MEDICARE PUBLISHES LONG-AWAITED PROPOSED RULE 

Several key elements of the next round of competitive bidding remain unknown - most importantly, the specific products to be included and the implementation timeline. But the proposed changes we do know about are potentially far reaching.

The possibility of 9-10 suppliers delivering OTS braces to all Medicare beneficiaries nationally stands in stark contrast to Round 2021, where contract suppliers in 127 different Competitive Bidding Areas could offer these devices. During the gap period currently in effect, all suppliers have the opportunity to fit OTS braces to Medicare beneficiaries at the competitive bidding fee schedule amount. When the next round of competitive bidding goes into effect, only those suppliers awarded contracts will be permitted to fit Medicare beneficiaries. You should therefore analyze how many OTS braces included in Round 2021/listed above you currently provide to Medicare patients to understand the potential impact on your business if you are not awarded a contract . (NOTE: Physicians have historically been exempt from competitive bidding when providing OTS braces to their own patients. The proposed rule does not change that exemption.)

In addition, the proposed modifications to calculating the Single Payment Amount, if implemented, will have a further downward effect on Medicare fees for OTS braces. This means we can expect to see continued price pressure on all OTS braces included in the next round of competitive bidding.

The deadline for submitting comments regarding the proposed rule is 5 PM Eastern Time on September 2nd, 2025. You can email your comments to https://www.regulations.gov/ - follow the instructions under the "Submit a Comment" tab.