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

Current through Rules and Regulations filed through June 27, 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).