Compilation of Rules and Regulations of the State of Georgia
Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH
Chapter 111-2 - HEALTH PLANNING
Subject 111-2-2 - CERTIFICATE OF NEED
Rule 111-2-2-.07 - Review Procedures
Universal Citation: GA Rules and Regs r 111-2-2-.07
Current through Rules and Regulations filed through March 20, 2024
(1) Beginning of Review Process.
(a) When an application is deemed by the
Department to be complete, the Department shall provide written notice to the
applicant of the completeness of the application and the schedule for review.
The Department shall provide similar notice to a newspaper of general
circulation in the county of the project, to the appropriate Regional
Development Center, and to the chief elected official of the county and
municipal government, if any, within whose boundaries the proposed project
would be located. The date on the letter of notification shall be deemed to be
the date of notification and the beginning date of the Certificate of Need
review cycle.
(b) The Department
will schedule reviews so that, unless joined with another application, no
review shall, except as noted in (d) below, take longer than one hundred and
twenty (120) days from the date of notification of the beginning of review
until the date the decision to issue or not to issue a Certificate of Need is
sent electronically to the applicant. Absent good cause, the Department
generally will not issue a decision prior to the sixtieth (60th) day of the
review cycle.
(c) In the event
that, from the time an application is declared complete until thirty (30) days
thereafter, one or more additional applications are declared complete which
involve similar projects in the same or overlapping service areas, the
Department may declare that such applications will be joined with the first
application for review purposes. Following such joinder, none of the subsequent
applications so joined may be considered as a first application for purposes of
future joinder. The Department shall notify all applicants whose applications
have been joined and shall set a new time parameter for Department actions. The
one hundred and twenty (120) day final decision deadline shall run from the
latest date that any one of the joined applications was declared complete for
review. Except as otherwise provided in Ga. Comp. R. & Regs. r.
111-2-2-.08(1),
such joinder shall be the sole method of comparative review for all
applications filed after July 1, 2008.
(d) Where the Department determines that
conditions exist which make it impractical to complete a review in one hundred
and twenty (120) days, the Department may, on notification to the applicant,
extend the time limit another thirty (30) days to one hundred and fifty (150)
days. Conditions, including but not limited to the following, may constitute
cause for extending the time:
1. The
Department anticipates issuance of new demographic or utilization, data
affecting the application;
2. The
Department has received conflicting or contradictory information necessitating
further investigation;
3. Results
of impending legal action may have an effect on the application.
(e) For good cause shown, as shall
be determined by the Department, a public hearing will be held at a time and
location specified by the Department.
1. A
request for a public hearing shall be signed by at least fifty (50) residents
of the area where the project is located and must be received by the Department
within twenty (20) days after the beginning date of the review cycle. The
request shall include justification for the public hearing based on
circumstances described in this paragraph.
2. To the extent possible, notification will
be provided in a newspaper of general circulation in the area where the project
is located approximately two weeks in advance of the hearing.
3. Any person desiring to offer testimony at
the hearing will be given the opportunity to do so, but the providing of such
testimony or evidence shall not confer upon the person or persons so testifying
the status of "party" as that term is used in the Administrative Procedure
Act.
4. Where distance and the
nature of the project warrant, and within the budget constraints of the
Department, the public hearing may be held by the Department in the area where
the project is proposed to be located. Circumstances, which may indicate good
cause for a hearing in the area, include but are not limited to:
(i) Projects, which could have significant
effect on access to frequently used services by a sizable population
group;
(ii) Projects generating
strong conflicting viewpoints by the residents of an area;
(iii) Projects with potential for unusually
significant impact on existing services.
5. A summary report of the hearing will be
prepared, a copy of which will be sent to the party requesting the hearing and
to the applicant. Such report will be made a part of the master record
regarding the project. The Department may charge a fee for the summary
report.
(f) If during the
first two (2) months of the review of the application the Department finds
there are factors that create a potential for denial of the application, the
Department shall, on or before the sixtieth (60th) day of the review period,
provide the applicant an opportunity to meet with the Department. The problems
with the application will be described and an opportunity offered to amend or
to withdraw the application or to submit additional information. The sixty (60)
day meeting with the applicant(s) is restricted to the Department and the
applicant(s). Parties opposing an application(s) may not attend or participate
in an applicant sixty (60) day meeting. Such addition information must be
submitted prior to the seventy-fifth (75th) day of the review period.
1. "Additional information" is information
and data submitted in response to a direct request from the Department at the
meeting afforded an applicant after the first two (2) months of the review of
the application or in response to issues and concerns raised by the Department
in said meeting, or in the lack of such a meeting or request by the Department,
information and data submitted consistent with the scope, physical location,
cost, charges, service, and owners in the originally submitted application.
Additional information must be submitted to the Department prior to the
seventy-fifth (75th) day of the review period;
2. "Amendment" is a revision to the
additional information or application as originally submitted that is submitted
to the Department no later than the one hundred and tenth (110th) day of the
review cycle and that constitutes a change in scope, physical location, cost,
charge, service, or owner. The following changes in an application will qualify
as an amendment:
(i) A reduction or increase
in the proposed physical space capacity; or
(ii) A reduction or increase in the number of
proposed beds or service units (e.g., operating rooms); or
(iii) A change in the owners of the legal
applicant entity, as long as the legal applicant entity remains the same;
or
(iv) A reduction or increase in
a proposal's capital or operating costs; or
(v) A change in site within three (3) miles
of the site proposed in the original application or within the same service
area as long as the population to be served and the service area to be served
is not substantially different from that originally proposed as long as the
proposed change does not require the application of a new need study or
different rules; or
(vi) A
reduction or subtraction in the scope of the original application; or
(vii) A change in the amount of commitment to
indigent or charity care, projected utilization, financial information or
patient charges that do not alter the basic financing or operations of the
proposed project.
(g) The Department shall be notified with
either a new application or written amendment to the current completed
application when there are changes in the scope, physical location, cost,
charges, service or owners of the applicant entity. Any revisions that
constitute a total change in or addition to the scope of an application, in the
location (except for the exemption in Ga. Comp. R. & Regs. r.
111-2-2-.07(1)(f)
2.(v)), or in the legal applicant that would
require the submission of a new application. If the Department determines that
the amendment constitutes a total change in either the scope, location, or
legal applicant, the original application will be considered to be withdrawn
and the applicant will be so notified. An application may be amended by the
applicant at any time up to the one hundred and tenth (110th) day of the review
cycle.
(g.1) No party may oppose an
application for a Certificate of Need for a proposed project unless:
1. Such party offers substantially similar
services as proposed within a 35 mile radius, in Georgia, of the proposed
project or has a service area in Georgia that overlaps the applicant's proposed
service area; or
2. Such party has
submitted a competing application in the same batching cycle and is proposing
to establish in Georgia the same type of facility proposed or offers, in
Georgia, substantially similar services as proposed and has a service area
located in Georgia that overlaps the applicant's proposed service
area.
(h) Any party,
pursuant to O.C.G.A. §
31-6-43(d)(2),
who is permitted to oppose an application, or an application(s) joined for
review, must submit a notice of opposition, on the form provided by the
Department, no later than the sixtieth (60th) day of the review cycle. The
notice must contain the information specified by the form. The notice of
opposition form submission shall also include one signed original of the
written vendor lobbyist certification required by Ga. Comp. R. & Regs. r.
111-1-2-.03(2). The
notice of opposition must not contain the substantive arguments against a
particular application.
1. Those parties who
are opposed to an application will be given an opportunity to meet with the
Department at a time and place specified by the Department after a review of
the opposition notices. The opposition meeting provided for by O.C.G.A. §
31-6-43(h), shall
be held no earlier than the ninetieth (90th) day of the review cycle. The
applicant(s) shall be entitled to attend the opposition meeting. Only one
designated person on behalf of each party opposed to a particular application
will be allowed to speak on behalf of the opposition to said application at the
opposition meeting. The time period provided for the opposition spokesperson
shall be determined in the sole discretion of the Department. The applicant(s)
will not be allowed to speak in rebuttal of the opposition remarks at the
opposition meeting. The Department shall make no formal substantive comments
regarding the review of the application(s) at the opposition meeting. The
opposition parties shall submit via the Department's web portal, substantive
written comments and arguments regarding the nature of their opposition to the
particular project. The opposition parties must provide one copy of the
substantive opposition comments to the applicant at the opposition meeting. In
order for an opposing party to have standing to appeal an adverse decision
pursuant to O.C.G.A. §
31-6-44, such party must attend
and participate in an opposition meeting. Substantive opposition comments must
pertain to only one application and one applicant. In no case shall the
Department accept substantive opposition comments that concern multiple
applicants or applications.
2.
Letters of support for a particular application must be submitted pursuant to
and in compliance with Ga. Comp. R. & Regs. r.
111-2-2-.06(6) via
the Department's web portal, and can be submitted no later than the one
hundredth (100th) day of the review cycle.
3. Applicants shall be given the opportunity
to respond to the substantive opposition comments made orally and submitted in
writing at the opposition meeting. The last day for the applicant(s) to submit
final amendments to the application and/or to respond to the opposition meeting
comments shall be the one hundred and tenth (110th) day of the review cycle.
The Department reserves the right, but is not required to, ask the applicant(s)
for information in response to the substantive opposition comments. If the
Department asks the applicant for information as a result of the comments
provided at the opposition meeting, the applicant must submit the information
requested no later than the one hundred and tenth (110th) day of the review
cycle.
4. The Department shall
provide written notification of its decision to issue or deny a Certificate of
Need no later than the one hundred and twentieth (120th) day of the review
cycle, or, if the project was extended, no later than the one hundred and
fiftieth (150th) day of the review cycle.
(i) The Department, in accordance with the
provisions of subsections (k)-(m) below, will give special expedited
consideration to emergency expenditures required solely to cope with a
situation posing an immediate threat to the health and safety of patients,
visitors, or staff. The General Counsel, or his designee, upon a showing that a
proposed replacement facility is critical to the welfare, health and stability
of the immediate community as evidenced by written support from the local,
county and state governing bodies may, authorize an expenditure based on a
request by telephone, with written documentation to be provided later. In the
event that the authorized emergency expenditure requires an application to
replace an existing health care facility, the application will not be subject
to joinder.
"Emergency expenditures" as set forth in this subparagraph (i) shall include but not be limited to expenditures necessitated by circumstances arising from an authorized hazardous condemnation as well as from acts of God including but not limited to earthquakes, hurricanes, tornados or floods.
(j) The Department
will decline to review through Certificate of Need application capital
expenditures that do not reach the dollar threshold as required under the
Certificate of Need program, provided the person proposing such expenditure
receives from the Department a prior written authorization for the expenditure.
Where a proposal is considered to meet the language of this subsection, a
letter describing the reasons for the expenditure, the cost and the anticipated
date the expenditure is proposed to be made should be submitted to the
Department, in accordance with the provisions of Ga. Comp. R. & Regs. r.
111-2-2-.10, prior to the obligation
of such funds. If, in the opinion of the Department, the expenditure is
consistent with those expenditures not subject to review the Department will
issue a confirmation to the requestor, which shall serve as authorization for
the expenditure;
(k) Pursuant to
the provisions of O.C.G.A. §
31-6-43(g), the
Department shall conduct an expedited review with a review period of no longer
than (30) thirty days for those projects deemed an emergency. When the Governor
has declared a state of emergency in a region of the state, existing health
care facilities in the affected region may seek emergency approval from the
Department to make expenditures in excess of the capital expenditure threshold
or to offer services that may otherwise require a Certificate of Need. The
Department shall give special expedited consideration to such requests and may
authorize such requests for good cause. Once the state of emergency has been
lifted, any services offered by an affected health care facility under this
subsection shall cease to be offered until such time as the health care
facility that received the emergency authorization has requested and received a
Certificate of Need. For purposes of this subsection, "good cause" means that
authorization of the request shall directly resolve a situation posing an
immediate threat to the health and safety of the public.
(l) The Department shall issue a decision on
applications for a Certificate of Need for emergency projects as provided in
subsection (k) above, no later than thirty (30) days after the application has
been deemed complete for review; failure to issue the decision on or before the
thirtieth (30th) day after it has been deemed complete for review shall result
in an automatic approval of the application, subject to subsection (n) below;
the decision issued by the Department shall be a summary statement of the
findings during the review of the project;
(m) If, during the course of the review
period, the Department finds that there are factors that create the potential
for denial of the application, the Department shall immediately discontinue its
emergency review, notify the applicant in writing of that decision, and review
the application in accordance with the applicable non- emergency review
procedures set forth in Ga. Comp. R. & Regs. r.
111-2-2-.07.
(n) The review of such projects as outlined
in subsections (k) - (m) above shall be governed by the emergency provisions of
the referenced subsections and not the provisions of subsections (a) - (h)
above.
(o) The filing fee for
applications of the type specifically listed in subsections (k) - (n) above
shall be $1,000.00, notwithstanding the filing fee provisions of Ga. Comp. R.
& Regs. r.
111-2-2-.06(4)(a).
(2) Department Review.
(a) In reviewing the
application, the Department will take into consideration the review
considerations and policies provided in Ga. Comp. R. & Regs. r.
111-2-2-.09. The latest applicable
data from official data sources will be used in the Department analysis, unless
otherwise provided by a service-specific Rule. Such data sources will include,
but not be limited to, the State Office of Planning and Budget,
Medicare/Medicaid Cost Reports, and questionnaires or surveys initiated by the
Department.
(b) Upon completion of
review, the Department shall provide written notification of its decision to
issue or deny a Certificate of Need. In the event of a favorable decision, the
letter shall serve as the Certificate.
1. Such
decision will be issued no later than one hundred twenty (120) days from the
beginning of the review period unless the total review period is extended in
accordance with Ga. Comp. R. & Regs. r.
111-2-2-.07(1)(d).
2. The date of the decision shall be the date
on the notification letter of the Department.
(c) The decision letter shall contain at
least the following:
1. A detailed statement
of the findings related to each applicable consideration and standard relevant
to the decision to issue or deny a Certificate of Need; and
2. Information pertaining to the availability
of an appeal hearing.
(d)
The decision shall be to approve or deny the application as submitted or as
amended by the applicant during the course of review.
(e) A copy of the notification will be sent
to the applicant or, in the case of joined applications, to all applicants, to
the appropriate Regional Development Center and to the chief elected official
of the applicable county and municipal government, if any. A copy may be made
available to other interested persons on request.
(f) Should the Department fail to issue a
decision letter on a Certificate of Need application within the time limits set
forth in these Rules, the application shall be deemed approved as of the one
hundred and twenty-first (121st) day, or the one hundred fifty-first (151st)
day if the review period was extended pursuant to Ga. Comp. R. & Regs. r.
111-2-2-.07(1)(d),
following the date of notice from the Department that an application, or the
last of any applications joined pursuant to Ga. Comp. R. & Regs. r.
111-2-2-.07(1)(c)
was declared complete for review.
(g) Appeals of the decision of the Department
shall be processed in accordance with rules promulgated by the Certificate of
Need Appeal Panel found in Ga. Comp. R. & Regs. Chapter 274.
(h) When a project undergoes judicial review,
the Department may stay the effective date of the CON pending the outcome of
the judicial review upon appropriate terms for good cause shown.
O.C.G.A. §§ 31-2et seq., 31-6et seq.
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