Tenn. Comp. R. & Regs. 0720-11-.01 - GENERAL CRITERIA FOR CERTIFICATE OF NEED
The Agency will consider the following general criteria in determining whether an application for a certificate of need should be granted:
(1) Need. The health care
needed in the area to be served may be evaluated upon the following factors:
(a) The relationship of the proposal to any
existing applicable plans;
(b) The
population served by the proposal;
(c) The existing or certified services or
institutions in the area;
(d) The
reasonableness of the service area;
(e) The special needs of the service area
population, including the accessibility to consumers, particularly women,
racial and ethnic minorities, TennCare participants, and low-income
groups;
(f) Comparison of
utilization/occupancy trends and services offered by other area
providers;
(g) The extent to which
Medicare, Medicaid, TennCare, medically indigent, charity care patients and
low-income patients will be served by the project. In determining whether this
criteria is met, the Agency shall consider how the applicant has assessed that
providers of services which will operate in conjunction with the project will
also meet these needs.
(2) Quality. Whether the proposal will
provide health care that meets appropriate quality standards may be evaluated
upon the following factors:
(a) Whether the
applicant commits to maintaining staffing comparable to the staffing chart
presented in its CON application;
(b) Whether the applicant will obtain and
maintain all applicable state licenses in good standing;
(c) Whether the applicant will obtain and
maintain TennCare and Medicare certification(s), if participation in such
programs was indicated in the application;
(d) Whether an existing healthcare
institution applying for a CON has maintained substantial compliance with
applicable federal and state regulation for the three years prior to the CON
application. In the event of non-compliance, the nature of noncompliance and
corrective action shall be considered;
(e) Whether an existing health care
institution applying for a CON has been decertified within the prior three
years. This provision shall not apply if a new, unrelated owner applies for a
CON related to a previously decertified facility;
(f) Whether the applicant will participate,
within 2 years of implementation of the project, in self-assessment and
external assessment against nationally available benchmark data to accurately
assess its level of performance in relation to established standards and to
implement ways to continuously improve.
1.
This may include accreditation by any organization approved by Centers for
Medicare and Medicaid Services (CMS) and other nationally recognized programs.
The Joint Commission or its successor, for example, would be acceptable if
applicable. Other acceptable accrediting organizations may include, but are not
limited to, the following:
(i) Those having
the same accrediting standards as the licensed hospital of which it will be a
department, for a Freestanding Emergency Department;
(ii) Accreditation Association for Ambulatory
Health Care, and where applicable, American Association for Accreditation of
Ambulatory Surgical Facilities, for Ambulatory Surgical Treatment Center
projects;
(iii) Commission on
Accreditation of Rehabilitation Facilities (CARF), for Comprehensive Inpatient
Rehabilitation Services and Inpatient Psychiatric projects;
(iv) American Society of Therapeutic
Radiation and Oncology (ASTRO), the American College of Radiology (ACR), the
American College of Radiation Oncology (ACRO), National Cancer Institute (NCI),
or a similar accrediting authority, for Megavoltage Radiation Therapy
projects;
(v) American College of
Radiology, for Positron Emission Tomography, Magnetic Resonance Imaging and
Outpatient Diagnostic Center projects;
(vi) Community Health Accreditation Program,
Inc., Accreditation Commission for Health Care, or another accrediting body
with deeming authority for hospice services from CMS or state licensing survey,
and/or other third party quality oversight organization, for Hospice
projects;
(vii) Behavioral Health
Care accreditation by the Joint Commission for Nonresidential Substitution
Based Treatment Center, for Opiate Addiction projects;
(viii) American Society of Transplantation or
Scientific Registry of Transplant Recipients, for Organ Transplant
projects;
(ix) Joint Commission or
another appropriate accrediting authority recognized by CMS, or other
nationally recognized accrediting organization, for a Cardiac Catheterization
project that is not required by law to be licensed by the Department of
Health;
(x) Participation in the
National Cardiovascular Data Registry, for any Cardiac Catheterization
project;
(xi) Participation in the
National Burn Repository, for Burn Unit projects;
(xii) Community Health Accreditation Program,
Inc., Accreditation Commission for Health Care, and/or other accrediting body
with deeming authority for home health services from CMS and participation in
the Medicare Quality Initiatives, Outcome and Assessment Information Set, and
Home Health Compare, or other nationally recognized accrediting organization,
for Home Health projects;
(xiii)
Participation in the National Palliative Care Registry, for Hospice projects;
and
(xiv) As an alternative to the
provision of third party accreditation information, applicants may provide
information on any other state, federal, or national quality improvement
initiatives, for Nursing Home projects.
(g) For Ambulatory Surgical Treatment Center
projects, whether the applicant has estimated the number of physicians by
specialty expected to utilize the facility, developed criteria to be used by
the facility in extending surgical and anesthesia privileges to medical
personnel, and documented the availability of appropriate and qualified staff
that will provide ancillary support services, whether on- or
off-site.
(h) For Cardiac
Catheterization projects:
1. Whether the
applicant has documented a plan to monitor the quality of its cardiac
catheterization program, including but not limited to, program outcomes and
efficiencies;
2. Whether the
applicant has agreed to cooperate with quality enhancement efforts sponsored or
endorsed by the State of Tennessee; and
3. Whether the applicant will staff and
maintain at least one cardiologist who has performed 75 cases annually averaged
over the previous 5 years (for an adult program), and 50 cases annually
averaged over the previous 5 years (for a pediatric program).
(i) For Open Heart projects:
1. Whether the applicant will staff with the
number of cardiac surgeons who will perform the volume of cases consistent with
the State Health Plan (annual average of the previous 2 years), and whether the
applicant will maintain this volume in the future;
2. Whether the applicant will staff and
maintain at least one surgeon with 5 years of experience; and
3. Whether the applicant will participate in
a data reporting, quality improvement, outcome monitoring, and external
assessment system that benchmarks outcomes based on national norms
(demonstrated active participation in the STS National Database is expected and
shall be considered evidence of meeting this standard);
(j) For Comprehensive Inpatient
Rehabilitation Services projects, whether the applicant will have a
board-certified physiatrist on staff (preferred);
(k) For Home Health projects, whether the
applicant has documented its existing or proposed plan for quality data
reporting, quality improvement, and an outcome and process monitoring
system;
(l) For Hospice projects,
whether the applicant has documented its existing or proposed plan for quality
data reporting, quality improvement, and an outcome and process monitoring
system;
(m) For Megavoltage
Radiation Therapy projects, whether the applicant has demonstrated that it will
meet the staffing and quality assurance requirements of the American Society of
Therapeutic Radiation and Oncology (ASTRO), the American College of Radiology
(ACR), the American College of Radiation Oncology (ACRO), National Cancer
Institute (NCI), or a similar accrediting authority;
(n) For Neonatal Intensive Care Unit
projects, whether the applicant has documented its existing or proposed plan
for data reporting, quality improvement, and outcome and process monitoring
systems; whether the applicant has documented the intention and ability to
comply with the staffing guidelines and qualifications set forth by the
Tennessee Perinatal Care System Guidelines for Regionalization, Hospital Care
Levels, Staffing and Facilities; and whether the applicant will participate in
the Tennessee Initiative for Perinatal Quality Care (TIPQC);
(o) For Nursing Home projects, whether the
applicant has documented its existing or proposed plan for data reporting,
quality improvement, and outcome and process monitoring systems, including in
particular details on its Quality Assurance and Performance Improvement
program;
(p) For Freestanding
Emergency Department projects, whether the applicant has demonstrated that it
will be accredited with the Joint Commission or other applicable accrediting
agency, subject to the same accrediting standards as the licensed hospital with
which it is associated;
(q) For
Organ Transplant projects, whether the applicant has demonstrated that it will
achieve and maintain institutional membership in the national Organ Procurement
and Transportation Network (OPTN), currently operating as the United Network
for Organ Sharing (UNOS), within one year of program initiation; additionally,
the applicant shall comply with CMS regulations set forth by 42 CFR Parts 405, 482, and 498, Medicare Program; Hospital Conditions of Participation:
Requirements for Approval and ReApproval of Transplant Centers To Perform Organ
Transplants; and
(r) For Relocation
and/or Replacement of Health Care Institution projects:
1. For hospital projects, Acute Care Bed Need
Services measures are applicable; and
2. For all other healthcare institutions,
applicable facility and/or service specific measures are applicable.
(s) The Agency will notify the
applicant and any applicable licensing agency if any quality measure has not
been met.
(t) Within one month of
notification the applicant must submit a corrective action plan and must report
on the progress of the plan within one year of that submission.
(3) The effects attributed to
competition or duplication would be positive for the consumers. Whether the
effects attributed to competition or duplication would be positive for the
consumers may be evaluated upon the following factors:
(a) Access to high quality, cost-effective
healthcare services;
(b) The impact
upon patient charges;
(c)
Participation in TennCare, Medicare and other federal and state reimbursement
programs; participation in other insurance plans; and charity care;
(d) Whether the applicant commits to
maintaining an actual payor mix that is comparable to the payor mix projected
in its CON application, particularly as it relates to Medicare,
TennCare/Medicaid, Charity Care, and the Medically Indigent; and
(e) The availability and accessibility of
human resources required by the proposal, including those required by existing
providers.
(4)
Applications for Change of Site. When considering a certificate of need
application which is limited to a request for a change of site, the Agency may
consider, in addition to the foregoing factors, the following factors:
(a) Need. The applicant should show the
proposed new site will serve the health care needs in the area to be served at
least as well as the original site. The applicant should show that there is
some significant legal, financial, or practical need to change to the proposed
new site.
(b) Quality of Health
Care to be provided. The applicant should show the quality of health care to be
provided will be served at least as well as at the original site.
(c) The effects attributed to competition or
duplication would be positive for the consumers. The applicant should address
whether the effects attributed to competition or duplication would be positive
for the consumers.
(5)
Certificate of need conditions. In accordance with T.C.A. § 68-11-1609,
the Agency, in its discretion, may place such conditions upon a certificate of
need it deems appropriate and enforceable to meet the applicable criteria as
defined in statute and in these rules.
Notes
Authority: T.C.A. §§ 4-5-201, et seq., 4-5-202, 68-11-1605, 68-11-1607, 68-11-1609, and 68-11-1633; and 2021 Tenn. Pub. Acts Ch. 557.
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