Frequently Asked Questions Relating to DME Facilities

CLICK HERE FOR FAQs ON RENEWAL OF YOUR DME PERMIT.

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Q: What are the record keeping requirements for a DME facility?

a. Where should I keep my DME records? Records must be maintained on site at a permitted DME facility per 21 NCAC 46.2604 “[a]ll orders and records for devices and medical equipment…shall be maintained at the dispensing site.” The “dispensing site” refers to the permitted DME facility.

b. What are the requirements for records being accessible / available? 21 NCAC 46.2607 provides that records required to be kept at a DME facility “shall be available to Board inspectors or agents [during normal business hours].” A DME facility must have orders and records maintained on-site at the DME facility. Orders and records must be immediately accessible at the facility itself for purposes of safe and proper provision of devices, medical equipment and services to the patients.

c. How much time do I have to fulfill a request from the Board for printed documentation of records? 21 NCAC 46.2607 requires that [a]ll records…shall be archived in a readily retrievable manner and open for review, copying or seizure by the Board...within 48 hours of a request for inspection for a period of three (3) years.” The 48-hour allowance sets the time in which a permit holder is required to physically hand over copies of records to the Board. The 48-hour allowance for time to gather records does NOT relieve a DME facility from the obligation to have orders and records maintained on-site and immediately accessible at the facility itself for purposes of proper and safe provision of devices, medical equipment and related services to patients.

d. Can the records at a DME facility be kept electronically? 21 NCAC 46.2508 provides that that documentation required by the North Carolina Board of Pharmacy may be maintained electronically. The system that creates and maintains the electronic records must:

i. be accessible for the proper and safe provision of devices, medical equipment and services,

ii. be capable of printing documentation so that the Person in Charge or the Pharmacy Manager can provide it to the Board within 48 hours of a request,

iii. contains security features to prevent unauthorized access to records, and

iv. contains daily back-up functionality to protect against record loss.

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Q: How do I determine if I need a DME permit?

A: Click here for details.

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Q: Are expiration dates required on medical gas cylinders?

A: Pharmacies and DME facilities that dispense medical gases are aware that Board of Pharmacy Rule 21 NCAC 46.2610(b) requires that medical gas cylinders be affixed with “lot numbers and expiration dates.”  The Board’s rule is not intended to create an expiry date requirement that would differ from that required under the federal or North Carolina Food Drug and Cosmetic Acts.

The Board is aware that the issue of medical gas cylinder expiry dating has been a matter of substantial controversy and discussion at the federal level for a number of years.  The Board is aware that the federal Food and Drug Administration has, as a matter of enforcement policy, advised its inspectors to not cite medical gas suppliers for the absence of an expiration date on a medical gas cylinder.  The North Carolina Department of Agriculture Food and Drug Safety Division has advised its field staff similarly. 

Given Rule .2610(b)’s intent to mirror federal requirements, Board of Pharmacy staff will likewise not cite a medical gas dispenser for the absence of an expiration date on a medical gas cylinder.  Board staff understands that this issue remains one of discussion at the federal level, and that the FDA is working on a guidance document for medical gas suppliers that will, among other things, more explicitly address expiry dating.

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Q: When is the next Durable Medical Equipment Committee Election?

A: The next DME election will take place in June 2014 for the Medical Equipment Supplier seat.

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Q: What are a DME provider’s back-up oxygen requirements where the patient has title to oxygen equipment?

A: The Board of Pharmacy does not interpret its Rules as requiring a DME supplier to provide maintenance services for oxygen equipment that is not owned by the DME supplier or otherwise subject to a maintenance program provided by the DME supplier. However, a DME supplier that provides maintenance services for oxygen equipment must comply with all applicable home medical equipment laws of North Carolina and all applicable Board of Pharmacy Rules, regardless of whether such maintenance services are deemed reasonable and necessary services by CMS.

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Q: How do I notify the Board of a change in Person-in-Charge (PIC)?

A: Please complete the top portion of the DME Certificate with the new PIC’s information and picture.  Once complete, mail to the Board’s office and the change will be processed within 7-10 days of receipt.  An email will be sent to the new PIC notifying them that the change has been made and they will then be instructed to print an updated certificate.

Please contact Missy Betz with any questions, mbetz@ncbop.org or 919-246-1050 x 208.

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Q: If an entity ships glucose meters to North Carolina residents, must it obtain a DME permit?

A: Glucose meters. NCGS 90-85.22(b) provides that any place delivering "medical equipment" must obtain a DME permit to ship to North Carolina residents. NCGS 90-85.3(l1) defines "medical equipment" to include "diagnostic equipment." Board Rule .1317(7) (21 NCAC 46.1317(7)) specifically excludes "glucose meters" from the definition of "diagnostic equipment. Accordingly, the mere fact of shipping glucose meters to North Carolina residents would not require a business to obtain a DME permit. Of course, if the business were also shipping other items that satisfy the definition of "device" or "medical equipment" to North Carolina residents, it must obtain a DME permit.

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Q: If an entity ships power wheelchairs or scooters to North Carolina residents, must it obtain a DME permit?

A: Scooters. Again, NCGS 90-85.22(b) provides that any place delivering "medical equipment" must obtain a DME permit to ship to North Carolina residents. NCGS 90-85.3(l1) defines "medical equipment" to include "mobility equipment." Board Rule .1317(22) (21 NCAC 46.1317(22)) defines mobility equipment to "includ[e] manual or power wheelchairs and scooters." Accordingly, any business shipping motorized wheelchairs or scooters to North Carolina residents must obtain a DME permit before doing so.

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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 should review the following information to determine if you are required to have a DME permit: http://www.ncbop.org/dmedefinitions.htm

If any device, equipment, or supplies that you intend to provide to North Carolina residents meets any of these definitions, you must obtain a North Carolina DME permit prior to dispensing them. The Board of Pharmacy does not provide “exemption” letters from statutory and rules-based requirements. If you have further questions, please contact Wendy Watson at the Board office either by email, phone, fax, or regular mail.

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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.

 

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