As used in these Rules, the term:
(1) "Acquisition of an existing health care
facility" means to come into possession or control of a health care facility by
purchase, gift, merger of corporations, lease, purchase of stock, inheritance,
or by any other legal means.
(2)
"Acquisition of diagnostic, therapeutic, or other imaging equipment":
(a) as it relates to a diagnostic, treatment,
or rehabilitation center, means to come into possession, or control of, or to
otherwise use diagnostic, therapeutic, or other imaging equipment by purchase,
gift, donation, lease, transfer, or by any other legal means by or on behalf of
diagnostic, treatment, or rehabilitation center; and
(b) as it relates to a health care facility,
means to come into possession or control of diagnostic, therapeutic, or other
imaging equipment by purchase or lease by or on behalf of the health care
facility.
(3) "Ambulatory
surgery" means surgical procedures that include but are not limited to those
recognized by the Centers for Medicare and Medicaid Services ("CMS"), by the
Georgia Division of Medical Assistance ("DMA"), by the State Health Benefit
Plans, or by any successor entities as reimbursable ambulatory surgery
procedures. Ambulatory surgery is provided only to patients who are admitted to
a facility which offers ambulatory surgery and which does not admit patients
for treatment that normally requires stays that are overnight or exceed 24
hours and which does not provide accommodations for treatment of patients for
periods of twenty-four hours or longer.
(4) "Ambulatory surgical or obstetrical
facility", as defined at O.C.G.A. §
31-6-2(1), means
a public or private facility, not a part of a hospital, which provides surgical
or obstetrical treatment performed under general or regional anesthesia in an
operating room environment to patients not requiring hospitalization.
(5) "Applicant" means the owner or lessee of
an existing health care facility or the person who would be the owner or lessee
of a proposed facility, as named in the application. An applicant may also be
multiple owners or lessees of existing health care facilities who share common
ownership or corporate affiliation and wish to submit an application to the
Department for a single Certificate of Need for certain non-clinical health
services, for example, but not limited to, parking decks, infrastructure
improvement or replacement, and capital renovation expenditures.
(6) "Application", as defined at O.C.G.A. §
31-6-2(2), means
a written request for a Certificate of Need made to the Department, containing
such documentation and information as the Department may require.
(7) "Approved date" means the date that the
Department issues a Certificate of Need to an applicant.
(8) "Associated with and simultaneously
developed or proposed" means that if the Department determines that a single
project or the substantial equivalent of a single project is divided into
separate components which are associated and which are developed or planned
simultaneously, so that the project or the substantial equivalent of a project
or any component thereof does not require a total capital expenditure in excess
of the capital expenditure or diagnostic, therapeutic, or other imaging
equipment threshold as applicable, the Department shall combine the components
for purposes of computing the amount of the total capital expenditure or
expense and shall treat the combined components as a single project or
substantial equivalent of a project. The Department shall include items and
expenditures which are related and which occur simultaneously in computing an
applicable threshold regardless of whether the items or expenditures
individually may otherwise be below the threshold or may be otherwise
unreviewable exclusive of the items exempted from review by Ga. Comp. R. &
Regs. r.
111-2-2-.03(1)-(3)
and Ga. Comp. R. & Regs. r.
111-2-2-.03(5)-(19);
(a) The Department may determine that
activities, services, expenditures, and items are associated if they share a
relationship or association based on law, regulation, definition, function,
procedure, or process; and
(b) The
Department shall determine that expenditures related to activities, services,
and items are simultaneously developed or planned if such expenditures occur
within a 6-month period. The 6-month period shall run from operation of the
activity, service or item to initial capital expenditure on the second activity
or item or from operation of the activity or item to operation of the second
activity or item. For services, the date of operation shall be the date that
the service is actually offered. If applicable, for facilities, the date of
operation shall be the date a Certificate of Occupancy is issued.
(9)
Reserved.
(10) "Basic
perinatal services" means providing basic inpatient care for pregnant women and
newborns without complications; managing perinatal emergencies; consulting with
and referring to specialty and subspecialty hospitals; identifying high-risk
pregnancies; providing follow-up care for new mothers and infants; and
providing public/community education on perinatal health.
(11) "Bed capacity", as defined at O.C.G.A. §
31-6-2(4), means
space used exclusively for inpatient care, including space designed or
remodeled for inpatient beds even though temporarily not used for such
purposes. The number of beds to be counted in any patient room shall be the
maximum number for which adequate square footage is provided as established by
Rules of the Department, except that single beds in single rooms shall be
counted even if the room contains inadequate square footage.
(12) "By or on behalf of" means any
expenditures made by a health care facility, a political subdivision of the
State, a diagnostic, treatment, or rehabilitation center, or a hospital
authority, itself as well as capital expenditures made by other persons or
related entities to assist the facility, subdivision, center, or authority,
directly or indirectly, to offer services to its patients or residents. Related
entities include entities that are associated or affiliated with, have control
over or are controlled by, or have any direct financial interest in, the health
care facility, political subdivision of the State, diagnostic, treatment, or
rehabilitation center, or hospital authority, including, without limitation, an
underwriter, guarantor, parent organization, sister organization, subsidiary or
sub-entity, foreign corporation, joint venturer, partner, general partner, or
building lessor, as applicable.
(13) "Capital expenditure" in relation to a
proposed modification, renovation, or addition to a health care facility or to
a diagnostic, treatment, or rehabilitation center, or acquisition of equipment,
means an expenditure by or on behalf of a health care facility or diagnostic,
treatment, or rehabilitation center that, under generally accepted accounting
principles, is not properly chargeable as an expense of operation or
maintenance. Any series of capital expenditures, which are associated and
simultaneously developed or proposed, will be presumed to be a single
project.
(14) "Certificate of Need"
or "CON", as defined at O.C.G.A. §
31-6-2(6), means
an official finding by the Department, evidenced by certification issued
pursuant to an application, that the action proposed in the application
satisfies and complies with the criteria contained in the Statute and Rules
promulgated pursuant thereto.
(15)
Reserved.
(16)
"Clinical health services", as defined at O.C.G.A. §
31-6-2(8), means
diagnostic, treatment, or rehabilitative services provided in a health care
facility and includes, but is not limited to, the following: radiology and
diagnostic imaging, such as magnetic resonance imaging and positron emission
tomography (PET); radiation therapy; biliary lithotripsy; surgery; intensive
care; coronary care; pediatrics; gynecology; obstetrics; general medical care;
medical-surgical care; inpatient nursing care, whether intermediate, skilled or
extended care; cardiac catheterization; open heart surgery; inpatient
rehabilitation; and alcohol, drug abuse, and mental health services.
(17) "Consumer", as defined at O.C.G.A. §
31-6-2(10), means
a person who is not employed by any health care facility or provider and who
has no financial or fiduciary interest in any health care facility or
provider.
(18) "Cost estimate"
means an estimate of the total cost of a project's development and construction
prepared by a licensed architect or engineer within sixty days prior to the
date of submittal of an application.
(19) "Defined location", as it relates to the
approved location of a project or substantial equivalent of a project, means
the address of the project, or in the case of a health care facility or
diagnostic, treatment, or rehabilitation center with multiple addresses, the
campus of such health care facility or diagnostic, treatment, or rehabilitation
center. However, in no case shall a campus be considered a single defined
location if varying locations and facilities of such campus are more than 3
miles apart or within more than one county.
(20) "Destination cancer hospital" means an
institution with a licensed bed capacity of fifty (50) or less which provides
diagnostic, therapeutic, treatment, and rehabilitative care services to cancer
inpatients and outpatients, by or under the supervision of physicians, and
whose proposed annual patient base is composed of a minimum of sixty-five
percent (65%) of patients who reside outside of the State of Georgia.
(21) "Develop", as defined at O.C.G.A. §
31-6-2(14), with
reference to a project, means constructing, remodeling, installing, or
proceeding with a project, or any part of a project. Notwithstanding the
provisions of this paragraph, the expenditure or commitment or incurring an
obligation for the expenditure of funds to develop Certificate of Need
applications, studies, reports, schematics, preliminary plans and
specifications, or working drawings, or to acquire, develop, or prepare sites
shall not be considered to be the developing of a project.
(22) "Diagnostic imaging" means magnetic
resonance imaging, computed tomography (CT) scanning, positron emission
tomography (PET) scanning, positron emission tomography/computed tomography,
and other advanced imaging services as defined by the Department by rule, but
such term shall not include X-rays, fluoroscopy, or ultrasound
services.
(23) "Diagnostic,
treatment, or rehabilitation center", as defined at O.C.G.A. §
31-6-2(16), means
any professional or business undertaking, whether for profit or not for profit,
which offers or proposes to offer any clinical health service in a setting
which is not part of a hospital; provided, however, that any such diagnostic,
treatment, or rehabilitation center that offers or proposes to offer surgery in
an operating room environment and to allow patients to remain more than
twenty-three (23) hours shall be considered a hospital for purposes of O.C.G.A.
§ 31-6 et seq.
(24) "Effective
date" means:
(a) for approved projects that
have not been appealed pursuant to the appeal provisions of the Rules of the
Certificate of Need Appeal Panel, the approved date;
(b) for projects, which are appealed pursuant
to the appeal provisions of the Rules of the Certificate of Need Appeal Panel,
the date of the final resolution of any such administrative appeal if the
resolution results in the approval of the project; or
(c) for projects which undergo judicial
review, the effective date shall be the date referenced in (b) above, unless
the Department, pursuant to Ga. Comp. R. & Regs. r.
111-2-2-.07(2)(h),
or the reviewing court stays the effective date of the project pending the
outcome of the judicial review. If the Department or the reviewing court stays
the effective date, the effective date shall be the date of the final
resolution of any such judicial review if the resolution results in approval of
the project.
(25)
"Expiration date" is the date upon which a Certificate of Need expires and
becomes null and void.
(26)
"Functionally related diagnostic, therapeutic, or other imaging equipment"
means that pieces of diagnostic, therapeutic, or other imaging equipment are
interdependent to the extent that one piece of equipment is unable to function
in the absence of or without the functioning piece or equipment, or that pieces
of equipment are normally used together in the provision of a single health
care facility or diagnostic, treatment, or rehabilitation center
service.
(27) "General cancer
hospital" means an institution which was an existing and approved destination
cancer hospital as of January 1, 2019; has obtained final Certificate of Need
approval for conversion from a destination cancer hospital to a general cancer
hospital in accordance with O.C.G.A. §
31-6-40.3; and offers inpatient
and outpatient diagnostic, therapeutic, treatments, and rehabilitative cancer
care service or other services to diagnose or treat co-morbid medical
conditions or diseases of cancer patients so long as such services do not
result in the offering of any new or expanded clinical health service that
would require a Certificate of Need under this chapter unless a Certificate of
Need or letter of determination has been obtained for such new or expanded
services.
(28) "Health care
facility", as defined at O.C.G.A. §
31-6-2(17), means
hospitals; destination cancer hospitals; other special care units, including
but not limited to podiatric facilities; skilled nursing facilities;
intermediate care facilities; personal care homes; ambulatory surgical or
obstetrical facilities; freestanding emergency departments or facilities not
located on a hospital's primary campus; health maintenance organizations; home
health agencies; diagnostic, treatment, or rehabilitation centers, but only to
the extent that O.C.G.A. §
31-6-40(a)(3) or
(7) or both are applicable thereto.
(29) "Health maintenance organization", as
defined at O.C.G.A. §
31-6-2(18), means
a public or private organization organized under the laws of this state which:
(a) provides or otherwise makes available to
enrolled participants health care services, including at least the following
basic health care services: usual physicians' services, hospitalization,
laboratory, X-ray, emergency and preventive services, and out-of-area
coverage;
(b) is compensated,
except for co-payments, for the provision of the basic health care services
listed in subparagraph (a) of this paragraph to enrolled participants on a
predetermined periodic rate basis; and
(c) provides physicians' services primarily:
1. directly through physicians who are either
employees or partners of such organization; or
2. through arrangements with individual
physicians organized on a group practice or individual practice
basis.
(30)
"Home health agency", as defined at O.C.G.A. §
31-6-2(20), means
a public agency or private organization, or a subdivision of such an agency or
organization, which is primarily engaged in providing to individuals who are
under a written plan of care of a physician, on a visiting basis in the places
of residence used as such individuals' homes, part-time or intermittent nursing
care provided by or under the supervision of a registered professional nurse,
and one or more of the following services:
(a)
physical therapy;
(b) occupational
therapy;
(c) speech
therapy;
(d) medical social
services under the direction of a physician; or
(e) part-time or intermittent services of a
home health aide.
(31)
"Hospital", as defined at O.C.G.A. §
31-6-2(21), means
an institution which is primarily engaged in providing to inpatients, by or
under the supervision of physicians, diagnostic services and therapeutic
services for medical diagnosis, treatment, and care of injured, disabled, or
sick persons or rehabilitation services for the rehabilitation of injured,
disabled, or sick persons. Such term includes public, private, psychiatric,
rehabilitative, geriatric, osteopathic, micro-hospitals, general cancer
hospitals, and other specialty hospitals.
(32) "Incur a financial obligation", in
relation to the offering of a new institutional health service, means that,
within time periods described in Ga. Comp. R. & Regs. r.
111-2-2-.02(5) and
(6) of these Rules, the applicant has
fulfilled the following performance requirements.
(a) With regard to new construction or
renovation:
1. has acquired title, an option
to purchase or a leasehold to an appropriate site;
2. has filed with the Department the complete
set of plans, drawings, and specifications for the project in the electronic
format designated by the Department;
3. has obtained a firm commitment for
adequate capital financing; and
4.
has entered into a construction contract that provides for a specific date for
commencement, and completion of construction within a reasonable time
span.
With regard to equipment not associated with a construction
project;
1. a purchase or lease
agreement has been entered into or, if acquired by a comparable arrangement,
the applicant has possession of the equipment.
(33)
Reserved.
(34) "Intermediate care facility", as defined
at O.C.G.A. §
31-6-2(22), means
an institution which provides, on a regular basis, health related care and
services to individuals who do not require the degree of care and treatment
which a hospital or skilled nursing facility is designed to provide but who,
because of their mental or physical condition, require health related care and
services beyond the provision of room and board.
(35) "Joined applications" means two or more
applications which involve similar projects in the same service area or
overlapping service areas all of which have been declared complete by the
twenty-fifth (25th) calendar days of the reviewcycle
of the first application, and whose time limits are scheduled to run from the
latest date that any one of the joined applications was received.
(36) "Joint venture ambulatory surgical
center" means a freestanding ambulatory surgical center that is jointly owned
by a hospital in the same county as the center or a hospital in a contiguous
county if there is no hospital in the same county as the center and a single
group of physicians practicing in the center and that provides surgery in a
single specialty as defined by the Department. Such ambulatory surgical center
shall only be utilized by physicians who are of the same single specialty, who
may include physicians who are not owners or employees of the single group
practice of physicians that own and operate the center; provided, however, that
general surgery, a group practice which includes one or more physiatrists who
perform services that are reasonably related to the surgical procedures
performed in the center, and a group practice in orthopedics which includes
hand surgeons with a certificate of added qualifications in Surgery of the Hand
from the American Board of Plastic and Reconstructive Surgery shall be
considered a single specialty. The ownership interest of the hospital shall be
no less than thirty percent (30%) and the collective ownership of the
physicians or group of physicians shall be no less than thirty percent (30%).
Nothing in this paragraph shall prohibit the owners of the center from entering
into an arrangement with an outside entity for practice management,
administrative services, or both.
(37) "Life plan community" means an
organization, whether operated for profit or not, whose owner or operator
undertakes to provide shelter, food, and either nursing care or personal
services, whether such nursing care or personal services are provided in the
facility or in another setting, and other services, as designated by agreement,
to an individual not related by consanguinity or affinity to such owner or
operator providing such care pursuant to an agreement for a fixed or variable
fee, or for any other remuneration of any type, whether fixed or variable, for
the period of care, payable in a lump sum, lump sum and monthly maintenance
charges or in installments. Agreements to provide continuing care include
agreements to provide care for any duration, including agreements that are
terminable by either party.
(38)
"Medical use rights" means rights or interests in real property in which the
owner of the property has agreed not to sell or lease such real property for
identified medical uses or purposes.
(a) It
shall be unlawful for any health care facility to purchase, renew, extend,
lease, maintain, or hold medical use rights.
(39) "Micro-hospital" means a hospital in a
rural county which has at least two and not more than seven inpatient beds and
which provides emergency services seven days per week and 24 hours per
day.
(40) "Mobile unit" means an
object with the ability by structure, function or design to move or be moved
from one site to another, such that upon arriving at a site the object is not
permanently fixed but is temporarily secured for the purpose of providing a
service to individuals.
(41) "New
and emerging health care service" means a health care service or utilization of
medical equipment which has been developed and has become acceptable or
available for implementation or use but which has not yet been addressed under
the Rules and regulations promulgated, adopted and included within and
hereto.
(42) "New institutional
health service", as defined at O.C.G.A. §
31-6-40(a) means:
(a) the construction, development, or other
establishment of a new, expanded, or relocated health care facility, except as
otherwise provided in O.C.G.A. §
31-6-47;
(b)
Reserved;
(c) any increase in the bed capacity of a
health care facility, regardless of whether a capital expenditure is made,
which increases the total bed capacity. An exception to this Rule will be made
in accordance with Ga. Comp. R. & Regs. r.
111-2-2-.03(14);
(d) clinical health services that are offered
in or through a health care facility, which were not offered on a regular basis
in or through such health care facility within the twelve (12) month period
prior to the time such services would be offered;
(e) any conversion or upgrading of any
general acute care hospital to a specialty hospital or of a facility such that
it is converted from a type of facility not covered by these Rules to any of
the types of health care facilities which are covered by these Rules;
(f) the purchase or lease by or on behalf of
a health care facility of diagnostic or therapeutic equipment except as
otherwise provided in O.C.G.A. §
31-6-47 and Ga. Comp. R. &
Regs. r.
111-2-2-.03 and
Ga. Comp. R. & Regs. r.
111-2-2-.10;
(g) clinical health services which are
offered in or through a diagnostic, treatment, or rehabilitation center which
were not offered on a regular basis in or through that center within the twelve
(12) month period to the time such services would be offered, but only if the
clinical health services are any of the following:
1. Radiation therapy;
2. Biliary lithotripsy;
3. Surgery in an operating room environment,
including but not limited to ambulatory surgery; and
4. Cardiac catheterization.
(h) The conversion of a
destination cancer hospital to a general cancer hospital.
(43) "Nonclinical health services", as
defined at O.C.G.A. §
31-6-2(25), means
services or functions provided or performed by a health care facility, and the
parts of the physical plant where they are located in a health care facility
that are not diagnostic, therapeutic, or rehabilitative services to patients
and are not clinical health services as defined in this chapter.
(44) "Offer", as defined at O.C.G.A. §
31-6-2(26), means
that the health care facility is open for the acceptance of patients or
performance of services and has qualified personnel, equipment, and supplies
necessary to provide specified clinical health services.
(45) "Operating room environment", as defined
at O.C.G.A. §
31-6-2(27), means
an environment which meets the minimum physical plant and operational standards
specified in the applicable administrative rules of the state which shall
consider and use the design and construction specifications as set forth in the
Guidelines for Design and Construction of Health Care Facilities published by
the American Institute of Architects.
(46) "Pediatric cardiac catheterization"
means the performance of angiographic, physiologic, and as appropriate,
therapeutic cardiac catheterization on children fourteen (14) years of age or
younger.
(47) "Person", as defined
at O.C.G.A. §
31-6-2(29), means
any individual, trust, or estate, partnership, limited liability company or
partnership, corporation (including associations, joint-stock companies and
insurance companies), state, political subdivision, hospital authority, or
instrumentality (including a municipal corporation) of a state as defined in
the laws of this State. This term shall include all related parties, including
individuals, business corporations, general partnerships, limited partnerships,
limited liability companies, limited liability partnerships, joint ventures,
nonprofit corporations, or any other for profit or not for profit entity that
owns or controls, is owned or controlled by, or operates under common ownership
or control with a person.
(48)
"Personal Care Home", as defined at O.C.G.A. §
31-6-2(30), means
a residential facility that is certified as a provider of medical assistance
for Medicaid purposes pursuant to Article 7 of Chapter 4 of Title 49 having at
least twenty-five (25) beds and providing, for compensation, protective care
and oversight of ambulatory, non-related persons who need a monitored
environment but who do not have injuries or disabilities which require chronic
or convalescent care, including medical, nursing, or intermediate care.
Personal care homes including those facilities which monitor daily residents'
functioning and location, have the capability for crisis intervention, and
provide supervision in areas of nutrition, medication, and provision of
transient medical care. Such term does not include:
(a) Old age residences which are devoted to
independent living units with kitchen facilities in which residents have the
option of preparing and serving some or all of their own meals; or
(b) Boarding facilities that do not provide
personal care.
(49)
"Primary campus" means the building at which the majority of a hospital's or a
remote location of a hospital's licensed and operational inpatient hospital
beds are located, and includes the health care facilities of such hospital
within 1,000 yards of such building. Any health care facility operated under a
hospital's license prior to July 1, 2019, but not on the hospital's primary
campus shall remain part of such hospital but shall not constitute such
hospital's primary campus unless otherwise meeting the requirements of this
paragraph.
(50) "Project", as
defined at O.C.G.A. §
31-6-2(31), means
a proposal to take an action for which Certificate of Need review is required
under these Rules. A project or proposed project may refer to the proposal from
its earliest planning stages up through the point at which the new
institutional health service is offered. In accordance with the definition of
"associated with and simultaneously developed or proposed", the Department
shall consider simultaneous activities, including, but not limited to,
construction, remodeling, development, and acquisitions, unless expressly not
included by other provisions of these Rules, which are determined by the
Department to be associated with one another, to be a single project.
(51) "Remote location of a hospital" means a
hospital facility or organization that is either created by, or acquired by, a
hospital that is the main provider for the purpose of furnishing inpatient
hospital services under the name, ownership, and financial and administrative
control of the main provider.
(52)
"Rural county" means a county having a population of less than 50,000 according
to the United States decennial census of 2010 or any future such
census.
(53) "Service-specific
Rule" means those rules that are part of Ga. Comp. R. & Regs. r. 111-2-2
that regard specific clinical health care services as outlined at Ga. Comp. R.
& Regs. r.
111-2-2-.20 et seq.
(54) "Single specialty ambulatory surgical
center" means an ambulatory surgical center where surgery is performed in the
offices of an individual private physician or single group practice of private
physicians if such surgery is performed in a facility that is owned and
operated by the individual private physician or single group practice of
private physicians who are also of a single specialty; such ambulatory surgical
center shall only be utilized by physicians who are of the same single
specialty, who may include physicians who are not owners or employees of the
individual private physician or single group practice of private physicians
that own and operate the center; provided, however, that general surgery, a
group practice which includes one or more physiatrists who perform services
that are reasonably related to the surgical procedures performed in the center,
and a group practice in orthopedics which includes plastic hand surgeons with a
certificate of added qualifications in Surgery of the Hand from the American
Board of Plastic and Reconstructive Surgery shall be considered a single
specialty. Nothing in this paragraph shall prohibit an individual private
physician or a single group practice of private physicians from entering into
an arrangement with an outside entity for practice management, administrative
services, or both.
(55) "Skilled
nursing facility", as defined at O.C.G.A. §
31-6-2(34), means
a public or private institution or a distinct part of an institution which is
primarily engaged in providing inpatient skilled nursing care and related
services for patients who require medical or nursing care or rehabilitation
services for the rehabilitation of injured, disabled, or sick
persons.
(56) "Specialty hospital"
means a hospital that is primarily or exclusively engaged in the care and
treatment of one of the following: patients with a cardiac condition, patients
with an orthopedic condition, patients receiving a surgical procedure, or
patients receiving any other specialized category of services defined elsewhere
in these Rules. A "specialty hospital" does not include a destination cancer
hospital or a general cancer hospital.
(57) "State health plan", as defined at
O.C.G.A. §
31-6-2(36), means
a comprehensive program based on recommendations by the Health Strategies
Council and the board, approved by the Governor, and implemented by the State
of Georgia for the purpose of providing adequate health care services and
facilities throughout the State. The State Health Plan is divided into a series
of component plans. The Department shall review and update the state health
plan at least every five years beginning no later than January 1, 2025, to
ensure the plan meets the evolving needs of the state.
(58) "Substantial equivalent of a project"
means a proposal to take an action for which a letter of determination is
sought under these Rules. A substantial equivalent of a project may refer to
the proposal from its earliest planning stages up through the point at which
the service is offered. In accordance with the definition of "associated with
and simultaneously developed or proposed", the Department shall consider
simultaneous activities, including, but not limited to, construction,
remodeling, development, and acquisitions, unless expressly not included by
other provisions of these Rules, which are determined by the Department to be
associated with one another, to be a single substantial equivalent of a
project.
(59) "Threshold" means the
dollar amount of capital expenditures.
(a) In
calculating the dollar amounts of a proposed project for purposes of
111-2-2-.01(54) and
(36) of these Rules, the capital costs of all
items subject to review by these Rules and items not subject to review by these
Rules associated with and simultaneously developed or proposed with the project
shall be counted;
(b) The following
threshold amounts are effective as of July 1, 2024:
1.
Reserved;
2.
Reserved;
3. The physician-owned, single-specialty,
office-based ambulatory surgery center threshold of Ga. Comp. R. & Regs. r.
111-2-2-.01(54) is
$2.5 million;
4. The joint venture
ambulatory surgical center threshold of Ga. Comp. R. & Regs. r.
111-2-2-.01(36) is
$5 million;
With respect to (b)3. and 4. above, beginning on July 1,
2009, the Department shall update or adjust this CON threshold amount by the
annual percentage of change in an appropriate composite price index that, in
the judgment of the Department, represents national construction prices for the
preceding calendar year such as those published by the Department of Commerce
of the United States government or other government agency;
Diagnostic or other imaging services that are not offered in
a hospital or in the offices of an individual private physician or single group
practice of physicians exclusively for use on patients of that physician or
group practice shall be deemed to be a new institutional health service
regardless of the cost of the equipment except as provided in O.C.G.A. §
31-6-47 AND Ga. Comp. R. &
Regs. 111-2-2-.03 and
exclusive of the expenditure or commitment of or incurring an obligation for
the expenditure of funds to develop Certificate of Need applications, studies,
reports, schematics, preliminary plans and specifications or working drawings,
or to acquire sties.
(c) For purposes of computing the capital
expenditure threshold of the physician-owned, single specialty ambulatory
surgical center threshold of Ga. Comp. R. & Regs. r.
111-2-2-.03(21) and
the joint venture ambulatory surgical center threshold of Ga. Comp. R. &
Regs. r.
111-2-2-.03(22),
the Department shall include, but not be limited to, the following guidelines:
1. Pursuant to the definition of "associated
with and simultaneously developed or proposed", the total cost of all
associated capital expenditures for items to be obligated for or purchased
within a six (6) month period for a single program, service, plan, or project,
regardless of whether or not the cost of any individual item is in excess of
the capital expenditure threshold and regardless of whether or not the
expenditure or item is otherwise reviewable under these Rules or the CON
Statute, is included in the computation;
2. The cost of depreciable equipment that is
not used for diagnosis or treatment, such as office equipment, usual business
equipment, and office and waiting room furniture, is included in the
computation, if such items are associated with and simultaneously developed or
proposed with the project. If such furnishing and equipment are used, the cost
that shall be used in calculating the threshold shall be the depreciated value
or current market value of the furnishings or equipment, whichever is
greater;
3. The cost of normal
inventories of supplies, such as glassware, chemicals, drugs, linens, and
paper, is exempt from the computation as an operating expense;
4. The value of the facilities to be acquired
by lease, gift, donation or other means is based on a current (within six (6)
months) appraisal of the facility, except that the value of newly constructed
facilities shall be based on the actual square footage cost to construct the
facility;
5. For facilities that
are acquired by lease, the computation of value shall be based on the rentable
square footage of the facility and not the useable square footage.
Notwithstanding this Rule, lease payments shall be considered to be operating
expenses for leases other than capital leases;
6. For facilities that are only partly
occupied by a person, the computation shall include a pro-rata share of the
value of the common space, unless the rentable square footage is provided as
required by 5. above and that rentable square footage already includes an
allocation for common space, as documented by the lease agreement;
and
7. In the case of a gift or
donation, the value of equipment, furnishings or facilities is the fair market
value of the equipment, furnishings, or facilities;
(d) For purposes of computing the equipment
threshold Ga. Comp. R. & Regs. r.
111-2-2-.01(42)(f),
the Department shall include, but not be limited to, the following guidelines:
1. The cost of diagnostic, therapeutic, or
other imaging equipment includes all capital costs, expenditures, charges, fees
and assessments which are reasonably necessary to put the equipment into use
for the purposes for which the equipment was intended, including but not
limited to the following expenses:
(i) Any
expense incurred for the purchase of a warranty on the diagnostic, therapeutic,
or other imaging equipment from the manufacturer or vendor for the first five
years of operation;
(ii) Any
expense incurred for operator training;
(iii) Any expense incurred for installation
and assembly of the equipment;
(iv)
Any expense incurred for transportation and insurance costs pertaining to the
purchase and/or delivery of the equipment;
(v) Any expense incurred for functionally
related diagnostic, therapeutic or other imaging equipment, such as, but not
limited to, water chillers, surge protectors, laser cameras, computer
workstations, etc.
(vi) Any expense
incurred for any options, extra packages, or accessories to be used in the
operation of the equipment;
(vii)
Any expense incurred for RF shielding, lead shielding, magnetic shielding
necessary to protect patients or staff in the operation of the
equipment;
(viii) Any dollar amount
attributable to service contracts for the first five (5) years of
operation;
(ix) Any dollar amount
attributable to volume or bulk purchase discounts given to the party requesting
a letter of determination by the manufacturer or vendor of the
equipment;
(x) For mobile units of
equipment, expenditures and values associated with the motor coach, trailer,
van, rig, or other form of modular or transitional housing shall be included in
the computation of the threshold;
2. The acquisition by whatever means of one
or more items of functionally related diagnostic, therapeutic, other imaging
equipment shall be considered as one project. The acquisition of functionally
related accessories shall also be counted. Pursuant to the definition of
"functionally related diagnostic, therapeutic, or other imaging equipment", any
individual components or pieces of diagnostic, therapeutic, or other imaging
equipment, which depend on one another in order to function and that are
purchased within a six (6) month period, shall be considered in the aggregate
in calculating the threshold;
3.
Diagnostic, therapeutic, or other imaging equipment shall include single and
multiple units of equipment, if such units are associated with and
simultaneously developed or proposed with one another. Pursuant to the
definition of "associated with and simultaneously developed or proposed", the
Department may determine that individual pieces or units of diagnostic,
therapeutic, or other imaging equipment are associated with one another if such
pieces or units of equipment are used for the same or similar health services
and if such pieces or units of equipment are developed, proposed, or acquired
simultaneously. Such associated and simultaneous units purchased within a six
(6) month period shall be aggregated to calculate the threshold;
4. Purchase or lease shall include purchases,
contracts, encumbrances of funds, lease arrangements, conditional sales or a
comparable arrangements that purport to be a transfer of ownership in whole or
in part;
5. In the case of a lease,
loan, or gift, the value of the diagnostic, therapeutic, or other imaging
equipment is the fair market value of the diagnostic, therapeutic, or other
imaging equipment, as evidenced by documentation from a reputable vendor or
manufacturer.
(60) "Uncompensated indigent or charity care"
means the dollar amount of "net uncompensated indigent or charity care after
direct and indirect (all) compensation" as defined by, and calculated in
accordance with, the Department's Hospital Financial Survey and related
instructions.
(61) "Urban county"
means a county having a population equal to or greater than 50,000 according to
the United States decennial census of 2010 or any future such census.