An Act relating to certificate-of-need; amending s. 408.032;
adding open heart surgery to the list of tertiary services; amending s.
408.034; adding an occupancy standard for the nursing home bed need
methodology; amending s. 408.036(1); deleting hospice inpatient facility from
the projects subject to review; amending s. 408.036(2); deleting shared service
projects from expedited reviews; modifying circumstances requiring transfer of
a certificate of need; modifying expedited review for replacement of a nursing
home; adding expedited review for relocation of nursing home beds; amending s.
408.036(3); adding exemptions for addition of comprehensive medical
rehabilitation beds, conversion of mental health services beds, provision of
percutaneous coronary intervention at hospitals without open heart surgery,
replacement of a rural hospital, establishment of a Level II neonatal intensive
care unit, addition of Level II or Level III neonatal intensive care beds,
replacement of a licensed nursing home, and consolidation or combination of
nursing home beds by providers that operate multiple nursing homes; amending s.
408.037; allowing a consolidated audit of a parent company; providing that the
acquisition of a licensed hospital includes acquisition of any pending
certificate of need application; amending s. 408.038; revising the fee schedule
for certificate-of-need applications; amending section 408.039; providing that
without agency action within 45 days the recommended order of the Division of
Administrative Hearings becomes the final order; providing that a hospital that
is the losing party in a judicial review must pay reasonable fees and costs of
the prevailing hospital; amending s. 408.043(2); deleting a reference to
hospice inpatient facility; creating a Certificate of Need Nursing Home
Advisory Panel; directing the Agency for Health Care Administration to develop
outcome-oriented licensure standards for interventional cardiology; providing
an effective date.
Be It Enacted by the Legislature of the State of Florida:
Section 1. Subsection (17) of section 408.032, Florida
Statutes, is amended as follows:
408.032 Definitions relating to Health Facility and
Services Development Act.-- As used in ss. 408.031-408.045, the term:
(17) "Tertiary health service" means a
health service which, due to its high level of intensity, complexity,
specialized or limited applicability, and cost, should be limited to, and
concentrated in, a limited number of hospitals to ensure the quality,
availability, and cost-effectiveness of such service. Examples of such service
include, but are not limited to, organ transplantation, adult and pediatric
open heart surgery, specialty burn units, neonatal intensive care units,
comprehensive rehabilitation, and medical or surgical services which are
experimental or developmental in nature to the extent that the provision of
such services is not yet contemplated within the commonly accepted course of
diagnosis or treatment for the condition addressed by a given service. The
agency shall establish by rule a list of all tertiary health services.
Section 2.
Subsection (5) of section 408.034, Florida Statutes, is amended to read:
408.034 Duties and Responsibilities of agency;
rules.--
(5) The agency shall establish by rule a
nursing-home-bed-need methodology that has a goal of maintaining a district
average occupancy of 94 percent; and that reduces the community nursing
home bed need for the areas of the state where the agency establishes pilot
community diversion programs through the Title XIX aging waiver program.
Section 3.
Paragraph (e) of subsection (1) of section 408.036, Florida Statutes, is
amended as follows:
408.036 Projects subject to review.--
(1) APPLICABILITY.--Unless exempt under
subsection (3), all health-care-related projects, as described in paragraphs
(a)-(h), are subject to review and must file an application for a certificate
of need with the agency. The agency is exclusively responsible for determining
whether a health-care-related project is subject to review under ss.
408.031-408.045.
(e) The establishment of a hospice or hospice
inpatient facility, except as provided in s. 408.043.
Section 4.
Subsection (2) of section 408.036, Florida Statutes, is amended as
follows:
408.036 Projects subject to review.--
(2) PROJECTS SUBJECT TO EXPEDITED REVIEW.-- Unless exempt pursuant to
subsection (3), projects subject to an expedited review shall include, but not
be limited to:
(a) Research, education, and training programs.
(b) Shared services contracts or projects.
(b)(c) A transfer of a certificate of need,
except that when an existing hospital is acquired by a purchaser, all
certificates of need issued to the hospital which are not yet operational shall
be acquired by the purchaser, without need for a transfer.
(c)(d) A 50-percent increase in nursing home beds
for a facility incorporated and operating in this state for at least 60 years
on or before July 1, 1988, which has a licensed nursing home facility located
on a campus providing a variety of residential settings and supportive
services. The increased nursing home beds shall be for the exclusive use of the
campus residents. Any application on behalf of an applicant meeting this
requirement shall be subject to the base fee of $5,000 provided in s. 408.038.
(d)(e) Replacement of a health care facility when
the proposed project site is located in the same district and within a 1-mile
radius of the replaced health care facility.
(e)(f) The conversion of mental health services
beds licensed under chapter 395 or hospital-based distinct part skilled
nursing unit beds to general acute care beds; the conversion of mental
health services beds between or among the licensed bed categories defined as
beds for mental health services; or the conversion of general acute care beds
to beds for mental health services.
1. Conversion under this paragraph shall not
establish a new licensed bed category at the hospital but shall apply only to
categories of beds licensed at that hospital.
2. Beds converted under this paragraph must be
licensed and operational for at least 12 months before the hospital may apply
for additional conversion affecting beds of the same type.
(f) Replacement of a
nursing home within the same district, provided the proposed project site is
located within a geographic area that contains at least 65 percent of the
facility’s current residents, and is within a 30-mile radius of the replaced
nursing home.
(g) Relocation of a
portion of a nursing home’s licensed beds to a replacement facility within the
same district, provided the relocation is within a 30-mile radius of the
existing facility, and the total number of nursing home beds in the district
does not increase.
The agency shall develop rules
to implement the provisions for expedited review, including time schedule,
application content which may be reduced from the full requirements of s.
408.037(1), and application processing.
Section 5. Subsection (3) of section 408.036, Florida
Statutes, is amended as follows:
408.036 Projects subject to review.--
(3) EXEMPTIONS.--Upon request, the following projects are subject to
exemption from the provisions of subsection (1):
(n) For the addition of hospital beds licensed
under chapter 395. for
1. Beds in the following licensed categories
may be increased under this paragraph:
a. Acute care beds, mental health
services, or a hospital-based distinct part skilled nursing unit in a
number that may not exceed 30 10 total beds or 10 percent of the
licensed capacity of acute care beds the bed category being expanded,
whichever is greater;
b. Hospital-based distinct part skilled nursing
unit beds, in a number that may not exceed 10 beds or 10 percent of the
licensed capacity of skilled nursing unit beds, whichever is greater;
c. Comprehensive medical rehabilitation beds in
a number that may not exceed 8 total beds or 10 percent of the licensed
capacity of comprehensive medical rehabilitation beds, whichever
is greater;
d Level II or Level III neonatal intensive care beds, in a number
that may not exceed 6 beds or 10 percent of licensed capacity in that category,
whichever is greater; or
e. Mental health services beds, in a number
that may not exceed 10 total beds or 10 percent of the licensed capacity of the
mental health bed category being expanded, whichever is greater.
2. Beds for specialty burn units, neonatal
intensive care units, or comprehensive rehabilitation, or at a long-term
care hospital, may not be increased under this paragraph.
3.1. In addition to any other documentation
otherwise required by the agency, a request for exemption submitted under this
paragraph must:
a. Certify that the prior 12-month average
occupancy rate for the category of licensed beds being expanded at the
facility meets or exceeds 80 percent is at least 75 percent for acute
care; at least 96 percent for a hospital-based distinct part skilled
nursing unit; at least 90 percent for comprehensive medical rehabilitation
beds; or at least 75 percent for the level of neonatal intensive care beds
being expanded or, for a hospital-based distinct part skilled nursing
unit, the prior 12-month average occupancy rate meets or exceeds 96 percent.
b. Certify that any beds of the same type
authorized for the facility under this paragraph before the date of the current
request for an exemption have been licensed and operational for at least 12
months.
4.2. The timeframes and monitoring process
specified in s. 408.040(2)(a)-(c) apply to any exemption issued under this
paragraph.
5.3. The agency shall count beds authorized under
this paragraph as approved beds in the published inventory of hospital beds
until the beds are licensed.
(o) For the addition of acute care beds, as
authorized by rule consistent with s. 395.003(4), in a number that may not
exceed 30 10 total beds or 10 percent of licensed bed capacity,
whichever is greater, for temporary beds in a hospital that has experienced
high seasonal occupancy within the prior 12-month period or in a hospital that
must respond to emergency circumstances.
(p) For the addition of nursing home beds licensed
under chapter 400 in a number not exceeding 10 total beds or 10 percent of the
number of beds licensed in the facility being expanded, whichever is greater.
1. In addition to any other documentation
required by the agency, a request for exemption submitted under this paragraph
must:
a. Effective until June 30, 2001, Ccertify
that the facility has not had any class I or class II deficiencies within the
30 months preceding the request for addition.
b. Effective on July 1, 2001, certify that the
facility has been designated as a Gold Seal nursing home under s. 400.235.
b.c. Certify that the prior 12-month average
occupancy rate for the nursing home beds at the facility meets or exceeds 96
percent.
c.d. Certify that any beds authorized for the
facility under this paragraph before the date of the current request for an
exemption have been licensed and operational for at least 12 months.
2. The timeframes and monitoring process
specified in s. 408.040(2)(a)-(c) apply
to any exemption issued under this paragraph.
3. The agency shall count beds authorized under
this paragraph as approved beds in the published inventory of nursing home beds
until the beds are licensed.
(q) For establishment of a specialty hospital
offering a range of medical service restricted to a defined age or gender group
of the population or a restricted range of services appropriate to the
diagnosis, care, and treatment of patients with specific categories of medical
illnesses or disorders, through the transfer of beds and services from an
existing hospital in the same county.
(q)(r) For the conversion of hospital-based
Medicare and Medicaid certified skilled nursing beds to acute care beds, if the
conversion does not involve the construction of new facilities.
(s) For fiscal year 2001-2002 only, for transfer
by a health care system of existing services and not more than 100 licensed and
approved beds from a hospital in district 1, subdistrict 1, to another location
within the same subdistrict in order to establish a satellite facility that
will improve access to outpatient and inpatient care for residents of the
district and subdistrict and that will use new medical technologies, including
advanced diagnostics, computer assisted imaging, and telemedicine to improve
care. This paragraph is repealed on July 1, 2002.
(r) For the conversion of mental health services
beds between or among the licensed bed categories defined as beds for mental
health services, provided that conversion under this paragraph shall not
establish a new licensed bed category at the hospital but shall apply only to
categories of beds licensed at that hospital.
(s)
For the provision of percutaneous coronary intervention for patients
presenting with emergency myocardial infarctions in a hospital without an operational
adult open heart surgery program. In
addition to any other documentation otherwise required by the agency, a request
for an exemption submitted under this paragraph must comply with the following:
1. The applicant must certify that it will meet
and continuously maintain the licensure requirements adopted by the agency for
the provision of these services. These
licensure requirements are to be adopted by rule and are to be consistent with
the guidelines published by the American College of Cardiology and the American
Heart Association for the provision of percutaneous coronary interventions in
hospitals without adult open heart services. At a minimum, the rules shall
require the following:
a.
Cardiologists must be experienced interventionalists who have performed
a minimum of 75 interventions within the previous 12 months;
b.
The hospital must provide a minimum of 36 emergency interventions
annually, in order to continue to provide the service;
c.
The hospital must have sufficient physician, nursing and laboratory
staff to provide the services twenty four hours a day, seven days a week;
d.
Nursing and technical staff must have demonstrated experience in
handling acutely ill patients requiring intervention based on previous
experience in dedicated interventional laboratories or surgical centers;
e.
Cardiac care nursing staff must be adept in hemodynamic monitoring and
IABP management;
f.
Formalized written transfer agreements must be developed with a hospital
with an adult open heart surgery program and written transport protocols must
be in place to ensure safe and efficient transfer of a patient within 60
minutes. Transfer and transport
agreements must reviewed and tested, with appropriate documentation maintained
at least every 3 months;
g.
Hospitals implementing the service must first undertake a 3 to 6 month
training program which includes establishing standards, testing logistics,
creating quality assessment and error management practices, and formalizing
patient selection criteria.
2.
The applicant must certify that it will utilize at all times the patient
selection criteria for the performance of primary angioplasty at hospitals
without adult open heart surgery programs issued by the American College of
Cardiology and the American Heart Association.
At a minimum, these criteria would provide for the following:
a.
Avoidance of interventions in hemodynamically stable patients presenting
with identified symptoms or medical histories;
b.
Transfer of patients presenting with a history of coronary disease and
clinical presentation of hemodynamic instability.
3.
The applicant must agree to submit a quarterly report to the agency
detailing patient characteristics, treatment and outcomes for all patients
receiving emergency percutaneous coronary interventions pursuant to this
exemption. This report must be
submitted within 15 days of the close of each calendar quarter. The
exemption provided by this paragraph shall not apply unless the agency
determines that the hospital has taken all necessary steps to be in compliance
with the requirements, including the training program required pursuant to
sub-subparagraph 1.g.
4.
Failure of the hospital to continuously comply with the rules adopted
pursuant to sub-subparagraphs 1.c. through 1.f. and subparagraphs 2. and 3.
will result in the immediate expiration of this exemption.
5.
Failure of the hospital to meet the volume requirements of
sub-subparagraph 1.a. and 1.b. within 18 months after the program begins
offering the service will result in the immediate expiration of this exemption.
(t) For the replacement of a statutory rural
hospital within the same district, provided the proposed project site is within
10 miles of the existing facility, and is within the current primary service
area, defined as the least number of ZIP codes comprising 75 percent of the
hospital’s inpatient admissions.
(u) For the establishment of a Level II neonatal
intensive care unit with at least 10 beds, upon documentation to the agency
that the applicant hospital had a minimum of 1500 births during the previous 12
months.
(v) For replacement of a licensed nursing home
on the same site, or within 3 miles of the same site, provided the number of
licensed beds does not increase.
(w) For consolidation or combination of licensed
nursing homes or transfer of beds between licensed nursing homes within the
same district, by providers that operate multiple nursing homes within that
district, provided there is no increase in the district total of nursing home beds,
and the relocation does not exceed 30 miles from the original location.
Section
6. Paragraph (c) of
subsection (1) of section 408.037, Florida Statutes, is amended to read:
408.037 Application
content.--
(c) An audited financial statement of the applicant;
or, if the applicant is included in a parent company’s consolidated
audit which details each entity separately, an audited financial statement of
the parent company. In an
application submitted by an existing health care facility, health maintenance
organization, or hospice, financial condition documentation must include, but
need not be limited to, a balance sheet and a profit-and-loss statement of the
2 previous fiscal years' operation.
Section 7. Subsection (2) of section 408.037, Florida Statutes,
is amended to read:
408.037 Application
content.--
(2) The applicant must certify that it will
license and operate the health care facility.
For an existing health care facility, the applicant must be the license
holder of the facility. Provided,
however, that acquisition of a licensed hospital prior to final agency action
on its application for a certificate of need shall transfer the application to
the new owner and license holder.
Section 8. Section 408.038, Florida Statutes, is
amended to read:
408.038 Fees.--The agency shall assess fees on
certificate-of-need applications. Such
fees shall be for the purpose of funding the functions of the local health
councils and the activities of the agency and shall provide funds to the
local health councils. Except for the
increased amount of fees received pursuant to subsection (3), the fees and
shall be allocated as provided in s. 408.033(2)(f). The fee shall be determined as follows:
(1) A minimum base fee of $10,000 $5,000.
(2) In addition to the base fee of $10,000
$5,000, 0.015 of each dollar of proposed expenditure, except that a fee
may not exceed $50,000 $22,000.
(3) Any increase in fee revenue generated by
increases in the minimum base fee or increases in the fee limit, as authorized by
the 2003 Legislature, shall be used only to fund activities of the certificate
of need program.
Section 9. Paragraph (e) of subsection (5) of section
408.039, Florida Statutes, is amended as follows:
(5) ADMINISTRATIVE HEARINGS.--
(e) The agency shall issue its final order
within 45 days after receipt of the recommended order. If the agency fails to take action within 45
days, the recommended order of the Division of Administrative Hearings becomes
the agency’s final order such time, or as otherwise agreed to by the
applicant and the agency, the applicant may take appropriate legal action to
compel the agency to act. When
making a determination on an application for a certificate of need, the agency
is specifically exempt from the time limitations provided in s. 120.60(1).
Section
10. Paragraph (c) of subsection (6) of
section 408.039, Florida Statutes, is amended as follows:
(6) JUDICIAL REVIEW.--
(c) The court, in its discretion, may award
reasonable attorney's fees and costs to the prevailing party if the court finds
that there was a complete absence of a justiciable issue of law or fact raised
by the losing party. If the losing
party is a hospital, the court shall order it to pay the reasonable attorney’s
fees and costs of the prevailing hospital party, which shall include fees and
costs incurred as a result of the administrative hearing and the judicial
appeal.
Section 11. Subsection (2) of section 408.043, Florida
Statutes, is amended as follows:
408.043 Special provisions.--
(2) HOSPICES.-- When an application is made for
a certificate of need to establish or to expand a hospice, the need for such
hospice shall be determined on the basis of the need for and availability of
hospice services in the community. The
formula on which the certificate of need is based shall discourage regional
monopolies and promote competition. The
inpatient hospice care component of a hospice which is a freestanding facility,
or a part of a facility, which is primarily engaged in providing inpatient care
and related services and is not licensed as a health care facility shall also
be required to obtain a certificate of need. Provision of hospice care by any current provider of health care
is a significant change in service and therefore requires a certificate of need
for such services.
Section 12.
Certificate of Need
Nursing Home Advisory Panel
(1)
There is hereby created a Certificate of Need
Nursing Home Advisory Panel to serve as a body of experts to guide the agency
in its development of policy related to nursing home certificate of need
issues. The agency shall provide staff
support to the Panel. The Panel shall
be composed of the following members:
(a)
The designee of the Deputy Secretary of Health Quality Assurance;
(b)
The designee of the Deputy Secretary of Medicaid;
(c)
The designee of the Secretary of the Department of Elder Affairs;
(d)
Two representatives of the Local Health Councils;
(e)
One representative of the Florida Association of Homes for the Aging;
(f)
One representative of the Florida Health Care Association;
(g)
One representative of nonprofit nursing homes;
(h)
One representative of for-profit nursing homes; and
(i) One representative
of Florida Hospices and Palliative Care, Inc.
(2) The Panel shall meet
at least quarterly and advise the agency regarding:
(a)
Long term care needs of Florida’s elderly;
(b)
Issues specific to different districts or subdistricts;
(c)
Options for ensuring access to long term care for Medicaid eligible and
other individuals;
(d) Reimbursement policy
that will encourage development of alternative long term care initiatives;
(e)
Development of a timely utilization reporting schedule for assisted
living facilities and home and community based services; and
(f) Changes necessary for a more viable nursing
home bed need formula which will ensure access, and take into account the
alternatives to nursing home care available in each district or subdistrict
using information from the reports submitted by such providers.
Section
13. The
Agency for Health Care Administration is directed to develop outcome-oriented
licensure standards for interventional cardiology, including open heart surgery
and cardiac catheterization.
Section
14.
This Act shall take effect upon becoming a law.