Ga. Comp. R. & Regs. R. 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; or that acquires a piece of diagnostic or therapeutic equipment 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.
(II) 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;
and
3. 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; or
3. 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:
1. catheter atherectomy;
2. catheter endomyocardial biopsy;
3. left ventricular puncture;
4. percutaneous transluminal coronary
angioplasty;
5. percutaneous
catheter balloon valvuloplasty; and
6. 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; and
2. 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
(II) 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;
and
6. 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; and
6. 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.
Notes
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No prior version found.