Current through Register Vol. 30, No. 38, September 20, 2024
A.Permit. A person shall not sell, lease, or
supply durable medical equipment or a compressed medical gas to a patient or
consumer 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 do 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 specified in
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 supplier permittee shall submit using the permittee's
online profile or provide written notice by mail, fax, or e-mail to the Board
office within 10 days of changes involving the telephone or fax number, email
or mailing address, or business name.
D. Change of ownership. A resident or
nonresident DME and CMG supplier permittee shall comply with
R4-23-601(F).
E. Relocation.
1. No fewer than 30 days before a resident
DME and CMG supplier permittee relocates, the permittee shall submit a
completed application for relocation electronically or manually on a form
furnished by the Board, and the documentation required in subsection (B). A fee
is not required with an application for relocation.
2. A nonresident DME and CMG supplier
permittee shall provide written notice by mail, fax, or e-mail to the Board
office no fewer than 10 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,
only under a prescription or medication order from a medical practitioner;
and
2. A compressed medical gas
only under a compressed medical gas order from a medical
practitioner.
G.
Restriction. A DME and CMG supplier permit authorizes the permittee to procure,
possess, and provide a prescription-only device or compressed medical gas to a
patient or consumer as specified in subsection (F). A DME and CMG supplier
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, sanitary, temperature controlled, and secure from
unauthorized access. A permittee shall maintain separate and identified storage
areas in the facility and in 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 stated in subsection (K).
J. Records. A resident or nonresident DME and
CMG supplier permittee shall establish and implement written procedures for
maintaining records about acquisition, distribution, returns, recalls, training
of personnel, maintenance, cleaning, and complaints.
K. A permittee shall:
1. Ensure a prescription order, medication
order, or compressed medical gas order is obtained as specified in subsection
(F);
2. Ensure each compressed
medical gas container supplied by the permittee contains a label bearing the
name and address of the permittee;
3. Ensure 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 fewer 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 for inspection by the Board or its
compliance officer, or if stored in a centralized recordkeeping system apart
from the inspection location and not electronically retrievable for inspection,
provide the records within four working days of a request by the Board or its
staff.
L. 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 10 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 resident 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.
M. Permit renewal. To renew a resident or nonresident
DME and CMG supplier permit, the permittee shall comply with in
R4-23-602(D).
N. Nothing in this Section shall be construed to
prohibit the emergency administration of oxygen by licensed health-care
personnel, emergency medical technicians, first responders, fire fighters, law
enforcement officers, and other emergency personnel trained in the proper use
of emergency oxygen.
