CHAPTER 323D - HEALTH PLANNING AND RESOURCES DEVELOPMENT AND HEALTH CARE COST CONTROL

PART I. GENERAL PROVISIONS SECTION

323D-1 PURPOSE

323D-2 DEFINITIONS

PART II. STATE HEALTH PLANNING AND DEVELOPMENT PROGRAM

323D-11 STATE HEALTH PLANNING AND DEVELOPMENT AGENCY

323D-12 HEALTH PLANNING AND DEVELOPMENT FUNCTIONS; STATE AGENCY

323D-12.5 REPEALED

323D-13 STATEWIDE HEALTH COORDINATING COUNCIL

323D-13.5 DISQUALIFICATION FROM POSITION OR MEMBERSHIP

323D-14 FUNCTIONS; STATEWIDE HEALTH COORDINATING COUNCIL

323D-15 STATE HEALTH SERVICES AND FACILITIES PLAN

323D-16 ANNUAL IMPLEMENTATION PLAN

323D-17 PUBLIC HEARINGS REQUIRED

323D-18 INFORMATION REQUIRED OF PROVIDERS

323D-18.5 INFORMATION FROM PROVIDERS OF HEALTH INSURANCE

323D-18.6 CONFIDENTIALITY OF INFORMATION

PART III. SUBAREA HEALTH PLANNING COUNCILS

323D-21 SUBAREA HEALTH PLANNING COUNCILS, ESTABLISHED

323D-22 SUBAREA HEALTH PLANNING COUNCILS, FUNCTIONS, QUORUM AND NUMBER OF MEMBERS NECESSARY TO TAKE VALID ACTION

323D-23 SUBAREA HEALTH PLANNING COUNCILS, COMPOSITION, APPOINTMENT

323D-24 TO 27 REPEALED

PART IV. STATE MEDICAL FACILITIES

323D-31 TO 33 REPEALED

PART V. CERTIFICATE OF NEED

323D-41 REPEALED

323D-42 REVIEW PANEL

323D-43 CERTIFICATES OF NEED

323D-44 APPLICATIONS FOR CERTIFICATES OF NEED

323D-44.5 ADMINISTRATIVE REVIEW OF CERTAIN APPLICATIONS FOR CERTIFICATE OF NEED

323D-44.6 REVIEW OF CERTAIN APPLICATIONS FOR CERTIFICATE OF NEED; WAIVER

323D-44.7 MONITORING OF APPROVED CERTIFICATES OF NEED

323D-45 SUBAREA COUNCIL, REVIEW PANEL, AND STATEWIDE COUNCIL RECOMMENDATIONS FOR ISSUANCE OR DENIAL OF CERTIFICATES OF NEED

323D-45.1 EX PARTE CONTACTS PROHIBITED

323D-45.2 REPEALED

323D-45.3 APPROVAL OF APPLICATIONS REQUIRED TO MEET SAFETY, LICENSURE, OR ACCREDITATION STANDARDS

323D-46 CONDITIONAL CERTIFICATION

323D-46.1 REPEALED

323D-46.2 WITHDRAWAL OF A CERTIFICATE OF NEED

323D-47 REQUEST FOR RECONSIDERATION

323D-48 JUDICIAL REVIEW OF STATE AGENCY DECISIONS

323D-49 CERTIFICATES OF NEED, LICENSES AND PERMITS

323D-50 CERTIFICATES OF NEED, PENALTIES

323D-51 INJUNCTIVE RELIEF

323D-52 LETTERS OF INTENT

323D-53 PERIODIC REPORTS FROM HEALTH FACILITIES

323D-54 EXEMPTIONS FROM CERTIFICATE OF NEED REQUIREMENTS

323D-55 REPEALED

PART VI. GENERAL ADMINISTRATION

323D-61 PERSONNEL

323D-62 RULES

PART I. GENERAL PROVISIONS

§323D-1 Purpose. The purpose of this chapter is to establish a health planning and resources development program to promote accessibility for all the people of the State to quality health care services at reasonable cost.

§323D-2 Definitions. As used in this chapter:

"Annual implementation plan" means the annual program plan pursuant to section 323D-16.

"Applicant" means any person who applies for a certificate of need under part V.

"Capital expenditure" means any purchase or transfer of money or anything of value or enforceable promise or agreement to purchase or transfer money or anything of value incurred by or in behalf of any person for construction, expansion, alteration, conversion, development, initiation, or modification as defined in this section. The term includes the:

(1) Cost of studies, surveys, designs, plans, working drawings, specifications, and other preliminaries necessary for construction, expansion, alteration, conversion, development, initiation, or modification;

(2) Fair market values of facilities and equipment obtained by donation or lease or comparable arrangements as though the items had been acquired by purchase; and

(3) Fair market values of facilities and equipment transferred for less than fair market value, if a transfer of the facilities or equipment at fair market value would be subject to review under section 323D-43.

"Certificate of need" means an authorization, when required pursuant to section 323D-43, to construct, expand, alter, or convert a health care facility or to initiate, expand, develop, or modify a health care service.

"Construct", "expand", "alter", "convert", "develop", "initiate", or "modify" includes the erection, building, reconstruction, modernization, improvement, purchase, acquisition, or establishment of a health care facility or health care service; the purchase or acquisition of equipment attendant to the delivery of health care service and the instruction or supervision therefor; the arrangement or commitment for financing the offering or development of a health care facility or health care service; any obligation for a capital expenditure by a health care facility; and studies, surveys, designs, plans, working drawings, specifications, procedures, and other actions necessary for any such undertaking, which will:

(1) Result in a total capital expenditure in excess of the expenditure minimum,

(2) Substantially modify, decrease, or increase the scope or type of health service rendered, or

(3) Increase, decrease, or change the class of usage of the bed complement of a health care facility.

"Expenditure minimum" means $4,000,000 for capital expenditures, $1,000,000 for new or replacement medical equipment and $400,000 for used medical equipment.

"Health" includes physical and mental health.

"Health care facility" and "health care service" include any program, institution, place, building, or agency, or portion thereof, private or public, other than federal facilities or services, whether organized for profit or not, used, operated, or designed to provide medical diagnosis, treatment, nursing, rehabilitative, or preventive care to any person or persons. The terms include, but are not limited to, health care facilities and health care services commonly referred to as hospitals, extended care and rehabilitation centers, nursing homes, skilled nursing facilities, intermediate care facilities, hospices for the terminally ill that require licensure or certification by the department of health, kidney disease treatment centers including freestanding hemodialysis units, outpatient clinics, organized ambulatory health care facilities, emergency care facilities and centers, home health agencies, health maintenance organizations, and others providing similarly organized services regardless of nomenclature.

"Health care provider" means a health care facility, physician, dentist licensed under chapter 448, chiropractor licensed under chapter 442, optometrist licensed under chapter 459, podiatrist licensed under chapter 463E, psychologist licensed under chapter 465, occupational therapist subject to chapter 457G, and physical therapist licensed under chapter 461J.

"Organized ambulatory health care facility" means a facility not part of a hospital, which is organized and operated to provide health services to outpatients. This term includes the following facilities: clinical health centers; diagnostic centers; treatment centers; family planning clinics; family health centers; neighborhood health centers; ambulatory surgical facilities; cosmetic surgery centers; optometric clinics; community mental health and mental retardation centers; outpatient mental health facilities; prenatal or abortion clinics; drug abuse or alcoholism treatment centers; facilities for the provision of outpatient physical therapy services including speech pathology; rehabilitation facilities; any provision of medical or health services by a provider of medical or health services organized as a not-for-profit or business corporation other than a professional corporation; and any provider of nonbed services as defined in the agency's rules of standard categories of health care services. The state agency may adopt rules to establish further criteria for differentiating between the private practice of medicine and organized ambulatory health care facilities.

"Person" means an individual or a natural person, a trust or estate, a society, a firm, an assembly, a partnership, a corporation, a professional corporation, an association, the State, any political subdivision of the State, a county, a state agency or any instrumentality of the State, a county agency or any instrumentality of a county.

"Physician" means a doctor of medicine or osteopathy who is legally authorized to practice medicine and surgery by the State.

"Review panel" means the panel established pursuant to section 323D-42.

"Secretary" means the secretary of the United States Department of Health and Human Services, or the secretary of the federal agency that is the successor to the United States Department of Health and Human Services.

"State agency" means the state health planning and development agency established in section 323D-11.

"State health services and facilities plan" means the comprehensive plan for the economical delivery of health services in the State prepared by the statewide council.

"Statewide council" means the statewide health coordinating council established in section 323D-13.

"Subarea" means one of the geographic subareas designated by the state agency pursuant to section 323D-21.

"Subarea council" means a subarea health planning council established pursuant to section 323D-21.

"Substantially modify, decrease, or increase the scope or type of health service" refers to the establishment of a new health care facility or health care service or the addition of a clinically related (i.e., diagnostic, curative, or rehabilitative) service not previously provided or the termination of such a service which had previously been provided.

PART II. STATE HEALTH PLANNING AND DEVELOPMENT PROGRAM

§323D-11 State health planning and development agency. There is established within the department of health for administrative purposes only, the state health planning and development agency. The state agency shall be headed by an administrator who shall be appointed by the governor subject to section 2634. The state agency shall administer the state health planning and cost containment activities as required by law.

§323D-12 Health planning and development functions; state agency.

(a) The state agency shall:

(1) Have as a principal function the responsibility for controlling increases in health care costs. The state agency shall conduct such studies and investigations as may be necessary as to the causes of health care costs including inflation. The state agency may contract for services to implement this paragraph. The certificate of need program mandated under part V shall serve this function. The state agency shall promote the sharing of facilities or services by health care providers whenever possible to achieve economies and shall restrict unusual or unusually costly services to individual facilities or providers where appropriate.

(2) Serve as staff to and provide technical assistance and advice to the statewide council and the subarea councils in the preparation, review, and revision of the state health services and facilities plan.

(3) Conduct the health planning activities of the State in coordination with the subarea councils, implement the state health services and facilities plan, and determine the statewide health needs of the State after consulting with the statewide council.

(4) Administer the state certificate of need program pursuant to part V.

(b) The state agency may:

(1) Prepare such reports and recommendations on Hawaii's health care costs and public or private efforts to reduce or control costs and health care quality as it deems necessary. The report may include, but not be limited to, a review of health insurance plans, the availability of various kinds of health insurance and malpractice insurance to consumers, and strategies for increasing competition in the health insurance field.

(2) Prepare and revise as necessary the state health services and facilities plan.

(3) Prepare, review, and revise the annual implementation plan.

(4) Assist the statewide council in the performance of its functions.

(5) Determine the need for new health services proposed to be offered within the State.

(6) Assess existing health care services and facilities to determine whether there are redundant, excessive, or inappropriate services or facilities and make public findings of any that are found to be so. The state agency shall weigh the costs of the health care services or facilities against the benefits the services or facilities provide and there shall be a negative presumption against marginal services.

(7) Provide technical assistance to persons, public or private, in obtaining and filling out the necessary forms for the development of projects and programs.

(8) Prepare reports, studies, and recommendations on emerging health issues, such as medical ethics, health care rationing, involuntary care, care for the indigent, and standards for research and development of biotechnology and genetic engineering.

(9) Conduct such other activities as are necessary to meet the purposes of this chapter.

§323D-12.5 REPEALED.

§323D-13 Statewide health coordinating council. (a) There is established a statewide health coordinating council which shall be advisory to the state agency and the membership of which as appointed by the governor shall not exceed twenty members.

(b) The members of the statewide council shall be appointed by the governor in accordance with section 2634, provided that a nonvoting, ex officio member who is the representative of the Veterans' Administration shall be designated by the Veterans' Administration. The membership of the statewide council shall be broadly representative of the age, sex, ethnic, income, and other groups that make up the population of the State and shall include representation from the subarea councils, business, labor, and health care providers. A majority but not more than eleven of the members shall be consumers of health care who are not also providers of health care.

(c) The statewide council shall select a chairman from among its members. The members of the statewide council shall not be compensated but shall be reimbursed for necessary expenses incurred in the performance of their duties.

(d) The number of members necessary to constitute a quorum to do business shall consist of a majority of all members who have accepted nomination to the council, and have been confirmed and qualified as members of the council. When a quorum is in attendance, the concurrence of a majority of the members in attendance shall make any action of the council valid.

(e) No member of the statewide council shall, in the exercise of any function of the statewide council described in section 323D-14(5), vote on any matter before the statewide council respecting any individual or entity with which the member has or, within the twelve months preceding the vote, had any substantial ownership, employment, medical staff, fiduciary, contractual, creditor, or consultative relationship. The statewide council shall require each of its members who has or has had such a relationship with an individual or entity involved in any matter before the statewide council to make a written disclosure of the relationship before any action is taken by the statewide council with respect to the matter in the exercise of any function described in section 323D14 and to make the relationship public in any meeting in which the action is to be taken.

§323D-13.5 Disqualification from position or membership. The chairpersons of the statewide council, the subarea health planning councils and the review panel, shall not be employed by or married to health care providers.

§323D-14 Functions; statewide health coordinating council. The statewide council shall:

(1) Prepare and revise as necessary the state health services and facilities plan.

(2) Advise the state agency on actions under section 323D-12.

(3) Appoint the review panel pursuant to section 323D-42.

(4) Review and comment upon the following actions by the state agency before such actions are made final:

(A) The establishment, annual review, and amendment of the annual implementation plan.

(B) The development and publication of specific plans and programs for achieving the objectives established in the annual implementation plan.

(C) The making of findings as to applications for certificate of need.

(D) The making of findings as to the appropriateness of those institutional and noninstitutional health services offered in the State.

§323D-15 State health services and facilities plan. There shall be a state health services and facilities plan which shall address the health care needs of the State, including inpatient care, health care facilities, and special needs. The plan shall depict the most economical and efficient system of care commensurate with adequate quality of care, and shall include standards for utilization of health care facilities and major medical equipment. The plan shall provide for the reduction or elimination of underutilized, redundant, or inappropriate health care facilities and health care services.

§323D-16 Annual implementation plan. The state agency shall prepare and execute annually an implementation plan which guides the agency in achieving the system of care envisioned in the state health services and facilities plan and administering the certificate of need program. The implementation plan shall embody specific strategies for appropriateness review and other activities designed to produce economical and efficient care, including the setting of priorities for health care facilities, major medical equipment, and health care services.

§323D-17 Public hearings required. In the preparation of the state health services and facilities plan or amendments to the state health services and facilities plan, the state agency and the statewide council shall conduct a public hearing on the proposed plan or the amendments and shall comply with the provisions for notice of public bearings in chapters 91 and 92.

§323D-18 Information required of providers. Providers of health care doing business in the State shall submit such statistical and other reports of information related to health and health care as the state agency finds necessary to the performance of its functions.

§323D-18.5 Information from providers of health insurance. The state agency may request providers of health insurance doing business in the State to submit to the state agency available statistical, financial, and other reports of information that the state agency finds necessary to perform its functions.

§323D-18.6 Confidentiality of information. The state agency may adopt rules in accordance with chapter 91 to provide that information submitted to the state agency by providers of health care and health care insurance concerning recipients of health care or health care insurance, or both, shall be confidential.

PART III. SUBAREA HEALTH PLANNING COUNCILS

§323D-21 Subarea health planning councils, established. There are established, subarea health planning councils for geographical areas which shall be designated by the state agency in consultation with the statewide council. Each county shall have at least one subarea health planning council. The subarea health planning councils shall be placed within the state agency for administrative purposes.

§323D-22 Subarea health planning councils, functions, quorum and number of members necessary to take valid action. (a) Each subarea health planning council shall review, seek public input, and make recommendations relating to health planning for the geographical subarea it serves. In addition, the subarea health planning councils shall:

(1) Identify and recommend to the state agency and the council the data needs and special concerns of the respective subareas with respect to the preparation of the state plan.

(2) Provide specific recommendations to the state agency and the council regarding the highest priorities for health services and resources development.

(3) Review the state health services and facilities plan and the annual implementation plan as they relate to the respective subareas and make recommendations to the state agency and the council.

(4) Advise the state agency in the administration of the certificate of need program for their respective subareas.

(5) Advise the state agency on the cost of reimbursable expenses incurred in the performance of their functions for inclusion in the state agency budget.

(6) Advise the State agency in the performance of its specific functions.

(7) Perform other such functions as agreed upon by the state agency and the respective subarea councils.

(8) each subarea health planning council shall recommend for gubernatorial appointment at least one person from its membership to be on the statewide council.

(b) The number of members necessary to constitute a quorum to do business shall consist of a majority of all the members who have accepted nomination to the council, and have been confirmed and qualified as members of the council. When a quorum is in attendance, the concurrence of a majority of the members in attendance shall make any action of the council valid.

§323D-23 [OLD] REPEALED.

§323D-23 Subarea health planning councils, composition, appointment. Members of subarea health planning councils shall be appointed by the governor, subject to section 2634. Nominations for appointment shall be solicited from health related and other interested organizations, and agencies, including health planning councils, providers of health care within the appropriate subarea, and other interested persons. The members of the subarea health planning councils shall not be compensated for their services but shall be reimbursed for reasonable expenses necessary to the performance of their function.

§323D-24 to 27 REPEALED.

PART IV. STATE MEDICAL FACILITIES

§323D-31 to 33 REPEALED.

PART V. CERTIFICATE OF NEED

§323D-41 REPEALED.

§323D-42 Review panel. There is established a review panel for the purposes of reviewing applications for certificates of need. The review panel shall be appointed by the statewide council. The review panel shall include at least one member from each county and a majority of the members shall be consumers. Membership on the statewide council shall not preclude membership on the review panel established in this section.

§323D-43 Certificates of need. (a) No person, public or private, nonprofit or for profit, shall:

(1) Construct, expand, alter, convert, develop, initiate, or modify a health care facility or health care services in the State which requires a total capital expenditure in excess of the expenditure minimum; or

(2) Substantially modify, decrease, or increase the scope or type of health service rendered, or

(3) Increase, decrease, or change the class of usage of the bed complement of a health care facility, or relocate beds from one physical facility or site to another, unless a certificate of need therefor has first been issued by the state agency.

(b) No certificate of need shall be issued unless the state agency has determined that:

(1) There is a public need for the facility or the service; and

(2) The cost of the facility or service will not be unreasonable in the light of the benefits it will provide and its impact on health care costs.

(c) The state agency may adopt criteria for certificate of need review which are consistent with this section. Such criteria may include but are not limited to need, cost, quality, accessibility, availability, and acceptability.

Each decision of the state agency to issue a certificate of need shall, except in an emergency situation that poses a threat to public health, be consistent with the state health services and facilities plan in effect under section 323D-15. Each certificate of need issued shall be valid for a period of one year from the date of issuance unless the period is extended for good cause by the state agency and expenditures for the project shall not exceed the maximum amount of the expenditures approved in the certificate of need.

§323D-44 Applications for certificates of need. (a) An applicant for a certificate of need shall file an application with the state agency. The state agency shall provide technical assistance to the applicant in the preparation and filing of the application.

Each application shall include a statement evaluating the facility's or service's probable impact on health care costs. The statement shall include, in addition to an estimate of the total cost, a projection of the effect the facility or service will have on the following: total patient care budget; total number of admissions; total number of patient days; total number of outpatient visits; and such other information as the state agency may request. The statement shall include cost projections for at least the first and fifth years after its approval.

The state agency shall not accept an application for review until the application is complete and includes all necessary information required by the state agency. The state agency shall determine if the application is complete within thirty days of receipt of the application. If the state agency determines that the application is incomplete, the state agency shall inform the applicant of the additional information that is required to complete the application. When the state agency determines that the application is complete, the period for agency review described in subsection (b) shall begin, and the state agency shall transmit the completed application to the appropriate subarea councils, the review panel, the statewide council, appropriate individuals, and appropriate public agencies. The state agency may require the applicant to provide copies of the application to the state agency, the appropriate subarea councils, the review panel, the statewide council, appropriate individuals, and appropriate public agencies. If, during the period for agency review, the state agency requires the applicant to submit information respecting the subject of the review, the period for agency review shall, at the request of the applicant, be extended fifteen days.

(b) The state agency shall issue a decision on the application within ninety days after the beginning of the period for agency review, unless the state agency within the ninety days notifies the applicant in writing that the period for agency review has been extended by the state agency sixty days beyond the ninety days. The decision shall be subject to postdecision review procedures which the state agency may provide for by rules adopted in conformity with chapter 91.

(c) The state agency may adopt rules in conformity with chapter 91 for the issuance of certificates of need for those applications for which the procedures in section 323D-45 would be infeasible because of an emergency situation or other unusual circumstances.

(d) Notwithstanding anything to the contrary in subsections (a) and (b), the state agency may adopt rules in conformity with chapter 91 providing that all completed applications pertaining to similar types of services, facilities, or equipment affecting the same health service area shall be considered in relation to each other but no less often than twice a year.

§323D-44.5 Administrative review of certain applications for certificate of need. The state agency shall adopt rules in conformity with chapter 91 providing for administrative review and decision on certain applications for certificate of need without referring the applications to the subarea council, review panel, or statewide council for recommendation as provided under section 323D-45. Each application reviewed under this section shall be subject to a public information meeting before the state agency makes its decision, which public information meeting may be at a meeting of the subarea council, review panel, or statewide council. Applications subject to administrative review and decision under this section shall include, but are not limited to, applications which are:

(1) Inconsistent with or contrary to the state health services and facilities plan under section 323D-15;

(2) Determined not to have a significant impact on the health care system; or

(3) Involve capital or annual operating expenses below a significant level.

§323D-44.6 Review of certain applications for certificate of need; waiver. The subarea council, the review panel, and the statewide council may, at their discretion, choose to waive their respective prerogatives of review of any certificate of need application.

§323D-44.7 Monitoring of approved certificates of need. The state agency may monitor implementation of approved certificates of need grunted by the agency.

§323D-45 Subarea council, review panel, and statewide council recommendations for issuance or denial of certificates of need. (a) Except for an administrative review as provided in section 323D-44.5, or in an emergency situation or other unusual circumstances as provided in section 323D-44(c), the state agency shall refer every application for a certificate of need to the appropriate subarea council or councils, the review panel, and the statewide council. The subarea council and the review panel shall consider all relevant data and information submitted by the state agency, subarea councils, other areawide or local bodies, and the applicant, and may request from them additional data and information. The review panel shall consider each application at a public meeting and shall submit its recommendations with findings to the statewide council. The statewide council shall consider the recommendation of the review panel at a public meeting and shall submit its recommendations to the state agency within such time as the state agency prescribes. The statewide council and the review panel may join together to hear or consider simultaneously information related to an application for a certificate of need.

(b) At a public meeting in which a subarea council or the review panel considers an application for a certificate of need, any person shall have the right to be represented by counsel and to present oral or written arguments and evidence relevant to the application; any person directly affected by the application may conduct reasonable questioning of persons who make factual allegations relevant to the application; any staff member of the state agency may conduct reasonable questioning of persons who make factual allegations relevant to the application; and a record of the meeting shall be kept.

§323D-45.1 Ex parte contacts prohibited. (a) There shall be no ex parte contacts:

(1) In the case of an application for a certificate of need, between the applicant for the certificate of need, any person acting on behalf of the applicant, any person in favor of the application or any person opposed to the issuance of a certificate of need and any person in the state agency who exercises any responsibility respecting the application, after the commencement of the state agency's review of the application and before the state agency makes a decision on the application, on any matter related to or arising out of the application for a certificate of need;

(2) In the case of a proposed withdrawal of a certificate of need, between the holder of the certificate of need, any person acting on behalf of the holder, any person opposed to the withdrawal or any person in favor of the withdrawal and any person in the state agency who exercises any responsibility respecting withdrawal of the certificate of need, after the commencement of state agency proceedings on the proposed withdrawal and before the state agency makes a decision on the proposed withdrawal, on any matter related to or arising out of the proposed withdrawal of the certificate of need; and

(3) In the case of an application for an exemption from obtaining a certificate of need, between the applicant for an exemption, any person acting on behalf of the applicant, any person in favor of the application or any person opposed to the application and any person in the state agency who exercises any responsibility respecting the application, after the commencement of the state agency's review of the application and before the state agency makes a decision on the application, on any matter related to or arising out of the application for an exemption from obtaining a certificate of need.

(b) The prohibition against ex parte contacts shall not apply to any written communication or a copy thereof which is promptly filed as a government record with the state agency.

§323D-45.2 REPEALED.

§323D-45.3 Approval of applications required to meet safety, licensure, or accreditation standards. (a) Notwithstanding section 323D-43, the state agency shall approve an application for a certificate of need for a capital expenditure which is required:

(1) To eliminate or prevent imminent safety hazards as defined by federal, state, or county fire, building, or life safety codes or regulations, or

(2) To comply with state licensure standards,

(3) To comply with accreditation standards, compliance with which is required to receive reimbursements under title XVIII of the Social Security Act or payments under a state plan for medical assistance approved under title XIX of such Act, unless the state agency finds that the facility or service with respect to which the capital expenditure is proposed to be made is not needed or that the obligation of the capital expenditure is not consistent with the state health services and facilities plan in effect under section 323D-15.

(b) An application for a certificate of need approved by the state agency under this section shall be approved only to the extent that the capital expenditure is required to eliminate or prevent the hazards described in paragraph (1) or to comply with the standards described in paragraph (2) or (3).

§323D-46 Conditional certification. The state agency shall provide by rules adopted in conformity with chapter 91 for the conditional certification of those proposals which, by modification of specific items of the proposal, would successfully meet the criteria for approval. The state agency shall establish a time period not to exceed one hundred fifty days from the date of the conditional certification within which the applicant shall certify to the state agency that the required modifications have been made. The state agency shall require a statement from the applicant certifying that the required modifications have been made before a certificate of need is issued. The state agency shall deny any application in which the required modifications have not been made within the time period established by the state agency.

§323D-46.1 REPEALED.

§323D-46.2 Withdrawal of a certificate of need. (a) After the issuance of a certificate of need, the state agency shall periodically review the progress of the project. The state agency may withdraw the certificate of need, if the state agency determines on the basis of the review that:

(1) The holder of the certificate of need is not meeting the timetable specified in the approved application for the certificate of need and is not making a good faith effort to meet it; or

(2) The project being implemented differs substantially from that which was approved by the state agency.

(b) The state agency may withdraw at any time a certificate of need or an exemption from obtaining a certificate of need, if the state agency determines that the applicant procured the certificate of need or the exemption by fraud, misrepresentation, or corruption, or that the applicant submitted or caused to be submitted to the state agency false statements or information in connection with the application for the certificate of need or the exemption.

(c) The state agency shall adopt rules in conformity with chapter 91 for the withdrawal of certificates of need.

§323D-47 Request for reconsideration. The state agency may provide by rules adopted in conformity with chapter 91 for a procedure by which any person may, for good cause shown, request in writing a public hearing before a reconsideration committee for purposes of reconsideration of the agency's decision. The reconsideration committee shall consist of the administrator of the state agency and the chairpersons of the statewide council, the review panel, the plan development committee of the statewide council, and the appropriate subarea health planning council. The administrator shall be the chairperson of the reconsideration committee. A request for a public hearing shall be deemed by the reconsideration committee to have shown good cause, if:

(1) It presents significant, relevant information not previously considered by the state agency;

(2) It demonstrates that there have been significant changes in factors or circumstances relied upon by the state agency in reaching its decision;

(3) It demonstrates that the state agency has materially failed to follow its adopted procedures in reaching its decision;

(4) It provides such other bases for a public bearing as the state agency determines constitutes good causes; or

(5) The decision of the administrator differs from the recommendation of the statewide council.

To be effective a request for such a hearing shall be received within thirty days of the state agency decision. A decision of the reconsideration committee following a public hearing under this section shall be considered a decision of the state agency for purposes of section 323D-44.

§323D-48 Judicial review of state agency decisions. (a) If an application for a certificate of need or for an exemption from obtaining a certificate of need is denied, the state agency shall give notice to the applicant in writing stating the grounds for the denial. Any person adversely affected by a final decision of the state agency with respect to a certificate of need or an application for an exemption may appeal in the manner provided in chapter 91 to the circuit court of the circuit in which the person resides or in the circuit in which the health care facility or health care service is or was planned to be located.

(b) Any person adversely affected by a final decision of the state agency with respect to the withdrawal of a certificate of need may appeal in the manner provided in chapter 91 to the circuit court of the circuit in which the person resides or in the circuit in which the health care facility or health care service is or was planned to be located.

§323D-49 Certificates of need, licenses and permits. No permit or license shall be issued by any county or state officer for the development, construction, expansion, alteration, conversion, initiation, or modification of a health care facility or health care service or for the operation of a new health care facility or health care service unless there is submitted in connection with the application for such permit or license a current certificate of need issued by the state agency or a statement issued by the state agency that the health care facility or health care service is not required to hold a certificate of need under this part.

§323D-50 Certificates of need, penalties. (a) Any person who violates any provision of this part, or rules thereunder, with respect to the requirement for certificate of need shall be guilty of a misdemeanor for each seven day period or fraction thereof that the violation continues. Each subsequent seven day period shall constitute a separate offense.

(b) Any license to operate a health facility may be revoked or suspended by the department of health at any time in a proceeding before the department for any person proceeding with an action covered under section 323D-43 without a certificate of need. If any such license is revoked or suspended by the department, the holder of the license shall be notified in writing by the department of the revocation or suspension. Any license to operate a health facility which has been revoked under this section shall not be restored except by action of the department.

§323D-51 Injunctive relief. The state agency may, in the name of the people of the State through the attorney general of the State, apply for an injunction in any court of competent jurisdiction to enjoin any person who is not the holder of a certificate of need and who is not exempted from obtaining a certificate of need; and, upon the filing of a verified petition in the court, the court or any judge thereof, if satisfied by affidavit or otherwise, that the person is or has been proceeding with an action covered under section 323D-43 without a certificate of need, may issue a temporary injunction, without notice or bond, enjoining the defendant from further action. A copy of the verified complaint shall be served upon the defendant and the proceedings shall thereafter be conducted as in other civil cases. If it is established that the defendant has been or is proceeding with an action covered under section 323D-43 without a certificate of need, the court or any judge thereof may enter a decree enjoining the defendant from further action. In case of violation of any injunction issued under this section, the court may summarily try and punish the offender for contempt of court. The injunction proceeding shall be in addition to, and not in lieu of, all penalties and other remedies provided in this chapter.

§323D-52 Letters of intent. Persons proposing construction projects shall submit to the state agency letters of intent in such detail as may be necessary to inform the agency of the scope and nature of the projects at the earliest possible opportunity in the course of planning of such construction projects.

§323D-53 Periodic reports from health facilities. Any health facility or business subject to regulation under this part shall, at the request of the state agency, supply such information to the state agency as is necessary to carry out the purposes of this chapter, including but not limited to:

(1) Periodic reports from holders of certificates of need respecting the development of the proposals for which certificates have been issued,

(2) Master plans, feasibility studies, and other long range plans and studies,

(3) Financial information, and

(4) Utilization information.

§323D-54 Exemptions from certificate of need requirements. Nothing in this part or rules thereunder with respect to the requirement for certificates of need applies to:

(1) Offices of physicians, dentists, or other practitioners of the healing arts in private practice as distinguished from organized ambulatory health care facilities, except in any case of purchase or acquisition of equipment attendant to the delivery of health care service and the instruction or supervision therefor for any private office or clinic involving a total expenditure in excess of the expenditure minimum;

(2) Laboratories, as defined in section 321-11(12), except in any case of purchase or acquisition of equipment attendant to the delivery of health care service and the instruction or supervision therefor for any laboratory involving a total expenditure in excess of the expenditure minimum;

(3) Dispensaries and first aid stations located within business or industrial establishments and maintained solely for the use of employees; provided such facilities do not regularly provide inpatient or resident beds for patients or employees on a daily twenty four hour basis;

(4) Dispensaries or infirmaries in correctional or educational facilities;

(5) Dwelling establishments, such as hotels, motels, and rooming or boarding houses that do not regularly provide health care facilities or health care services;

(6) Any home or institution conducted only for those who, pursuant to the teachings, faith, or belief of any group, depend for healing upon prayer or other spiritual means;

(7) Dental clinics; or

(8) Other facilities or services which the agency through the statewide council chooses to exempt, by rules pursuant to section 323D-62.

§323D-55 REPEALED.

PART VI. GENERAL ADMINISTRATION

§323D-61 Personnel. The administrator of the state agency shall }hire necessary personnel under chapters 76 and 77 to carry out the purposes of this chapter.

§323D-62 Rules. The state agency and the statewide health coordinating council may adopt necessary rules for the purposes of this chapter in accordance with chapter 91.

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