Section R4-23-693. Durable Medical Equipment (DME) and Com- pressed Medical Gas (CMG) Supplier-Resident or Nonresident

A.      Permit. A person shall not sell, lease, or supply durable medi- cal equipment or a compressed medical gas to a patient or con- sumer in Arizona for use in a home or residence without a current Board-issued resident or nonresident durable medical equipment and compressed medical gas supplier permit.

1.        The permit requirements of this Section shall not apply to the following unless there is a separate business entity engaged in the business of providing durable medical equipment or a compressed medical gas to a patient or consumer for use in a home or residence:

a.         A medical practitioner licensed under A.R.S. Title 32;

b.        A hospital, long-term care facility, hospice, or other health care facility using durable medical equipment or a compressed medical gas in the normal course of treating a patient; and

c.         A pharmacy.

2.        Nothing in this Section shall be construed to prohibit a person with a current Board-issued nonprescription drug permit from the retail sale of nonprescription drugs or devices.

B.       Application. To obtain a resident or nonresident DME and CMG supplier permit, a person shall submit a completed application form and fee as specified in R4-23-602.

1.        A resident DME and CMG supplier permit applicant shall include documentation of compliance with local zoning laws, if required by the Board.

2.        A nonresident DME and CMG supplier permit applicant that resides in a jurisdiction that issues an equivalent license or permit shall include a copy of the equivalent license or permit.

C.      Notification. A resident or nonresident DME and CMG sup- plier permittee shall provide written notice by mail, facsimile, or e-mail to the Board office within ten days of changes involving the telephone number, facsimile number, email address, mailing address, or name of business.

D.      Change of ownership. No less than 14 days before a change of ownership occurs that involves changes of stock ownership of 30% or more of the voting stock of a corporation or an existing and continuing corporation that is not actively traded on any securities market or over-the-counter market, the prospective owner shall submit a completed application form and fee as specified in subsection (B).

E.       Relocation.

1.        No less than 30 days before an existing resident DME and CMG supplier permittee relocates, the permittee shall submit a completed application for relocation electroni- cally or manually on a form furnished by the Board, and the documentation required in subsection (B).

2.        A nonresident DME and CMG supplier permittee shall provide written notice by mail, facsimile, or e-mail to the Board office no less than ten days before relocating.

F.       Orders. A resident or nonresident DME and CMG supplier shall sell, lease, or provide:

1.        Durable medical equipment that is a prescription-only device as defined in A.R.S. § 32-1901(75) only pursuant to a prescription order or medication order from a medi- cal practitioner; and

2.        A compressed medical gas only pursuant to a compressed medical gas order from a medical practitioner.

G.      Restriction. A DME and CMG supplier permit shall authorize the permittee to procure, possess, and provide a prescription- only device or compressed medical gas to a patient or con- sumer as specified in subsection (F). A DME and CMG sup- plier permit does not authorize the permittee to procure, possess, or provide narcotics or other controlled substances, prescription-only drugs other than compressed medical gases, precursor chemicals, or regulated chemicals.

H.      Facility. A resident or nonresident DME and CMG supplier permittee shall ensure the facility is clean, uncluttered, sani- tary, temperature controlled, and secure from unauthorized access. A permittee shall maintain separate and identified stor- age areas in the facility and in the delivery vehicles for clean, dirty, contaminated, or damaged durable medical equipment or compressed medical gases.

I.        A resident or nonresident DME and CMG supplier permittee shall not manufacture, process, transfill, package, or label a compressed medical gas, except as set forth in subsection (J).

J.        Records. A resident or nonresident DME and CMG supplier permittee shall establish and implement written procedures for maintaining records pertaining to acquisition, distribution, returns, recalls, training of personnel, maintenance, cleaning, and complaints. A permittee shall:

1.        Ensure that a prescription order, medication order, or compressed medical gas order is obtained as specified in subsection (F);

2.        Ensure that each compressed medical gas container sup- plied by the permittee contains a label bearing the name and address of the permittee;

3.        Ensure that all appropriate warning labels are present on the durable medical equipment or compressed medical gas;

4.        Retain the records required by Section R4-23-601 and this Section for not less than three years, or if supplying a compressed medical gas, one year after the expiration date of the compressed medical gas, whichever is longer; and

5.        Make the records required by Section R4-23-601 and this Section available on inspection by the Board or its com- pliance officer, or if stored in a centralized recordkeeping system apart from the inspection location and not elec- tronically retrievable for inspection, shall provide the records within four working days of a request by the Board or its staff.

K.      Inspection.

1.        A resident DME and CMG supplier permittee shall make the DME and CMG supplier’s facility available for inspection by the Board or its compliance officers under

A.R.S. § 32-1904.

2.        Within ten days from the date of a request by the Board or its staff, a nonresident DME and CMG supplier permittee shall provide a copy of the most recent inspection report completed by the permittee’s resident licensing authority, or a copy of the most recent inspection report completed by a third-party auditor approved by the permittee’s resi- dent licensing authority or the Board or its designee. The Board may inspect, or may employ a third-party auditor to inspect, a nonresident permittee as specified in A.R.S.

§ 32-1904.

L.       Permit renewal. Permit renewal shall be as specified in R4-23- 602(D).

M.     Nothing in this Section shall be construed to prohibit the emer- gency administration of oxygen by licensed health care per- sonnel, emergency medical technicians, first responders, fire fighters, law enforcement officers, and other emergency per- sonnel trained in the proper use of emergency oxygen.

Historical Note

Adopted effective January 12, 1998 (Supp. 98-1).

Amended by final rulemaking at 20 A.A.R. 1364, effec- tive August 2, 2014 (Supp. 14-2).