Specialty Pharmacy Information Packet | Page 21

MEDICARE DMEPOS SUPPLIER STANDARDS
Note : This is an abbreviated version of the supplier standards every Medicare DMEPOS supplier must meet in order to obtain and retain their billing privileges . These standards , in their entirety , are listed in 42 C . F . R . 424.57 ( c ).
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 . A supplier must have an authorized individual ( whose signature is binding ) sign the enrollment application for billing privileges . 4 . A supplier must fill orders from its own inventory , or 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 programs , or any other Federal procurement or non-procurement programs .
5 . A supplier must advise beneficiaries that they may 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 must maintain a visible sign with posted hours of operation . The location must be accessible to the public and staffed during posted hours of business . The location must be at least 200 square feet and contain space for storing records . 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 in a local directory or a toll free number available through directory assistance . The exclusive use of a beeper , answering machine , answering service or cell phone during posted business hours is prohibited .
10 . A supplier must have 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 . If the supplier manufactures its own items , this insurance must also cover product liability and completed operations . 11 . A supplier is prohibited from direct solicitation to Medicare beneficiaries . For complete details on this prohibition see 42 CFR § 424.57 ( c ) ( 11 ). 12 . A supplier is responsible for delivery of and must instruct beneficiaries on the use of Medicare covered items , 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 cost either 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 it supplies a Medicare-covered item . 17 . A supplier must disclose any person having ownership , financial , or control interest in the supplier . 18 . A supplier must not convey or reassign a supplier number ; i . e ., 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 . A record of these complaints must be maintained at the physical facility . 20 . Complaint records must include : 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 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 in order for the supplier to receive payment for those specific products and services ( except for certain exempt pharmaceuticals ). 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 physicians ( as defined in section 1848 ( j ) ( 3 ) of the Act ) or physical and occupational therapists or a DMEPOS supplier working with custom made orthotics and prosthetics .
MEDICARE DMEPOS SUPPLIER STANDARDS DMEPOS suppliers have the option to disclose the following statement to satisfy the requirement outlined in Supplier Standard 16 in lieu of providing a copy of the standards to the beneficiary .
The products and / or services provided to you by ( supplier legal business name or DBA ) are subject to the supplier standards contained in the Federal regulations shown at 42 Code of Federal Regulations Section 424.57 ( c ). These standards concern business professional and operational matters ( e . g . honoring warranties and hours of operation ). The full text of these standards can be obtained at http :// www . ecfr . gov . Upon request we will furnish you a written copy of the standards .
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