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How do I determine if I need to obtain a DME permit?

If you are dispensing medical supplies to patients in NC you are required to have a permit. Please read the following definitions to see if you meet any of the qualifications. If you meet any of the definitions below you can obtain an application here. Make sure to read the Procedure Sheet for obtaining a permit (which preceeds the actual application.)

NOTE: Make sure to familiarize yourself with all rules and regulations concerning the DME permit. It is your responsibility to be in compliance. Below are examples of a few laws and rules to refer to. Additional Laws/Rules can be found here.

 

§ 90-85.22. Device and medical equipment permits.

(a) Devices. – Each place, whether located in this State or out-of-state, where devices are dispensed or delivered to the user in this State shall register annually with the Board on a form provided by the Board and obtain a device permit. A business that has a current pharmacy permit does not have to register and obtain a device permit. Records of devices dispensed in pharmacies or other places shall be kept in accordance with rules adopted by the Board.

(b) Medical Equipment. – Each place, whether located in this State or out-of-state, that delivers medical equipment to the user of the equipment in this State shall register annually with the Board on a form provided by the Board and obtain a medical equipment permit. A business that has a current pharmacy permit or a current device permit does not have to register and obtain a medical equipment permit. Medical equipment shall be delivered only in accordance with requirements established by rules adopted by the Board.

(c) This section shall not apply to either of the following:

(1) A pharmaceutical manufacturer registered with the Food and Drug Administration.

(2) A wholly owned subsidiary of a pharmaceutical manufacturer registered with the Food and Drug Administration. (1981 (Reg. Sess., 1982), c. 1188, s. 1; 1993 (Reg. Sess., 1994), c. 692, s. 1; 2001-339, s. 1.)

 

§ 90-85.3. Definitions.

(e) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article including any component part or accessory, whose label or labeling bears the statement "Caution: federal law requires dispensing by or on the order of a physician." The term does not include:

(1) Devices used in the normal course of treating patients by health care facilities and agencies licensed under Chapter 131E or Article 2 of Chapter 122C of the General Statutes;

(2) Devices used or provided in the treatment of patients by medical doctors, dentists, physical therapists, occupational therapists, speech pathologists, optometrists, chiropractors, podiatrists, and nurses licensed under Chapter 90 of the General Statutes, provided they do not dispense devices used to administer or dispense drugs.

(l1) "Medical equipment" means any of the following items that are intended for use by the consumer in the consumer's place of residence:

(1) A device.
(2) Ambulation assistance equipment.
(3) Mobility equipment.
(4) Rehabilitation seating.
(5) Oxygen and respiratory care equipment.
(6) Rehabilitation environmental control equipment.
(7) Diagnostic equipment.
(8) A bed prescribed by a physician to treat or alleviate a medical condition.
The term "medical equipment" does not include (i) medical equipment used or dispensed in the normal course of treating patients by or on behalf of home care agencies, hospitals, and nursing facilities licensed under Chapter 131E
of the General Statutes or hospitals or agencies licensed under Article 2 of Chapter 122C of the General Statutes; (ii) medical equipment used or dispensed by professionals licensed under Chapters 90 or 93D of the General Statutes,
provided the professional is practicing within the scope of that professional's practice act; (iii) upper and lower extremity prosthetics and related orthotics; or (iv) canes, crutches, walkers, and bathtub grab bars.

(t) "Prescription order" means a written or verbal order for a prescription drug, prescription device, or pharmaceutical service from a person authorized by law to prescribe such drug, device, or service. A prescription order includes an order entered in a chart or other medical record of a patient.

 

21 NCAC 46 .1317 DEFINITIONS

The definitions of various terms used in this Chapter are found in G.S. 90, Article 4A, and as follows:

(1) Ambulation Assistance Equipment. Devices that aid in walking, excluding canes, crutches, and walkers.

(7) Diagnostic equipment. Equipment used to record physiological information while a person goes about normal daily living or while asleep in order to document a disease process. Early pregnancy tests (EPTs), thermometers, glucose meters, and cholesterol equipment are not included as diagnostic equipment.

(22) Mobility equipment. Devices that aid a person in self-movement, other than walking, including manual or power wheelchairs and scooters.

(23) Oxygen and respiratory care equipment. Equipment or devices used to administer oxygen or other legend drugs, maintain viable airways or monitor cardio-respiratory conditions or events, including compressed medical gases; oxygen concentrators; liquid oxygen; nebulizers; compressors; aerosol therapy devices; portable suction machines; nasal continuous positive airway pressure (CPAP) machines; Bi-phasic positive pressure devices (BiPAP); infant monitors, such as apnea monitors and cardio-respiratory monitors; positive and negative pressure mechanical ventilators; and pulse oximeters.

(31) Rehabilitation environmental control equipment. Equipment or devices which permit a person with disabilities to control his or her immediate surroundings.

(32) Rehabilitation Services. Services and equipment required to maintain or improve functional status and general health as prescribed by the physician which are uniquely specified for each individual's lifestyle. The people involved in this process include the patient, caregiver, physician, therapist, rehabilitation equipment supplier and others who impact on the individual's life style and endeavors.

History Note: Authority G.S. 90-85.3; 90-85.6; 90-85.8; 90-85.13; 90-85.14; 90-85.15; 90-85.21; 90-85.38; 90-85.40;
Eff. May 1, 1989;
Amended Eff. February 1, 2007; March 1, 2004; April 1, 1999; May 1, 1997; September 1, 1995; September 1, 1993; October 1, 1990; January 1, 1990.

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Please see Section 2600 of the Pharmacy Rules for additional rules related to DME.

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If a permit is required, please read the following information which pertains to permits:

21 NCAC 46 .1608 DEVICE AND MEDICAL EQUIPMENT PERMITS

(a) Applications for device and medical equipment permits, whether original or renewal, shall be made upon forms provided by the Board. The Board shall not issue any original or annual renewal device and medical equipment permit until the Board is satisfied that:

(1) Adequate qualified personnel have been secured by the management of the facility to properly render device and medical equipment services in the manner prescribed by law.

(2) Such personnel shall be maintained during the period for which the permit is issued.

(3) 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
(B) An oxygen analyzer in the permitted facility, if concentrators are dispensed.

(4) Suitable facilities shall be maintained to house inventory, to allow for fabrication work space, and to record and file prescription orders as required by law.

(5) A copy of the pharmacy laws of North Carolina, including the North Carolina Pharmacy Practice Act and the rules of the Board shall be present in the facility at all times.

(6) The facility is equipped with a functioning lavatory where hot and cold running water or hand washing appliances or waterless hand cleaner are available.

(7) The facility is kept in a clean, orderly, and sanitary condition.

(8) The applicants' services are accessible to its customer base.

(9) All prescription medications are labeled in accordance with G.S. 106-134 and 106-134.1.

(10) The applicant complies with all USP and FDA requirements regarding the storage, packaging, and shipping of prescription medications, including medical oxygen.

(11) The applicant's services are available 24 hours, seven days per week when essential to the maintenance of life or when the lack of such services might reasonably cause harm.

(12) The applicant implements and maintains a written procedure at each location for handling complaints and problems, which includes a complaint file documenting complaints and problems and resolution of the complaints or problems.

(13) The applicant complies with local/state fire and building laws.

(14) The applicant complies with current Occupational Safety and Health Administration (OSHA) laws and requirements as enforced by the NC Department of Labor/Division of OSHA, including the approach to infection control known as "Universal Precautions."

(b) Device and medical equipment permits, whether original or renewal, shall be issued to the person in charge of the facility pursuant to a joint application of the owner and person in charge. The issuance of said permit shall not be complete and the permit shall not be valid until it has been countersigned by the person in charge as represented in the application. The permit so issued is valid only so long as the person in charge to whom it was issued assumes his duties and responsibilities. Permits may be reissued at any time to a successor person in charge pursuant to the proper amendment of the application for the permit. The hours of operation shall be posted conspicuously at the facility for public viewing. The person in charge or the designee of the person in charge shall be present at the facility during the hours of operation of the facility. The person in charge shall notify the Board in writing of a change in the facility address within 30 days from the date of the change.

(c) When a device and medical equipment dispensing facility is to be closed permanently, the person in charge shall inform the Board of the closing and arrange for the proper disposition of devices and medical equipment and return the permit to the Board's offices within 10 days of the closing date. The person in charge, jointly with the owner (if the owner is someone other than the person in charge), shall provide for the orderly transfer of records to another
permit holder for maintenance of patient therapy and inform the public of such transfer by posted notice or otherwise.

(d) Charitable organizations providing devices and medical equipment at no charge must register with the Board. The Board shall waive the fee for a permit upon a showing that the organization meets the Internal Revenue Service charitable purpose requirements for exemption from taxation and that at least 75 percent of the organization's funds are used for a charitable purpose. Loaner closets providing device and medical equipment at no charge, excluding oxygen or other life support devices, must register with the Board but are exempt from the fee for device and
medical equipment permits.

History Note: Authority G.S. 90-85.6; 90-85.22;
Eff. September 1, 1995;
Amended eff. April 1, 2007

 

NOTE: Make sure to familiarize yourself with all rules and regulations concerning the DME permit. It is your responsibility to be in compliance. These are examples above of a few laws and rules to refer to. Additional Laws/Rules can be found here.


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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