hb581_LC_33_1949_a

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07 LC 33 1949

House Bill 581

By: Representatives Channell of the 116th, Manning of the 32nd, Stephenson of the 92nd, Carter of the 159th, Mitchell of the 88th, and others

A BILL TO BE ENTITLED
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 the declaration of policy for state health planning; to revise and add definitions; to revise the composition and duties of the Health Strategies Council; to revise the duties of the Department of Community Health; to provide for graduated fines for noncompliance with notice provisions; to revise provisions relating to the scope and validity of a certificate of need; to provide for specific conditions for the issuance of a certificate of need; to provide for the establishment of service-specific need methodologies in certain cases; to provide for favorable consideration for applicants providing services in underrepresented areas; to provide for a letter of intent for proposed projects; to provide for batching and comparative review of applications; to provide for participation of opposing parties; to provide for the imposition of a temporary moratorium on the issuance of certificates of need for new and emerging technologies; to establish a Certificate of Need Appeal Panel composed of independent hearing officers; to revise provisions relating to administrative and judicial review; 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; to provide graduated fines for services conducted without a required certificate of need; to add requirements relating to the annual report prepared by the Department of Community Health; to revise provisions relating to exemptions to certificate of need requirements; to require provision of indigent care, participation as a Medicaid provider, and annual reporting as a condition of exemption from certificate of need requirements for certain entities; to require prior notice to the Department of Community Health that certain activities are exempt from the certificate of need requirements; to provide for transfer of some duties from the Health Strategies Council to the Board of Community Health; 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 others to submit annual reports to the Department of Community Health; to provide graduated fines for untimely and incomplete reports; to revise a provision relating to the applicability of the article regarding the Office of State Administrative Hearings; 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 the licensing of freestanding imaging centers; 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 effective dates; to repeal conflicting laws; and for other purposes.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:

PART I
Revisions to 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 adequate 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 those public policy policies and purpose 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, 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 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 arising from unforeseen complications of low-risk pregnancies; 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. This term shall not include neonatal intermediate care or neonatal intensive care.

(3)(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 of Human Resources 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.

(4)(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' means the panel of independent hearing officers created pursuant to Code Section 31-6-44 to conduct de novo evidentiary appeal hearings.

(5)(8) 'Clinical health services' means diagnostic, treatment, therapeutic, 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 community health.

(6)(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 which offers a 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 for at least one year and may be for as long as the lifetime of the resident.

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

(7)(13) 'Develop,' with reference to a project, means:

(A) Constructing 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 for orders, purchases, leases, or acquisitions through other comparable arrangements of major medical equipment.

Notwithstanding subparagraphs (A) and (B) of this paragraph, the threshold specified in subparagraph (B) of paragraph (23) of this Code section; provided, however, that 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.

(14) 'Diagnostic and other imaging services' 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.

(7.1)(15) '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.

(8)(16) '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, but only those that are certified as providers of medical assistance for Medicaid purposes pursuant to Article 7 of Chapter 4 of Title 49; ambulatory surgical or obstetrical facilities; health maintenance organizations; home health agencies; and diagnostic, treatment, or rehabilitation centers, but only to the extent that subparagraph (F)(G) or (H), or both subparagraphs (G) and (H), of paragraph (14)(23) of this Code section are 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)(17) '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)(18) 'Health Strategies Council' or 'council' means the body created by this chapter to advise the Department of Community Health in accordance with Code Section 31-6-20 and adopt the state health plan.

(11)(19) '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)(20) '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.

(21) 'Imaging center' means a freestanding facility which provides diagnostic and other imaging services.

(13)(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.

(14)(23) '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 $1,750,000.00 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; or

(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)(F) Clinical health services which are offered in or through a diagnostic, treatment, or rehabilitation center which were not offered to a substantial number of patients 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 and

(v) Diagnostic and other imaging services.

For purposes of this subparagraph, general surgery and other single specialties shall be treated in a consistent manner.

(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 subparagraph (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 2007, and on each anniversary thereafter of publication of the index. The department shall immediately institute rule-making procedures to adopt publish such adjusted dollar amounts annually. In calculating the dollar amounts amount of a proposed project for purposes of subparagraphs subparagraph (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.

(24) 'New or emerging technology' means diagnostic or therapeutic equipment which has not previously been utilized in this state and the need for which has not been addressed in the state health plan or existing department rules.

(15)(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.

(16)(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.

(16.1)(27) 'Operating room environment' means an environment which meets the minimum physical plant and operational standards specified on January 1, 1991, for ambulatory surgical treatment centers in Section 290-5-33-.10 of for purposes of obtaining a permit or license to operate in the rules of the Department of Human Resources in effect January 1, 2007, or any successor rules adopted by the department.

(17)(28) '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.

(18)(29) '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)(30) '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.

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

(22)(31) '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.

(23)(32) 'State health plan' means a comprehensive program or subcomponents thereof adopted by the Health Strategies Council or by the board as its successor for this purpose, 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.

ARTICLE 2

31-6-20.

(a) There is created a 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 Health Strategies Council, that shall be the successor to the Health Policy Strategies Council in existence on June 30, 2007. Those members of the previously existing Health Policy Strategies Council who are serving as such on January 1, 1991, shall continue to serve until July 1, 1991, at which time June 30, 2007, shall have their terms shall expire on that date and that council as it existed on June 30, 2007, shall be abolished. On and after that date July 1, 2007, the council shall be composed of 25 13 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 urban hospitals;

(2) One member representing the private insurance industry rural hospitals;

(3) One member representing the private insurance industry;

(4) One member who is a primary care physician;

(5) One member who is a physician in a board certified specialty;

(6) One member representing freestanding ambulatory surgical centers;

(7) One member representing the nursing home/long-term care industry;

(8) One member representing home health agencies;

(9) One member representing health care needs of women and children;

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

(11) One member representing health care needs of the indigent and uninsured;

(12) One member who represents populations with mental health care needs; and

(13) One member representing health care needs as it relates to business.

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

(A) One member representing rural hospitals;

(B) One member representing urban hospitals;

(D) One member who is a physician in a board certified specialty;

(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) One member representing nursing homes;

(H) One member representing home health agencies;

(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) One member representing health care needs of women;

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

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

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

(F) 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 or members of the United States House of Representatives as a result of reapportionment, the Governor shall appoint, subject to confirmation by the Senate, from the each new congressional district thus created at least one additional member representing local or county governments 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.

(c) The initial members of the reconstituted council who are appointed to succeed those members whose terms expire July 1, 1991, shall take office July 1, 1991 2007, and 12 eight of them shall be designated in such appointment to serve initial terms of office of two years and 13 seven of them shall be designated in such appointment to serve initial terms of office of four years. If two additional members are appointed to the council to represent a new congressional district as provided in subsection (b) of this Code section, one half of such additional members 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 of such additional members 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 the Governor for incompetence, neglect of duty, at his or her discretion, with or without cause, or for removal by the chairperson of the council or for failing to attend at least 75 50 percent of the meetings of the council in any calendar year or failing to attend any three consecutive meetings. 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 council shall meet no less often than bimonthly, but may meet more frequently at the call of the chairperson as necessary to perform its functions.

(g)(h) The functions function of the council shall be to serve as an advisory body to the department. The department shall be authorized to seek input from the council and its technical advisory committees on proposed changes to rules and regulations relative to this chapter and to the state health plan.:

(1) Adopt 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 review;

(2) Review, comment on, and make recommendations to the department on proposed rules for the administration of this chapter, except emergency rules, prior to their adoption 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 consistent with the laws of the State of Georgia, a state health plan adopted by the Health Strategies Council and approved by the board 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 or components thereof of the state health plan which relate to the government of the state;

(2) To prepare and revise a draft state health plan for submission to the Health Strategies Council for adoption by the board and submission to the Governor;

(3) To assist seek advice, at its discretion, from the Health Strategies Council in the performance by the department of its functions pursuant to this chapter;

(4) With the prior advice, comment, and recommendations of the Health Strategies Council, except with respect to emergency rules and regulations, to 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 preparing the record for appeals before the hearing officers and review board Certificate of Need Appeal Panel of the decisions of the department, which costs may include reasonable sharing between the department and the parties to appeal hearings;

(8) For the purpose of health planning and for the evaluation of certificate of need applications, to develop and maintain a comprehensive health care data base and to require the submission of information from health care facilities and institutions which is determined by the department, through rule, to be necessary to meet the department´s responsibilities as established in this chapter;

(9) 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;

(10) To provide sufficient staffing to perform its duties under this chapter and to periodically review and determine its budgeting and staffing needs;

(8)(11) To provide, by rule, for a reasonable and equitable fee schedule for certificate of need applications and administrative appeals;

(9)(12) To grant, deny, or revoke a certificate of need as applied for or as amended; and

(10)(13) 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.

(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 the 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 such 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.

31-6-22.

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

ARTICLE 3

31-6-40.

(a) From and after July 1, 1999 the effective date of this Act for purposes of diagnostic and other imaging services and ambulatory surgical centers, and from and after July 1, 2007, for all other new institutional health services and health care facilities, only such new institutional health services or and 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 and health care facilities which had been found to be needed by the department or its predecessor, 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 the effective date of this Act, 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, offering diagnostic and other imaging services and ambulatory surgical services pursuant to an exemption from the requirements of this chapter as of the effective date of this subsection 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.

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 up to $1,000.00 per day for each day that such notification is late. The fine imposed pursuant to this subsection shall increase to $5,000.00 per day upon the seventy-fifth day following the acquisition for each day thereafter that notification has not been made. Such fine or fines 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; and

(4) New and emerging technologies,

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 July 1, 2007, 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) 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; provided, however, that a certificate holder may relocate pursuant to paragraph (17) of subsection (a) of Code Section 31-6-47. 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; provided, however, that a certificate holder may relocate pursuant to paragraph (17) of subsection (a) of Code Section 31-6-47.

(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. The license or permit of any health care facility or institutional health services provider subject to the provisions of this chapter shall specify the number of beds and identify the clinical health services authorized or exempted by the department pursuant to this chapter.

(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.

31-6-41.1.

(a) The department may require that an applicant agree to meet certain specified conditions, either prescribed by applicable rule or based upon representations of intent by the applicant in the application, in order to obtain a certificate of need and may issue a certificate of need predicated upon the applicant´s compliance with those conditions. Any such conditions imposed on a certificate of need specified by the department shall be stated by the department in its decision to grant the certificate and on the face of the certificate of need issued to the applicant.

(b) The department may revoke the certificate of need, assess a monetary penalty against the certificate holders, or both, if the holder of a certificate of need fails to comply substantially with a condition imposed pursuant to subsection (a) of this Code section. The maximum amount of the fine imposed shall not exceed $5,000.00 per failure per day of noncompliance. The department shall promulgate rules for reporting compliance with conditions imposed on a certificate of need. Failure by the certificate holder to report compliance with any condition upon which the issuance of the certificate was granted shall constitute noncompliance. In assessing the appropriate penalty, the department shall take into account as mitigation the degree of noncompliance and good cause demonstrated by the certificate holder.

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 (d)(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; and

(14) The applicant for the proposed new institutional health service:

(A) If an existing health care facility, demonstrates that it provides high quality care and complies fully with relevant licensure and accreditation standards; or

(B) If not an existing provider, demonstrates that it will provide quality care and will comply fully with relevant licensure and accreditation standards; and

(14)(15) The proposed new institutional health service fosters the special needs and circumstances of health maintenance organizations.

(b) No later than January 1, 2008, the department shall develop and adopt a service-specific need methodology for each clinical health service and for all diagnostic and other imaging services; diagnostic, treatment, or rehabilitation centers; and diagnostic imaging and therapeutic equipment subject to review under this chapter.

(b)(c) 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.

(d) In the case of applications that are joined for comparative review, the department may give favorable consideration to projects and applicants where the applicant agrees to provide a clinical health service that is underrepresented in the service area of the proposed project, and the department shall condition the award of a certificate of need upon the applicant´s providing such underrepresented clinical health service. Such favorable consideration shall only be available where each applicant competing in the comparative review may provide such underrepresented clinical health services.

(c)(e) 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 favorable 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)(f) 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)(g) The department shall specify in its written findings of fact and decision which of the considerations contained in this Code section and in the department´s applicable rules are applicable to an application and its reasoning as to and any evidentiary support for its evaluation of each such applicable consideration and rule.

31-6-43.

(a) 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 will be developed that the application has been deemed complete and shall publish notice of the application in a department tracking report established for these purposes. 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. If the requested information is not filed with the department within 14 days of the date of the notice, the application shall be deemed incomplete and deemed withdrawn from consideration. The applicant shall be afforded an opportunity to correct such deficiencies, and upon such correction If the applicant corrects such deficiencies, 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 will be developed that the application has been so declared and notice published in the department tracking report. 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.

(b) At least 45 days prior to filing an application, the applicant shall file a letter of intent with the department respecting the development of a project subject to review. The department shall provide by rule a process for filing letters of intent and a mechanism by which applications may be filed to compete with and be reviewed comparatively with proposals described in filed letters of intent. Letters of intent must describe the proposal; specify the number of beds sought, if any; identify the services to be provided and the specific location and service area; and identify the applicant. Within 14 days after receipt of a letter of intent, the department shall publish notice of the letter of intent in the department tracking report.

(b)(c) An The department shall specify by rule the time within which an applicant may amend its application, but no amendment shall be allowed at any time no later than ten days prior to the end within 30 days of the end of the review period, and the department may request an applicant to make amendments an amendment. The department decision shall be made on an application as amended, if at all, by the applicant.

(c)(d) Except as provided in subsection (d) of this Code section, there There shall be a time limit of 90 120 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 90 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 shall 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.

(d)(f) The department may order the joinder of shall join 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 the:

(1) The first and subsequent applications involve similar projects in the same service area or overlapping medical 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.