Every supplier of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) must meet these standards to obtain and keep its Medicare billing privileges. This is a plain-language summary. The full text is 42 CFR 424.57(c), at ecfr.gov.
- Operates its business and furnishes Medicare-covered items in compliance with all applicable federal and state licensure and regulatory requirements, including accessibility for people with disabilities.
- Provides complete and accurate information on its Medicare enrollment application, and reports any change to CMS within 30 days.
- Has its enrollment application signed by a person whose signature binds the supplier.
- Fills orders from its own inventory or by contracting with other companies, and does not contract with any entity excluded from Medicare, any state health care program, or any other federal procurement or non-procurement program.
- Tells beneficiaries they may rent or purchase inexpensive or routinely purchased durable medical equipment, and about the purchase option for capped rental equipment.
- Honors all warranties under state law, does not charge the beneficiary or Medicare to repair or replace items covered under warranty, and tells beneficiaries about warranty coverage.
- Maintains a physical facility on an appropriate site: accessible to the public, staffed during posted hours, with a permanent visible sign, posted hours, and space to store business records.
- Permits CMS or its agents to conduct on-site inspections.
- Maintains a primary business telephone at the practice location, listed under the business name. A cell phone, beeper or pager cannot be the primary line, and calls to it cannot be forwarded only to one.
- Carries comprehensive liability insurance of at least $300,000 covering its place of business and all customers and employees.
- Does not telephone a beneficiary about a Medicare-covered item unless the beneficiary gave written permission, the call is to coordinate delivery of an item already furnished, or the supplier has furnished a covered item to the beneficiary in the past 15 months.
- Is responsible for delivering Medicare-covered items, keeps proof of delivery, and documents that the beneficiary was told how to use the item safely and effectively.
- Answers questions and responds to complaints about items it sold or rented, refers Medicare questions to the right Medicare contractor, and documents those contacts.
- Maintains, repairs or replaces at no charge the Medicare-covered items it rents to beneficiaries, directly or through a service contract. The item must work as intended afterwards.
- Accepts returns of substandard items (less than full quality) and unsuitable items (inappropriate for the beneficiary when fitted and rented or sold).
- Gives each beneficiary it supplies with a Medicare-covered item a copy of these standards.
- Discloses its ownership and control information as required by 42 CFR 420.206.
- Does not convey or reassign its supplier number.
- Has a complaint resolution protocol for complaints about these standards, and keeps written complaints, related correspondence and notes of actions taken.
- Keeps a record of every written and oral complaint: the beneficiary’s name, address, telephone and Medicare number, a summary of the complaint, the date received, who received it, and what was done to resolve it.
- Provides CMS, on request, any information the Medicare statute and regulations require.
- Meets the DMEPOS quality standards and is accredited by a CMS-approved accreditation organization. Every location is separately accredited, and the accreditation names the specific products and services the supplier bills.
- Notifies its accreditation organization when it opens a new location.
- Is surveyed and reaccredited at least once every 12 months.
- Discloses all its products and services at enrollment, and notifies its accreditation organization of any new product line so it can be surveyed and accredited for it.
- Meets the surety bond requirements of 42 CFR 424.57(d).
- Obtains oxygen from a state-licensed oxygen supplier, where the state requires oxygen licensure.
- Maintains ordering and referring documentation as required by 42 CFR 424.516(f).
- Does not share a practice location with any other Medicare supplier or provider, except as the regulation allows.
- Is open to the public at least 30 hours a week, except as the regulation allows.
Also in the sleeptech Welcome Guide. Ask any staff member for a printed copy, or call 503-496-5239.