Off-the-Shelf Brace Suppliers and Competitive Bidding

Medicare competitive bidding for off-the-shelf braces is not new; Round 2021's only contracts were for OTS back and knee braces, and they expired December 31, 2023. Round 2028 brings braces back with three categories instead of two, a single nationwide area instead of local ones, and far fewer contracts. It also arrives after CMS spent much of 2026 describing OTS braces as one of its biggest fraud problems.

What makes a brace "off-the-shelf"?

42 CFR 414.402 defines off-the-shelf orthotics as orthotics "that require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling or customizing to fit a beneficiary." The classification is made product by product through the Pricing, Data Analysis and Coding (PDAC) contractor, which keeps the Product Classification List from manufacturers' code verification applications.

On October 7, 2026, CMS said it is reviewing "a small percentage of products that may have been inappropriately classified as OTS braces," may remove some products from certain HCPCS codes, but does not expect to remove any HCPCS codes from the three brace categories. Suppliers should watch the PDAC site and CBIC updates.

What are the three brace categories, and how many contracts are planned?

From CBIC's Product Categories page and its contract award fact sheet:

• OTS back braces. Lead item L0651, bid limit $855.26, 3 contracts planned.
• OTS knee braces. Lead item L1852, bid limit $691.80, 4 contracts planned.
• OTS upper extremity braces. Lead item L3916, bid limit $591.58, 5 contracts planned.

Those are national numbers, because the remote item delivery area covers every state, DC and the territories. CMS may award more to reach its 30 percent small supplier target or to meet demand, but planning around a handful of national winners per category is realistic. The bid limits for the back and knee lead items are the average 2026 adjusted fee schedule amounts for nonrural areas (42 CFR 414.412(b)(11)).

Why did CMS single out braces?

In the 2026 moratorium notice (CMS-6099-N), CMS cited the Inspector General's May 2024 report on OTS orthotic braces, which found Medicare paid for braces ordered without a treating relationship and marketed through prohibited telemarketing. CMS added its own data: from 2023 through late October 2025, medical supply companies submitted more than 80 percent of the more than 1.5 million OTS brace claim lines from DMEPOS suppliers. The notice also lists prosecutions built on purchased brace orders and offshore call centers. That history explains the moratorium on new medical supply companies from February 27 to August 27, 2026, and it explains the scrutiny a new brace supplier should expect at its site visit.

Which supplier standards matter most for brace companies?

• No unsolicited calls. Supplier standard 11 bars telephoning a beneficiary about a Medicare item unless the beneficiary gave written permission, the call coordinates delivery of an item already furnished, or the supplier furnished a covered item to that person in the prior 15 months (42 CFR 424.57(c)(11)).
• Orders from treating practitioners. Keep the ordering and referring documentation the rules require (424.57(c)(28) and 424.516(f)).
• Delivery and instruction. Proof of delivery and instructions for safe use for every item (424.57(c)(12)).
• Accreditation by product. Your accreditation must name the specific products you bill (424.57(c)(22)(ii)).

Who can furnish OTS braces without a contract?

Under 42 CFR 414.404 and CBIC's exceptions fact sheet, physicians and treating practitioners (physician assistants, nurse practitioners and clinical nurse specialists) may furnish competitively bid OTS orthotics to their own patients as part of a professional service without a contract, and hospitals may do so for their own patients during an admission or on the day of discharge. A physical or occupational therapist in private practice may furnish OTS orthotics to the therapist's own patients as part of the therapy service. Payment is the single payment amount for the patient's area. A hospital-owned DME supplier, or a DME company a physician owns, gets no exception. See when a physician practice supplies DME.

Are custom and prefabricated braces affected?

Not by Round 2028. Only OTS products in the listed codes are in the program; custom-fabricated orthotics and braces that require expertise to fit are not part of it. That line matters for O&P practices, which often supply both kinds. Some states license orthotists and orthotic facilities separately from DME suppliers; see O&P facility licensing.

Which state licenses do brace suppliers need?

It varies more than for most products, because some states treat braces as general medical equipment, some regulate them through orthotics licensing, and some through device registration. Pennsylvania, for example, has no dedicated HME license but requires a yearly Department of Health registration for each place of business that retails devices within the Commonwealth, and its device definition lists "orthopedic braces and supports" (28 Pa. Code 25.1 and 25.113). For Round 2028, every license a state requires for the brace categories you bid must be in PECOS by the close of the bid window, targeted for March 10, 2027. See the licensing deadline and our state index.

How do we help brace suppliers?

We build the state license map for the brace categories you would bid, prepare each application for your owner or officer to sign, and report each license so it appears in PECOS. If you are a new supplier, Accreditation Readiness ($2,495) prepares your policies, intake and delivery records and runs a mock unannounced survey, and the Medicare DMEPOS Enrollment Package ($1,295) prepares the 855S for your authorized official to sign. State licenses are $699 each ($899 in California, Florida, Georgia and Alabama), or $4,995 for 10 states. You pay every government and accreditation fee directly. We do not sell braces or bonds, and no one can promise a contract. Start with a $149 Readiness Review.