Rule 111-2-2-.21 - Specific Review Considerations for Adult Cardiac Catheterization Services(1)Applicability.(a) For Certificate of Need purposes, Adult Cardiac Catheterization Services is classified as a specialized service and is defined as a new institutional health service which must be delivered in a permanently fixed location in either an acute care hospital or in a diagnostic, treatment, or rehabilitation center ("DTRC"). A Certificate of Need will be required prior to the establishment of a new or expanded adult cardiac catheterization service, if not exempt as provided by O.C.G.A. § 31-6-47(a)(21) and Ga. Comp. R. & Regs. r. 111-2-2-.03(24).(b) If the service will be provided within a licensed acute care hospital, the hospital shall be the applicant.(c) If cardiac catheterization services will be provided in a DTRC, the organizational entity that develops the service shall be the applicant.(d) Seeking and receiving approval from the Department under the provisions of Ga. Comp. R. & Regs. r. 111-2-2-.21(3)(f)3. shall neither be considered a new adult cardiac catheterization service nor an expanded service. Additionally, the issuance of such an approval shall not be construed to be anything other than a time-limited approval to participate in the particular medical research trial specified in Ga. Comp. R. & Regs. r. 111-2-2-.21(3)(f)(3).(2)Definitions.(a) "Adjacent acute care hospital" means an acute care hospital which is physically connected to another acute care hospital in a manner that emergency transport of a patient by a stretcher or gurney can be achieved rapidly, conveniently, and effectively without the use of motorized vehicles.(b) "Adult" means a person fifteen (15) years of age and over.(c) "Authorized service" means an adult cardiac catheterization service that is either existing or approved. An existing service is an authorized service that has become operational, and an approved service is an authorized service that has not yet become operational.(d) "Capacity" means 1300 adult cardiac catheterization procedure equivalents per dedicated and multipurpose room per year. In the computation of the use rate (percent of capacity) of authorized adult cardiac catheterization rooms, each adult diagnostic cardiac catheterization and other cardiac catheterizations of similar complexity shall equal a 1.0 procedure equivalent, each coronary angioplasty procedure shall equal 1.5 procedure equivalents, and each electrophysiological (EP) study shall equal 2.0 procedure equivalents. If pediatric catheterizations are performed in a room in which adult cardiac catheterizations are performed, each pediatric procedure shall equal 2.0 procedure equivalents.(e) "Cardiac catheterization" means a medical diagnostic or therapeutic procedure during which a catheter is inserted into a vein or artery in the patient; subsequently, the free end of the catheter is manipulated by the physician to travel along the course of the blood vessel into the chambers or vessels of the heart. X-rays and an electronic image intensifier are used as aids in placing the catheter tip in the desired position. When the catheter is in place, the physician is able to perform various diagnostic studies and/or therapeutic procedures on the heart or its vessels.(f) "Cardiac catheterization service" means an organized program which serves inpatients and/or outpatients of an acute care hospital or diagnostic, treatment and rehabilitation center (DTRC) with a room or a suite of rooms, with equipment to perform angiographic, physiologic, and as appropriate, therapeutic cardiac catheterization procedures. An authorized adult cardiac catheterization service is prohibited from performing coronary angioplasty procedures unless the acute care hospital where the service is located meets the requirements identified in Ga. Comp. R. & Regs. r. 111-2-2-.21(3)(f).(g) "Coronary angioplasty" means a cardiac catheterization procedure to treat coronary artery disease by utilizing a catheter with a balloon, laser, laser-assisted device, rotational device, stent placement or other mechanical means to unblock an occluded coronary artery.(h) "Diagnostic cardiac catheterization" means the performance of cardiac catheterization for the purpose of detecting and identifying defects in the great arteries or veins of the heart, or abnormalities in the heart structure, whether congenital or acquired. Post-operative evaluation of the effectiveness of prostheses (e.g. heart valves or vein grafts) also can be accomplished through use of diagnostic cardiac catheterization.(i) "Diagnostic, treatment, or rehabilitation center (DTRC)" means any professional or business undertaking, whether for profit or not for profit, which offers or proposes to offer any clinical health service in a setting that is not part of a hospital.(j) "Expanded Service" or "Expansion" means an adult cardiac catheterization service that undertakes any capital renovation or construction project in and to the physical space within the hospital where the cardiac catheterization services are or will be offered, the cost of which exceeds the capital expenditure threshold at that time; or that acquires a piece of diagnostic or therapeutic equipment with a value above the equipment threshold at that time which is to be utilized in the provision of cardiac catheterization services; or that seeks the addition of a new catheterization laboratory or room regardless of cost. Replacement or repair of existing diagnostic or therapeutic equipment utilized in the provision of such services is not an expansion for purposes of these Rules.(k) "Horizon year" means the last year of a five-year projection period for need determinations for any adult cardiac catheterization services.(l) "Official inventory" means the Department's inventory of all authorized hospital-based and diagnostic, treatment, or rehabilitation center (DTRC) adult cardiac catheterization laboratories or any other authorized laboratory approved for operation at the time of adoption of these Rules.(m) "Official state component plan" means the document related to specialized cardiovascular services developed by the Department adopted by the Health Strategies Council and approved by the Board of Community Health.(n) "Procedure" means a cardiac catheterization study or treatment or combination of studies and/or treatments performed in a single session on a single patient who appears for cardiac catheterization.(o) "Planning area" means each of the planning areas designated in the official State Component Plan.(p) "Therapeutic cardiac catheterization" means the performance of cardiac catheterization for the purpose of ameliorating certain conditions that have been determined to exist in the heart or great arteries or veins of the heart.(3)Standards.(a) The need for new or expanded adult cardiac catheterization services shall be determined through application of a numerical need method and an analysis of service demand based on an assessment of the aggregate utilization rate of existing services; 1. the numerical need for new or expanded adult cardiac catheterization services shall be determined by a population-based formula which includes current usage patterns and projected population as follows: (i) calculate the current state adult cardiac catheterization rate for the most recent year of reported survey or hospital and outpatient discharge data by dividing the total number of adult cardiac catheterizations performed on Georgia residents by the total state adult Resident population;(ii) determine the projected adult cardiac catheterization procedures for the horizon year by multiplying the state rate by the adult Resident population for the planning area for the horizon year;(iii) adjust the projected adult cardiac catheterization procedures for the planning area by adding the out-of-state hospital-based catheterizations for the most recent year based on the percentage of total procedures performed on out-of-state patients by hospitals in each planning area;(iv) convert projected adult cardiac catheterization procedures to procedure equivalents by multiplying the projected procedures by the statewide rate of equivalents per catheterization; and(v) determine the projected net surplus or deficit for adult cardiac catheterization capacity, expressed in terms of rooms/laboratories, in the planning area by subtracting the rooms/laboratories needed for the total projected procedure equivalents calculated in steps (i) through (iv) from the total capacity (1300 procedure equivalents per room/laboratory) based on the official inventory.2. before a new or expanded adult cardiac catheterization service will be approved in any planning area, the aggregate utilization rate of all adult cardiac catheterization services in that planning area shall be eighty-five percent (85%) or more during the most recent year;(b)1. The Department may allow an exception to Ga. Comp. R. & Regs. r. 111-2-2-.21(3)(a) in the following circumstances: (i) actual utilization in the applicant's existing service has exceeded ninety percent (90%) of capacity over the past two (2) years;(ii) to remedy an atypical barrier to adult cardiac catheterization services based on cost, quality, financial access, or geographic accessibility. The types of atypical barriers outlined below are intended to be illustrative and not exclusive. (I) An atypical barrier to services based on cost may include the failure of existing providers of adult cardiac catheterization services to provide services at reasonable cost, as evidenced by the providers' charges and/or reimbursement being significantly higher (one or more standard deviations from the mean) than the charges and/or reimbursement for other providers in the state and/or planning area.(II) An atypical barrier to services based on quality may include the failure of existing providers of adult cardiac catheterization services to provide services with outcomes generally in keeping with accepted clinical guidelines of the American College of Cardiology, peer review programs and comparable state rates for similar populations.(III) An atypical barrier to services based on financial access may include the repeated failure, as exhibited by a documented pattern over two or more years prior to the submission of the application, of existing providers of services within the community to provide services to indigent, charity, and Medicaid patients.(IV) An atypical barrier to services based on geographic accessibility may include a planning area which has an adult cardiac catheterization rate significantly less than the state rate (two or more standard deviations from the mean), a cardiovascular disease rate as projected through death and hospital discharge data which is significantly higher than the state rate (two or more standard deviations from the mean), and other demographic risk factors which can be documented through research and clinical studies.(V) An applicant seeking approval for a new or expanded adult cardiac catheterization service solely for the purpose of providing cardiac electrophysiological studies may apply for consideration under the terms of an atypical barrier; provided, however, that any such applicant if approved shall be restricted to the provision of electrophysiological studies.2. The Department may allow an exception to Ga. Comp. R. & Regs. r. 111-2-2-.21(3)(a) and (3)(c) for any cardiac catheterization service seeking an expansion, other than the addition of another laboratory or room; provided the applicant complies with the general considerations and policies of Ga. Comp. R. & Regs. r. 111-2-2-.09 and submits an application that demonstrates the applicant's compliance with or documents a plan and agreement to comply with Ga. Comp. R. & Regs. r. 111-2-2-.21(3)(d),(e),(f),(g),(h),(j),(k) and (l).(c) An applicant for a new or expanded adult cardiac catheterization service shall document that authorized cardiac catheterization services which could be adversely impacted by the establishment of the new or expanded service are not predicted to perform less than eighty percent (80%) of capacity as a result of the establishment of the new or expanded service. In the case of an approved service, service volume should be projected in accordance with the volume projections in the approved application.(d) An applicant for a new or expanded adult catheterization service shall demonstrate a plan whereby the service and its medical staff agree to provide a full array of cardiovascular services to the community, including, but not limited to, education and outreach, prevention and screening, diagnosis and treatment, and rehabilitation.(e) An applicant for a new or expanded adult cardiac catheterization services shall: 1. demonstrate the ability to meet the optimal clinical and physical environment standards established in the most recent American College of Cardiology/American Heart Association's Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. These standards include, but are not limited to, physical facility requirements, staffing, training, quality assurance, patient safety, screening patients for appropriate settings, and linkages with supporting emergency services;2. document the availability of, or shall present a plan for recruiting, at least two board-certified cardiologists with training and qualification in cardiac catheterization, and, if applicable with training and qualification in coronary intervention, who will reside within one hour drive of the service site; and3. document a plan for obtaining a sufficient number of clinical, professional and technical staff to safely and effectively operate the service.(f) An authorized adult cardiac catheterization service shall not perform catheterization procedures requiring open heart surgery backup as part of its service unless the acute care hospital where the service is located: 1. operates an existing adult open heart surgery service;2. has a Department approved written agreement for open heart surgery backup with an adjacent acute care hospital as defined by these Rules; or3. has been accepted as a participant in a randomized medical research trial comparing patient outcomes after non-primary Percutaneous Coronary Intervention (PCI) in hospitals with and without cardiac surgery on-site, which also requires the performance of Primary PCI and has a parallel Primary PCI Registry, and which is coordinated by the Atlantic Cardiovascular-Patient Outcomes Research Team (Atlantic C-PORT). The authorized adult cardiac catheterization service must receive such Atlantic C-PORT acceptance and also must obtain written approval from the Department to perform such procedures, except that the Department may approve no more than ten (10) existing and authorized hospital services for participation, regardless of the number of such services that are accepted by Atlantic C-PORT. (i) Any request for such Departmental approval must be submitted to the Department no later than June 30, 2005 in writing on a form developed by the Department for such purposes. Prior to final approval to participate by the Department, the requesting authorized service must provide written proof it has been accepted by Atlantic C-PORT as a participant in said trial under all applicable protocols;(ii) In reviewing and approving such requests, the Department shall take into consideration such factors including, but not limited to, rural, suburban or urban location of the service, mix of patients to be treated, whether the service has the capability of performing a minimum of 100 PCIs (elective and primary combined) during the first year of such approval, 200 PCIs (elective and primary combined) during the second year of such approval unless a lower number, but not below 150 PCIs, is approved for specific reasons by both the Department and the trial chairperson, and 200 PCIs (elective and primary combined) during the third year of such approval, and whether the service has on its staff physicians and support staff with training and experience in both therapeutic and diagnostic cardiac catheterizations;(iii) The selection of an authorized service for participation pursuant to this Rule will be made at the sole discretion of the Department; however, the Department shall consult with medical experts in the fields of cardiology and percutaneous coronary intervention when making the decision to approve or not approve a particular service for participation in such trial;(iv) Any approval obtained from the Department in this regard shall only be valid for as long as the health care facility receiving such approval is an active participant in the trial; however, in no case shall such approval continue to be valid upon Atlantic C-PORT declaring the trial concluded, or under no circumstance for a period in excess of three (3) years from the time the authorized service's first procedure is conducted under the authority of the Department's approval and Atlantic C-PORT's acceptance to begin active participation in the trial; whichever event occurs first; and(v) As any such Departmental approval is conditioned on being an active participant in the trial, should an authorized service which has received approval under the provisions of this Rule be expelled or otherwise lose the approval of Atlantic C-PORT to continue participation, the Department's approval will be simultaneously withdrawn without said service's or facility's right to an appeal of the Department's withdrawal of its approval to participate in such trial.(g) Catheterization procedures requiring open heart surgery backup include coronary angioplasty and the following: 2. catheter endomyocardial biopsy;3. left ventricular puncture;4. percutaneous transluminal coronary angioplasty;5. percutaneous catheter balloon valvuloplasty; and6. transeptal catheterization.(h) An applicant for a new or expanded adult cardiac catheterization service shall: 1. submit a written plan to the Department which, when implemented, will ensure access to cardiac catheterization services for all segments of the population in the documented and proposed service area of the applicant. Such plan shall provide a detailed strategy to reach patients not currently served within the service area, ensure continuity of care for patients transferred between facilities and shall promote planning for a continuum of cardiac services within the service area; and2. propose a heart disease prevention and clinical intervention program to be provided by the applicant or through formal referral agreements which, when implemented, shall include: (i) A clinical intervention program for all catheterization patients that shall provide for the following in a comprehensive, systematic way: (I) Assessment of risk factors including lipid disorders, hypertension, diabetes, obesity, cigarette smoking, and sedentary lifestyle;(II) Assessment of risk factors and referral for appropriate care in first-degree relatives; and(III) Assure risk management including modification of lipid disorders by diet/exercise/drugs, modification of blood pressure level by diet/exercise/drugs, control of blood glucose level by diet/exercise/drugs, dietary counseling aimed at reduced caloric and fat intake and appropriate weight management, smoking cessation, and exercise prescription. Patients should be referred to their primary care provider with documentation of treatments provided and actions recommended including preventive therapies.(ii) The program, if not operated by a facility with an existing Open Heart Surgical Service, shall submit a written affiliation agreement with at least one Open Heart Surgical Service that provides, at a minimum, for: (I) a plan to transplant and handle acute cardiac emergencies;(II) a plan to facilitate referral of patients for whom surgery or angioplasty may be indicated without unnecessarily repeating diagnostic studies; and(III) a plan for ongoing communications between representatives of the Open-Heart Surgical Service and the proposed applicant, to allow for review of pre-operative and post-operative processes and specific cases.(iii) The program shall provide for annual support and participation in at least three (3) professional education programs targeted to community-based health professionals, related to heart disease risk assessment, diagnostic procedures, disease management in clinical settings, and case finding and referral strategies.(iv) Community based heart health promotion: (I) The program shall provide for organization of or participation in a consortium of community-based organizations to complete an assessment of heart disease risk factors in the community as well as resources available to provide programs and services. The objective of this consortium is to mobilize and coordinate resources to target at-risk populations in the community; and(II) Organization of or participation in at least one major community-based campaign each year related to major heart disease risk factors.3. propose a system of outcome monitoring and quality improvement and identify at least five clinical outcomes that the applicant proposes to monitor for performance on a regular basis.(i) An applicant for a new or expanded adult cardiac catheterization service must project and, if approved, shall document that the proposed service will be performing a minimum of 1040 adult cardiac catheterization procedure equivalents within three (3) years of initiation of the service and annually thereafter within the authorized guidelines for such services. Such projections, at a minimum, shall include consideration of patient origin data for catheterization services, the use rate of existing services, referral data and market patterns for existing hospital and DTRC services in the community, and cardiovascular disease incidence rates and related health indicators. An applicant seeking approval solely for the purpose of providing electrophysiological (EP) studies shall not be required to document a projected performance minimum but shall be required to document compliance with guidelines for EP studies issued by the American College of Cardiology.(j) An applicant for a new or expanded adult cardiac catheterization service shall provide documentation that the service is fully accredited by the Joint Commission or another nationally recognized health care accreditation body, in the case of an applicant proposing a new facility location, shall provide a written commitment to secure full accreditation by the Joint Commission or another nationally recognized health care accreditation body within eighteen (18) months of initiating operation.(k) An applicant for a new or expanded adult cardiac catheterization service shall foster an environment that assures access to individuals unable to pay, regardless of payment source or circumstances, by the following: 1. providing a written policy regarding the provision of any services provided by or on behalf of the applicant to include disease prevention and intervention services outlined in Ga. Comp. R. & Regs. r. 111-2-2-.21(3)(h), that such services shall be provided regardless of race, age, sex, creed, religion, disability or patient's ability to pay, and documentation or evidence that the applicant has a service history reflecting the principles of such a policy;2. providing a written commitment that services for indigent and charity patients will be offered at a standard which meets or exceeds three percent (3%) of annual, adjusted gross revenues for the adult cardiac catheterization service, or the applicant may request that the Department consider allowing the commitment for services to indigent and charity to patients to be applied to the entire facility;3. providing a written commitment to accept any patient within the facility's service area, without regard to the patient's ability to pay, unless such patient is clinically inappropriate;4. providing a written commitment to participate in the Medicaid, PeachCare and Medicare programs and to accept any Medicaid-, PeachCare- and/or Medicare-eligible patient for services unless such patient is clinically inappropriate;5. providing a written commitment that the applicant, subject to good faith negotiations, will participate in any state health benefits insurance programs for which the service is deemed eligible; and6. providing documentation of the past record of performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid and indigent and charity patients. The applicant's or its parent organization's failure to provide services at an acceptable level to Medicare, Medicaid and indigent and charity patients, and/or the failure to fulfill any previously made commitment to indigent and charity care may constitute sufficient justification to deny the application.(l) An applicant for a new or expanded adult cardiac catheterization service must agree in writing to the following conditions: 1. establishment and maintenance of a system of continuity of care and coordination of service, as evidenced by regular and ongoing planning and quality improvement sessions with community health providers and advocacy programs;2. participation in a data reporting, quality improvement, outcome monitoring, and peer review system within the applicant hospital or DTRC as well as a national, state or multi-program system which benchmarks outcomes based on national norms and which shall be named in the application and which provides for peer review between and among professionals practicing in facilities and programs other than the applicant hospital or DTRC;3. development of procedures to ensure that cardiologists and any other physicians providing care in the cardiac catheterization service or related services shall be required to accept Medicaid, PeachCare and Medicare payment for services without discrimination;4. commitment that charges for services shall be reasonable and comparable to other providers in the state and the service area;5. provision of all required data and survey information to the Department as requested; and6. commitment to act in good faith to fulfill all provisions and commitments documented in the application for a new or expanded service.(m) The Department may revoke a Certificate of Need after notice to the holder of the certificate and a fair hearing pursuant to the Georgia Administrative Procedure Act for failure to comply with the defined scope, location, cost, service area, and person named in an application as approved by the Department and for the intentional provision of false information to the Department by an applicant in that applicant's application.Ga. Comp. R. & Regs. R. 111-2-2-.21
O.C.G.A. §§31-2et seq., 31-6 et seq.
Original Rule entitled "Specific Review Considerations for Adult Cardiac Catheterization Services" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.Amended: F. Apr. 18, 2005; eff. May 8, 2005.Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.Note: Rule 111-2-2-.21, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.