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711Type of Legislation: General Bill GBIntroducing Body: SenateIntroduced Date: 19990408Primary Sponsor: FairAll Sponsors: Fair and MooreDrafted Document Number: l:\council\bills\gjk\20341afc99.docResiding Body: SenateCurrent Committee: Medical Affairs Committee 13 SMASubject: Certificate of Need and Health Facility Licensure Act, Medical, Health and Environmental Control, DepartmentHistory Body Date Action Description Com Leg Involved ______ ________ ______________________________________ _______ ____________ Senate 19990408 Introduced, read first time, 13 SMA referred to Committee Versions of This Bill
TO AMEND SECTION 44-7-110, AS AMENDED, CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO THE CITATION TO ARTICLE 3, CHAPTER 7, TITLE 44, ENTITLED "STATE CERTIFICATION OF NEED AND HEALTH FACILITY LICENSURE ACT", SO AS TO REVISE THE ARTICLE NAME; TO AMEND SECTION 44-7-120, AS AMENDED, RELATING TO THE PURPOSE OF THIS ARTICLE, SO AS TO REVISE THE PURPOSE TO INCLUDE CARRYING OUT THE STATE'S HEALTH PLANNING EFFORT AND TO DELETE THE PROVISION RELATING TO DEVELOPING PROCEDURES FOR THE APPLICATION AND REVIEW PROCESS FOR CERTIFICATES OF NEED; TO AMEND SECTION 44-7-130, AS AMENDED, RELATING TO DEFINITIONS USED IN THIS ARTICLE, SO AS TO REVISE CERTAIN DEFINITIONS AND TO DELETE OTHERS; TO AMEND SECTION 44-7-150, AS AMENDED, RELATING TO DUTIES OF THE DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL IN CARRYING OUT THE PURPOSES OF THIS ARTICLE, SO AS TO INCLUDE DATA COLLECTION; TO AMEND SECTION 44-7-160, AS AMENDED, RELATING TO CIRCUMSTANCES UNDER WHICH A CERTIFICATE OF NEED IS REQUIRED, SO AS TO REVISE THESE CIRCUMSTANCES; TO AMEND SECTION 44-7-170, AS AMENDED, RELATING TO EXEMPTIONS FROM THE ARTICLE, SO AS TO REVISE THE EXEMPTIONS; TO AMEND SECTION 44-7-180, AS AMENDED, RELATING TO THE HEALTH PLANNING COMMITTEE AND THE STATE HEALTH PLAN, SO AS TO REVISE THE CONTENTS OF THE PLAN AND TO REQUIRE THAT THE DEPARTMENT BE NOTIFIED WHEN A PERSON PROPOSES TO OFFER HEALTH SERVICES FOR WHICH UTILIZATION DATA ARE MAINTAINED IN THE STATE HEALTH PLAN; TO AMEND SECTION 44-7-190 RELATING TO PROJECT REVIEW CRITERIA FOR USE IN DETERMINING THE NEED FOR HEALTH CARE FACILITIES, BEDS, SERVICES, AND EQUIPMENT, SO AS TO SPECIFICALLY DEFINE THE EQUIPMENT REQUIRING USE OF THIS CRITERIA IN DETERMINING THE NEED FOR THE EQUIPMENT; TO AMEND SECTION 44-7-200, AS AMENDED, RELATING TO THE CERTIFICATE OF NEED APPLICATION, SO AS TO MAKE TECHNICAL CORRECTIONS; TO AMEND SECTION 44-7-210, AS AMENDED, RELATING TO PROCEDURES FOR COMPLETION OF CERTIFICATE OF NEED APPLICATIONS AND FOR APPEALS OF STAFF DECISIONS, SO AS TO CLARIFY THESE PROCEDURES TO REVISE THE DATE INDICATING WHEN CERTAIN METHADONE TREATMENT FACILITIES DO NOT HAVE TO OBTAIN A CERTIFICATE OF NEED; TO AMEND SECTION 44-7-220, AS AMENDED, RELATING TO JUDICIAL REVIEW OF A FINAL BOARD DECISION, SO AS TO MAKE A TECHNICAL CORRECTION; TO AMEND SECTION 44-7-230, AS AMENDED, RELATING TO LIMITATIONS ON A CERTIFICATE OF NEED, SO AS TO PROVIDE PENALTIES WHEN IMPLEMENTATION OF A PROJECT OR THE OPERATION OF A FACILITY IS NOT IN ACCORDANCE WITH CERTAIN REQUIREMENTS; TO AMEND SECTION 44-69-75, AS AMENDED, RELATING TO HOME HEALTH AGENCIES REQUIRING A CERTIFICATE OF NEED, SO AS TO DELETE THE PROVISION EXEMPTING HOME HEALTH AGENCIES FROM THE CERTIFICATE OF NEED IF THE AGENCY PROVIDED HOME HEALTH SERVICES BEFORE JULY 1, 1980; TO REQUIRE THE DEPARTMENT TO CONDUCT A STUDY BEFORE JULY 1, 2003, OF OTHER STATES THAT HAVE REPEALED THEIR CERTIFICATE OF NEED PROGRAMS; AND TO REPEAL SECTION 44-7-185 RELATING TO A TASK FORCE TO STUDY OPEN HEART SURGERY AND THERAPEUTIC CARDIAC CATHETERIZATION SERVICES AND SECTION 44-7-240 RELATING TO FACILITIES CONSTRUCTION PROGRAM.
Be it enacted by the General Assembly of the State of South Carolina:
SECTION 1. Section 44-7-110 of the 1976 Code, as last amended by Act 670 of 1988, is further amended to read:
"Section 44-7-110. This article may be cited as the 'State
Certification Certificate of Need and Health Facility Licensure Act'."
SECTION 2. Section 44-7-120 of the 1976 Code, as last amended by Act 511 of 1992, is further amended to read:
"Section 44-7-120. The purpose of this article is to promote cost containment, prevent unnecessary duplication of health care facilities and certain services as required by Section 44-7-160, guide the establishment of health facilities and certain services which will best serve public needs, carry out the state's health planning effort, and ensure that high quality services are provided in health facilities in this State. To achieve these purposes, this article requires:
(1) the issuance of a Certificate of Need before undertaking a project prescribed by this article;
adoption of procedures and criteria for submittal of an application and appropriate review before issuance of a Certificate of Need;
(3) preparation and publication of a State Health Plan as prescribed by this article;
(4)(3) the licensure of facilities rendering medical, nursing, and other health care."
SECTION 3. Section 44-7-130 of the 1976 Code, as last amended by Act 351 of 1998, is further amended to read:
"Section 44-7-130. As used in this article:
(1) 'Affected person' means the applicant, a person residing within the
geographic service area served or proposed to be served by the applicant, including persons located in the health service area in which the project is to be located and who provide similar services to the proposed project, persons who before receipt by the department of the proposal being reviewed have formally indicated an intention to provide similar services in the future, persons who pay for health services in the health service area in which the project is to be located and who have notified the department of their interest in Certificate of Need applications, the State Consumer Advocate, and the State Ombudsman. Persons This term does not include persons from another state who would otherwise be considered 'affected persons' are not included unless that state provides for similar involvement of persons from South Carolina in its certificate of need process.
(2) 'Ambulatory surgical facility' means a facility organized and administered for the purpose of performing surgical procedures for which patients are scheduled to arrive, receive surgery, and be discharged on the same day. The owner or operator makes the facility available to other providers who comprise an organized professional staff which must include, at a minimum, a chief of staff and a credentialing committee, governance by medical staff by-laws, and recorded minutes of medical staff meetings.
(3) 'Board' means the State Board of Health and Environmental Control.
(4) 'Chiropractic inpatient facility' means a facility organized and administered to provide overnight care for patients requiring chiropractic services, including vertebral sublaxation, analysis, and adjustment.
(5) 'Competing applicants' means two or more persons or health care facilities as defined in this article who apply for Certificates of Need to provide similar services or facilities in the same service area within a time frame as established by departmental regulations and whose applications, if approved, would exceed the need for services or facilities.
(6) 'Community residential care facility' means a facility which offers room and board and provides a degree of personal assistance for two or more persons eighteen years old or older.
(7) 'Day-care facility for adults' means a facility for adults
eighteen twenty-one years or older which offers in a group setting a program of individual and group activities and therapies. The program is directed toward providing community-based care for those in need of a supportive setting for less than twenty-four hours a day, thereby preventing unnecessary institutionalization, and shall provide a minimum of four and a maximum of fourteen hours of operation a day.
(8) 'Department' means the Department of Health and Environmental Control.
'The federal act' means Title VI of the United States Public Health Service Act (the Hill-Burton Construction Program); Title XVI of the United States Public Health Service Act (National Health Planning and Resources Development Act of 1974 - Public Law 93-641); grants for all center and facility construction under Public Law 91-211 (community mental health centers' amendments to Title II, Public Law 88-164, Community Mental Health Centers Act); grants for all facility construction under Public Law 91-517 (developmental disabilities services and facilities construction amendments of 1970 to Part C, Title I, grants for construction of facilities for the mentally retarded - Public Law 88-164); and other federal programs as may exist or be enacted which provide for the construction of hospitals or related health facilities. RESERVED.
(10) 'Health care facility' means acute care hospitals, psychiatric hospitals, alcohol and substance abuse hospitals, methadone treatment facilities, tuberculosis hospitals, nursing homes, ambulatory surgical facilities, rehabilitation facilities, and residential treatment facilities for children and adolescents
, habilitation centers for mentally retarded persons or persons with related conditions, and any other facility for which Certificate of Need review is required by federal law.
'Health service' means clinically related, diagnostic, treatment, or rehabilitative services and includes alcohol, drug abuse, and mental health services for which specific standards or criteria are prescribed in the State Health Plan. RESERVED.
(12) 'Hospital' means a facility organized and administered to provide overnight medical or surgical care or nursing care of illness, injury, or infirmity and may provide obstetrical care, and in which all diagnoses, treatment, or care is administered by or under the direction of persons currently licensed to practice medicine, surgery, or osteopathy.
Hospital may include residential treatment facilities for children and adolescents in need of mental health treatment which are physically a part of a licensed psychiatric hospital. This definition does not include facilities which are licensed by the Department of Social Services.
(13) 'Nursing home' means a facility with an organized nursing staff to maintain and operate organized facilities and services to accommodate two or more unrelated persons over a period exceeding twenty-four hours which is operated either in connection with a hospital or as a freestanding facility for the express or implied purpose of providing intermediate or skilled nursing care for persons who are not in need of hospital care.
(14) 'Facility for chemically dependent or addicted persons' means a facility organized to provide outpatient or residential services to chemically dependent or addicted persons and their families based on an individual treatment plan including diagnostic treatment, individual and group counseling, family therapy, vocational and educational development counseling, and referral services.
(15) 'Person' means an individual, a trust or estate, a partnership, a corporation including an association, joint stock company, insurance company, and a health maintenance organization, a state, a political subdivision, or an instrumentality including a municipal corporation of a state, or any legal entity recognized by the State.
(16) 'Residential treatment facility for children and adolescents' means a facility operated for the assessment, diagnosis, treatment, and care by two or more persons of 'children and adolescents in need of mental health treatment' which provides:
(a) a special education program with a minimum program defined by the South Carolina Department of Education;
(b) recreational facilities with an organized youth development program; and
(c) residential treatment for a child or adolescent in need of mental health treatment.
'Solely for research' means a service, procedure, or equipment which has not been approved by the Food and Drug Administration (FDA) but which is currently undergoing review by the FDA as an investigational device. FDA research protocol and any applicable Investigational Device Exemption (IDE) policies and regulations must be followed by a facility proposing a project 'solely for research'. 'Service area' means that geographic area specified in the State Health Plan which is determined by population data, patient origin data, or area health facilities offering services to the area. This service area is used in planning for specified health facilities and services and is to be used when considering applications to provide health facilities and services.
(18) 'Children and adolescents in need of mental health treatment' in a residential treatment facility means a child or adolescent under age eighteen or a child or adolescent under age twenty-one who is a client of, committed to the custody of, or in the legal custody of an agency of the State of South Carolina who manifests a substantial disorder of cognitive or emotional process, which lessens or impairs to a marked degree that child's or adolescent's capacity either to develop or to exercise age-appropriate or age-adequate behavior. The behavior includes, but is not limited to, marked disorders of mood or thought processes, severe difficulties with self-control and judgment including behavior dangerous to self or others, and serious disturbances in the ability to care for and relate to others.
(19) 'Intermediate Care Facility for the Mentally Retarded' means a facility that serves four or more mentally retarded persons or persons with related conditions and provides health or rehabilitative services on a regular basis to individuals whose mental and physical conditions require services including room, board, and active treatment for their mental retardation or related conditions.
(20) 'Freestanding or mobile technology' means medical equipment owned or operated by a person other than a health care facility for which
the total cost is in excess of that prescribed by regulation and for which specific standards or criteria are prescribed in the State Health Plan a Certificate of Need is required by this article.
'Like equipment with similar capabilities' means medical equipment which does not increase the potential volume or type of procedures possible. RESERVED.
(22) 'Facilities wherein abortions are performed' means a facility, other than a hospital, in which any second trimester or five or more first trimester abortions are performed in a month."
SECTION 4. Section 44-7-150(1) of the 1976 Code, as amended by Act 670 of 1988, is amended to read:
"(1) require reports, collect data, and make inspections and investigations as considered necessary;"
SECTION 5. Section 44-7-160 of the 1976 Code, as last amended by Act 511 of 1992, is further amended to read:
"Section 44-7-160. A person or health care facility as defined in this article is required to obtain a Certificate of Need from the department before undertaking any of the following:
(1) the construction or other establishment of a new health care facility;
(2) a change in the existing bed complement of a health care facility through the addition of one or more beds or change in the classification of licensure of one or more beds;
an expenditure by or on behalf of a health care facility in excess of an amount to be prescribed by regulation which, under generally acceptable accounting principles consistently applied, is considered a capital expenditure except those expenditures exempted in Section 44-7-170(B)(1). The cost of any studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the development, acquisition, improvement, expansion, or replacement of any plant or equipment must be included in determining if the expenditure exceeds the prescribed amount establishment, implementation, or expansion of a diagnostic or therapeutic cardiac catherization program;
a capital expenditure by or on behalf of a health care facility which is associated with the addition or substantial expansion of a health service for which specific standards or criteria are prescribed in the State Health Plan establishment, implementation, or expansion of an open heart surgery program or other cardiac revascularization program;
the offering of a health service by or on behalf of a health care facility which has not been offered by the facility in the preceding twelve months and which has an annual operating cost in excess of an amount to be prescribed by regulation and for which specific standards or criteria are prescribed in the State Health Plan establishment, implementation, or expansion of a nursery for the care of a level III infant;
the acquisition of medical equipment which is to be used for diagnosis or treatment if the total project cost is in excess of that prescribed by regulation establishment, implementation, or expansion of a linear accelerator or gamma knife;
the acquisition or change in ownership or in controlling interest of a health care facility or entity owning a health care facility directly or indirectly by purchase, lease, gift, donation, sale of stock, or comparable arrangement if the acquisition or change in ownership or controlling interest may result in an increase in cost to the facility or increase in government-sponsored reimbursement establishment, implementation, or expansion of a magnetic resonance imaging (MRI) system including free standing MRI's; and
the acquisition of an existing health care facility by a person who has failed to notify the department and seeks an exemption before entering into a contractual arrangement to acquire an existing facility;
(9) an expenditure or financial obligation made in preparation for the offering or developing of a project which requires certification of need pursuant to this section if the expenditure or financial obligation is in excess of an amount to be prescribed by regulation the construction or other establishment of an ambulatory surgical facility."
SECTION 6. Section 44-7-170 of the 1976 Code, as last amended by Act 303 of 1998, is further amended to read:
"Section 44-7-170. (A) The provisions of this article do not apply to:
(1) health care facilities owned and operated by the federal government;
(2) the offices of a licensed private practitioner whether for individual or group practice except as provided for in Section 44-7-160
(3) the acquisition by a health care facility of medical equipment to be used solely for research, the offering of an institutional health service by a health care facility solely for research, or the obligation of a capital expenditure by a health care facility to be made solely for research if it does not (a) affect the charges of the facility for the provision of medical or other patient care services other than the services which are included in the research; (b) change the bed capacity of the facility; or (c) substantially change the medical or other patient care services of the facility. A written description of the proposed research project must be submitted to the department in order for the department to determine if the above conditions are met. A Certificate of Need is required in order to continue use of the equipment or service after research restrictions are removed;
(4) purchases of or agreements to purchase real estate; however, the costs associated with the purchase of real estate must be included in determining the total project cost at the time the real estate is proposed to be developed.
(B) The Certificate of Need provisions of this article do not apply to:
an expenditure by or on behalf of a health care facility for nonmedical projects for services such as refinancing existing debt, parking garages, laundries, roof replacements, computer systems, telephone systems, heating and air conditioning systems, upgrading facilities which do not involve additional square feet or additional health services, replacement of like equipment with similar capabilities, or similar projects as described in regulations;
(2) facilities owned and operated by the State Department of Mental Health and the South Carolina Department of Mental Retardation, except an addition of one or more beds to the total number of beds of the departments' health care facilities existing on July 1, 1988 Disabilities and Special Needs;
(3)(2) educational and penal institutions maintaining infirmaries for the exclusive use of student bodies and inmate populations;
(4)(3) any federal health care facility sponsored and operated by this State;
(4) purchases of or agreements to purchase real estate; however, the value associated with the purchase of real estate must be included in determining the total project cost at the time the real estate is proposed to be developed;
(5) community-based housing designed to promote independent living for persons with mental or physical disabilities. This does not include a facility defined in this article as a 'health care facility'
(6) kidney disease treatment centers including, but not limited to, free standing hemodialysis centers and renal dialysis centers
(7) inpatient hospices serving only terminally ill patients;
(8) methadone treatment facilities licensed as of January 1, 1998."
SECTION 7. Section 44-7-180 of the 1976 Code, as last amended by Act 511 of 1992, is further amended to read:
"Section 44-7-180. (A) There is created a health planning committee comprised of fourteen members. The Governor shall appoint twelve members, at least one member from each congressional district. Each of the following groups must be equally represented among the Governor's appointees: health care consumers, health care financiers to include business and insurance, and health care providers. The chairman of the board shall appoint one member. The South Carolina Consumer Advocate or the Consumer Advocate's designee is an ex officio nonvoting member. Members are appointed for four-year terms, may serve only two consecutive terms, and are allowed the usual mileage and subsistence as provided for members of boards, committees, and commissions.
(B) With the advice of the health planning committee, the department shall prepare a State Health Plan for use in the state's health planning program and administration of the Certificate of Need Program provided in this article. The plan at a minimum must include:
(1) an inventory of existing health care facilities, licensed beds, specified health services, and equipment;
(2) projections of need for additional health care facilities, licensed beds, health services, and equipment described in Section 44-7-160;
standards for distribution of health care facilities, beds, specified health services, and equipment including scope of services to be provided, utilization, and occupancy rates, travel time, regionalization, other factors relating to proper placement of services, and proper planning of health care facilities statistical documentation of the health status of the citizens of South Carolina; comparisons of the utilization by providers of specified services to state or nationally recommended standards, or both; individual county profiles including inventories of existing health systems and their utilization; and other relevant statistical or programmatic information as may be necessary to adequately document the health status of the State. Where feasible, other health related plans, data, and goals of the department and other agencies or organizations must be incorporated into the State Health Plan; and
a general statement as to the project review criteria considered most important in evaluating certificate of need applications for each type of facility, service, and equipment, including a finding as to whether the benefits of improved accessibility to each such type of facility, service, and equipment may outweigh the adverse affects caused by the duplication of any existing facility, service, or equipment.
The State Health Plan must address and include projections and standards for specified health services and equipment which have a potential to substantially impact health care cost and accessibility. Nothing in this provision shall be construed as requiring the department to approve any project which is inconsistent with the State Health Plan state or national quality indicators and other outcome data if used by the department to conduct comparative analysis.
(C) A person proposing to offer one or more health services for which utilization data are maintained in the State Health Plan shall notify the department in writing upon initiation of the service. The notification must include the name, address, and telephone number for the site where the service will be provided and a brief description of the proposed service. All providers must supply utilization and other data as requested by the department as being necessary to fulfill development of the relevant sections of the State Health Plan.
(C)(D) Upon approval by the health planning committee, the State Health Plan must be submitted at least once every two years to the board for final revision and adoption. Once adopted by the board, the plan may later be revised through the same planning and approval process. The department shall adopt by regulation a procedure to allow public review and comment, including regional public hearings, before adoption or revision of the plan.
(D)(E) The Department of Health and Environmental Control may charge and collect fees to cover the cost of operating the Certificate of Need program. Upon submission of a complete Certificate of Need application, the applicant must pay a fee of five hundred dollars plus five-tenths of one percent of the project cost for review of the project, not to exceed seven thousand, five hundred dollars; however, for an applicant whose review fee would exceed seven thousand, five hundred dollars an additional fee of seven thousand, five hundred dollars is imposed if the applicant is awarded a Certificate of Need, which must be paid at the time of the award. Fees paid pursuant to this subsection must be deposited to the credit of the general fund of the State."
SECTION 8. Section 44-7-190 of the 1976 Code, as added by Act 670 of 1988, is amended to read:
"Section 44-7-190. The department shall adopt, upon approval of the board, Project Review Criteria which, at a minimum, must provide for the determination of need for health care facilities, beds, services, and equipment described in Section 44-7-160, to include demographic needs, appropriate distribution, and utilization; accessibility to underserved groups; availability of facilities and services without regard to ability to pay; absence of less costly and more effective alternatives; appropriate financial considerations to include method of financing, financial feasibility, and cost containment; consideration of impact on health systems resources; site and building suitability; consideration of quality of care; and relevant special considerations as may be appropriate. The Project Review Criteria must be adopted as a regulation pursuant to the Administrative Procedures Act."
SECTION 9. Section 44-7-200 of the 1976 Code, as last amended by Act 511 of 1992, is further amended to read:
"Section 44-7-200. (A) An application for a Certificate of Need must be submitted to the department in a form established by regulation. The application must address all applicable standards and requirements set forth in departmental regulations, Project Review Criteria of the department, and the State Health Plan. The application must include the payment of a nonrefundable initial application fee of five hundred dollars. The department shall deduct this fee from the
Certificate of Need filing fee which is payable in accordance with departmental regulations when the application is determined to be complete.
(B) Within twenty days before submission of an application, the applicant shall publish notification that an application is to be submitted to the department in a newspaper serving the area where the project is to be located for three consecutive days. The notification must contain a brief description of the scope and nature of the project. No application may be accepted for filing by the department unless accompanied by proof that publication has been made for three consecutive days within the prior twenty-day period and payment of the initial application fee has been received.
(C) Upon publication of this notice and until a contested case hearing is requested pursuant to Section 44-7-210:
(1) members of the board
and persons appointed by the board to hear appeals from department staff decisions may not communicate directly or indirectly with any person in connection with the application; and
(2) no person shall communicate, or cause another to communicate, as to the merits of the application with members of the board
and persons appointed by the board to hear appeals from department staff decisions.
A person who violates this subsection is subject to the penalties provided in Section 1-23-360.
(D) After receipt of an application with proof of publication and payment of the initial application fee, the department shall publish in the State Register a notice that an application has been accepted for filing. Within thirty days of acceptance of the application, the department may request additional information as may be necessary to complete the application. The applicant has thirty days from the date of the request to submit the additional information. If the applicant fails to submit the requested information within the thirty-day period, the application is considered withdrawn."
SECTION 10. Section 44-7-210 of the 1976 Code, as last amended by Act 303 of 1998, is further amended to read:
"Section 44-7-210. (A) After the department has determined that an application is complete, affected persons must be notified in accordance with departmental regulations. The notification of affected persons begins the review period. During the review process, the department shall determine the relative importance of the project review criteria for this project and shall notify the applicant of this determination. The applicant has thirty days from the date of the receipt of this notice to submit any additional information regarding determination by the department of the relative importance of the project review criteria. The review period for a completed application is sixty days from the date of notification of affected persons, or up to sixty days from the date that applicants are notified of the relative importance of project review criteria provided for in this section, whichever is longer. One extension of up to sixty days may be granted by the department in accordance with departmental regulations with the exception of an extension that is granted to comply with a request for a public hearing.
(B) The department may hold a public hearing, if timely requested, to gather information and obtain public comment and opinion about the proposed project.
(C) The department may not issue a Certificate of Need unless an application complies with the State Health Plan, Project Review Criteria, and other regulations. Based on project review criteria and other regulations, which must be identified by the department, the department may refuse to issue a Certificate of Need even if an application complies with the State Health Plan. In the case of competing applications, the department shall award a Certificate of Need, if appropriate, on the basis of which, if any, most fully complies with the requirements, goals, and purposes of this article and the State Health Plan, Project Review Criteria, and the regulations adopted by the department.
(D) On the basis of staff review of the application, the staff of the department shall make a proposed decision to grant or deny the Certificate of Need. Notice of the proposed decision must be sent to the applicant and affected persons who have asked to be notified. The proposed decision becomes the final agency decision within ten days after the receipt of a notice of the proposed decision by the applicant unless:
(1) a reconsideration by the staff of the department is requested in writing within the ten-day period by an affected person showing good cause for reconsideration of the proposed decision; reconsideration by the staff must occur within thirty days from receipt of the request; or
contested case hearing before the board , or its designee, regarding the grant or denial of the Certificate of Need is requested in writing within the ten-day period by the applicant or other affected person with standing to contest the grant or denial of the application.
Reconsideration by the staff must occur within thirty days from receipt of the request.
(E) Appeals of staff decisions, other than motions for reconsideration, must be contested pursuant to the Administrative Procedures Act. Prior to a contested case hearing, all parties shall participate in nonbinding mediation as provided for in regulation. The department's proposed decision is not final until the completion of reconsideration, mediation that results in settlement, or contested case proceedings. The burden of proof in a reconsideration or contested case hearing must be upon the moving party.
The contested case hearing before the board or its designee is conducted as a contested case under the Administrative Procedures Act. The issues considered at the contested case hearing are limited to those presented or considered during the staff review and decision process.
(F) The department may not issue a Certificate of Need approval for a methadone treatment facility until licensure standards are promulgated by the department, in accordance with the Administrative Procedures Act, for these facilities. The department shall convene a study group to revise and propose licensure standards for methadone clinics. The study group shall consist of representatives of the department, the Department of Alcohol and Other Drug Abuse Services, methadone providers in South Carolina, and the Medical University of South Carolina. The licensure standards shall include standards for location of these facilities within the community. Methadone treatment facilities licensed as of January 1, 1998, must not be required to obtain a Certificate of Need pursuant to this section."
SECTION 11. The first paragraph of Section 44-7-220 of the 1976 Code, as amended by Act 471 of 1990, is further amended to read:
contested case hearing is concluded and a final board decision is made, a party who participated in the contested case hearing before an administrative law judge and who is affected adversely by the board's decision may obtain judicial review of the decision in the circuit court pursuant to the Administrative Procedures Act. An appeal taken to the circuit court from a decision of the board on a Certificate of Need application has precedence on the court's calendar and must be heard not later than forty-five days from the date the petition is filed."
SECTION 12. Section 44-7-230(A) of the 1976 Code, as last amended by Act 511 of 1992, is further amended to read:
"(A) The Certificate of Need, if issued, is valid only for the project described in the application including location, beds and services to be offered, physical plant, capital or operating costs, or other factors as set forth in the application, except as may be modified in accordance with regulations. The department shall require periodic reports and make inspections to determine compliance with the Certificate of Need. Implementation of the project or operation of the facility
or medical equipment that is not in accordance with the Certificate of Need application or conditions subsequently agreed to by the applicant and the department may be considered a violation of this article and subject to penalties provided for in Section 44-7-320 or other appropriate remedy as allowed by law."
SECTION 13. Section 44-69-75(A) of the 1976 Code, as last amended by Act 381 of 1996, is further amended to read:
"(A) A home health agency shall obtain a certificate of need before licensure. Procedures for applying for a certificate must be in accordance with the 'State
Certification Certificate of Need and Health Facility Licensure Act'. No certificate is required for home health agencies providing home health services before July 1, 1980."
SECTION 14. Before July 1, 2003, but not sooner than July 1, 2001, the Department of Health and Environmental Control shall conduct a study of other states which have repealed their certificate of need programs. The study shall review what effects, if any, the repeal of this program had on cost of health care, quality of health care, accessibility of health care, and indigent care. The department shall submit a report on the study, its findings, and recommendations to the Governor and General Assembly upon completion of the study.
SECTION 15. Sections 44-7-185 and 44-7-240 of the 1976 Code are repealed.
SECTION 16. This act takes effect July 1, 1999.
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