1. Operates its business and furnishes Medicare-covered items in compliance with all applicable Federal and State licensure and regulatory requirements;
  2. Has not made, or caused to be made, any false statement or misrepresentation of a material fact on its application for billing privileges. (The supplier must provide complete and accurate information in response to questions on its application for billing privileges. The supplier must report to CMS any changes in information supplied on the application within 30 days of the change.)
  3. Must have the application for billing privileges signed by an individual whose signature binds a supplier;
  4. 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. If it does, it must provide, upon request, copies of contracts or other documentation showing compliance with this standard. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs, or from any other Federal Government Executive Branch procurement or non-procurement program or activity;
  5. 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, as defined in § 414.220(a) of this subchapter. (The supplier must provide, upon request, documentation that it has provided beneficiaries with this information, in the form of copies of letters, logs, or signed notices.);
  6. 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. This standard applies to all purchased and rented items, including capped rental items, as described in § 414.229 of this subchapter. The supplier must provide, upon request, documentation that it has provided beneficiaries with information and Medicare covered items covered under warranty, in the form of copies of letters, logs, or signed notices;
  7. 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. In the case of a multi-site supplier, records may be maintained at a centralized location;
  8. Permits CMS, or its agents to conduct on-site inspections to ascertain supplier compliance with the requirements of this section. The supplier location must be accessible during the reasonable business hours the beneficiaries and to CMS, and must maintain a visible sign and posted hours of operation;
  9. Maintains a primary business telephone listed under the name of the business locally or toll-free for beneficiaries. The supplier must furnish information to beneficiaries at the time of delivery of items on how the beneficiary can contact the supplier by telephone. The exclusive use of a beeper number, answering service, pager, facsimile machine, car phone, an answering machine may not be used as a primary business telephone for purposes of this regulation;
  10. 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. In the case of a supplier that manufactures its own items, this insurance must also cover product liability and completed operations. Failure to maintain required insurance at all times will result in revocation of the supplier’s billing privileges retroactive to the date the insurance lapsed;
  11. Must agree not to contact a beneficiary by telephone when supplying a Medicare-covered item unless one of the following applies:
    1. The individual has given written permission to the supplier to contact them by telephone concerning the furnishing of a Medicare-covered item that is to be rented or purchased.
    2. 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.
    3. 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 preceding the date on which the supplier makes such contact.
  12. Must be responsible for the delivery of Medicare-covered items to beneficiaries and maintain proof of delivery. ( the supplier must document that it or another qualified party has at an appropriate time, provided beneficiaries with necessary information and instructions on how to use Medicare-covered items safely and effectively);
  13. Must answer questions and respond to complaints a beneficiary has about the Medicare-covered item that was sold or rented. A supplier must refer beneficiaries with Medicare questions to the appropriate carrier. A supplier must maintain documentation of contacts with beneficiaries regarding complaints or questions;
  14. Must maintain and replace at no charge or repair directly, go through a service contract with another company, Medicare-covered items it has rented to beneficiaries. The items must function as required and intended after being repaired or replaced;
  15. Must accept returns from beneficiaries 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);
  16. Must disclose their supplier standards to each beneficiary to whom it supplies a Medicare-covered item;
  17. Must comply with the disclosure provisions in § 420.206 of this subchapter;
  18. Must not convey or reassign a supplier number;
  19. Must have a complaint resolution protocol to address beneficiary complaints that relate to supplier standards in paragraph ( c ) of this section and keep written complaints, related correspondence and any notes of actions taken in response to written and oral complaints. Failure to maintain such information.
  20. Must maintain the following information on all written and oral beneficiary complaints, including telephone complaints, it receives.
    1. The name, address, telephone number, and health insurance claim number of the beneficiary.
    2. 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.
    3. If an investigation was not conducted, the name of the person making the decision and the reason for the decision.
  21. Provides to CMS, upon request, any information required by the Medicare statute and implementing regulations.