Healthcare Providers

Frequently Asked Questions

CMS Proposed Changes to OTS Orthopedic Braces1

What changes is CMS proposing regarding OTS orthopedic braces?

A nationwide RID CBP is being phased into the DMEPOS CBP for items typically furnished on a national mail order basis. The nationwide RID CBP includes all areas (all states, territories, and the District of Columbia). Contract suppliers for each product category will be responsible for furnishing all items under the product category to all Medicare beneficiaries regardless of where they live. Only contract suppliers can furnish items included under the nationwide RID CBP that are covered under Medicare Part B. Unlike a national mail order program, the items included under a RID CBP may be shipped or delivered to a beneficiary’s home or may be picked up at a local pharmacy or storefront if the beneficiary or caregiver for the beneficiary chooses to pick up the items in person and the local pharmacy or storefront is owned by a contract supplier or a subcontractor of the contract supplier.  

Why is CMS reviewing and proposing changes to OTS orthopedic braces now?

The DMEPOS CBP reduces the amount Medicare pays for DMEPOS and brings the payment amounts more in line with that of a competitive market. In addition, contract suppliers must submit claims for competitive bidding items on an assignment basis. In contrast, Medicare enrolled, fee-for-service DMEPOS suppliers in non-CBAs that have not elected to be participating suppliers under Medicare are not required to accept assignment, meaning they can charge any amount to the beneficiary. These factors help limit the financial burden on beneficiaries by reducing their out-of-pocket expenses. 

Which types of orthopedic braces are impacted by the proposal?

The proposal impacts certain OTS back braces, knee braces, and upper extremity braces that CMS considers appropriate for remote delivery. However, many OTS HCPCS codes included in CMS’s proposal are currently furnished with in‑person fitting, adjustment, and education, creating concern among clinical suppliers. The full list of the next round DMEPOS CBP product categories: 

  • Class II Continuous Glucose Monitors (CGMs) and Insulin Pumps
  • Urological Supplies
  • Ostomy Supplies
  • Hydrophilic Urinary Catheters
  • Off-The-Shelf (OTS) Back Braces
  • OTS Knee Braces
  • OTS Upper Extremity Braces

*All product categories for the next round will be included in the Nationwide Remote Item Delivery Program.

How many suppliers will be awarded contracts?

The number of contracts offered for each product category will be based on 125% of the number of suppliers furnishing at least 3% of total national allowed services for the lead item in 2025. Based on 2024 claims data, we believe this would result in approximately ten national contract suppliers for the CGM/insulin pump product category, eight national contract suppliers for the urological supplies and ostomy supplies product categories, six national contract suppliers for the OTS upper extremity braces and OTS knee braces product categories, and four national contract suppliers for the OTS back braces product category (note, the actual number of contract suppliers will be based on 2025 or 2026 claims data and will be announced in late Spring/early Summer 2026). If less than 30% of the winning suppliers are small suppliers, additional contracts may be offered towards the goal of meeting the 30% small supplier target. 

Does the proposal differentiate between clinical treatment braces and general support products?

CMS classifies OTS orthotics affected by HCPCS. When a physician specifically prescribes a particular brand name product or mode of delivery to avoid an adverse medical outcome, DMEPOS CBP contract suppliers are required either to furnish that item or mode of delivery, to assist the beneficiary in finding another contract supplier in the CBA that can provide that item or service, or to consult with the physician to find a suitable alternative product or mode of delivery for the beneficiary.  If the physician or treating practitioner determines that an alternative product is not acceptable, the contract supplier much furnish the item as prescribed.

Will a prescription or additional clinical documentation be required under the proposal?

The proposal does not introduce new prescription requirements but assumes existing ordering practitioner documentation and medical necessity requirements remain in place. However, replacing in‑person delivery with RID may weaken the practical safeguards that currently support accurate documentation and appropriate utilization.  

How does CMS define appropriate clinical oversight for brace use under the proposal?

Beneficiaries in CBAs receive products that meet applicable United States Food and Drug Administration (FDA) requirements from contract suppliers in their area. Contract suppliers meet specific, detailed DMEPOS supplier standards in regulations at 42 CFR 424.57, quality standards section 1834(a)(20) of the Act, and applicable State and Federal licensing requirements and be accredited by an approved independent accrediting organization. For more information, go to: https://www.cms.gov/medicare/payment/fee-schedules/dmepos-competitive-bidding/quality-standards-accreditation-licensing.2 The standards address quality control procedures and product and effectiveness. For example, suppliers delivery of items and must document that beneficiaries have been given necessary information and instructions on how to use Medicare-covered items safely and effectively. Suppliers must accept the return of any substandard items (less than full quality for the particular item or unsuitable items, inappropriate for the beneficiary at the time it was fitted and rented or sold).

How could the proposal affect patient access to orthopedic braces?

The RID model is expected to significantly reduce the number of eligible suppliers, potentially limiting access to providers who offer hands‑on care. This impact may be more pronounced for rural and mobility‑limited Medicare beneficiaries who rely on in‑person fitting services.  

What are the potential reimbursement implications for Medicare patients?

Reimbursement would be determined by national competitive bid pricing, which could lower payment rates for included braces. While CMS anticipates savings, stakeholders warn that reduced reimbursement may discourage clinical suppliers from participating. 

The bid amounts submitted for an OTS back brace or OTS knee brace identified as the lead item in the product category for 2025 cannot exceed the average of the 2026 nonrural fee schedule amounts for the item. The bid amounts submitted for the OTS upper extremity brace, urological supply, or ostomy supply identified as the lead item for each of these three product categories for 2025 cannot exceed the average of the 2026 fee schedule amounts for the item. 

Is this proposal final, and what is the proposed CMS timeline for implementation?

Next Round Timeline

To ensure bidders are prepared for the next round, CMS has announced the following next steps for the program: 

December 2025 

  • CMS begins pre-bidding supplier awareness program 
    *Late Spring/Early Summer 2026 
    • CMS announces specific dates for registration and bidding 
    • CMS announces lead items for the DMEPOS CBP product categories and number of contracts to award for each product category 
    • CMS begins bidder education program *Late Summer/Early Fall 2026 
      • Bidder registration period to obtain user IDs and passwords begins 
      • Bid window opens *Late Summer/Early Fall 2027 
        • Contracts awarded and single payment amounts announced 
        • Beneficiary education begins *No Later Than January 1, 2028 
          • Start of Next Round - Contracts and single payment amounts (SPAs) in effect 
          • Six-month transition period begins for beneficiaries to switch to contract suppliers *Dates listed are target dates 

            Next Round DMEPOS CBP Product Categories 

            • Class II Continuous Glucose Monitors (CGMs) and Insulin Pumps 
            • Urological Supplies
            • Ostomy Supplies 
            • Hydrophilic Urinary Catheters 
            • Off-The-Shelf (OTS) Back Braces 
            • OTS Knee Braces 
            • OTS Upper Extremity Braces 
            • *All product categories for the next round will be included in the Nationwide Remote Item Delivery Program. 

            Reference

            1. Centers for Medicare & Medicaid Services. (n.d.). Durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) competitive bidding program updates. U.S. Department of Health & Human Services.
              https://www.cms.gov/newsroom/fact-sheets/durable-medical-equipment-prosthetics-orthotics-supplies-competitive-bidding-program-updates
            2. Centers for Medicare & Medicaid Services. (n.d.). DMEPOS competitive bidding: Quality standards, accreditation, and licensing. CMS.gov. https://www.cms.gov/medicare/payment/fee-schedules/dmepos-competitive-bidding/quality-standards-accreditation-licensing

            Disclosure & Transparency Statement

            This website and the advocacy campaign presented here are operated by DJO, LLC, an Enovis Corporation subsidiary, for-profit company (“Enovis”) a for‑profit company with a direct business interest in the policies and legislation discussed. 

            The information provided on this site is intended to inform and empower patients, caregivers, and advocates to engage with their elected representatives. Enovis stands to be directly affected—financially and operationally—by the outcomes of the legislative and regulatory actions referenced on this site. In other words, we have a clear stake in the issues being addressed. 

            We believe transparency matters. While we are committed to sharing accurate, patient‑focused information, visitors should understand that this advocacy effort reflects both: 

            • Our perspective as a company operating in this space, and 
            • Our belief that these issues have significant implications for patient access, care quality, and outcomes. 

            Engaging with policymakers is always a personal choice. We encourage visitors to review multiple sources, consider diverse viewpoints, and decide for themselves whether and how to contact their elected officials. 

            If you have questions about our role, motivations, or business interests related to this campaign, please contact us at 1.800.321.9549