Senate Bill sb2132

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    Florida Senate - 2003                                  SB 2132

    By Senator Saunders





    37-696A-03

  1                      A bill to be entitled

  2         An act relating to certificates of need;

  3         amending s. 408.032, F.S.; redefining the term

  4         "tertiary health service," as used in the

  5         Health Facility and Services Development Act,

  6         to include open-heart surgery; amending s.

  7         408.036, F.S.; amending provisions specifying

  8         which health-care-related projects are subject

  9         to review and must file an application for a

10         certificate of need; exempting certain projects

11         from review, including the provision of

12         percutaneous coronary intervention, in

13         specified circumstances; providing for the

14         expiration of such an exemption and for

15         postponement of the renewal of the exemption,

16         as specified; providing additional exemptions;

17         amending s. 408.038, F.S.; providing increases

18         in fees for certificate-of-need applications;

19         providing for uses of the increased revenues;

20         amending s. 408.039, F.S.; amending the review

21         process for certificates of need; providing for

22         automatic approval if the Agency for Health

23         Care Administration does not issue a final

24         order within a specified time; providing that a

25         court must require the losing party to pay

26         attorney's fees and costs of the prevailing

27         party in certain circumstances; creating the

28         Hospital Statutory and Regulatory Reform

29         Council; providing legislative intent;

30         providing for membership and duties of the

31         council; providing an effective date.

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    Florida Senate - 2003                                  SB 2132
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 1  Be It Enacted by the Legislature of the State of Florida:

 2  

 3         Section 1.  Subsection (17) of section 408.032, Florida

 4  Statutes, is amended to read:

 5         408.032  Definitions relating to Health Facility and

 6  Services Development Act.--As used in ss. 408.031-408.045, the

 7  term:

 8         (17)  "Tertiary health service" means a health service

 9  which, due to its high level of intensity, complexity,

10  specialized or limited applicability, and cost, should be

11  limited to, and concentrated in, a limited number of hospitals

12  to ensure the quality, availability, and cost-effectiveness of

13  such service. Examples of such service include, but are not

14  limited to, organ transplantation, adult and pediatric

15  open-heart surgery, specialty burn units, neonatal intensive

16  care units, comprehensive rehabilitation, and medical or

17  surgical services which are experimental or developmental in

18  nature to the extent that the provision of such services is

19  not yet contemplated within the commonly accepted course of

20  diagnosis or treatment for the condition addressed by a given

21  service.  The agency shall establish by rule a list of all

22  tertiary health services.

23         Section 2.  Subsections (2) and (3) of section 408.036,

24  Florida Statutes, are amended to read:

25         408.036  Projects subject to review; exemptions.--

26         (2)  PROJECTS SUBJECT TO EXPEDITED REVIEW.--Unless

27  exempt pursuant to subsection (3), projects subject to an

28  expedited review shall include, but are not be limited to:

29         (a)  Research, education, and training programs.

30         (b)  Shared services contracts or projects.

31  

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 1         (b)(c)  A transfer of a certificate of need, except

 2  that a purchaser who acquires an existing hospital also

 3  acquires all pending certificates of need filed by the

 4  existing hospital and all approved certificates of need owned

 5  by that hospital.

 6         (c)(d)  A 50-percent increase in nursing home beds for

 7  a facility incorporated and operating in this state for at

 8  least 60 years on or before July 1, 1988, which has a licensed

 9  nursing home facility located on a campus providing a variety

10  of residential settings and supportive services.  The

11  increased nursing home beds shall be for the exclusive use of

12  the campus residents.  Any application on behalf of an

13  applicant meeting this requirement shall be subject to the

14  base fee of $5,000 provided in s. 408.038.

15         (d)(e)  Replacement of a health care facility when the

16  proposed project site is located in the same district and

17  within a 1-mile radius of the replaced health care facility.

18         (f)  The conversion of mental health services beds

19  licensed under chapter 395 or hospital-based distinct part

20  skilled nursing unit beds to general acute care beds; the

21  conversion of mental health services beds between or among the

22  licensed bed categories defined as beds for mental health

23  services; or the conversion of general acute care beds to beds

24  for mental health services.

25         1.  Conversion under this paragraph shall not establish

26  a new licensed bed category at the hospital but shall apply

27  only to categories of beds licensed at that hospital.

28         2.  Beds converted under this paragraph must be

29  licensed and operational for at least 12 months before the

30  hospital may apply for additional conversion affecting beds of

31  the same type.

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 1  

 2  The agency shall develop rules to implement the provisions for

 3  expedited review, including time schedule, application content

 4  which may be reduced from the full requirements of s.

 5  408.037(1), and application processing.

 6         (3)  EXEMPTIONS.--Upon request, the following projects

 7  are subject to exemption from the provisions of subsection

 8  (1):

 9         (a)  For replacement of a licensed health care facility

10  on the same site, provided that the number of beds in each

11  licensed bed category will not increase.

12         (b)  For hospice services or for swing beds in a rural

13  hospital, as defined in s. 395.602, in a number that does not

14  exceed one-half of its licensed beds.

15         (c)  For the conversion of licensed acute care hospital

16  beds to Medicare and Medicaid certified skilled nursing beds

17  in a rural hospital, as defined in s. 395.602, so long as the

18  conversion of the beds does not involve the construction of

19  new facilities. The total number of skilled nursing beds,

20  including swing beds, may not exceed one-half of the total

21  number of licensed beds in the rural hospital as of July 1,

22  1993. Certified skilled nursing beds designated under this

23  paragraph, excluding swing beds, shall be included in the

24  community nursing home bed inventory.  A rural hospital which

25  subsequently decertifies any acute care beds exempted under

26  this paragraph shall notify the agency of the decertification,

27  and the agency shall adjust the community nursing home bed

28  inventory accordingly.

29         (d)  For the addition of nursing home beds at a skilled

30  nursing facility that is part of a retirement community that

31  provides a variety of residential settings and supportive

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 1  services and that has been incorporated and operated in this

 2  state for at least 65 years on or before July 1, 1994. All

 3  nursing home beds must not be available to the public but must

 4  be for the exclusive use of the community residents.

 5         (e)  For an increase in the bed capacity of a nursing

 6  facility licensed for at least 50 beds as of January 1, 1994,

 7  under part II of chapter 400 which is not part of a continuing

 8  care facility if, after the increase, the total licensed bed

 9  capacity of that facility is not more than 60 beds and if the

10  facility has been continuously licensed since 1950 and has

11  received a superior rating on each of its two most recent

12  licensure surveys.

13         (f)  For an inmate health care facility built by or for

14  the exclusive use of the Department of Corrections as provided

15  in chapter 945. This exemption expires when such facility is

16  converted to other uses.

17         (g)  For the termination of an inpatient health care

18  service, upon 30 days' written notice to the agency.

19         (h)  For the delicensure of beds, upon 30 days' written

20  notice to the agency. A request for exemption submitted under

21  this paragraph must identify the number, the category of beds,

22  and the name of the facility in which the beds to be

23  delicensed are located.

24         (i)  For the provision of adult inpatient diagnostic

25  cardiac catheterization services in a hospital.

26         1.  In addition to any other documentation otherwise

27  required by the agency, a request for an exemption submitted

28  under this paragraph must comply with the following criteria:

29         a.  The applicant must certify it will not provide

30  therapeutic cardiac catheterization pursuant to the grant of

31  the exemption.

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 1         b.  The applicant must certify it will meet and

 2  continuously maintain the minimum licensure requirements

 3  adopted by the agency governing such programs pursuant to

 4  subparagraph 2.

 5         c.  The applicant must certify it will provide a

 6  minimum of 2 percent of its services to charity and Medicaid

 7  patients.

 8         2.  The agency shall adopt licensure requirements by

 9  rule which govern the operation of adult inpatient diagnostic

10  cardiac catheterization programs established pursuant to the

11  exemption provided in this paragraph. The rules shall ensure

12  that such programs:

13         a.  Perform only adult inpatient diagnostic cardiac

14  catheterization services authorized by the exemption and will

15  not provide therapeutic cardiac catheterization or any other

16  services not authorized by the exemption.

17         b.  Maintain sufficient appropriate equipment and

18  health personnel to ensure quality and safety.

19         c.  Maintain appropriate times of operation and

20  protocols to ensure availability and appropriate referrals in

21  the event of emergencies.

22         d.  Maintain appropriate program volumes to ensure

23  quality and safety.

24         e.  Provide a minimum of 2 percent of its services to

25  charity and Medicaid patients each year.

26         3.a.  The exemption provided by this paragraph shall

27  not apply unless the agency determines that the program is in

28  compliance with the requirements of subparagraph 1. and that

29  the program will, after beginning operation, continuously

30  comply with the rules adopted pursuant to subparagraph 2.  The

31  

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 1  agency shall monitor such programs to ensure compliance with

 2  the requirements of subparagraph 2.

 3         b.(I)  The exemption for a program shall expire

 4  immediately when the program fails to comply with the rules

 5  adopted pursuant to sub-subparagraphs 2.a., b., and c.

 6         (II)  Beginning 18 months after a program first begins

 7  treating patients, the exemption for a program shall expire

 8  when the program fails to comply with the rules adopted

 9  pursuant to sub-subparagraphs 2.d. and e.

10         (III)  If the exemption for a program expires pursuant

11  to sub-sub-subparagraph (I) or sub-sub-subparagraph (II), the

12  agency shall not grant an exemption pursuant to this paragraph

13  for an adult inpatient diagnostic cardiac catheterization

14  program located at the same hospital until 2 years following

15  the date of the determination by the agency that the program

16  failed to comply with the rules adopted pursuant to

17  subparagraph 2.

18         (j)  For the provision of percutaneous coronary

19  intervention for patients presenting with emergency myocardial

20  infarctions in a hospital that does not have an approved adult

21  open-heart surgery program. In addition to any other

22  documentation otherwise required by the agency, the

23  prerequisites to a request for an exemption which is submitted

24  under this paragraph include:

25         1.  The applicant must certify that it will meet and

26  continuously maintain the requirements adopted by the agency

27  for the provision of these services. These licensure

28  requirements must be adopted by rule and must be consistent

29  with the guidelines for the provision of emergency

30  percutaneous coronary interventions in hospitals that do not

31  have adult open-heart services which are published by the

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 1  American College of Cardiology and the American Heart

 2  Association. At a minimum, the rules must provide that:

 3         a.  Cardiologists must be experienced

 4  interventionalists who have performed a minimum of 75

 5  interventions within the previous 12 months.

 6         b.  The hospital must provide a minimum of 36 emergency

 7  interventions annually, in order to continue to provide the

 8  service.

 9         c.  The hospital must offer sufficient physician,

10  nursing, and laboratory staff to provide the services 24 hours

11  a day, 7 days a week.

12         d.  Nursing and technical staff must have demonstrated

13  experience in handling acutely ill patients who require

14  intervention, which is based on previous experience in

15  dedicated interventional laboratories or surgical centers.

16         e.  Cardiac care nursing staff must be adept in

17  hemodynamic monitoring and IABP (Intra-Aortic Balloon Pump)

18  management.

19         f.  Formalized written transfer agreements must be

20  developed with a hospital that has an adult open-heart surgery

21  program, and written transport protocols must be in place to

22  ensure safe and efficient transfer of a patient within 60

23  minutes. Transfer and transport agreements must be reviewed

24  and tested at least every 3 months and appropriate

25  documentation must be maintained.

26         g.  Hospitals that implement the service must first

27  undertake a 3 to 6-month training program that includes

28  establishing standards, testing logistics, creating

29  quality-assessment and error-management practices, and

30  formalizing patient-selection criteria.

31  

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 1         2.  The applicant must certify that it will at all

 2  times use the patient-selection criteria for the performance

 3  of primary angioplasty at hospitals that do not have

 4  open-heart surgery programs which are issued by the American

 5  College of Cardiology and the American Heart Association.

 6         3.  The applicant must agree to submit to the agency a

 7  quarterly report that details patient characteristics and

 8  treatment and outcomes for all patients who receive emergency

 9  percutaneous coronary interventions pursuant to this

10  exemption. The report must be submitted within 15 days after

11  the close of each calendar quarter.

12         4.  The agency must have determined that the hospital

13  has taken all necessary steps to be in compliance with this

14  paragraph.

15  

16  An exemption provided under this paragraph expires immediately

17  if the hospital fails to meet the requirements of

18  sub-subparagraphs 1.a. and b. within 18 months after the

19  program begins offering the service or to comply continuously

20  with the rules adopted under sub-subparagraphs 1.c., d., e.,

21  and f. or with subparagraphs 2. and 3. If the exemption

22  provided under this paragraph expires because of such

23  deficiencies, the agency may not grant another exemption under

24  this paragraph to the same hospital for 2 years and, after the

25  2-year period has expired, may grant such an exemption only if

26  the hospital demonstrates its willingness to remain in

27  compliance with the adopted rules by correcting the

28  deficiencies that caused the exemption to expire.

29         (k)(j)  For mobile surgical facilities and related

30  health care services provided under contract with the

31  

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 1  Department of Corrections or a private correctional facility

 2  operating pursuant to chapter 957.

 3         (l)(k)  For state veterans' nursing homes operated by

 4  or on behalf of the Florida Department of Veterans' Affairs in

 5  accordance with part II of chapter 296 for which at least 50

 6  percent of the construction cost is federally funded and for

 7  which the Federal Government pays a per diem rate not to

 8  exceed one-half of the cost of the veterans' care in such

 9  state nursing homes. These beds shall not be included in the

10  nursing home bed inventory.

11         (m)(l)  For combination within one nursing home

12  facility of the beds or services authorized by two or more

13  certificates of need issued in the same planning subdistrict.

14  An exemption granted under this paragraph shall extend the

15  validity period of the certificates of need to be consolidated

16  by the length of the period beginning upon submission of the

17  exemption request and ending with issuance of the exemption.

18  The longest validity period among the certificates shall be

19  applicable to each of the combined certificates.

20         (n)(m)  For division into two or more nursing home

21  facilities of beds or services authorized by one certificate

22  of need issued in the same planning subdistrict.  An exemption

23  granted under this paragraph shall extend the validity period

24  of the certificate of need to be divided by the length of the

25  period beginning upon submission of the exemption request and

26  ending with issuance of the exemption.

27         (o)(n)  For the addition of hospital beds licensed

28  under chapter 395 for acute care, mental health services, or a

29  hospital-based distinct part skilled nursing unit in a number

30  that may not exceed 30 10 total beds or 10 percent of the

31  licensed capacity of the bed category being expanded,

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 1  whichever is greater; for the addition of medical

 2  rehabilitation beds licensed under chapter 395 in a number

 3  that may not exceed 8 total beds or 10 percent of capacity,

 4  whichever is greater; or for the addition of mental health

 5  services beds licensed under chapter 395 in a number that may

 6  not exceed 10 total beds or 10 percent of the licensed

 7  capacity of the bed category being expanded, whichever is

 8  greater. Beds for specialty burn units or, neonatal intensive

 9  care units, or comprehensive rehabilitation, or at a long-term

10  care hospital, may not be increased under this paragraph.

11         1.  In addition to any other documentation otherwise

12  required by the agency, a request for exemption submitted

13  under this paragraph must:

14         a.  Certify that the prior 12-month average occupancy

15  rate for the category of licensed beds being expanded at the

16  facility meets or exceeds 75 80 percent or, for a

17  hospital-based distinct part skilled nursing unit, the prior

18  12-month average occupancy rate meets or exceeds 96 percent

19  or, for medical rehabilitation beds, meets or exceeds 80

20  percent.

21         b.  Certify that any beds of the same type authorized

22  for the facility under this paragraph before the date of the

23  current request for an exemption have been licensed and

24  operational for at least 12 months.

25         2.  The timeframes and monitoring process specified in

26  s. 408.040(2)(a)-(c) apply to any exemption issued under this

27  paragraph.

28         3.  The agency shall count beds authorized under this

29  paragraph as approved beds in the published inventory of

30  hospital beds until the beds are licensed.

31  

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 1         (p)(o)  For the addition of acute care beds, as

 2  authorized by rule consistent with s. 395.003(4), in a number

 3  that may not exceed 30 10 total beds or 10 percent of licensed

 4  bed capacity, whichever is greater, for temporary beds in a

 5  hospital that has experienced high seasonal occupancy within

 6  the prior 12-month period or in a hospital that must respond

 7  to emergency circumstances.

 8         (q)(p)  For the addition of nursing home beds licensed

 9  under chapter 400 in a number not exceeding 10 total beds or

10  10 percent of the number of beds licensed in the facility

11  being expanded, whichever is greater.

12         1.  In addition to any other documentation required by

13  the agency, a request for exemption submitted under this

14  paragraph must:

15         a.  Effective until June 30, 2001, certify that the

16  facility has not had any class I or class II deficiencies

17  within the 30 months preceding the request for addition.

18         b.  Effective on July 1, 2001, certify that the

19  facility has been designated as a Gold Seal nursing home under

20  s. 400.235.

21         c.  Certify that the prior 12-month average occupancy

22  rate for the nursing home beds at the facility meets or

23  exceeds 96 percent.

24         d.  Certify that any beds authorized for the facility

25  under this paragraph before the date of the current request

26  for an exemption have been licensed and operational for at

27  least 12 months.

28         2.  The timeframes and monitoring process specified in

29  s. 408.040(2)(a)-(c) apply to any exemption issued under this

30  paragraph.

31  

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 1         3.  The agency shall count beds authorized under this

 2  paragraph as approved beds in the published inventory of

 3  nursing home beds until the beds are licensed.

 4         (q)  For establishment of a specialty hospital offering

 5  a range of medical service restricted to a defined age or

 6  gender group of the population or a restricted range of

 7  services appropriate to the diagnosis, care, and treatment of

 8  patients with specific categories of medical illnesses or

 9  disorders, through the transfer of beds and services from an

10  existing hospital in the same county.

11         (r)  For the conversion of hospital-based Medicare and

12  Medicaid certified skilled nursing beds to acute care beds, if

13  the conversion does not involve the construction of new

14  facilities.

15         (s)  For the replacement of a statutory rural hospital

16  the proposed site of which is in the same district and within

17  10 miles of the existing facility and within the current

18  primary service area, defined as the fewest number of zip

19  codes comprising 75 percent of the hospital's inpatient

20  admissions. For fiscal year 2001-2002 only, for transfer by a

21  health care system of existing services and not more than 100

22  licensed and approved beds from a hospital in district 1,

23  subdistrict 1, to another location within the same subdistrict

24  in order to establish a satellite facility that will improve

25  access to outpatient and inpatient care for residents of the

26  district and subdistrict and that will use new medical

27  technologies, including advanced diagnostics, computer

28  assisted imaging, and telemedicine to improve care. This

29  paragraph is repealed on July 1, 2002.

30         (t)  For the conversion of mental health services beds

31  licensed under chapter 395 or hospital-based distinct part

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 1  skilled nursing unit beds to general acute care beds; the

 2  conversion of mental health services beds between or among the

 3  licensed bed categories defined as beds for mental health

 4  services; or the conversion of general acute care beds to beds

 5  for mental health services.

 6         1.  Conversion under this paragraph does not establish

 7  a new licensed bed category at the hospital but applies only

 8  to categories of beds licensed at that hospital.

 9         2.  Beds converted under this paragraph must be

10  licensed and operational for at least 12 months before the

11  hospital may apply for additional conversion affecting beds of

12  the same type.

13         (u)  For the creation of at least a 10-bed Level II

14  neonatal intensive care unit in an applicant hospital that has

15  demonstrated to the agency that the hospital had at least

16  1,500 births during the previous 12 months.

17         (v)  For the addition of Level II or Level III neonatal

18  intensive care beds in a number not to exceed 6 beds or 10

19  percent of licensed capacity in that category, whichever is

20  greater, if the hospital certifies that the average occupancy

21  rate for the category of licensed neonatal intensive care beds

22  during the immediately preceding 12 months is at least 75

23  percent.

24         Section 3.  Section 408.038, Florida Statutes, is

25  amended to read:

26         408.038  Fees.--The agency shall assess fees on

27  certificate-of-need applications.  Such fees shall be for the

28  purpose of funding the functions of the local health councils

29  and the activities of the agency. Except for the increased

30  amount of funds received under subsection (3), the fees must

31  

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 1  and shall be allocated as provided in s. 408.033. The fee

 2  shall be determined as follows:

 3         (1)  A minimum base fee of $10,000 $5,000.

 4         (2)  In addition to the base fee of $10,000 $5,000,

 5  0.015 of each dollar of proposed expenditure, except that a

 6  fee may not exceed $50,000 $22,000.

 7         (3)  Any increase in fee revenues which is generated by

 8  increases in the minimum base fee or increases in the fee

 9  limit, as authorized by the 2003 Legislature, must be used

10  only to fund activities of the certificate-of-need program.

11         Section 4.  Paragraph (e) of subsection (5) and

12  paragraph (c) of subsection (6) of section 408.039, Florida

13  Statutes, are amended to read:

14         408.039  Review process.--The review process for

15  certificates of need shall be as follows:

16         (5)  ADMINISTRATIVE HEARINGS.--

17         (e)  The agency shall issue its final order within 45

18  days after receipt of the recommended order. If the agency

19  fails to take action within 45 days, the Division of

20  Administrative Hearing's recommended order is considered

21  approved such time, or as otherwise agreed to by the applicant

22  and the agency, the applicant may take appropriate legal

23  action to compel the agency to act. When making a

24  determination on an application for a certificate of need, the

25  agency is specifically exempt from the time limitations

26  provided in s. 120.60(1).

27         (6)  JUDICIAL REVIEW.--

28         (c)  The court, in its discretion, may award reasonable

29  attorney's fees and costs to the prevailing party if the court

30  finds that there was a complete absence of a justiciable issue

31  of law or fact raised by the losing party. If the losing party

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 1  is a hospital, the court shall order it to pay the reasonable

 2  attorney's fees and costs of the hospital that is the

 3  prevailing party, including fees and costs incurred as a

 4  result of the administrative hearing and the judicial appeal.

 5         Section 5.  Hospital Statutory and Regulatory Reform

 6  Council; legislative intent; creation; membership; duties.--

 7         (1)  It is the intent of the Legislature to provide for

 8  the protection of the public health and safety in the

 9  establishment, construction, maintenance, and operation of

10  hospitals. However, the Legislature further intends that the

11  police power of the state be exercised toward that purpose

12  only to the extent necessary and that regulation remain

13  current with the ever-changing standard of care and not

14  restrict the introduction and use of new medical technologies

15  and procedures.

16         (2)  In order to achieve the purposes expressed in

17  subsection (1), it is necessary that the state establish a

18  mechanism for the ongoing review and updating of laws

19  regulating hospitals. The Hospital Statutory and Regulatory

20  Reform Council is created and located, for administrative

21  purposes only, within the Agency for Health Care

22  Administration. The council shall consist of no more than 15

23  members, including:

24         (a)  Nine members appointed by the Florida Hospital

25  Association who represent acute care, teaching, specialty,

26  rural, government-owned, for-profit, and not-for-profit

27  hospitals;

28         (b)  Two members appointed by the Governor who

29  represent patients;

30         (c)  Two members appointed by the President of the

31  Senate who represent private businesses that provide health

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 1  insurance coverage for their employees, one of whom represents

 2  small private businesses and one of whom represents large

 3  private businesses. As used in this paragraph, the term

 4  "private business" does not include an entity licensed under

 5  chapter 627, Florida Statutes, or chapter 641, Florida

 6  Statutes, or otherwise licensed or authorized to provide

 7  health insurance services, either directly or indirectly, in

 8  this state; and

 9         (d)  Two members appointed by the Speaker of the House

10  of Representatives who represent physicians.

11         (3)  Council members shall be appointed to serve 2-year

12  terms and may be reappointed. A member shall serve until his

13  or her successor is appointed. The council shall annually

14  elect from among its members a chair and a vice chair. The

15  council shall meet at least twice a year and shall hold

16  additional meetings as it considers necessary. Members

17  appointed by the Florida Hospital Association may not receive

18  compensation or reimbursement of expenses for their services.

19  Members appointed by the Governor, the President of the

20  Senate, or the Speaker of the House of Representatives may be

21  reimbursed for travel expenses by the agency.

22         (4)  The council, as its first priority, shall review

23  chapters 395 and 408, Florida Statutes, and shall make

24  recommendations to the Legislature for the repeal of

25  regulatory provisions that are no longer necessary or that

26  fail to promote cost-efficient, high-quality medicine.

27         (5)  The council, as its second priority, shall

28  recommend to the Secretary of Health and the Secretary of

29  Health Care Administration regulatory changes relating to

30  hospital licensure and regulation to assist the Department of

31  Health and the Agency for Health Care Administration in

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    Florida Senate - 2003                                  SB 2132
    37-696A-03




 1  carrying out their duties and to ensure that the intent of the

 2  Legislature as expressed in this subsection is carried out.

 3         (6)  In determining whether a statute or rule is

 4  appropriate or necessary, the council shall consider whether:

 5         (a)  The statute or rule is necessary to prevent

 6  substantial harm, which is recognizable and not remote, to the

 7  public health, safety, or welfare;

 8         (b)  The statute or rule restricts the use of new

 9  medical technologies or encourages the implementation of more

10  cost-effective medical procedures;

11         (c)  The statute or rule has an unreasonable effect on

12  job creation or job retention in the state;

13         (d)  The public is or can be effectively protected by

14  other means;

15         (e)  The overall cost-effectiveness and economic effect

16  of the proposed statute or rule, including the indirect costs

17  to consumers, will be favorable; and

18         (f)  A lower-cost regulatory alternative to the statute

19  or rule could be adopted.

20         Section 6.  This act shall take effect July 1, 2003.

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    Florida Senate - 2003                                  SB 2132
    37-696A-03




 1            *****************************************

 2                          SENATE SUMMARY

 3    Relates to certificates of need. Redefines the term
      "tertiary health service" as used in the Health Facility
 4    and Services Development Act, to include adult and
      pediatric open-heart surgery. Amends provisions
 5    specifying which health-care-related projects are subject
      to review and must file an application for a certificate
 6    of need. Exempts certain projects from review, including
      the provision of percutaneous coronary intervention, in
 7    specified circumstances. Provides for the expiration of
      such an exemption and for postponing the renewal of the
 8    exemption, as specified. Provides additional exemptions.
      Provides for increases in fees for certificate-of-need
 9    applications. Provides that such increased revenues must
      be used only to fund the certificate-of-need program.
10    Provides for automatic approval of a certificate-of-need
      application if the Agency for Health Care Administration
11    does not issue its final order within 45 days after
      receipt of the recommended order. Provides that a court
12    must order a hospital that is a losing party to pay
      reasonable attorney's fees and costs of a hospital that
13    is the prevailing party. Creates the Hospital Statutory
      and Regulatory Reform Council. Provides legislative
14    intent. Provides membership and duties of the council.

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