Q: Does North Carolina have a minimal requirement for the amount of back-up oxygen that a DME company must provide to patients?
A: Yes. 21 NCAC 46 .1608 (a) (3) (A) states that "If the applicant dispenses medical oxygen to a patient, then the applicant must reasonably ensure that the following medical equipment is maintained: (A) Sufficient backup of oxygen in that patient's home and supplies for equipment serviced to maintain continuation of therapy for 24 hours; and . . . "
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Q. When is a DME supplier who is licensed by the Division of Facility Services (DFS) also required to hold a DME permit from the Board of Pharmacy?
A. A health care facility or agency that is licensed under either Chapter 131E (Health Care Facilities and Services) or Article 2 of Chapter 122C (Facilities for the Mentally Ill, The Developmentally Disabled, and Substance Abusers) of the North Carolina General Statutes is required to hold a DME permit from the Board if the facility or agency dispenses devices or medical equipment outside of the normal course of treating its patients. The law therefore requires permitting by any DFS licensee that dispenses devices and medical equipment to customers who are not patients of the facility or agency’s health care services. On the other hand, the law does not require a DME permit from the Board for a facility or agency that is licensed under either Chapter 131E or Chapter 122 of the North Carolina General Statutes and that dispenses devices or medical equipment only in the normal course of treating its patients.
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Q: What criteria are used in determining if a DME business may not operate under a Pharmacy Permit?
A: Criteria:
- If the DME portion of the business is at a separate address, to include a separate suite at the same address
- At the same address but under separate ownership from the pharmacy
- Managed by someone other than the Pharmacist-Manager
- Has a separate tax identification number
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Q: What do I need to know when opening my DME business - is there a checklist available?
A: Download our DME self checklist here.
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Q: Is it permissible for a person to serve as the Person-In-Charge at more than one location?
A: No
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Q: Must the Person-In-Charge be present before the Board Investigator conducts an inspection?
A: No - Inspections are unannounced to allow the Investigator to achieve ultimate exposure to the operation of the business. If the Person-In-Charge is not present upon arrival of the Investigator, an attempt will be made to notify the PIC of the inspection by phone. If contact is not made, the inspection will still proceed.
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Q: Who do I contact at the Board if I was told that I need an exemption letter for a DME Permit?
A: You submit a request in writing to Wendy Watson at the Board’s office either by email at wwatson@ncbop.org, fax or regular mail. You need to describe what equipment or services your DME business is providing to patients. A letter will be mailed to you letting you know if you are exempt or if you are required to have a permit.
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Q: Can I operate a DME Business from my home or residence?
A: No, you can not operate a DME Business from residential property. See Section.2600-Devices 21 NCAC 46.2601 (c).
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FAQs on the NABP DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics, and Supplies) Accreditation Program
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» APRIL 10, 2007 - CMS has issued a final rule establishing a competitive bidding program for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) furnished to Medicare beneficiaries under Part B. The law requires that competition under the program begin in 2007 in 10 of the largest metropolitan statistical areas (MSAs), 80 of the largest MSAs in 2009, and additional areas after 2009. Because CMS received more than 2,000 comments on the proposed rule and because the rule is extremely complex, the agency has extended the time line for publication of the final rule until April 30. Diabetic supplies provided by community pharmacies are not included in the competitive bidding process -- however, diabetic supplies provided by mail order are subject to competitive bidding. Click here for a copy of the final rule.
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For questions about DME permits, please contact Wendy Watson at 919.246.1050 ext. 221 or by email at wwatson@ncbop.org.
