or billing advice.

Found a figure that does not match the CMS file? Report a data correction with the CMS file and the value you expected; the request reaches the editorial team through the contact form.