Medicare DMEPOS Supplier Standards

The Code of Federal Regulations (42 C.F.R. 424.57) requires durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers to meet certain standards in order to bill Medicare. The following is an abbreviated version of those standards; the complete standards are set out in 42 C.F.R. 424.57(c) and (d), which govern in all cases.

1. A supplier must be in compliance with all applicable Federal and State licensure and regulatory requirements.
2. A supplier must provide complete and accurate information on the DMEPOS supplier application. Any changes to this information must be reported to the National Supplier Clearinghouse within 30 days.
3. An authorized individual (one whose signature is binding) must sign the application for billing privileges.
4. A supplier must fill orders from its own inventory, or must contract with other companies for the purchase of items necessary to fill orders. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care program, or any other Federal procurement or non-procurement program.
5. A supplier must advise beneficiaries that they may either rent or purchase inexpensive or routinely purchased durable medical equipment, and of the purchase option for capped-rental equipment.
6. A supplier must notify beneficiaries of warranty coverage and honor all warranties under applicable State law, and repair or replace free of charge Medicare-covered items that are under warranty.
7. A supplier must maintain a physical facility on an appropriate site and maintain a visible sign with posted hours of operation. The location must be accessible and staffed during posted hours, contain space for storing records, and be at least 200 square feet (with limited exceptions).
8. A supplier must permit CMS or its agents to conduct on-site inspections to ascertain the supplier's compliance with these standards.
9. A supplier must maintain a primary business telephone listed under the name of the business locally or toll-free for beneficiaries. The exclusive use of a beeper, answering machine, answering service, or cell phone during posted business hours is prohibited.
10. A supplier must maintain comprehensive liability insurance in the amount of at least $300,000 that covers both the supplier's place of business and all customers and employees of the supplier.
11. A supplier is prohibited from directly soliciting to Medicare beneficiaries, with limited exceptions described in 42 CFR 424.57(c)(11).
12. A supplier is responsible for the delivery of Medicare-covered items to beneficiaries and must instruct beneficiaries on their use, and maintain proof of delivery and beneficiary instruction.
13. A supplier must answer questions and respond to complaints of beneficiaries, and maintain documentation of such contacts.
14. A supplier must maintain and replace at no charge, or repair directly or through a service contract with another company, any Medicare-covered items it has rented to beneficiaries.
15. A supplier must accept returns of substandard (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) from beneficiaries.
16. A supplier must disclose these standards to each beneficiary to whom it supplies a Medicare-covered item.
17. A supplier must disclose to the government any person having ownership, financial, or control interest in the supplier.
18. A supplier must not convey or reassign a supplier number; that is, the supplier may not sell or allow another entity to use its Medicare billing number.
19. A supplier must have a complaint resolution protocol established to address beneficiary complaints that relate to these standards, and keep written complaints, related correspondence, and notes of actions taken in response to written and oral complaints at its physical facility.
20. A supplier must maintain, on any written or oral complaint, the name, address, telephone number, and health insurance claim number of the beneficiary; a summary of the complaint; and any actions taken to resolve it.
21. A supplier must agree to furnish CMS any information required by the Medicare statute and implementing regulations.
22. All suppliers must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services for which the supplier is accredited.
23. All suppliers must notify their accreditation organization when a new DMEPOS location is opened.
24. All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare.
25. All suppliers must disclose, upon enrollment, all products and services — including the addition of new product lines for which they are seeking accreditation.
26. A supplier must meet the surety bond requirements specified in 42 CFR 424.57(d).
27. A supplier must obtain oxygen from a State-licensed oxygen supplier.
28. A supplier must maintain ordering and referring documentation consistent with provisions found in 42 CFR 424.516(f).
29. A supplier is prohibited from sharing a practice location with other Medicare providers and suppliers.
30. A supplier must remain open to the public for a minimum of 30 hours per week, except in certain circumstances.

Provided for transparency and to satisfy Supplier Standard #16. This is an abbreviated summary for general information; the official standards at 42 C.F.R. 424.57(c)–(d) are controlling. For a printed copy, call us at (607) 270-2777.