Ga. Comp. R. & Regs. R. 111-2-2-.09 - General Review Considerations
(1)
General Considerations. The burden of proof for producing information and
evidence that an application is consistent with the applicable considerations
and review policies, which follow, shall be on the applicant. In conducting
review and making findings for Certificates of Need, the Department will
consider whether:
(a) the proposed new
institutional health services is reasonably consistent with the relevant
general goals and objectives of the State Health Plan. The goals and objectives
related to issues and addressed in the State Health Plan, which are relevant to
the Certificate of Need proposal, will be considered in the review. It should
be recognized that the goals of the State Health Plan express the ideal and, in
some respects, may be incompatible with the concept of cost containment. The
statutes and Rules represent the final authority for review decisions and the
content of the Plan, or any component thereof shall not supersede the Rules in
such determination;
(b) the
population residing in the area served, or to be served, by the new
institutional health service has a need for such services;
1. Population projections used by the
Department will be resident population figures prepared or approved by the
Office of Planning and Budget or other official figures that may be applicable
as determined by the Department.
2.
Updated resident population projections will be utilized upon the official
effective date as stated by the Department, pursuant to these Rules, replacing
and superseding the older data.
3.
The projection period or horizon year for need determinations will be five
years for hospital services and three years for all other services, unless
otherwise provided by the Rules for the specified service. The projection
period or horizon year will be advanced to the next projection year or horizon
year on or about April 1 of each year.
4. Inpatient facilities will be inventoried
on the basis of bed capacity approved, grandfathered, or authorized through the
Certificate of Need process regardless of the number of beds in operation at
any given time or which may be licensed by the Healthcare Facility Regulation
Division.
5. Data sources to be
utilized by the Department to evaluate need, population characteristics,
referral patterns, seasonal variations, utilization patterns, financial
feasibility, and future trends will include, but not be limited to, the
following:
(i) any surveys required by the
Department, including but not limited to those for hospitals, nursing
facilities, home health agencies, specialized services, and ambulatory surgery
facilities;
(ii) Cost reports
submitted to fiscal intermediaries and the Department;
(iii) periodic special studies or surveys, as
produced or formally adopted or used by the Department;
(iv) the United States Census and other
studies conducted by the Census and other Federal and State agencies and
bureaus, including but not limited to, the Department of Labor; and
(v) such other data sources utilized by the
Department for measurement of community health status. Such data may include
information submitted by the applicant pursuant to Ga. Comp. R. & Regs.
111-2-2-.06(2)(f),
which may be necessary for the Department to ensure that the project is
consistent with applicable general consideration provisions.
6. All data used by the Department
in a Certificate of Need review will be available to the applicant on request,
in accordance with Department policies on requested information. The most
recent data reported and validated will be used in the analysis of a
proposal.
(c) existing
alternatives for providing services in the service area the same as the new
institutional health service proposed are neither currently available,
implemented, similarly utilized, nor capable of providing a less costly
alternative, or no Certificate of Need to provide such alternative services has
been issued by the Department and is currently valid
1. The Department supports the concept of
regionalization of those services for which a service-specific Rule
exists.
2. The Department shall
consider economies of scale where need exists for additional services or
facilities.
3. Utilization of
existing facilities and services similar to a proposal to initiate services
shall be evaluated to assure that unnecessary duplication of services is
avoided. Where there exists significant unused capacity, initiating a similar
service in another health care facility would require strong justification
under other criteria.
(d)
the project can be financed adequately and is in the immediate and long term,
financially feasible;
(e) the
effects of the new institutional health service on payors for health services,
including governmental payors, are reasonable;
(f) the costs and methods of a proposed
construction project, including the costs and methods of energy provision and
conservation, are reasonable and adequate for quality health care. Construction
plans will be reviewed in detail to assure that space is designed economically.
Space shelled-in for some future use will not be accepted unless the applicant
demonstrates that the shelled-in space will not be directly related to the
provision of any clinical health service;
(g) the new institutional health service
proposed is reasonably financially and physically accessible to the residents
of the proposed service area and will not discriminate by virtue of race, age,
sex, handicap, color, creed or ethnic affiliation;
1. In accordance with the provision found in
O.C.G.A. §
31-6-42(7), the
Department will evaluate the extent to which each applicant applying for a
Certificate of Need participates in a reasonable share of the total community
burden of care for those unable to pay. This provision shall not apply to
applicants for life plan communities, skilled nursing facilities or units, and
to projects that are reviewed by the Department on an emergency basis in
accordance with Ga. Comp. R. & Regs. r.
111-2-2-.07(1)(k).
In all other instances, the following indicators will be evaluated:
(i) administrative policies and directives
related to acceptance of indigent, medically indigent, and Medicaid
patients;
(ii) policies relating
medical staff privileges, if applicable, to reasonable acceptance of emergency
referrals of Medicaid and PeachCare patients and all other patients who are
unable to pay all or a portion of the cost of care;
(iii) evidence of specific informational
efforts targeted toward patients regarding arrangements for satisfying
charges;
(iv) documented records of
refunds, if any, received from the Federal, State, county, city, philanthropic
agencies, donations, and any other source of funds other than from direct
operations, such as indigent care trust fund distributions and disproportionate
share payments, if applicable;
(v)
the applicant's commitment to participate in the Medicare/Medicaid and
PeachCare programs; to provide legitimate emergency care, if applicable,
regardless of ability to pay; and to provide indigent and charity care;
and
(vi) documented records of care
provided to patients unable to pay, Medicare and Medicaid contractual
adjustment, Hill-Burton payments (if applicable), other indigent care, and
other itemized deductions from revenue including bad debt. Such records shall
demonstrate that the levels of care provided correspond to a reasonable
proportion of those persons who are medically or financially indigent and those
who are eligible for Medicare or Medicaid within the service area.
2. The evaluation in 1. above is
in addition to satisfaction of a minimum indigent and charity care commitment
required by prior CON(s), if any.
(h) the proposed new institutional health
service has a positive relationship to the existing health care delivery system
in the service area;
(i) the
proposed new institutional health service encourages more efficient utilization
of the health care facility proposing such service;
(j) the proposed new institutional health
service provides, or would provide a substantial portion of its services to
individuals not residing in its defined service area or the adjacent service
area;
(k) the proposed new
institutional health service conducts biomedical or behavioral research
projects or new service development that is designed to meet a national,
regional, or statewide need;
(l)
the proposed new institutional health service meets the clinical needs of
health professional training programs;
(m) the proposed new institutional health
service fosters improvements or innovations in the financing or delivery of
health services; promotes health care quality assurance or cost effectiveness;
or fosters competition that is shown to result in lower patient costs without a
significant result in lower patient costs without a significant deterioration
in the quality of care;
(n) the
proposed new institutional health service fosters the special needs and
circumstances of Health Maintenance Organizations;
(o) the proposed new institutional health
service meets the Department's minimum quality standards, including, but not
limited to, standards relating to accreditation, minimum volumes, quality
improvements, assurance practices, and utilization review procedures;
(p) the proposed new institutional health
service can obtain the necessary resources, including health care management
personnel; and
(q) the proposed new
institutional health service is an underrepresented health service, as
determined annually by the Department. The Department shall, by rule, provide
for an advantage to equally qualified applicants that agree to provide an
underrepresented service in addition to the services for which the application
was originally submitted.
(3)
General Cancer Hospital
(a) On and after July 1, 2019, a destination
cancer hospital may apply for a letter of determination in accordance with
O.C.G.A. §
31-6-40(a)(8).
(b) Upon its receipt of a complete
application for a destination cancer hospital to convert to a general cancer
hospital, the Department shall issue such determination within 60
days.
(c) Upon the conversion of a
destination cancer hospital to a general cancer hospital:
1. The general cancer hospital may continue
to provide all institutional health care services and other services it
provided as of the date of such conversion, including but not limited to
inpatient beds, outpatient services, surgery, radiation therapy, imaging, and
positron emission tomography (PET) scanning, without any further approval from
the Department;
2. The destination
cancer hospital shall be classified as a general cancer hospital under this
chapter and shall be subject to all requirements and conditions applicable to
hospitals under this article, including but not limited to, indigent and
charity care and inventories and methodologies to determine need for additional
providers or services; and
3. The
hospital's inpatient beds, operating rooms, radiation therapy equipment, and
imaging equipment existing on the date of conversion shall not be counted in
the inventory by the Department for purposes of determining need for additional
providers or services, except that any inpatient beds, operating rooms,
radiation therapy equipment, and imaging equipment added after the date of
conversion shall be counted in accordance with the Department's rules and
regulations.
(d) In the
event that a destination cancer hospital does not convert to a general cancer
hospital, it shall remain subject to all requirements and conditions applicable
to destination cancer hospitals under this article.
(4) In the case of applications for basic
perinatal services in counties where:
(a) Only
one civilian health care facility or health system is currently providing basic
perinatal services; and
(b) There
are not at least three (3) different health care facilities in a contiguous
county providing basic perinatal services, the Department shall not apply the
consideration contained in paragraph (b) of section (1) of this Rule.
(5)
Osteopathic
Considerations. When an application is made for a Certificate of Need to
develop or offer a new institutional health service or health care facility for
osteopathic medicine, the need for such facility shall be determined on the
basis of the need and availability in the community for osteopathic services
and facilities. Nothing in this chapter shall, however, be construed as
recognizing any distinction between allopathic and osteopathic
medicine.
(6)
Minority-Administered Hospital Considerations. If the denial of an
application for a Certificate of Need for a new institutional health service
proposed to be offered or developed by a minority-administered hospital serving
a socially and economically disadvantaged minority population in an urban
setting, or by a minority-administered hospital utilized for the training of
minority medical practitioners, would adversely impact upon the facility and
population served by said facility, the special needs of such hospital facility
and the population to be served by said facility for the new institutional
health service shall be given extraordinary consideration by the Department in
making its determination of need. The term "minority-administered" means a
hospital controlled or operated by a governing body or administrative staff
composed predominantly of members of a minority race. The Department shall have
the authority to vary or modify strict adherence to the provisions of Code
Chapter 31-6-42(c) and this Chapter in considering the special needs of said
facility and its population served and to avoid an adverse impact on the
facility and the population served thereby.
(7)
Considerations for Joined
Applications.
(a) In evaluating joined
applications, if the services proposed are found to be needed, and if any or
all applications equally meet the statutory considerations, priority
consideration will be given to a comparison of the applications with regard to:
1. the past and present records of the
facility, and other existing facilities in Georgia, if any, owned by the same
parent organization, regarding the provision of service to all segments of the
population, particularly including Medicare, Medicaid, minority patients and
those patients with limited or no ability to pay;
2. specific services to be offered;
3. appropriateness of the site, i.e., the
accessibility to the population to be served, availability of utilities,
transportation systems, adequacy of size, cost of acquisition, and cost to
develop;
4. demonstrated readiness
to implement the project, including commitment of financing;
5. patterns of past performance, if any, of
the applicants in implementing previously approved projects in timely
fashion;
6. past record, if any, of
the applicant facility, and other existing facilities owned by the same parent
organization, if any, in meeting licensure requirements and factors relevant to
providing accessible, quality health care;
7. evidence of attention to factors of cost
containment, which do not diminish the quality of care or safety of the
patient, but which demonstrate sincere efforts to avoid significant costs
unrelated to patient care;
8. past
compliance, if any, with survey and post-approval reporting requirements and
indigent and charity care commitments;
9. hospital and physician collaborations that
promote greater cost efficiency to patients, ensure greater quality assurance
outcomes and foster positive relationships within the existing healthcare
delivery network which benefits both providers and members within the impacted
service area population; and
10.
proposed services that include or involve a clinical healthcare service that is
or has been underrepresented in the proposed service area for more than twelve
(12) months as evidenced by geographical barriers to the service, insufficient
staffing to provide the service and/or recent termination of the service in the
proposed planning area.
Notes
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