Operates its business and furnishes Medicare-covered items in compliance with all applicable Federal and State licensure and regulatory requirements.

Has not made, or caused to be made, any false statement or misrepresentation of a material fact on its application for billing privileges.

Has the application for billing privileges signed by an individual whose signature binds a supplier?

Fills orders, fabricates, or fits items from its own inventory or by contracting with other companies for the purchase of items necessary to fill the order.

Advises beneficiaries that they may either rent or purchase inexpensive or routinely purchased durable medical equipment, and of the purchase option for capped rental durable medical equipment.

Honors all warranties expressed and implied under applicable State law. A supplier must not charge the beneficiary or the Medicare program for the repair or replacement of Medicare-covered items or for services covered under warranty.

Maintains a physical facility on an appropriate site. The physical facility must contain space for storing business records including the supplier’s delivery, maintenance, and beneficiary communication records. For purposes of this standard, a post office box or commercial mailbox is not considered a physical facility.

Permits CMS, or its agents to conduct on-site inspections to as certain supplier compliance with the requirements of this section. The supplier location must be accessible during reasonable business hours to beneficiaries and to CMS, and must maintain a visible sign and posted hours of operation.

Maintains a primary business telephone listed under the name of the business locally or toll-free for beneficiaries.

Has a comprehensive liability insurance policy 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.

Agrees not to contact a beneficiary by telephone when supplying a Medicare-covered item unless one of the following applies:

• The individual has given written permission to the supplier to contact them by telephone.

• The supplier has furnished a Medicare-covered item to the individual and the supplier is contacting the individual to coordinate the delivery of the item.

• If the contact concerns the furnishing of a Medicare-covered item other than a covered item already furnished to the individual, the supplier has furnished at least one covered item to the individual during the 15-month period proceeding the date on which the supplier makes such contact.

Is responsible for the delivery of Medicare-covered items to beneficiaries and maintain proof of delivery.

Answers questions and respond to complaints a beneficiary has about the Medicare-covered item that was sold or rented.

Maintains and replace at no charge or repair directly, or through a service contract with another company, Medicare-covered items it has rented to beneficiaries.

Accepts returns from beneficiaries of substandard items.

Discloses these supplier standards to each beneficiary to whom it supplies a Medicare-covered item.

Complies with the disclosure provisions in § 420.206 of this subchapter.

Will not convey or reassign a supplier number.

Has a complaint resolution protocol to address beneficiary complaints that relate to supplier standards.

Maintains the following information on all written and oral beneficiary complaints, including telephone complaints, it receives:

• The name, address, telephone number, and health insurance claim number of the beneficiary.

• A summary of the complaint; the date it was received; the name of the person receiving the complaint, and a summary of actions taken to resolve the complaint.

• If an investigation was not conducted, the name of the person making the decision and the reason for the decision.

Provides to CMS, upon request, any information required by the Medicare statute and implementing regulations.

All suppliers of DMEPOS and other items and services 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 in order for the supplier to receive payment for those specific products and services.

All DMEPOS suppliers must notify their accreditation organization when a new DMEPOS location is opened. The accreditation organization may accredit the new supplier location for three months after it is operational without requiring a new site visit.

All DMEPOS supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare. An accredited supplier may be denied enrollment or their enrollment may be revoked, if CMS determines that they are not in compliance with the DMEPOS quality standards.

All DMEPOS suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation. If a new product line is added after enrollment, the DMEPOS supplier will be responsible for notifying the accrediting body of the new product so that the DMEPOS supplier can be re-surveyed and accredited for these new products

Must meet the surety bond requirements specified in 42 C.F.R. 424.57(c). Implementation date- May 4, 2009

A supplier must obtain oxygen from a state-licensed oxygen supplier.

A supplier must maintain ordering and referring documentation consistent with provisions found in 42 C.F.R. 424.516(f).

DMEPOS suppliers are prohibited from sharing a practice location with certain other Medicare providers and suppliers.

DMEPOS suppliers must remain open to the public for a minimum of 30 hours per week with certain exceptions.