LCD Reference Article Response To Comments Article

Response to Comments: Knee Orthoses - DL33318

A60371

Expand All | Collapse All
Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website.
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A60371
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Knee Orthoses - DL33318
Article Type
Response to Comments
Original Effective Date
12/11/2025
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association.

Current Dental Terminology © 2025 American Dental Association. All rights reserved.

Copyright © 2025, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at ub04@aha.org or 312‐422‐3366.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

Article Guidance

Article Text

During the 45-day comment period, which was open from July 24, 2025 through September 6, 2025, the DME MACs received comments from 21 commenters.

NOTE: DME MACs review all submitted comments and may choose to consolidate similar thematic comments or redact or withhold certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language or duplicate/near duplicate submissions. As a result, there may be a discrepancy between the number of comments in the article and the actual number of comments received.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period for the proposed Knee Orthoses Local Coverage Determination (LCD) (DL33318).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support optimal health outcomes in Medicare beneficiaries.

Response To Comments

Number Comment Response
1

Nearly all commenters expressed their support for the proposed revision of the Knee Orthoses (KO) LCD to include a new pathway to coverage for knee orthoses with single or double upright, adjustable flexion and extension joint, medial-lateral and rotation control, with varus/valgus adjustment for the management or treatment of ambulatory Medicare beneficiaries with pain or reduction in mobility and/or function due to medial or lateral tibiofemoral osteoarthritis (OA).

The DME MAC Medical Directors would like to thank the individuals and associations for submitting detailed comments and offering support for the proposed Knee Orthoses LCD (DL33318).

2

Two commenters expressed concern regarding the requirement to document a beneficiary’s willingness to use the knee orthosis in the medical records. One commenter noted this requirement would lead to technical denials, administrative burden and delays in care. Alternative options to satisfy this requirement were suggested, including acceptance of a physician’s order or the beneficiary’s receipt of the brace as evidence of willingness, or the creation of a standardized document for use in medical records.

Adherence to KO treatment is required to experience the clinical benefit of the brace; therefore, a beneficiary’s willingness to use a valgus or varus KO is needed for the successful management of pain and reduction in mobility/function associated with medial or lateral tibiofemoral OA. A beneficiary’s willingness to use the prescribed knee brace for the treatment of OA can be documented in the medical records by either the treating practitioner or the orthotist/prosthetist.

3

Two commenters requested the joint stability testing language in the KO LCD be updated to confirm acceptance of a broader range of standard knee stability assessments. One of the commenters also suggested the addition of a note to communicate that the list of stability test examples is not exhaustive.

If coverage for KO is being sought using one of the pathways that requires objective knee joint laxity, the proposed KO LCD requires documentation of the physical examination of the knee including the joint laxity test(s) performed. The proposed LCD does not dictate a specific list of acceptable joint laxity test(s); however, to support payment, the policy specific documentation requirements state that documentation in the medical records must demonstrate at least one knee laxity test was performed, as well as a description of the exam finding(s) that support objective knee joint laxity.

4

One commenter requested expansion of KO coverage to include beneficiaries with symptoms of stiffness, reduced range of motion, or swelling due to OA in the absence of instability or recent surgery. 

The DME MACs analyzed the best available clinical literature and found evidence to support expansion of coverage for valgus or varus braces for the treatment of medial or lateral tibiofemoral OA for the management of pain or reduction in mobility/function. There was insufficient evidence to support coverage of valgus or varus knee braces for the management of symptoms of stiffness, reduced range of motion, or swelling related to OA in the absence of instability without associated pain or reduction in mobility/function. A new LCD reconsideration request may be submitted with published peer-reviewed literature supporting this request.

5

One commenter expressed concern regarding inconsistences between the proposed coverage criteria in the KO LCD and the attached KO LCD-related Policy Article (PA). 

The proposed KO LCD outlines the criteria under which valgus or varus knee braces will be covered. The policy specific documentation requirements section of the attached KO LCD-related PA is not intended to be a reiteration of the proposed LCD coverage criteria, but rather provides guidance related to what documentation must be included in the medical records to support that the coverage criteria have been met. 

6

One commenter requested clarification regarding whether an orthotist’s clinical documentation would be considered part of the medical record to support coverage of knee orthoses.

As noted in the KO LCD-related PA, based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by the treating practitioner. Therefore, an orthotist’s clinical notes can be used to help support coverage for knee orthoses so long as these notes are not in conflict with the medical records from the treating practitioner.

7

One commenter requested clarification of accepted documentation for functional reduction of mobility or pain, as well as the minimum required elements of a physical examination for OA.

Neither the proposed KO LCD nor the attached KO LCD-related PA dictate the form or format of the documentation used to describe a beneficiary’s functional reduction of mobility or pain, nor do they outline a minimum number of required elements for a physical examination of the knee; however, documentation in the medical records must be sufficient to determine that all KO LCD coverage criteria have been met and all policy specific documentation requirements located in the KO LCD-related PA have been satisfied. 

8

One commenter requested clarification regarding how the valgus or varus function of a knee orthosis should be documented in the medical record. 

Neither the proposed KO LCD nor the attached KO LCD-related PA dictate the form or format used to document the valgus or varus function of a knee orthosis; however, documentation in the medical records must be sufficient to determine that either a valgus or varus brace is being prescribed to manage pain or the reduction in mobility/function due to medial or lateral tibiofemoral OA.

9

One commenter inquired if any specific imaging criteria are required for KO coverage. 

If coverage for a valgus or varus KO is being sought for the management of pain or a reduction of mobility/function due to medial or lateral tibiofemoral OA without objective knee joint laxity, the Policy Specific Documentation Requirements section of the KO LCD-related PA attached to the proposed KO LCD outlines that an imaging report (e.g., x-ray, CT scan, MRI) describing arthritic changes (e.g., joint space narrowing, bone spurs, cysts) consistent with medial or lateral compartment tibiofemoral OA must be included in the medical records. 

10

One commenter inquired if other types of arthritis without instability, such as patellofemoral osteoarthritis, will be considered for knee orthosis coverage.

Knee orthoses for the management of OA other than medial or lateral tibiofemoral OA using a valgus or varus KO is outside the scope of this reconsideration. A new LCD reconsideration request may be submitted with published peer-reviewed literature supporting the use of KO for the management of symptoms related to other knee OA types, such as patellofemoral, bicompartmental or tricompartmental OA.

11

One commenter inquired if a Dear Physician Letter will be developed to explain the new KO LCD coverage criteria.

The DME MACs may consider future development of additional educational resources, such as a Dear Physician Letter, if a need is identified.

12

One commenter requested allowing board certified orthotic and prosthetic facilities to provide knee braces rather than allowing physicians and physical therapy groups to bill for services they are not trained to provide, such as brace aftercare and adjustments.

Implementing limitations on who can provide knee braces is outside the scope of this reconsideration.

N/A

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L33318 - Knee Orthoses
Related National Coverage Documents
NCDs
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
12/04/2025 12/11/2025 - N/A Currently in Effect You are here

Keywords

N/A