Chapter 480-7B DURABLE MEDICAL EQUIPMENT SUPPLIERS
| (1) |
"Board" shall
mean the Georgia Board of Pharmacy. |
| (2) |
"Designated representative" means an
individual proposed by a DME supplier and approved by the Board as the
supervisor or manager responsible for ensuring the DME supplier's compliance
with all state and federal laws and regulations pertaining to practice as a DME
supplier. |
| (3) |
"Durable medical
equipment" or "DME" shall mean equipment for which a prescription is required,
including repair and replacement parts for such equipment, and which
| (a) |
Can withstand repeated use; |
| (b) |
Has an expected life of at least three
years; |
| (c) |
Is primarily and
customarily used to serve a medical purpose; |
| (d) |
Generally is not useful to a person in
the absence of illness or injury; and |
| (e) |
Is appropriate for use in the
home. |
|
| (4) |
"Durable
medical equipment supplier" or "DME supplier" means a person or entity that
provides durable medical equipment to a consumer and submits a claim for
reimbursement by a third party, either directly or through a contractual
arrangement. |
| (5) |
"GDNA Agent" or
"GDNA Agents" shall mean the director, a deputy director or a special agent of
the Georgia Drugs and Narcotics agency. |
| (1) |
Licensing requirement. A
person or entity located in the State of Georgia that provides durable medical
equipment to a consumer and submits a claim for reimbursement by a third party,
either directly or through a contractual arrangement, and any Medicare enrolled
out-of-state DME manufacture or wholesale distributor that provides durable
medical equipment to consumers in this state and who holds a valid license from
another state must hold a license issued by the Board. Licensure as a DME
supplier will be considered on the basis of the completion of a Board approved
application filed with the Board, payment of a fee, a report from GDNA
certifying that the applicant possesses the necessary qualifications for
licensure including meeting all safety standards and requirements established
by the Board, satisfactory licensure status in other states, and if located in
the State of Georgia, maintenance of an office or place of business in the
State of Georgia. When reviewing an application, the Board may determine that a
person or entity accredited by an organization recognized by the federal
Centers for Medicare and Medicaid Services has met all or some of the
requirements for licensure. |
| (2) |
Applications Licensure as a DME supplier.
| (a) |
The Board requires the following
information from each DME supplier as part of the initial licensing procedure:
| 1. |
The name, full business address, and
telephone number of the applicant; |
| 2. |
All trade of business names used by the
applicant; |
| 3. |
Address, telephone
number(s), and the name(s) of the proposed designated representative(s) for the
facility and evidence showing the qualifications of the proposed designated
representative(s) to serve; |
| 4. |
The
type of ownership or operations (i.e. partnership, corporation, or sole
proprietorship); |
| 5. |
The name(s) of
the owner and/or operator of the applicant, including:
| (i) |
If a person, the name of the
person; |
| (ii) |
If a partnership, the
name of each partner and the name of the partnership; |
| (iii) |
If a corporation, the name and title of
each corporate officer and director, the corporate names, the name of the
incorporation, and the name of the parent company, if any; |
| (iv) |
If a sole proprietorship, the full name
of the sole proprietorship and the name of the business entity; |
|
| 6. |
If located out of state, proof
of a valid, unexpired license to operate as a DME supplier in the compliance
with the laws and rules of the other state; and |
| 7. |
Information necessary to demonstrate
compliance with O.C.G.A. Title 50, Chapter 36. |
|
| (b) |
Application fees and renewal fees shall
be set by the Board in a fee schedule and shall not be refundable. |
| (c) |
Applications are only valid for one
year. |
|
| (3) |
Denial
of Applications for Licensure. Applications for licensure may be denied for failure to meet
the minimum qualifications for a license, failure to comply with the laws or
regulations of this State, the United States or any other state having to do
with DME suppliers, making false representations on an application, failure to
meet the safety standards established by the Board, or for any other grounds
set forth in O.C.G.A. §§ 26-4-60 and
43-1-19. The denial of an
application for licensure shall not be considered a contested case under the
provisions of O.C.G.A. T. 50, Ch. 13, but the applicant shall be entitled to an
appearance before the Board.
|
| (4) |
Term of license. Licenses are issued for thirty-six months, expire on June
30th of every third year, and may be renewed for
three years upon the payment of the required fee for each place of business and
the filing of a completed application for renewal. If the application for
renewal is not made and the fee not paid before September 1st of the third
year, the license shall lapse and shall not be renewed, and an application for
reinstatement shall be required. Reinstatement is at the sole discretion of the
Board.
|
| (5) |
Licenses
are Location Specific and Non-Transferable. Where operations are
conducted at more than one licensed place of business by a DME supplier, each
place of business shall be licensed by the Board, and each place of business
requires a separate application for licensure. If a licensed business moves
locations, the license does not transfer to the new location and a new
application is required. |
| (6) |
Exemption from Licensure Requirement.
| (a) |
The following persons and entities are
not required to obtain a DME supplier license from the Board, unless such
person or entity has a separate company, corporation, or division that is in
the business of supplying durable medical equipment to consumers and submits a
claim for reimbursement by a third party:
| 1. |
Pharmacies and pharmacists. |
| 3. |
Ambulatory surgical
centers. |
| 4. |
Health care facilities
owned or operated by the state or federal government. |
| 5. |
Skilled nursing facilities. |
| 6. |
Assisted living facilities. |
| 7. |
Health care practitioners who:
| (i) |
Provide durable medical equipment within
the scope of practice of the health care practitioner's profession;
and |
| (ii) |
Are licensed in the State
of Georgia to practice the health care practitioner's profession. |
|
| 8. |
Suppliers of insulin pumps and
related supplies or services; |
| 9. |
Manufacturers or wholesale distributors that do not sell or rent durable
medical equipment directly to consumers; |
| 10. |
Renal dialysis providers licensed under
O.C.G.A. § 31-44-4 and persons or entities
that distribute devices necessary to perform home renal dialysis to patients
with chronic kidney disease; and |
| 11. |
Suppliers of osteogenesis stimulators,
transcutaneous electrical nerve stimulators, pneumatic compression devices, and
related supplies or services. |
|
| (b) |
Facilities that meet the criteria
established in O.C.G.A. Section
26-4-6 are not required to be
licensed as DME Suppliers. |
|
| (1) |
Requirement for Designated Representatives. The Board shall only
issue a license to a DME supplier if a qualified individual has been approved
as a designated representative for the DME supplier. The designated
representative will provide sufficient and qualified supervision of the DME
supplier's place of business, ensuring compliance with all state and federal
laws and regulations. The designated representative shall ensure the protection
of the public health and safety in the handling, storage, warehousing,
distribution, and shipment of durable medical equipment in the DME supplier's
place of business. Where operations are conducted at more than one licensed
place of business by a DME supplier, each licensed place of business shall have
at least one designated representative present. |
| (2) |
Qualifications of Designated
Representatives. In order to serve as a designated representative, an
individual shall:
| (a) |
Be at least 18 years of
age; |
| (b) |
Submit a Board approved
personnel certification form as part of the DME supplier's application to the
Board; |
| (c) |
Attest to the knowledge
and understanding of applicable state and federal laws and regulations relating
to the distribution of durable medical equipment, knowledge and understanding
of quality control systems, and knowledge and understanding of the United
States Pharmacopeia of federal Food and Drug Administration standards relating
to the safe storage, handling, and transport of durable medical
equipment; |
| (d) |
Consent to provide
the necessary information to conduct, and pay for a background check to be
conducted by the Board, its agent or a firm or firms approved by the Board,
which background check will include a criminal history, driver license history
and other information as the Board deems necessary, and will authorize the
Board and the Georgia Drugs and Narcotics Agency to receive the results;
and |
| (e) |
If the designated
representative is a licensed pharmacist, provide the state(s) of licensure,
license number(s), and license status(es) of said license(s). |
|
| (3) |
Notice to Designated
Representative. Any notice made to a DME supplier licensee shall be made
to the designated representative on record with the Board. If notices are
returned as undeliverable or unclaimed, service shall be made on the Executive
Director, and any disciplinary proceedings shall proceed, or if a final
decision, the decision shall become effective. |
A DME supplier licensee shall cooperate with the Board in any
investigation involving durable medical equipment distributed by such DME
supplier licensee from, into, or within this State. The licensee shall respond
within ten (10) business days to all communications from the Board or its
designee. Failure to respond or cooperate with the Board shall be grounds for
the immediate suspension of the DME supplier license, pending a hearing on
further disciplinary action by the Board. Failure to cooperate with the Board
is grounds for disciplinary action by the Board.
| (1) |
State or Federal Actions. A
DME supplier licensee must notify the Board within ten (10) business days of
the receipt of any final order or decision by any other licensing board or
federal agency of the imposition of disciplinary action or restriction by such
other licensing board or federal agency in which a license or privilege was
suspended or revoked. A final order or decision includes a consent order or
agreement and is any decision, regardless whether there still exists an
appellate right to the state or federal courts. Any revocation or suspension of
a state or federal license or permit may result in the immediate suspension of
the DME license by the Board, pending a final decision by the Board. |
| (2) |
Felony convictions. A DME
supplier licensee, its owner, or designated representative who is convicted
under the laws of this state, the United States, or any other state, territory,
or country of a felony shall be required to notify the Board of the conviction
within ten (10) days of the conviction. The failure to notify the Board of a
conviction shall be considered grounds for revocation of the DME supplier
license. |
| (1) |
Consumer
counseling. All personnel engaged in delivery or in-home maintenance and
repair of durable medical equipment shall instruct the patient or patient's
caregiver on how to use the durable medical equipment provided. |
| (2) |
Continuing education.
Written annual education plan procedures for each classification of personnel
must be made available to the Board upon request that includes the following
information: description of training content, training method, frequency, and
issuance of individual certificates of competence. |
| (3) |
Background Checks. DME
suppliers shall conduct background checks on any person who will have direct
contact with patients. Such background check will include at a minimum criminal
history. The background check shall be maintained on such persons as long as
the person is still performing services for the DME supplier. |
| (4) |
Receipt of complaints from
consumers. DME suppliers shall maintain a telephone number operational
during the licensee's regular hours of operation in order to provide support
for consumers. Such number shall be capable of receiving inbound calls from
consumers to the licensee, and such number shall be on file with Board, and
shall be included with any material sent to the consumer with the durable
medical equipment. |
| (5) |
Delivery by mail. A DME supplier that uses delivery by mail is
accountable to the Board to arrange for the appropriate mailing/shipping
process. The DME supplier shall provide a method by which a patient or
patient's caregiver can notify the DME supplier as to any irregularity in the
delivery of their DME to include but not be limited to: timeliness of delivery;
condition of the DME upon delivery; and failure to receive the DME ordered. A
DME supplier using delivery by mail shall document the instances when DME have
been compromised during shipment and delivery by mail or when the DME does not
arrive in a timely manner, and shall maintain such documentation for two (2)
years. In addition, the DME supplier shall maintain reports of patient
complaints and internal/external audits about timeliness of deliveries,
condition of the DME when received by patient including situations when it was
compromised in delivery, the wrong equipment was provided, and the patient
failed to receive the DME. Such records shall be provided to the Board, upon
request. |
| (6) |
Records.
| (a) |
A DME supplier shall maintain records for
all devices shipped, mailed or delivered to patients in the State of Georgia
for a period of at least two (2) years. DME suppliers shall notify the Board of
each location where the required records are being maintained, and such records
must be readily retrievable and produced to the Board or a GDNA Agent upon
request. If the DME supplier is out located out of state, the records must be
received by the Board or GDNA within fifteen (15) days of the written
request. |
| (b) |
A DME supplier shall
maintain records of all education plan procedures and certificates of
competence, for each employee, for a period of at least two (2) years. A DME
supplier shall maintain background checks for each person having in-home
contact with a customer for the period that such person remains affiliated with
the DME supplier. DME suppliers shall notify the Board of each location where
the required records are being maintained, and such records must be readily
retrievable and produced to the Board or GDNA Agent upon request. If the DME
supplier is out located out of state, the records must be received by the Board
or GDNA within fifteen (15) days of the written request. |
|
GDNA Agents, on behalf of the Board, may initially and/or
periodically inspect a DME Supplier applicant's or licensee's office or place
of business within this state. During such inspection, the GDNA Agents shall
have the authority to inspect the facility and all inventories, and shall have
the authority to examine, copy, or remove all records, including but not
limited to purchase and sales records, repair records, employee records,
background checks, and training records. At the conclusion of an inspection,
the GDNA Agent(s) conducting the inspection shall have the responsibility of
providing to such applicant or licensee a copy of a written inspection report
on which any deficiencies or violations are made along with any
recommendations. If a follow-up inspection is required due to deficiencies, the
Board may charge the applicant or licensee a fee for the re-inspection as
provided in its fee schedule established pursuant to paragraph (37) of
subsection (a) of Code Section
26-4-28 to cover the cost of such
inspection.
