CMS / Medicare DMEPOS Supplier Standards
(As required under 42 C.F.R. § 424.57(c) & related rules)
These standards reflect the current guidance and updates as of latest CMS publications.
Supplier Enrollment & Regulatory Compliance
- A supplier must comply with all applicable Federal and State licensure, certification, and regulatory requirements, and may not contract with an individual or entity to provide services that require such licensing if the contractor itself is not properly licensed.
- A supplier must provide complete and accurate information on its DMEPOS supplier application and enrollment forms. Any changes to that information must be reported within 30 days to the National Provider Enrollment (NPE) DMEPOS contractor.
- The enrollment / billing application must be signed by an authorized individual whose signature is legally binding on the organization.
Service, Inventory, & Contracting
4. A supplier must fill orders from its own inventory or may contract with other companies to procure items necessary to fulfill those orders. In doing so, the supplier must not contract with any entity that is excluded from Medicare, State health programs, or other federal procurement/non-procurement programs.
5. A supplier must inform beneficiaries that they may either rent or purchase inexpensive or routinely purchased durable medical equipment and must clearly explain the purchase option for capped rental items.
6. A supplier must notify beneficiaries of warranty coverage, honor all warranties under applicable State law, and repair or replace items under warranty free of charge.
Physical Location & Inspection
7. A supplier must maintain a physical facility at an appropriate site, accessible to the public, with posted hours of business, visible signage, and staffed appropriately during those posted hours. The facility must be at least 200 square feet and provide adequate space for storing records.
8. CMS or its agents must be permitted to conduct on-site inspections of supplier locations to verify compliance with these standards.
9. The supplier location must be accessible to beneficiaries during reasonable business hours, with posted hours of operation and a clearly visible sign.
Communications & Contact Requirements
10. A supplier must maintain a primary business telephone number in the name of the business, listed in a local directory or a toll-free number accessible via directory assistance. Using only a beeper, answering machine, answering service, or cell phone during posted business hours is not sufficient.
11. A supplier must have comprehensive liability insurance of at least $300,000, covering the business location, customers, and employees. If the supplier manufactures its own devices, this insurance must include product liability and completed operations coverage.
Marketing, Solicitation & Beneficiary Contact
12. A supplier is prohibited from initiating unsolicited telephone contact with Medicare beneficiaries, except in limited exceptions. In particular, a supplier may not solicit based on a physician’s oral order unless a regulatory exception applies.
13. A supplier must deliver Medicare-covered items, instruct beneficiaries (or caregivers) in their proper use, and maintain proof of delivery and instruction.
14. A supplier must promptly answer beneficiary questions and complaints and maintain documentation of such contacts.
Equipment Rental, Returns & Replacements
15. A supplier must maintain, repair, or replace (at no cost to the beneficiary) Medicare-covered equipment that it has rented (either directly or via a service contract).
16. A supplier must accept returns of substandard or unsuitable items (i.e., items that are less than full quality or are inappropriate for the beneficiary) when provided.
17. A supplier must disclose these supplier standards to each beneficiary to whom it supplies a Medicare-covered item and provide a written copy upon request.
Ownership, Billing, Complaints & Compliance
18. A supplier must disclose to CMS any person or entity with ownership, financial, or control interest in the supplier.
19. A supplier may not convey or reassign its Medicare supplier number; i.e., the supplier may not sell or allow another entity to use its billing number.
20. A supplier must have a complaint resolution protocol for beneficiary complaints related to these standards. Records of complaints must be maintained at the physical facility.
21. Complaint records must include: the beneficiary’s name, address, telephone number, health insurance claim number, a summary of the complaint, and actions taken to resolve it.
22. A supplier must agree to furnish CMS (or its agents) any information required under the Medicare statute or implementing regulations.
Accreditation & Quality Requirements
23. All DMEPOS suppliers must be accredited by a CMS-approved accreditation organization (AO) to establish and maintain a supplier billing number. The accreditation must explicitly cover the specific products and services for which the supplier seeks payment (excluding certain exempt pharmaceuticals).
24. Suppliers must notify their AO when they open a new DMEPOS location.
25. All supplier locations—whether directly owned or subcontracted—must meet DMEPOS quality standards individually and be separately accredited to bill Medicare.
26. Suppliers must disclose all products and services they intend to provide at enrollment and must notify appropriate parties (AO, NPE) when adding new product lines.
27. Suppliers must meet surety bond requirements as specified in 42 C.F.R. § 424.57(d).
28. A supplier must obtain oxygen supplies from a state-licensed oxygen supplier.
29. A supplier must maintain ordering and referring documentation consistent with requirements in 42 C.F.R. § 424.516(f).
30. DMEPOS suppliers are prohibited from sharing a practice location with certain other Medicare providers and suppliers in some cases (per CMS rules).
31. Suppliers must remain open to the public for a minimum of 30 hours per week, except certain exempt types (e.g., physicians, physical/occupational therapists, or suppliers specializing in custom prosthetics/orthotics).
How This Applies to Beneficiaries
When we supply a Medicare-covered item to you as a beneficiary, you should receive notice of these standards, and you have rights under them. If you wish to review the full regulatory text, see 42 C.F.R. § 424.57(c) and related provisions or visit the Electronic Code of Federal Regulations (eCFR).
