hb568.html

07 LC 33 2059S

The House Special Committee on Certificate of Need offers the following

substitute to HB 568:

A BILL TO BE ENTITLED
AN ACT

To amend Chapter 6 of Title 31 of the Official Code of Georgia Annotated, relating to state health planning and development, so as to enact the "Health Care Competition, Transparency, and Improvement Act"; to provide for extensive revision of the certificate of need program; to revise the declaration of policy for state health planning; to revise and add definitions; to establish the Health Strategies Advisory Council as the successor to the Health Strategies Council; to provide for its composition and duties; to revise provisions relating to the Department of Community Health; to provide for a temporary moratorium on certificate of need applications under certain circumstances; to provide for penalties, sanctions, and enforcement actions relating to certificates of need; to provide for automatic revocation of a certificate of need by operation of law; to require all health care related projects to receive a certificate of need; to repeal certain provisions relating to certificates of need for perinatal services; to provide for requirements and conditions on certificate holders; to provide for review criteria for certificates of need; to provide for required contents of a certificate of need application; to provide for timetables and review cycles for certificate of need applications; to provide for letters of intent; to establish review procedures; to establish the Certificate of Need Appeal Panel; to provide for administrative hearings and judicial review of department decisions; to provide for additional exemptions from certificate of need requirements; to provide for contingent exemptions based on meeting certain conditions; to abolish the Health Planning Review Board; to abolish the Health Strategies Council and transfer pending matters to the Health Strategies Advisory Council; to revise provisions relating to required reports from health care facilities; to provide for the acquisition of a health care facility; to provide for annual reports; to amend Title 31 of the Official Code of Georgia Annotated, relating to health, so as to establish a new article with respect to the powers of the Department of Community Health relating to licensing of health care facilities; to provide for legislative findings; to provide for applicability; to provide for hearings and appeals; to provide for rules; to authorize the Department of Community Health to obtain inspection warrants; to authorize the Department of Community Health to impose sanctions relating to health care facility licensing; to amend Chapter 7 of Title 31 of the Official Code of Georgia Annotated, relating to the regulation and construction of hospitals and other health care institutions, so as to transfer licensing functions for health care facilities from the Department of Human Resources to the Department of Community Health; to provide for transition; to amend various other titles for purposes of conformity; to provide for related matters; to provide an effective date; to repeal conflicting laws; and for other purposes.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:

PART I
SECTION 1-1.

This Act shall be known and may be cited as the "Health Care Competition, Transparency, and Improvement Act."

PART II
SECTION 2-1.

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 that adequate and quality 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 this public policy and purpose, it is essential that appropriate health planning activities be undertaken and implemented and that a system of mandatory review of new institutional clinical health services and health care facilities be provided. Health care services and facilities should be provided in a manner that avoids unnecessary duplication of services, that is cost effective, and that is compatible with the health care needs of the various areas and populations of the state.

31-6-2. Definitions.

As used in this chapter, the term:

(1) 'Ambulatory surgical 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) '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 of Human Resources department, except that single beds in single rooms shall be counted even if the room contains inadequate square footage.

(4) 'Board' means the Board of Community Health.

(4)(5) '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.

(5)(6) '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.

(7) 'Commissioner' means the commissioner of community health.

(6)(8) '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.

(9) 'Continuing care retirement community' means an organization which offers, upon payment of an entrance fee, a continuing care contract to provide an individual of retirement status, other than an individual related by consanguinity or affinity to the provider furnishing the care, with board and lodging, licensed nursing facility care, and medical or other health related services. These services are provided pursuant to the contract for at least one year and may be for as long as the lifetime of the resident.

(6.1)(10) 'Department' means the Department of Community Health established under Chapter 5A of this title.

(7)(11) '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 $900,000.00; or

(B) The expenditure or commitment of funds exceeding $500,000.00 $1,500,000.00 for orders, purchases, leases, or acquisitions through other comparable arrangements of major medical equipment by a health care facility located in an urban county.

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. 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 change in a composite construction index representing national construction prices published by the United States government for the preceding calendar year, commencing on October 1, 2008, and on each anniversary thereafter of publication of such index.

(7.1)(12) '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 and in which patients shall not remain for over 23 hours.

(8)(13) 'Health care facility' means hospitals; other special care units, including but not limited to podiatric facilities; skilled nursing facilities; intermediate care facilities; personal care homes; ambulatory surgical or obstetrical facilities; health maintenance organizations; home health agencies; and diagnostic, treatment, or rehabilitation centers, but only to the extent that subparagraph (G) or (H), or both subparagraphs (G) and (H), of paragraph (14) of this Code section are paragraph (10) of subsection (a) of Code Section 31-6-40 is applicable thereto.; and facilities which are devoted to the provision of treatment and rehabilitative care for periods continuing for 24 hours or longer for persons who have traumatic brain injury, as defined in Code Section 37-3-1.

(9)(14) '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

(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.

(10)(15) 'Health Strategies Advisory Council' or 'council' means the body created by this chapter to advise the Department of Community Health and adopt the state health plan.

(11)(16) '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;

(D) Medical social services under the direction of a physician; or

(E) Part-time or intermittent services of a home health aide.

(12)(17) '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.

(18) 'Hospital owned limited purpose ambulatory surgical facility' means an ambulatory surgical facility that is owned by a hospital and that provides surgery by physicians that are solely employed by the hospital and practice in a single surgical field as may be verified by utilization of procedure codes appropriate for such surgical field. Such surgical fields shall include, but are not limited to, general surgery, oral surgery, obstetrics/gynecology, urology, gastroenterology, ophthalmology, orthopedics, otorhinolaryngology, neurology, plastic surgery, podiatry, and pulmonary medicine. Such facility shall have no more than four operating rooms, excluding treatment and minor procedures rooms.

(13)(19) '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.

(14) 'New institutional health service' means:

(A) The construction, development, or other establishment of a new health care facility;

(B) Any expenditure by or on behalf of a health care facility in excess of $900,000.00 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;

(D) 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;

(E) Any conversion or upgrading 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;

(F) The purchase or lease by or on behalf of a health care facility of diagnostic or therapeutic equipment with a value in excess of $500,000.00. The acquisition of one or more items of functionally related diagnostic or therapeutic equipment shall be considered as one project;

(G) Clinical health services which are offered in or through a diagnostic, treatment, or rehabilitation center which were not offered on a regular basis in or through that center within the 12 month period prior to the time such services would be offered, but only if the clinical health services are any of the following:

(i) Radiation therapy;

(ii) Biliary lithotripsy;

(iii) Surgery in an operating room environment, including but not limited to ambulatory surgery; provided, however, this provision shall not apply to surgery 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 and the capital expenditure associated with the construction, development, or other establishment of the clinical health service does not exceed the amount of $1 million; and

(iv) Cardiac catheterization; or

(H) The purchase, lease, or other use by or on behalf of a diagnostic, treatment, or rehabilitation center of diagnostic or therapeutic equipment with a value in excess of $500,000.00. The acquisition of one or more items of functionally related diagnostic or therapeutic equipment shall be considered as one project.

The dollar amounts specified in subparagraphs (B), (F), and (H) of this paragraph, division (iii) of subparagraph (G) of this paragraph, and of paragraph (7) of this Code section 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 construction index, or its successor or appropriate replacement index, if any, published by the Bureau of the Census of the Department of Commerce of the United States government for the preceding calendar year, commencing on July 1, 1991, 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 subparagraphs (B), (F), and (H) of this paragraph, division (iii) of subparagraph (G) of this paragraph, and of paragraph (7) of this Code section, 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.

(20) 'Joint venture limited purpose ambulatory surgical facility' means an ambulatory surgical facility that is owned by a hospital and a single group of physicians practicing in the facility that are not employed by the hospital and that provide surgery in a single surgical field as may be verified by utilization of procedure codes appropriate for such surgical field. Such surgical fields shall include, but are not limited to, general surgery, oral surgery, obstetrics/gynecology, urology, gastroenterology, ophthalmology, orthopedics, otorhinolaryngology, neurology, plastic surgery, podiatry, and pulmonary medicine. Such facility shall have no more than four operating rooms, excluding treatment and minor procedures rooms.

(15)(21) '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.

(16)(22) '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.

(16.1)(23) 'Operating room environment' means an environment which meets the minimum physical plant and operational standards specified for ambulatory surgical treatment centers in the permit and licensure rules of the department. on January 1, 1991, for ambulatory surgical treatment centers in Section 290-5-33-.10 of the rules of the Department of Human Resources.

(17)(24) '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 and entities, including 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.

(18)(25) 'Personal care home' means a residential facility 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.

(19) Reserved.

(20)(26) '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 clinical health service is offered or health facility established.

(21) 'Review board' means the Health Planning Review Board created by this chapter.

(27) '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.

(28) 'Single practice limited purpose ambulatory surgical facility' means an ambulatory surgical facility that is owned and utilized by a sole physician or a single group practice of physicians and that provides surgery in a single surgical field as may be verified by utilization of procedure codes appropriate for such surgical field. Such surgical fields shall include, but are not limited to, general surgery, oral surgery, obstetrics/gynecology, urology, gastroenterology, ophthalmology, orthopedics, otorhinolaryngology, neurology, plastic surgery, podiatry, and pulmonary medicine. Such facility shall have no more than four operating rooms, excluding treatment and minor procedures rooms.

(22)(29) '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.

(30) 'Specialty hospital' means an acute care facility qualified to be licensed as a hospital owned by physicians and dedicated to the provision of a single area of medicine or surgery, including but not limited to surgery, cardiology, orthopedics, or spine surgery, but excluding hospitals dedicated to psychiatric treatment, substance abuse, rehabilitation, long-term acute care, traumatic brain injury, or services to children.

(23)(31) 'State health plan' means a comprehensive program adopted based on recommendations by the Health Strategies Advisory 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.

(32) '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 Health Strategies Advisory 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 Health Strategies Advisory Council shall be the successor to the Health Policy Strategies Council. Those members of the previously existing Health Policy Strategies Council who are were serving as such on January 1, 1991 2007, shall continue to serve until July 1, 1991, September 30, 2007 at which time their terms shall expire and that council shall be abolished. On and after that date the council shall be composed of 25 15 members. Of those members, at least one shall be appointed from each congressional district. The council shall be composed as follows:

(1) One member representing county governments;

(2) One member representing the private insurance industry;

(3) Ten members representing health care providers as follows:

(A)(1) One member Two members each representing rural hospitals a hospital in a rural county;

(B)(2) One member Two members each representing urban hospitals a hospital in an urban county;

(C)(3) One member who is a board certified primary care physician in active practice;

(D)(4) One member who is a physician in a board certified surgical specialty, including the practice of general surgery;

(E) One member who is a registered professional nurse;

(F) One member who is a registered professional nurse who is certified as a nurse practitioner;

(G)(5) One member representing nursing homes;

(H)(6) One member representing home health agencies;

(7) One member representing a physician owned freestanding ambulatory surgical facility;

(8) One member representing the private insurance industry;

(I) One member representing primary care centers; and

(J) One member who is a primary care dentist;

(4) Ten consumer representatives who are knowledgeable as to health care needs in the fields they represent but who have no financial interest in the health care industry as follows:

(A)(9) One member representing health care needs of women and children and is a board certified pediatrician, obstetrician, or obstetrician/gynecologist in active practice;

(B) One member representing health care needs of children;

(C)(10) One member representing health care needs of the disabled and elderly;

(D) One member representing health care needs of the elderly;

(E)(11) One member representing health care needs of low-income persons the indigent;

(12) One member representing mental health care needs; and

(F)(13) One member representing health care needs of small business personnel.;

(G) One member representing health care needs of large business personnel;

(H) One member representing health care needs of labor organization members; and

(I) Two members who represent populations with special health care access problems; and

(5) Three at-large members.

(b) If the state obtains an additional member of the United States House of Representatives as a result of reapportionment, the Governor shall appoint, subject to confirmation by the Senate, from the new congressional district thus created one health care provider member who meets the requirements of subparagraph (a)(3)(J) of this Code section and one consumer member who meets the requirements of subparagraph (a)(4)(I) of this Code section as to a population specified in those subparagraphs which is not then represented on the council. With the addition of these two members, the council shall be composed of 27 members represents local or county government.

(c) The members of the council who are appointed to succeed those members whose terms expire July 1, 1991 September 30, 2007, shall take office July 1, 1991 October 1, 2007, and 12 seven of them shall be designated in such appointment to serve initial terms of office of two years and 13 eight of them shall be designated in such appointment to serve initial terms of office of four years. If two an additional members are member is appointed to the council to represent a new congressional district as provided in subsection (b) of this Code section, one said member shall be designated to serve an initial term of office which expires when the above initial two-year terms of office expire and one 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: by

(1) By the Governor after notice and opportunity for hearing for: incompetence, neglect of duty, or for failing

(A) Inability or neglect to perform the duties required of members;

(B) Incompetence; or

(2) For failure to attend at least 75 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 chairman 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 functions of the council shall be to:

(1) Adopt Review, comment, and make recommendations to the board on components of the state health plan and submit it to the board for approval which shall include all of the components of the council´s functions and be regularly updated;

(2) Review, Review and comment on, and make recommendations to the department on proposed rules for the administration of this chapter, except emergency rules, prior to their adoption as requested by the department;

(3) Conduct an ongoing evaluation of Georgia´s existing health care resources for accessibility, including but not limited to financial, geographic, cultural, and administrative accessibility, quality, comprehensiveness, and cost;

(4) Study long-term comprehensive approaches to providing health insurance coverage to the entire population; and

(5) Perform such other functions as may be specified for the council by the department or its board.

(h) The council shall prepare an annual report to the board and the General Assembly which presents information and updates on the functions outlined in subsection (g) of this Code section. The annual report shall include information for Georgia´s congressional delegation which highlights issues regarding federal laws and regulations influencing Medicaid and medicare, insurance and related tax laws, and long-term health care. The council shall not be required to distribute copies of the annual report to the members of the General Assembly but shall notify the members of the availability of the annual report in the manner which it deems to be most effective and efficient.

(i) The council at the department´s request shall involve and coordinate functions with such state entities as necessary.

(j) As used in subsections (g), (h), and (i) of this Code section, the term:

(1) 'Board' means the Board of Community Health established under Chapter 5A of this title.

(2) 'Department' means the Department of Community Health established under Chapter 5A of this title.

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 recommended by the Health Strategies Advisory Council and the board and approved by the board Governor. 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 components of the state health plan for review by and input from the Heath Strategies Advisory Council and for state health plan for submission to the Health Strategies Council for adoption and submission to the Governor;

(3) To assist the Health Strategies Council in the performance of its functions;

(4)(3) With the prior advice, comment, and recommendations as needed, of the Health Strategies Advisory Council, except with respect to emergency rules and regulations, to adopt, promulgate, and implement rules and regulations sufficient to administer the provisions of this chapter including the certificate of need program;

(5)(4) To define, by rule, the form, content, schedules, and procedures for submission of applications for certificates of need and periodic reports;

(6)(5) 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 preparing the record for appeals before the hearing officers and review board of the decisions of the department, which costs may include reasonable sharing between the department and the parties to appeal hearings;

(8)(6) To provide, by rule, for a reasonable and equitable fee schedule for certificate of need applications and other health planning determinations;

(7) To establish, by rule, uniform need methodologies for new institutional health services and health facilities. In developing such uniform 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;

(9)(8) To grant, deny, or suspend, revoke in whole or in part, or place conditions upon a certificate of need as applied for or as amended; and

(10)(9) 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 Social Security Act of 1935, as amended.

31-6-21.1. 31-6-22.

(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 and that the department shall not be required to comply with any provision of Chapter 13 of Title 50 in implementing moratoriums as permitted by subsection (j) of this Code section.

(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. 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 his 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 chairmen 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 his a veto, the rule shall remain in effect. In the event of his the Governor´s approval, the rule shall be void on the day after the date of his 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.

(j) The department may implement a temporary moratorium on the submission and review of certificate of need applications at such times when the department is considering developing review standards and criteria specific to a particular clinical health service or emerging technology, as defined by the department. Any such moratorium shall be implemented by issuance of a written policy statement approved and authorized by the board and shall not be in effect for a time period exceeding six months, except that the board may authorize a single extension of any such moratorium for an additional three-month period following expiration of the initial six-month period. Written policy statements implementing moratoriums pursuant to this subsection shall not be subject to subsections (b), (c), (d), (e), and (f) of this Code section.

(k) Beginning on July 1, 2008, the department shall not consider applications for specialty hospitals for a period of five years.

31-6-22. 31-6-23.

The department shall be directed by the commissioner of community health.

31-6-45. 31-6-24.

(a) The department may revoke a certificate of need in whole or in part, may suspend any certificate of need for a definite period or for a period of time until any condition which may be attached to the restoration of said certificate of need has been satisfied, or may impose a fine in connection with any condition under which a certificate of need was issued. Such actions may be taken after notice to the holder of the certificate and a fair hearing, if requested, held in accordance with subsection (i) of this Code section for any of the following reasons:

(1) Failure to comply with the provisions of Code Section 31-6-41;

(2) The intentional provision of false information to the department by an applicant in that applicant´s application; or

(3) Failure to substantially comply with any condition, including minimal volume and quality standards, upon which the certificate of need was granted.

The department may not, however, revoke a certificate of need if a certificate holder, prior to the implementation of a project for which a certificate of need has been granted, changes the defined location of the project within the same county less than three miles from the location specified in the certificate of need for financial reasons or other reasons beyond its control, including, but not limited to, failure to obtain any required approval from zoning or other governmental agencies or entities, provided such change in location is otherwise consistent with the considerations and rules applied in the evaluation of the project.

(b) Any health care facility offering a new clinical health service without having obtained a certificate of need and which has not previously received a certificate of need for such health care facility shall be denied a review of an application subject to a hearing pursuant to subsection (i) of this Code section. In addition, any health care facility that offers a service requiring a certificate of need pursuant to Code Section 31-6-40 without having obtained a certificate of need for such service shall be subject to suspension or revocation of its underlying certificate of need.

(c) In the event a service that requires a certificate of need pursuant to Code Section 31-6-40 is knowingly offered without having obtained a certificate of need as required by this chapter, or the certificate of need for such service is revoked according to the provisions of this Code section, a facility or applicant may be fined an amount not to exceed $5,000.00 per day for every day that the violation of this chapter has existed and knowingly and willingly continues for the first 30 days, an amount not to exceed $10,000.00 per day for every day that the violation of this chapter exists and knowingly and willingly continues beyond the first 30 days and through 60 days, and an amount not to exceed $25,000.00 per day for every day that the violation of this chapter exists and knowingly and willingly continues beyond 60 days; provided, however, that the expenditure or commitment of or incurring an obligation for the expenditure of funds to take or perform actions not subject to this chapter or to acquire, develop, or prepare a health care facility site for which a certificate of need application is denied shall not be a violation of this chapter and shall not be subject to such a fine. Any fine levied as provided in this Code section shall not be collected until an opportunity for a fair hearing has been provided pursuant to subsection (i) of this Code section.

(d) In addition, for purposes of this Code section, the State of Georgia, acting by and through the department, or any other interested person, shall have standing in any court of competent jurisdiction to maintain an action for injunctive relief to enforce the provisions of this chapter.

(e) Pursuant to a condition placed upon the issuance of a certificate of need or exemption pursuant to paragraph (1) of subsection (e) of Code Section 31-6-41, paragraph (9) or (10) of subsection (a) of Code Section 31-6-47, or paragraph (1) of subsection (e) of Code Section 31-6-47, a certificate holder or exemption holder may be fined an amount equal to the difference in the monetary amount of clinical health services to indigent and charity care patients on which the certificate of need was predicated and the monetary amount actually provided by the certificate holder or exemption holder. Any fine levied as provided in this subsection shall not be collected until an opportunity for a fair hearing has been provided pursuant to subsection (i) of this Code section.

(f) For purposes of this Code section, the State of Georgia, acting by and through the department, may in its discretion by settlement dispose of an enforcement or sanctioning action enforced pursuant to this Code section. In such cases, all parties, successors, and assigns to any settlement agreement shall be bound by the terms specified in the settlement, and violation thereof by any certificate holder or any exemption holder shall constitute grounds for any action enumerated in subsection (a) of this Code section.

(g) The department shall have the authority to make public or private investigations or examinations inside or outside of this state to determine whether all provisions of this Code section or any other law, rule, regulation, or formal order relating to the provisions of Code Section 31-6-40 has been violated. Such investigations may be initiated at any time in the discretion of the department and may continue during the pendency of any action initiated by the department pursuant to subsection (a) of this Code section. For the purpose of conducting any investigation or inspection pursuant to this subsection, the department shall have the authority to require the production of any books, records, papers, or other information related to any certificate of need issue.

(h) Pursuant to the investigation, enforcement, and sanctioning powers given to the department by this Code section and other applicable laws, the department may assess against any health care facility reasonable and necessary expenses incurred by the department during any administrative or legal action required by the failure of the health care facility to fully comply with the provisions of any law, rule, regulation, or formal order related to its certificate of need or application. Assessments shall not include attorney´s fees and expenses of litigation, shall not exceed other actual expenses, and shall only be assessed if such investigations, enforcement, or sanctioning actions result in adverse findings, as finally determined by the department.

(i) Any enforcement action or sanction undertaken by the department pursuant to this Code section shall be reviewable by a fair hearing, if requested, pursuant to the provisions of Chapter 13 of Title 50, except that such hearing must be requested within ten business days of the date of the enforcement or sanctioning action and a timely requested hearing shall then be convened within 20 days.

(j) In an administrative or legal proceeding under this Code section, a person or entity claiming an exemption or an exception granted by law, rule, regulation, or formal order has the burden of proving this exemption or exception.

(k) The department is authorized to promulgate rules and regulations to implement the provisions of this Code section.

31-6-25.

A health care facility which has a certificate of need or is otherwise authorized to operate pursuant to this chapter shall have such certificate of need automatically revoked by operation of law without any action by the department when that facility´s permit to operate is finally revoked pursuant to Code Section 31-7-4 by order of the department. For purposes of this subsection, the date of such final revocation shall be as follows:

(1) When there is no appeal of the order pursuant to Article 2 of Chapter 5A of this title, the one hundred and eightieth day after the date upon which expires the time for appealing the revocation order without such an appeal being filed; or

(2) When there is an appeal of the order pursuant to Article 2 of Chapter 5A of this title, the date upon which expires the time to appeal the last administrative or judicial order affirming or approving the revocation or revocation order without such appeal being filed.

ARTICLE 3

31-6-40.

(a) From and after July 1, 1999, only such new institutional health services or health care facilities as are found by the department to be needed shall be offered in the state. Prior to that date, only such new institutional health services or health care facilities which had been found to be needed by the Health Planning Agency under any prior provisions of this chapter and the regulations issued thereunder shall have been offered in the state, unless otherwise exempt from the requirements of the law or unless that law was not applicable. It is the intent of this provision to assure that no new institutional health services or health care facilities, as defined prior to July 1, 1999, are allowed to avoid the requirements of any prior provisions of this chapter, and applicable regulations, if those laws and regulations were applicable to them.

(b) Any person proposing to develop or offer a new institutional health service or health care facility shall, before commencing such activity, submit 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 offered new institutional health services, as defined only in subparagraphs (G) and (H) of paragraph (14) of Code Section 31-6-2, within the 12 month period prior to July 1, 1999, and for which services a certificate of need was not required under the provisions of this chapter as they existed prior to July 1, 1999, shall not be required to obtain a certificate of need in order to continue to offer those previously offered services after that date if that person obtains an exemption therefor as provided in this subsection.

(1.1) Any person who, on July 1, 1999:

(A) Has in place a valid written contract of purchase, construction, or assembly for purposes of offering new institutional health services, as defined only in subparagraphs (G) and (H) of paragraph (14) of Code Section 31-6-2;

(B) Has prior to said date paid in cash or made an irrevocable and secured commitment or obligation of a minimum of 30 percent of the price called for under said contract;

(D) Has notified the Health Planning Agency no later than July 1, 1991, of that person´s intent to apply for an exemption under this paragraph

shall not be required to obtain a certificate of need in order to offer those services if that person obtains an exemption therefor as provided in this subsection.

(2) A person claiming an exemption under paragraph (1) or (1.1) of this subsection shall apply to the Health Planning Agency for that exemption no later than July 1, 1992. The application shall be in such form and manner as established by the Health Planning Agency to provide sufficient proof that the applicant qualifies for the exemption claimed. The Health Planning Agency shall notify the applicant within 90 days after the required application and proof have been properly submitted that the application for exemption is denied; otherwise, the application shall be deemed granted by operation of law upon the ninety-first day. Such a grant of the exemption shall be final and no appeal therefrom shall be authorized. A denial of such application for exemption shall constitute a contested case under Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.' Any person having a certificate of need or authorization to offer the services for which an application for exemption has been denied may intervene in the contested case if such person offers those services within the same service area as the service area in which were to be offered the services for which the application for exemption was denied.

(3) A person who claims an exemption pursuant to this subsection may continue to offer the services for which the exemption may be claimed without applying for the exemption, but those services may not be offered after October 1, 1992, or any date prior thereto upon which a decision denying the exemption has become final unless:

(A) The person applied for the exemption as provided in paragraph (2) of this subsection but on October 1, 1992, there has either been no decision made denying the exemption or a decision denying the exemption has not become final, in either of which events the services for which the application for exemption was made may be offered until there is a final decision denying the exemption;

(B) The person is granted the exemption; or

For purposes of this subsection, a decision denying an application for an exemption shall become final when the time for appealing that decision expires without an appeal of such decision having been properly made.

(4) An exemption obtained pursuant to this subsection may be transferred to another person if the department is notified thereof within 45 days after the transfer occurs.

(5) The Health Planning Agency shall establish procedures for obtaining exemptions under this subsection and shall publish a list not later than October 1, 1992, of all such applications granted or pending on that date.

(d) Any person that had formally requested, prior to February 1, 1991, a determination from the Health Planning Agency of the applicability of the certificate of need requirements for a specific project that is subsequently approved by the Health Planning Agency or by appeal of the Health Planning Agency´s denial shall be exempt under the provisions of this chapter from the requirement of obtaining a certificate of need for that project.

(a) Unless exempt under Code Section 31-6-47, from and after October 1, 2007, all health care related projects, as described in this subsection, are subject to review and must file an application for a certificate of need with the department. The department is exclusively authorized to determine whether a health care related project is subject to review under this chapter. Health care related projects include:

(1) The construction, development, or other establishment of a new health care facility;

(2)(A) Any expenditure by or on behalf of a skilled nursing facility or intermediate care facility in excess of $1,750,000.00 which, under generally accepted accounting principles consistently applied, is a capital expenditure, except expenditures for acquisition of an existing skilled nursing facility or intermediate 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; or

(B) The purchase or lease by or on behalf of a health care facility or a diagnostic, treatment, or rehabilitation center located in an urban county of diagnostic or therapeutic equipment with a value in excess of $1,500,000.00. The acquisition of one or more items of functionally related diagnostic or therapeutic equipment shall be considered as one project.

The dollar amounts specified in this paragraph shall be adjusted annually by an amount calculated by multiplying each such dollar amount as adjusted for the preceding year by the annual percentage change in a composite construction index representing national construction prices published by the United States government for the preceding calendar year, commencing on October 1, 2008, and on each anniversary thereafter of publication of such index. In calculating the dollar amount of a proposed project for 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, or preliminary plans and specifications or working drawings or to acquire sites;

(3) The provision of diagnostic imaging services in a rural county utilizing equipment that includes, but is not limited to, 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;

(4) Any increase in the bed capacity of a health care facility or in the bed capacity of a clinical health service except as provided in Code Section 31-6-47;

(5) Any increase in the number of freestanding ambulatory surgery operating rooms except as provided in Code Section 31-6-47;

(6) Any increase in the number of units of major radiation therapy or radiosurgical equipment;

(7) Any increase in the counties served by a home health agency, except for the transfer of counties from one licensed home health agency to another as may be provided for by the department´s rules;

(8) Clinical health services which are offered in or through a health care facility, except for a diagnostic, treatment, or rehabilitation center, 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;

(9) Any conversion or upgrading 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

(10) 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;

(D) Surgery in an operating room environment; and

(E) Cardiac catheterization.

(b) It shall be unlawful for any person to undertake a project subject to review pursuant to subsection (a) of this Code section without a valid certificate 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.

(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. A grantee or successor in interest of a certificate of need or an authorization to operate under this chapter which violates such an agreement, whether made before or after July 1, 1991, 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. Any penalty so recovered shall be paid into the state treasury.

(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.

(6) '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 Indigent Care Survey and related instructions.

(7) 'Year' means one of the three consecutive 12 month periods in a new perinatal service´s 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) Subject to conditions placed on a A certificate of need, such certificate 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. In addition, a certificate of need shall be valid for an alternate location if the existing facility that holds the certificate of need is relocated pursuant to an exemption contained in Code Section 31-6-47. For purposes of a home health agency, the defined location shall be the individual counties approved to be served in the certificate of need application.

(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 A certificate holder shall implement a project for which a certificate of need has been obtained within 12 months of the issuance of the certificate of need. Implementation means that a certificate holder 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 implementation period of a certificate of need when an applicant a certificate holder, by petition, makes a good faith showing that the conditions to be specified according to subsection (b) of this Code section will be performed project will be implemented within the extended period and that the reasons for the extension are beyond the control of the applicant.

(c) A certificate holder shall complete the project and begin offering the clinical health service, if applicable, within five years of the issuance of the certificate of need for hospitals and hospital related projects and within three years of the issuance of the certificate of need for all other projects. By rule, the department may provide for extension of the completion period of a certificate of need when a certificate holder, by petition, makes a good faith showing that the project will be completed within the extended period and that the reasons for the extension are beyond the control of the applicant.

(d) Provided that a certificate holder has complied with subsections (b) and (c) of this Code section, a certificate of need shall be valid and effective until the certificate holder ceases offering a service authorized by the certificate of need for a period in excess of 12 months or until the certificate of need is revoked or suspended pursuant to Code Section 31-6-24.

(e) On or after October 1, 2007, the department may issue a certificate of need predicated upon statements of intent expressed by an applicant in the application for a certificate of need or predicated upon conditions to which an applicant has agreed during the review process. Any conditions imposed on a certificate of need based on such statements of intent or upon such agreement shall be stated on the face of the certificate of need. Pursuant to this subsection, the department may issue one or more conditions as a condition for the grant of a certificate of need, including, but not limited to, the following:

(1) An agreement to provide a specified amount of clinical health services to indigent and charity care patients the amount of which may range from 1 percent to 6 percent of the adjusted gross revenue of the applicant as may be specified by rule by the department. For purposes of this paragraph, the department shall apply the medicare allowable amount or, if no such amount exists, the Medicaid allowable amount plus 10 percent;

(2) An agreement to participate in Medicaid or the PeachCare for Kids Program;

(3) An agreement to provide a clinical health service for which the department, by written policy statement, has designated as underrepresented. The department shall issue written policy statements at least annually delineating the services which are designated as underrepresented in this state; and

(4) An intent to obtain minimum volumes associated with the offering of a clinical health service, except that the department may not revoke a certificate of need for failure to meet this condition unless a certificate holder has failed to substantially comply with the minimum volume condition. For purposes of this paragraph, 'subst