Important Change Proposed to Knee Orthoses LCD

What You Need to Know

The DME MACs have proposed a key change to the Knee Orthoses LCD when fitting a knee brace to treat osteoarthritis. In response to a submission from the American Orthotic and Prosthetic Association, they concluded that "there is sufficient evidence to support that the use of unloader knee braces may be a potential non-surgical therapeutic option for the reduction of pain or improvement in mobility and/or function in some Medicare beneficiaries with a diagnosis of medial or lateral unicompartmental knee OA, regardless of the presence of objective joint laxity” [emphasis added]. This represents a significant shift in policy, as the current LCD requires a recent injury/surgery or objective documentation of joint laxity as a prerequisite to fit an OA brace.

The proposed LCD offers a third alternative for coverage:

A single or double-upright brace described by L1843, L1844, L1845, L1846, L1851, and L1852 is covered if the beneficiary has a documented diagnosis of medial or lateral tibiofemoral osteoarthritis and meets the following criteria:

a.      The beneficiary is ambulatory; and

b.      The beneficiary is experiencing pain or a reduction in their mobility and/or function secondary to the medial or lateral tibiofemoral osteoarthritis;

c.      The knee orthosis provides either varus or valgus adjustment; and,

d.      The beneficiary expresses a willingness to use the knee orthosis.

The proposed Policy Article further spells out documentation requirements, stating that the beneficiary's medical record must include all of the following:

1.      The beneficiary's ambulatory status; and

2.      The beneficiary's pain symptoms, or mobility and/or functional reduction due to the medial or lateral tibiofemoral osteoarthritis; and

3.      A physical examination of the beneficiary's affected knee(s); and

4.      An imaging report (e.g., x-ray, CT scan, MRI) that describes arthritic changes (e.g., joint space narrowing, bone spurs, cysts) consistent with medial or lateral compartment tibiofemoral osteoarthritis; and

5.      The beneficiary's willingness to use the knee orthosis.

Note: HCPCS codes L1843 and L1845 must also have appropriate custom-fit documentation for coverage, and HCPCS codes L1844 and L1846 must meet LCD requirements for a custom-fabricated knee orthosis.

What This Means for You

For years, physicians, certified/licensed orthotists, and DME companies have noted that OA can present without objective evidence of joint laxity. However, the LCD's current requirement prevents some patients who could benefit from the pain-reducing/mobility-enhancing effects of OA knee braces from getting them. In contrast, the proposed LCD, if finalized, will increase access to these devices so long as the provider treating the patient can satisfy the requirements listed above.

The DME MACs are hosting an open meeting on August 27, 2025 to discuss the proposed LCD. You can register for that meeting here. CMS also has a public comment period that is now open. The deadline to submit comments is September 6, 2025 and you can send them to the following email: [email protected].