AMARILLO, TX – The 2028 Round of the Medicare Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DME) Competitive Bidding Program (CBP) will impact the orthotics space. While the full effects will not be felt until the program is implemented, one thing is already becoming clear: suppliers who understand the difference between off-the-shelf (OTS) and custom-fitted braces will be in a much stronger position than those who do not.
For years, many suppliers have operated under a simple assumption: if a brace is prefabricated, it must be an OTS product. Medicare, however, has never viewed the issue that way.
Both OTS and custom-fitted braces are prefabricated orthoses. The distinction is not based on how the brace is manufactured. Instead, it depends on what must happen during the final fitting process and whether specialized expertise is required to make the device functional for the individual patient. That distinction is about to take on even greater importance. The CBP brace category includes only OTS orthotics: OTS back braces, OTS knee braces, and OTS upper extremity braces.
Because the number of contract awards will be limited, most DME suppliers will lose the ability to provide OTS braces to traditional Medicare fee-for-service (FFS) beneficiaries and receive Medicare reimbursement.
Importantly, competitive bidding does not apply to Medicare Advantage plans. Its impact is confined to traditional Medicare FFS beneficiaries.
For suppliers that depend heavily on Medicare OTS brace volume, the change will be significant. Suppliers that intend to remain active in the orthotics space should begin evaluating alternative business models, including non-FFS OTS channels and properly supported custom-fitted orthotic services.
Where Suppliers Can Focus Going Forward
OTS orthotics are not disappearing. What is changing is access to the traditional Medicare FFS market, which will largely be reserved for suppliers awarded competitive bidding contracts. However, there continues to be opportunities for suppliers to participate in the orthotics space. One such opportunity is in the custom-fitted space.
Expand Custom-Fitted Orthotic Services
Competitive bidding requirements apply to OTS braces, not custom-fitted braces. Suppliers that invest in qualified personnel, clinical training, fitting expertise, and robust documentation processes can continue serving all patient populations, including traditional Medicare FFS beneficiaries.
Success in this environment begins with a clear understanding of what actually separates an OTS brace from a custom-fitted one.
A prefabricated brace may be delivered assembled, partially assembled, or as a kit and still qualify under either category. The key questions are:
- What adjustments are required during the final fitting?
- Who performs those adjustments?
If only minor adjustments are needed and those adjustments do not require specialized orthotic expertise, the brace is generally considered OTS. But if the fitting requires modifications that go beyond minimal self-adjustment and must be performed by a qualified professional, the brace is classified as custom-fitted.
OTS Braces
OTS braces are prefabricated orthoses that require only minimal self-adjustment at the time of delivery. Under Medicare guidance, minimal self-adjustment refers to adjustments that can be performed without the skills of a certified orthotist or similarly trained professional.
Common Characteristics of OTS Braces:
- Prefabricated construction
- Delivery as either a fully assembled product or a kit
- Assembly that does not alter classification
- Only minimal adjustments required for fit or function
- Adjustments that can be performed by the patient, caregiver, or supplier
- No need for specialized orthotic expertise during fitting
Typical OTS fitting activities include:
- Tightening or loosening straps
- Adjusting closures
- Selecting the appropriate size
- Minor positioning changes for comfort
- Basic functional adjustments
Because these tasks do not require specialized clinical modification, OTS braces fall within the scope of Medicare’s competitive bidding requirements.
Custom-Fitted Braces
Custom-fitted braces are also prefabricated orthoses. What distinguishes them is the level of modification necessary to create an individualized fit for the patient. These devices require adjustments beyond minimal self-adjustment and demand specialized fitting knowledge.
Common Characteristics of Custom-Fitted Braces:
- Prefabricated construction
- Delivery as either an assembled device or a kit
- Classification based on fitting requirements rather than assembly
- Material modifications during delivery and fitting
- Adjustments that exceed minimal self-adjustment
- Fitting performed by qualified orthotic personnel
Custom-fitted orthoses may require trimming, bending, heat molding, cold molding, reshaping, and other material modifications necessary to achieve a patient-specific fit. These modifications must be performed by a certified orthotist or an individual with specialized training and expertise in fitting the orthosis to the beneficiary.
These adjustments must be more than minimal self-adjustment because they involve clinical modification of the device to accommodate the patient’s individual anatomy and needs.
Documentation Will Be More Important Than Ever
Providing a custom-fitted brace includes additional compliance obligations. Suppliers should ensure that documentation clearly demonstrates both the fitting process and the modifications performed. Best practices include fitting the brace at the time of delivery, documenting the professional involvement, and tying each modification to the patient’s individualized needs. It is important that the DMW supplier:
- Avoid situations where the brace is shipped without the required professional fitting
- Record the specific modifications made to the device
- Explain how those modifications created an individualized fit for the patient
As claim reviews and audits continue to focus on orthotic services, detailed documentation will remain one of the strongest defenses against classification disputes and reimbursement challenges.
Conclusion
As Medicare competitive bidding expands, the distinction between OTS and custom-fitted braces will become increasingly important from both a compliance and business perspective.
The central point is straightforward: both categories are prefabricated orthoses. A brace does not become custom-fitted merely because it is assembled at the time of delivery or includes additional components. The deciding factors are the nature of the final fitting and the level of expertise required to complete it.
For suppliers planning for the future, two strategies stand out: continue serving non-traditional Medicare FFS patients with OTS braces and develop the clinical capabilities necessary to provide properly fitted custom orthoses. Those that understand the rules, apply them correctly, and document their services thoroughly will be best positioned to navigate the changing orthotics landscape.
Jeffrey S. Baird, Esq., is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm based in Texas with a national healthcare practice. He represents pharmacies, infusion companies, HME companies, manufacturers, and other healthcare providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].
Jacque K. Steelman, Esq., is a member of the Health Care Group at Brown & Fortunato, PC, a law firm with a national healthcare practice based in Texas. She represents pharmacies, infusion companies, HME companies, manufacturers, and other healthcare providers throughout the United States. Ms. Steelman can be reached at (972) 684-5789 or [email protected].