08 SB433/AP
Senate
Bill 433
By:
Senators Williams of the 19th, Rogers of the 21st, Johnson of the 1st, Mullis of
the 53rd, Moody of the 56th and others
AS
PASSED
AN
ACT
To
amend Title 31 of the Official Code of Georgia Annotated, relating to health, so
as to provide for extensive revision of the certificate of need program; to
revise and add definitions; to revise the declaration of policy for state health
planning; to revise the composition and duties of the Health Strategies Council;
to revise the duties of the Department of Community Health; to revise provisions
relating to requirements for certificate of need; to provide for destination
cancer hospitals; to allow for set times to accept applications for capital
projects; to provide for the establishment of conditions for approval of a
certificate of need; to change certain provisions relating to perinatal
services; to provide for certain facilities to divide; to change certain
provisions relating to considerations; to provide for a letter of intent for
proposed new clinical health services; to provide for batching and comparative
review of applications for clinical health services; to revise provisions
relating to time frames for review of applications; to provide for the
imposition of a temporary moratorium on the issuance of certificates of need for
new and emerging health care services; to reassign the hearing functions from
the Health Planning Review Board to a Certificate of Need Appeal Panel; to
revise provisions relating to judicial review of a final agency decision; to add
grounds for which a certificate of need may be revoked; to provide that a
portion of a certificate of need may be revoked under certain circumstances; to
increase the penalties for services conducted without a required certificate of
need; to provide for investigating authority of the department; to provide that
applicants for certificates of need may be required to participate as a provider
of medical assistance for purposes of Medicaid; to change certain provisions
relating to an annual report; to add, revise, and delete certain exemptions to
the certificate of need requirements; to authorize the Department of Community
Health to require notice and its certification that an activity is exempt from
the certificate of need requirements; to provide for the transfer of certain
functions relating to the state health plan to the Board of Community Health
from the Health Strategies Council; to abolish the Health Planning Review Board;
to transfer pending matters of the Health Planning Review Board to the
Certificate of Need Appeal Panel; to revise a provision relating to application
of review procedures to expenditures under a federal law; to require health care
facilities and other entities to submit annual reports to the Department of
Community Health; to increase the penalties for untimely and incomplete reports;
to transfer licensing of hospitals and other health care facilities from the
Department of Human Resources to the Department of Community Health; to provide
for transition; to provide for licensure standards on a clinical service level
for hospitals and related institutions; to amend various other titles of the
Official Code of Georgia Annotated so as to revise provisions for purposes of
conformity; to provide for related matters; to provide for an effective date; to
repeal conflicting laws; and for other purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
PART
I
Revision of Certificate of Need Program.
Revision of Certificate of Need Program.
SECTION
1-1.
Title
31 of the Official Code of Georgia Annotated, relating to health, is amended by
revising Chapter 6, relating to state health planning and development, as
follows:
"ARTICLE
1
31-6-1.
The
policy of this state and the purposes of this chapter are to ensure access to
quality health care services and to ensure that health care services and
facilities are developed in an orderly and economical manner and are made
available to all citizens and that only those health care services found to be
in the public interest shall be provided in this state. To achieve such public
policy and and purposes, it is essential that appropriate health planning
activities be undertaken and implemented and that a system of mandatory review
of new institutional health services be provided. Health care services and
facilities should be provided in a manner that avoids unnecessary duplication of
services, that is cost effective, that provides quality health care services,
and that is compatible with the health care needs of the various areas and
populations of the state.
31-6-2.
As
used in this chapter, the term:
(1)
'Ambulatory surgical center or obstetrical facility' 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.
(2)
'Application' means a written request for a certificate of need made to the
department, containing such documentation and information as the department may
require.
(3)
'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.
(4)
'Bed capacity' 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.
(5)
'Board' means the Board of Community Health.
(6)
'Certificate of need' means an official determination 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 this chapter and rules promulgated pursuant hereto.
(7)
'Certificate of Need Appeal Panel' or 'appeal panel' means the panel of
independent hearing officers created pursuant to Code Section 31-6-44 to conduct
appeal hearings.
(8)
'Clinical health services' means diagnostic, treatment, or rehabilitative
services provided in a health care facility, or parts of the physical plant
where such services are located 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; 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.
(9)
'Commissioner' means the Commissioner of the Department of Community
Health.
(10)
'Consumer' 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.
(11)
'Continuing care retirement 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 or 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.
(12)
'Department' means the Department of Community Health established under Chapter
5A of this title.
(13)
'Destination cancer hospital' means an institution with a licensed bed capacity
of 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 65 percent of patients who reside outside of the State
of Georgia.
(14)
'Develop,' with reference to a project, means:
(A)
Constructing, remodeling, installing, or proceeding with a project, or any part
of a project, or a capital expenditure project, the cost estimate for which
exceeds $2,500,000.00; or
(B)
The expenditure or commitment of funds exceeding $1,000,000.00 for orders,
purchases, leases, or acquisitions through other comparable arrangements of
major medical equipment; provided, however, that this shall not include build
out costs, as defined by the department, but shall include all functionally
related equipment, software, and any warranty and services contract costs for
the first five years.
Notwithstanding
subparagraphs (A) and (B) 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.
(15)
'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.
(16)
'Diagnostic, treatment, or rehabilitation center' 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 23 hours shall be
considered a hospital for purposes of this chapter.
(17)
'Health care facility' 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 centers or obstetrical facilities; health maintenance
organizations; home health agencies; and diagnostic, treatment, or
rehabilitation centers, but only to the extent paragraph (3) or (7), or both
paragraphs (3) and (7), of subsection (a) of Code Section 31-6-40 are applicable
thereto;.
(18)
'Health maintenance organization' 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 copayments, 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:
(i)
Directly through physicians who are either employees or partners of such
organization; or
(ii)
Through arrangements with individual physicians organized on a group practice or
individual practice basis.
(19)
'Health Strategies Council' or 'council' means the body created by this chapter
to advise the Department of Community Health.
(20)
'Home health agency' 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.
(21)
'Hospital' 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, and other specialty
hospitals.
(22)
'Intermediate care facility' 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.
(23)
'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 an 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;
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. The ownership interest of the
hospital shall be no less than 30 percent and the collective ownership of the
physicians or group of physicians shall be no less than 30 percent.
(24)
'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 by the department pursuant
to this chapter.
(25)
'Nonclinical health services' 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 defined
in this chapter.
(26)
'Offer' 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.
(27)
'Operating room environment' means an environment which meets the minimum
physical plant and operational standards specified in the rules of the
department 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.
(28)
'Pediatric cardiac catheterization' means the performance of angiographic,
physiologic, and as appropriate, therapeutic cardiac catheterization on children
14 years of age or younger.
(29)
'Person' 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.
(30)
'Personal care home' 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 25 beds and providing, for compensation,
protective care and oversight of ambulatory, nonrelated 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 include 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 which do not provide personal care.
(31)
'Project' means a proposal to take an action for which a certificate of need is
required under this chapter. 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.
(32) 'Rural county' means a county having a population of less than 35,000
according to the United States decennial census of 2000 or any future such
census.
(33)
'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, operated, and utilized by such physicians
who also are of a single specialty; 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.
(34)
'Skilled nursing facility' 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.
(35)
'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 by the department. A 'specialty hospital' does not include a
destination cancer hospital.
(36)
'State health plan' 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.
(37)
'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.
(38)
'Urban county' means a county having a population equal to or greater than
35,000 according to the United States decennial census of 2000 or any future
such census.
ARTICLE
2
31-6-20.
(a)
There is created a newly reconstituted Health Strategies Council to be appointed
by the Governor, subject to confirmation by the Senate. Any appointment made
when the Senate is not in session shall be effective until the appointment is
acted upon by the Senate. The newly reconstituted Health Strategies Council
shall be the successor to the Health Strategies Council as it existed on June
30, 2008. Those members of the previously existing Health Strategies Council who
are serving as such on June 30, 2008, shall have their terms expire on June 30,
2008, at which time that council shall be abolished. On and after that date the
council shall be composed of 13 members, except as otherwise provided for in
subsection (b) of this Code section. One member shall be appointed from each
congressional district. The council shall be composed as follows:
(1) One member representing the private insurance industry;
(2) One member representing rural hospitals;
(3)
One member representing urban hospitals;
(4)
One member who is a primary care physician in the active practice of
medicine;
(5)
One member who is a physician in a board certified specialty in the active
practice of medicine;
(6)
One member representing nursing homes;
(7)
One member representing home health agencies;
(8)
One member representing freestanding ambulatory surgical centers;
(9)
One member representing health care needs of women;
(10)
One member representing health care needs of the disabled and
elderly;
(11)
One member representing mental health care needs;
(12)
One member representing health care needs of indigent persons; and
(13)
One member representing health care needs of business personnel
(b)
If the state obtains one or more additional members of the United States House
of Representatives as a result of reapportionment, the Governor shall appoint,
subject to confirmation by the Senate, from each new congressional district thus
created one member representing local or county governments.
(c)
The initial members of the newly reconstituted council shall take office July 1,
2008, and six of them shall be designated in such appointment to serve initial
terms of office of two years and seven of them shall be designated in such
appointment to serve initial terms of office of four years. If additional
members are appointed to the council to represent a new congressional district
as provided in subsection (b) of this Code section, one half shall be designated
to serve an initial term of office which expires when the above initial two-year
terms of office expire and one half shall be designated to serve an initial term
of office which expires when the above initial four-year terms of office expire.
After the initial terms provided in this subsection, members of the council
shall be appointed to serve for four-year terms of office. Members of the
council shall serve out their terms of office and until their respective
successors are appointed and qualified.
(d)
Members of the council shall be subject to removal:
(1)
By the Governor after notice and opportunity for hearing for:
(A)
Inability or neglect to perform the duties required of members;
(B)
Incompetence; or
(C)
Dishonest conduct; or
(2)
For failure to attend at least 50 percent of the meetings of the council in any
year; provided, however, that an absence caused by a medical condition or death
of a family member shall constitute an excused absence and shall not provide
grounds for removal.
Vacancies
on the council shall be filled by appointment by the Governor, subject to
confirmation by the Senate.
(e)
The Governor shall appoint the chairperson of the council. A majority of the
members of the council shall constitute a quorum.
(f)
The members of the council attending meetings of such council, or attending a
subcommittee meeting thereof authorized by such council, shall receive no salary
but shall be reimbursed for their expenses in attending meetings and for
transportation costs as authorized by Code Section 45-7-21, which provides for
the compensation and allowances of certain state officials.
(g)
The function of the council shall be to serve as an advisory body to the
department and to:
(1)
Review, comment, and make recommendations to the board on components of the
state health plan; and
(2)
Review and comment on proposed rules for the administration of this chapter,
except emergency rules, as requested by the department
(h)
The council at the department´s request shall involve and coordinate
functions with such state entities as necessary.
31-6-21.
(a)
The Department of Community Health, established under Chapter 5A of this title,
is authorized to administer the certificate of need program established under
this chapter and, within the appropriations made available to the department by
the General Assembly of Georgia and consistently with the laws of the State of
Georgia, a state health plan adopted by the Board of Community Health. The
department shall provide, by rule, for procedures to administer its functions
until otherwise provided by the Board of Community Health.
(b)
The functions of the department shall be:
(1)
To conduct the health planning activities of the state and to implement those
parts of the state health plan which relate to the government of the
state;
(2)
To prepare and revise a draft state health plan;
(3)
To seek advice, at its discretion, from the Health Strategies Council in the
performance by the department of its functions pursuant to this
chapter;
(4)
To adopt, promulgate, and implement rules and regulations sufficient to
administer the provisions of this chapter including the certificate of need
program;
(5)
To define, by rule, the form, content, schedules, and procedures for submission
of applications for certificates of need and periodic reports;
(6)
To establish time periods and procedures consistent with this chapter to hold
hearings and to obtain the viewpoints of interested persons prior to issuance or
denial of a certificate of need;
(7)
To provide, by rule, for such fees as may be necessary to cover the costs of
hearing officers, preparing the record for appeals before such hearing officers
and the Certificate of Need Appeal Panel of the decisions of the department, and
other related administrative costs, which costs may include reasonable sharing
between the department and the parties to appeal hearings;
(8)
To establish, by rule, need methodologies for new institutional health services
and health facilities. In developing such need methodologies, the department
shall, at a minimum, consider the demographic characteristics of the population,
the health status of the population, service use patterns, standards and trends,
financial and geographic accessibility, and market economics. The department
shall establish service-specific need methodologies and criteria for at least
the following clinical health services: short stay hospital beds, adult
therapeutic cardiac catheterization, adult open heart surgery, pediatric cardiac
catheterization and open heart surgery, Level II and III perinatal services,
freestanding birthing centers, psychiatric and substance abuse inpatient
programs, skilled nursing and intermediate care facilities, home health
agencies, and continuing care retirement community sheltered
facilities;
(9)
To provide, by rule, for a reasonable and equitable fee schedule for certificate
of need applications;
(10)
To grant, deny, or revoke a certificate of need as applied for or as amended;
and
(11)
To perform powers and functions delegated by the Governor, which delegation may
include the powers to carry out the duties and powers which have been delegated
to the department under Section 1122 of the federal Social Security Act of 1935,
as amended.
31-6-21.1.
(a)
Rules of the department shall be adopted, promulgated, and implemented as
provided in this Code section and in Chapter 13 of Title 50, the 'Georgia
Administrative Procedure Act,' except that the department shall not be required
to comply with subsections (c) through (g) of Code Section 50-13-4.
(b)
The department shall transmit three copies of the notice provided for in
paragraph (1) of subsection (a) of Code Section 50-13-4 to the legislative
counsel. The copies shall be transmitted at least 30 days prior to that
department´s intended action. Within five days after receipt of the copies,
if possible, the legislative counsel shall furnish the presiding officer of each
house with a copy of the notice and mail a copy of the notice to each member of
the Health and Human Services Committee of the Senate and each member of the
Health and Human Services Committee of the House of Representatives. Each such
rule and any part thereof shall be subject to the making of an objection by
either such committee within 30 days of transmission of the rule to the members
of such committee. Any rule or part thereof to which no objection is made by
both such committees may become adopted by the department at the end of such 30
day period. The department may not adopt any such rule or part thereof which has
been changed since having been submitted to those committees
unless:
(1)
That change is to correct only typographical errors;
(2)
That change is approved in writing by both committees and that approval
expressly exempts that change from being subject to the public notice and
hearing requirements of subsection (a) of Code Section 50-13-4;
(3)
That change is approved in writing by both committees and is again subject to
the public notice and hearing requirements of subsection (a) of Code Section
50-13-4; or
(4)
That change is again subject to the public notice and hearing requirements of
subsection (a) of Code Section 50-13-4 and the change is submitted and again
subject to committee objection as provided in this subsection.
Nothing
in this subsection shall prohibit the department from adopting any rule or part
thereof without adopting all of the rules submitted to the committees if the
rule or part so adopted has not been changed since having been submitted to the
committees and objection thereto was not made by both committees.
(c)
Any rule or part thereof to which an objection is made by both committees within
the 30 day objection period under subsection (b) of this Code section shall not
be adopted by the department and shall be invalid if so adopted. A rule or part
thereof thus prohibited from being adopted shall be deemed to have been
withdrawn by the department unless the department, within the first 15 days of
the next regular session of the General Assembly, transmits written notification
to each member of the objecting committees that the department does not intend
to withdraw that rule or part thereof but intends to adopt the specified rule or
part effective the day following adjournment sine die of that regular session.
A resolution objecting to such intended adoption may be introduced in either
branch of the General Assembly after the fifteenth day but before the thirtieth
day of the session in which occurs the notification of intent not to withdraw a
rule or part thereof. In the event the resolution is adopted by the branch of
the General Assembly in which the resolution was introduced, it shall be
immediately transmitted to the other branch of the General Assembly. It shall
be the duty of the presiding officer of the other branch to have that branch,
within five days after receipt of the resolution, consider the resolution for
purposes of objecting to the intended adoption of the rule or part thereof.
Upon such resolution being adopted by two-thirds of the vote of each branch of
the General Assembly, the rule or part thereof objected to in that resolution
shall be disapproved and not adopted by the department. If the resolution is
adopted by a majority but by less than two-thirds of the vote of each such
branch, the resolution shall be submitted to the Governor for his or her
approval or veto. In the event of a veto, or if no resolution is introduced
objecting to the rule, or if the resolution introduced is not approved by at
least a majority of the vote of each such branch, the rule shall automatically
become adopted the day following adjournment sine die of that regular session.
In the event of the Governor´s approval of the resolution, the rule shall
be disapproved and not adopted by the department.
(d)
Any rule or part thereof which is objected to by only one committee under
subsection (b) of this Code section and which is adopted by the department may
be considered by the branch of the General Assembly whose committee objected to
its adoption by the introduction of a resolution for the purpose of overriding
the rule at any time within the first 30 days of the next regular session of the
General Assembly. It shall be the duty of the department in adopting a proposed
rule over such objection so to notify the chairpersons of the Health and Human
Services Committee of the Senate and the Health and Human Services Committee of
the House within ten days after the adoption of the rule. In the event the
resolution is adopted by such branch of the General Assembly, it shall be
immediately transmitted to the other branch of the General Assembly. It shall
be the duty of the presiding officer of the other branch of the General Assembly
to have such branch, within five days after the receipt of the resolution,
consider the resolution for the purpose of overriding the rule. In the event
the resolution is adopted by two-thirds of the votes of each branch of the
General Assembly, the rule shall be void on the day after the adoption of the
resolution by the second branch of the General Assembly. In the event the
resolution is ratified by a majority but by less than two-thirds of the votes of
either branch, the resolution shall be submitted to the Governor for his or her
approval or veto. In the event of a veto, the rule shall remain in effect. In
the event of the Governor´s approval, the rule shall be void on the day
after the date of approval.
(e)
Except for emergency rules, no rule or part thereof adopted by the department
after April 3, 1985, shall be valid unless adopted in compliance with
subsections (b), (c), and (d) of this Code section and subsection (a) of Code
Section 50-13-4.
(f)
Emergency rules shall not be subject to the requirements of subsection (b), (c),
or (d) of this Code section but shall be subject to the requirements of
subsection (b) of Code Section 50-13-4. Upon the first expiration of any
department emergency rules, where those emergency rules are intended to cover
matters which had been dealt with by the department´s nonemergency rules
but such nonemergency rules have been objected to by both legislative committees
under this Code section, the emergency rules concerning those matters may not
again be adopted except for one 120 day period. No emergency rule or part
thereof which is adopted by the department shall be valid unless adopted in
compliance with this subsection.
(g)
Any proceeding to contest any rule on the ground of noncompliance with this Code
section must be commenced within two years from the effective date of the
rule.
(h)
For purposes of this Code section, 'rules' shall mean rules and
regulations.
(i)
The state health plan or the rules establishing considerations, standards, or
similar criteria for the grant or denial of a certificate of need pursuant to
Code Section 31-6-42 shall not apply to any application for a certificate of
need as to which, prior to the effective date of such plan or rules,
respectively, the evidence has been closed following a full evidentiary hearing
before a hearing officer.
ARTICLE
3
31-6-40.
(a)
On and after July 1, 2008, any new institutional health service shall be
required to obtain a certificate of need pursuant to this chapter. New
institutional health services include:
(1)
The construction, development, or other establishment of a new health care
facility;
(2)
Any expenditure by or on behalf of a health care facility in excess of
$2,500,000.00 which, under generally accepted accounting principles consistently
applied, is a capital expenditure, except expenditures for acquisition of an
existing health care facility not owned or operated by or on behalf of a
political subdivision of this state, or any combination of such political
subdivisions, or by or on behalf of a hospital authority, as defined in Article
4 of Chapter 7 of this title, or certificate of need owned by such facility in
connection with its acquisition. The dollar amounts specified in this paragraph
and in subparagraph (A) of paragraph (14) of Code Section 31-6-2 shall be
adjusted annually by an amount calculated by multiplying such dollar amounts (as
adjusted for the preceding year) by the annual percentage of change in the
composite index of construction material prices, or its successor or appropriate
replacement index, if any, published by the United States Department of Commerce
for the preceding calendar year, commencing on July 1, 2009, and on each
anniversary thereafter of publication of the index. The department shall
immediately institute rule-making procedures to adopt such adjusted dollar
amounts. In calculating the dollar amounts of a proposed project for purposes of
this paragraph and subparagraph (A) of paragraph (14) of Code Section 31-6-2,
the costs of all items subject to review by this chapter and items not subject
to review by this chapter associated with and simultaneously developed or
proposed with the project shall be counted, except for 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 sites;
(3)
The purchase or lease by or on behalf of a health care facility or a diagnostic,
treatment, or rehabilitation center of diagnostic or therapeutic equipment with
a value in excess of $1,000,000.00; provided, however, that 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 equipment; and
provided, further, that this shall not include build out costs, as defined by
the department, but shall include all functionally related equipment, software,
and any warranty and services contract costs for the first five years. The
acquisition of one or more items of functionally related diagnostic or
therapeutic equipment shall be considered as one project. The dollar amount
specified in this paragraph, in subparagraph (B) of paragraph (14) of Code
Section 31-6-2, and in paragraph (10) of subsection (a) of Code Section 31-6-47
shall be adjusted annually by an amount calculated by multiplying such dollar
amounts (as adjusted for the preceding year) by the annual percentage of change
in the consumer price index, or its successor or appropriate replacement index,
if any, published by the United States Department of Labor for the preceding
calendar year, commencing on July 1, 2010;
(4)
Any increase in the bed capacity of a health care facility except as provided in
Code Section 31-6-47;
(5)
Clinical health services which 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 12 month period prior to the time such services would be
offered;
(6)
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 this chapter to any of the types of health care facilities which are
covered by this chapter; and
(7)
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 12 month period prior to the time such
services would be offered, but only if the clinical health services are any of
the following:
(A)
Radiation therapy;
(B)
Biliary lithotripsy;
(C)
Surgery in an operating room environment, including but not limited to
ambulatory surgery; and
(D)
Cardiac catheterization.
(b)
Any person proposing to develop or offer a new institutional health service or
health care facility shall, before commencing such activity, submit a letter of
intent and an application to the department and obtain a certificate of need in
the manner provided in this chapter unless such activity is excluded from the
scope of this chapter.
(c)(1)
Any person who had a valid exemption granted or approved by the former Health
Planning Agency or the Department of Community Health prior to July 1, 2008,
shall not be required to obtain a certificate of need in order to continue to
offer those previously offered services.
(2)
Any facility offering ambulatory surgery pursuant to the exclusion designated on
June 30, 2008, as division (14)(G)(iii) of Code Section 31-6-2; any diagnostic,
treatment, or rehabilitation center offering diagnostic imaging or other imaging
services in operation and exempt prior to July 1, 2008; or any facility
operating pursuant to a letter of nonreviewability and offering diagnostic
imaging services prior to July 1, 2008, shall:
(A)
Provide notice to the department of the name, ownership, location, single
specialty, and services provided in the exempt facility;
(B)
Beginning on January 1, 2009, provide annual reports in the same manner and in
accordance with Code Section 31-6-70; and
(C)(i)
Provide care to Medicaid beneficiaries and, if the facility provides medical
care and treatment to children, to PeachCare for Kids beneficiaries and provide
uncompensated indigent and charity care in an amount equal to or greater than 2
percent of its adjusted gross revenue; or
(ii)
If the facility is not a participant in Medicaid or the PeachCare for Kids
Program, provide uncompensated care for Medicaid beneficiaries and, if the
facility provides medical care and treatment to children, for PeachCare for Kids
beneficiaries, uncompensated indigent and charity care, or both in an amount
equal to or greater than 4 percent of its adjusted gross revenue if
it:
(I)
Makes a capital expenditure associated with the construction, development,
expansion, or other establishment of a clinical health service or the
acquisition or replacement of diagnostic or therapeutic equipment with a value
in excess of $800,000.00 over a two-year period;
(II)
Builds a new operating room; or
(III)
Chooses to relocate in accordance with Code Section 31-6-47.
Noncompliance
with any condition of this paragraph shall result in a monetary penalty in the
amount of the difference between the services which the center is required to
provide and the amount actually provided and may be subject to revocation of its
exemption status by the department for repeated failure to pay any fees or
monies due to the department or for repeated failure to produce data as required
by Code Section 31-6-70 after notice to the exemption holder and a fair hearing
pursuant to Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.'
The dollar amount specified in this paragraph shall be adjusted annually by an
amount calculated by multiplying such dollar amount (as adjusted for the
preceding year) by the annual percentage of change in the consumer price index,
or its successor or appropriate replacement index, if any, published by the
United States Department of Labor for the preceding calendar year, commencing on
July 1, 2009. In calculating the dollar amounts of a proposed project for the
purposes of this paragraph, the costs of all items subject to review by this
chapter and items not subject to review by this chapter associated with and
simultaneously developed or proposed with the project shall be counted, except
for 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 sites. Subparagraph (C) of this paragraph shall not apply to
facilities offering ophthalmic ambulatory surgery pursuant to the exclusion
designated on June 30, 2008, as division (14)(G)(iii) of Code Section 31-6-2
that are owned by physicians in the practice of ophthalmology.
(d)
A certificate of need issued to a destination cancer hospital shall authorize
the beds and all new institutional health services of such destination cancer
hospital. As used in this subsection, the term 'new institutional health
service' shall have the same meaning provided for in subsection (a) of this Code
section. A certificate of need shall only be issued to a destination cancer
hospital that locates itself and all affiliated facilities within 25 miles of a
commercial airport in this state with five or more runways. Such destination
cancer hospital shall not be required to apply for or obtain additional
certificates of need for new institutional health services related to the
treatment of cancer patients, and such new institutional health services related
to the treatment of cancer patients offered by the destination cancer hospital
shall not be reviewed under any service specific need methodology or rules
except for those promulgated by the department for destination cancer hospitals.
After commencing operations, in order to add an additional new institutional
health service, a destination cancer hospital shall apply for and obtain an
additional certificate of need under the applicable statutory provisions and any
rules promulgated by the department for destination cancer hospitals, and such
applications shall only be granted if the patient base of such destination
cancer hospital is composed of at least 65 percent of out-of-state patients for
two consecutive years. The department may apply rules for a destination cancer
hospital only for those services that the department determines are to be used
by the destination cancer hospital in connection with the treatment of cancer.
In no case shall a destination cancer hospital specific rules be used in the
case of an application for open heart surgery, perinatal services, cardiac
catheterization, and other services deemed by the department to be not
reasonably related to the diagnosis and treatment of cancer; provided, however,
that the department shall apply the destination cancer hospital specific rules
if a destination cancer hospital applies for services and equipment required for
it to meet federal or state laws applicable to a hospital. If such destination
cancer hospital cannot show a patient base of a minimum of 65 percent from
outside of this state, then its application for any new institutional health
service shall be evaluated under the specific statutes and rules applicable to
that particular service. If such destination cancer hospital applies for a
certificate of need to add an additional new institutional health service before
commencing operations or completing two consecutive years of operation, such
applicant may rely on historical data from its affiliated entities, as set forth
in paragraph (2) of subsection (b.1) of Code Section 31-6-42. Because
destination cancer hospitals provide services primarily to out-of-state
residents, the number of beds, services, and equipment destination cancer
hospitals use shall not be counted as part of the department´s inventory
when determining the need for those items by other providers. No person shall
be issued more than one certificate of need for a destination cancer hospital.
Nothing in this Code section shall in any way require a destination cancer
hospital to obtain a certificate of need for any purpose that is otherwise
exempt from the certificate of need requirement. Beginning January 1, 2010, the
department shall not accept any application for a certificate of need for a new
destination cancer hospital; provided, however, all other provisions regarding
the upgrading, replacing, or purchasing of diagnostic or therapeutic equipment
shall be applicable to an existing destination cancer hospital.
(e)
The commissioner shall be authorized, with the approval of the board, to place a
temporary moratorium of up to six months on the issuance of certificates of need
for new and emerging health care services. Any such moratorium placed shall be
for the purpose of promulgating rules and regulations regarding such new and
emerging health care services. A moratorium may be extended one time for an
additional three months if circumstances warrant, as approved by the board. In
the event that final rules and regulations are not promulgated within the time
period allowed by the moratorium, any applications received by the department
for a new and emerging health care service shall be reviewed under existing
general statutes and regulations relating to certificates of need.
31-6-40.1.
(a)
Any person who acquires a health care facility by stock or asset purchase,
merger, consolidation, or other lawful means shall notify the department of such
acquisition, the date thereof, and the name and address of the acquiring person.
Such notification shall be made in writing to the department within 45 days
following the acquisition and the acquiring person may be fined by the
department in the amount of $500.00 for each day that such notification is late.
Such fine shall be paid into the state treasury.
(b)
The department may limit the time periods during which it will accept
applications for the following health care facilities:
(1)
Skilled nursing facilities;
(2)
Intermediate care facilities; and
(3)
Home health agencies,
to
only such times after the department has determined there is an unmet need for
such facilities. The department shall make a determination as to whether or not
there is an unmet need for each type of facility at least every six months and
shall notify those requesting such notification of that
determination.
(b.1)
The department may establish, by rule, set times during the year in which
applications for capital projects exceeding the threshold amounts
in:
(1)
Paragraph (14) of Code Section 31-6-2; and
(2)
Paragraph (2) or (3) of subsection (a) of Code Section 31-6-40
shall
be accepted.
(c)
The department may require that any applicant for a certificate of need agree to
provide a specified amount of clinical health services to indigent patients as a
condition for the grant of a certificate of need; provided, however, that each
facility granted a certificate of need by the department as a destination cancer
hospital shall be required to provide uncompensated indigent or charity care for
residents of Georgia which meets or exceeds 3 percent of such destination cancer
hospital´s adjusted gross revenues and provide care to Medicaid
beneficiaries. A grantee or successor in interest of a certificate of need or
an authorization to operate under this chapter which violates such an agreement
or violates any conditions imposed by the department relating to such services,
whether made before or after July 1, 2008, shall be liable to the department for
a monetary penalty in the amount of the difference between the amount of
services so agreed to be provided and the amount actually provided and may be
subject to revocation of its certificate of need, in whole or in part, by the
department pursuant to Code Section 31-6-45. Any penalty so recovered shall be
paid into the state treasury.
(c.1)(1)
A destination cancer hospital that does not meet an annual patient base composed
of a minimum of 65 percent of patients who reside outside this state in a
calendar year shall be fined $2,000,000.00 for the first year of noncompliance,
$4,000,000.00 for the second consecutive year of noncompliance, and
$6,000,000.00 for the third consecutive year of noncompliance. Such fine amount
shall reset to $2,000,000.00 after any year of compliance. In the event that a
destination cancer hospital does not meet an annual patient base composed of a
minimum of 65 percent of patients who reside outside this state for three
calendar years in any five-year period, such hospital shall be fined an
additional amount of $8,000,000.00. It is the intent of the General Assembly
that all revenues collected from any such fine shall be dedicated and deposited
by the department into the Indigent Care Trust Fund created pursuant to Code
Section 31-8-152.
(2)
In the event a certificate of need for a destination cancer hospital is revoked
pursuant to this subsection, such hospital shall be subject to fines pursuant to
subsection (c) of Code Section 31-6-45 for operating without a certificate of
need.
(3)
In addition to the annual report required pursuant to Code Section 31-6-70, a
destination cancer hospital shall submit an annual statement, in accordance with
timeframes and a format specified by the department, affirming that the hospital
has met an annual patient base composed of a minimum of 65 percent of patients
who reside outside this state. The chief executive officer of the destination
cancer hospital shall certify under penalties of perjury that the statement as
prepared accurately reflects the composition of the annual patient base. The
department shall have the authority to inspect any books, records, papers, or
other information pursuant to subsection (e) of Code Section 31-6-45 of the
destination cancer hospital to confirm the information provided on such
statement or any other information required of the destination cancer hospital.
Nothing in this paragraph shall be construed to require the release of any
information which would violate the Health Insurance Portability and
Accountability Act of 1996, P.L. 104-191.
(d)
Penalties authorized under this Code section shall be subject to the same
notices and hearing for the levy of fines under Code Section
31-6-45.
31-6-40.2.
(a)
As used in this Code section only, the term:
(1)
'Certificate of need application' means an application for a certificate of need
filed with the department, any amendments thereto, and any other written
material relating to the application and filed by the applicant with the
department.
(2)
'First three years of operation' means the first three consecutive 12 month
periods beginning on the first day of a new perinatal service´s first full
calendar month of operation.
(3)
'First year of operation' means the first consecutive 12 month period beginning
on the first day of a new perinatal service´s first full calendar month of
operation.
(4)
'New perinatal service' means a perinatal service whose first year of operation
ends after April 6, 1992.
(5)
'Perinatal service' means obstetric and neonatal services relating to managing
high-risk pregnancies, care for moderately ill newborns, care for all maternal
and fetal complications either on site or by referral, and operation of neonatal
intensive care units equipped to treat critically ill newborns; provided
however, this shall not include basic perinatal services as defined in Code
Section 31-6-2.
(6)
'Year' means one of the three consecutive 12 month periods in a new perinatal
service first 36 months of operation.
(b)(1)
A new perinatal service shall provide uncompensated indigent or charity care in
an amount which meets or exceeds the department´s established minimum at
the time the department issued the certificate of need approval for such service
for each of the service´s first three years of operation; provided,
however, that if the certificate of need application under which a new perinatal
service was approved included a commitment that uncompensated indigent or
charity care would be provided in an amount greater than the established minimum
for any time period described in the certificate of need application that falls
completely within such new perinatal service´s first three years of
operation, such new perinatal service shall provide indigent or charity care in
an amount which meets or exceeds the amount committed in the certificate of need
application for each time period described in the certificate of need
application that falls completely within the service´s first three years of
operation.
(2)
The department shall revoke the certificate of need and authority to operate of
a new perinatal service if after notice to the grantee of the certificate or
such grantee´s successors, and after opportunity for a fair hearing
pursuant to Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act,'
the department determines that such new perinatal service has failed to provide
indigent or charity care in accordance with the requirements of paragraph (1) of
this subsection and such failure is determined by the department to be for
reasons substantially within the perinatal service provider´s control. The
department shall provide the requisite notice, conduct the fair hearing, if
requested, and render its determination within 90 days after the end of the
first year, or, if applicable, the first time period described in paragraph (1)
of this subsection during which the new perinatal service fails to provide
indigent or charity care in accordance with the requirements of paragraph (1) of
this subsection. Revocation shall be effective 30 days after the date of the
determination by the department that the requirements of paragraph (1) of this
subsection have not been met.
(c)(1)
A new perinatal service shall achieve the standard number of births specified in
the state health plan in effect at the time of the issuance of the certificate
of need approval by the department in at least one year during its first three
years of operation.
(2)
The department shall revoke the certificate of need and authority to operate of
a new perinatal service if after notice to the grantee of the certificate of
need or such grantee´s successors, and after opportunity for a fair hearing
pursuant to Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act,'
the department determines that such new perinatal service has failed to comply
with the applicable requirements of paragraph (1) of this subsection and such
failure is determined by the department to be for reasons substantially within
the perinatal service provider´s control. The department shall provide the
requisite notice, conduct the fair hearing, if requested, and render its
determination within 90 days after the end of the new perinatal service´s
first three years of operation. Revocation shall be effective 30 days after the
date of the determination by the department that the requirements of this
paragraph or paragraph (1) of this subsection have not been met.
(d)
Nothing contained in this Code section shall limit the department´s
authority to regulate perinatal services in ways or for time periods not
addressed by the provisions of this Code section.
31-6-41.
(a)
A certificate of need shall be valid only for the defined scope, location, cost,
service area, and person named in an application, as it may be amended, and as
such scope, location, area, cost, and person are approved by the department,
unless such certificate of need owned by an existing health care facility is
transferred to a person who acquires such existing facility. In such case, the
certificate of need shall be valid for the person who acquires such a facility
and for the scope, location, cost, and service area approved by the department.
However, in reviewing an application to relocate all or a portion of an existing
skilled nursing facility, intermediate care facility, or intermingled nursing
facility, the department may allow such facility to divide into two or more such
facilities if the department determines that the proposed division is
financially feasible and would be consistent with quality patient
care.
(b)
A certificate of need shall be valid and effective for a period of 12 months
after it is issued, or such greater period of time as may be specified by the
department at the time the certificate of need is issued. Within the effective
period after the grant of a certificate of need, the applicant of a proposed
project shall fulfill reasonable performance and scheduling requirements
specified by the department, by rule, to assure reasonable progress toward
timely completion of a project.
(c)
By rule, the department may provide for extension of the effective period of a
certificate of need when an applicant, by petition, makes a good faith showing
that the conditions to be specified according to subsection (b) of this Code
section will be performed within the extended period and that the reasons for
the extension are beyond the control of the applicant.
31-6-42.
(a)
The written findings of fact and decision, with respect to the department´s
grant or denial of a certificate of need, shall be based on the applicable
considerations specified in this Code section and reasonable rules promulgated
by the department interpretive thereof. The department shall issue a certificate
of need to each applicant whose application is consistent with the following
considerations and such rules deemed applicable to a project, except as
specified in subsection(f) of Code Section 31-6-43:
(1)
The proposed new institutional health services are reasonably consistent with
the relevant general goals and objectives of the state health plan;
(2)
The population residing in the area served, or to be served, by the new
institutional health service has a need for such services;
(3)
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;
(4)
The project can be adequately financed and is, in the immediate and long term,
financially feasible;
(5)
The effects of new institutional health service on payors for health services,
including governmental payors, are not unreasonable;
(6)
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;
(7)
The new institutional health service proposed is reasonably financially and
physically accessible to the residents of the proposed service
area;
(8)
The proposed new institutional health service has a positive relationship to the
existing health care delivery system in the service area;
(9)
The proposed new institutional health service encourages more efficient
utilization of the health care facility proposing such service;
(10)
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;
(11)
The proposed new institutional health service conducts biomedical or behavioral
research projects or new service development which is designed to meet a
national, regional, or state-wide need;
(12)
The proposed new institutional health service meets the clinical needs of health
professional training programs which request assistance;
(13)
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 loss of the quality of
care;
(14)
The proposed new institutional health service fosters the special needs and
circumstances of health maintenance organizations;
(15)
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;
(16)
The proposed new institutional health service can obtain the necessary
resources, including health care personnel and management personnel;
and
(17)
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.
(b)
In the case of applications for the development or offering of a new
institutional health service or health care facility for osteopathic medicine,
the need for such service or facility shall be determined on the basis of the
need and availability in the community for osteopathic services and facilities
in addition to the considerations in subsection (a) of this Code section.
Nothing in this chapter shall, however, be construed as otherwise recognizing
any distinction between allopathic and osteopathic medicine.
(b.1)
In the case of applications for the construction, development, or establishment
of a destination cancer hospital, the applicable considerations as to the need
for such service shall not include paragraphs (1), (2), (3), (7), (8), (10),
(11), and (14) of subsection (a) of this Code section but shall
include:
(1)
Paragraphs (4), (5), (6), (9), (12), (13), (15), (16), and (17) of subsection
(a) of this Code section;
(2)
That the proposed new destination cancer hospital can demonstrate, based on
historical data from the applicant or its affiliated entities, that its annual
patient base shall be composed of a minimum of 65 percent of patients who reside
outside of the State of Georgia;
(3)
That the proposed new destination cancer hospital states its intent to provide
uncompensated indigent or charity care which shall meet or exceed 3 percent of
its adjusted gross revenues and provide care to Medicaid
beneficiaries;
(4)
That the proposed new destination cancer hospital shall conduct biomedical or
behavioral research projects or service development which is designed to meet a
national or regional need;
(5)
That the proposed new destination cancer hospital shall be reasonably
financially and physically accessible;
(6)
That the proposed new destination cancer hospital shall have a positive
relationship to the existing health care delivery system on a regional
basis;
(6.1)
That the proposed new destination cancer hospital shall enter into a hospital
transfer agreement with one or more hospitals within a reasonable distance from
the destination cancer hospital or the medical staff at the destination cancer
hospital has admitting privileges or other acceptable documented arrangements
with such hospital or hospitals to ensure the necessary backup for the
destination cancer hospital for medical complications. The destination cancer
hospital shall have the capability to transfer a patient immediately to a
hospital within a reasonable distance from the destination cancer hospital with
adequate emergency room services. Hospitals shall not unreasonably deny a
transfer agreement with the destination cancer hospital. In the event that a
destination cancer hospital and another hospital cannot agree to the terms of a
transfer agreement as required by this paragraph, the department shall mediate
between such parties for a period of no more than 45 days. If an agreement is
still not reached within such 45 day period, the parties shall enter into
binding arbitration conducted by the department;
(7)
That an applicant for a new destination cancer hospital shall document in its
application that the new facility is not predicted to be detrimental to existing
hospitals within the planning area. Such demonstration shall be made by
providing an analysis in such application that compares current and projected
changes in market share and payor mix for such applicant and such existing
hospitals within the planning area. Impact on an existing hospital shall be
determined to be adverse if, based on the utilization projected by the
applicant, such existing hospital would have a total decrease of 10 percent or
more in its average annual utilization, as measured by patient days for the two
most recent and available preceding calendar years of data; and
(8)
That the destination cancer hospital shall express its intent to participate in
medical staffing work force development activities.
(b.2)
In the case of applications for basic perinatal services in counties
where:
(1)
Only one civilian health care facility or health system is currently providing
basic perinatal services; and
(2)
There are not at least three different health care facilities in a contiguous
county providing basic perinatal services,
the
department shall not apply the consideration contained in paragraph (2) of
subsection (a) of this Code section.
(c)
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:
(1)
Minority administered hospital facility serving a socially and economically
disadvantaged minority population in an urban setting; or
(2)
Minority administered hospital facility 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 served by said
facility for the new institutional health service shall be given extraordinary
consideration by the department in making its determination of need as required
by this Code section. The department shall have the authority to vary or modify
strict adherence to the provisions of this chapter and the rules enacted
pursuant hereto in considering the special needs of such facility and its
population served and to avoid an adverse impact on the facility and the
population served thereby. For purposes of this subsection, the term 'minority
administered hospital facility' means a hospital controlled or operated by a
governing body or administrative staff composed predominantly of members of a
minority race.
(d)
For the purposes of the considerations contained in this Code section and in the
department´s applicable rules, relevant data which were unavailable or
omitted when the state health plan or rules were prepared or revised may be
considered in the evaluation of a project.
(e)
The department shall specify in its written findings of fact and decision which
of the considerations contained in this Code section and the department´s
applicable rules are applicable to an application and its reasoning as to and
evidentiary support for its evaluation of each such applicable consideration and
rule.
31-6-43.
(a)
At least 30 days prior to submitting an application for a certificate of need
for clinical health services, a person shall submit a letter of intent to the
department. The department shall provide by rule a process for submitting
letters of intent and a mechanism by which applications may be filed to compete
with and be reviewed comparatively with proposals described in submitted letters
of intent.
(b)
Each application for a certificate of need shall be reviewed by the department
and within ten working days after the date of its receipt a determination shall
be made as to whether the application complies with the rules governing the
preparation and submission of applications. If the application complies with
the rules governing the preparation and submission of applications, the
department shall declare the application complete for review, shall accept and
date the application, and shall notify the applicant of the timetable for its
review. The department shall also notify a newspaper of general circulation in
the county in which the project shall be developed that the application has been
deemed complete. The department shall also notify the appropriate regional
development center and the chief elected official of the county and municipal
governments, if any, in whose boundaries the proposed project will be located
that the application is complete for review. If the application does not comply
with the rules governing the preparation and submission of applications, the
department shall notify the applicant in writing and provide a list of all
deficiencies. The applicant shall be afforded an opportunity to correct such
deficiencies, and upon such correction, the application shall then be declared
complete for review within ten days of the correction of such deficiencies, and
notice given to a newspaper of general circulation in the county in which the
project shall be developed that the application has been so declared. The
department shall also notify the appropriate regional development center and the
chief elected official of the county and municipal governments, if any, in whose
boundaries the proposed project will be located that the application is complete
for review or when in the determination of the department a significant
amendment is filed.
(c)
The department shall specify by rule the time within which an applicant may
amend its application. The department may request an applicant to make
amendments. The department decision shall be made on an application as amended,
if at all, by the applicant.
(d)
There shall be a time limit of 120 days for review of a project, beginning on
the day the department declares the application complete for review or in the
case of applications joined for comparative review, beginning on the day the
department declares the final application complete. The department may adopt
rules for determining when it is not practicable to complete a review in 120
days and may extend the review period upon written notice to the applicant but
only for an extended period of not longer than an additional 30 days. The
department shall adopt rules governing the submission of additional information
by the applicant and for opposing an application.
(e)
To allow the opportunity for comparative review of applications, the department
may provide by rule for applications for a certificate of need to be submitted
on a timetable or batching cycle basis no less often than two times per calendar
year for each clinical health service. Applications for services, facilities,
or expenditures for which there is no specified batching cycle may be filed at
any time.
(f)
The department may order the joinder of an application which is determined to be
complete by the department for comparative review with one or more subsequently
filed applications declared complete for review during the same batching cycle
when:
(1)
The first and subsequent applications involve similar clinical health service
projects in the same service area or overlapping service areas; and
(2)
The subsequent applications are filed and are declared complete for review
within 30 days of the date the first application was declared complete for
review.
Following
joinder of the first application with subsequent applications, none of the
subsequent applications so joined may be considered as a first application for
the purposes of future joinder. The department shall notify the applicant to
whose application a joinder is ordered and all other applicants previously
joined to such application of the fact of each joinder pursuant to this
subsection. In the event one or more applications have been joined pursuant to
this subsection, the time limits for department action for all of the applicants
shall run from the latest date that any one of the joined applications was
declared complete for review. In the event of the consideration of one or more
applications joined pursuant to this subsection, the department may award no
certificate of need or one or more certificates of need to the application or
applications, if any, which are consistent with the considerations contained in
Code Section 31-6-42, the department´s applicable rules, and the award of
which will best satisfy the purposes of this chapter.
(g)
The department shall review the application and all written information
submitted by the applicant in support of the application and all information
submitted in opposition to the application to determine the extent to which the
proposed project is consistent with the applicable considerations stated in Code
Section 31-6-42 and in the department´s applicable rules. During the
course of the review, the department staff may request additional information
from the applicant as deemed appropriate. Pursuant to rules adopted by the
department, a public hearing on applications covered by those regulations may be
held prior to the date of the department´s decision thereon. Such rules
shall provide that when good cause has been shown, a public hearing shall be
held by the department. Any interested person may submit information to the
department concerning an application, and an applicant shall be entitled to
notice of and to respond to any such submission.
(h)
The department shall provide the applicant an opportunity to meet with the
department to discuss the application and to provide an opportunity to submit
additional information. Such additional information shall be submitted within
the time limits adopted by the department. The department shall also provide an
opportunity for any party that is opposed to an application to meet with the
department and to provide additional information to the department. In order
for an opposing party to have standing to appeal an adverse decision pursuant to
Code Section 31-6-44, such party must attend and participate in an opposition
meeting.
(i)
Unless extended by the department for an additional period of up to 30 days
pursuant to subsection (d) of this Code section, the department shall, no later
than 120 days after an application is determined to be complete for review, or,
in the event of joined applications, 120 days after the last application is
declared complete for review, provide written notification to an applicant of
the department´s decision to issue or to deny issuance of a certificate of
need for the proposed project. Such notice shall contain the department´s
written findings of fact and decision as to each applicable consideration or
rule and a detailed statement of the reasons and evidentiary support for issuing
or denying a certificate of need for the action proposed by each applicant. The
department shall also mail such notification to the appropriate regional
development center and the chief elected official of the county and municipal
governments, if any, in whose boundaries the proposed project will be located.
In the event such decision is to issue a certificate of need, the certificate of
need shall be effective on the day of the decision unless the decision is
appealed to the Certificate of Need Appeal Panel in accordance with this
chapter. Within seven days of the decision, the department shall publish notice
of its decision to grant or deny an application in the same manner as it
publishes notices of the filing of an application.
(j)
Should the department fail to provide written notification of the decision
within the time limitations set forth in this Code section, an application shall
be deemed to have been approved as of the one hundred twenty-first day following
notice from the department that an application, or the last of any applications
joined pursuant to subsection(f) of this Code section, is declared 'complete for
review.'
(g)
Notwithstanding other provisions of this article, 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. The department shall establish, by rule,
procedures whereby requirements for the process of review and issuance of a
certificate of need may be modified and expedited as a result of emergency
situations.
31-6-44.
(a)
Effective July 1, 2008, there is created the Certificate of Need Appeal Panel,
which shall be an agency separate and apart from the department and shall
consist of a panel of independent hearing officers. The purpose of the appeal
panel shall be to serve as a panel of independent hearing officers to review the
department´s initial decision to grant or deny a certificate of need
application. The Health Planning Review Board which existed on June 30, 2008,
shall cease to exist after that date and the Certificate of Need Appeal Panel
shall be constituted effective July 1, 2008, pursuant to this Code section. The
terms of all members of the Health Planning Review Board serving as such on June
30, 2008, shall automatically terminate on such date.
(b)
On and after July 1, 2008, the appeal panel shall be composed of five members
appointed by the Governor for a term of up to four years each. The Governor
shall appoint to the appeal panel attorneys who practice law in this state and
who are familiar with the health care industry but who do not have a financial
interest in or represent or have any compensation arrangement with any health
care facility. Each member of the appeal panel shall be an active member of the
State Bar of Georgia in good standing, and each attorney shall have maintained
such active status for the five years immediately preceding such person´s
appointment. The Governor shall name from among such members a chairperson and
a vice chairperson of the appeal panel. The vice chairperson shall have the
same authority as the chairperson; provided, however, the vice chairperson shall
not exercise such authority unless expressly delegated by the chairperson or in
the event the chairperson becomes incapacitated, as determined by the Governor.
Vacancies on the appeal panel caused by resignation, death, or any other cause
shall be filled for the unexpired term in the same manner as the original
appointment. No person required to register with the Secretary of State as a
lobbyist or registered agent shall be eligible for appointment by the Governor
to the appeal panel.
(c)
The appeal panel shall promulgate reasonable rules for its operation and rules
of procedure for the conduct of initial administrative appeal hearings held by
the appointed hearing officers, including an appropriate fee schedule for filing
such appeals. Members of the appeal panel shall serve as hearing officers for
appeals that are assigned to them on a random basis by the chairperson of the
appeal panel. The members of the appeal panel shall receive no salary but
shall be reimbursed for their expenses in attending meetings and for
transportation costs as authorized by Code Section 45-7-21, which provides for
compensation and allowances of certain state officials; provided, however, that
the chairperson and vice chairperson of the appeal panel shall also be
compensated for their services rendered to the appeal panel outside of
attendance at an appeal panel meeting, such as for time spent assigning hearing
officers, the amount of which compensation shall be determined according to
regulations of the Department of Administrative Services. Appeal panel members
shall receive compensation for the administration of the cases assigned to them,
including prehearing, hearing, and posthearing work, in an amount determined to
be appropriate and reasonable by the Department of Administrative Services.
Such compensation to the members of the appeal panel shall be made by the
Department of Administrative Services.
(d)
Any applicant for a project, any competing applicant in the same batching cycle,
any competing health care facility that has notified the department prior to its
decision that such facility is opposed to the application before the department,
or any county or municipal government in whose boundaries the proposed project
will be located who is aggrieved by a decision of the department shall have the
right to an initial administrative appeal hearing before an appeal panel hearing
officer or to intervene in such hearing. Such request for hearing or
intervention shall be filed with the chairperson of the appeal panel within 30
days of the date of the decision made pursuant to Code Section 31-6-43. In the
event an appeal is filed by a competing applicant, or any competing health care
facility, or any county or municipal government, the appeal shall be accompanied
by payment of such fee as is established by the appeal panel. In the event an
appeal is requested, the chairperson of the appeal panel shall appoint a hearing
officer for each such hearing within 30 days after the date the appeal is
received. Within 14 days after the appointment of the hearing officer, such
hearing officer shall confer with the parties and set the date or dates for the
hearing, provided that no hearing shall be scheduled less than 60 days nor more
than 120 days after the filing of the request for a hearing, unless the
applicant consents or, in the case of competing applicants, all applicants
consent to an extension of this time period to a specified date. Unless the
applicant consents or, in the case of competing applicants, all applicants
consent to an extension of said 120 day period, any hearing officer who
regularly fails to commence a hearing within the required time period shall not
be eligible for continued service as a hearing officer for the purposes of this
Code section. The hearing officer shall have the authority to dispose of all
motions made by any party before the issuance of the hearing officer´s
decision and shall make such rulings as may be required for the conduct of the
hearing.
(e)
In fulfilling the functions and duties of this chapter, the hearing officer
shall act, and the hearing shall be conducted as a full evidentiary hearing, in
accordance with Chapter 13 of Title 50, the 'Georgia Administrative Procedure
Act,' relating to contested cases, except as otherwise specified in this Code
section. Subject to the provisions of Article 4 of Chapter 18 of Title 50, all
files, working papers, studies, notes, and other writings or information used by
the department in making its decision shall be public records and available to
the parties, and the hearing officer may permit each party to exercise such
reasonable rights of prehearing discovery of such information used by the
parties as will expedite the hearing.
(f)
In addition to evidence submitted to the department, a party may present any
additional relevant evidence to the appeal panel hearing officer reviewing the
decision of the department if the evidence was not reasonably available to the
party presenting the evidence at the time of the department´s review. The
burden of proof as to whether the evidence was reasonably available shall be on
the party attempting to introduce the new evidence. The issue for the decision
by the hearing officer shall be whether, and the hearing officer shall order the
issuance of a certificate of need if, in the hearing officer´s judgment,
the application is consistent with the considerations as set forth in Code
Section 31-6-42 and the department´s rules, as the hearing officer deems
such considerations and rules applicable to the review of the project. The
appeal hearing conducted by the appeal panel hearing officer shall be a de novo
review of the decision of the department. The hearing officer shall also
consider:
(1)
Whether the department committed prejudicial procedural error in its
consideration of the application;
(2)
Whether the appeal lacks substantial justification; and
(3)
Whether such appeal was undertaken primarily for the purpose of delay or
harassment.
The
burden of proof shall be on the appellant. Appellants or applicants shall
proceed first with their cases before the hearing officer in the order
determined by the hearing officer, and the department, if a party, shall proceed
last. In the event of a consolidated hearing on applications which were joined
for comparative review pursuant to subsection(f) of Code Section 31-6-43, the
hearing officer shall have the same powers specified for the department in
subsection (f) of Code Section 31-6-43 to order the issuance of no certificate
of need or one or more certificates of need.
(g)
All evidence shall be presented at the initial administrative appeal hearing
conducted by the appointed hearing officer. A party or intervenor may present
any relevant evidence on all issues raised by the hearing officer or any party
to the hearing or revealed during discovery and shall not be limited to evidence
or information presented to the department prior to its decision, except that an
applicant may not present a new need study or analysis responsive to the general
need consideration or service-specific need formula as provided in the
applicable rules that is substantially different from any such study or analysis
submitted to the department prior to its decision and that could have reasonably
been available for submission. The hearing officer may consider the latest data
available, including updates of studies previously submitted, in deciding
whether an application is consistent with the applicable considerations or
rules. The hearing officer shall consider the applicable considerations and
rules in effect on the date the appeal is filed, even if the provisions of those
considerations or rules were changed after the department´s decision. The
hearing officer may remand a matter to the department if the hearing officer
determines that it would be beneficial for the department to consider new data,
studies, or analyses that were not available before the decision or changes to
the provisions of the applicable considerations or rules made after the
department´s decision. The hearing officer shall establish the time
deadlines for completion of the remand and shall retain jurisdiction of the
matter throughout the completion of the remand.
(h)
After the issuance of a decision by the department pursuant to Code Section
31-6-43, no party to an appeal hearing, nor any person on behalf of such party,
including the department, shall make any ex parte contact with the appeal panel
hearing officer appointed to conduct the appeal hearing, any other member of the
appeal panel, or the commissioner in regard to a decision under
appeal.
(i)
Within 30 days after the conclusion of the hearing, the hearing officer shall
make written findings of fact and conclusions of law as to each consideration as
set forth in Code Section 31-6-42 and the department´s rules, including a
detailed statement of the reasons for the decision of the hearing officer. If
any party has alleged that an appeal lacks substantial justification or was
undertaken primarily for the purpose of delay or harassment, the decision of the
hearing officer shall make findings of fact addressing the merits of the
allegation. The hearing officer shall file such decision with the chairperson
of the appeal panel who shall serve such decision upon all parties, and shall
transmit the administrative record to the commissioner. Any party, including
the department, which disputes any finding of fact or conclusion of law rendered
by the hearing officer in such hearing officer´s decision and which wishes
to appeal that decision may appeal to the commissioner and shall file its
specific objections with the commissioner or his or her designee within 30 days
of of the date of the hearing officer´s decision pursuant to rules adopted
by the department.
(j)
The decision of the appeal panel hearing officer will become the final decision
of the department upon the sixty-first day following the date of the decision
unless an objection thereto is filed with the commissioner within the time limit
established in subsection(i) of this Code section.
(k)(1) In the event an appeal of the hearing officer´s decision is filed,
the commissioner may adopt the hearing officer´s order as the final order
of the department or the commissioner may reject or modify the conclusions of
law over which the department has substantive jurisdiction and the
interpretation of administrative rules over which it has substantive
jurisdiction. By rejecting or modifying such conclusion of law or
interpretation of administrative rule, the department must state with
particularity its reasons for rejecting or modifying such conclusion of law or
interpretation of administrative rule and must make a finding that its
substituted conclusion of law or interpretation of administrative rule is as or
more reasonable than that which was rejected or modified. Rejection or
modification of conclusions of law may not form the basis for rejection or
modification of findings of fact. The commissioner may not reject or modify the
findings of fact unless the commissioner first determines from a review of the
entire record, and states with particularity in the order, that the findings of
fact were not based upon any competent substantial evidence or that the
proceedings on which the findings were based did not comply with the essential
requirements of law.
(2)
If, before the date set for the commissioner´s decision, application is
made to the commissioner for leave to present additional evidence and it is
shown to the satisfaction of the commissioner that the additional evidence is
material and there were good reasons for failure to present it in the
proceedings before the hearing officer, the commissioner may order that the
additional evidence be taken before the same hearing officer who rendered the
initial decision upon conditions determined by the commissioner. The hearing
officer may modify the initial decision by reason of the additional evidence and
shall file that evidence and any modifications, new findings, or decision with
the commissioner. Unless leave is given by the commissioner in accordance with
the provisions of this subsection, the appeal panel may not consider new
evidence under any circumstances. In all circumstances, the commissioner´s
decision shall be based upon considerations as set forth in Code Section 31-6-42
and the department´s rules.
(l)
If, based upon the findings of fact by the hearing officer, the commissioner
determines that the appeal filed by any party of a decision of the department
lacks substantial justification and was undertaken primarily for the purpose of
delay or harassment, the commissioner may enter an award in his or her written
order against such party and in favor of the successful party or parties,
including the department, of all or any part of their respective reasonable and
necessary attorney´s fees and expenses of litigation, as the commissioner
deems just. Such award may be enforced by any court undertaking judicial review
of the final decision. In the absence of any petition for judicial review, then
such award shall be enforced, upon due application, by any court having personal
jurisdiction over the party against whom such an award is made.
(m)
Unless the hearing officer´s decision becomes the department´s final
decision by operation of law as provided in subsection (j) of this Code section,
the decision of the commissioner shall become the department´s final
decision by operation of law. Such final decision shall be the final department
decision for purposes of Chapter 13 of Title 50, the 'Georgia Administrative
Procedure Act.' The appeals process provided by this Code section shall be the
administrative remedy only for decisions made by the department pursuant to Code
Section 31-6-43 which involve the approval or denial of applications for
certificates of need.
(n)
A party responding to an appeal to the commissioner may be ent