Prosthetics and orthotics marketing: the rules

A prosthetic and orthotic practice fits, fabricates and maintains artificial limbs and braces for people after an amputation, an injury or a stroke, and for people with a condition they have lived with since childhood. Patients reach the practice through a surgeon, a rehabilitation team, a therapist or a hospital case manager, or they search for one themselves after a clinician writes the order. The relationship lasts years: a limb or brace is fitted, adjusted, repaired and replaced as the body and the device change. That makes trust the asset, and it makes accurate wording about devices, coverage and service the core of the marketing.

Two related topics have their own guides and are not repeated here. The full rules on unsolicited telephone calls, third-party marketers, purchased leads and free offers for equipment suppliers are in our DME supplier marketing guide. Bracing sold inside an orthopedic or sports medicine practice, and the difference between cleared and approved devices, is in our orthopedic practice marketing guide. This guide covers what is specific to a prosthetic and orthotic practice: the Medicare supplier standards that read like marketing promises, custom and medical-grade wording, function claims for limbs and braces, referral sources and patient stories.

This is general information, not legal or medical advice. Whether a device is medically necessary is decided by the ordering clinician and the payer, and licensure for orthotic and prosthetic practitioners is set state by state. Sources cited were checked on October 30, 2026: 42 CFR 424.57 (DMEPOS supplier standards), 42 U.S.C. 1395m(a)(17) and (h)(1)(F), 42 CFR 414.402, the Medicare.gov coverage pages on artificial eyes and limbs, braces, prosthetic devices and durable medical equipment, 15 U.S.C. 45 and 52, the FTC Health Products Compliance Guidance (December 2022), 42 U.S.C. 1320a-7b(b), 16 CFR 255.2 and 255.5, and 45 CFR 164.508. Have a health care attorney review your marketing.

Start with what Medicare tells patients

A patient on Medicare who searches for a new limb or brace is likely to land on the Medicare.gov coverage pages, so it helps to know what they say. The page on artificial eyes and limbs says Part B covers medically necessary artificial eyes, legs and arms when a doctor or other health care provider orders them. The braces page says Part B covers arm, leg, back and neck braces when medically necessary and when a doctor or other health care provider orders them. The prosthetic devices page says Medicare will only pay for a prosthetic device from a supplier that participates in Medicare. The durable medical equipment page tells patients to ask a supplier whether it participates in Medicare or will accept assignment before they get an item, and warns that if a supplier does not participate or will not accept assignment, the patient may be charged more.

Those pages tell you what a patient will ask your front desk. A supplier website can answer the same questions, in plain words and accurate for your business:

Whether you are enrolled in Medicare as a supplier, and whether you participate and accept assignment on all claims or decide claim by claim.
That a limb or brace needs an order from the patient’s doctor or other health care provider, and how the patient or their clinician sends one to you.
Which other health plans you are in network with, stated as a current fact and updated when it changes.
That coverage depends on medical necessity and on the patient’s plan, which carries a deductible and coinsurance, with no promise that a device will be covered or cost nothing.

Wording such as “Medicare pays for your new leg” or “no cost to you” promises a coverage decision you do not make. A cost estimate belongs in a conversation about the patient’s own plan, and self-pay patients may be owed a good faith estimate; see our guide to good faith estimates for self-pay patients.

Supplier standards that are also service promises

Under 42 CFR 424.57(c), a supplier of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) has to meet a list of standards to receive and keep Medicare billing privileges. Several of them describe service a patient can expect, which makes them a sound base for website copy, as long as the copy matches what you do. Among the standards, a supplier:

Must be responsible for delivery and keep proof of delivery, and must document that the patient was given the information and instructions needed to use the item safely and effectively (paragraph (c)(12)).
Must answer questions and respond to complaints about the item, and must refer Medicare questions to the appropriate Medicare contractor (paragraph (c)(13)).
Must accept returns of substandard items, and of items that were unsuitable or inappropriate for the patient at the time they were fitted and rented or sold (paragraph (c)(15)).
Must disclose the supplier standards to each Medicare patient it supplies (paragraph (c)(16)).
Must have a complaint resolution protocol and keep written complaints and notes of actions taken (paragraph (c)(19)).
Must be accredited, and the accreditation must name the specific products and services the supplier is accredited for (paragraph (c)(22)).
Must be licensed to provide an item or service where a state requires licensure for it (paragraph (c)(1)(ii)).

A “What to expect” page built from those standards tells a new patient how fitting and delivery work, what instructions they will get, how adjustments are scheduled, how to raise a concern and who answers it. That page earns trust without a single outcome claim. Two cautions. First, state your accreditation and licensure for the products and services they cover, not as a blanket badge. Second, a service promise in an ad is a claim like any other: write “lifetime adjustments”, “free repairs” or “same-day fittings” only if a written policy says so, and state its limits. The repair and replacement duty in paragraph (c)(14) applies to items the supplier has rented; repair terms for purchased items are yours to define, so define them in writing before you advertise them.

Custom, fitted and off-the-shelf

Custom is the word that sells in this field, and it has a specific meaning in Medicare payment law. Under 42 U.S.C. 1395m(h)(1)(F), Medicare pays for an item of prosthetics, or for a listed item of custom-fabricated orthotics, only if it is furnished by a qualified practitioner and fabricated by a qualified practitioner or a qualified supplier at a facility that meets criteria the Secretary sets. The listed orthotics are items that require education, training and experience to custom-fabricate, and the statute says no item may be on the list unless it is individually fabricated for the patient over a positive model of the patient. Shoes and shoe inserts are excluded from that list. The statute ties qualified practitioner to state licensure in orthotics or prosthetics where a state licenses them, and to specified training and certification where it does not.

At the other end, 42 CFR 414.402 describes 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 the patient. Minimal self-adjustment is adjustment the patient, a caretaker or the supplier can perform without the services of a certified orthotist or an individual with specialized training.

Those definitions govern payment, not advertising, but patients and referral sources read the words the same way, and 15 U.S.C. 45 makes a misleading description of a product unlawful. A simple rule set:

Call a device custom only if it is made for the patient, and say how: a cast, scan or mold of the patient, then fabrication.
Describe a prefabricated device that your staff fit and adjust as fitted or adjusted, not as custom.
Do not call an off-the-shelf brace or insert custom because it comes in sizes or can be heat molded.
Name who does the fitting and state each credential and license exactly as it stands.

Shoes and inserts for patients with diabetes have their own Medicare rules, covered in our podiatry practice marketing guide.

Medical-grade, pain-free and other function claims

Under 15 U.S.C. 45, deceptive acts or practices in commerce are unlawful, and 15 U.S.C. 52 makes it unlawful to disseminate a false advertisement to induce the purchase of devices or services. The FTC Health Products Compliance Guidance says claims about the health benefits or safety of health-related products require substantiation in the form of competent and reliable scientific evidence. It says that when an ad lends itself to more than one reasonable interpretation, the advertiser is responsible for substantiating each interpretation, and that anecdotal evidence about individual experiences is never sufficient to substantiate claims about the effects of a health product. Words in prosthetic and orthotic ads that carry a claim: Statements that a device is American-made are held to the FTC origin standard covered in our guide to Made in USA claims.

Medical-grade, clinical-grade or doctor-recommended. Each implies a standard or an endorsement; use it only if you can name the standard or the recommendation and support it.
Pain-free, corrects, cures or fixes, applied to back pain, scoliosis, foot pain or a gait problem.
Walk again, run again, back to normal or feels like your own leg, presented as a result a patient will reach.
Better, lighter, more stable or more natural than other components, sockets or techniques, without evidence for the comparison.
FDA approved, for a device that was not approved. The orthopedic guide linked above explains the difference.

What you can say is what the device is designed to do, how the evaluation, casting or scanning, fitting and training steps work, the number of visits the process takes at your practice, and who the patient calls when the fit changes. Describe the process and the people, not a result.

Phone calls, referral sources and events

Under 42 U.S.C. 1395m(a)(17), a supplier may not contact a Medicare patient by telephone about furnishing a covered item unless the patient gave written permission, the supplier is calling only about an item it already furnished to that patient, or, for a different item, the supplier furnished at least one covered item to the patient in the 15 months before the call. If a supplier knowingly breaks the rule, no Medicare payment may be made for any item it later furnishes to that patient, and a pattern of such calls leads to exclusion from the program. The same rule is a supplier standard at 42 CFR 424.57(c)(11). For a prosthetic and orthotic practice, follow-up calls about a device you fitted fit the second exception; a call to offer a new device fits only the 15-month rule or written permission; and a person who signs in at a support group or community event has not given permission to be called about an item unless they gave it in writing. The rest of the rule, including third-party callers, is in the DME guide linked above.

Referral sources in this field are surgeons, physiatrists, therapists, wound clinics and hospital case managers. Under 42 U.S.C. 1320a-7b(b), it is a crime to knowingly and willfully offer or pay remuneration, directly or indirectly, in cash or in kind, to induce or reward referrals of items or services paid for by a federal health care program. Do not offer anything of value to a referral source for the patients they send. What you can give a referral source, such as clear information about your services, fast reports and a reliable intake process, is in our guide to patient and physician referrals. Offers to Medicare patients themselves, including discounts and gifts, are in our guide to marketing to Medicare patients.

Education events for amputee and limb loss groups, or for families of children who use braces, can be useful when they teach. Keep them about care and daily life, not a sales pitch, and use our guide to patient education seminar marketing for how to plan and promote one.

Patient stories, videos and ambassadors

A video of a patient walking, running or climbing stairs on a new limb is persuasive content for a prosthetic practice, and it carries an outcome claim. Under 16 CFR 255.2, an ad that presents one person’s experience on a key point is likely to be read as showing what others will experience, and without substantiation that the result is representative, the ad should clearly disclose the generally expected results. A story should say it is one person’s experience and describe their own path, including the time and work it took.

Patients who appear in your content as ambassadors or peer visitors may receive something from you: a fee, a discount, a free component or travel to an event. Under 16 CFR 255.5, when a connection between the endorser and the seller might materially affect the weight or credibility of the endorsement, and the audience would not expect it, the connection must be disclosed clearly and conspicuously. Photos and stories held by the practice are protected health information if your business is a HIPAA covered entity, and 45 CFR 164.508 generally requires written authorization before using them in marketing; see our guide to patient testimonials and before-and-after photos. Intake and order forms should keep health information away from ad tracking tools; see our guide to tracking pixels on practice websites.

Spinal braces for children and teens with scoliosis have their own evidence and audience. Our guide to scoliosis clinic marketing covers what NIAMS and the USPSTF say about bracing and how to write for parents and teens.

Illustration: two ways to advertise a prosthetic and orthotic practice

Illustration: [Practice name] runs an ad that reads “Medical-grade custom braces, pain-free in days. Medicare pays for your new leg, no cost to you. Call us today.” The landing page shows a patient running with a quote about feeling normal again, and the practice calls everyone who signed in at a limb loss support meeting. The ad calls fitted devices custom, makes medical-grade and pain-free claims without support, promises a coverage decision, uses an unrepresentative story with no disclosure, and makes phone calls the federal rule does not allow.

Illustration: [Practice name] runs an ad that reads “Prosthetic and orthotic care with a licensed practitioner. Evaluation, casting, fitting and follow-up adjustments in one office. Bring your doctor’s order.” The landing page explains each step, states which devices are made for the patient and which are fitted, lists the Medicare and plan participation as of the date checked, explains how to raise a concern, and shows a patient story with written authorization, a disclosure of what patients generally experience and a note that the patient received a fee.

Checklist before a prosthetic and orthotic campaign goes live

Medicare enrollment, participation and plan networks stated as current facts, with no promise of coverage or zero cost.
A what to expect page that matches your delivery, instruction, complaint and return practices under 42 CFR 424.57(c).
Accreditation and licensure stated for the products and services they cover.
Custom used only for devices made for the patient; fitted and off-the-shelf devices described as such.
No medical-grade, pain-free, corrects or walk again claims without evidence, and no comparison claims without support.
Repair, adjustment and replacement promises backed by a written policy with its limits stated.
Phone outreach to Medicare patients checked against 42 U.S.C. 1395m(a)(17) and the written permission on file.
Nothing of value offered to referral sources for referrals.
Patient stories with written authorization, a disclosure of generally expected results and any material connection disclosed.
Intake and order forms kept away from ad tracking tools.

How we help

We build websites, local search, Google Ads and AI front desk tools for independent practices and health businesses. For a prosthetic and orthotic practice, that means service and what to expect pages that match your supplier standards, search content written around the questions patients and referral sources ask, and intake and order forms that keep health information away from tracking tools. We do not decide medical necessity or whether a claim is substantiated; your practitioners and counsel do. Our tools are built with HIPAA in mind. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We are not a healthcare provider and we do not give legal or medical advice. We do not sell lead lists and we do not pay for referrals. For the wider rules, see our healthcare marketing rules hub.

Can we call our braces custom?

Only if they are made for the patient, for example from a cast or scan. Medicare payment law treats custom-fabricated orthotics as items individually fabricated over a positive model of the patient, and 42 CFR 414.402 describes off-the-shelf orthotics as items that need only minimal self-adjustment. Describe fitted devices as fitted.

Can we say medical-grade?

Only if you can name the standard it refers to and support the claim. Under 15 U.S.C. 45 and 52 and the FTC Health Products Compliance Guidance, the advertiser has to substantiate each reasonable interpretation of a claim.

Can we tell patients Medicare will pay for their prosthesis?

Not as a promise. Medicare.gov says Part B covers medically necessary artificial limbs when a doctor or other health care provider orders them, and that the patient pays a deductible and coinsurance. Coverage depends on the patient and the plan.

Can we call people who attended our limb loss education event?

For Medicare patients, only within the exceptions in 42 U.S.C. 1395m(a)(17), such as written permission to call about a covered item. A sign-in sheet alone is not that permission.

Can we post videos of patients walking on their new limbs?

With written authorization under 45 CFR 164.508 if you are a HIPAA covered entity, a disclosure of generally expected results under 16 CFR 255.2, and disclosure of any payment or free product under 16 CFR 255.5.

Can we advertise free lifetime adjustments?

Only if a written policy provides them, and the ad states its conditions and limits. A service promise in an ad is a claim under 15 U.S.C. 45.

Sources

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Prosthetics and orthotics marketing: supplier standards, custom claims and patient stories