CHAPTER 393

FORMERLY

HOUSE BILL NO. 956

AS AMENDED BY

HOUSE AMENDMENTS 2 & 3

AN ACT TO AMEND PART VIII, TITLE 16 OF THE DELAWARE CODE RELATING TO HOSPITALS AND OTHER HEALTH FACILITIES; AND PROVIDING A SYSTEM OF HEALTH PLANNING AND REVIEW.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend Part VIII, Title 16 of the Delaware Code by adding thereto a new chapter, designated as Chapter 93, which new Chapter shall read as follows:

"CHAPTER 93. EQUITABLE HEALTH PLANNING AND REVIEW

§301. Purpose

It is the purpose of this Chapter to create a rational framework for, and to promote effective and equitable health planning and review of, the development, acquisition, construction, expansion, and modification of health facilities and services.

It is the policy of this State that health planning and review shall be based upon evaluation of the needs and resources of the community and the State for health facilties and services, and that participation in this decision-making process shall be accorded to both interested consumers and providers of health care services.

It is the purpose of the General Assembly in enacting this Chapter to further the above-stated public policy by providing a procedure for applying for and obtaining a Certificate of Need prior to undertaking any of the aforesaid regulated activities.

§9302. Definitions

The following words, terms and phrases, when used in this Chapter, shall have the meanings ascribed to them in this section, except where the context indicates a different meaning:

which the proposed new health service is. to be offered or developed, health systems agencies serving contiguous health service areas, health care facilities and health maintenance organizations located in the health service area, and those members of the public who are to be served by the proposed new health services.

(b) 'Certificate of Need' means the written approval by the State Agency, as defined in this section, of an application for a new health service as described in §9303 of this Chapter.

(a) 'To develop', when used in connection with health services, means to undertake those activities which on their completion will result in the offering a new health service or the incurring of a financial obligation, as described in §9303 of this Chapter, in relation to the offering of such a service.

(a) 'Health care facility' shall include hospital, psychiatric hospital, tuberculosis hospital, skilled nursing facility, kidney disease treatment center, including freestanding hemodialysis unit, intermediate care facility, ambulatory health care facility, freestanding emergency room, community mental health and retardation facility, home health agency, and blood bank, whether or not licensed or required to be licensed by the State, whether operated for profit or non-profit and whether privately owned or operated or owned or operated by a unit of State or local government. The term does not include Christian Science sanitoriums operated or listed and certified by the First Church of Christ Scientist, Boston, Massachusetts. The term shall not include any physician's office, whether an individual or group practice, any independent clinical laboratory or any radiology laboratory. The term shall also not include the office of any other licensed health care provider, including but not limited to, physical therapist, dentist, physician assistant, podiatrist, chiropractor, an independently practicing nurse or nurse practitioner, optometrist, pharmacist or psychologist. The term also shall not include any dispensary or first aid station located within a business or industrial establishment maintained solely for the use of employees; provided that the facility does not contain inpatient beds, nor shall it apply to any first aid station or dispensary or infirmary offering non-acute services exclusively for use by students and employees of a school or university, or by inmates and employees of a prison provided that services delivered therein are not the substantial equivalent of hospital services in the same area or community. However, the purchase, lease or donation of any single item of medical equipment not usually associated with the provision of primary health care, the purchase price of

which exceeds the threshold to be set by the State Agency annually on or about July 1; such threshold to be between $100,000 and $150,000, shall be subject to review under this Chapter if the purchaser, lessee, or recipient is a health care facility. For purposes of this section, the following words and phrases shall have the specific meanings set forth herein:

(1) 'Hospital' shall mean a licensed institution which is primiarily 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 does not include psychiatric or tuberculosis hospitals.

(2) 'Psychiatric hospital' shall mean a licensed institution which is primarily engaged in providing to inpatients, by or under the supervision of a physician, psychiatric services for.the diagnosis and treatment of mentally ill persons.

(3) 'Tuberculosis hospital' shall mean a licensed institution which is primarily engaged in providing to inpatients, by or under the supervision of a physician, medical services for the diagnosis and treatment of tuberculosis.

(4) 'Skilled nursing facility' shall mean a licensed institution or a distinct part of an institution which is primarily engaged in providing to inpatients 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.

(5) 'Intermediate care facility' shall mean a licensed insitution 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 (above the level of room and board).

(6) 'Kidney disease treatment center' shall mean a facility (other than the patitent's residence) in which patients suffering from permanent or temporary kidney failure are treated by use of an artificial kidney which separates wastes or poisons from the blood.

(7) 'Ambulatory health care facility' shall mean a facility other than a physician's private office, incorporated, that provides medical or surgical care on an organized basis to patients not requiring medical supervision for more than 24 hours and that is not part of a hospital but is organized and operated to provide medical or surgical care to outpatients.

(8) 'Freestanding emergency room' shall mean a facility physically separated from another health care facility which provides diagnosis and treatment services to individuals which are in urgent need of them.

(9) 'Community mental health and retardation facility' shall mean a facility which provides such comprehensive services and continuity of care as emergency, outpatient, hospitalization, inpatient and consultation and education for individuals with mental illness, mental retardation or drug or alcohol addiction.

(10) 'Home health agency' is an organization primarily engaged in providing directly or through contract arrangements, professional nursing services, home health aide services, and other therapeutic and related services including, but not limited to, physical, speech and occupational therapy and nutritional and medical social services, to persons in their place of residence on a part-time or intermittent basis.

(11) 'Blood bank' shall mean an independent organization collecting or storing human blood or plasma.

(e) 'Health maintenance organization' shall mean a public or private organization, organized under the laws of any State, which:

(1) provides or otherwise makes available to enrolled participants health care services, including at least the following basic health care services: usual physician services, hospitalization, laboratory, x-ray, emergency and preventive services, and out-of-area coverage;

(2) is compensated (except for copayment) for the provision of the basic health care services listed in paragraph (e) (1) of this section to enroll participants on a predetermined periodic rate basis; and

(3) provides physicians' services primarily (i) directly through physicians who are either employees or partners of such organization, or (ii) through arrangements with individual physicians or one or more groups of physicians (organized on a group practice or individual practice basis).

(f) 'Health services' shall mean clinically related (i.e., diagnostic, curative or rehabilitative) services provided in or through health care facilities or health maintenace organizations and includes the entities in or through which such services are provided.

(g) 'Health Systems Agency' shall mean any agency within Delaware, designated as same by the U. S. Department of Health, Education, and Welfare under Section 1515 of P.L. 93-641.

(h) 'To offer', when used in connection with health services, means that the health care facility or health maintenance organization holds itself out as capable of providing, or as having the means for the provision of, specified health services.

(i) 'Person' shall mean an individual, a trust or estate, a partnership, a corporation (including associations, joint stock companies, and insurance companies) a State, or a political subdivision or instrumentality (including a municipal corporation) of a State.

(j) 'Person directly affected' shall include the person whose application is being reviewed, members of the public who are to be served by the proposed new health services, health care facilities and health maintenance organizations located in the health service area in which the new health service is proposed to be offered or developed which provides services similar to the proposed services, and health care facilities and health maintenance organizations which, prior to receipt of the application being reviewed, have formally indicated an intention to provide similar services in the future.

(a) 'State Agency' shall mean the Bureau of Health Planning and Resources Development within the Department of Health and Social Services which is the designated State Health Planning and Development Agency under Section 1521 of P.L. 93-641.

(1) 'Statewide Health Coordinating Council' shall mean the duly authorized body established pursuant to Section 1524 of P. L. 93-641.

§9303. New Health Services Subject to Review

(a) On and after the effective date of this Chapter, any person proposing to offer or to develop a 'new health service' within the State shall be required to obtain a Certificate of Need prior to such offering or development. For purposes of this section, a 'new health service' shall include:

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

(2) any expenditure by or on behalf of a health care facility or health maintenance organization in excess of the dollar threshold established by the State Agency in accordance with §9302 (d), such threshold to be between $100,000 and $150,000 which, under generally accepted accounting principles consistently applied, is a capital expenditure. Where a person makes an acquisition by or on behalf of a health care facility or health maintenance organization under lease or comparable arrangement, or through donation, which would have required review if the acquisition had been by purchase, such acquisition shall be deemed a capital expenditure subject to review;

(3) a change in bed capacity of a health care facility or health maintenance organization which increases or decreases the total number of beds (or distributes beds among various categories, or relocates such beds from one physical facility or site to another) by more than ten beds or more than ten percent of total licensed bed capacity, whichever is less, over a two-year period;

(1) health services, including home health services, which are offered in or through a health care facility or health maintenance organization and which were not offered on a regular basis in or through such health care facility or health maintenance organization within the twelve-month period prior to the time such services would be offered.

(b) Pre-Development Activities.

(1) Any expenditure by or on behalf of a health care facility or health maintenance organization in excess of $50,000 made in preparation for the offering or development of a new health service and any arrangement or commitment made for financing the offering or development of the new institutional health services shall be subject to review under this Chapter. Nothing in this Chapter shall preclude the retention of consultants by health care facilities for the purpose of planning activities which do not entail the planning of specific new services.

(2) Nothing in this Chapter shall preclude the State Agency from granting a Certificate of Need which permits expenditures only for predevelopment activities, but does not authorize the offering or development of the new health service with respect to which such predevelopment activities are proposed. Expenditures in preparation for the offering of a new health service shall include expenditures for architectural

designs, plans, working drawings and specifications, site acquisitions, and preliminary plans, studies and surveys.

(c) Prior to conducting reviews under this Chapter, the State Agency shall disseminate to all health care facilities and health maintenance organizations within the State, and shall publish in one or more newspapers of general circulation in the State, a description of the scope of coverage of its program for review of new health services. Such description shall include, at a minimum, the coverage required by subsections (a) and (b) of this section. Whenever the scope of such coverage is revised, the State Agency shall disseminate and publish a revised description thereof.

(d) Any project or proposal for which an approval by the Designated Planning Agency was granted under Section 1122 of the Social Security Act, and which was not terminated by action of the Designated Planning Agency at any time prior to the passage or effective date of this Chapter, shall be exempt from further review.

§9304. Procedures for Review

(a) The procedures for conducting reviews under this Chapter shall be as follows:

(1) Letters of Intent.

At least thirty (30) days prior to submitting in application for review under this Chapter, applicants shall submit to the State Agency and Health Systems Agency letters of intent in such form as may be determined by the State Agency to cover the scope and nature of the project. A letter of intent may be submitted less than thirty days prior to submission of an application only with the written approval of both the State Agency and Health Systems Agency.

(2) Application for Review.

Application forms will be developed by the State Agency after consultation with the Health Systems Agency and Statewide Health Coordinating Council and may vary according to the nature of the application. Blank application forms shall be provided by either the State Agency or the Health Systems Agency to all persons subject to review under this Chapter. Completed applications shall be submitted simultaneously to the Health Systems Agency and the State Agency. No information may be required of

the applicant which is not prescribed by the application form; such information may be requested.

(3) Deadlines and Time Limitations.

Upon receipt of an application under this Chapter, the State Agency shall have a maximum of fifteen (15) days (including the day of receipt) to notify the applicant as to whether the application is considered complete, written notification in accordance with paragraph (a)(4) of this section will be provided. If incomplete, the applicant will be notified in writing of such determination and will be advised of what additional information is required to make the application complete. When that additional information is received, the State Agency has a maximum of fifteen (15) days to determine whether the application is complete. The same steps shall be taken as with the initial submission each time that additional information is required.

Except where a public hearing is requested under paragraph (a) (6) of this section, the review of any application shall take no longer than 90 days from the date of notification as covered under paragraph (a) (4) of this section. If a public hearing is requested under paragraph (a) (6) of this section, the maximum review period will be extended to 120 days from the date of notification.

The Health Systems Agency shall be allotted 60 days (90 days if a public hearing is requested under paragraph (a) (6) of this section) from the date of notification as prescribed in paragraph (a) (4) of this section to complete its review and provide a written recommendation to the State Agency and notify the applicant of its findings. A period of lesser than or greater than 69 days (90 days if a public hearing is requested under paragraph (a) (6) of this section) may be allotted only by a written agreement between the Health Systems Agency and the State Agency.

In the case of a project required to remedy an emergency situation which threatens the safety of patients or the ability of the health facility or health maintenance organization to remain in operation, an abbreviated application shall be submitted in such format as the State Agency prescribes. As quickly as possible, but within seventy-two (72) hours after receipt, the State Agency, after consultation with the Health Systems Agency and the

Chairperson or Vice-Chairperson of the Statewide Health Coordinating Council, if available, shall render a decision as to whether or not the project should be treated as an emergency and whether or not the application shall be approved.

(4) Agency Review; Notification.

Within five (5) working days of determing that an application under this Chapter is complete, the State Agency shall provide to 'affected persons' as defined in §9302 of this Chapter, written notification of the beginning of a review. Such notification shall include the proposed schedule for review, the period during which a public hearing in the course of the review as covered in paragraph (a) (6) of this section may be requested, and the manner in which notice will be provided of the time and place of any hearing so rquested.

The date of notification is the date on which notification is sent directly to 'affected persons' other than the general public or the date on which the notice appears in a newspaper of general circulation, whichever is later. Such newspaper notice shall constitute written notification to members of the public to be served by the proposed new institutional health service.

(5) Findings and Recommendations.

Upon completion of a review under this Chapter, and within the time-frames outlined in paragraph (a) (3) of this section, the State Agency shall notify in writing the applicant and the Health Systems Agency and anyone else upon request, as to its decision, including the basis on which the decision was made. Decisions can be conditional but the conditions must be related to the specific project in question. Subject to the same limitations, the Health Systems Agency and Statewide Health Coordinating Council may make a conditional recommendation to the State Agency. Such recommendation, whether conditional or not, shall also be submitted in writing to the applicant and anyone else upon request and shall include the basis on which the recommendation is made.

In the case of any proposed new health service for the provision of health services to inpatients, a State Agency shall not grant a Certificate of Need under this Chapter, nor shall the Health Systems Agency or Statewide Health Coordinating Council make a recommendation under this Chapter, unless, after consideration of the

appropriateness of the use of existing facilities providing inpatient services similar to those being proposed, the State Agency, Health Systems Agency, and Statewide Health Coordinating Council make each of the following findings in writing:

(i) that superior alternatives to such inpatient services in terms of cost, efficiency, and appropriateness do not exist and that the development of such alternatives is not practicable;

(ii) that in the case of new construction, alternatives to new construction (e.g., modernization or sharing arrangements) have been considered and have been implemented to the maximum extent practicable;

(iii) that patients will experience serious problems in terms of cost, availability, or accessibility, or such other problems as may be identified by the reviewing agency, in obtaining inpatient care of the type proposed in the absence of the proposed new service; and

(iv) that in the case of a proposal for the addition of beds for the provision of skilled nursing or intermediate care the relationshsip of the addition to the plans of other agencies of the State responsible for providing and financing long-term care (including home health services) has been considered.

In the case of any new health service proposed to be provided by or through a health maintenance organization, a State Agency shall not deny a Certificate of Need with respect to such service, nor shall the Health Systems Agency or Statewide Health Coordinating Council recommend that a Certificate of Need be denied, in the following instances: when the State Agency has granted a Certificate of Need which authorized the development of the service, or expenditures in preparation for such offering or development (or has otherwise made a finding that such development or expenditure is needed); and when the offering of this new health service will be consistent with the basic objectives, time schedules, and plans of the previously approved application; provided that the State Agency may impose a limitation on the duration of the Certificate of Need which shall expire at the end of such time unless the health service is offered prior thereto.

(6) Public Hearings.

hearing in the course of review may be requested by 'persons directly affected' as defined in §9302 of this Chapter. Such request shall be in writing and made to the Health Systems Agency. The Health Systems Agency shall provide for a public hearing if requested and shall provide notification of the time and place for such hearing in a newspaper of general circulation within its health service area. The public hearing shall be held not less than fourteen (14) days after such notice appears in the newspaper. The Health Systems Agency shall not impose fees for such hearings. An opportunity must be provided for any person to present testimony.

(7) Administrative Reconsideration; Procedure for State Agency.

Any person may, for good cause shown, request in writing a public hearing for purposes of reconsideration of a State Agency decision. The agency may not impose fees for such a hearing. For purposes of this subsection, a request for a public hearing shall be deemed by the State Agency to have shown good cause if it:

(i) presents significant, relevant information not previously considered by the State Agency;

(ii) demonstrates that there have been significant changes in factors or circumstances relied upon by the State Agency in reaching its decision;

(iii) demonstrates that the State Agency has materially failed to follow its adopted procedures in reaching its decision; or

(iv) provides such other basis for a public hearing as the State Agency determines constitutes good cause.

To be effective, a request for such a hearing shall be received within 30 days of the State Agency decision, and the hearing shall commence within 30 days of receipt of the request.

Notification of such a public hearing shall be sent, prior to the date of the hearing, to the person requesting the hearing, the person proposing the new institutional health service, and the Health Systems Agency for the health service area in which the new institutional health service is proposed to be offered or developed, and shall be sent to others upon request. The State Agency shall

make written findings which state the basis for its decision within 45 days after the conclusion of such hearing. A decision of the State Agency following a public hearing under this paragraph shall be considered a decision of the State Agency for purposes of paragraphs (5), (8), (9), (10), (12) and (14) of this subsection.

(8) Administrative Reconsideration; Procedure for Health Systems Agency.

If the State Agency makes a decision regarding a proposed new health service which is inconsistent with a recommendation made with respect thereto by the Health Systems Agency making such recommendation, the State Agency shall submit to such Health Systems Agency within 30 days awritten, detailed statement of the reasons for the inconsistency.

Such decision (and the record upon which it was made) shall, upon written request of the Health Systems Agency, be reviewed, under an appeals mechanism not inconsistent with State law governing the practices and procedures of administrative agencies, by an attorney appointed by the Department of Justice of the State of Delaware. A request for review under this section by the Health Systems Agency must be received within 30 days of the State Agency decision. The hearing shall commence within 30 days of receipt of the request. The decision of the Department of Justice shall be made in writing within 45 days after the conclusion of such review. These written findings shall be sent to the person proposing the new health service, to the Health Systems Agency requesting the review, and to the State Agency, and shall be made available by the State Agency to others upon request.

The decision of the Department of Justice shall be considered the final decision of the State Agency; however, the Department of Justice may remand the matter to the State Agency for further action or consideration. The decision of the Department of Justice may be appealed by the Health Systems Agency within thirty (30) days to the Superior Court of the county in which the proposed new health service or facility is to be located.

(9) Administrative Reconsideration for Person Proposing New Health Service.

Any decision of the State Agency under this Chapter (and the record upon which it was made) shall, upon request of the person proposing the new health service, be reviewed, under an appeals mechanism not inconsistent with State law

governing the practices and procedures of administrative agencies, by an attorney appointed by the Department of Justice of the State of Delaware.

The request for review by the person proposing the new health service must be received within 30 days of the State Agency decision, and the hearing shall commence within 30 days of receipt of the request. The decision of the Department of Justice shall be made in writing within 45 days after the conclusion of such review. These written findings shall be sent to the person proposing the new health service, the appropriate Health Systems Agency, and to the State Agency, and shall be made available by the State Agency to others upon request.

The decision of the Department of Justice shall be considered the final decision of the State Agency; however, the Department of Justice may remand the matter to the State Agency for further action or consideration.

The decision of the Department of Justice may be appealed by the aggrieved applicant within thirty (30) days to the Superior Court of the county in which the proposed new service or facility is to be located.

(10) Inconsistencies; Administrative Procedures.

If the State Agency (or the Department of Justice or court, under paragraph (a)(8) or paragraph (a)(9) of this section) makes a decision regarding a proposed new health service which the State Agency determines is not consistent with the goals of the applicable health systems plan (established under Section 1513 (b) (2) of P.L. 93-641) or the priorities of the applicable annual implementation plan (established under Section 1513 (b)(3) of P.L. 93-641), the State Agency (or the Department of Justice or court, as appropriate) shall submit to the appropriate Health Systems Agency within 30 days a written, detailed statement of the reasons for the inconsisteny.

(11) Status of Anticipated Projectl.

At least annually, health care facilities and health maintenance organizations shall submit to the State Agency a report, in such form as the State Agency requires, which sets forth the status of anticipated projects which would be subject to review under this Chapter. The State Agency shall consult with the Health Systems Agency regarding the form which such report shall take. The State Agency shall send a copy of all such reports received to the Health Systems Agency.

(12) Status Report to Health Care Facility or Health Maintenance Organization.

Upon request of a health care facility or health maintenance organization, the State Agency and Health Systems Agency shall notify such persons of the status of a review under this Chapter, findings made in the course of such review and other appropriate information with respect to such review.

(13) Both the State Agency and Health Systems Agency shall provide for access by the general public to all applications reviewed under this Chapter and to all other written materials pertinent to any such review.

(14) At least annually, the State Agency and the Health Systems Agency shall publish reports of reviews conducted under this Chapter. Such report shall include a statement concerning the status of each such review then in progress, and for reviews completed since the last report shall include a general statement of findings and recommendations or decisions made during the course of such reviews.

§9305. Criteria for Review

(a) In conducting reviews under this Chapter, the State Agency shall consider the recommendations of the Health Systems Agency and Statewide Health Coordinating Council.

(b) In conducting reviews under this Chapter, the State Agency, Health Systems Agency, and Statewide Health Coordinating Council shall consider as appropriate at least the following:

(1) The relationship of the health services being reviewed to the applicable health systems plan and State health plan adopted pursuant to Section 1513 (b)(2) and Section 1524 (c) (2), respectively, of P.L. 93-641, and the annual implementation plan adopted pursuant to Section 1513 (b)(3) of P.L. 93-641.

(2) The relationship of services reviewed to the long-range development plan (if any) of the person providing or proposing such services.

(3) The need that the population or to be served by such services has for such services.

(4) The availability of less costly or more effective alternative methods of providing such services.

(5) The immediate and long-term financial feasibility of the proposal, as well as the probable impact of the proposal on the costs of and charges for providing health services by the person proposing the new health service.

(6) The relationship of the services proposed to be provided to the existing health care system of the area in which such services are proposed to be provided.

(7) The availability of resources (including health manpower, management personnel, and funds to capital and operating needs) for the provision of the services proposed to be provided and the availability of alternative uses of such resources for the provision of other health services.

(8) The relationship, including the organizational relationship, of the health services proposed to be provided to ancillary or support services and the impact of the health services being reviewed on quality of care.

(9) Special needs and circumstances of those entities which provide a substantial portion of their services or resources, or both, to individuals not residing in the health service areas in which the entities are located or in adjacent health service areas. Such entities may include medical and other health professions schools, multi-disciplinary clinics and specialty centers.

(10) The special needs and circumstances of health maintenance organizations for which assistance may be provided under Title XIII of the Public Health Service Act. Such needs and circumstances include the needs of and costs to members and projected members of the health maintenance organization in obtaining health services and the potential for a reduction in the use of inpatient care in the community through an extension of preventive health services and the provision of more systematic and comprehensive health services. The consideration of a new institutional health service proposed by a health maintenance organization shall also address the availability and cost of obtaining the proposed new health service from the existing providers in the area that are not health maintenance organizations.

(11) The special needs and circumstances of biomedical and behavioral research projects which are designed to meet a national need and for which local conditions offer special advantages.

(12) In the case of a construction project:

(i) the costs and methods of the proposed construction, including the costs and methods of energy provision, and

(ii) the probable impact of the construction project reviewed on the costs of providing health services by the person proposing such construction project.

(c) Criteria adopted for reviews in accordance with subsection (b) of this section may vary according to the purpose for which a particular review is being conducted or the type of health service reviewed.

§9306. Adoption and Public Notice of Additional Review Procedures and Criteria

(a) Prior to adopting review procedures and criteria in addition to those set forth in §9304 and §9305 of this Chapter, respectively, both the State Agency and Health Systems Agency shall afford interested parties an opportunity to offer written comments or oral comments at a public hearing on the proposed additional procedures and criteria in the following manner:

(1) The State Agency shall distribute copies of its proposed additional review procedures and criteria Co the Statewide Health Coordinating Council, the Health Systems Agency and all health care facilities covered by this Chapter, as their names and addresses appear with the State Agency.

(2) The State Agency shall publish in one or more newspapers of general circulation in the State, a notice of the proposed additional review procedures and criteria, with the publication of such notice being made not more than 45 days, and not less than 30 days, prior to the time set for the hearing. The notice shall refer to the fact that additional review procedures and criteria have been proposed for adoption and are available at specified addresses for inspection and copying by interested persons and the time and location of the hearing. No changes in review procedures and criteria may be implemented without the public hearing as required in this section.

(3) The State Agency shall distribute copies of its additional adopted review procedures and criteria and any revisions thereof, to the agencies and organizations specified in paragraph (a)(1) of this section and shall provide-such copies to other persons upon request.

(4) The Health Systems Agency shall distribute copies of its proposed additional review procedures and criteria to the agencies, institutions and associations with which the agency must coordinate its activities pursuant to Section 1513 (d) of P.L. 93-641 and its designation agreement, to units of general local government within its health service area, to the State Agency and Statewide Health Coordinating Council, and to Health Systems Agencies designated for contiguous health service areas.

(5) The Health Systems Agency shall publish, in one or more newspapers of general circulation in the State, a notice of the proposed additional review procedures and criteria, with the publication of such notice being made not more than 45 days and not less than 30 days prior to the time set for the hearing. The notice shall state that additional review procedures and criteria have been proposed for adoption and are available at specified addresses for inspection and copying by interested persons, as well as the time and location of the public hearing. No changes in review procedures and criteria shall be made without the public hearing as required in this section.

(6) The Health Systems Agency shall distribute copies of its additional adopted review procedures and criteria, and any revisions thereof, to the agencies and organizations specified in paragraph (a)(4) of this section, and shall provide such copies to other persons upon request.

§9307. Certificate of Need and its Period of Effectiveness

(a) When an application for review under this Chapter is approved, the State Agency shall issue a Certificate of Need to the applicant. A Certificate of Need shall be valid for one (1) year from the date such approval was granted.

(b) At least thirty days prior to the expiration of the Certificate of Need, the applicant shall inform the State Agency of the project's status. After consultation with the Health Systems Agency, the State Agency shall determine if sufficient progress has been made for the Certificate of Need to continue in effect. If sufficient progress has not been made, the applicant may request, in writing, to the State Agency that a six month extension to the Certificate be granted. The State Agency shall then either allow the Certificate to expire or grant such extension.

§9308. Sanctions

(a) Any person offering or developing a new health service as described in §9303 of this Chapter without first being issued a Certificate of Need for such new health service, shall have his license or other authority to operate, denied, revoked, or restricted as deemed appropriate by the responsible licensing or authorizing agency of the State and an order in writing to such effect shall be issued by that licensing or authorizing agency.

(b) In addition to the provisions of subsection (a) of this section, the State Agency, the Health Systems Agency or

an adversely affected health care facility may maintain a civil action in the Court of Chancery to restrain or prohibit any person from offering or developing a new health service as described in §9303 of this Chapter without first being issued a Certificate of Need.

(c) A person who willfully offers or develops a new health service as defined in §9303 of this Chapter which is subject to review under this Chapter and who has not received a Certificate of Need for that new health service, shall not be reimbursed for that new health service by any government agency organized under the laws of the State of Delaware.

(d) A person who willfully offers or develops a new health service as defined in §9303 of this Chapter which is subject to review under this Chapter and who has not received a Certificate of Need for that new health service, shall be fined not less than $500 nor more than $2,500 for each offense and each day of a continuing violation after notice of violation shall be considered a separate offense. The Superior Court shall have jurisdiction over criminal violations under this subsection.

§9309. Surrender, Revocation and Transfer ofCertificateof Need

(a) An existing Certificate of Need may be surrendered by the holder upon written notification to the State Agency and such surrender shall become effective immediately upon receipt by the State Agency.

(b) A Certificate of Need may be revoked by the State Agency in the case of misrepresentation in the Certificate of Need application, failure to render the new health services applied for or loss of license or other authority to operate the new health services applied for. Revocation of a Certificate of Need shall not be executed, however, without the holder of the Certificate of Need being given an opportunity to voluntarily surrender the Certificate of Need.

(c) No Certificate of Need issued under this Chapter, and no rights or privileges arising therefrom, shall be subject to transfer or assignment, directly or indirectly, except upon order or decision of the State Agency specifically approving the same, issued pursuant to application supported by a finding from the evidence that the public to be served will not be adversely affected thereby. In like manner, any transaction having the effect of conferring, transferring or assigning the controlling interest of any holder of a Certificate of Need issued under this Chapter shall be subject to the same conditions applicable to transfer or assignment of the Certificate of Need itself.

§9310. Immunity

No member, officer or employee of any planning body or health care facility shall be subject to, and such persons shall be immune from, any claim, suit, liability, damages or any other recourse, civil or criminal, arising from any act or proceeding, decision or determination undertaken or performed, or recommendation made while discharging any duty or authority under this Chapter, so long as such person acted in good faith, without malice, and within the scope of his duty or authority under this Chapter or any other provisions of the Delaware law, Federal law or regulations, or duly adopted rules and regulations providing for the administration of this Chapter, good faith being presumed until proven otherwise, with malice required to be shown by the complainant."

Section 2. Severability.

If any clause, sentence, section, provision or part of this Act shall be adjudged to be unconstitutional or invlaid for any reason by any court of competent jurisdiction, such judgement shall not impair, invalidate or affect the remainder of this Act which shall remain in full force and effect.

Section 3. Repealing Clause.

All laws and parts of laws in conflict herewith are hereby repealed to the extent of such conflict.

Section 4. Effective Date.

This Act shall become effective 180 days after its passage.

Approved June 30, 1978.