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Quick answer: A “Medicare-approved” durable medical equipment (DME) supplier is one that is enrolled in Medicare, holds billing privileges for each location, and certifies that it meets the supplier standards in 42 CFR 424.57. Medicare.gov states that Medicare will only pay for DME items obtained from suppliers enrolled in Medicare. This guide is for clinic staff, buyers and patients who need to check a supplier before an order is placed.
Related reading: what Medicare DME coverage reimburses, DMEPOS accreditation, PECOS and the certificate of medical necessity (CMN).
What “Medicare-approved” means for a DME supplier
There is no separate “approved supplier” badge in the regulation. The rule at 42 CFR 424.57 defines a DMEPOS supplier (durable medical equipment, prosthetics, orthotics and supplies) as an entity or individual, including a physician or a Part A provider, that sells or rents Part B covered items to Medicare beneficiaries and meets the standards in paragraphs (c) and (d). To be paid for a covered item, the supplier must have submitted a completed application, and the item must have been furnished on or after the date CMS issued a DMEPOS supplier number conveying billing privileges. CMS issues one supplier number for each location, and billing privileges must not have been revoked or excluded when the item was furnished.
In practice, “approved” therefore combines three separate things: enrollment with billing privileges, certified compliance with the supplier standards, and accreditation of the products and services being supplied.
Enrolled, participating and accepting assignment
These terms are often used interchangeably, but Medicare.gov treats them differently.
| Term | What it means | Why it matters to the buyer |
|---|---|---|
| Enrolled in Medicare | The supplier holds Medicare billing privileges. Medicare.gov: Medicare only pays for DME from enrolled suppliers. | Items from an unenrolled supplier are not paid for by Medicare. |
| Participating supplier | A supplier that participates in Medicare must accept assignment. | Charges are limited to the Part B coinsurance and deductible on the Medicare-approved amount. |
| Non-participating supplier | Not required to accept assignment, but may. | If it does not accept assignment, the patient may be charged more. |
Medicare.gov advises asking the supplier before getting equipment whether it accepts assignment. For rentals, confirm assignment applies to all rental months; otherwise the patient may have to pay the full cost up front and be reimbursed later. Source: Medicare.gov, Durable medical equipment (DME) coverage, checked 2026-11-01.
The supplier standards in 42 CFR 424.57(c)
The supplier certifies in its application that it meets and will continue to meet these standards. Several are directly checkable by a buyer.
| Standard | What the regulation says | Paragraph |
|---|---|---|
| Licensure and law | Operates in compliance with federal and state requirements; if a state requires a license for an item or service, the supplier must be licensed to provide it (it may contract with a licensed party unless state law prohibits). | (c)(1) |
| Excluded entities | May not contract with any entity currently excluded from Medicare, state health programs or other federal procurement programs. | (c)(4) |
| Rent or buy information | Advises beneficiaries they may rent or purchase inexpensive or routinely purchased DME, and of the purchase option for capped rental items; must provide documentation on request. | (c)(5) |
| Warranties | Honors all warranties under state law; must not charge the beneficiary or Medicare for repair or replacement covered by warranty. | (c)(6) |
| Physical facility | Maintains a physical facility on an appropriate site: accessible to the public, staffed during posted hours, with a visible sign and posted hours. A practice location of at least 200 square feet applies to most suppliers (exceptions for certain orthotic and prosthetic personnel). | (c)(7) |
| Business telephone | Primary business telephone at the site, listed under the business name; not exclusively a cell phone, pager, answering machine or forwarding line. | (c)(9) |
| Liability insurance | Comprehensive liability policy of at least $300,000 covering the place of business, customers and employees. | (c)(10) |
| Delivery and instructions | Responsible for delivery and keeps proof of delivery, including that beneficiaries received information on using items safely and effectively. | (c)(12) |
| Complaints and questions | Answers questions and complaints; keeps documentation of contacts and a complaint resolution protocol with written complaint records. | (c)(13), (19), (20) |
| Rental maintenance | Maintains and replaces at no charge, or repairs, items it has rented. | (c)(14) |
| Returns | Accepts returns of substandard or unsuitable items. | (c)(15) |
| Disclosure of standards | Discloses the supplier standards to each beneficiary it supplies. | (c)(16) |
| Supplier number | Must not convey or reassign a supplier number. | (c)(18) |
| Opening hours | Open to the public at least 30 hours per week, with listed exceptions (for example a physician furnishing items to their own patients). | (c)(30) |
Source: 42 CFR 424.57, eCFR, current text checked 2026-11-01.
Accreditation, surety bond and revalidation
Under 424.57(c)(22), all DMEPOS suppliers and all of their locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited to enroll in and bill Medicare. The accreditation must indicate the specific products and services the supplier is accredited for, and payment is tied to those products and services. A supplier must notify its accrediting organization when it opens a new location (c)(23), accredited suppliers must be surveyed and reaccredited at least every 12 months (c)(24), and a new product line added after enrollment requires notifying the accreditor so the supplier can be re-surveyed (c)(25). See DMEPOS accreditation for the process.
Paragraph (c)(26) requires the supplier to meet the surety bond requirements of paragraph (d), which apply for each assigned National Provider Identifier (NPI). A supplier enrolling, changing ownership or responding to a revalidation request submits a surety bond from an authorized surety; the regulation sets the base amount at $50,000 and allows an elevated bond if required by the CMS contractor. Billing privileges must also be kept current; see Medicare revalidation for DME suppliers, and PTAN numbers for how a supplier’s Medicare identifier is used.
Checklist: what to verify before ordering
This is a verification workflow built from the standards above, not a ranking of suppliers.
- Enrollment. Confirm the supplier is enrolled in Medicare and the location you will use holds billing privileges (one supplier number per location). Enrollment records sit in PECOS.
- Assignment. Ask whether the supplier participates and accepts assignment, and for rentals, for every rental month.
- Accreditation scope. Ask for proof of accreditation for that location and confirm the product category you need is listed, since accreditation must specify products and services.
- State licence. Where the state requires a licence for the item, confirm the supplier holds it.
- Physical location. Confirm a listed business telephone, posted hours and a public site; the standards require them.
- Rent-or-buy information. Ask for the written rent-or-purchase information the supplier must be able to document.
- Delivery and complaints. Ask how proof of delivery, user instructions, warranty claims, returns and complaints are handled.
- Order paperwork. Check whether the item needs a CMN and whether the taxonomy and billing identifiers match; see taxonomy codes for DME suppliers.
Medicare supplier directory and “Medicare DME supplier” searches
A “Medicare supplier directory” search is about finding an enrolled supplier. Whichever list is used, the checks above still apply: a listing is a starting point, and enrollment, assignment and accreditation scope for the specific location and product are what determine whether Medicare will pay.
Common mistakes
- Assuming that an enrolled supplier always accepts assignment; only participating suppliers must.
- Checking the company rather than the location; billing privileges and accreditation are location-specific.
- Skipping the product scope of the accreditation.
- Not confirming assignment for every month of a rental.
- Overlooking supplier red flags; see DME fraud schemes.
FAQ
What is a Medicare-approved DME supplier?
A supplier enrolled in Medicare with billing privileges that certifies it meets the 42 CFR 424.57 supplier standards, including accreditation for the products it supplies.
Does Medicare pay for DME from any supplier?
No. Medicare.gov states that Medicare will only pay for DME items from suppliers enrolled in Medicare.
What is the difference between a participating supplier and one that accepts assignment?
A participating supplier must accept assignment. A non-participating supplier may accept assignment on a claim but is not required to, and if it does not, the patient may be charged more.
Do supplier standards apply to every location?
Yes. Separate physical locations used to furnish covered DMEPOS must be enrolled (except locations used solely as warehouses or repair facilities), and all locations must be separately accredited.
How often is a DME supplier reaccredited?
Accredited DMEPOS suppliers must be surveyed and reaccredited at least once every 12 months under 424.57(c)(24).
What does Medicare DME coverage include?
See what Medicare DME covers; fees are covered in the DMEPOS fee schedule guide, and Medicaid differs, see Medicaid DME.
Sources
- eCFR, 42 CFR 424.57, Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges, https://www.ecfr.gov/current/title-42/part-424/section-424.57 (checked 2026-11-01).
- Medicare.gov, Durable medical equipment (DME) coverage, https://www.medicare.gov/coverage/durable-medical-equipment-dme-coverage (checked 2026-11-01).
