CHAPTER 29

FORMERLY

HOUSE BILL NO. 162

AS AMENDED BY HOUSE AMENDMENT NO. 1

AN ACT TO AMEND CHAPTER 93, TITLE 16, DELAWARE CODE RELATING TO HEALTH PLANNING AND CERTIFICATE OF NEED PROGRAMS.

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

Section 1. Amend §9302(2), Chapter 93, Title 16 of the Delaware Code by striking §9302(2) a. through i. in its entirety and substituting new §9302(2) a. through j. as follows:

"a. 'Hospital' shall mean any non-federal facility licensed as such

pursuant to Chapter 10 of this title and more particularly Section 50 of the State Board of Health Regulations.

b. 'Nursing Home' shall mean any non-federal facility licensed as such pursuant to Chapter 11 of this title and more particularly Sections 57 (Skilled Care) and 58 (Intermediate Care) of the State Board of Health Regulations.

a. 'Freestanding birthing center' shall mean any facility licensed as
such pursuant to Chapter 1 of this title and more particularly in the State Board of Health Regulations.

a. 'Freestanding surgical center' shall mean any facility licensed as
such pursuant to Chapter 1 of this title and more particularly Section 51 of the State Board of Health Regulations.

a. 'Freestanding emergency center' shall mean any facility licensed as
such pursuant to Chapter 1 of this title and more particularly Section 52 of the State Board of Health Regulations.

a. 'Prescribed pediatric extended care center' shall mean any facility
licensed as such pursuant to Chapter 1 of this title and more particularly in the State Board of Health Regulations.

a. 'Medical detoxification setting' shall mean any facility licensed
as such pursuant to Chapter 22 and 48 of this title and more particularly Section 6 of the Division of Alcoholism, Drug Abuse and Mental Health Regulations.

a. 'Blood bank' shall mean an independent organization collecting or
storing human blood or plasma.

b. 'Kidney disease treatment center' shall mean a facility (other than the patient'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.

a. 'Alcoholism rehabilitation facility' shall mean a facility which
provides post-detoxification intensive residential treatment for alcoholism involving a highly structured program not exceeding 28 days for a majority of residents."

Section 2. Amend §9302, Chapter 93, Title 16 of the Delaware Code by

designating §9302(5) as §9302(6) and §9302(6) as §9302(7) and inserting a new §9302(5) as follows:

"(5) 'Major medical equipment' shall mean a single unit of medical

equipment or a single system of components with related functions which is used for the diagnosis or treatment of patients and which: (i) Entails a capital expenditure as set forth in this chapter which exceeds $750,000; or (ii) Represents medical technology which is not yet available in Delaware; or (iii) Represents medical technology which has been designated by the Health Resources Management Council as being subject to review. The State Agency may, with the concurrence of the Health Resources Management Council, exempt from review a capital expenditure used to acquire major medical equipment which represents medical technology which is not yet available in Delaware. A notice of intent filed pursuant to §9305 of this title along with any other information deemed necessary by the Health Resources Management Council or the State Agency shall provide the basis for exempting such a capital expenditure from review."

Section 3. Amend §9303(b), Chapter 93, Title 16 of the Delaware Code by striking the first two sentences and substituting the following:

The Health Resources Management Council shall consist of 18 members to be appointed by the Governor. Appointments shall be for 3—year terms except that the initial appointment of an individual may be for less than 3 years so that approximately one—third of the terms expire each year."

Section 4. Amend §9303(d), Chapter 93, Title 16 of the Delaware Code by striking §9303(d)(6) and §9303(d)(8) in their entirety and substituting new §9303(d)(6) and §9303(d)(8) as follows:

"(6) Review certificate of need applications filed pursuant to this Chapter and make recommendations thereon to the State Agency;

(8) Adopt bylaws as necessary for conducting its affairs. Such bylaws shall incorporate adequate provisions to assure that Council members shall not vote on matters in which they have a conflict of interest."

Section 5. Amend §9304, Chapter 93, Title 16 of the Delaware Code by striking §9304(1) in its entirety and substituting a new §9304(1) as follows:

"(1) The construction, acquisition, development, or other

establishment of a health care facility. The acquisition of a health care facility by acquiring the assets or a controlling equity interest may be exempted from review by the State Agency, with the concurrence of the Health Resources Management Council. A notice of intent filed pursuant to §9305 of this title along with any other information deemed necessary by the Health Resources Management Council or the State Agency shall provide the basis for exempting such capital expenditure from review;"

Section 6. Amend §9304, Chapter 93, Title 16 of the Delaware Code by adding thereto a new §9304(5) which shall read as follows:

"(5) Any expenditure which under generally accepted accounting

principles consistently applied is a capital expenditure and is used to acquire major medical equipment. An acquisition by lease or comparable arrangement or through donation which would have required review if the acquisition had been by purchase, shall be deemed a capital expenditure subject to review. Major medical equipment which is acquired for use in a dispensary or first aid station located within a business or industrial establishment maintained solely for the use of employees or in a first aid station, dispensary or infirmary offering services exclusively for use by students and employees of a school or university or by inmates and employees of a prison is not subject to review."

Section 7. Amend §9305, Chapter 93, Title 16 of the Delaware Code by striking §9305(8) and §9305(9) in their entirety and substituting new §9305(8) and §9305(9) as follows:

"(8) Same -- Procedure for Health Resources Management Council. -- If the State Agency makes a decision regarding a certificate of need application which is inconsistent with the recommendation from the Health Resources Management Council, the State Agency shall submit to the Council within 10 days a written 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 Resources Management Council, be reviewed by a 5—person Appeals Board appointed by the Secretary, Department of Health and Social Services. A request for review under this subdivision must be received by the Secretary, Department of Health and Social Services, within 30 days of the State Agency decision. The hearing shall commence within 45 days of receipt of the request. The decision of the Board shall be made in writing within 45 days after the conclusion of such hearing. These written

findings shall be sent to the applicant, the Health Resources Management Council and the State Agency.

The review of the decision by the Appeals Board shall be on the record. The Appeals Board shall review the record and determine whether the State Agency observed the statutory procedures for review set forth in this Chapter and whether there was substantial evidence to support the decision. The Appeals Board may, at its discretion, consider additional evidence when such evidence embodies significant changes in factors or circumstances relied upon by the State Agency in reaching its decision. However, when the Appeals Board does consider additional evidence, it shall not reverse a State Agency decision solely on the basis of such additional evidence without first remanding the matter to the State Agency for further action or consideration.

The decision of the Appeals Board or the State Agency after a remand from the Appeals Board, shall be considered the final decision of the State Agency.

(9) Same -- Applicant. -- Any decision of the State Agency under this chapter (and the record upon which it was made) shall, upon written request of the applicant, be reviewed by a 5-person Appeals Board appointed by the Secretary, Department of Health and Social Services. A request for review under this subdivision must be received by the Secretary, Department of Health and Social Services, within 30 days of the State Agency decision. The hearing shall commence within 45 days of receipt of the request. The decision of the Appeals Board shall be made in writing within 45 days after the conclusion of such hearing. These written findings shall be sent to the applicant, the Health Resources Management Council and the State Agency.

The review of the decision by the Appeals Board shall be on the record. The Appeals Board shall review the record and determine whether the State Agency observed the statutory procedures for review set forth in this Chapter and whether there was substantial evidence to support the decision. The Appeals Board may, at its discretion, consider additional evidence when such evidence embodies significant changes in factors or circumstances relied upon by the State Agency in reaching its decision. However, when the Appeals Board does consider additional evidence, it shall not reverse a State Agency decision solely on the basis of such additional evidence without first remanding the matter to the State Agency for further action or consideration.

The decision of the Appeals Board or the State Agency after a remand from the Appeals Board, shall be considered the final decision of the State Agency. The decision of the Appeals Board or the State Agency after a remand from the Appeals Board, may be appealed by the applicant within 30 days to the Superior Court. Such appeal shall be on the record."

Section 8. SeverabiIity

If any clause, sentence, section, provision or part of this Act shall be adjudged to be unconstitutional or invalid 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 9. Repealing Clause

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

Section 10. Effective Date

This Act shall become effective upon the signature of the Governor.

Approved May 15, 1991.