The Florida Senate

408.031  Short title.

408.032  Definitions relating to Health Facility and Services Development Act.

408.033  Local and state health planning.

408.034  Duties and responsibilities of agency; rules.

408.035  Review criteria.

408.036  Projects subject to review; exemptions.

408.0361  Cardiology services and burn unit licensure.

408.037  Application content.

408.038  Fees.

408.039  Review process.

408.040  Conditions and monitoring.

408.041  Certificate of need required; penalties.

408.042  Limitation on transfer.

408.043  Special provisions.

408.044  Injunction.

408.045  Certificate of need; competitive sealed proposals.

408.0455  Rules; pending proceedings.

408.05  State Center for Health Statistics.

408.061  Data collection; uniform systems of financial reporting; information relating to physician charges; confidential information; immunity.

408.062  Research, analyses, studies, and reports.

408.063  Dissemination of health care information.

408.07  Definitions.

408.08  Inspections and audits; violations; penalties; fines; enforcement.

408.09  Assistance on cost containment strategies.

408.10  Consumer complaints.

408.15  Powers of the agency.

408.16  Health Care Trust Fund; moneys to be deposited therein.

408.18  Health Care Community Antitrust Guidance Act; antitrust no-action letter; market-information collection and education.

408.185  Information submitted for review of antitrust issues; confidentiality.

408.20  Assessments; Health Care Trust Fund.

408.301  Legislative findings.

408.302  Interagency agreement.

408.40  Public Counsel.

408.50  Prospective payment arrangements.

408.70  Health care; managed competition; legislative findings and intent.

408.7056  Subscriber Assistance Program.

408.7057  Statewide provider and health plan claim dispute resolution program.

408.7071  Standardized claim form.

408.831  Denial, suspension, or revocation of a license, registration, certificate, or application.

408.90  Legislative findings and intent.

408.901  Definitions; ss. 408.901-408.908.

408.902  MedAccess program; creation; program title.

408.903  Eligibility.

408.904  Benefits.

408.905  Limitations and exclusions.

408.906  Payment of claims.

408.907  Collection of premiums.

408.908  Administration.

408.909  Health flex plans.

408.911  Short title.

408.913  Comprehensive Health and Human Services Eligibility Access System.

408.914  Phased implementation plan.

408.915  Eligibility pilot project.

408.916  Steering committee.

408.917  Evaluation of the pilot project.

408.918  Florida 211 Network; uniform certification requirements.

408.031  Short title.--Sections 408.031-408.045 shall be known and may be cited as the "Health Facility and Services Development Act."

History.--s. 18, ch. 87-92; s. 15, ch. 92-33; s. 7, ch. 95-144.

Note.--Former s. 381.701.

408.032  Definitions relating to Health Facility and Services Development Act.--As used in ss. 408.031-408.045, the term:

(1)  "Agency" means the Agency for Health Care Administration.

(2)  "Capital expenditure" means an expenditure, including an expenditure for a construction project undertaken by a health care facility as its own contractor, which, under generally accepted accounting principles, is not properly chargeable as an expense of operation and maintenance, which is made to change the bed capacity of the facility, or substantially change the services or service area of the health care facility, health service provider, or hospice, and which includes the cost of the studies, surveys, designs, plans, working drawings, specifications, initial financing costs, and other activities essential to acquisition, improvement, expansion, or replacement of the plant and equipment.

(3)  "Certificate of need" means a written statement issued by the agency evidencing community need for a new, converted, expanded, or otherwise significantly modified health care facility, health service, or hospice.

(4)  "Commenced construction" means initiation of and continuous activities beyond site preparation associated with erecting or modifying a health care facility, including procurement of a building permit applying the use of agency-approved construction documents, proof of an executed owner/contractor agreement or an irrevocable or binding forced account, and actual undertaking of foundation forming with steel installation and concrete placing.

(5)  "District" means a health service planning district composed of the following counties:

District 1.--Escambia, Santa Rosa, Okaloosa, and Walton Counties.

District 2.--Holmes, Washington, Bay, Jackson, Franklin, Gulf, Gadsden, Liberty, Calhoun, Leon, Wakulla, Jefferson, Madison, and Taylor Counties.

District 3.--Hamilton, Suwannee, Lafayette, Dixie, Columbia, Gilchrist, Levy, Union, Bradford, Putnam, Alachua, Marion, Citrus, Hernando, Sumter, and Lake Counties.

District 4.--Baker, Nassau, Duval, Clay, St. Johns, Flagler, and Volusia Counties.

District 5.--Pasco and Pinellas Counties.

District 6.--Hillsborough, Manatee, Polk, Hardee, and Highlands Counties.

District 7.--Seminole, Orange, Osceola, and Brevard Counties.

District 8.--Sarasota, DeSoto, Charlotte, Lee, Glades, Hendry, and Collier Counties.

District 9.--Indian River, Okeechobee, St. Lucie, Martin, and Palm Beach Counties.

District 10.--Broward County.

District 11.--Dade and Monroe Counties.

(6)  "Exemption" means the process by which a proposal that would otherwise require a certificate of need may proceed without a certificate of need.

(7)  "Expedited review" means the process by which certain types of applications are not subject to the review cycle requirements contained in s. 408.039(1), and the letter of intent requirements contained in s. 408.039(2).

(8)  "Health care facility" means a hospital, long-term care hospital, skilled nursing facility, hospice, or intermediate care facility for the developmentally disabled. A facility relying solely on spiritual means through prayer for healing is not included as a health care facility.

(9)  "Health services" means inpatient diagnostic, curative, or comprehensive medical rehabilitative services and includes mental health services. Obstetric services are not health services for purposes of ss. 408.031-408.045.

(10)  "Hospice" or "hospice program" means a hospice as defined in part VI of chapter 400.

(11)  "Hospital" means a health care facility licensed under chapter 395.

(12)  "Intermediate care facility for the developmentally disabled" means a residential facility licensed under chapter 393 and certified by the Federal Government pursuant to the Social Security Act as a provider of Medicaid services to persons who are mentally retarded or who have a related condition.

(13)  "Long-term care hospital" means a hospital licensed under chapter 395 which meets the requirements of 42 C.F.R. s. 412.23(e) and seeks exclusion from the acute care Medicare prospective payment system for inpatient hospital services.

(14)  "Mental health services" means inpatient services provided in a hospital licensed under chapter 395 and listed on the hospital license as psychiatric beds for adults; psychiatric beds for children and adolescents; intensive residential treatment beds for children and adolescents; substance abuse beds for adults; or substance abuse beds for children and adolescents.

(15)  "Nursing home geographically underserved area" means:

(a)  A county in which there is no existing or approved nursing home;

(b)  An area with a radius of at least 20 miles in which there is no existing or approved nursing home; or

(c)  An area with a radius of at least 20 miles in which all existing nursing homes have maintained at least a 95 percent occupancy rate for the most recent 6 months or a 90 percent occupancy rate for the most recent 12 months.

(16)  "Skilled nursing facility" means an institution, or a distinct part of an institution, which is primarily engaged in providing, to inpatients, skilled nursing care and related services for patients who require medical or nursing care, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons.

(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, pediatric cardiac catheterization, pediatric open-heart surgery, organ transplantation, 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.

History.--s. 19, ch. 87-92; s. 19, ch. 88-294; s. 2, ch. 89-308; s. 7, ch. 89-354; s. 21, ch. 91-158; s. 54, ch. 91-221; s. 1, ch. 91-282; ss. 15, 16, ch. 92-33; s. 10, ch. 92-58; s. 22, ch. 93-214; s. 8, ch. 95-144; s. 28, ch. 95-210; s. 2, ch. 95-394; s. 1, ch. 97-270; s. 3, ch. 2000-256; s. 4, ch. 2000-318; s. 2, ch. 2004-383.

Note.--Former s. 381.702.

408.033  Local and state health planning.--

(1)  LOCAL HEALTH COUNCILS.--

(a)  Local health councils are hereby established as public or private nonprofit agencies serving the counties of a district. The members of each council shall be appointed in an equitable manner by the county commissions having jurisdiction in the respective district. Each council shall be composed of a number of persons equal to 1¹/₂ times the number of counties which compose the district or 12 members, whichever is greater. Each county in a district shall be entitled to at least one member on the council. The balance of the membership of the council shall be allocated among the counties of the district on the basis of population rounded to the nearest whole number; except that in a district composed of only two counties, no county shall have fewer than four members. The appointees shall be representatives of health care providers, health care purchasers, and nongovernmental health care consumers, but not excluding elected government officials. The members of the consumer group shall include a representative number of persons over 60 years of age. A majority of council members shall consist of health care purchasers and health care consumers. The local health council shall provide each county commission a schedule for appointing council members to ensure that council membership complies with the requirements of this paragraph. The members of the local health council shall elect a chair. Members shall serve for terms of 2 years and may be eligible for reappointment.

(b)  Each local health council may:

1.  Develop a district area health plan that permits each local health council to develop strategies and set priorities for implementation based on its unique local health needs.

2.  Advise the agency on health care issues and resource allocations.

3.  Promote public awareness of community health needs, emphasizing health promotion and cost-effective health service selection.

4.  Collect data and conduct analyses and studies related to health care needs of the district, including the needs of medically indigent persons, and assist the agency and other state agencies in carrying out data collection activities that relate to the functions in this subsection.

5.  Monitor the onsite construction progress, if any, of certificate-of-need approved projects and report council findings to the agency on forms provided by the agency.

6.  Advise and assist any regional planning councils within each district that have elected to address health issues in their strategic regional policy plans with the development of the health element of the plans to address the health goals and policies in the State Comprehensive Plan.

7.  Advise and assist local governments within each district on the development of an optional health plan element of the comprehensive plan provided in chapter 163, to assure compatibility with the health goals and policies in the State Comprehensive Plan and district health plan. To facilitate the implementation of this section, the local health council shall annually provide the local governments in its service area, upon request, with:

a.  A copy and appropriate updates of the district health plan;

b.  A report of hospital and nursing home utilization statistics for facilities within the local government jurisdiction; and

c.  Applicable agency rules and calculated need methodologies for health facilities and services regulated under s. 408.034 for the district served by the local health council.

8.  Monitor and evaluate the adequacy, appropriateness, and effectiveness, within the district, of local, state, federal, and private funds distributed to meet the needs of the medically indigent and other underserved population groups.

9.  In conjunction with the Department of Health, plan for services at the local level for persons infected with the human immunodeficiency virus.

10.  Provide technical assistance to encourage and support activities by providers, purchasers, consumers, and local, regional, and state agencies in meeting the health care goals, objectives, and policies adopted by the local health council.

11.  Provide the agency with data required by rule for the review of certificate-of-need applications and the projection of need for health services and facilities in the district.

(c)  Local health councils may conduct public hearings pursuant to s. 408.039(3)(b).

(d)  Each local health council shall enter into a memorandum of agreement with each regional planning council in its district that elects to address health issues in its strategic regional policy plan. In addition, each local health council shall enter into a memorandum of agreement with each local government that includes an optional health element in its comprehensive plan. Each memorandum of agreement must specify the manner in which each local government, regional planning council, and local health council will coordinate its activities to ensure a unified approach to health planning and implementation efforts.

(e)  Local health councils may employ personnel or contract for staffing services with persons who possess appropriate qualifications to carry out the councils' purposes. However, such personnel are not state employees.

(f)  Personnel of the local health councils shall provide an annual orientation to council members about council member responsibilities.

(g)  Each local health council is authorized to accept and receive, in furtherance of its health planning functions, funds, grants, and services from governmental agencies and from private or civic sources and to perform studies related to local health planning in exchange for such funds, grants, or services. Each local health council shall, no later than January 30 of each year, render an accounting of the receipt and disbursement of such funds received by it to the Department of Health. The department shall consolidate all such reports and submit such consolidated report to the Legislature no later than March 1 of each year.

(2)  FUNDING.--

(a)  The Legislature intends that the cost of local health councils be borne by assessments on selected health care facilities subject to facility licensure by the Agency for Health Care Administration, including abortion clinics, assisted living facilities, ambulatory surgical centers, birthing centers, clinical laboratories except community nonprofit blood banks and clinical laboratories operated by practitioners for exclusive use regulated under s. 483.035, home health agencies, hospices, hospitals, intermediate care facilities for the developmentally disabled, nursing homes, health care clinics, and multiphasic testing centers and by assessments on organizations subject to certification by the agency pursuant to chapter 641, part III, including health maintenance organizations and prepaid health clinics.

(b)1.  A hospital licensed under chapter 395, a nursing home licensed under chapter 400, and an assisted living facility licensed under chapter 400 shall be assessed an annual fee based on number of beds.

2.  All other facilities and organizations listed in paragraph (a) shall each be assessed an annual fee of $150.

3.  Facilities operated by the Department of Children and Family Services, the Department of Health, or the Department of Corrections and any hospital which meets the definition of rural hospital pursuant to s. 395.602 are exempt from the assessment required in this subsection.

(c)1.  The agency shall, by rule, establish fees for hospitals and nursing homes based on an assessment of $2 per bed. However, no such facility shall be assessed more than a total of $500 under this subsection.

2.  The agency shall, by rule, establish fees for assisted living facilities based on an assessment of $1 per bed. However, no such facility shall be assessed more than a total of $150 under this subsection.

3.  The agency shall, by rule, establish an annual fee of $150 for all other facilities and organizations listed in paragraph (a).

(d)  The agency shall, by rule, establish a facility billing and collection process for the billing and collection of the health facility fees authorized by this subsection.

(e)  A health facility which is assessed a fee under this subsection is subject to a fine of $100 per day for each day in which the facility is late in submitting its annual fee up to the maximum of the annual fee owed by the facility. A facility which refuses to pay the fee or fine is subject to the forfeiture of its license.

(f)  The agency shall deposit in the Health Care Trust Fund all health care facility assessments that are assessed under this subsection and shall transfer such funds to the Department of Health for funding of the local health councils. The remaining certificate-of-need application fees shall be used only for the purpose of administering the certificate-of-need program.

(3)  DUTIES AND RESPONSIBILITIES OF THE AGENCY.--

(a)  The agency is responsible for the coordinated planning of health care services in the state.

(b)  The agency shall develop and maintain a comprehensive health care database for the purpose of health planning and for certificate-of-need determinations. The agency or its contractor is authorized to require the submission of information from health facilities, health service providers, and licensed health professionals which is determined by the agency, through rule, to be necessary for meeting the agency's responsibilities as established in this section.

(c)  The Department of Health shall contract with the local health councils for the services specified in subsection (1). All contract funds shall be distributed according to an allocation plan developed by the department. The department may withhold funds from a local health council or cancel its contract with a local health council which does not meet performance standards agreed upon by the department and local health councils.

History.--s. 20, ch. 87-92; s. 40, ch. 88-380; s. 35, ch. 88-394; s. 1, ch. 89-104; s. 24, ch. 89-294; s. 2, ch. 89-296; s. 15, ch. 89-527; s. 2, ch. 91-48; s. 22, ch. 91-158; ss. 2, 104, ch. 91-282; s. 5, ch. 91-429; ss. 15, 17, ch. 92-33; s. 2, ch. 92-174; s. 66, ch. 92-289; s. 22, ch. 93-120; s. 11, ch. 93-129; s. 33, ch. 93-206; s. 8, ch. 93-267; s. 9, ch. 95-144; s. 29, ch. 95-210; s. 3, ch. 95-394; s. 11, ch. 97-79; s. 1, ch. 97-91; s. 35, ch. 97-103; s. 62, ch. 97-237; s. 175, ch. 99-8; s. 4, ch. 2000-256; s. 5, ch. 2000-318; s. 3, ch. 2004-383.

Note.--Former s. 381.703.

408.034  Duties and responsibilities of agency; rules.--

(1)  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 present and future federal and state statutes. The agency is designated as the state health planning agency for purposes of federal law.

(2)  In the exercise of its authority to issue licenses to health care facilities and health service providers, as provided under chapters 393, 395, and parts II and VI of chapter 400, the agency may not issue a license to any health care facility or health service provider that fails to receive a certificate of need or an exemption for the licensed facility or service.

(3)  The agency shall establish, by rule, uniform need methodologies for health services and health facilities. In developing uniform need methodologies, the agency shall, at a minimum, consider the demographic characteristics of the population, the health status of the population, service use patterns, standards and trends, geographic accessibility, and market economics.

(4)  Prior to determining that there is a need for additional community nursing facility beds in any area of the state, the agency shall determine that the need cannot be met through the provision, enhancement, or expansion of home and community-based services. In determining such need, the agency shall examine nursing home placement patterns and demographic patterns of persons entering nursing homes and the availability of and effectiveness of existing home-based and community-based service delivery systems at meeting the long-term care needs of the population. The agency shall recommend to the Office of Long-Term Care Policy changes that could be made to existing home-based and community-based delivery systems to lessen the need for additional nursing facility beds.

(5)  The agency shall establish by rule a nursing-home-bed-need methodology that has a goal of maintaining a subdistrict average occupancy rate 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.

(6)  The agency may adopt rules necessary to implement ss. 408.031-408.045.

History.--s. 21, ch. 87-92; s. 8, ch. 89-354; s. 1, ch. 91-263; s. 15, ch. 92-33; s. 18, ch. 93-214; s. 10, ch. 95-144; s. 2, ch. 98-85; s. 5, ch. 2000-256; s. 6, ch. 2000-318; s. 13, ch. 2002-223; s. 9, ch. 2004-298; s. 4, ch. 2004-383.

Note.--Former s. 381.704.

408.035  Review criteria.--The agency shall determine the reviewability of applications and shall review applications for certificate-of-need determinations for health care facilities and health services in context with the following criteria:

(1)  The need for the health care facilities and health services being proposed.

(2)  The availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district of the applicant.

(3)  The ability of the applicant to provide quality of care and the applicant's record of providing quality of care.

(4)  The availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation.

(5)  The extent to which the proposed services will enhance access to health care for residents of the service district.

(6)  The immediate and long-term financial feasibility of the proposal.

(7)  The extent to which the proposal will foster competition that promotes quality and cost-effectiveness.

(8)  The costs and methods of the proposed construction, including the costs and methods of energy provision and the availability of alternative, less costly, or more effective methods of construction.

(9)  The applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent.

(10)  The applicant's designation as a Gold Seal Program nursing facility pursuant to s. 400.235, when the applicant is requesting additional nursing home beds at that facility.

History.--s. 22, ch. 87-92; s. 20, ch. 88-294; s. 15, ch. 92-33; ss. 37, 50, ch. 93-217; s. 30, ch. 95-210; s. 36, ch. 97-103; s. 39, ch. 97-264; s. 2, ch. 97-270; s. 20, ch. 99-394; s. 6, ch. 2000-256; s. 7, ch. 2000-318; s. 5, ch. 2004-383.

Note.--Former s. 381.705.

408.036  Projects subject to review; exemptions.--

¹(1)  APPLICABILITY.--Unless exempt under subsection (3), all health-care-related projects, as described in paragraphs (a)-(g), 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.

(a)  The addition of beds in community nursing homes or intermediate care facilities for the developmentally disabled by new construction or alteration.

(b)  The new construction or establishment of additional health care facilities, including a replacement health care facility when the proposed project site is not located on the same site as or within 1 mile of the existing health care facility, if the number of beds in each licensed bed category will not increase.

(c)  The conversion from one type of health care facility to another, including the conversion from a general hospital, a specialty hospital, or a long-term care hospital.

(d)  The establishment of a hospice or hospice inpatient facility, except as provided in s. 408.043.

(e)  An increase in the number of beds for comprehensive rehabilitation.

(f)  The establishment of tertiary health services, including inpatient comprehensive rehabilitation services.

(g)  An increase in the number of beds for acute care in a hospital that is located in a low-growth county. A low-growth county is defined as a county that has:

1.  A hospital with an occupancy rate for licensed acute care which has been below 60 percent for the previous 5 years;

2.  Experienced a growth rate of 4 percent or less for the most recent 3-year period for which data are available, as determined using the population statistics published in the most recent edition of the Florida Statistical Abstract;

3.  A population of 400,000 or fewer according to the most recent edition of the Florida Statistical Abstract; and

4.  A hospital that has combined gross revenue from Medicaid and charity patients which exceeds $60 million per year for the previous 2 years.

This paragraph is repealed effective July 1, 2009.

(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)  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.

(b)  Replacement of a nursing home within the same district, if 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.

(c)  Relocation of a portion of a nursing home's licensed beds to a facility within the same district, if 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.

(3)  EXEMPTIONS.--Upon request, the following projects are subject to exemption from the provisions of subsection (1):

(a)  For hospice services or for swing beds in a rural hospital, as defined in s. 395.602, in a number that does not exceed one-half of its licensed beds.

(b)  For the conversion of licensed acute care hospital beds to Medicare and Medicaid certified skilled nursing beds in a rural hospital, as defined in s. 395.602, so long as the conversion of the beds does not involve the construction of new facilities. The total number of skilled nursing beds, including swing beds, may not exceed one-half of the total number of licensed beds in the rural hospital as of July 1, 1993. Certified skilled nursing beds designated under this paragraph, excluding swing beds, shall be included in the community nursing home bed inventory. A rural hospital that subsequently decertifies any acute care beds exempted under this paragraph shall notify the agency of the decertification, and the agency shall adjust the community nursing home bed inventory accordingly.

(c)  For the addition of nursing home beds at a skilled nursing facility that is part of a retirement community that provides a variety of residential settings and supportive services and that has been incorporated and operated in this state for at least 65 years on or before July 1, 1994. All nursing home beds must not be available to the public but must be for the exclusive use of the community residents.

(d)  For an inmate health care facility built by or for the exclusive use of the Department of Corrections as provided in chapter 945. This exemption expires when such facility is converted to other uses.

(e)  For mobile surgical facilities and related health care services provided under contract with the Department of Corrections or a private correctional facility operating pursuant to chapter 957.

(f)  For state veterans' nursing homes operated by or on behalf of the Florida Department of Veterans' Affairs in accordance with part II of chapter 296 for which at least 50 percent of the construction cost is federally funded and for which the Federal Government pays a per diem rate not to exceed one-half of the cost of the veterans' care in such state nursing homes. These beds shall not be included in the nursing home bed inventory.

(g)  For combination within one nursing home facility of the beds or services authorized by two or more certificates of need issued in the same planning subdistrict. An exemption granted under this paragraph shall extend the validity period of the certificates of need to be consolidated by the length of the period beginning upon submission of the exemption request and ending with issuance of the exemption. The longest validity period among the certificates shall be applicable to each of the combined certificates.

(h)  For division into two or more nursing home facilities of beds or services authorized by one certificate of need issued in the same planning subdistrict. An exemption granted under this paragraph shall extend the validity period of the certificate of need to be divided by the length of the period beginning upon submission of the exemption request and ending with issuance of the exemption.

(i)  For the addition of hospital beds licensed under chapter 395 for comprehensive rehabilitation in a number that may not exceed 10 total beds or 10 percent of the licensed capacity, whichever is greater.

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 licensed beds being expanded meets or exceeds 80 percent.

b.  Certify that the beds 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 hospital beds until the beds are licensed.

(j)  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; or, for the addition of nursing home beds licensed under chapter 400 at a facility that has been designated as a Gold Seal nursing home under s. 400.235 in a number not exceeding 20 total beds or 10 percent of the number of licensed beds 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.  Certify that the facility has not had any class I or class II deficiencies within the 30 months preceding the request for addition.

b.  Certify that the prior 12-month average occupancy rate for the nursing home beds at the facility meets or exceeds 96 percent.

c.  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.

(k)  For the establishment of:

1.  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 1,500 births during the previous 12 months; or

2.  A Level III neonatal intensive care unit with at least 15 beds, upon documentation to the agency that the applicant hospital has a Level II neonatal intensive care unit of at least 10 beds and had a minimum of 3,500 births during the previous 12 months,

if the applicant demonstrates that it meets the requirements for quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting found in agency certificate-of-need rules for Level II and Level III neonatal intensive care units and if the applicant commits to the provision of services to Medicaid and charity patients at a level equal to or greater than the district average. Such a commitment is subject to s. 408.040.

(l)  Notwithstanding any other provisions of this chapter to the contrary:

1.  For an adult open-heart-surgery program to be located in a new hospital provided the new hospital is being established in the location of an existing hospital with an adult open-heart-surgery program, the existing hospital and the existing adult open-heart-surgery program are being relocated to a replacement hospital, and the replacement hospital will utilize a closed-staff model. A hospital is exempt from the certificate-of-need review for the establishment of an open-heart-surgery program if the application for exemption submitted under this paragraph complies with the following criteria:

a.  The applicant must certify that it will meet and continuously maintain the minimum Florida Administrative Code and any future licensure requirements governing adult open-heart programs adopted by the agency, including the most current guidelines of the American College of Cardiology and American Heart Association Guidelines for Adult Open Heart Programs.

b.  The applicant must certify that it will maintain sufficient appropriate equipment and health personnel to ensure quality and safety.

c.  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.

d.  The applicant is a newly licensed hospital in a physical location previously owned and licensed to a hospital performing more than 300 open-heart procedures each year, including heart transplants.

e.  The applicant must certify that it can perform more than 300 diagnostic cardiac catheterization procedures per year, combined inpatient and outpatient, by the end of the third year of its operation.

f.  The applicant's payor mix at a minimum reflects the community average for Medicaid, charity care, and self-pay patients or the applicant must certify that it will provide a minimum of 5 percent of Medicaid, charity care, and self-pay to open-heart-surgery patients.

g.  If the applicant fails to meet the established criteria for open-heart programs or fails to reach 300 surgeries per year by the end of its third year of operation, it must show cause why its exemption should not be revoked.

h.  In order to ensure continuity of available services, the applicant of the newly licensed hospital may apply for this cerificate of need before taking possession of the physical facilities. The effective date of the cerificate of need will be concurrent with the effective date of the newly issued hospital license.

2.  By December 31, 2004, and annually thereafter, the agency shall submit a report to the Legislature providing information concerning the number of requests for exemption received under this paragraph and the number of exemptions granted or denied.

3.  This paragraph is repealed effective January 1, 2008.

(m)1.  For the provision of adult open-heart services in a hospital located within the boundaries of a health service planning district, as defined in s. 408.032(5), which has experienced an annual net out-migration of at least 600 open-heart-surgery cases for 3 consecutive years according to the most recent data reported to the agency, and the district's population per licensed and operational open-heart programs exceeds the state average of population per licensed and operational open-heart programs by at least 25 percent. All hospitals within a health service planning district which meet the criteria reference in sub-subparagraphs 2.a.-h. shall be eligible for this exemption on July 1, 2004, and shall receive the exemption upon filing for it and subject to the following:

a.  A hospital that has received a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for the establishment of an open-heart-surgery program is entitled to receive a letter of exemption for the establishment of an adult open-heart-surgery program upon filing a request for exemption and complying with the criteria enumerated in sub-subparagraphs 2.a.-h., and is entitled to immediately commence operation of the program.

b.  An otherwise eligible hospital that has not received a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for the establishment of an open-heart-surgery program is entitled to immediately receive a letter of exemption for the establishment of an adult open-heart-surgery program upon filing a request for exemption and complying with the criteria enumerated in sub-subparagraphs 2.a.-h., but is not entitled to commence operation of its program until December 31, 2006.

2.  A hospital shall be exempt from the certificate-of-need review for the establishment of an open-heart-surgery program when the application for exemption submitted under this paragraph complies with the following criteria:

a.  The applicant must certify that 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.

b.  The applicant must certify that it will maintain sufficient appropriate equipment and health personnel to ensure quality and safety.

c.  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.

d.  The applicant can demonstrate that it has discharged at least 300 inpatients with a principal diagnosis of ischemic heart disease for the most recent 12-month period as reported to the agency.

e.  The applicant is a general acute care hospital that is in operation for 3 years or more.

f.  The applicant is performing more than 300 diagnostic cardiac catheterization procedures per year, combined inpatient and outpatient.

g.  The applicant's payor mix at a minimum reflects the community average for Medicaid, charity care, and self-pay patients or the applicant must certify that it will provide a minimum of 5 percent of Medicaid, charity care, and self-pay to open-heart-surgery patients.

h.  If the applicant fails to meet the established criteria for open-heart programs or fails to reach 300 surgeries per year by the end of its third year of operation, it must show cause why its exemption should not be revoked.

3.  By December 31, 2004, and annually thereafter, the agency shall submit a report to the Legislature providing information concerning the number of requests for exemption it has received under this paragraph during the calendar year and the number of exemptions it has granted or denied during the calendar year.

(n)  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 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 requirements adopted by the agency for the provision of these services. These licensure requirements shall be adopted by rule pursuant to ss. 120.536(1) and 120.54 and must 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 24 hours a day, 7 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 Intra-aortic Balloon Pump (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 be ²reviewed and tested, with appropriate documentation maintained at least every 3 months.

g.  Hospitals implementing the service must first undertake a training program of 3 to 6 months' duration, which includes establishing standards and testing logistics, creating quality assessment and error management practices, and formalizing patient-selection criteria.

2.  The applicant must certify that it will use 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 who have identified symptoms or medical histories.

b.  Transfer of patients who have 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 paragraph. This report must be submitted within 15 days after the close of each calendar quarter.

4.  The exemption provided by this paragraph does not apply unless the agency determines that the hospital has taken all necessary steps to be in compliance with all requirements of this paragraph, including the training program required under sub-subparagraph 1.g.

5.  Failure of the hospital to continuously comply with the requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2. and 3. will result in the immediate expiration of this exemption.

6.  Failure of the hospital to meet the volume requirements of sub-subparagraphs 1.a. and b. within 18 months after the program begins offering the service will result in the immediate expiration of the exemption.

If the exemption for this service expires under subparagraph 5. or subparagraph 6., the agency may not grant another exemption for this service to the same hospital for 2 years and then only upon a showing that the hospital will remain in compliance with the requirements of this paragraph through a demonstration of corrections to the deficiencies that caused expiration of the exemption. Compliance with the requirements of this paragraph includes compliance with the rules adopted pursuant to this paragraph.

(o)  For the addition of mental health services or beds if the applicant commits to providing services to Medicaid or charity care patients at a level equal to or greater than the district average. Such a commitment is subject to s. 408.040.

(p)  For replacement of a licensed nursing home on the same site, or within 3 miles of the same site, if the number of licensed beds does not increase.

(q)  For consolidation or combination of licensed nursing homes or transfer of beds between licensed nursing homes within the same planning subdistrict, by providers that operate multiple nursing homes within that planning subdistrict, if there is no increase in the planning subdistrict total number of nursing home beds and the site of the relocation is not more than 30 miles from the original location.

(r)  For beds in state mental health treatment facilities operated under s. 394.455(30) and state mental health forensic facilities operated under s. 916.106(8).

(s)  For beds in state developmental services institutions as defined in s. 393.063.

(4)  REQUESTS FOR EXEMPTION.--A request for exemption under subsection (3) may be made at any time and is not subject to the batching requirements of this section. The request shall be supported by such documentation as the agency requires by rule. The agency shall assess a fee of $250 for each request for exemption submitted under subsection (3).

(5)  NOTIFICATION.--Health care facilities and providers must provide to the agency notification of:

(a)  Replacement of a health care facility when the proposed project site is located in the same district and on the existing site or within a 1-mile radius of the replaced health care facility, if the number and type of beds do not increase.

(b)  The termination of a health care service, upon 30 days' written notice to the agency.

(c)  The addition or delicensure of beds.

Notification under this subsection may be made by electronic, facsimile, or written means at any time before the described action has been taken.

History.--s. 23, ch. 87-92; s. 21, ch. 88-294; s. 2, ch. 89-527; ss. 3, 16, ch. 91-282; s. 15, ch. 92-33; s. 67, ch. 92-289; s. 30, ch. 93-129; s. 19, ch. 93-214; s. 38, ch. 93-217; ss. 3, 4, ch. 94-206; s. 58, ch. 95-144; s. 143, ch. 95-418; s. 3, ch. 97-270; s. 4, ch. 97-290; s. 3, ch. 98-14; s. 22, ch. 98-80; s. 3, ch. 98-85; s. 8, ch. 98-303; s. 7, ch. 2000-256; s. 15, ch. 2000-305; s. 8, ch. 2000-318; s. 15, ch. 2001-104; s. 13, ch. 2003-2; s. 1, ch. 2003-274; s. 1, ch. 2003-289; s. 10, ch. 2004-298; s. 1, ch. 2004-382; s. 6, ch. 2004-383.

¹Note.--Section 69(2), ch. 2000-318, and s. 38, ch. 2000-367, provide that "[n]otwithstanding any provision to the contrary contained in [chapter 2000-256, Laws of Florida], enacted in the 2000 Regular Session of the Legislature, the establishment of a specialty hospital offering a range of medical services 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, is not exempt from the provisions of section 408.036(1), Florida Statutes."

²Note.--As amended by s. 1, ch. 2004-382. The amendment by s. 6, ch. 2004-383, used "received" instead of "reviewed."

Note.--Former s. 381.706.

408.0361  Cardiology services and burn unit licensure.--

(1)  Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs:

(a)  Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories.

(b)  Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services.

(c)  Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety.

(d)  Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies.

(e)  Demonstrate a plan to provide services to Medicaid and charity care patients.

(2)  Each provider of adult interventional cardiology services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult interventional cardiology services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult interventional cardiology services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult interventional cardiology services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or a period specified in the rule, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period.

(3)  In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for:

(a)  Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery.

(b)  For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes.

(c)  For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease.

(d)  Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.

(e)  Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies.

(f)  Demonstration of a plan to provide services to Medicaid and charity care patients.

(4)  The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of interventional cardiac programs. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the interventional cardiac programs that include at least the following:

(a)  A standard data set consisting primarily of data elements reported to the agency in accordance with s. 408.061.

(b)  A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state.

(c)  Outcome standards specifying expected levels of performance in Level I and Level II adult interventional cardiology services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery.

(d)  Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans.

(5)  The Secretary of Health Care Administration shall appoint an advisory group to study the issue of replacing certificate-of-need review of organ transplant programs under this chapter with licensure regulation of organ transplant programs under chapter 395. The advisory group shall include three representatives of organ transplant providers, one representative of an organ procurement organization, one representative of the Division of Health Quality Assurance, one representative of Medicaid, and one organ transplant patient advocate. The advisory group shall, at minimum, make recommendations regarding access to organs, delivery of services to Medicaid and charity care patients, staff training, and resource requirements for organ transplant programs in a report due to the secretary and the Legislature by July 1, 2005.

(6)  The Secretary of Health Care Administration shall appoint a workgroup to study certificate-of-need regulations and changing market conditions related to the supply and distribution of hospital beds. The assessment by the workgroup shall include, but not be limited to, the following:

(a)  The appropriateness of current certificate-of-need methodologies and other criteria for evaluating proposals for new hospitals and transfer of beds to new sites.

(b)  Additional factors that should be considered, including the viability of safety net services, the extent of market competition, and the accessibility of hospital services.

The workgroup shall submit a report by January 1, 2005, to the secretary and the Legislature identifying specific problem areas and recommending needed changes in statutes or rules.

History.--s. 5, ch. 99-356; s. 48, ch. 2001-62; s. 2, ch. 2004-382; s. 7, ch. 2004-383.

408.037  Application content.--

(1)  An application for a certificate of need must contain:

(a)  A detailed description of the proposed project and statement of its purpose and need in relation to the district health plan.

(b)  A statement of the financial resources needed by and available to the applicant to accomplish the proposed project. This statement must include:

1.  A complete listing of all capital projects, including new health facility development projects and health facility acquisitions applied for, pending, approved, or underway in any state at the time of application, regardless of whether or not that state has a certificate-of-need program or a capital expenditure review program pursuant to s. 1122 of the Social Security Act. The agency may, by rule, require less-detailed information from major health care providers. This listing must include the applicant's actual or proposed financial commitment to those projects and an assessment of their impact on the applicant's ability to provide the proposed project.

2.  A detailed listing of the needed capital expenditures, including sources of funds.

3.  A detailed financial projection, including a statement of the projected revenue and expenses for the first 2 years of operation after completion of the proposed project. This statement must include a detailed evaluation of the impact of the proposed project on the cost of other services provided by the applicant.

(c)  An audited financial statement of the applicant. 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.

(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 licenseholder of the facility.

History.--s. 24, ch. 87-92; s. 15, ch. 92-33; s. 4, ch. 97-270; s. 8, ch. 2000-256; s. 9, ch. 2000-318.

Note.--Former s. 381.707.

408.038  Fees.--The agency shall assess fees on certificate-of-need applications. Such fees shall be for the purpose of funding the activities of the agency and shall be allocated as provided in s. 408.033. The fee shall be determined as follows:

(1)  A minimum base fee of $10,000.

(2)  In addition to the base fee of $10,000, 0.015 of each dollar of proposed expenditure, except that a fee may not exceed $50,000.

History.--s. 25, ch. 87-92; s. 2, ch. 89-104; s. 16, ch. 89-527; s. 4, ch. 91-282; s. 15, ch. 92-33; s. 11, ch. 95-144; s. 17, ch. 97-79; s. 9, ch. 2000-256; s. 10, ch. 2000-318; s. 8, ch. 2004-383.

Note.--Former s. 381.708.

408.039  Review process.--The review process for certificates of need shall be as follows:

(1)  REVIEW CYCLES.--The agency by rule shall provide for applications to be submitted on a timetable or cycle basis; provide for review on a timely basis; and provide for all completed applications pertaining to similar types of services or facilities affecting the same service district to be considered in relation to each other no less often than annually.

(2)  LETTERS OF INTENT.--

(a)  At least 30 days prior to filing an application, a letter of intent shall be filed by the applicant with the agency, respecting the development of a proposal subject to review. No letter of intent is required for expedited projects as defined by rule by the agency.

(b)  The agency shall provide a mechanism by which applications may be filed to compete with proposals described in filed letters of intent.

(c)  Letters of intent must describe the proposal; specify the number of beds sought, if any; identify the services to be provided and the specific subdistrict location; and identify the applicant.

(d)  Within 21 days after filing a letter of intent, the agency shall publish notice of the filing of letters of intent in the Florida Administrative Weekly and notice that, if requested, a public hearing shall be held at the local level within 21 days after the application is deemed complete. Notices under this paragraph must contain due dates applicable to the cycle for filing applications and for requesting a hearing.

(3)  APPLICATION PROCESSING.--

(a)  An applicant shall file an application with the agency and shall furnish a copy of the application to the agency. Within 15 days after the applicable application filing deadline established by agency rule, the staff of the agency shall determine if the application is complete. If the application is incomplete, the staff shall request specific information from the applicant necessary for the application to be complete; however, the staff may make only one such request. If the requested information is not filed with the agency within 21 days after the receipt of the staff's request, the application shall be deemed incomplete and deemed withdrawn from consideration.

(b)  Upon the request of any applicant or substantially affected person within 14 days after notice that an application has been filed, a public hearing may be held at the agency's discretion if the agency determines that a proposed project involves issues of great local public interest. The public hearing shall allow applicants and other interested parties reasonable time to present their positions and to present rebuttal information. A recorded verbatim record of the hearing shall be maintained. The public hearing shall be held at the local level within 21 days after the application is deemed complete.

(4)  STAFF RECOMMENDATIONS.--

(a)  The agency's review of and final agency action on applications shall be in accordance with statutory criteria and the implementing administrative rules. In the application review process, the agency shall give a preference, as defined by rule of the agency, to an applicant which proposes to develop a nursing home in a nursing home geographically underserved area.

(b)  Within 60 days after all the applications in a review cycle are determined to be complete, the agency shall issue its State Agency Action Report and Notice of Intent to grant a certificate of need for the project in its entirety, to grant a certificate of need for identifiable portions of the project, or to deny a certificate of need. The State Agency Action Report shall set forth in writing its findings of fact and determinations upon which its decision is based. If the agency intends to grant a certificate of need, the State Agency Action Report or the Notice of Intent shall also include any conditions which the agency intends to attach to the certificate of need. The agency shall designate by rule a senior staff person, other than the person who issues the final order, to issue State Agency Action Reports and Notices of Intent.

(c)  The agency shall publish its proposed decision set forth in the Notice of Intent in the Florida Administrative Weekly within 14 days after the Notice of Intent is issued.

(d)  If no administrative hearing is requested pursuant to subsection (5), the State Agency Action Report and the Notice of Intent shall become the final order of the agency. The agency shall provide a copy of the final order to the appropriate local health council.

(5)  ADMINISTRATIVE HEARINGS.--

(a)  Within 21 days after publication of notice of the State Agency Action Report and Notice of Intent, any person authorized under paragraph (c) to participate in a hearing may file a request for an administrative hearing; failure to file a request for hearing within 21 days of publication of notice shall constitute a waiver of any right to a hearing and a waiver of the right to contest the final decision of the agency. A copy of the request for hearing shall be served on the applicant.

(b)  Hearings shall be held in Tallahassee unless the administrative law judge determines that changing the location will facilitate the proceedings. The agency shall assign proceedings requiring hearings to the Division of Administrative Hearings of the Department of Management Services within 10 days after the time has expired for requesting a hearing. Except upon unanimous consent of the parties or upon the granting by the administrative law judge of a motion of continuance, hearings shall commence within 60 days after the administrative law judge has been assigned. All parties, except the agency, shall bear their own expense of preparing a transcript. In any application for a certificate of need which is referred to the Division of Administrative Hearings for hearing, the administrative law judge shall complete and submit to the parties a recommended order as provided in ss. 120.569 and 120.57. The recommended order shall be issued within 30 days after the receipt of the proposed recommended orders or the deadline for submission of such proposed recommended orders, whichever is earlier. The division shall adopt procedures for administrative hearings which shall maximize the use of stipulated facts and shall provide for the admission of prepared testimony.

(c)  In administrative proceedings challenging the issuance or denial of a certificate of need, only applicants considered by the agency in the same batching cycle are entitled to a comparative hearing on their applications. Existing health care facilities may initiate or intervene in an administrative hearing upon a showing that an established program will be substantially affected by the issuance of any certificate of need, whether reviewed under s. 408.036(1) or (2), to a competing proposed facility or program within the same district.

(d)  The applicant's failure to strictly comply with the requirements of s. 408.037(1) or paragraph (2)(c) is not cause for dismissal of the application, unless the failure to comply impairs the fairness of the proceeding or affects the correctness of the action taken by the agency.

(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 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).

(6)  JUDICIAL REVIEW.--

(a)  A party to an administrative hearing for an application for a certificate of need has the right, within not more than 30 days after the date of the final order, to seek judicial review in the District Court of Appeal pursuant to s. 120.68. The agency shall be a party in any such proceeding.

(b)  In such judicial review, the court shall affirm the final order of the agency, unless the decision is arbitrary, capricious, or not in compliance with ss. 408.031-408.045.

(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.

History.--s. 26, ch. 87-92; s. 9, ch. 89-354; s. 15, ch. 92-33; s. 125, ch. 92-279; s. 55, ch. 92-326; s. 12, ch. 95-144; s. 190, ch. 96-410; s. 18, ch. 97-79; s. 5, ch. 97-270; s. 10, ch. 2000-256; s. 11, ch. 2000-318; s. 9, ch. 2004-383.

Note.--Former s. 381.709.

408.040  Conditions and monitoring.--

(1)(a)  The agency may issue a certificate of need, or an exemption, predicated upon statements of intent expressed by an applicant in the application for a certificate of need or an exemption. Any conditions imposed on a certificate of need or an exemption based on such statements of intent shall be stated on the face of the certificate of need or in the exemption approval.

(b)  The agency may consider, in addition to the other criteria specified in s. 408.035, a statement of intent by the applicant that a specified percentage of the annual patient days at the facility will be utilized by patients eligible for care under Title XIX of the Social Security Act. Any certificate of need issued to a nursing home in reliance upon an applicant's statements that a specified percentage of annual patient days will be utilized by residents eligible for care under Title XIX of the Social Security Act must include a statement that such certification is a condition of issuance of the certificate of need. The certificate-of-need program shall notify the Medicaid program office and the Department of Elderly Affairs when it imposes conditions as authorized in this paragraph in an area in which a community diversion pilot project is implemented.

(c)  A certificateholder or an exemption holder may apply to the agency for a modification of conditions imposed under paragraph (a) or paragraph (b). If the holder of a certificate of need or an exemption demonstrates good cause why the certificate or exemption should be modified, the agency shall reissue the certificate of need or exemption with such modifications as may be appropriate. The agency shall by rule define the factors constituting good cause for modification.

(d)  If the holder of a certificate of need or an exemption fails to comply with a condition upon which the issuance of the certificate or exemption was predicated, the agency may assess an administrative fine against the certificateholder or exemption holder in an amount not to exceed $1,000 per failure per day. Failure to annually report compliance with any condition upon which the issuance of the certificate or exemption was predicated constitutes noncompliance. In assessing the penalty, the agency shall take into account as mitigation the degree of noncompliance. Proceeds of such penalties shall be deposited in the Public Medical Assistance Trust Fund.

(2)(a)  Unless the applicant has commenced construction, if the project provides for construction, unless the applicant has incurred an enforceable capital expenditure commitment for a project, if the project does not provide for construction, or unless subject to paragraph (b), a certificate of need shall terminate 18 months after the date of issuance. The agency shall monitor the progress of the holder of the certificate of need in meeting the timetable for project development specified in the application, and may revoke the certificate of need, if the holder of the certificate is not meeting such timetable and is not making a good-faith effort, as defined by rule, to meet it.

(b)  A certificate of need issued to an applicant holding a provisional certificate of authority under chapter 651 shall terminate 1 year after the applicant receives a valid certificate of authority from the Office of Insurance Regulation of the Financial Services Commission.

(c)  The certificate-of-need validity period for a project shall be extended by the agency, to the extent that the applicant demonstrates to the satisfaction of the agency that good-faith commencement of the project is being delayed by litigation or by governmental action or inaction with respect to regulations or permitting precluding commencement of the project.

(3)  The agency shall require the submission of an executed architect's certification of final payment for each certificate-of-need project approved by the agency. Each project that involves construction shall submit such certification to the agency within 30 days following completion of construction.

History.--s. 27, ch. 87-92; s. 22, ch. 88-294; s. 15, ch. 92-33; s. 13, ch. 95-144; s. 6, ch. 97-270; s. 4, ch. 98-85; s. 11, ch. 2000-256; s. 12, ch. 2000-318; s. 434, ch. 2003-261; s. 10, ch. 2004-383.

Note.--Former s. 381.710.

408.041  Certificate of need required; penalties.--It is unlawful for any person to undertake a project subject to review under ss. 408.031-408.045 without a valid certificate of need. Any person violating the provisions of this section is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083. Each day of continuing violation shall be considered a separate offense.

History.--s. 28, ch. 87-92; s. 62, ch. 91-224; s. 15, ch. 92-33; s. 14, ch. 95-144.

Note.--Former s. 381.711.

408.042  Limitation on transfer.--The holder of a certificate of need shall not charge a price for the transfer of the certificate of need to another person that exceeds the total amount of the actual costs incurred by the holder in obtaining the certificate of need. Such actual costs must be documented by an affidavit executed by the transferor under oath. A holder who violates this section is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082, or by a fine not exceeding $10,000, or both.

History.--s. 29, ch. 87-92; s. 15, ch. 92-33; s. 7, ch. 97-270.

Note.--Former s. 381.712.

408.043  Special provisions.--

(1)  OSTEOPATHIC ACUTE CARE HOSPITALS.--When an application is made for a certificate of need to construct or to expand an osteopathic acute care hospital, the need for such hospital shall be determined on the basis of the need for and availability of osteopathic services and osteopathic acute care hospitals in the district. When a prior certificate of need to establish an osteopathic acute care hospital has been issued in a district, and the facility is no longer used for that purpose, the agency may continue to count such facility and beds as an existing osteopathic facility in any subsequent application for construction of an osteopathic acute care hospital.

(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.

(3)  RURAL HEALTH NETWORKS.--Preference shall be given in the award of a certificate of need to members of certified rural health networks, as provided for in s. 381.0406, subject to the following conditions:

(a)  Need must be shown pursuant to s. 408.035.

(b)  The proposed project must:

1.  Strengthen health care services in rural areas through partnerships between rural care providers; or

2.  Increase access to inpatient health care services for Medicaid recipients or other low-income persons who live in rural areas.

(c)  No preference shall be given under this section for the establishment of skilled nursing facility services by a hospital.

(4)  PRIVATE ACCREDITATION NOT REQUIRED.--Accreditation by any private organization may not be a requirement for the issuance or maintenance of a certificate of need under ss. 408.031-408.045.

History.--s. 30, ch. 87-92; s. 15, ch. 91-282; s. 15, ch. 92-33; s. 31, ch. 93-129; s. 8, ch. 97-270; s. 1, ch. 2003-161; s. 11, ch. 2004-383.

Note.--Former s. 381.713.

408.044  Injunction.--Notwithstanding the existence or pursuit of any other remedy, the agency may maintain an action in the name of the state for injunction or other process against any person to restrain or prevent the pursuit of a project subject to review under ss. 408.031-408.045, in the absence of a valid certificate of need.

History.--s. 31, ch. 87-92; s. 15, ch. 92-33; s. 15, ch. 95-144; s. 12, ch. 2000-256; s. 13, ch. 2000-318.

Note.--Former s. 381.714.

408.045  Certificate of need; competitive sealed proposals.--

(1)  The application, review, and issuance procedures for a certificate of need for an intermediate care facility for the developmentally disabled may be made by the agency by competitive sealed proposals.

(2)  The agency shall make a decision regarding the issuance of the certificate of need in accordance with the provisions of s. 287.057(17), rules adopted by the agency relating to intermediate care facilities for the developmentally disabled, and the criteria in s. 408.035, as further defined by rule.

(3)  Notification of the decision shall be issued to all applicants not later than 28 calendar days after the date responses to a request for proposal are due.

(4)  The procedures provided for under this section are exempt from the batching cycle requirements and the public hearing requirement of s. 408.039.

(5)  The agency may use the competitive sealed proposal procedure for determining a certificate of need for other types of health care facilities and services if the agency identifies an unmet health care need and when funding in whole or in part for such health care facilities or services is authorized by the Legislature.

History.--s. 3, ch. 83-244; s. 42, ch. 85-81; s. 32, ch. 87-92; s. 3, ch. 89-308; s. 30, ch. 90-268; ss. 15, 18, ch. 92-33; s. 16, ch. 95-144; s. 13, ch. 2000-256; s. 14, ch. 2000-318; s. 67, ch. 2002-1; s. 37, ch. 2002-207.

Note.--Former s. 381.4961; s. 381.715.

408.0455  Rules; pending proceedings.--The rules of the agency in effect on June 30, 2004, shall remain in effect and shall be enforceable by the agency with respect to ss. 408.031-408.045 until such rules are repealed or amended by the agency.

History.--s. 38, ch. 87-92; s. 19, ch. 92-33; s. 74, ch. 92-289; s. 19, ch. 97-79; s. 4, ch. 97-98; s. 9, ch. 97-270; s. 12, ch. 2004-383.

Note.--Former s. 381.7155.

408.05  State Center for Health Statistics.--

(1)  ESTABLISHMENT.--The agency shall establish a State Center for Health Statistics. The center shall establish a comprehensive health information system to provide for the collection, compilation, coordination, analysis, indexing, dissemination, and utilization of both purposefully collected and extant health-related data and statistics. The center shall be staffed with public health experts, biostatisticians, information system analysts, health policy experts, economists, and other staff necessary to carry out its functions.

(2)  STATISTICS.--The comprehensive health information system operated by the State Center for Health Statistics shall collect data on:

(a)  The extent and nature of illness and disability of the state population, including life expectancy, the incidence of various acute and chronic illnesses, and infant and maternal morbidity and mortality.

(b)  The impact of illness and disability of the state population on the state economy and on other aspects of the well-being of the people in this state.

(c)  Environmental, social, and other health hazards.

(d)  Health knowledge and practices of the people in this state and determinants of health and nutritional practices and status.

(e)  Health resources, including physicians, dentists, nurses, and other health professionals, by specialty and type of practice and acute, long-term care and other institutional care facility supplies and specific services provided by hospitals, nursing homes, home health agencies, and other health care facilities.

(f)  Utilization of health care by type of provider.

(g)  Health care costs and financing, including trends in health care prices and costs, the sources of payment for health care services, and federal, state, and local expenditures for health care.

(h)  Family formation, growth, and dissolution.

(i)  The extent of public and private health insurance coverage in this state.

(j)  The quality of care provided by various health care providers.

(3)  COMPREHENSIVE HEALTH INFORMATION SYSTEM.--In order to produce comparable and uniform health information and statistics, the agency shall perform the following functions:

(a)  Coordinate the activities of state agencies involved in the design and implementation of the comprehensive health information system.

(b)  Undertake research, development, and evaluation respecting the comprehensive health information system.

(c)  Review the statistical activities of the Department of Health to assure that they are consistent with the comprehensive health information system.

(d)  Develop written agreements with local, state, and federal agencies for the sharing of health-care-related data or using the facilities and services of such agencies. State agencies, local health councils, and other agencies under contract with the Department of Health shall assist the center in obtaining, compiling, and transferring health-care-related data maintained by state and local agencies. Written agreements must specify the types, methods, and periodicity of data exchanges and specify the types of data that will be transferred to the center.

(e)  The agency shall establish by rule the types of data collected, compiled, processed, used, or shared. Decisions regarding center data sets should be made based on consultation with the Comprehensive Health Information System Advisory Council and other public and private users regarding the types of data which should be collected and their uses.

(f)  The center shall establish standardized means for collecting health information and statistics under laws and rules administered by the agency.

(g)  Establish minimum health-care-related data sets which are necessary on a continuing basis to fulfill the collection requirements of the center and which shall be used by state agencies in collecting and compiling health-care-related data. The agency shall periodically review ongoing health care data collections of the Department of Health and other state agencies to determine if the collections are being conducted in accordance with the established minimum sets of data.

(h)  Establish advisory standards to assure the quality of health statistical and epidemiological data collection, processing, and analysis by local, state, and private organizations.

(i)  Prescribe standards for the publication of health-care-related data reported pursuant to this section which ensure the reporting of accurate, valid, reliable, complete, and comparable data. Such standards should include advisory warnings to users of the data regarding the status and quality of any data reported by or available from the center.

(j)  Prescribe standards for the maintenance and preservation of the center's data. This should include methods for archiving data, retrieval of archived data, and data editing and verification.

(k)  Ensure that strict quality control measures are maintained for the dissemination of data through publications, studies, or user requests.

(l)  Develop, in conjunction with the State Comprehensive Health Information System Advisory Council, and implement a long-range plan for making available performance outcome and financial data that will allow consumers to compare health care services. The performance outcomes and financial data the agency must make available shall include, but is not limited to, pharmaceuticals, physicians, health care facilities, and health plans and managed care entities. The agency shall submit the initial plan to the Governor, the President of the Senate, and the Speaker of the House of Representatives by March 1, 2005, and shall update the plan and report on the status of its implementation annually thereafter. The agency shall also make the plan and status report available to the public on its Internet website. As part of the plan, the agency shall identify the process and timeframes for implementation, any barriers to implementation, and recommendations of changes in the law that may be enacted by the Legislature to eliminate the barriers. As preliminary elements of the plan, the agency shall:

1.  Make available performance outcome and patient charge data collected from health care facilities pursuant to s. 408.061(1)(a) and (2). The agency shall determine which conditions and procedures, performance outcomes, and patient charge data to disclose based upon input from the council. When determining which conditions and procedures are to be disclosed, the council and the agency shall consider variation in costs, variation in outcomes, and magnitude of variations and other relevant information. When determining which performance outcomes to disclose, the agency:

a.  Shall consider such factors as volume of cases; average patient charges; average length of stay; complication rates; mortality rates; and infection rates, among others, which shall be adjusted for case mix and severity, if applicable.

b.  May consider such additional measures that are adopted by the Centers for Medicare and Medicaid Studies, National Quality Forum, the Joint Commission on Accreditation of Healthcare Organizations, the Agency for Healthcare Research and Quality, or a similar national entity that establishes standards to measure the performance of health care providers, or by other states.

When determining which patient charge data to disclose, the agency shall consider such measures as average charge, average net revenue per adjusted patient day, average cost per adjusted patient day, and average cost per admission, among others.

2.  Make available performance measures, benefit design, and premium cost data from health plans licensed pursuant to chapter 627 or chapter 641. The agency shall determine which performance outcome and member and subscriber cost data to disclose, based upon input from the council. When determining which data to disclose, the agency shall consider information that may be required by either individual or group purchasers to assess the value of the product, which may include membership satisfaction, quality of care, current enrollment or membership, coverage areas, accreditation status, premium costs, plan costs, premium increases, range of benefits, copayments and deductibles, accuracy and speed of claims payment, credentials of physicians, number of providers, names of network providers, and hospitals in the network. Health plans shall make available to the agency any such data or information that is not currently reported to the agency or the office.

3.  Determine the method and format for public disclosure of data reported pursuant to this paragraph. The agency shall make its determination based upon input from the Comprehensive Health Information System Advisory Council. At a minimum, the data shall be made available on the agency's Internet website in a manner that allows consumers to conduct an interactive search that allows them to view and compare the information for specific providers. The website must include such additional information as is determined necessary to ensure that the website enhances informed decisionmaking among consumers and health care purchasers, which shall include, at a minimum, appropriate guidance on how to use the data and an explanation of why the data may vary from provider to provider. The data specified in subparagraph 1. shall be released no later than March 1, 2005. The data specified in subparagraph 2. shall be released no later than March 1, 2006.

(4)  TECHNICAL ASSISTANCE.--The center shall provide technical assistance to persons or organizations engaged in health planning activities in the effective use of statistics collected and compiled by the center. The center shall also provide the following additional technical assistance services:

(a)  Establish procedures identifying the circumstances under which, the places at which, the persons from whom, and the methods by which a person may secure data from the center, including procedures governing requests, the ordering of requests, timeframes for handling requests, and other procedures necessary to facilitate the use of the center's data. To the extent possible, the center should provide current data timely in response to requests from public or private agencies.

(b)  Provide assistance to data sources and users in the areas of database design, survey design, sampling procedures, statistical interpretation, and data access to promote improved health-care-related data sets.

(c)  Identify health care data gaps and seek cooperative agreements with other public or private organizations for meeting documented health care data needs.

(d)  Assist other organizations in developing statistical abstracts of their data sets that could be used by the center.

(e)  Provide statistical support to state agencies with regard to the use of databases maintained by the center.

(f)  To the extent possible, respond to multiple requests for information not currently collected by the center or available from other sources by initiating data collection.

(g)  Maintain detailed information on data maintained by other local, state, federal, and private agencies in order to advise those who use the center of potential sources of data which are requested but which are not available from the center.

(h)  Respond to requests for data which are not available in published form by initiating special computer runs on data sets available to the center.

(5)  PUBLICATIONS; REPORTS; SPECIAL STUDIES.--The center shall provide for the widespread dissemination of data which it collects and analyzes. The center shall have the following publication, reporting, and special study functions:

(a)  The center shall publish and make available periodically to agencies and individuals health statistics publications of general interest, including HMO report cards; publications providing health statistics on topical health policy issues; publications that provide health status profiles of the people in this state; and other topical health statistics publications.

(b)  The center shall publish, make available, and disseminate, promptly and as widely as practicable, the results of special health surveys, health care research, and health care evaluations conducted or supported under this section. Any publication by the center must include a statement of the limitations on the quality, accuracy, and completeness of the data.

(c)  The center shall provide indexing, abstracting, translation, publication, and other services leading to a more effective and timely dissemination of health care statistics.

(d)  The center shall be responsible for publishing and disseminating an annual report on the center's activities.

(e)  The center shall be responsible, to the extent resources are available, for conducting a variety of special studies and surveys to expand the health care information and statistics available for health policy analyses, particularly for the review of public policy issues. The center shall develop a process by which users of the center's data are periodically surveyed regarding critical data needs and the results of the survey considered in determining which special surveys or studies will be conducted. The center shall select problems in health care for research, policy analyses, or special data collections on the basis of their local, regional, or state importance; the unique potential for definitive research on the problem; and opportunities for application of the study findings.

(6)  PROVIDER DATA REPORTING.--This section does not confer on the agency the power to demand or require that a health care provider or professional furnish information, records of interviews, written reports, statements, notes, memoranda, or data other than as expressly required by law.

(7)  BUDGET; FEES; TRUST FUND.--

(a)  The Legislature intends that funding for the State Center for Health Statistics be appropriated from the General Revenue Fund.

(b)  The State Center for Health Statistics may apply for and receive and accept grants, gifts, and other payments, including property and services, from any governmental or other public or private entity or person and make arrangements as to the use of same, including the undertaking of special studies and other projects relating to health-care-related topics. Funds obtained pursuant to this paragraph may not be used to offset annual appropriations from the General Revenue Fund.

(c)  The center may charge such reasonable fees for services as the agency prescribes by rule. The established fees may not exceed the reasonable cost for such services. Fees collected may not be used to offset annual appropriations from the General Revenue Fund.

(d)  The agency shall establish a Comprehensive Health Information System Trust Fund as the repository of all funds appropriated to, and fees and grants collected for, services of the State Center for Health Statistics. Any funds, other than funds appropriated to the center from the General Revenue Fund, which are raised or collected by the agency for the operation of the center and which are not needed to meet the expenses of the center for its current fiscal year shall be available to the agency in succeeding years.

(8)  STATE COMPREHENSIVE HEALTH INFORMATION SYSTEM ADVISORY COUNCIL.--

(a)  There is established in the agency the State Comprehensive Health Information System Advisory Council to assist the center in reviewing the comprehensive health information system and to recommend improvements for such system. The council shall consist of the following members:

1.  An employee of the Executive Office of the Governor, to be appointed by the Governor.

2.  An employee of the Office of Insurance Regulation, to be appointed by the director of the office.

3.  An employee of the Department of Education, to be appointed by the Commissioner of Education.

4.  Ten persons, to be appointed by the Secretary of Health Care Administration, representing other state and local agencies, state universities, the Florida Association of Business/Health Coalitions, local health councils, professional health-care-related associations, consumers, and purchasers.

(b)  Each member of the council shall be appointed to serve for a term of 4 years from the date of appointment, except that a vacancy shall be filled by appointment for the remainder of the term and except that:

1.  Three of the members initially appointed by the Director of Health Care Administration shall each be appointed for a term of 3 years.

2.  Two of the members initially appointed by the Director of Health Care Administration shall each be appointed for a term of 2 years.

3.  Two of the members initially appointed by the Director of Health Care Administration shall each be appointed for a term of 1 year.

(c)  The council may meet at the call of its chair, at the request of the department, or at the request of a majority of its membership, but at least quarterly.

(d)  Members shall elect a chair annually.

(e)  A majority of the members constitutes a quorum, and the affirmative vote of a majority of a quorum is necessary to take action.

(f)  The council shall maintain minutes of each meeting and shall make such minutes available to any person.

(g)  Members of the council shall serve without compensation but shall be entitled to receive reimbursement for per diem and travel expenses as provided in s. 112.061.

(9)  Nothing in this section shall limit, restrict, affect, or control the collection, analysis, release, or publication of data by any state agency pursuant to its statutory authority, duties, or responsibilities.

History.--s. 39, ch. 88-394; s. 1, ch. 90-347; s. 50, ch. 91-297; s. 5, ch. 91-429; s. 14, ch. 92-33; s. 4, ch. 95-201; s. 37, ch. 97-103; s. 10, ch. 98-89; s. 176, ch. 99-8; s. 1, ch. 99-393; s. 42, ch. 2000-153; s. 16, ch. 2000-305; s. 435, ch. 2003-261; s. 11, ch. 2004-297; s. 12, ch. 2004-390.

Note.--Former s. 381.0612; s. 381.0401.

408.061  Data collection; uniform systems of financial reporting; information relating to physician charges; confidential information; immunity.--

(1)  The agency shall require the submission by health care facilities, health care providers, and health insurers of data necessary to carry out the agency's duties. Specifications for data to be collected under this section shall be developed by the agency with the assistance of technical advisory panels including representatives of affected entities, consumers, purchasers, and such other interested parties as may be determined by the agency.

(a)  Data submitted by health care facilities, including the facilities as defined in chapter 395, shall include, but are not limited to: case-mix data, patient admission and discharge data, hospital emergency department data which shall include the number of patients treated in the emergency department of a licensed hospital reported by patient acuity level, data on hospital-acquired infections as specified by rule, data on complications as specified by rule, data on readmissions as specified by rule, with patient and provider-specific identifiers included, actual charge data by diagnostic groups, financial data, accounting data, operating expenses, expenses incurred for rendering services to patients who cannot or do not pay, interest charges, depreciation expenses based on the expected useful life of the property and equipment involved, and demographic data. The agency shall adopt nationally recognized risk adjustment methodologies or software consistent with the standards of the Agency for Healthcare Research and Quality and as selected by the agency for all data submitted as required by this section. Data may be obtained from documents such as, but not limited to: leases, contracts, debt instruments, itemized patient bills, medical record abstracts, and related diagnostic information. Reported data elements shall be reported electronically in accordance with rule 59E-7.012, Florida Administrative Code. Data submitted shall be certified by the chief executive officer or an appropriate and duly authorized representative or employee of the licensed facility that the information submitted is true and accurate.

(b)  Data to be submitted by health care providers may include, but are not limited to: Medicare and Medicaid participation, types of services offered to patients, amount of revenue and expenses of the health care provider, and such other data which are reasonably necessary to study utilization patterns. Data submitted shall be certified by the appropriate duly authorized representative or employee of the health care provider that the information submitted is true and accurate.

(c)  Data to be submitted by health insurers may include, but are not limited to: claims, premium, administration, and financial information. Data submitted shall be certified by the chief financial officer, an appropriate and duly authorized representative, or an employee of the insurer that the information submitted is true and accurate.

(d)  Data required to be submitted by health care facilities, health care providers, or health insurers shall not include specific provider contract reimbursement information. However, such specific provider reimbursement data shall be reasonably available for onsite inspection by the agency as is necessary to carry out the agency's regulatory duties. Any such data obtained by the agency as a result of onsite inspections may not be used by the state for purposes of direct provider contracting and are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.

(e)  A requirement to submit data shall be adopted by rule if the submission of data is being required of all members of any type of health care facility, health care provider, or health insurer. Rules are not required, however, for the submission of data for a special study mandated by the Legislature or when information is being requested for a single health care facility, health care provider, or health insurer.

(2)  The agency shall, by rule, after consulting with appropriate professional and governmental advisory bodies and holding public hearings and considering existing and proposed systems of accounting and reporting utilized by health care facilities, specify a uniform system of financial reporting for each type of facility based on a uniform chart of accounts developed after considering any chart of accounts developed by the national association for such facilities and generally accepted accounting principles. Such systems shall, to the extent feasible, use existing accounting systems and shall minimize the paperwork required of facilities. This provision shall not be construed to authorize the agency to require health care facilities to adopt a uniform accounting system. As a part of such uniform system of financial reporting, the agency may require the filing of any information relating to the cost to the provider and the charge to the consumer of any service provided in such facility, except the cost of a physician's services which is billed independently of the facility.

(3)  When more than one licensed facility is operated by the reporting organization, the information required by this section shall be reported for each facility separately.

(4)  Within 120 days after the end of its fiscal year, each health care facility, excluding continuing care facilities and nursing homes as defined in s. 408.07(14) and (36), shall file with the agency, on forms adopted by the agency and based on the uniform system of financial reporting, its actual financial experience for that fiscal year, including expenditures, revenues, and statistical measures. Such data may be based on internal financial reports which are certified to be complete and accurate by the provider. However, hospitals' actual financial experience shall be their audited actual experience. Every nursing home shall submit to the agency, in a format designated by the agency, a statistical profile of the nursing home residents. The agency, in conjunction with the Department of Elderly Affairs and the Department of Health, shall review these statistical profiles and develop recommendations for the types of residents who might more appropriately be placed in their homes or other noninstitutional settings.

(5)  In addition to information submitted in accordance with subsection (4), each nursing home shall track and file with the agency, on a form adopted by the agency, data related to each resident's admission, discharge, or conversion to Medicaid; health and functional status; plan of care; and other information pertinent to the resident's placement in a nursing home.

(6)  The agency may require other reports based on the uniform system of financial reporting necessary to accomplish the purposes of this chapter.

(7)  Portions of patient records obtained or generated by the agency containing the name, residence or business address, telephone number, social security or other identifying number, or photograph of any person or the spouse, relative, or guardian of such person, or any other identifying information which is patient-specific or otherwise identifies the patient, either directly or indirectly, are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.

(8)  The identity of any health care provider, health care facility, or health insurer who submits any data which is proprietary business information to the agency pursuant to the provisions of this section shall remain confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. As used in this section, "proprietary business information" shall include, but not be limited to, information relating to specific provider contract reimbursement information; information relating to security measures, systems, or procedures; and information concerning bids or other contractual data, the disclosure of which would impair efforts to contract for goods or services on favorable terms or would injure the affected entity's ability to compete in the marketplace. Notwithstanding the provisions of this subsection, any information obtained or generated pursuant to the provisions of former s. 407.61, either by the former Health Care Cost Containment Board or by the Agency for Health Care Administration upon transfer to that agency of the duties and functions of the former Health Care Cost Containment Board, is not confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. Such proprietary business information may be used in published analyses and reports or otherwise made available for public disclosure in such manner as to preserve the confidentiality of the identity of the provider. This exemption shall not limit the use of any information used in conjunction with investigation or enforcement purposes under the provisions of s. 456.073.

(9)  No health care facility, health care provider, health insurer, or other reporting entity or its employees or agents shall be held liable for civil damages or subject to criminal penalties either for the reporting of patient data to the agency or for the release of such data by the agency as authorized by this chapter.

(10)  The agency shall be the primary source for collection and dissemination of health care data. No other agency of state government may gather data from a health care provider licensed or regulated under this chapter without first determining if the data is currently being collected by the agency and affirmatively demonstrating that it would be more cost-effective for an agency of state government other than the agency to gather the health care data. The director shall ensure that health care data collected by the divisions within the agency is coordinated. It is the express intent of the Legislature that all health care data be collected by a single source within the agency and that other divisions within the agency, and all other agencies of state government, obtain data for analysis, regulation, and public dissemination purposes from that single source. Confidential information may be released to other governmental entities or to parties contracting with the agency to perform agency duties or functions as needed in connection with the performance of the duties of the receiving entity. The receiving entity or party shall retain the confidentiality of such information as provided for herein.

(11)  The agency shall cooperate with local health councils and the state health planning agency with regard to health care data collection and dissemination and shall cooperate with state agencies in any efforts to establish an integrated health care database.

(12)  It is the policy of this state that philanthropic support for health care should be encouraged and expanded, especially in support of experimental and innovative efforts to improve the health care delivery system.

(13)  For purposes of determining reasonable costs of services furnished by health care facilities, unrestricted grants, gifts, and income from endowments shall not be deducted from any operating costs of such health care facilities, and, in addition, the following items shall not be deducted from any operating costs of such health care facilities:

(a)  An unrestricted grant or gift, or income from such a grant or gift, which is not available for use as operating funds because of its designation by the health care facility's governing board.

(b)  A grant or similar payment which is made by a governmental entity and which is not available, under the terms of the grant or payment, for use as operating funds.

(c)  The sale or mortgage of any real estate or other capital assets of the health care facility which the health care facility acquired through a gift or grant and which is not available for use as operating funds under the terms of the gift or grant or because of its designation by the health care facility's governing board, except for recovery of the appropriate share of gains and losses realized from the disposal of depreciable assets.

History.--s. 68, ch. 92-33; s. 14, ch. 93-129; ss. 3, 4, ch. 95-201; s. 248, ch. 96-406; s. 40, ch. 97-98; s. 11, ch. 98-89; s. 27, ch. 98-166; s. 177, ch. 99-8; s. 43, ch. 2000-153; s. 19, ch. 2000-160; s. 11, ch. 2000-209; s. 30, ch. 2003-57; s. 9, ch. 2004-297.

408.062  Research, analyses, studies, and reports.--

(1)  The agency shall conduct research, analyses, and studies relating to health care costs and access to and quality of health care services as access and quality are affected by changes in health care costs. Such research, analyses, and studies shall include, but not be limited to:

(a)  The financial status of any health care facility or facilities subject to the provisions of this chapter.

(b)  The impact of uncompensated charity care on health care facilities and health care providers.

(c)  The state's role in assisting to fund indigent care.

(d)  In conjunction with the Office of Insurance Regulation, the availability and affordability of health insurance for small businesses.

(e)  Total health care expenditures in the state according to the sources of payment and the type of expenditure.

(f)  The quality of health services, using techniques such as small area analysis, severity adjustments, and risk-adjusted mortality rates.

(g)  The development of physician information systems which are capable of providing data for health care consumers taking into account the amount of resources consumed, including such information at licensed facilities as defined in chapter 395, and the outcomes produced in the delivery of care.

(h)  The collection of a statistically valid sample of data on the retail prices charged by pharmacies for the 50 most frequently prescribed medicines from any pharmacy licensed by this state as a special study authorized by the Legislature to be performed by the agency quarterly. If the drug is available generically, price data shall be reported for the generic drug and price data of a brand-named drug for which the generic drug is the equivalent shall be reported. The agency shall make available on its Internet website for each pharmacy, no later than October 1, 2005, drug prices for a 30-day supply at a standard dose. The data collected shall be reported for each drug by pharmacy and by metropolitan statistical area or region and updated quarterly.

(i)  The use of emergency department services by patient acuity level and the implication of increasing hospital cost by providing nonurgent care in emergency departments. The agency shall submit an annual report based on this monitoring and assessment to the Governor, the Speaker of the House of Representatives, the President of the Senate, and the substantive legislative committees with the first report due January 1, 2006.

(j)  The making available on its Internet website no later than October 1, 2004, and in a hard-copy format upon request, of patient charge, volumes, length of stay, and performance outcome indicators collected from health care facilities pursuant to s. 408.061(1)(a) for specific medical conditions, surgeries, and procedures provided in inpatient and outpatient facilities as determined by the agency. In making the determination of specific medical conditions, surgeries, and procedures to include, the agency shall consider such factors as volume, severity of the illness, urgency of admission, individual and societal costs, and whether the condition is acute or chronic. Performance outcome indicators shall be risk adjusted or severity adjusted, as applicable, using nationally recognized risk adjustment methodologies or software consistent with the standards of the Agency for Healthcare Research and Quality and as selected by the agency. The website shall also provide an interactive search that allows consumers to view and compare the information for specific facilities, a map that allows consumers to select a county or region, definitions of all of the data, descriptions of each procedure, and an explanation about why the data may differ from facility to facility. Such public data shall be updated quarterly. The agency shall submit an annual status report on the collection of data and publication of performance outcome indicators to the Governor, the Speaker of the House of Representatives, the President of the Senate, and the substantive legislative committees with the first status report due January 1, 2005.

(2)  The agency may assess annually the caesarean section rate in Florida hospitals using the analysis methodology that the agency determines most appropriate. To assist the agency in determining the impact of this chapter on Florida hospitals' caesarean section rates, each provider hospital, as defined in s. 383.336, shall notify the agency of the date of implementation of the practice parameters and the date of the first meeting of the hospital peer review board created pursuant to this chapter. The agency shall use these dates in monitoring any change in provider hospital caesarean section rates. An annual report based on this monitoring and assessment shall be submitted to the Governor, the Speaker of the House of Representatives, and the President of the Senate by the agency, with the first annual report due January 1, 1993.

(3)  The agency may also prepare such summaries and compilations or other supplementary reports based on the information analyzed by the agency under this section, as will advance the purposes of this chapter.

(4)(a)  The agency shall conduct data-based studies and evaluations and make recommendations to the Legislature and the Governor concerning exemptions, the effectiveness of limitations of referrals, restrictions on investment interests and compensation arrangements, and the effectiveness of public disclosure. Such analysis shall include, but need not be limited to, utilization of services, cost of care, quality of care, and access to care. The agency may require the submission of data necessary to carry out this duty, which may include, but need not be limited to, data concerning ownership, Medicare and Medicaid, charity care, types of services offered to patients, revenues and expenses, patient-encounter data, and other data reasonably necessary to study utilization patterns and the impact of health care provider ownership interests in health-care-related entities on the cost, quality, and accessibility of health care.

(b)  The agency may collect such data from any health facility or licensed health care provider as a special study.

(5)  The agency shall develop and implement a strategy for the adoption and use of electronic health records. The agency may develop rules to facilitate the functionality and protect the confidentiality of electronic health records. The agency shall report to the Governor, the Speaker of the House of Representatives, and the President of the Senate on legislative recommendations to protect the confidentiality of electronic health records.

History.--s. 69, ch. 92-33; s. 12, ch. 93-129; s. 12, ch. 98-89; s. 17, ch. 2000-209; s. 31, ch. 2003-57; s. 10, ch. 2004-297.

408.063  Dissemination of health care information.--

(1)  The agency, relying on data collected pursuant to this chapter, shall establish a reliable, timely, and consistent information system that distributes information and serves as the basis for the agency's public education programs. The agency shall seek advice from consumers, health care purchasers, health care providers, health care facilities, health insurers, and local health councils in the development and implementation of its information system. Whenever appropriate, the agency shall use the local health councils for the dissemination of information and education of the public.

(2)  The agency shall publish and disseminate information to the public which will enhance informed decisionmaking in the selection of health care providers, facilities, and services. Such publications may identify average charges for specified services, lengths of stay associated with established diagnostic groups, readmission rates, mortality rates, recommended guidelines for selection and use of health care providers, health care facilities, and health care services, and such other information as the agency deems appropriate.

(3)  The agency shall educate consumers and health care purchasers by conducting or sponsoring seminars and other educational programs at locations throughout the state.

(4)  The agency shall serve as a clearinghouse for information concerning:

(a)  Innovations in the delivery of health care services and the enhancement of competition in the health care market.

(b)  Federal and state legislative initiatives affecting the private health care delivery system and governmental health care programs.

(c)  Health promotion, illness prevention, and wellness in the work setting.

(5)  The agency shall publish annually a comprehensive report of state health expenditures. The report shall identify:

(a)  The contribution of health care dollars made by all payors.

(b)  The dollars expended by type of health care service in Florida.

(6)  The staff of the agency may conduct or sponsor consumer information and education seminars at locations throughout the state and may hold public hearings to solicit consumer concerns or complaints relating to health care costs and make recommendations to the agency for study, action, or investigation.

History.--s. 70, ch. 92-33; s. 13, ch. 98-89.

408.07  Definitions.--As used in this chapter, with the exception of ss. 408.031-408.045, the term:

(1)  "Accepted" means that the agency has found that a report or data submitted by a health care facility or a health care provider contains all schedules and data required by the agency and has been prepared in the format specified by the agency, and otherwise conforms to applicable rule or Florida Hospital Uniform Reporting System manual requirements regarding reports in effect at the time such report was submitted, and the data are mathematically reasonable and accurate.

(2)  "Adjusted admission" means the sum of acute and intensive care admissions divided by the ratio of inpatient revenues generated from acute, intensive, ambulatory, and ancillary patient services to gross revenues. If a hospital reports only subacute admissions, then "adjusted admission" means the sum of subacute admissions divided by the ratio of total inpatient revenues to gross revenues.

(3)  "Agency" means the Agency for Health Care Administration.

(4)  "Alcohol or chemical dependency treatment center" means an organization licensed under chapter 397.

(5)  "Ambulatory care center" means an organization which employs or contracts with licensed health care professionals to provide diagnosis or treatment services predominantly on a walk-in basis and the organization holds itself out as providing care on a walk-in basis. Such an organization is not an ambulatory care center if it is wholly owned and operated by five or fewer health care providers.

(6)  "Ambulatory surgical center" means a facility licensed as an ambulatory surgical center under chapter 395.

(7)  "Audited actual data" means information contained within financial statements examined by an independent, Florida-licensed, certified public accountant in accordance with generally accepted auditing standards, but does not include data within a financial statement about which the certified public accountant does not express an opinion or issues a disclaimer.

(8)  "Birth center" means an organization licensed under s. 383.305.

(9)  "Cardiac catheterization laboratory" means a freestanding facility that employs or contracts with licensed health care professionals to provide diagnostic or therapeutic services for cardiac conditions such as cardiac catheterization or balloon angioplasty.

(10)  "Case mix" means a calculated index for each health care facility or health care provider, based on patient data, reflecting the relative costliness of the mix of cases to that facility or provider compared to a state or national mix of cases.

(11)  "Clinical laboratory" means a facility licensed under s. 483.091, excluding: any hospital laboratory defined under s. 483.041(6); any clinical laboratory operated by the state or a political subdivision of the state; any blood or tissue bank where the majority of revenues are received from the sale of blood or tissue and where blood, plasma, or tissue is procured from volunteer donors and donated, processed, stored, or distributed on a nonprofit basis; and any clinical laboratory which is wholly owned and operated by physicians who are licensed pursuant to chapter 458 or chapter 459 and who practice in the same group practice, and at which no clinical laboratory work is performed for patients referred by any health care provider who is not a member of that same group practice.

(12)  "Comprehensive rehabilitative hospital" or "rehabilitative hospital" means a hospital licensed by the agency as a specialty hospital as defined in s. 395.002; provided that the hospital provides a program of comprehensive medical rehabilitative services and is designed, equipped, organized, and operated solely to deliver comprehensive medical rehabilitative services, and further provided that all licensed beds in the hospital are classified as "comprehensive rehabilitative beds" pursuant to s. 395.003(4), and are not classified as "general beds."

(13)  "Consumer" means any person other than a person who administers health activities, is a member of the governing body of a health care facility, provides health services, has a fiduciary interest in a health facility or other health agency or its affiliated entities, or has a material financial interest in the rendering of health services.

(14)  "Continuing care facility" means a facility licensed under chapter 651.

(15)  "Cross-subsidization" means that the revenues from one type of hospital service are sufficiently higher than the costs of providing such service as to offset some of the costs of providing another type of service in the hospital. Cross-subsidization results from the lack of a direct relationship between charges and the costs of providing a particular hospital service or type of service.

(16)  "Deductions from gross revenue" or "deductions from revenue" means reductions from gross revenue resulting from inability to collect payment of charges. For hospitals, such reductions include contractual adjustments; uncompensated care; administrative, courtesy, and policy discounts and adjustments; and other such revenue deductions, but also includes the offset of restricted donations and grants for indigent care.

(17)  "Diagnostic-imaging center" means a freestanding outpatient facility that provides specialized services for the diagnosis of a disease by examination and also provides radiological services. Such a facility is not a diagnostic-imaging center if it is wholly owned and operated by physicians who are licensed pursuant to chapter 458 or chapter 459 and who practice in the same group practice and no diagnostic-imaging work is performed at such facility for patients referred by any health care provider who is not a member of that same group practice.

(18)  "FHURS" means the Florida Hospital Uniform Reporting System developed by the agency.

(19)  "Freestanding" means that a health facility bills and receives revenue which is not directly subject to the hospital assessment for the Public Medical Assistance Trust Fund as described in s. 395.701.

(20)  "Freestanding radiation therapy center" means a facility where treatment is provided through the use of radiation therapy machines that are registered under s. 404.22 and the provisions of the Florida Administrative Code implementing s. 404.22. Such a facility is not a freestanding radiation therapy center if it is wholly owned and operated by physicians licensed pursuant to chapter 458 or chapter 459 who practice within the specialty of diagnostic or therapeutic radiology.

(21)  "GRAA" means gross revenue per adjusted admission.

(22)  "Gross revenue" means the sum of daily hospital service charges, ambulatory service charges, ancillary service charges, and other operating revenue. Gross revenues do not include contributions, donations, legacies, or bequests made to a hospital without restriction by the donors.

(23)  "Health care facility" means an ambulatory surgical center, a hospice, a nursing home, a hospital, a diagnostic-imaging center, a freestanding or hospital-based therapy center, a clinical laboratory, a home health agency, a cardiac catheterization laboratory, a medical equipment supplier, an alcohol or chemical dependency treatment center, a physical rehabilitation center, a lithotripsy center, an ambulatory care center, a birth center, or a nursing home component licensed under chapter 400 within a continuing care facility licensed under chapter 651.

(24)  "Health care provider" means a health care professional licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 463, chapter 464, chapter 465, chapter 466, part I, part III, part IV, part V, or part X of chapter 468, chapter 483, chapter 484, chapter 486, chapter 490, or chapter 491.

(25)  "Health care purchaser" means an employer in the state, other than a health care facility, health insurer, or health care provider, who provides health care coverage for her or his employees.

(26)  "Health insurer" means any insurance company authorized to transact health insurance in the state, any insurance company authorized to transact health insurance or casualty insurance in the state that is offering a minimum premium plan or stop-loss coverage for any person or entity providing health care benefits, any self-insurance plan as defined in s. 624.031, any health maintenance organization authorized to transact business in the state pursuant to part I of chapter 641, any prepaid health clinic authorized to transact business in the state pursuant to part II of chapter 641, any multiple-employer welfare arrangement authorized to transact business in the state pursuant to ss. 624.436-624.45, or any fraternal benefit society providing health benefits to its members as authorized pursuant to chapter 632.

(27)  "Home health agency" means an organization licensed under part IV of chapter 400.

(28)  "Hospice" means an organization licensed under part VI of chapter 400.

(29)  "Hospital" means a health care institution licensed by the Agency for Health Care Administration as a hospital under chapter 395.

(30)  "Lithotripsy center" means a freestanding facility that employs or contracts with licensed health care professionals to provide diagnosis or treatment services using electro-hydraulic shock waves.

(31)  "Local health council" means the agency defined in s. 408.033.

(32)  "Market basket index" means the Florida hospital input price index (FHIPI), which is a statewide market basket index used to measure inflation in hospital input prices weighted for the Florida-specific experience which uses multistate regional and state-specific price measures, when available. The index shall be constructed in the same manner as the index employed by the Secretary of the United States Department of Health and Human Services for determining the inflation in hospital input prices for purposes of Medicare reimbursement.

(33)  "Medical equipment supplier" means an organization that provides medical equipment and supplies used by health care providers and health care facilities in the diagnosis or treatment of disease.

(34)  "Net revenue" means gross revenue minus deductions from revenue.

(35)  "New hospital" means a hospital in its initial year of operation as a licensed hospital and does not include any facility which has been in existence as a licensed hospital, regardless of changes in ownership, for over 1 calendar year.

(36)  "Nursing home" means a facility licensed under s. 400.062 or, for resident level and financial data collection purposes only, any institution licensed under chapter 395 and which has a Medicare or Medicaid certified distinct part used for skilled nursing home care, but does not include a facility licensed under chapter 651.

(37)  "Operating expenses" means total expenses excluding income taxes.

(38)  "Other operating revenue" means all revenue generated from hospital operations other than revenue directly associated with patient care.

(39)  "Physical rehabilitation center" means an organization that employs or contracts with health care professionals licensed under part I or part III of chapter 468 or chapter 486 to provide speech, occupational, or physical therapy services on an outpatient or ambulatory basis.

(40)  "Prospective payment arrangement" means a financial agreement negotiated between a hospital and an insurer, health maintenance organization, preferred provider organization, or other third-party payor which contains, at a minimum, the elements provided for in s. 408.50.

(41)  "Rate of return" means the financial indicators used to determine or demonstrate reasonableness of the financial requirements of a hospital. Such indicators shall include, but not be limited to: return on assets, return on equity, total margin, and debt service coverage.

(42)  "Rural hospital" means an acute care hospital licensed under chapter 395, having 100 or fewer licensed beds and an emergency room, and which is:

(a)  The sole provider within a county with a population density of no greater than 100 persons per square mile;

(b)  An acute care hospital, in a county with a population density of no greater than 100 persons per square mile, which is at least 30 minutes of travel time, on normally traveled roads under normal traffic conditions, from another acute care hospital within the same county;

(c)  A hospital supported by a tax district or subdistrict whose boundaries encompass a population of 100 persons or fewer per square mile;

(d)  A hospital with a service area that has a population of 100 persons or fewer per square mile. As used in this paragraph, the term "service area" means the fewest number of zip codes that account for 75 percent of the hospital's discharges for the most recent 5-year period, based on information available from the hospital inpatient discharge database in the State Center for Health Statistics at the Agency for Health Care Administration; or

(e)  A hospital designated as a Critical Access Hospital by the Department of Health in accordance with federal regulations and state requirements.

Population densities used in this subsection must be based upon the most recently completed United States census. A hospital that received funds under s. 409.9116 for a quarter beginning no later than July 1, 2002, is deemed to have been and shall continue to be a rural hospital from that date through June 30, 2012, if the hospital continues to have 100 or fewer licensed beds and an emergency room, or meets the criteria of s. 395.602(2)(e)4. An acute care hospital that has not previously been designated as a rural hospital and that meets the criteria of this subsection shall be granted such designation upon application, including supporting documentation, to the Agency for Health Care Administration.

(43)  "Special study" means a nonrecurring data-gathering and analysis effort designed to aid the agency in meeting its responsibilities pursuant to this chapter.

(44)  "Teaching hospital" means any Florida hospital officially affiliated with an accredited Florida medical school which exhibits activity in the area of graduate medical education as reflected by at least seven different graduate medical education programs accredited by the Accreditation Council for Graduate Medical Education or the Council on Postdoctoral Training of the American Osteopathic Association and the presence of 100 or more full-time equivalent resident physicians. The Director of the Agency for Health Care Administration shall be responsible for determining which hospitals meet this definition.

History.--s. 71, ch. 92-33; s. 75, ch. 92-289; s. 13, ch. 93-129; s. 39, ch. 93-217; s. 17, ch. 95-144; s. 38, ch. 97-103; s. 2, ch. 98-14; s. 2, ch. 98-21; s. 14, ch. 98-89; s. 44, ch. 2000-153; s. 28, ch. 2000-163; s. 2, ch. 2000-227; s. 2, ch. 2003-258.

408.08  Inspections and audits; violations; penalties; fines; enforcement.--

(1)  The agency may inspect and audit books and records of individual or corporate ownership, including books and records of related organizations with which a health care provider or a health care facility had transactions, for compliance with this chapter. Upon presentation of a written request for inspection to a health care provider or a health care facility by the agency or its staff, the health care provider or the health care facility shall make available to the agency or its staff for inspection, copying, and review all books and records relevant to the determination of whether the health care provider or the health care facility has complied with this chapter.

(2)  Any health care facility that refuses to file a report, fails to timely file a report, files a false report, or files an incomplete report and upon notification fails to timely file a complete report required under s. 408.061; that violates this section, s. 408.061, or s. 408.20, or rule adopted thereunder; or that fails to provide documents or records requested by the agency under this chapter shall be punished by a fine not exceeding $1,000 per day for each day in violation, to be imposed and collected by the agency. Pursuant to rules adopted by the agency, the agency may, upon a showing of good cause, grant a one-time extension of any deadline for a health care facility to timely file a report as required by this section, s. 408.061, or s. 408.20.

(3)  Any health care provider that refuses to file a report, fails to timely file a report, files a false report, or files an incomplete report and upon notification fails to timely file a complete report required under s. 408.061; that violates this section, s. 408.061, or s. 408.20, or rule adopted thereunder; or that fails to provide documents or records requested by the agency under this chapter shall be referred to the appropriate licensing board which shall take appropriate action against the health care provider.

(4)  If a health insurer does not comply with the requirements of s. 408.061, the agency shall report a health insurer's failure to comply to the Office of Insurance Regulation of the Financial Services Commission, which shall take into account the failure by the health insurer to comply in conjunction with its approval authority under s. 627.410. The agency shall adopt any rules necessary to carry out its responsibilities required by this subsection.

(5)  Refusal to file, failure to timely file, or filing false or incomplete reports or other information required to be filed under the provisions of this chapter, failure to pay or failure to timely pay any assessment authorized to be collected by the agency, or violation of any other provision of this chapter or lawfully entered order of the agency or rule adopted under this chapter, shall be punished by a fine not exceeding $1,000 a day for each day in violation, to be fixed, imposed, and collected by the agency. Each day in violation shall be considered a separate offense.

(6)  Notwithstanding any other provisions of this chapter, when a hospital alleges that a factual determination made by the agency is incorrect, the burden of proof shall be on the hospital to demonstrate that such determination is, in light of the total record, not supported by a preponderance of the evidence. The burden of proof remains with the hospital in all cases involving administrative agency action.

History.--s. 73, ch. 92-33; s. 77, ch. 92-289; s. 16, ch. 93-129; s. 23, ch. 95-146; s. 15, ch. 98-89; s. 1, ch. 98-120; s. 45, ch. 2000-153; s. 436, ch. 2003-261.

408.09  Assistance on cost containment strategies.--The agency shall:

(1)  Assist purchasers and employers who seek technical assistance from the agency for the purpose of cost-effective purchasing of health care.

(2)  Develop cost containment strategies for use by providers, employers, or consumers of health care.

(3)  Develop an outreach program to assist small business to include cost containment initiatives for small business health insurance plans.

(4)  Assist existing health coalitions and local health councils as needed in carrying out their respective goals in an efficient and effective manner.

History.--s. 75, ch. 92-33.

408.10  Consumer complaints.--The agency shall:

(1)  Publish and make available to the public a toll-free telephone number for the purpose of handling consumer complaints and shall serve as a liaison between consumer entities and other private entities and governmental entities for the disposition of problems identified by consumers of health care.

(2)  Be empowered to investigate consumer complaints relating to problems with health care facilities' billing practices and issue reports to be made public in any cases where the agency determines the health care facility has engaged in billing practices which are unreasonable and unfair to the consumer.

History.--s. 76, ch. 92-33.

408.15  Powers of the agency.--In addition to the powers granted to the agency elsewhere in this chapter, the agency is authorized to:

(1)  Enter into contracts and execute all instruments necessary or convenient for carrying out its business.

(2)  Acquire, own, hold, dispose of, and encumber personal property and to lease real property in exercising its powers and performing its duties.

(3)  Enter into agreements with any federal, state, or municipal agency, or other public institution, or with any private individual, partnership, firm, corporation, association, or other entity.

(4)  Establish ad hoc advisory committees to expand public participation in agency decisions and draw on the experience of representatives from all areas of health insurance, financing, cost containment, and operations, including, but not limited to, providers, consumers, third-party payors, businesses, and academicians.

(5)  Establish such staff as needed to carry out the purposes of this chapter.

(6)  Apply for and receive and accept grants, gifts, and other payments, including property and services, from any governmental or other public and private entity or person and make arrangements as to the use of same. Funds obtained under this subsection may be used as matching funds for public or private grants.

(7)  Seek federal statutory changes and any waivers of federal laws or regulations that will aid in implementing health care reforms. This may include seeking amendments to:

(a)  The Employee Retirement and Income Security Act of 1974 to permit greater state regulation of employer insurance plans.

(b)  The Medicaid program to permit alternative organizational alignments, elimination of all program eligibility requirements except income, and a moratorium on further federal mandates.

(c)  The Medicare program to seek state administration of benefits, provider payments, or case management of beneficiaries.

(d)  Federal tax laws to permit a 100-percent tax deduction for all private health insurance plans, including those of self-employed persons and unincorporated employers, and reform of the flexible sharing account requirements to maximize pretax health care expenditures.

(e)  Other federal programs to permit full implementation of state health care reforms.

(8)  Adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter.

(9)  Hold public hearings, conduct investigations, and subpoena witnesses, papers, records, and documents in connection therewith. The agency may administer oaths or affirmations in any hearing or investigation.

(10)  Exercise all other powers which are reasonably necessary or essential to carry out the expressed intent, objects, and purposes of this chapter, unless specifically prohibited in this chapter.

(11)  Grant extensions of time for compliance with any filing requirement of this chapter.

(12)  Establish, in coordination with the Department of Health, uniform standards of care to be provided in special needs units or shelters during times of emergency or major disaster.

History.--s. 77, ch. 92-33; s. 111, ch. 98-200; s. 19, ch. 2000-140; s. 12, ch. 2000-209.

408.16  Health Care Trust Fund; moneys to be deposited therein.--

(1)  There is created in the State Treasury a special fund to be designated as the Health Care Trust Fund, which shall be used in the operation of the Agency for Health Care Administration in the performance of the various functions and duties required of it by law.

(2)  All fees, license fees, and other charges collected by the agency shall be deposited in the State Treasury to the credit of the Health Care Trust Fund, to be used in the operation of the agency as authorized by the Legislature. However, penalties and interest assessed and collected by the agency shall not be deposited in the trust fund but shall be deposited in the General Revenue Fund. The Health Care Trust Fund shall be subject to the service charge imposed pursuant to chapter 215.

(3)  The agency shall maintain separate revenue and expenditure accounts in the Health Care Trust Fund for every provider licensed by the agency.

(4)  All other moneys in the Health Care Trust Fund shall be for the use of the agency in the performance of its functions and duties as provided by law, subject to the fiscal and budgetary provisions of general law and the General Appropriations Act.

History.--s. 50, ch. 92-33; s. 23, ch. 93-129; s. 36, ch. 96-418; s. 59, ch. 97-261.

Note.--Former s. 455.2205.

408.18  Health Care Community Antitrust Guidance Act; antitrust no-action letter; market-information collection and education.--

(1)  This section may be cited as the "Florida Health Care Community Antitrust Guidance Act."

(2)  This section is created to provide instruction to the health care community in a time of tremendous change, and to resolve, as completely as possible, the problem of antitrust uncertainty that may deter mergers, joint ventures, or other business activities that can improve the delivery of health care, without creating costly, time-consuming regulations that can lead to more litigation and delay.

(3)  For purposes of this section, the term:

(a)  "Health care community" means all licensed health care providers, insurers, networks, purchasers, and other participants in the health care system.

(b)  "Antitrust no-action letter" means a letter that states the intention of the Attorney General's office not to take antitrust enforcement actions with respect to the requesting party, based on the specific facts then presented, as of the date the letter is issued.

(4)(a)  Members of the health care community who seek antitrust guidance may request a review of their proposed business activity by the Attorney General's office. In conducting its review, the Attorney General's office may seek whatever documentation, data, or other material it deems necessary from the Agency for Health Care Administration, the State Center for Health Statistics, and the Office of Insurance Regulation of the Financial Services Commission.

(b)  In order to receive an antitrust no-action letter, a member of the health care community must submit in writing to the Attorney General's office a request for an antitrust no-action letter.

(c)  The requesting parties are under an affirmative obligation to make full, true, and accurate disclosure with respect to the activities for which the antitrust no-action letter is requested. Requests relating to unnamed persons or companies may not be answered. Each request must be accompanied by all relevant material information; relevant data, including background information; complete copies of all operative documents; the provisions of law under which the request arises; and detailed statements of all collateral oral understandings, if any.

(d)  All parties requesting the antitrust no-action letter must provide the Attorney General's office with whatever additional information or documents the Attorney General's office requests for its review of the matter.

(5)  The Attorney General's office shall act on the no-action letter request within 90 days after it receives all information necessary to complete its review.

(6)  At the completion of its review of a request for an antitrust no-action letter, the Attorney General's office shall do one of the following:

(a)  Issue the antitrust no-action letter;

(b)  Decline to issue any type of letter; or

(c)  Take such other position or action as it considers appropriate.

(7)  The recipient of a no-action letter must annually file with the Attorney General's office an affidavit stating that there has been no change in the facts the recipient has presented, at which time the Attorney General may renew the no-action letter. As long as there is no change in any material fact, the Attorney General's office is estopped from bringing any action pursuant to the antitrust laws concerning any specific conduct that is the subject of the no-action letter. Further, the no-action letter, if it meets the requirements of the Florida Evidence Code, is admissible in any court proceeding in this state. The Attorney General's office remains free to bring an action or proceeding based on a different set of facts presented.

(8)  The Agency for Health Care Administration shall coordinate all existing data received, such as the hospital patient discharge database, ambulatory patient database, ambulatory facilities' financial data, health facility licensure and certification tracking system, health facility plans and construction data, local health council data, Medicaid data, provider claims data, psychiatric hospital discharge data, pharmaceutical data, licensure data of health maintenance organizations, licensure data of health insurers, health care practitioner licensure data, hospital financial database, health facility utilization and projected need data, nursing home financial database, nursing home patient database, and joint venture database. This information shall be made available to the Attorney General's office, as needed.

(9)  When the member of the health care community seeking the no-action letter is regulated by the Office of Insurance Regulation, the office shall make available to the Attorney General's office, as needed, any information it maintains in its regulatory capacity.

History.--s. 12, ch. 96-223; s. 98, ch. 97-261; s. 437, ch. 2003-261.

Note.--Former s. 455.277.

408.185  Information submitted for review of antitrust issues; confidentiality.--The following information held by the Office of the Attorney General, which is submitted by a member of the health care community pursuant to a request for an antitrust no-action letter shall be confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution for 1 year after the date of submission.

(1)  Documents that reveal trade secrets as defined in s. 688.002.

(2)  Preferred provider organization contracts.

(3)  Health maintenance organization contracts.

(4)  Documents that reveal a health care provider's marketing plan.

(5)  Proprietary confidential business information as defined in s. 364.183(3).

History.--s. 1, ch. 96-373; s. 99, ch. 97-261; s. 1, ch. 2001-72.

Note.--Former s. 455.2775.

408.20  Assessments; Health Care Trust Fund.--

(1)  The data collection and analysis activities of the agency shall be financed, in part, by an assessment on:

(a)  Hospitals in an amount to be determined annually by the agency, but not to exceed 0.04 percent of the gross operating expenses of each hospital for the provision of hospital services for its last fiscal year. Every new hospital shall pay its initial assessment upon being licensed by the state and shall base its assessment payment during the first year of operation upon its projections for gross operating expenses for that year. Each hospital under new ownership shall pay its initial assessment for the first year of operation under new ownership based on its gross operating expenses for the last fiscal year under previous ownership. The assessments shall be levied and collected quarterly.

(b)  Nursing homes in an amount set by the agency to cover the agency's approved budget. The agency shall calculate the amount to be collected per bed, rounded to the nearest whole dollar. All assessments collected under this section which are due after the date of notification by the agency shall be at a rate sufficient to cover the agency's approved budget. Assessments shall be levied and collected annually by the agency. Each new nursing home shall pay its initial assessment upon being licensed, and each nursing home under new ownership shall pay its initial assessment under the new ownership based on its number of beds.

(2)  All moneys collected are to be deposited into the Health Care Trust Fund created pursuant to s. 408.16.

(3)  Any amounts raised by the collection of assessments provided for in this section which are not required to meet appropriations in the budget act for the current fiscal year shall be available to the agency in succeeding years.

(4)  Hospitals operated by the Department of Children and Family Services, the Department of Health, or the Department of Corrections are exempt from the assessments required under this section.

History.--s. 78, ch. 92-33; s. 34, ch. 96-418; s. 174, ch. 98-166; s. 178, ch. 99-8.

408.301  Legislative findings.--The Legislature has found that access to quality, affordable, health care for all Floridians is an important goal for the state. The Legislature recognizes that there are Floridians with special health care and social needs which require particular attention. The people served by the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs are examples of citizens with special needs. The Legislature further recognizes that the Medicaid program is an intricate part of the service delivery system for the special needs citizens. However, the Agency for Health Care Administration is not a service provider and does not develop or direct programs for the special needs citizens. Therefore, it is the intent of the Legislature that the Agency for Health Care Administration work closely with the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs in developing plans for assuring access to all Floridians in order to assure that the needs of special citizens are met.

History.--s. 18, ch. 93-129; s. 179, ch. 99-8; s. 13, ch. 2000-209; s. 83, ch. 2004-267.

408.302  Interagency agreement.--

(1)  The Agency for Health Care Administration shall enter into an interagency agreement with the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs to assure coordination and cooperation in serving special needs citizens. The agreement shall include the requirement that the secretaries or directors of the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs approve, prior to adoption, any rule developed by the Agency for Health Care Administration where such rule has a direct impact on the mission of the respective state agencies, their programs, or their budgets.

(2)  For rules which indirectly impact on the mission of the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs, their programs, or their budgets, the concurrence of the respective secretaries or directors on the rule is required.

(3)  For all other rules developed by the Agency for Health Care Administration, coordination with the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs is encouraged.

(4)  The interagency agreement shall also include any other provisions necessary to ensure a continued cooperative working relationship between the Agency for Health Care Administration and the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs as each strives to meet the needs of the citizens of Florida.

History.--s. 19, ch. 93-129; s. 180, ch. 99-8; s. 84, ch. 2004-267.

408.40  Public Counsel.--

(1)  Notwithstanding any other provisions of this chapter, the Public Counsel shall represent the public in any proceeding before the agency or its advisory panels in any administrative hearing conducted pursuant to chapter 120 or before any other state and federal agencies and courts in any issue before the agency, any court, or any agency. With respect to any such proceeding, the Public Counsel is subject to the provisions of and may use the powers granted to him or her by ss. 350.061-350.0614.

(2)  The Public Counsel shall:

(a)  Recommend to the agency, by petition, the commencement of any proceeding or action or to appear, in the name of the state or its citizens, in any proceeding or action before the agency and urge therein any position that he or she deems to be in the public interest, whether consistent or inconsistent with positions previously adopted by the agency, and use therein all forms of discovery available to attorneys in civil actions generally, subject to protective orders of the agency, which shall be reviewable by summary procedure in the circuit courts of this state.

(b)  Have access to and use of all files, records, and data of the agency available to any other attorney representing parties in a proceeding before the agency.

(c)  In any proceeding in which he or she has participated as a party, seek review of any determination, finding, or order of the agency, or of any administrative law judge, or any hearing officer or hearing examiner designated by the agency, in the name of the state or its citizens.

(d)  Prepare and issue reports, recommendations, and proposed orders to the agency, the Governor, and the Legislature on any matter or subject within the jurisdiction of the agency, and to make such recommendations as he or she deems appropriate for legislation relative to agency procedures, rules, jurisdiction, personnel, and functions.

(e)  Appear before other state agencies, federal agencies, and state and federal courts in connection with matters under the jurisdiction of the agency, in the name of the state or its citizens.

History.--s. 80, ch. 92-33; s. 192, ch. 96-410; s. 1017, ch. 97-103; s. 16, ch. 98-89.

408.50  Prospective payment arrangements.--

(1)  Hospitals as defined in s. 395.002, and health insurers regulated pursuant to parts VI and VII of chapter 627, shall establish prospective payment arrangements that provide hospitals with financial incentives to contain costs. Each hospital shall enter into a rate agreement with each health insurer which represents 10 percent or more of the private-pay patients of the hospital to establish a prospective payment arrangement. Hospitals and health insurers regulated pursuant to this section shall report annually the results of each specific prospective payment arrangement adopted by each hospital and health insurer to the board. The agency shall report a health insurer's failure to comply to the Office of Insurance Regulation of the Financial Services Commission, which shall take into account the failure by the health insurer to comply in conjunction with its approval authority under s. 627.410. The agency shall adopt any rules necessary to carry out its responsibilities required by this section.

(2)  The prospective payment system established pursuant to this section shall include, at a minimum, the following elements:

(a)  A maximum allowable payment amount established for individual hospital products, services, patient diagnoses, patient day, patient admission, or per insured, or any combination thereof, which is preset at the beginning of the budget year of the hospital and fixed for the entirety of that budget year, except when extenuating and unusual circumstances acceptable to the department warrant renegotiation.

(b)  Timely payment to the hospital by the insurer or the insured, or both, of the maximum allowable payment amount, as so negotiated by the insurer or group of insurers.

(c)  Acceptance by the hospital of the maximum payment amount as payment in full, which shall include any deductible or coinsurance provided for in the insurer's benefit plan.

(d)  Utilization reviews for appropriateness of treatment.

(e)  Preadmission screening of nonemergency admissions.

(3)  Nothing contained in this section prohibits the inclusion of deductibles, coinsurance, or other cost containment provisions in any health insurance policy.

History.--s. 81, ch. 92-33; s. 438, ch. 2003-261.

408.70  Health care; managed competition; legislative findings and intent.--

(1)  The Legislature finds that the current health care system in this state does not provide access to affordable health care for all persons in this state. Almost one in five persons is without health insurance. For many, entry into the health care system is through a hospital emergency room rather than a primary care setting. The availability of preventive and primary care and managed, family-based care is limited. Health insurance underwriting practices have led to the avoidance, rather than to the sharing, of insurance risks, limiting access to coverages for small-sized employer groups and high-risk populations. Spiraling premium costs have placed health insurance policies out of the reach of many small-sized and medium-sized businesses and their employees. Lack of outcome and cost information has forced individuals and businesses to make critical health care decisions with little guidance or leverage. Health care resources have not been allocated efficiently, leading to excess and unevenly distributed capacity. These factors have contributed to the high cost of health care. Rural and other medically underserved areas have too few health care resources. Comprehensive, first-dollar coverages have allowed individuals to seek care without regard to cost. Provider competition and liability concerns have led to a medical technology arms race. Rather than competing on the basis of price and patient outcome, health care providers compete for patients on the basis of service, equipping themselves with the latest and best technologies. Managed-care and group-purchasing mechanisms are not widely available to small group purchasers. Health care regulation has placed undue burdens on health care insurers and providers, driving up costs, limiting competition, and preventing market-based solutions to cost and quality problems. Health care costs have been increasing at several times the rate of general inflation, eroding employer profits and investments, increasing government revenue requirements, reducing consumer coverages and purchasing power, and limiting public investments in other vital governmental services.

(2)  It is the intent of the Legislature that a structured health care competition model, known as "managed competition," be implemented throughout the state to improve the efficiency of the health care markets in this state. The managed competition model will promote the pooling of purchaser and consumer buying power; ensure informed cost-conscious consumer choice of managed care plans; reward providers for high-quality, economical care; increase access to care for uninsured persons; and control the rate of inflation in health care costs.

History.--s. 66, ch. 93-129; s. 60, ch. 2000-256; s. 11, ch. 2000-296.

408.7056  Subscriber Assistance Program.--

(1)  As used in this section, the term:

(a)  "Agency" means the Agency for Health Care Administration.

(b)  "Department" means the Department of Financial Services.

(c)  "Grievance procedure" means an established set of rules that specify a process for appeal of an organizational decision.

(d)  "Health care provider" or "provider" means a state-licensed or state-authorized facility, a facility principally supported by a local government or by funds from a charitable organization that holds a current exemption from federal income tax under s. 501(c)(3) of the Internal Revenue Code, a licensed practitioner, a county health department established under part I of chapter 154, a prescribed pediatric extended care center defined in s. 400.902, a federally supported primary care program such as a migrant health center or a community health center authorized under s. 329 or s. 330 of the United States Public Health Services Act that delivers health care services to individuals, or a community facility that receives funds from the state under the Community Alcohol, Drug Abuse, and Mental Health Services Act and provides mental health services to individuals.

(e)  "Managed care entity" means a health maintenance organization or a prepaid health clinic certified under chapter 641, a prepaid health plan authorized under s. 409.912, or an exclusive provider organization certified under s. 627.6472.

(f)  "Office" means the Office of Insurance Regulation of the Financial Services Commission.

(g)  "Panel" means a subscriber assistance panel selected as provided in subsection (11).

(2)  The agency shall adopt and implement a program to provide assistance to subscribers, including those whose grievances are not resolved by the managed care entity to the satisfaction of the subscriber. The program shall consist of one or more panels that meet as often as necessary to timely review, consider, and hear grievances and recommend to the agency or the office any actions that should be taken concerning individual cases heard by the panel. The panel shall hear every grievance filed by subscribers on behalf of subscribers, unless the grievance:

(a)  Relates to a managed care entity's refusal to accept a provider into its network of providers;

(b)  Is part of an internal grievance in a Medicare managed care entity or a reconsideration appeal through the Medicare appeals process which does not involve a quality of care issue;

(c)  Is related to a health plan not regulated by the state such as an administrative services organization, third-party administrator, or federal employee health benefit program;

(d)  Is related to appeals by in-plan suppliers and providers, unless related to quality of care provided by the plan;

(e)  Is part of a Medicaid fair hearing pursued under 42 C.F.R. ss. 431.220 et seq.;

(f)  Is the basis for an action pending in state or federal court;

(g)  Is related to an appeal by nonparticipating providers, unless related to the quality of care provided to a subscriber by the managed care entity and the provider is involved in the care provided to the subscriber;

(h)  Was filed before the subscriber completed the entire internal grievance procedure of the managed care entity, the managed care entity has complied with its timeframes for completing the internal grievance procedure, and the circumstances described in subsection (6) do not apply;

(i)  Has been resolved to the satisfaction of the subscriber who filed the grievance, unless the managed care entity's initial action is egregious or may be indicative of a pattern of inappropriate behavior;

(j)  Is limited to seeking damages for pain and suffering, lost wages, or other incidental expenses, including accrued interest on unpaid balances, court costs, and transportation costs associated with a grievance procedure;

(k)  Is limited to issues involving conduct of a health care provider or facility, staff member, or employee of a managed care entity which constitute grounds for disciplinary action by the appropriate professional licensing board and is not indicative of a pattern of inappropriate behavior, and the agency, office, or department has reported these grievances to the appropriate professional licensing board or to the health facility regulation section of the agency for possible investigation; or

(l)  Is withdrawn by the subscriber. Failure of the subscriber to attend the hearing shall be considered a withdrawal of the grievance.

(3)  The agency shall review all grievances within 60 days after receipt and make a determination whether the grievance shall be heard. Once the agency notifies the panel, the subscriber, and the managed care entity that a grievance will be heard by the panel, the panel shall hear the grievance either in the network area or by teleconference no later than 120 days after the date the grievance was filed. The agency shall notify the parties, in writing, by facsimile transmission, or by phone, of the time and place of the hearing. The panel may take testimony under oath, request certified copies of documents, and take similar actions to collect information and documentation that will assist the panel in making findings of fact and a recommendation. The panel shall issue a written recommendation, supported by findings of fact, to the subscriber, to the managed care entity, and to the agency or the office no later than 15 working days after hearing the grievance. If at the hearing the panel requests additional documentation or additional records, the time for issuing a recommendation is tolled until the information or documentation requested has been provided to the panel. The proceedings of the panel are not subject to chapter 120.

(4)  If, upon receiving a proper patient authorization along with a properly filed grievance, the agency requests records from a health care provider or managed care entity, the health care provider or managed care entity that has custody of the records has 10 days to provide the records to the agency. Records include medical records, communication logs associated with the grievance both to and from the subscriber, and contracts. Failure to provide requested records may result in the imposition of a fine of up to $500. Each day that records are not produced is considered a separate violation.

(5)  Grievances that the agency determines pose an immediate and serious threat to a subscriber's health must be given priority over other grievances. The panel may meet at the call of the chair to hear the grievances as quickly as possible but no later than 45 days after the date the grievance is filed, unless the panel receives a waiver of the time requirement from the subscriber. The panel shall issue a written recommendation, supported by findings of fact, to the office or the agency within 10 days after hearing the expedited grievance.

(6)  When the agency determines that the life of a subscriber is in imminent and emergent jeopardy, the chair of the panel may convene an emergency hearing, within 24 hours after notification to the managed care entity and to the subscriber, to hear the grievance. The grievance must be heard notwithstanding that the subscriber has not completed the internal grievance procedure of the managed care entity. The panel shall, upon hearing the grievance, issue a written emergency recommendation, supported by findings of fact, to the managed care entity, to the subscriber, and to the agency or the office for the purpose of deferring the imminent and emergent jeopardy to the subscriber's life. Within 24 hours after receipt of the panel's emergency recommendation, the agency or office may issue an emergency order to the managed care entity. An emergency order remains in force until:

(a)  The grievance has been resolved by the managed care entity;

(b)  Medical intervention is no longer necessary; or

(c)  The panel has conducted a full hearing under subsection (3) and issued a recommendation to the agency or the office, and the agency or office has issued a final order.

(7)  After hearing a grievance, the panel shall make a recommendation to the agency or the office which may include specific actions the managed care entity must take to comply with state laws or rules regulating managed care entities.

(8)  A managed care entity, subscriber, or provider that is affected by a panel recommendation may within 10 days after receipt of the panel's recommendation, or 72 hours after receipt of a recommendation in an expedited grievance, furnish to the agency or office written evidence in opposition to the recommendation or findings of fact of the panel.

(9)  No later than 30 days after the issuance of the panel's recommendation and, for an expedited grievance, no later than 10 days after the issuance of the panel's recommendation, the agency or the office may adopt the panel's recommendation or findings of fact in a proposed order or an emergency order, as provided in chapter 120, which it shall issue to the managed care entity. The agency or office may issue a proposed order or an emergency order, as provided in chapter 120, imposing fines or sanctions, including those contained in ss. 641.25 and 641.52. The agency or the office may reject all or part of the panel's recommendation. All fines collected under this subsection must be deposited into the Health Care Trust Fund.

(10)  In determining any fine or sanction to be imposed, the agency and the office may consider the following factors:

(a)  The severity of the noncompliance, including the probability that death or serious harm to the health or safety of the subscriber will result or has resulted, the severity of the actual or potential harm, and the extent to which provisions of chapter 641 were violated.

(b)  Actions taken by the managed care entity to resolve or remedy any quality-of-care grievance.

(c)  Any previous incidents of noncompliance by the managed care entity.

(d)  Any other relevant factors the agency or office considers appropriate in a particular grievance.

(11)(a)  The panel shall consist of the Insurance Consumer Advocate, or designee thereof, established by s. 627.0613; at least two members employed by the agency and at least two members employed by the department, chosen by their respective agencies; a consumer appointed by the Governor; a physician appointed by the Governor, as a standing member; and, if necessary, physicians who have expertise relevant to the case to be heard, on a rotating basis. The agency may contract with a medical director, a primary care physician, or both, who shall provide additional technical expertise to the panel but shall not be voting members of the panel. The medical director shall be selected from a health maintenance organization with a current certificate of authority to operate in Florida.

(b)  A majority of those panel members required under paragraph (a) shall constitute a quorum for any meeting or hearing of the panel. A grievance may not be heard or voted upon at any panel meeting or hearing unless a quorum is present, except that a minority of the panel may adjourn a meeting or hearing until a quorum is present. A panel convened for the purpose of hearing a subscriber's grievance in accordance with subsections (2) and (3) shall not consist of more than 11 members.

(12)  Every managed care entity shall submit a quarterly report to the agency, the office, and the department listing the number and the nature of all subscribers' and providers' grievances which have not been resolved to the satisfaction of the subscriber or provider after the subscriber or provider follows the entire internal grievance procedure of the managed care entity. The agency shall notify all subscribers and providers included in the quarterly reports of their right to file an unresolved grievance with the panel.

(13)  A proposed order issued by the agency or office which only requires the managed care entity to take a specific action under subsection (7) is subject to a summary hearing in accordance with s. 120.574, unless all of the parties agree otherwise. If the managed care entity does not prevail at the hearing, the managed care entity must pay reasonable costs and attorney's fees of the agency or the office incurred in that proceeding.

(14)(a)  Any information that identifies a subscriber which is held by the panel, agency, or department pursuant to this section is confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. However, at the request of a subscriber or managed care entity involved in a grievance procedure, the panel, agency, or department shall release information identifying the subscriber involved in the grievance procedure to the requesting subscriber or managed care entity.

(b)  Meetings of the panel shall be open to the public unless the provider or subscriber whose grievance will be heard requests a closed meeting or the agency or the department determines that information which discloses the subscriber's medical treatment or history or information relating to internal risk management programs as defined in s. 641.55(5)(c), (6), and (8) may be revealed at the panel meeting, in which case that portion of the meeting during which a subscriber's medical treatment or history or internal risk management program information is discussed shall be exempt from the provisions of s. 286.011 and s. 24(b), Art. I of the State Constitution. All closed meetings shall be recorded by a certified court reporter.

History.--ss. 1, 32, 47, ch. 85-177; s. 15, ch. 88-388; ss. 123, 187, 188, ch. 91-108; s. 4, ch. 91-429; s. 76, ch. 93-129; s. 23, ch. 95-398; s. 3, ch. 96-199; s. 250, ch. 96-406; s. 24, ch. 96-418; s. 1, ch. 98-10; s. 1, ch. 98-256; s. 2, ch. 99-393; s. 34, ch. 2000-256; s. 1, ch. 2000-296; s. 1, ch. 2003-105; s. 439, ch. 2003-261; s. 13, ch. 2004-297.

Note.--Former s. 641.311; (4) former s. 119.07(3)(s).

408.7057  Statewide provider and health plan claim dispute resolution program.--

(1)  As used in this section, the term:

(a)  "Agency" means the Agency for Health Care Administration.

(b)  "Health plan" means a health maintenance organization or a prepaid health clinic certified under chapter 641, a prepaid health plan authorized under s. 409.912, an exclusive provider organization certified under s. 627.6472, or a major medical expense health insurance policy, as defined in s. 627.643(2)(e), offered by a group or an individual health insurer licensed pursuant to chapter 624, including a preferred provider organization under s. 627.6471.

(c)  "Resolution organization" means a qualified independent third-party claim-dispute-resolution entity selected by and contracted with the Agency for Health Care Administration.

(2)(a)  The agency shall establish a program by January 1, 2001, to provide assistance to contracted and noncontracted providers and health plans for resolution of claim disputes that are not resolved by the provider and the health plan. The agency shall contract with a resolution organization to timely review and consider claim disputes submitted by providers and health plans and recommend to the agency an appropriate resolution of those disputes. The agency shall establish by rule jurisdictional amounts and methods of aggregation for claim disputes that may be considered by the resolution organization.

(b)  The resolution organization shall review claim disputes filed by contracted and noncontracted providers and health plans unless the disputed claim:

1.  Is related to interest payment;

2.  Does not meet the jurisdictional amounts or the methods of aggregation established by agency rule, as provided in paragraph (a);

3.  Is part of an internal grievance in a Medicare managed care organization or a reconsideration appeal through the Medicare appeals process;

4.  Is related to a health plan that is not regulated by the state;

5.  Is part of a Medicaid fair hearing pursued under 42 C.F.R. ss. 431.220 et seq.;

6.  Is the basis for an action pending in state or federal court; or

7.  Is subject to a binding claim-dispute-resolution process provided by contract entered into prior to October 1, 2000, between the provider and the managed care organization.

(c)  Contracts entered into or renewed on or after October 1, 2000, may require exhaustion of an internal dispute-resolution process as a prerequisite to the submission of a claim by a provider or a health plan to the resolution organization.

(d)  A contracted or noncontracted provider or health plan may not file a claim dispute with the resolution organization more than 12 months after a final determination has been made on a claim by a health plan or provider.

(e)  The resolution organization shall require the health plan or provider submitting the claim dispute to submit any supporting documentation to the resolution organization within 15 days after receipt by the health plan or provider of a request from the resolution organization for documentation in support of the claim dispute. The resolution organization may extend the time if appropriate. Failure to submit the supporting documentation within such time period shall result in the dismissal of the submitted claim dispute.

(f)  The resolution organization shall require the respondent in the claim dispute to submit all documentation in support of its position within 15 days after receiving a request from the resolution organization for supporting documentation. The resolution organization may extend the time if appropriate. Failure to submit the supporting documentation within such time period shall result in a default against the health plan or provider. In the event of such a default, the resolution organization shall issue its written recommendation to the agency that a default be entered against the defaulting entity. The written recommendation shall include a recommendation to the agency that the defaulting entity shall pay the entity submitting the claim dispute the full amount of the claim dispute, plus all accrued interest, and shall be considered a nonprevailing party for the purposes of this section.

(g)1.  If on an ongoing basis during the preceding 12 months, the agency has reason to believe that a pattern of noncompliance with s. 627.6131 and s. 641.3155 exists on the part of a particular health plan or provider, the agency shall evaluate the information contained in these cases to determine whether the information evidences a pattern and report its findings, together with substantiating evidence, to the appropriate licensure or certification entity for the health plan or provider.

2.  In addition, the agency shall prepare a report to the Governor and the Legislature by February 1 of each year, enumerating: claims dismissed; defaults issued; and failures to comply with agency final orders issued under this section.

(3)  The agency shall adopt rules to establish a process to be used by the resolution organization in considering claim disputes submitted by a provider or health plan which must include the issuance by the resolution organization of a written recommendation, supported by findings of fact, to the agency within 60 days after the requested information is received by the resolution organization within the timeframes specified by the resolution organization. In no event shall the review time exceed 90 days following receipt of the initial claim dispute submission by the resolution organization.

(4)  Within 30 days after receipt of the recommendation of the resolution organization, the agency shall adopt the recommendation as a final order.

(5)  The agency shall notify within 7 days the appropriate licensure or certification entity whenever there is a violation of a final order issued by the agency pursuant to this section.

(6)  The entity that does not prevail in the agency's order must pay a review cost to the review organization, as determined by agency rule. Such rule must provide for an apportionment of the review fee in any case in which both parties prevail in part. If the nonprevailing party fails to pay the ordered review cost within 35 days after the agency's order, the nonpaying party is subject to a penalty of not more than $500 per day until the penalty is paid.

(7)  The agency may adopt rules to administer this section.

History.--s. 8, ch. 2000-252; s. 3, ch. 2002-389.

408.7071  Standardized claim form.--The Agency for Health Care Administration shall develop a standardized claim form to be used by insurers and health care providers licensed in this state.

History.--s. 81, ch. 93-129; s. 41, ch. 97-103; s. 60, ch. 2000-158; s. 18, ch. 2000-209.

408.831  Denial, suspension, or revocation of a license, registration, certificate, or application.--

(1)  In addition to any other remedies provided by law, the agency may deny each application or suspend or revoke each license, registration, or certificate of entities regulated or licensed by it:

(a)  If the applicant, licensee, registrant, or certificateholder, or, in the case of a corporation, partnership, or other business entity, if any officer, director, agent, or managing employee of that business entity or any affiliated person, partner, or shareholder having an ownership interest equal to 5 percent or greater in that business entity, has failed to pay all outstanding fines, liens, or overpayments assessed by final order of the agency or final order of the Centers for Medicare and Medicaid Services, not subject to further appeal, unless a repayment plan is approved by the agency; or

(b)  For failure to comply with any repayment plan.

(2)  In reviewing any application requesting a change of ownership or change of the licensee, registrant, or certificateholder, the transferor shall, prior to agency approval of the change, repay or make arrangements to repay any amounts owed to the agency. Should the transferor fail to repay or make arrangements to repay the amounts owed to the agency, the issuance of a license, registration, or certificate to the transferee shall be delayed until repayment or until arrangements for repayment are made.

(3)  This section provides standards of enforcement applicable to all entities licensed or regulated by the Agency for Health Care Administration. This section controls over any conflicting provisions of chapters 39, 381, 383, 390, 391, 393, 394, 395, 400, 408, 468, 483, and 641 or rules adopted pursuant to those chapters.

History.--s. 12, ch. 2002-400; s. 32, ch. 2003-57.

408.90  Legislative findings and intent.--The Legislature finds that 2.5 million Floridians do not have access to health insurance coverage, often because the premiums are unaffordable. It is the intent of the Legislature to provide a state health insurance program for those people who are without health insurance so that they may have access to preventive and primary care services. The state health insurance program shall offer basic, affordable health care services to those Floridians who have not had access to the private health insurance market. The Legislature intends that the state program shall target the uninsured and not those who currently have private health insurance coverage.

History.--s. 37, ch. 93-129.

408.901  Definitions; ss. 408.901-408.908.--As used in ss. 408.901-408.908, except as otherwise specifically provided, the term:

(1)  "Agency" means the Agency for Health Care Administration.

(2)  "Agent" means a person who is licensed to sell health insurance in this state pursuant to chapter 626.

(3)  "Applicant" means a person who provides a written application to the agency for enrollment in the MedAccess program but whose application has not received final action.

(4)  "Eligible person" means any person who meets the residency requirements of ss. 408.901-408.908.

(5)  "Employer" means the state, its political subdivisions, any individual, partnership, association, corporation, or business trust, or any person or group of persons, acting in the interest of any employer in relation to an employee.

(6)  "Fund" means the Licensure Fees Trust Fund.

(7)  "Health services" means a set of basic health services covered by the MedAccess Program.

(8)  "Member" means a Florida resident who has enrolled in the MedAccess program provided in ss. 408.901-408.908.

(9)  "Participating provider" means any person who has a current provider agreement with the agency and who is authorized to furnish covered health services pursuant to ss. 408.901-408.908. The agency shall integrate county health departments, federally funded primary care centers, and other outpatient clinics as participating providers in the health insurance program.

(10)  "Premium" means the consideration paid or to be paid to the agency for the issuance of health insurance coverage provided by the MedAccess program.

(11)  "MedAccess" means the state health program created pursuant to ss. 408.901-408.908.

History.--s. 38, ch. 93-129; s. 109, ch. 97-101.

408.902  MedAccess program; creation; program title.--

(1)  Effective July 1, 1994, there is hereby created the MedAccess program to be administered by the Agency for Health Care Administration. The MedAccess program shall not be subject to the requirements of the Office of Insurance Regulation of the Financial Services Commission or chapter 627. The secretary of the agency shall appoint an administrator of the MedAccess program.

(2)  If the necessary federal waivers are obtained and state and federal funds are available to establish a Medicaid buy-in program pursuant to s. 409.914, the MedAccess program shall remain available to those members who do not qualify for enrollment or who do not choose to enroll in the Medicaid buy-in program.

History.--s. 39, ch. 93-129; s. 17, ch. 2000-305; s. 440, ch. 2003-261.

408.903  Eligibility.--

(1)  Every resident of this state who has a gross family income that is equal to or below 250 percent of the federal poverty level and who meets the requirements of this section is eligible to enroll in the MedAccess program. For purposes of ss. 408.901-408.908, a resident is defined as a person who has established a domicile in the state for a period of at least 6 months. As used in this section, the term "resident" shall mean United States citizens or United States legal permanent residents.

(2)  A person or family who applies for enrollment in the MedAccess program must provide documentation that demonstrates he or she has not been covered by a health insurance policy in the 12-month period prior to the effective date of enrollment in the program.

(3)  A person or family who is currently eligible for health care benefits under Medicare or the Florida Medicaid program is not eligible for enrollment in the MedAccess program. However, a person may convert to the program upon losing eligibility either for Medicare or Medicaid or upon disenrolling from the Medicaid buy-in program established pursuant to s. 409.914.

(4)  The agency shall not use any information related to an applicant's assets in determining eligibility for the program.

(5)  Applicants for the program shall complete an application form developed by the agency and shall provide information related to the family dependents to be enrolled and supply documentation concerning family income and place of residence.

(6)  Applications for enrollment in the MedAccess program shall be submitted to the agency during a single month-long open enrollment period each year. The agency shall review all completed applications within 45 days of receipt. Applicants who satisfy the eligibility criteria and have paid their initial premium shall be notified by the agency of the effective date of coverage.

(7)  The agency may request verification of continued eligibility from members once every 12 months.

(8)  The program may disenroll any member due to failure to meet eligibility criteria, nonpayment of premium, or good cause.

(9)  Enrollment in the MedAccess program is subject to eligibility and fiscal limitations and shall be renewed annually.

(10)  If the Agency for Health Care Administration obtains the necessary federal waivers to implement a Medicaid buy-in program, members of the MedAccess program who qualify shall be entitled to transfer their enrollment to the Medicaid buy-in program.

History.--s. 41, ch. 93-129.

408.904  Benefits.--

(1)  Every eligible person who enrolls in the MedAccess program is entitled to receive benefits for any covered service furnished within this state by a participating provider.

(2)  Covered health services include:

(a)  Physician services. Those services delivered by a physician licensed under chapter 458, chapter 459, chapter 460, chapter 461, or chapter 463 that are medically necessary for the treatment of an injury, illness, or disease. Physician services shall not include those services that are clinically unproven, experimental, or purely for cosmetic purposes. Each member is limited to 12 physician visits per calendar year, excluding those visits related to annual or periodic physical examinations for wellness pursuant to paragraph (g) or for immunizations.

(b)  Hospital inpatient services. Those services provided for the treatment of a member who is admitted as an inpatient by a licensed physician or dentist to a hospital licensed under part I of chapter 395 up to a limit of 10 days per calendar year per member.

(c)  Hospital outpatient services. Those services provided to a member in the outpatient portion of a hospital licensed under part I of chapter 395, up to a limit of $1,500 per calendar year per member, that are preventive, diagnostic, therapeutic, or palliative.

(d)  Laboratory services. Professional laboratory services ordered by a licensed physician or other licensed practitioner of the healing arts and provided in a laboratory that meets the requirements for Medicare participation and is licensed under chapter 483.

(e)  X-ray services. Radiological services ordered by a licensed physician or other licensed practitioner of the healing arts and that are provided by a licensed professional.

(f)  Family planning services. Drugs and supplies that will enable a member to plan family size.

(g)  Health appraisals, including physician examinations and related tests. Routine annual physical examinations conducted by or under the direction of a licensed physician, without regard to medical necessity, in order to detect disease, disability, or other physical or mental conditions. These services include well-baby and well-child screening and diagnostic services provided on a periodic basis to members under the age of 21.

(h)  Immunizations.

(i)  Advanced registered nurse practitioner services.

(j)  Outpatient mental health visits and substance abuse treatment. Outpatient mental health visits provided by community mental health centers as provided in chapter 394 and by a mental health therapist licensed under chapter 490 or chapter 491 and substance abuse treatment provided by a center licensed under chapter 397, up to a total of five visits per calendar year per member.

(3)  Covered health services do not include any of the following:

(a)  Surgery solely for cosmetic purposes.

(b)  Prescribed drugs.

(c)  Nursing home services.

(d)  Medical examinations conducted and medical reports prepared for either purchasing or renewing life insurance or participating as a plaintiff or defendant in a civil action for the recovery or settlement of damages.

(e)  Clinically unproven or experimental procedures.

History.--s. 42, ch. 93-129; s. 48, ch. 2000-153; s. 18, ch. 2000-256.

408.905  Limitations and exclusions.--

(1)  The MedAccess program shall not cover benefits that are provided as part of workers' compensation insurance.

(2)  The MedAccess program shall exclude coverage for preexisting conditions, except pregnancy, during a period of 12 months following the effective date of coverage as long as:

(a)  The condition manifested itself within a period of 6 months before the effective date of coverage; or

(b)  Medical advice or treatment was recommended or received within 6 months before the effective date of coverage.

(3)  In addition to the limitations otherwise provided in ss. 408.901-408.908, the MedAccess program shall not include coverage for outpatient prescription drugs, eyeglasses, dental services, custodial care, or emergency services for nonemergent conditions.

(4)  Any member of the MedAccess program who is determined to be at "high risk" by a participating primary care provider shall, upon renewal, agree to be placed in a case management system when it is determined by the program to be in the best interest of the member and the MedAccess program.

(5)  No person on whose behalf the program has paid out $500,000 in covered benefits is eligible for continued coverage in the MedAccess program.

History.--s. 43, ch. 93-129.

408.906  Payment of claims.--

(1)  The agency is designated as the single state agency authorized to make payments for health services covered under the MedAccess program. These payments shall be made only for services included in the MedAccess program and shall be made only on behalf of eligible members in accordance with the provisions of ss. 408.901-408.908.

(2)  The agency shall pay claims for covered health services provided to members at the same reimbursement rates and fees that are provided under the Florida Medicaid program, pursuant to s. 409.908.

History.--s. 44, ch. 93-129.

408.907  Collection of premiums.--

(1)  Premiums collected from members or from employers on behalf of members shall be made in accordance with rules adopted by the agency.

(2)  Premiums collected shall be deposited in the Licensure Fees Trust Fund of the agency. Moneys in this fund shall be used solely for the administration of the MedAccess program.

(3)  Employers are encouraged to participate in the payment of all or a portion of their employees' premium obligation. The agency is authorized to offer discounts to the premium obligation to those employers who pay at least 50 percent of the premium and who collect the premium from the employees on behalf of the agency.

(4)  The agency is authorized to contract with agents who may refer individuals to the MedAccess program and may pay those agents a modest referral fee if the individual's application is accepted for enrollment in the MedAccess program.

(5)  The agency is directed to develop strategies for marketing MedAccess to increase public awareness about the state program.

History.--s. 45, ch. 93-129.

408.908  Administration.--The agency shall be responsible for:

(1)  Developing a network of health care providers for providing managed health care services on a statewide basis.

(2)  Performing all eligibility and administrative claims payment functions relating to the program.

(3)  Evaluating the eligibility of each claim for payment under the program.

(4)  Establishing a premium billing procedure for the collection of premiums from insured persons.

(5)  Developing a schedule of copayments and deductibles that will encourage the use of preventive and primary care services, will deter members from overutilizing services, and will discourage the use of expensive, technology-driven services.

(6)  Marketing the MedAccess program.

(7)  Providing that the direct and indirect expenses of the program are fully covered by the collection of premiums from members of the MedAccess program.

(8)  Establishing policy and budget guidelines for the MedAccess program.

(9)  Adopting rules to carry out the provisions of ss. 408.901-408.908.

(10)  Implementing and administering the MedAccess program.

(11)  Providing to the public and to health care providers information concerning the MedAccess program.

(12)  Ensuring that the quality of service provided under the MedAccess program meets the standards of the community.

(13)  Identifying and eliminating health care providers who engage in fraudulent or abusive activities related to the MedAccess program.

(14)  Evaluating the adequacy of the services covered by the MedAccess program, the accessibility of the program to the uninsured, and the effectiveness of the MedAccess program in reducing the number of uninsured persons in the state.

History.--s. 46, ch. 93-129.

408.909  Health flex plans.--

(1)  INTENT.--The Legislature finds that a significant proportion of the residents of this state are unable to obtain affordable health insurance coverage. Therefore, it is the intent of the Legislature to expand the availability of health care options for low-income uninsured state residents by encouraging health insurers, health maintenance organizations, health-care-provider-sponsored organizations, local governments, health care districts, or other public or private community-based organizations to develop alternative approaches to traditional health insurance which emphasize coverage for basic and preventive health care services. To the maximum extent possible, these options should be coordinated with existing governmental or community-based health services programs in a manner that is consistent with the objectives and requirements of such programs.

(2)  DEFINITIONS.--As used in this section, the term:

(a)  "Agency" means the Agency for Health Care Administration.

(b)  "Office" means the Office of Insurance Regulation of the Financial Services Commission.

(c)  "Enrollee" means an individual who has been determined to be eligible for and is receiving health care coverage under a health flex plan approved under this section.

(d)  "Health care coverage" or "health flex plan coverage" means health care services that are covered as benefits under an approved health flex plan or that are otherwise provided, either directly or through arrangements with other persons, via a health flex plan on a prepaid per capita basis or on a prepaid aggregate fixed-sum basis.

(e)  "Health flex plan" means a health plan approved under subsection (3) which guarantees payment for specified health care coverage provided to the enrollee who purchases coverage directly from the plan or through a small business purchasing arrangement sponsored by a local government.

(f)  "Health flex plan entity" means a health insurer, health maintenance organization, health-care-provider-sponsored organization, local government, health care district, other public or private community-based organization, or public-private partnership that develops and implements an approved health flex plan and is responsible for administering the health flex plan and paying all claims for health flex plan coverage by enrollees of the health flex plan.

(3)  PROGRAM.--The agency and the office shall each approve or disapprove health flex plans that provide health care coverage for eligible participants. A health flex plan may limit or exclude benefits otherwise required by law for insurers offering coverage in this state, may cap the total amount of claims paid per year per enrollee, may limit the number of enrollees, or may take any combination of those actions. A health flex plan offering may include the option of a catastrophic plan supplementing the health flex plan.

(a)  The agency shall develop guidelines for the review of applications for health flex plans and shall disapprove or withdraw approval of plans that do not meet or no longer meet minimum standards for quality of care and access to care. The agency shall ensure that the health flex plans follow standardized grievance procedures similar to those required of health maintenance organizations.

(b)  The office shall develop guidelines for the review of health flex plan applications and provide regulatory oversight of health flex plan advertisement and marketing procedures. The office shall disapprove or shall withdraw approval of plans that:

1.  Contain any ambiguous, inconsistent, or misleading provisions or any exceptions or conditions that deceptively affect or limit the benefits purported to be assumed in the general coverage provided by the health flex plan;

2.  Provide benefits that are unreasonable in relation to the premium charged or contain provisions that are unfair or inequitable or contrary to the public policy of this state, that encourage misrepresentation, or that result in unfair discrimination in sales practices; or

3.  Cannot demonstrate that the health flex plan is financially sound and that the applicant is able to underwrite or finance the health care coverage provided.

(c)  The agency and the Financial Services Commission may adopt rules as needed to administer this section.

(4)  LICENSE NOT REQUIRED.--Neither the licensing requirements of the Florida Insurance Code nor chapter 641, relating to health maintenance organizations, is applicable to a health flex plan approved under this section, unless expressly made applicable. However, for the purpose of prohibiting unfair trade practices, health flex plans are considered to be insurance subject to the applicable provisions of part IX of chapter 626, except as otherwise provided in this section.

(5)  ELIGIBILITY.--Eligibility to enroll in an approved health flex plan is limited to residents of this state who:

(a)  Are 64 years of age or younger;

(b)  Have a family income equal to or less than 200 percent of the federal poverty level;

(c)  Are eligible under a federally approved Medicaid demonstration waiver and reside in Palm Beach County or Miami-Dade County;

(d)  Are not covered by a private insurance policy and are not eligible for coverage through a public health insurance program, such as Medicare or Medicaid, unless specifically authorized under paragraph (c), or another public health care program, such as KidCare, and have not been covered at any time during the past 6 months; and

(e)  Have applied for health care coverage through an approved health flex plan and have agreed to make any payments required for participation, including periodic payments or payments due at the time health care services are provided.

(6)  RECORDS.--Each health flex plan shall maintain enrollment data and reasonable records of its losses, expenses, and claims experience and shall make those records reasonably available to enable the office to monitor and determine the financial viability of the health flex plan, as necessary. Provider networks and total enrollment by area shall be reported to the agency biannually to enable the agency to monitor access to care.

(7)  NOTICE.--The denial of coverage by a health flex plan, or the nonrenewal or cancellation of coverage, must be accompanied by the specific reasons for denial, nonrenewal, or cancellation. Notice of nonrenewal or cancellation must be provided at least 45 days in advance of the nonrenewal or cancellation, except that 10 days' written notice must be given for cancellation due to nonpayment of premiums. If the health flex plan fails to give the required notice, the health flex plan coverage must remain in effect until notice is appropriately given.

(8)  NONENTITLEMENT.--Coverage under an approved health flex plan is not an entitlement, and a cause of action does not arise against the state, a local government entity, or any other political subdivision of this state, or against the agency, for failure to make coverage available to eligible persons under this section.

(9)  PROGRAM EVALUATION.--The agency and the office shall evaluate the pilot program and its effect on the entities that seek approval as health flex plans, on the number of enrollees, and on the scope of the health care coverage offered under a health flex plan; shall provide an assessment of the health flex plans and their potential applicability in other settings; shall use health flex plans to gather more information to evaluate low-income consumer driven benefit packages; and shall, by January 1, 2005, and annually thereafter, jointly submit a report to the Governor, the President of the Senate, and the Speaker of the House of Representatives.

(10)  EXPIRATION.--This section expires July 1, 2008.

History.--s. 1, ch. 2002-389; s. 441, ch. 2003-261; s. 5, ch. 2003-405; s. 2, ch. 2004-270; s. 17, ch. 2004-297.

408.911  Short title.--Sections 408.911-408.918 may be cited as the "Florida Health and Human Services Access Act."

History.--s. 1, ch. 2002-223.

408.913  Comprehensive Health and Human Services Eligibility Access System.--

(1)  The Agency for Health Care Administration shall develop a comprehensive, automated system for access to health care services. This system shall, to the greatest extent possible, use the capacity of existing automated systems so as to maximize the benefit of investments already made in information technology and minimize additional costs.

(2)  The benefit eligibility component of the system shall include simplified access through coordination with information and referral telephone systems. This does not preclude use of other methods of application, including mail-in applications, office visits, or on-line applications via the Internet. The eligibility component of the system shall include:

(a)  Improved access to eligibility-status information.

(b)  Development and sharing of information with eligible individuals and families regarding choices available to them for using health care services.

(3)  The state agencies providing the medical, clinical, and related health care support services for special populations, including frail elders, adults with disabilities, and children with special needs shall develop systems for these populations which integrate and coordinate care and improved communication. These systems must include development of standard protocols for care planning and assessment, a focus on family involvement, and methods to communicate across systems, including automated methods, in order to improve integration and coordination of services.

History.--s. 2, ch. 2002-223.

408.914  Phased implementation plan.--The Agency for Health Care Administration, in consultation with the Health Care Access Steering Committee created in s. 408.916, shall phase in the implementation of the Comprehensive Health and Human Services Eligibility Access System.

(1)  The first phase of implementation shall be a pilot project in one or more counties to demonstrate the feasibility of integrating eligibility determination for health care services with information and referral services. The department shall, when selecting an area to be designated as a model area, give consideration to an entity that is a community care for the elderly lead agency and has developed, through a joint effort, an integrated service delivery information network.

(2)  Upon demonstration of the feasibility of the first phase of implementation, and subject to appropriation of any necessary resources, the steering committee shall develop a detailed implementation plan for the care management component of the system. The implementation plan must include the steering committee's recommendation of one or more state agencies that should be designated to implement the care management component of the system.

(3)  Options for further implementation of the system may include a phased implementation of the eligibility component in additional sites before implementing the remaining components of the system or may include implementation of the care management and service system components along with the eligibility components.

(4)  The Agency for Health Care Administration, in consultation with the steering committee, shall complete analysis of the initial pilot project by November 1, 2003, and by January 1, 2004, shall submit a plan to the Governor, the President of the Senate, and the Speaker of the House of Representatives for statewide implementation of all components of the system, if warranted. This plan must also include recommendations for incorporating additional public assistance and human services programs into the Comprehensive Health and Human Services Eligibility Access System.

History.--s. 3, ch. 2002-223.

408.915  Eligibility pilot project.--The Agency for Health Care Administration, in consultation with the steering committee established in s. 408.916, shall develop and implement a pilot project to integrate the determination of eligibility for health care services with information and referral services.

(1)  The pilot project shall operate in one or more contiguous counties, as selected by the agency in consultation with the steering committee.

(2)  The pilot project shall focus on developing, to the maximum extent possible, a process for eligibility application which:

(a)  Uses a single uniform electronic application process, but permits applying for health services through various entry points, including information and referral providers, state agency program personnel or contracted providers, the mail, or the Internet;

(b)  Is linked to a shared database that will have the capability to sort or store information by families as well as individuals;

(c)  Permits electronic input and storage of data and electronic verification and exchange of information;

(d)  Is compliant with the federal Health Insurance Portability and Accountability Act, as well as all other applicable state and federal confidentiality, financial, and insurance requirements;

(e)  Includes an initial screening component for referring applicants to other health and human services programs provided through state agencies and the Florida Healthy Kids Corporation, including programs addressing developmental delays, developmental disabilities, chronic physical illness, mental health needs, substance abuse treatment needs, elder and aging needs, and other health care needs; and

(f)  Includes the level of customer service available to applicants and participants in the pilot project.

(3)  The information and referral provider in the site selected as the pilot project shall, at a minimum:

(a)  Execute a memorandum of understanding with the local community volunteer placement centers;

(b)  Implement, or be in the process of implementing, a shared, web-based, information and eligibility database with community health providers and funders;

(c)  Provide comprehensive information and referral services 24 hours per day, 7 days per week;

(d)  Agree, in writing, to become accredited within 3 years by a nationally recognized information and referral accrediting agency;

(e)  Execute a memorandum of understanding with 911 and other emergency response agencies in the pilot area;

(f)  Implement policies and structured training to effectively respond to crisis calls or obtain accreditation by a nationally recognized mental health or crisis accrediting agency;

(g)  Obtain teletypewriter and multi-language accessibility, either on-site or through a translation service;

(h)  Develop resources to support and publicize information and referral services and provide ongoing education to the public on the availability of such services; and

(i)  Provide periodic reports to the Governor, the President of the Senate, and the Speaker of the House of Representatives on the use of the information and referral system and on measures that demonstrate the effectiveness and efficiency of the information and referral services provided.

(4)  The pilot project shall include eligibility determinations for the following programs:

(a)  Medicaid under Title XIX of the Social Security Act.

(b)  Medikids as created in s. 409.8132.

(c)  Florida Healthy Kids as described in s. 624.91 and within eligibility guidelines provided in s. 409.814.

(d)  Eligibility for Florida Kidcare services outside of the scope of Title XIX or Title XXI of the Social Security Act as provided in s. 409.814.

(e)  State and local publicly funded health and social services programs as determined appropriate by the steering committee.

(5)  If the Secretary of Health Care Administration, in consultation with the steering committee established in s. 408.916, determines that it would facilitate operation of the pilot project to obtain federal waiver authority, the appropriate state agency shall request such waiver authority from the appropriate federal agency.

History.--s. 4, ch. 2002-223.

408.916  Steering committee.--In order to guide the implementation of the pilot project, there is created a Health Care Access Steering Committee.

(1)  The steering committee shall be composed of the following members:

(a)  The Secretary of Health Care Administration.

(b)  The Secretary of Children and Family Services.

(c)  The Secretary of Elderly Affairs.

(d)  The Secretary of Health.

(e)  A representative of the Florida Alliance of Information and Referral Services.

(f)  A representative of the Florida Healthy Kids Corporation.

(2)  The steering committee may designate additional ad hoc members or technical advisors as the committee finds is appropriate.

(3)  The Secretary of Health Care Administration shall be the chairperson of the steering committee.

(4)  The steering committee shall provide oversight to the ongoing implementation of the pilot project, provide consultation and guidance on matters of policy, and provide oversight to the evaluation of the pilot project.

(5)  The steering committee shall complete its activities by June 30, 2004, and the authorization for the steering committee ends on that date.

History.--s. 5, ch. 2002-223.

408.917  Evaluation of the pilot project.--The Agency for Health Care Administration, in consultation with the steering committee, shall conduct or contract for an evaluation of the pilot project under the guidance and oversight of the steering committee. The agency shall ensure that the evaluation is submitted to the Governor and Legislature by January 1, 2004. The evaluation report must address at least the following questions:

(1)  What has been the impact of the pilot project on improving access to the process of determining eligibility?

(2)  Based on the experience of the pilot project, what is the projected cost of statewide implementation?

(3)  What has been the impact of the pilot project on the caseload trends in publicly funded programs and what is the projected impact of statewide implementation?

(4)  How has the implementation of the pilot project affected customer satisfaction with access to eligibility determination for state-funded health services?

(5)  Does the experience of the pilot project support continued expansion of the concept?

(6)  What changes or modifications to the concepts of the pilot project are recommended for future sites?

History.--s. 6, ch. 2002-223.

408.918  Florida 211 Network; uniform certification requirements.--

(1)  The Legislature authorizes the planning, development, and, subject to appropriations, the implementation of a statewide Florida 211 Network, which shall serve as the single point of coordination for information and referral for health and human services. The objectives for establishing the Florida 211 Network shall be to:

(a)  Provide comprehensive and cost-effective access to health and human services information.

(b)  Improve access to accurate information by simplifying and enhancing state and local health and human services information and referral systems and by fostering collaboration among information and referral systems.

(c)  Electronically connect local information and referral systems to each other, to service providers, and to consumers of information and referral services.

(d)  Establish and promote standards for data collection and for distributing information among state and local organizations.

(e)  Promote the use of a common dialing access code and the visibility and public awareness of the availability of information and referral services.

(f)  Provide a management and administrative structure to support the Florida 211 Network and establish technical assistance, training, and support programs for information and referral-service programs.

(g)  Test methods for integrating information and referral services with local and state health and human services programs and for consolidating and streamlining eligibility and case management processes.

(h)  Provide access to standardized, comprehensive data to assist in identifying gaps and needs in health and human services programs.

(i)  Provide a unified systems plan with a developed platform, taxonomy, and standards for data management and access.

(2)  In order to participate in the Florida 211 Network, a 211 provider must be certified by the Agency for Health Care Administration. The agency shall develop criteria for certification, as recommended by the Florida Alliance of Information and Referral Services, and shall adopt the criteria as administrative rules.

(a)  If any provider of information and referral services or other entity leases a 211 number from a local exchange company and is not certified by the agency, the agency shall, after consultation with the local exchange company and the Public Service Commission, request that the Federal Communications Commission direct the local exchange company to revoke the use of the 211 number.

(b)  The agency shall seek the assistance and guidance of the Public Service Commission and the Federal Communications Commission in resolving any disputes arising over jurisdiction related to 211 numbers.

History.--s. 7, ch. 2002-223.