Proposal by the Florida Hospital Association
Proposed Legislative Language	Notes/Explanation
Definitions relating to Health Facility and Services Development: "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.	This change specifically adds open heart surgery programs to the statutory list of tertiary hospital services. While open heart surgery programs are not included in the statutory definition of tertiary services, they are defined as tertiary services in administrative rules that cover CON review of open heart surgery programs.
The Legislature intends that the cost of local health councils be borne by application fees for certificates of need and by assessments on selected health care facilities subject to facility licensure by the Agency for Health Care Administration …	This change would require the Legislature to find a source of funds other than CON fees for local health councils. This would also affect two or three positions at the Department of Health where the local health council contracts are managed. Workgroup Chairman Rich Morrison makes a similar proposal.
The agency, in conjunction with the local health councils, is responsible for the coordinated planning of health care services in the state.	This change would eliminate the remaining role for local health councils in the development in statewide health planning. Presently, applicable preferences included in district health plans are considered in the CON review process.

FHA –1

Proposed Legislative Language	Notes/Explanation
The agency is designated as the single state agency to issue, revoke, or deny certificates of need and to issue, revoke, or deny exemptions from certificate-of-need review in accordance with the district plans and present and future federal and state statutes. The agency is designated as the state health planning agency for purposes of federal law.	This change would eliminate consideration of district health plan preferences in the CON review process.
PROJECTS SUBJECT TO EXPEDITED REVIEW.-- … Shared services contracts or projects.	This change eliminates the notion of shared services programs among CON-reviewable services. It would require any hospital to get a CON in order to have the ability to operate a program that is subject to CON review. Any sharing or cooperation that they then wished to engage in would be subject only to licensure requirements — not CON review.
A transfer of a certificate of need except when an existing hospital is acquired by a purchaser, all pending certificates of need filed by the existing hospital and all approved certificates of need owned by that hospital would be acquired by the purchaser.	This change would allow the purchaser of a hospital to acquire any CONs that had already been obtained but not yet developed or implemented by the hospital. Currently, since undeveloped CONs are issued to the license holder, and the license holder would change in the event of a sale, the new owner would have to re-apply for any undeveloped CONs. This does not apply to beds that have already been licensed or services that are already operational — these assets would be part of the sale.

FHA –2

Proposed Legislative Language	Notes/Explanation
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.	The 2000 Legislature slightly streamlined the process to allow hospitals to convert beds among acute care, mental health and skilled nursing services. This was done by shifting the process from full batched CON review to expedited CON review. This proposed change would revert back to full batched review for the conversion of skilled nursing beds to acute care beds and, coupled with the change below, allow hospitals to convert beds among categories of mental health with a simple exemption request.
EXEMPTIONS.—Upon request, the following projects are subject to exemption from the provisions of subsection (1):
For the conversion of mental health services beds between or among the licensed bed categories defined as beds for mental health services.	This change would allow hospitals to convert between adult or pediatric inpatient psychiatric or substance abuse beds through a simple exemption letter. It would not change the hospital licensure requirements associated with these different categories of mental health services.

FHA-3

Proposed Legislative Language

Notes/Explanation

1. For the provision of percutaneous coronary intervention for patients presenting with emergency myocardial infarctions in a hospital without an approved 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: 2. The applicant must certify that it will meet and continuously maintain the 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 offer sufficient physician, nursing and laboratory staff to provide the services twenty four hours daily, 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. 3..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 hemodaynamic instability. 4. 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 the paragraph shall not apply unless the agency determines that the hospital has taken all necessary steps to be in compliance with these paragraphs, including the training program required pursuant to paragraph (1) subsection (g). 5. Failure of the hospital to continuously comply with the rules adopted pursuant to paragraph 1.sub-paragraphs c.d.e.f. and paragraphs 2 and 3 will result in the immediate expiration of this exemption. 6. Failure of the hospital to meet the volume requirements of paragraph1. subparagraphs a and b within 18monts after the programs begins offering the service will result in the immediate expiration of this exemption.

This change would allow hospitals to begin offering emergency angioplasty services without obtaining a CON for a back-up open heart surgery program. The Agency for Health Care Administration would be required to develop hospital licensure rules for the provision of angioplasty and related procedures in emergency situations. Currently, hospitals cannot legally provide angioplasty and related procedures in emergency situations unless they have CON-approved open heart surgery programs. Compare proposals by Mr. Morrison and Mr. Panza.

FHA-4

Proposed Legislative Language

Notes/Explanation

For the addition of hospital beds licensed under chapter 395 for acute care, 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 the bed category being expanded whichever if greater; for the addition of medical rehabilitation beds licensed under chapter 395 in a number that may not exceed 8 total beds or 10 percent of capacity whichever is greater; or for the addition of mental health services beds licensed under chapter 395 in a number that may not exceed 10 total beds or 10 percent of the licensed capacity of the bed category being expanded, whichever is greater. 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.

This change would expand hospitals’ ability to add beds through a CON exemption for highly utilized services. The proposal increases the number of acute care beds that could be added in smaller hospitals from10 to 30. Larger hospitals with high utilization could add more beds if they have more than 300 licensed acute care beds. This change would also expand the flexibility to add comprehensive inpatient medical rehabilitation beds and mental health beds through a CON exemption when the hospital experiences very high occupancy. Similar proposals are presented by Mr. Morrison and Mr. Panza.

FHA-5

Proposed Legislative Language	Notes/Explanation
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.	This change would expand hospitals’ ability to add beds through a CON exemption for beds that are highly utilized during a specific season (normally the winter quarter.) The proposal increases the number of acute care beds that could be added in smaller hospitals from10 to 30. Larger hospitals with high utilization could add more beds if they have more than 300 licensed acute care beds.
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.	This change would eliminate the CON exemption that allows a hospital to establish an age or gender-specific specialty hospital by transferring some of its beds to a new facility in the same county. The proposed change does not specify whether CON review should be full-batched or expedited.
For the replacement of a statutory rural hospital when the proposed project site is located in the same district and within 10 miles of the existing facility and within the current primary service area, defined as the least number of zip codes comprising 75 percent of the hospital’s inpatient admissions.	This change would allow a CON exemption for statutory rural hospitals to build replacement facilities within 10 miles of their present location when the new location is within their primary service area.

FHA-6

Proposed Legislative Language	Notes/Explanation
For the creation of at least a 10 bed Level II neonatal intensive care unit upon demonstrating to the agency that the applicant hospital had a minimum of 1500 births during the previous 12 months.	This change would allow hospitals that have a large OB program to add a NICU through a CON exemption.
For the addition of Level II or Level III neonatal intensive care beds in a number not to exceed 6 beds or 10 percent of licensed capacity in that category whichever is greater, provided that the hospital certifies that the prior 12-month average occupancy rate for the category of licensed neonatal intensive care beds meets or exceeds 75 percent.	This change would allow hospitals with highly utilized NICU services to add 6 beds through a CON exemption.
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 be allocated as provided in s. 408.033. The fee shall be determined as follows: A minimum base fee of $10,000 $5,000.	This change would raise the minimum CON fee from $5,000 to $10,000. Compare the proposal by Mr. Morrison.
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.	This change would increase the maximum CON fee from $22,000 to $50,000.
ADMINISTRATIVE HEARINGS.— 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 Division of Administrative Hearing recommended order is deemed approved. 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).	In cases of CON appeals, this change would require the Agency for Health Care Administration to issue a final order within 45 days of a recommended order forwarded from the Division of Administrative Hearings.
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, which shall include fees and costs incurred as a result of the administrative hearing and the judicial appeal, of the prevailing hospital party.	This change would require the challenger in a CON appeal to pay the attorney’s fees and costs of the approved CON applicant if the court finds in favor of the approved applicant.

FHA-7

Proposal by Workgroup Member Andrea Eliscu
Proposed Legislative Language	Notes/Explanation (Provided by Ms. Eliscu)
Repeal sections 395.1055, 400.071, 400.602, 400.606408.031, 408.032, 408.033(3), 408.034, 408.035, 408.036, 408.037, 408.038, 408.039, 408.040, 408.041, 408.042, 408.043, 408.044, 408.045, 408.0455 and 651.118, Florida Statutes.	Current CON laws seem to only have created an oligopoly of healthcare providers. Changes to the original laws appear limited to self-serving initiatives that maintain barriers to new providers and innovative new services. It does not seem that the existing statutes can be modified to help meet current and future demands on healthcare services by Florida's citizens. In my opinion, repealing the current CON laws may be the only way to allow the supply and demand marketplace to begin to grow and change where necessary to meet the explosive growth expected in our state. As an example, among other initiatives, elimination of CON review would allow further development and expanded operation of single-specialty surgical facilities. These Single-specialty surgical facilities would provide focused care in the management of specific areas of disease. These focused facilities could maintain appropriate program volumes that maximize quality and helps ensure patient safety. Not unlike full-service hospitals, these focused facilities could also be required to provide a minimum of 2% of it services to indigent care each year. The only major and reasonable concerns I have heard for maintaining the CON status quo for our future healthcare system are surrounding quality and indigent care. I believe the quality issue should be addressed through a licensure process that would provide time-limited provisional licensure status to new providers subject to quality/volume evaluation by the Local Health Council (in a possible new role for them). The indigent care problem could be reduced by collecting a 2% tax on revenues from all provider facilities. The state could use those revenues to partially reimburse those entities providing unusually high levels of indigent care.

ELISCU-1

Proposal by Workgroup Member Tom Panza
Proposed Legislative Language	Notes/Explanation
“Ambulatory surgical center” or “mobile surgical center” means a facility the primary purpose of which is to provide elective surgical care, in which the patient is admitted to and discharged from such facility within a 24 hour period the same working day and which is not permitted to stay overnight and which is not part of a hospital. However, a facility existing for the primary purpose of performing terminations of pregnancy, an office maintained by a physician for the practice of medicine, or an office maintained for the practice of dentistry shall not be construed to be an ambulatory surgical center, provided that any facility or office which is certified or seeks certification as a Medicare ambulatory surgical center shall be licensed as an ambulatory surgical center pursuant to s. 395.003. Any structure or vehicle in which a physician maintains an office and practices surgery, and which can appear to the public to be a mobile office because the structure or vehicle operates at	This change would allow patients in licensed ambulatory surgical centers to stay for up to 24 hours regardless of the time of day they are admitted. It deletes the prohibition against overnight stays. Remember that the 2001 Legislature added to the Workgroup’s original charge and asked you to consider the subject of overnight stays in ambulatory surgical centers. The 2002 legislature established a pilot project for overnight stays in a licensed ambulatory surgical center in Vero Beach.
EXEMPTIONS.- Upon request, the following projects are subject to exemption from the provisions subsection (1): For the addition of inpatient comprehensive rehabilitation beds licensed unde Chapter 395 in a number that may not exceed 10 beds or 10 percent of the licensed capacity, whichever is greater. In addition to any documentation otherwise required by the Agency, a request for exemption submitted under this paragraph must: Certify that the prior 12-month average occupancy rate for comprehensive rehabilitation beds at the facility meets or exceeds 96 percent. Certify that any comprehensive rehabilitation 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. The time frames and monitoring processes specified in s. 408.040(2)(a)-(c) apply to any exemption issued under this paragraph. The Agency shall count beds authorized under this paragraph as approved beds in the published inventory of hospital beds until the beds are licensed.	This change would allow hospitals that have highly utilized comprehensive inpatient rehabilitation beds to add up to 10 beds or 10 percent of their current number of licensed rehab beds — whichever is greater — through a simple exemption letter. This is similar to provisions that exist now for acute care beds. It includes a relatively high 96 percent occupancy standard, which reflects the relatively slow pace of admissions and discharges in long-term care services such as inpatient rehab, when compared to acute care.

PANZA-1

Proposed Legislative Language

Notes/Explanation

For the provision of adult open-heart services in a hospital. In addition to any documentation otherwise required by the Agency, a request for exemption submitted under this paragraph must: The applicant must certify that, prior to initiating adult open-heart services, it will meet and continuously maintain the minimum licensure requirements adopted by the Agency governing adult open-heart programs, including the most current guidelines of the American College of Cardiology and American Heart Association Guidelines for Adult Open-Heart Programs. The applicant must certify that it will provide a minimum of 2 pecent of its services to charity and Medicaid patients. The applicant must certify that it will maintain sufficient appropriate equipment and health personnel to ensure quality and safety. The applicant must certify that it will maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. The applicant must certify that it will provide a minimum of 300 open-heart procedures per year by the completion of the 3^rd full year of operation. If the exempted provider fails to meet the requirements listed in sub-subparagraph e., the Agency shall initiate revocation proceedings involving the open-heart services license within 90 days after the completion of the 3^rd full year of operation.

This change would eliminate CON review for adult open heart surgery services. It would require the Agency for Health Care Administration to promulgate administrative rules for the regulation of open heart surgery programs through licensure requirements. Programs would have three years to become fully accountable for all of the licensure standards. After that, the Agency would have the authority to revoke the hospital’s ability to perform open heart surgery if it failed to meet requirements.

PANZA-2

Proposal by Workgroup Chairman Rich Morrison
Proposed Legislative Language	Notes/Explanation
Rules and enforcement – The agency shall adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this part, which shall include reasonable and fair minimum standards for ensuring that: Minimum standards adopted for the regulation of adult open heart surgery programs, adult therapeutic cardiac catheterization and angioplasty programs, pediatric open heart surgery programs, and pediatric cardiac catheterization programs include standards for quality outcomes, staffing, necessary specialized equipment, and annual utilization. Such rules shall be adopted no later than June 30, 2003.	This change would require the Agency for Health Care Administration to develop licensure standards for adult and pediatric interventional cardiology programs by June 30, 2003. Compare proposals by the Florida Hospital Association and Mr. Panza.
Minimum standards adopted for the regulation of neonatal intensive care services, bone marrow transplant programs, and specialty burn units include standards for quality outcomes, staffing, necessary specialized equipment, and annual utilization. Such rules shall be adopted no later than June 30, 2004.	This change would require the Agency for Health Care Administration to develop licensure standards for NICU, bone marrow transplant and burn intensive care programs by June 30, 2004. Compare proposals by the Florida Hospital Association and Mr. Panza.
Minimum standards adopted for the regulation of comprehensive medical rehabilitation services, hospital-based skilled nursing services and long term acute care services include standards for quality outcomes, staffing, necessary specialized equipment and annual utilization. Such rules shall be adopted no later than June 30, 2005.	This change would require the Agency for Health Care Administration to develop licensure standards for comprehensive medical inpatient rehabilitation, hospital-based skilled nursing and long term acute care services by June 30, 2005. Compare proposals by the Florida Hospital Association and Mr. Panza.