The Agency is proposing to amend 59C-1.032 and 59C-1.033 to remove language regarding adult services, updates definitions and adds the collection of utilization reports. The amendments will also incorporate materials used to determine need for new ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Certificate of Need

RULE NOS.:RULE TITLES:

59C-1.032Cardiac Catheterization and Angioplasty Institutional Health Services

59C-1.033Open Heart Surgery Program

PURPOSE AND EFFECT: The Agency is proposing to amend Rules 59C-1.032 and 59C-1.033, F.A.C., to remove language regarding adult services, updates definitions and adds the collection of utilization reports. The amendments will also incorporate materials used to determine need for new pediatric services.

SUBJECT AREA TO BE ADDRESSED: The proposed amendments to these rules remove all references to adult open heart surgery programs, as these programs no longer require a certificate of need (CON) to be established, as well as removing travel standard language, need determination and other components of the adult program's CON criteria. The rule updates the definition of a pediatric patient, adds the collection of utilization reports and incorporates Medicare Severity Diagnosis Related Group coding. It also incorporates materials used to determine need for a new pediatric cardiac catheterization program and pediatric open heart surgery program.

RULEMAKING AUTHORITY: 408.034(3), (6), 408.15(8) FS.

LAW IMPLEMENTED: 408.032(17), 408.033(3)(b), 408.034(3), 408.035(1), 408.036(1)(f), 408.039(4)(a) FS.

A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: September 4, 2013, 9:00 a.m. – 10:30 a.m.

PLACE: Agency for Health Care Administration, Building #3, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida 32308

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 1 day before the workshop/meeting by contacting: Marisol Fitch at [e-mail] or at [phone]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT IS: Marisol Fitch at [e-mail] or at [phone]

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

 

59C-1.032 Cardiac Catheterization and Angioplasty Institutional Health Services.

(1) Agency Intent. This rule amendment implements the provision of Section 408.036(3)(k), F.S., which provides that a certificate of need shall not be required for an expenditure to provide an outpatient service. This rule defines the requirements for the establishment of pediatric inpatient cardiac catheterization services, including minimum requirements for staffing, equipment, and a numeric need methodology for cardiac catheterization programs. A certificate of need for the establishment of pediatric inpatient cardiac catheterization services shall not normally be approved unless the applicant meets the applicable review criteria in Section 408.035, F.S., and the standards and need determination criteria set forth in this rule. A cardiac catheterization program which is established and utilized for the purpose of serving outpatients exclusively is not regulated under this rule. A pediatric cardiac catheterization program which provides services to inpatients, regardless of the reason for their admission, including coronary angioplasty, valvuloplasty, or ablation of intracardiac bypass tracts, or pediatric cardiac catheterization, requires a certificate of need. Hospitals operating more than one hospital facility under the same hospital license in the same service planning area district, shall obtain a separate certificate of need for the establishment of a pediatric cardiac catheterization program in each health care facility.

(2) Definitions.

(a) Cardiac Catheterization. Cardiac catheterization is defined as a medical procedure requiring the passage of a catheter into one or more cardiac chambers of the left and right heart, with or without coronary arteriograms, for the purpose of diagnosing congenital or acquired cardiovascular diseases, or for determining measurement of blood pressure flow. Cardiac catheterization also includes the selective catheterization of the coronary ostia with injection of contrast medium into the coronary arteries.

(b) Coronary Angioplasty. Coronary angioplasty is defined as a hospital inpatient procedure requiring the dilation of narrowed segments of the coronary vessels, via a balloon-tipped catheter.

(c) Catheterization Program. A cardiac catheterization program is defined as an institutional health service which is provided by or on behalf of a health care facility and which consists of one or more laboratories which comprise a room or suite of rooms, and has the equipment and staff required to perform cardiac catheterization serving inpatients and outpatients. A cardiac catheterization program approved for angioplasty services, or other types of therapeutic cardiac procedures shall have the additional necessary equipment and staff to perform angioplasty procedures.

(d) Approved Program. A proposed pediatric cardiac catheterization and angioplasty program, not operational as defined by this rule, for which a certificate of need, a letter of intent to grant a certificate of need, or a final order granting a certificate of need was issued, consistent with the provisions of paragraph 59C-1.008(2)(b), F.A.C., on or before the most recent published deadline for agency initial decisions prior to publication of the fixed need pool, as specified in paragraph 59C-1.008(1)(g), F.A.C.

(e) Cardiac Catheterization Annual Program Volume. The cardiac catheterization annual program volume equals the total number of inpatient and outpatient admissions to the cardiac catheterization program, for the purpose of cardiac catheterization or angioplasty, for the 12-month period specified in paragraph (8)(c). A single admission is equivalent to one patient visit to the cardiac catheterization program. Each patient visit will be counted in determining the actual program volume regardless of whether the patient is an inpatient or outpatient at the facility performing the procedure, or has been admitted as an inpatient or outpatient at another facility.

(f) Inpatient. An inpatient is defined as a person who has been admitted to a hospital for bed occupancy for purposes of receiving inpatient hospital services. A person is considered an inpatient if he was formally admitted as an inpatient with the expectation that he would remain at least overnight and occupy a bed, even though it later develops that he can be discharged or that he is transferred to another hospital and does not actually use a hospital bed overnight. An inpatient of a hospital cannot be considered an outpatient of that or any other hospital at the same time.

(g) Outpatient. An outpatient is defined as a person who receives cardiac catheterization in a health care facility and does not meet the definition of inpatient in paragraph (e).

(h) Pediatric patient means a person under fifteen years of age. Service Planning Area. The service planning area for a cardiac catheterization program is the applicable district unless cardiac catheterization subdistricts have been defined by the respective local health council and promulgated into rule by the agency. Planning for pediatric cardiac catheterization services shall be done on a regionalized basis. Certificate of Need applications for pediatric cardiac catheterization services shall be competitively reviewed within each of the following five regions. The planning regions for pediatric services shall be:

1. Service Planning Area I includes districts 1 and 2.

2. Service Planning Area II includes districts 3 and 4.

3. Service Planning Area III includes districts 5, 6 and 8.

4. Service Area IV includes districts 7 and 9.

5. Service Area VI includes districts 10 and 11.

(i) Service Planning Area. Planning for pediatric cardiac catheterization services shall be done on a regionalized basis. Certificate of Need applications for pediatric cardiac catheterization services shall be competitively reviewed within each of the following five service planning areas. The service planning areas for pediatric services shall be: Operational Program. A new cardiac catheterization and angioplasty program approved by the agency that has performed at least one inpatient or outpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or, in the case of programs which performed only outpatient cardiac catheterization prior to agency approval, a program that has performed at least one inpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool.

1. Service Planning Area I includes districts 1 and 2.

2. Service Planning Area II includes districts 3 and 4.

3. Service Planning Area III includes districts 5, 6 and 8.

4. Service Area IV includes districts 7 and 9.

5. Service Area VI includes districts 10 and 11.

(j) Operational Program. A new pediatric cardiac catheterization and angioplasty program approved by the agency that has performed at least one inpatient or outpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or, in the case of programs which performed only outpatient cardiac catheterization prior to agency approval, a program that has performed at least one inpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool.

(3) Scope of Service.

(a) Each pediatric cardiac catheterization program shall be capable of providing immediate endocardiac catheter pacemaking in cases of cardiac arrest, and pressure recording for monitoring and to evaluate valvular disease, or heart failure. Applicants for pediatric cardiac catheterization programs shall document the manner in which they will meet this requirement.

(b) A range of non-invasive cardiac or circulatory diagnostic services must be available within the health care facility itself, including:

1. Hematology studies or coagulation studies;

2. Electrocardiography;

3. Chest x-ray;

4. Blood gas studies; and

5. Clinical pathology studies and blood chemistry analysis.

(c) At a minimum a pediatric cardiac catheterization program shall include:

1. A special procedure x-ray room;

2. A film storage and darkroom for proper processing of films;

3. X-ray equipment with the capability in cineangiocardiography, or equipment with similar capabilities;

4. An image intensifier;

5. An automatic injector;

6. A diagnostic x-ray examination table for special procedures;

7. An electrocardiograph;

8. A blood gas analyzer;

9. A multichannel polygraph; and

10. Emergency equipment including but not limited to a temporary pacemaker unit with catheters, ventilatory assistance devices, and a DC defibrillator; and.

11. A crash cart containing the necessary medication and equipment for ventilatory support shall be located in each cardiac catherization procedure room.

(4) Service Accessibility.

(a) Hours of Operation. Every pediatric cardiac catheterization program shall have the capability of rapid mobilization of the study team within 30 minutes for emergency procedures 24 hours a day, 7 days a week. Applicants for new pediatric cardiac catheterization programs shall document the manner in which they will meet this requirement. Travel Standard. An adult inpatient cardiac catheterization program shall be available within a maximum automobile travel time of 1 hour, under average travel conditions, for at least 90 percent of a service planning area’s population provided that the cardiac catheterization program can meet other applicable statutory and related rule criteria.

(b) Underserved Population Groups. Applicants for a pediatric cardiac catheterization program shall indicate the projected number of medically indigent and Medicaid patients to be served annually. Applicants shall indicate their past provision of health care services to medically indigent and Medicaid patients. Hours of Operation. Every cardiac catheterization program shall have the capability of rapid mobilization of the study team within 30 minutes for emergency procedures 24 hours a day, 7 days a week. Applicants for new cardiac catheterization programs shall document the manner in which they will meet this requirement.

(c) Underserved Population Groups. Applicants for a cardiac catheterization program shall indicate the projected number of medically indigent and Medicaid patients to be served annually. Applicants shall indicate their past provision of health care services to medically indigent and Medicaid patients.

(5) Service Quality.

(a) Quality of Care. Accreditation. Pediatric cardiac catheterization programs shall have a department, service or other similarly titled unit which shall be organized, directed and staffed, and intergrated with other units and departments of the hospital in a manner designed to assure the provision of quality patient care. Applicants proposing to establish a new pediatric cardiac catheterization program shall demonstrate how they will meet this provision. Any health care facility providing inpatient catheterization only, or inpatient and outpatient cardiac catheterization, or angioplasty, must be fully accredited by the Joint Commission on Accreditation of Health Care Organizations (JCAHO) for special care units, or be accredited by the American Osteopathic Association.

(b) Availability of Health Personnel. Any applicant proposing to establish a pediatric cardiac catheterization program must document that adequate numbers of properly trained personnel will be available. At a minimum, a team involved in cardiac catheterization consists of a physician, one nurse, and one or more technicians. An applicant for a new pediatric cardiac catheterization program shall document that the following staff are available:

1. A program director, board-certified or board-eligible in internal medicine, or radiology with subspecialty training in cardiology or cardiovascular, radiology; the program director for programs performing pediatric cardiac catheterization shall be board-eligible or board-certified by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics or the American Osteopathic Association in the area of pediatric cardiology;

2. A physician, board-certified or board-eligible in cardiology, radiology, or with specialized training in cardiac catheterization and angiographic techniques who will perform the examination;

3. Support staff, specially trained in critical care of cardiac patients, with a knowledge of cardiovascular medication and an understanding of catheterization and angiographic equipment;

4. Support staff, highly skilled in conventional radiographic techniques and angiographic principles, knowledgeable in every aspect of catheterization and angiographic instrumentation, with a thorough knowledge of the anatomy and physiology of the circulatory system;

5. Support staff for patient observation, handling blood samples and performing blood gas evaluation calculations;

6. Support staff for monitoring physiologic data and alerting the physician of any changes;

7. Support staff to perform systematic tests and routine maintenance on cardiac catheterization equipment, who must be available immediately in the event of equipment failure during a procedure;

8. Support staff trained in photographic processing and in the operation of automatic processors used for both sheet and cine film; and

9. A Medical Review Committee which reviews medical invasive procedures such as endoscopy and cardiac catheterization.

(6) Coordination of Services.

(a) Pediatric cardiac catheterization programs must be located in a hospital in which pediatric open heart surgery is being performed. Cardiac catheterization programs proposed in a facility not performing open heart surgery must submit a written protocol as part of their certificate of need application for the transfer of emergency patients to a hospital providing open heart surgery, which is within 30 minutes travel time by emergency vehicle under average travel conditions.

(b) Cardiac catheterization programs which include the provision of coronary angioplasty, valvuloplasty, or ablation of intracardiac bypass tracts must be located within a hospital which also provides open heart surgery.

(c) Pediatric cardiac catheterization programs must be located in a hospital in which pediatric open heart surgery is being performed.

(7) Service Cost. Cost data for pediatric cardiac catheterization programs, among similar institutions, shall be comparable when patient mix, cost accounting methods, labor market differences and other extenuating factors are taken into account.

(8) Need Determination.

(a) No additional pediatric cardiac catheterization program shall normally be approved if any of the following conditions exist:

1. One or more of the operational pediatric cardiac catheterization programs in the service planning area district that were operational for at least 12 months as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool had less than 300 admissions to the cardiac catheterization program during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or

2. One or more of the pediatric cardiac catheterization programs in the service planning area district that were operational for less than 12 months during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool had less than an average of 25 admissions to the cardiac catheterization program per month.

(b) Pediatric cardiac catheterization programs shall be established on a regional basis. A new pediatric cardiac catheterization program shall not normally be approved unless the number of live births in the service planning area, minus the number of existing and approved programs multiplied by 30,000, is at or exceeds 30,000. Live Births means the number of births during the most recent calendar year for which data is available from the Department of Health Office of Vital Statistics at least three months prior to publication of the fixed need pool. The following material is incorporated by reference within this rule; Department of Health Office of Vital Statistics Florida, Vital Statistics Annual Report 2012, Births. This publication is available on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Publications/index.shtml and http://www.flrules.org/Gateway/ reference.asp?No=Ref-01677.

(c) An applicant for a new pediatric cardiac catheterization program shall project a minimum service volume of 150 cardiac catheterizations per year within 2 years of the initial operation of the program. Programs serving both adult and pediatric patients shall project a program volume of 350 cardiac catheterizations per year.

(d) Actual inpatient and outpatient migration from one service planning area to another shall be considered in the review of Certificate of Need applications.

In order to assure patient safety and staff efficiency and to achieve maximum economic use of existing resources, the following criteria shall be considered in the approval of certificate of need applications for new adult cardiac catheterization programs.

(a) The minimum annual projected net program volume need for the establishment of a new adult cardiac catheterization program shall be at or exceed an annual program volume of 300 admissions for the service planning area.

(b) Applicants shall demonstrate that they will be able to reach an annual program volume of 300 admissions within 2 years after the program becomes operational.

(c) Need Determination. Numeric need for a new adult cardiac catheterization program in a service planning area is indicated if the difference between the projected program volume and the number of adult cardiac catheterizations performed in the service planning area during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, minus the number of approved adult programs times 300, is at or exceeds a program volume of 300 for the applicable service planning area. This need formula is expressed as follows:

NN = PCCPV – ACCPV – APP

Where:

NN is the 12-month net adult program volume need in the service planning area projected 2 years into the future for the respective planning horizon. Net need projections are published by the agency as a fixed need pool twice a year. The planning horizon for applications submitted between January 1 and June 30 shall be July of the year 2 years subsequent to the year the application is submitted. The planning horizon for applications submitted between July 1 and December 31 shall be January of the year 2 years subsequent to the year which follows the year the application is submitted.

PCCPV is the projected adult cardiac catheterization program volume which equals the actual adult cardiac catheterization program volume (ACCPV) rate per thousand adult population 15 years and over for the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, multiplied by the projected adult population 15 years of age and over 2 years into the future for the respective planning horizon. The population projections shall be based on the most recent population projections available from the Executive Office of the Governor which are available to the agency 3 weeks prior to the fixed need pool publication.

ACCPV equals the actual adult cardiac catheterization program volume for the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool.

APP is the projected program volume for approved adult programs. The projected program volume for each approved program shall be 300 admissions.

(d) Irrespective of the net need calculated under paragraph (c), no additional cardiac catheterization program shall normally be approved if any of the following conditions exist:

1. One or more of the operational cardiac catheterization programs in the district that were operational for at least 12 months as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool had less than 300 admissions to the cardiac catheterization program during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or

2. One or more of the cardiac catheterization programs in the district that were operational for less than 12 months during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool had less than an average of 25 admissions to the cardiac catheterization program per month.

(e) Pediatric cardiac catheterization programs shall be established on a regional basis. A new pediatric cardiac catheterization program shall not normally be approved unless the number of live births in the service planning area, minus the number of existing and approved programs multiplied by 30,000, is at or exceeds 30,000.

(f) Programs catheterizing pediatric patients only, shall project a minimum service volume of 150 cardiac catheterizations per year within 2 years of the initial operation of the program. Programs serving both adult and pediatric patients shall project a program volume of 350 cardiac catheterizations per year.

(g) Actual inpatient and outpatient migration from one service planning area to another shall be considered in the review of Certificate of Need applications.

(9) Utilization Reports. Facilities providing licensed pediatric inpatient cardiac catheterization services shall provide utilization reports to the agency or its designee, as follows: Decisions on certificate of need applications for the expansion of existing programs shall be made on the basis of the applicant’s justification for the level of the proposed capital expenditure and the utilization of existing laboratories in the facility.

(a) Within 45 days after the end of each calendar quarter, facilities shall provide a report of the number of pediatric inpatient and outpatient admissions to the cardiac catheterization program, for the purpose of cardiac catheterization or angioplasty which occurred during the quarter.

Rulemaking Authority 408.034(3), (6), 408.15(8) FS. Law Implemented 408.032(17), 408.033(3)(b), 408.034(3), 408.035(1), 408.036(1)(f), 408.039(4)(a) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(e), Amended 11-11-91, 7-6-92, Formerly 10-5.032, Amended 8-24-93, 9-12-94, 6-19-95, 8-23-95,_________.

 

59C-1.033 Open Heart Surgery Program.

(1) Agency Intent. This rule specifies the requirements for the establishment of an adult or pediatric open heart surgery program, including minimum requirements for staffing and equipment; and it specifies a methodology for determining the numeric need for additional programs. A certificate of need for the establishment of an open heart surgery program shall not normally be approved unless the applicant meets the applicable review criteria in Section 408.035, F.S., and the standards and need determination criteria set forth in this rule. Hospitals operating more than one hospital on separate premises under a single license shall obtain a separate certificate of need for the establishment of open heart surgery services in each facility. Separate certificates of need are required for the establishment of an adult or a pediatric open heart surgery program.

(2) Definitions.

(a) “Agency.” The Agency for Health Care Administration “Adult.” A person age 15 or older.

(b) “Approved Pediatric Open Heart Surgery Program.” A pediatric open heart surgery program, approved by the agency but not operational as defined by this rule, that had received a certificate of need or a statement of intent to award a certificate of need on or before the most recent published deadline for agency initial decisions prior to publication of the fixed need pool (as specified in paragraph 59C-1.008(1)(g), F.A.C). “Adult Open Heart Surgery Program Service Area.” The adult open heart surgery program service area is the district.

(c) “District.” A service district of the agency defined in Section 408.032(5), F.S. “Approved Pediatric Open Heart Surgery Program.” An open heart surgery program, approved by the agency but not operational as defined by this rule, that had received a certificate of need or a statement of intent to award a certificate of need on or before the most recent published deadline for agency initial decisions prior to publication of the fixed need pool (as specified in paragraph 59C-1.008(1)(g), F.A.C).

(d) “Fixed Need Pool.” The numerical open heart surgery program need for the applicable planning horizon, as established by the agency in accordance with this rule and subsection 59C-1.008(2), F.A.C. “Department.” The Agency for Health Care Administration.

(e) “Operational Pediatric Open Heart Surgery Program.” An open heart surgery program approved by the agency that has performed at least one pediatric open heart surgery operation as of 6 months prior to the beginning date of the quarter of the publication of the fixed need pool. “Fixed Need Pool.” The numerical open heart surgery program need for the applicable planning horizon, as established by the agency in accordance with this rule and subsection 59C-1.008(2), F.A.C.

(f) “Pediatric Open Heart Surgery Operation.” Surgical procedures that are used to treat conditions such as congenital heart defects, and heart and coronary artery diseases, including replacement of heart valves, cardiac vascularization, and cardiac trauma. One pediatric open heart surgery operation equals one patient admission to the operating room. Pediatric Open heart surgery operations are classified under the following diagnostic related groups (MS-DRGs): 216, 217, 218, 219, 220, 221, 228, 229, 230, 231, 232, 233, 234, 235, 236. “District.” A service district of the agency defined in Section 408.032(5), F.S.

(g) “Pediatric Open Heart Surgery Program.” A program established in a room or suite of rooms in a hospital, equipped for pediatric open heart surgery operations and staffed with qualified surgical teams and support staff. “Open Heart Surgery Operation.” Surgical procedures that are used to treat conditions such as congenital heart defects, and heart and coronary artery diseases, including replacement of heart valves, cardiac vascularization, and cardiac trauma. One open heart surgery operation equals one patient admission to the operating room. Open heart surgery operations are classified under the following diagnostic related groups (DRGs): DRGs 104, 105, 106, 107, 108, and 109.

(h) “Pediatric Open Heart Surgery Program Service Area.” For the purpose of certificate of need review, the pediatric open heart surgery program service areas are: “Open Heart Surgery Program.” A program established in a room or suite of rooms in a hospital, equipped for open heart surgery operations and staffed with qualified surgical teams and support staff.

1. Service area I includes districts 1 and 2.

2. Service area II includes districts 3 and 4.

3. Service area III includes districts 5, 6 and 8.

4. Service area IV includes districts 7 and 9.

5. Service area V includes districts 10 and 11.

(i) “Pediatric Patient” means a person under fifteen years of age. “Operational Open Heart Surgery Program.” An open heart surgery program approved by the agency that has performed at least one open heart surgery operation as of 6 months prior to the beginning date of the quarter of the publication of the fixed need pool.

(j) “Planning Horizon.” The projected date by which a proposed pediatric open heart surgery program would initiate service. For purposes of this rule, the planning horizon for applications submitted between January 1 and June 30 is July of the year 2 years subsequent to the year the application is submitted; the planning horizon for applications submitted between July 1 and December 31 is January of the year 2 years subsequent to the year which follows the year the application is submitted. “Pediatric Open Heart Surgery Program Service Area.” For the purpose of certificate of need review, the pediatric open heart surgery program service areas are:

1. Service area I includes districts 1 and 2.

2. Service area II includes districts 3 and 4.

3. Service area III includes districts 5, 6 and 8.

4. Service area IV includes districts 7 and 9.

5. Service area V includes districts 10 and 11.

(k) “Planning Horizon.” The projected date by which a proposed open heart surgery program would initiate service. For purposes of this rule, the planning horizon for applications submitted between January 1 and June 30 is July of the year 2 years subsequent to the year the application is submitted; the planning horizon for applications submitted between July 1 and December 31 is January of the year 2 years subsequent to the year which follows the year the application is submitted.

(3) Service Availability.

(a) Each adult or pediatric open heart surgery program must have the capability to provide a full range of pediatric open heart surgery operations, including, at a minimum:

1. Repair or replacement of heart valves;

2. Repair of congenital heart defects;

3. Cardiac revascularization;

4. Repair or reconstruction of intrathoracic vessels; and

5. Treatment of cardiac trauma.

(a) Applicants for adult or pediatric open heart surgery programs shall document the manner in which they will meet the requirements of this paragraph.

(b) Each adult or pediatric open heart surgery program must document its ability to implement and apply circulatory assist devices such as intra-aortic balloon assist and prolonged cardiopulmonary partial bypass.

(c) A health care facility with an adult or pediatric open heart surgery program shall provide the following services:

1. Cardiology, hematology, nephrology, pulmonary medicine, and treatment of infectious diseases;

2. Pathology, including anatomical, clinical, blood bank, and coagulation laboratory services;

3. Anesthesiology, including respiratory therapy;

4. Radiology, including diagnostic nuclear medicine;

5. Neurology;

6. Inpatient cardiac catheterization;

7. Non-invasive cardiographics, including electrocardiography, exercise stress testing, and echocardiography;

8. Intensive care; and

9. Emergency care available 24 hours per day for cardiac emergencies.

(4) Service Accessibility.

(a) Hours of Operation. Pediatric open heart surgery programs shall be available for elective pediatric open heart operations 8 hours per day, 5 days a week. Each open heart surgery program shall possess the capability for rapid mobilization of the surgical and medical support teams for emergency cases 24 hours per day, 7 days a week. Applicants pediatric open heart surgery programs shall document the manner in which they will meet this requirement. Travel Time. Adult open heart surgery shall be available within a maximum automobile travel time of 2 hours under average travel conditions for at least 90 percent of the district’s population.

(b) Open Heart Surgery Team Mobilization. Pediatric open heart surgery shall be available for emergency open heart surgery operations within a maximum waiting period of 2 hours. Hours of Operation. Adult or pediatric open heart surgery programs shall be available for elective open heart operations 8 hours per day, 5 days a week. Each open heart surgery program shall possess the capability for rapid mobilization of the surgical and medical support teams for emergency cases 24 hours per day, 7 days a week. Applicants for adult or pediatric open heart surgery programs shall document the manner in which they will meet this requirement.

(c) Underserved Population Groups. Pediatric open heart surgery shall be available to all persons in need. A patient’s eligibility for pediatric open heart surgery shall be independent of his or her ability to pay. Applicants for pediatric open heart surgery programs shall document the manner in which they will meet this requirement. Pediatric open and closed heart surgery shall be available in each pediatric open heart surgery program service area. Open Heart Surgery Team Mobilization. Adult or pediatric open heart surgery shall be available for emergency open heart surgery operations within a maximum waiting period of 2 hours.

(d) Underserved Population Groups. Adult or pediatric open heart surgery shall be available to all persons in need. A patient’s eligibility for open heart surgery shall be independent of his or her ability to pay. Applicants for adult or pediatric open heart surgery programs shall document the manner in which they will meet this requirement. Adult open heart surgery shall be available in each district to Medicare, Medicaid, and indigent patients. Pediatric open and closed heart surgery shall be available in each pediatric open heart surgery program service area.

(5) Service Quality.

(a) Availability of Health Personnel. Any applicant proposing to establish an adult or pediatric open heart surgery program must document that adequate numbers of properly trained personnel will be available to perform in the following capacities during open heart surgery:

1. A cardiovascular surgeon, board-certified by the American Board of Thoracic Surgery, or board-eligible;

2. A physician to assist the operating surgeon;

3. A board-certified or board-eligible anesthesiologist trained in open heart surgery;

4. A registered nurse or certified operating room technician trained to serve in open heart surgery operations and perform circulating duties; and

5. A perfusionist to perform extracorporeal perfusion, or a physician or a specially trained nurse, technician, or physician assistant under the supervision of the operating surgeon to operate the heart-lung machine.

(b) Follow-up Care. Following an open heart surgery operation, patients shall be cared for in an intensive care unit that provides 24 hour nursing coverage with at least one registered nurse for every two patients during the first hours of post-operative care for both adult and pediatric cases. There shall be at least two cardiac surgeons on the staff of a hospital with an adult open heart surgery program, at least one of whom is board-certified and the other at least board-eligible. One of these surgeons must be on call at all times. There shall be at least one board certified or board eligible pediatric cardiac surgeon on the staff of a hospital with a pediatric open heart surgery program. A clinical cardiologist must be available for consultation to the surgical team and responsible for the medical management of patients as well as the selection of suitable candidates for surgery along with the cardiovascular surgical team. Backup personnel in cardiology, anesthesiology, pathology, thoracic surgery and radiology shall be on call in case of an emergency. Twenty-four hour per day coverage must be arranged for the operation of the cardiopulmonary bypass pump. All members of the team caring for cardiovascular surgical patients must be proficient in cardiopulmonary resuscitation.

(6) Patient Charges. Charges for open heart surgery operations in a hospital shall be comparable with the charges established by similar institutions in the service area, when patient mix, reimbursement methods, cost accounting methods, labor market differences and other extenuating factors are taken into account.

(7) Pediatric Open Heart Surgery Program Need Determination. The need for pediatric open heart surgery programs shall be determined on a regional basis in accordance with the pediatric open heart surgery program service areas as defined in paragraph (2)(h). A new pediatric open heart surgery program shall not normally be approved unless the total of resident live births in the pediatric open heart surgery program service area, for the most recent calendar year available from the Department of Health, Office of Vital Statistics at least 3 months prior to publication of the fixed need pool, minus the number of existing and approved pediatric open heart surgery programs multiplied by 30,000, is at or exceeds 30,000. Live Births means the number of births during the most recent calendar year for which data is available from the Department of Health Office of Vital Statistics at least three months prior to publication of the fixed need pool. The following materials are incorporated by reference within this rule; Department of Health Office of Vital Statistics Florida, Vital Statistics Annual Report 2012, Births. This publication is available on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Publications/index.shtml and http://www.flrules.org/Gateway/ reference.asp?No=Ref-01677. Adult Open Heart Surgery Program Need Determination.

(a) An additional open heart surgery program shall not normally be approved in the district if any of the following conditions exist:

1. There is an approved adult open heart surgery program in the district;

2. One or more of the operational adult open heart surgery programs in the district that were operational for at least 12 months as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than 300 adult open heart surgery operations during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or,

3. One or more of the adult open heart surgery programs in the district that were operational for less than 12 months during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than an average of 25 adult open heart surgery operations per month.

(b) Provided that the provisions of paragraph (7)(a) do not apply, the agency shall determine the net need for an additional adult open heart surgery program in the district based on the following formula:

NN = [(POH/500) – OP] 0.5

Where:

1. NN = The need for an additional adult open heart surgery program in the district projected for the applicable planning horizon. The additional adult open heart surgery program may be approved when NN is 0.5 or greater.

2. POH = The projected number of adult open heart surgery operations that will be performed in the district in the 12-month period beginning with the planning horizon. To determine POH, the agency will calculate COH/CPOP x PPOP, where:

a. COH = The current number of adult open heart surgery operations, defined as the number of adult open heart surgery operations performed in the district during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool.

b. CPOP = The current district population age 15 years and over.

c. PPOP = The projected district population age 15 years and over. For applications submitted between January 1 and June 30, the population estimate used for CPOP shall be for January of the preceding year; for applications submitted between July 1 and December 31, the population estimate used for CPOP shall be for July of the preceding year. The population estimates used for CPOP and PPOP shall be the most recent population estimates of the Executive Office of the Governor that are available to the agency 3 weeks prior to publication of the fixed need pool.

3. OP = The number of operational adult open heart surgery programs in the district.

(c) In the event there is a demonstrated numeric need for an additional adult open heart surgery program pursuant to paragraph (7)(b), preference shall be given to any applicant from a county that meets the following criteria:

1. None of the hospitals in the county has an existing or approved open heart surgery program; and

2. Residents of the county are projected to generate at least 1200 annual hospital discharges with a principal diagnosis of ischemic heart disease, as defined by ICD-9-CM codes 410.0 through 414.9. The projected number of county residents who will be discharged with a principal diagnosis of ischemic heart disease will be determined as follows:

a. PIHD = (CIHD/CoCPOP x CoPPOP)

where:

b. PIHD = The projected 12-month total of discharges with a principal diagnosis of ischemic heart disease for residents of the county age 15 and over;

c. CIHD = The most recent 12-month total of discharges with a principal diagnosis of ischemic heart disease for residents of the county age 15 and over, as available in the agency’s hospital discharge data base;

d. CoCPOP = The current estimated population age 15 and over for the county, included as a component of CPOP in subparagraph 7(b)2.;

e. CoPPOP = The planning horizon estimated population age 15 and over for the county, included as a component of PPOP in subparagraph (7)(b)2.

(d) In the event no numeric need for an additional adult open heart surgery program is shown in paragraphs (7)(a) or (7)(b) above, the need for enhanced access to health care for the residents of a service district is demonstrated for an applicant in a county that meets the criteria of subparagraphs (7)(c)1. and 2. above.

(e) An additional adult open heart surgery program will not normally be approved for the district if the approval would reduce the 12 month total at an existing adult open heart surgery program in the district below 300 open heart surgery operations.

(8)(a) Utilization Reports. Facilities operating a licensed pediatric open heart surgery program shall provide utilization reports to the agency or its designee, as follows: Pediatric Open Heart Surgery Program Need Determination. The need for pediatric open heart surgery programs shall be determined on a regional basis in accordance with the pediatric open heart surgery program service areas as defined in paragraph (2)(j). A new pediatric open heart surgery program shall not normally be approved unless the total of resident live births in the pediatric open heart surgery program service area, for the most recent calendar year available from the Department of Health, Office of Vital Statistics at least 3 months prior to publication of the fixed need pool, minus the number of existing and approved pediatric open heart surgery programs multiplied by 30,000, is at or exceeds 30,000.

(b) Within 45 days after the end of each calendar quarter, facilities shall provide a report of the number of pediatric open heart surgery operations which occurred during the quarter.

Rulemaking Authority 408.034(6), 408.15(8) FS. Law Implemented 408.032(17), 408.034(3), 408.036(1)(f) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(f), Amended 1-26-92, Formerly 10-5.033, Amended 6-17-93, 8-24-93, 1-24-02,__________.