– Office of Health Policy and Planning

Title 15 - Mississippi Department of Health Part 8 – Office of Health Policy and Planning Subpart 90 – Planning and Resource Development Chapter 1 Introduction Legal Authority & Purpose Mississippi Code Ann. § 41-7-171 et seq. establishes the Mississippi State Department of Health (MSDH) as the sole and official agency to administer and supervise all health planning responsibilities for the state, including development and publication of the Mississippi State Health Plan. The effective dates of the Fiscal Year 2022 Mississippi State Health Plan extend from July 1, 2021, through June 30, 2022, or until superseded by a later Plan. The 2022 State Health Plan establishes criteria and standards for health-related activities which require Certificate of Need review in an effort to meet the priority health needs identified by the department. The priority health needs are as follows: • Disease prevention, health protection, and health promotion; • Health care for specific populations, such as mothers, babies, the elderly, the indigent, the uninsured, and minorities; • Implementation of a statewide trauma system; • Health needs of persons with mental illness, alcohol/drug abuse problems, mental retardation/developmental disabilities, and/or handicap; • Availability of adequate health manpower throughout the state; and • Enhance capacity for detention of a response to public health emergencies, including acts of bioterrorism. Section 41-7-191 requires Certificate of Need (CON) approval for the establishment, relocation, or expansion of healthcare facilities. The statute also requires CON approval for the acquisition or control of major medical equipment and for the change of ownership of defined healthcare facilities unless the facilities meet specific requirements. This Plan provides the service-specific CON criteria and standards developed and adopted by the MSDH for CON review of health-related activities requiring such review. The Mississippi Certificate of Need Review Manual provides additional general CON criteria by which the Department reviews all applications. Outline of the State Health Plan The State Health Plan describes existing services, evaluates the need for additional services in various aspects of health care, and provides Certificate of Need (CON) criteria and standards for each service requiring CON review. These services include: long-term care, including care for the aged and the intellectually disabled; mental health care, including psychiatric, chemical dependency, and long-term residential treatment facilities; perinatal care; acute care, including various types of diagnostic and therapeutic services; ambulatory care, including outpatient services and freestanding ambulatory surgical centers; comprehensive medical rehabilitation; home health services; and end stage renal disease facilities. The State Health Plan includes data provided by the Division of Licensure and Certification via the Applications for Renewal of Hospital License, the Annual Hospital Reports, and the Report on Institutions for the Aged or Infirmed. The Office of Licensure and Certification is responsible for the collection of these data through reports submitted by hospitals and healthcare facilities. These data are reported in the Plan as it has been provided by the Office of Licensure and Certification for health planning purposes. The Glossary contains definitions of terms and phrases used in this Plan. General Certificate of Need Policies Mississippi’s health planning and health regulatory activities have the following purposes: To improve the health of Mississippi residents; To increase the accessibility, acceptability, continuity, and quality of health services; To prevent unnecessary duplication of health resources; and To provide cost containment. MSDH intends to approve an application for CON if it substantially complies with the projected need and with the applicable criteria and standards presented in this Plan, and to disapprove all CON applications which do not substantially comply with the projected need or with applicable criteria and standards presented in this Plan. MSDH intends to disapprove CON applications which fail to confirm that the applicant shall provide a reasonable amount of indigent care or if the applicant’s admission policies deny or discourage access to care by indigent patients. Furthermore, MSDH intends to disapprove CON applications if such approval would have a significant adverse effect on the ability of an existing facility or service to provide Medicaid/indigent care. Finally, it is the intent of the Mississippi State Department of Health to strictly adhere to the criteria set forth in the State Health Plan and to ensure that any provider desiring to offer healthcare services covered by the Certificate of Need statutes undergoes review and is issued a Certificate of Need prior to offering such services. The State Health Officer shall determine whether the amount of indigent care provided or proposed to be offered is “reasonable.” The Department considers a reasonable amount of indigent care as that which is comparable to the amount of such care offered by other providers of the requested service within the same, or proximate, geographic area. MSDH may use a variety of statistical methodologies including, but not limited to, market share analysis or patient origin data to determine substantial compliance with projected need and with applicable criteria and standards in this Plan. 102.1 Teaching Hospital Exceptions Section 41-7-187, Mississippi Code Annotated, as amended, authorizes MSDH to develop and implement the CON program. As the Mississippi Supreme Court recognized in Jackson HMA, LLC, et al. v. Mississippi State Department of Health, et al., 98 So.3d 980, 986 (Miss. 2012), through this statute and others the Legislature delegated to MSDH the authority to adopt rules and regulations “to determine when a CON is required.” Therefore, any activity or project at the University of Mississippi Medical Center principally designed to train health professionals and/or further the academic research mission of the institution, shall not require the issuance of a CON, notwithstanding any provision in Section 41-7-171 et seq. to the contrary, provided that any person proposing to undertake any such activity that may be subject to the CON program shall file a Determination of Reviewability, as authorized by Section 41-7- 205 and the Mississippi Certificate of Need Review Manual or other regulations adopted by MSDH, that demonstrates the activity or project: 1. Is consistent with the teaching and/or academic research mission of the applicant; 2. Is undertaken in support of a program(s) accredited by the Accreditation Council for Graduate Medical Education (ACGME), Liaison Committee on Medical Education (LCME), or other academic accrediting body, including but not limited to, the Commission on Collegiate Nursing Education (CCNE), Accreditation Council for Pharmacy Education (ACPE), Commission on Dental Accreditation (CODA), and Southern Association of Colleges and Schools Commission on Colleges (SACSCOC); and 3. Addresses one or more priority health need(s) of the State Health Plan. 102.2 UMMC Academic Exemption Established by Statute Pursuant to House Bill 3 from the 2026 Legislative Session (effective February 4, 2026), the University of Mississippi Medical Center (UMMC) qualifies for the statutory academic exemption established by law, subject to the following provisions: 1. Grandfathered Projects: Hospital beds, services, healthcare facilities, and medical equipment approved and continuously operated pursuant to a teaching hospital exemption, and projects approved or applied for before February 4, 2026, shall not be subject to the geographic limitations established in this section. 2. Defined Boundary: For projects initiated on or after February 4, 2026, the academic exemption shall apply only within the area in the City of Jackson bounded by Livingston Road on the west, Woodrow Wilson Avenue on the south, Interstate 55 on the east, and Lakeland Drive on the north. 3. Academic Function Determination: To qualify for this statutory exemption, UMMC shall submit a request to the Department, and the State Health Officer must determine that the proposed project serves a substantial and meaningful academic function in furtherance of UMMC's teaching, research, or clinical education mission. 4. Relocation: Any facility, service, or equipment relocated after February 4, 2026, shall be subject to the requirements of this section and shall not retain any prior academic exemption status unless otherwise authorized by law. 102.3 Small Community Hospital Pilot Program Established by Statute Pursuant to House Bill 1622 from the 2026 Legislative Session, certain qualifying small community hospitals are eligible to participate in the Small Community Hospital Pilot Program established by law. The program authorizes specified exemptions from Certificate of Need requirements and the establishment or operation of certain healthcare services, including geriatric psychiatric services and end-stage renal disease (ESRD) services, subject to the eligibility requirements, geographic limitations, service restrictions, application deadlines, and other conditions established by statute. Projects undertaken pursuant to the Small Community Hospital Pilot Program shall be governed by applicable statutory provisions, Department licensing requirements, and the Mississippi Certificate of Need Review Manual. The Department shall administer the Small Community Hospital Pilot Program in accordance with applicable statutory provisions and the Mississippi Certificate of Need Review Manual. Nothing in this Plan shall be construed to expand, limit, or modify the authority granted under the Small Community Hospital Pilot Program. Population for Planning Population projections used in this Plan were calculated by the State Data Center of Mississippi, University of Mississippi Center for Population Studies, November 9, 2020. This plan is based on 2025 population projections. Map 1-1 depicts the state 2025 estimated population by county. Mississippi population projections for the years 2020 and 2025 were obtained from the State Data Center of Mississippi, University of Mississippi Center for Population Studies, November 9, 2020. Health Personnel High quality health care services depend on the availability of competent health personnel in sufficient numbers to meet the population's needs. Mississippi is traditionally a medically underserved state, particularly in sparsely populated rural areas and areas containing large numbers of poor people, elderly people, and minorities. This section discusses some of the areas of greatest need for health care personnel, focusing on physicians, dentists, and nurses. .0 Physicians Mississippi had 5,688 active medical doctors, 533 osteopaths, and sixty-seven (67) podiatrists licensed by the Board of Medical Licensure for FY 2019 (licensing year 2020) for a total of 6,288 active licensed physicians practicing in the state. This number represents an increase of sixty-nine (69) physicians, or more than 1.02 percent, from FY 2018 (licensing year 2019). Approximately 2,375 (42 percent) of the state's active medical doctors are primary care physicians, representing a ratio of one (1) primary care physician for every 1,303 persons, based on 2025 projected population. The primary care physicians included 758 family practitioners, sixty-nine (69) general practitioners, 741 internal medicine physicians, 317 obstetrical and gynecological physicians, and 490 pediatricians. Map 1-2 depicts the total number of primary care medical doctors by county. According to the Health Resources and Services Administration’s Division of Policy and Shortage Designation (HRSA/DPSD), Mississippi has a total of 149 primary care health professional shortage area (HPSA) designations. Seventy-nine (79) of the designations are single county designations. The United States Department of Health and Human Services defines a primary care HPSA as a geographic area that has a ratio in excess of 3,500 persons per primary care physician and insufficient access to those physicians within a thirty-minute (30) traveling radius. Also, areas with 3,000 to 3,500 persons per primary care physician that have unusually high needs for primary care services and have insufficient access to primary care doctors within a thirty-minute (30) traveling radius, can also be designated as a primary care HPSA. .1 Dentists The Mississippi State Board of Dental Examiners reported 1,620 licensed (1,450 “active” and 170 “inactive”) dentists in the state as of April 2021, seventy-four (74) new dentists licensed during calendar year 2020. Based on Mississippi’s projected population of 3,095,026 the state has one (1) active dentist for every 2,135 persons. According to the Health Resources and Services Administration’s Division of Policy and Shortage Designation (HRSA/DPSD), Mississippi currently has a total of 146 dental health professional shortage area (HPSA) designations. Seventy-nine (79) of the designations are single county designations. Mississippi’s two major population centers contain the most active dentists. The Jackson area had a total of 409 active dentists in the fall of 2021, with 158 in Hinds County, 121 in Rankin County, and 130 in Madison County. The Gulf Coast region had the second largest count at 198, with 119 in Harrison County, sixty-six (66) in Jackson County, and thirteen (13) in Hancock County. Combined, these two metropolitan areas contained forty-two percent of the state's total supply of active dentists. On the opposite end of the spectrum, six counties — Greene, Kemper, Noxubee, Quitman, Tishomingo, and Tunica – had only one active dentist each and six counties — Claiborne, Franklin, Humphreys, Issaquena, Jefferson, and Sharkey — had no active dentist. Map 1-3 depicts the number of dentists per county and indicates the number of in-state, active, licensed dentists who have mailing addresses in the state. .2 Nurses The Mississippi Board of Nursing reported 52,106 registered nurses (RNs) licensed in FY 2020 with 42,088 who worked full or part-time in nursing careers. That included 21,606 in hospitals; 3,781 in community, public, or home health; 2,654 in physicians’ offices; 2,326 in nursing homes; and 27,739 in other nursing careers. Registered Nurses by degree in FY 2020 included, 3,945 diploma, 20,164 associates, 3,996 baccalaureate non-nursing, 14,612 baccalaureate nursing, 8,313 masters nursing, and 1,076 doctorate degrees. Advanced Practice Registered Nurses Advanced practice registered nurse (APRN) includes any person licensed to practice nursing in Mississippi and certified by the Board of Nursing to practice in an expanded role as an advanced practice registered nurse including nurse midwives and certified registered nurse anesthetists. For FY 2020 there were 6,425 RNs certified as APRNs, with 5,444 family nurse practitioners; 948 certified registered nurse anesthetists; and thirty-three (33) certified nurse midwives. The APRN’S practiced in such specialties as adult and family mental health, gerontology, midwifery, neonatal, pediatric, women’s health care, family planning, and anesthesia care. Licensed Practical Nurses The Board of Nursing reported 12,909 licensed practical nurses (LPNs) licensed in FY 2020 with 10,537 who worked full or part-time in nursing careers. That included 3,652 in nursing homes; 1,049 in hospitals; 1,743 in community, public, or home health; and 5,196 in other nursing careers. There were 5,478 LPNs certified for an expanded role in FY2020, including intravenous therapy, 184 in hemodialysis, and 154 in both expanded roles. .3 Physical Therapy Practitioners Physical therapy (PT) practitioners provide preventive, diagnostic, and rehabilitative services to restore function or prevent disability from disease, trauma, injury, loss of a limb, or lack of use of a body part to individuals of all ages. The Mississippi State Board of Physical Therapy reported 2,192 licensed physical therapists in Mississippi as of March 16, 2021, with 1,867 residing in the state and 1,826 practicing in the state. Six percent of Mississippi resident physical therapist practitioners live in Hinds County, 4.74 percent in Harrison County, 2.28, percent in Madison County, and 4.74 percent in Lee County for a total of 17.79 percent in 4 counties. The Board also reported 1,480 licensed physical therapist assistants, with 1,325 residing in the state and 1,247 practicing in the state. .4 Occupational Therapists Occupational therapy (OT) is a health and rehabilitation profession that serves people of all ages who are physically, psychologically, or developmentally disabled. Their functions range from diagnosis to treatment, including the design and construction of various special and self-help devices. OTs direct their patients in activities designed to help them learn skills necessary to perform daily tasks, diminish or correct pathology, and promote and maintain health. MSDH reported 1,218 licensed occupational therapists and 670 licensed occupational therapy assistants on its Mississippi roster as of November 9, 2020, with 1,085 of OTs and 611 of OTAs residing in the state. .5 Emergency Medical Personnel The training of emergency medical personnel includes ambulance operators and emergency medical technicians (EMTs) of both advanced and basic levels. Mississippi requires all ambulance drivers to have EMS driver certification (EMS-D). To qualify, an individual must complete an approved driver training program that involves driving tasks, vehicle dynamics, vehicle preventative maintenance, driver perception, night driving, and information on different driving maneuvers. This training offers both academic and clinical (practical hands on) experiences for the prospective ambulance driver. In FY 2020, Mississippi issued 1,166 EMS driver certifications or recertifications. Additionally, all emergency medical technicians – both advanced level and basic level – must complete a National Highway Safety and Traffic Administration training program for the respective level. This training provides extensive academic and clinical hours for the prospective students. Upon completion, students must pass the National Registry for Emergency Medical Technicians test and receive their national certification before applying for the Mississippi certification. For FY 2020, the MSDH Bureau of Emergency Medical Services reported issuing a total of 4,334 EMT certifications or recertifications 1,265 for Paramedics, Advanced Emergency Medical Technicians Critical Care Paramedics. The Legislature authorized the MSDH Bureau of Emergency Medical Services (BEMS) to certify Mississippi’s medical first responders beginning July 1, 2004. In fiscal year 2020, BEMS certified nine (9) medical first responders. Chapter 2 Long-Term Care “Long-term care” refers to a variety of services rendered to assist a person with chronic conditions or disabilities that reduce their capacity to function independently. Mississippi’s long-term care (nursing home and home health) patients are primarily disabled, elderly people, who make up eighteen percent (18%) percent of the 2025 projected population above age sixty-five (65). Projections place the number of people in this age group at approximately 548,497 by 2025. The risk of becoming frail, disabled, and dependent rises dramatically with age. While the average length of life has increased, people are often living longer with disabling chronic conditions, which the present medical system can “manage” but not cure. As a result, aged individuals may become dependent on medical technology and professional care providers for years—not just weeks or months. Options for Long-Term Care Community based long-term care programs can potentially delay or prevent institutionalization. These programs, although not reviewable under Certificate of Need, drastically affect the demand for skilled nursing beds. Community based programs play a vital role in helping the elderly maintain some degree of independence. Examples of community-based elder-care include adult day care, senior centers, transportation, meals on wheels or meals at community locations, and home health services. More information concerning such services can be obtained by contacting the Mississippi Department of Human Services, Division of Aging and Adult Services. Housing for the Elderly Many elderly or infirm people do not need skilled nursing care on a daily basis, but may need safe, affordable housing and assistance with one or more activities of daily living. Housing for the elderly and infirmed population can take many forms. “Board and care homes” are residences providing rooms (often semi-private), shared common areas, meals, protective oversight, and help with bathing, dressing, grooming, and other daily needs. In Mississippi, these facilities are licensed as personal care homes: Personal Care Home - Residential Living facilities and Personal Care Home - Assisted Living facilities. Both types of facilities provide a sheltered environment and assistance with activities of daily living. Additionally, Personal Care Homes - Assisted Living may provide additional supplemental medical services that include the provision of certain routine health maintenance and emergency response services. In November of 2020, the state had 197 licensed personal care homes, with a total of 7,628 licensed beds. Personal care facilities presently are not reviewable under Certificate of Need authority. “Retirement communities” or “senior housing facilities” have become common around the state. These communities usually provide apartments for independent living, with services such as transportation, weekly or bi-weekly housekeeping, and one to three daily meals. Many of these facilities include a licensed personal care home where the resident may move when he or she is no longer physically or mentally able to remain in their own apartment. Most facilities do not require an initial fee or require their residents to sign a lifetime contract. Most facilities generally offer only independent living and personal care. Most also do not include a skilled nursing home as a part of the retirement community. Table 2-1 shows the distribution of personal care facilities by Long-Term Care Planning Districts. Nursing Facilities As of FY 2020, Mississippi has 210 licensed skill nursing facilities with a total of 18,068 licensed beds. Map 2-1 shows the general Long-Term Care Planning Districts and Table 2-2 presents the projected nursing home bed need for 2020 by Planning District. Both the map and table appear in the criteria and standards section of this chapter. For 2025 projections, see Table 2-2A in the Appendix, Long-Term Care Beds for Individuals with Intellectual & Developmental Disabilities Mississippi has 1,991 licensed beds classified as Intermediate Care Facility for the Intellectually Disabled (ICF/ID). The Department of Mental Health (DMH) operates five (5) comprehensive regional programs that contain 1,334 active licensed and staffed beds. In addition to intellectual and developmental disabilities, the residents of the DMH regional centers also have severe physical disabilities that result in residents requiring care at the nursing home level. Regular nursing facilities are not equipped to serve these individuals. Map 2-2 shows the ID/DD Long- Term Care Planning Districts and Table 2-3 presents the ID/DD nursing home bed need by Planning District. Both the map and table appear in the criteria and standards section of this chapter. Certificate of Need Criteria and Standards for Nursing Home Beds NOTE: Should the Mississippi State Department of Health receive a Certificate of Need application regarding the acquisition and/or control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until the Department of Health has developed and adopted CON criteria and standards. If the Department has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of the Mississippi State Department of Health. 204.1 Policy Statement Regarding Certificate of Need Applications for the Offering of Nursing Home Care Services 1. Legislation a. The 1990 Mississippi Legislature imposed a permanent moratorium which prohibits MSDH from granting approval for or issuing a Certificate of Need to any person proposing the new construction of, addition to, expansion of, or conversion of vacant hospital beds to provide skilled or intermediate nursing home care, except as specifically authorized by statute. b. Effective July 1, 1990, any healthcare facility defined as a psychiatric hospital, skilled nursing facility, intermediate care facility, intermediate care facility for the intellectually disabled, or psychiatric residential treatment facility that is owned by the State of Mississippi and under the direction and control of the State Department of Mental Health, is exempted from the requirement of the issuance of a Certificate of Need under Section 41-7-171 et seq., for projects which involve new construction, renovation, expansion, addition of new beds, or conversion of beds from one category to another in any such defined healthcare facility. c. The 1999 Mississippi Legislature temporarily lifted the 1990 moratorium to allow a sixty (60) bed nursing facility to be added to each of twenty-six (26) counties with the greatest need between the years 2000 and 2003. The Legislature also permitted CONs for sixty (60) nursing facility beds for individuals with Alzheimer’s in the northern, central, and southern parts of each of the Long-Term Care Planning Districts, for a total of 240 additional beds. d. Effective April 12, 2002, no healthcare facility shall be authorized to add any beds or convert any beds to another category of beds without a Certificate of Need. e. Effective March 4, 2003, if a healthcare facility has voluntarily delicensed some of its existing bed complement, it may later relicense some or all of its delicensed beds without the necessity of having to acquire a Certificate of Need. The facility must submit a letter requesting that the beds be placed in abeyance. The Department of Health shall maintain a record of the delicensing healthcare facility and its voluntarily delicensed beds and continue counting those beds as part of the state’s total bed count for health care planning purposes. f. A healthcare facility that has ceased to operate for a period of sixty (60) months or more shall require a Certificate of Need prior to reopening. g. Pursuant to Section 2 of House Bill 1622 (2026 Regular Session), the continuation of the moratorium on skilled nursing facilities, intermediate care facilities, and intermediate care facilities for individuals with intellectual disabilities is re- enacted. The Mississippi Legislature has determined that the current number of licensed beds in skilled nursing facilities within multiple regions of the state is sufficient to meet current needs, and that increasing capacity would lead to unnecessary institutionalization. This continuation is rationally related to preventing unnecessary expansion, avoiding excess institutional capacity, containing costs, and protecting the fiscal sustainability of the Medicaid program. h. MSDH shall determine the need for additional nursing home care beds based on the Long-Term Care Planning Districts (LTCPDs) as outlined on Map 2-1. MSDH shall calculate the statistical need for beds in each LTCPD independently of all other LTCPDs. 2. Bed Need: The need for nursing home care beds is established at: 0.5 beds per 1,000 population aged 64 and under 10 beds per 1,000 population aged 65-74 36 beds per 1,000 population aged 75-84 135beds per 1,000 population aged 85 and older 3. Population Projections: MSDH shall use population projections as presented in Table 2-3 when calculating bed need. These population projections are the most recent projections prepared by the State Data Center of Mississippi, University of Mississippi Center for Population Studies, February 13, 2018. 4. Bed Inventory: MSDH shall review the need for additional nursing home beds using the most recent information available regarding the inventory of such beds. 5. Size of Facility: MSDH shall not approve construction of a new or replacement nursing home care facility for less than sixty (60) beds. However, the number of beds authorized to be licensed in a new or replacement facility may be less than sixty (60) beds. 6. Definition of CCRC: See the Glossary of this Plan. 7. Medicare Participation: MSDH strongly encourages all nursing homes participating in the Medicaid program to also become certified for participation in the Medicare program. 8. Alzheimer’s/Dementia Care Unit: MSDH encourages all nursing home owners to consider the establishment of an Alzheimer’s/Dementia Care Unit as an integral part of their nursing care program. 204.2 Certificate of Need Criteria and Standards for Nursing Home Care Beds If the legislative moratorium were removed or partially lifted, MSDH would review applications for the offering of nursing home care under the statutory requirements of Sections 41-7-173 (h) subparagraphs (iv) and (vi), 41-7-191, and 41-7-193, Mississippi Code of 1972, as amended. MSDH will also review applications for Certificate of Need according to the applicable policy statements contained in this Plan; the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. Certificate of Need review is required for the offering of nursing home care services, as defined, if the capital expenditure exceeds $10,000,000; if the licensed bed capacity is increased through the conversion or addition of beds; or if nursing home care services have not been provided on a regular basis by the proposed provider of such services within the period of twelve (12) months prior to the time such services would be offered. Certificate of Need review is required for the construction, development, or otherwise establishment of new nursing home care beds regardless of capital expenditure. Need Criterion 1: Nursing Home Care Bed Need The applicant shall document a need for nursing home care beds using the need methodology as presented herein. The Long-Term Care Planning District wherein the proposed facility will be located must show a need using the following ratio: 0.5 beds per 1,000 population aged 64 and under 10 beds per 1,000 population aged 65- 74 36 beds per 1,000 population aged 75-84 135 beds per 1,000 population aged 85 and older Need Criterion 2: Number of Beds to be Constructed, Converted, and/or Licensed The applicant shall document the number of beds that will be constructed, converted, and/or licensed to provide nursing home care services. Need Criterion 3: Consideration of Statistical Need MSDH should consider the area of statistical need as one criterion when awarding Certificates of Need in the case of competing applications. Need Criterion 4: Alzheimer’s/Dementia Care Unit Any applicant applying for nursing home beds who proposes to establish an Alzheimer’s/Dementia Care Unit shall affirm that the applicant shall fully comply with all licensure regulations of MSDH for said Alzheimer’s/Dementia Care Unit. 204.3 Certificate of Need Criteria and Standards for the Relocation/Transfer of Nursing Home Beds Need Criterion 1: Relocation/Transfer of Nursing Home Care Beds An applicant proposing to relocate/transfer a portion or all of an existing facility’s nursing home care beds to another location shall document the relocation/transfer is within the current facility’s LTCPD. Need Criterion 2: Number of Beds to be Relocated/Transferred The applicant shall document the number of beds to be relocated/transferred to provide nursing home care services. Need Criterion 3: Alzheimer’s/Dementia Care Unit Any applicant applying for the relocation/transfer of nursing home beds in an Alzheimer’s/Dementia Care Unit shall affirm that the applicant shall fully comply with all licensure regulations of MSDH for said Alzheimer’s/Dementia Care Unit. 204.4 Certificate of Need Criteria and Standards for Nursing Home Beds as Part of a Continuing Care Retirement Community (CCRC) Entities desiring to establish nursing home beds as part of a CCRC shall meet all applicable requirements, as determined by MSDH, of the policy statements and general CON criteria and standards in the Mississippi Certificate of Need Review Manual and the CON criteria and standards for nursing home beds established in this State Health Plan. Policy Statement Regarding Certificate of Need Applications for a Pediatric Skilled Nursing Facility 1. The 1993 Mississippi Legislature authorized MSDH to issue a Certificate of Need for the construction of a pediatric skilled nursing facility not to exceed sixty (60) new beds. 2. A pediatric skilled nursing facility is defined as an institution or a distinct part of an institution that is primarily engaged in providing inpatients skilled nursing care and related services for persons under twenty-one (21) years of age who require medical, nursing care, or rehabilitation services. 3. MSDH will review applications for the construction of pediatric skilled nursing facility beds using the general CON review criteria and standards contained in the Mississippi Certificate of Need Review Manual, criteria and standards for nursing homes and ID/DD facilities contained in the State Health Plan, and all adopted rules, procedures, and plans of MSDH. 4. Effective April 12, 2002, no healthcare facility shall be authorized to add any beds or convert any beds to another category of beds without a Certificate of Need under the authority of Miss. Code Ann. § 41-7-191(1)(c). 5. Effective March 4, 2003, if a healthcare facility has voluntarily delicensed some of its existing bed complement, it may later relicense some or all of its delicensed beds without the necessity of having to acquire a CON. The facility must submit a letter requesting that the beds be placed in abeyance. MSDH shall maintain a record of the delicensing healthcare facility and its voluntarily delicensed beds and continue counting those beds as part of the state’s total bed count for healthcare planning purposes Certificate of Need Criteria and Standards for Nursing Home Care Services for Intellectually and Other Developmentally Disabled Individuals 206.1 Policy Statement Regarding Certificate of Need Applications for the Offering of Nursing Home Care Services for Intellectually and Other Developmentally Disabled Individuals 1. Legislation a. The 1990 Mississippi Legislature imposed a permanent moratorium which prohibits the MSDH from granting approval for or issuing a CON to any person proposing the new construction, addition to, or expansion of an intermediate care facility for the intellectually disabled (ICF/ID). b. Effective July 1, 1990, any healthcare facility defined as a psychiatric hospital, skilled nursing facility, intermediate care facility, intermediate care facility for the intellectually disabled, or psychiatric residential treatment facility which is owned by the State of Mississippi and under the direction and control of the Mississippi Department of Mental Health is exempted from the requirement of the issuance of a CON under Section 41-7-171 et seq., for projects which involve new construction, renovation, expansion, addition of new beds, or conversion of beds from one category to another in any such defined healthcare facility. c. Effective April 12, 2002, no healthcare facility shall be authorized to add any beds or convert any beds to another category of beds without a CON. d. Effective March 4, 2003, if a healthcare facility has voluntarily delicensed some of its existing bed complement may later relicense some or all of its delicensed beds without the necessity of having to acquire a CON. The facility must submit a letter requesting that the beds be placed in abeyance. MSDH shall maintain a record of the delicensing healthcare facility and its voluntarily delicensed beds and continue counting those beds as part of the state’s total bed count for health care planning purposes. e. 2026 Legislative Findings Regarding Continuation of Moratoria: Effective April 17, 2026, the Mississippi Legislature reaffirmed its determination that continuation of the moratorium on new intermediate care facilities and expansion of existing intermediate care facilities for individuals with intellectual disabilities remains in the public interest. The Legislature found that there is no comprehensive statewide demonstration of systemic capacity shortages requiring expansion of licensed intermediate care facility beds and that expansion of institutional capacity absent objective evidence of unmet need may increase aggregate public expenditures. The Legislature further determined that continuation of the moratorium is rationally related to preventing unnecessary expansion, avoiding duplication of services, ensuring appropriate allocation of healthcare resources, and protecting the fiscal sustainability of the Medicaid program. 2. Legislative Authorization – Madison County Community Living Program Beds: Pursuant to House Bill 3 from the 2026 Legislative Session (effective February 4, 2026), the Department shall issue a Certificate of Need to the nonprofit corporation specifically authorized by law for the construction, expansion, or conversion of twenty (20) additional beds in a community living program for developmentally disabled adults located in Madison County, Mississippi. This legislatively authorized issuance shall not be subject to the bed need methodology, planning district requirements, moratoria, or other review criteria contained in this Plan that would otherwise apply to applications for nursing home care services for intellectually and other developmentally disabled individuals. Pursuant to the statutory provisions governing this project, the formal Certificate of Need hearing process under Miss. Code Ann. § 41-7-197 is waived. No public hearing, third- party appeal, or cross-appeal shall be available with respect to the issuance of the Certificate of Need required by this subsection. 3. ID/DD Long-Term Care Planning Districts (ID/DD LTCPD): The need for additional ID/DD nursing home care beds shall be based on the ID/DD LTCPDs as outlined on Map 2-2. 4. Bed Need: The need for ID/DD nursing home care beds is established at one bed per 1,000 population less than 65 years of age. 5. Population Projections: MSDH shall use population projections as presented in Table 2-3 when calculating bed need. 6. Bed Limit: No ID/DD LTCPD shall be approved for more than its proportioned share of needed ID/DD nursing home care beds. No application shall be approved which would over-bed the state as a whole. 7. Bed Inventory: MSDH shall review the need for additional ID/DD nursing home care beds utilizing the most recent information available regarding the inventory of such beds. 206.2 Certificate of Need Criteria and Standards for Nursing Home Beds for Intellectually and Other Developmentally Disabled Individuals If the legislative moratorium were removed or partially lifted, MSDH would review applications for ID/DD nursing home care beds under the statutory requirements of Sections 41-7-173 (h) subparagraph (viii), 41-7-191, and 41-7-193, Mississippi Code 1972, as amended. MSDH will also review applications for Certificate of Need according to the applicable policy statements contained in this Plan; the general criteria as listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. Certificate of Need review is required for the offering of ID/DD nursing home care services, as defined, if the capital expenditure exceeds $10,000,000.00; if the licensed bed capacity is increased through the conversion or addition of beds; or if ID/DD nursing home care services have not been provided on a regular basis by the proposed provider of such services within the period of twelve (12) months prior to the time such services would be offered. Certificate of Need review is required for the construction, development, or otherwise establishment of new ID/DD nursing home care beds regardless of capital expenditure. Need Criterion 1: ID/DD Nursing Home Care Bed Need The applicant shall document need for ID/DD nursing home care beds using the need methodology as presented below. The applicant shall document in the application the following: A. Using the ratio of one bed per 1,000 population under sixty-five (65) years of age, the state as a whole must show a need; and B. The ID/DD Long-Term Care Planning District (LTCPD) where the proposed facility/beds/services are to be located must show a need. Need Criterion 2: Number of Beds to Be Constructed, Converted, and/or Licensed The applicant shall document the number of beds that will be constructed, converted and/or licensed as offering ID/DD nursing home care services. Need Criterion 3: Facilities Proposing to Add Fifteen or Less ID/DD Beds MSDH shall give priority consideration to those CON applications proposing the offering of ID/DD nursing home care services in facilities which are fifteen (15) beds or less in size. Chapter 3 Mental Health This chapter addresses mental illness, alcoholism, drug abuse, and developmental disabilities. These conditions result in social problems of such magnitude that mental health ranks as one of the state’s priority health issues. The Mississippi Department of Mental Health (DMH), regional Community Mental Health Centers (CMHCs) and licensed private sector facilities provide most of the state's mental health services. Unless otherwise specified, information in this chapter is limited to the programs and services of private non-governmental entities. Mississippi Department of Mental Health State law designates DMH as the agency to coordinate and administer the delivery of public mental health services, alcohol/drug abuse services, and services for persons with intellectual/developmental disabilities throughout the state, as well as community-based day programs for individuals with Alzheimer’s disease and other dementia. Responsibilities of DMH include: (a) state-level planning and expansion of all types of mental health, intellectual/developmental disabilities and substance abuse services, (b) standard-setting and support for community mental health and intellectual/developmental disabilities and alcohol/drug abuse programs, (c) state liaison with mental health training and educational institutions, (d) operation of the state's psychiatric facilities, and (e) operation of the state's facilities for individuals with intellectual/developmental disabilities. Regional community mental health centers provide a major component of the state's mental health services. Fourteen (14) centers currently operate in the state's mental health service areas, and most centers have satellite offices in other counties. Each center must meet federal and state program and performance standards. The major objectives of the regional community mental health centers include: (a) providing accessible services to all citizens with mental and emotional problems; (b) reducing the number of initial admissions to state hospitals; and (c) preventing re-admissions through supportive aftercare services. These centers are a vital element in the plan to provide an integrated system of mental health services to all residents of Mississippi. Mental Health Needs in Mississippi The prevalence of mental illness, although difficult to assess, serves as a good indicator of the volume of need for mental health services in a given population. The negative social stigma associated with the term “mental illness” also obstructs efforts to measure the true incidence/ prevalence of most types of mental illness and behavior disorders and the need for mental health services. Using the methodology updated by the federal Center for Mental Health Services (CMHS) for estimated prevalence of serious mental illness among adults (Federal Register, June 24, 1999) and U.S. Bureau of the Census 2010 population estimates, DMH estimates the 2019 prevalence rate of serious mental illness among adults in Mississippi, ages eighteen (18) years and above, as 5.2 percent or 109,000 individuals. The same methodology estimates the national prevalence for the same age group also as 5.2 percent. In Fiscal Year 2020, a total of 3,697 people received services at state-operated behavioral health programs which include the Mississippi State Hospital, East Mississippi State Hospital, North Mississippi State Hospital, South Mississippi State Hospital, Specialized Treatment Facility, and Central Mississippi Residential Center. A total of 2,197 adults received acute psychiatric services at the four (4) state hospitals in Fiscal Year 2020; and a total of 110,200 people were served at the fourteen (14) CMHCs in 2018. 301.1 Mental Health Needs of Children/Adolescents Precise data concerning the size of the country’s population of children and adolescents with emotional or mental disorders remain difficult to obtain. The National Institute of Mental Health estimates the prevalence of any mental disorder nationally among adolescents, aged thirteen (13) to eighteen (18), is 49.5 percent with an estimated 22.2 percent having a severe impairment. The methodology adjusts for socio-economic differences across states. In Fiscal Year 2018, the fourteen (14) CMHCs served 34,795 children and adolescents with serious emotional disturbance. (Note: Totals might include some duplication across community mental health centers and other nonprofit programs). 301.2 National Survey on Drug Use and Health for Mississippi According to the Substance Abuse and Mental Health Administration’s (SAMHSA) 2020 Behavioral Health Barometer for Mississippi (most available data), during 2017-2019, the annual average prevalence of past-year illicit drug use disorder among people aged twelve (12) years or older was 2.4% (or 58,000), similar to both the regional average (2.7%) and the national average (2.9%). Also, during 2017 – 2019, among people aged twelve (12) or older, the annual average prevalence of past-year marijuana use in Mississippi was 11.8% (or 290,000), lower than both the regional average (14.0%) and the national average (16.2%); and, the annual average prevalence of past-year alcohol use disorder was 4.4% (or 107,000), similar to both the regional average (4.5%) and the national average (5.3%). 301.3 Developmental Disabilities The nationally accepted prevalence rate estimate used by the Administration on Developmental Disabilities for estimating the state rate is 1.8 percent of the general population. By applying the 1.8 percent prevalence rate to Mississippi’s 2025 population projections, the results equal 56,072 individuals who may have a developmental disability. The intellectual and/or developmental disability bed need determinations can be found in Chapter 2 of this Plan. Adult Psychiatric Services (State Operated and Private) Mississippi’s four (4) state-operated hospitals and thirteen (13) crisis stabilization units provide the majority of inpatient psychiatric care and services throughout the state. In FY 2018, the Mississippi State Hospital at Whitfield reported a total of 118 active psychiatric licensed beds; East Mississippi State Hospital at Meridian reported 108 active psychiatric licensed beds, North Mississippi State Hospital in Tupelo reported fifty (50) licensed beds, and South Mississippi State Hospital in Purvis reported fifty (50) licensed beds. The four (4) facilities reported 2,197 adults received acute psychiatric services at the hospitals in FY 2020, 849 at the Mississippi State Hospital at Whitfield, 407 at the East Mississippi State Hospital, 475 at the North Mississippi State Hospital, and 466 at the South Mississippi State Hospital. Additionally, a total of 3,525 adults were served through the thirteen (13) crisis centers in FY 2020. Because the medically indigent have difficulty accessing private psychiatric facilities in their respective communities, many private facilities have low occupancy rates. State institutions provide the majority of inpatient care for the medically indigent. To address this problem, the Legislature provided funding for seven (7) state Crisis Intervention Centers to function as satellites to existing facilities operated by DMH. These centers are operational in Brookhaven, Corinth, Newton, Laurel, Cleveland, Grenada, Gulfport, and Batesville. DMH contracted with Life Help (Region VI Community Mental Health Center) to operate the crisis center in Grenada beginning September 1, 2009. This pilot program began with the purpose of studying the potential for increased efficiencies and improved access to services for individuals without them being involuntarily committed. The role of these centers in the regional system is to provide stabilization and treatment services to persons who are in a psychiatric crisis. Beginning July 1, 2010, DMH transitioned five (5) of the remaining state-operated crisis centers (now called Crisis Stabilization Units) to regional community mental health centers located in Batesville, Brookhaven, Cleveland, Corinth and Laurel. In 2017, DMH transitioned the remaining crisis center in Newton to Weems Community Mental Health Center. The Gulfport center is operated by Gulf Coast Mental Health (Region XIII CMHC) and is partially funded by a grant from DMH. Timber Hills operates a Crisis Stabilization Unit (CSU) in Batesville and Corinth. Region 8 Mental Health Services operates the Brookhaven CSU. Delta Community Mental Health (Region V CMHC) operates the Cleveland CSU. Pine Belt Mental Healthcare Resources operates the Laurel CSU. All CSUs accept voluntary and involuntary admissions twenty-four (24) hours a day, seven (7) days a week. In FY 2019, a shift in funds from the DMH’s inpatient programs to its service budget allowed for the opening of forty-eight (48) additional crisis stabilization beds. Previously, Mississippi had eight (8), 16-bed Crisis Stabilization Units across the state. Currently, there are thirteen (13) Crisis Stabilization Units with 176 beds. The new units include: LifeCore Health Group (Region 3) which opened eight (8) crisis beds in Tupelo; Community Counseling Services (Region 7) which opened eight (8) beds in West Point; Singing River (Region 14) which opened eight (8) beds in Gautier; Hinds Behavioral Health Services (Region 9) which opened sixteen (16) beds in Jackson; and Region 1 Community Mental Health Center which opened eight (8) beds in Marks. These beds offer time-limited residential treatment services to serve adults with severe mental health episodes that if not addressed would likely result in the need for inpatient treatment. In FY 2020, the CSUs had a 91% diversion rate from people having to enter the state hospitals for inpatient treatment. Mississippi has eighteen (18) adult psychiatric facilities, with a capacity of 677 licensed beds for adult psychiatric patients, including 231 beds held in abeyance by MSDH distributed throughout the state. The criteria and standards section of this chapter provides a full description of the services that private facilities must provide. Map 3-1 shows the location of inpatient facilities in Mississippi serving adult acute psychiatric patients; Table 3-1 shows utilization statistics. Child Adolescent Psychiatric Services Nine facilities, with a total of 277 licensed beds, provide acute psychiatric inpatient services for children and adolescents. Map 3-2 shows the location of inpatient facilities that serve adolescent acute psychiatric patients; Table 3-2 gives utilization statistics. The criteria and standards section of this chapter provides a further description of the programs that inpatient facilities offering child/adolescent psychiatric services must provide. DMH operates a separately licensed twenty-two (22) bed facility (Oak Circle Center) at Mississippi State Hospital to provide short-term inpatient psychiatric treatment for children and adolescents between the ages of four (4) and seventeen (17). Psychiatric Residential Treatment Facilities Psychiatric Residential Treatment Facilities (PRTF) serve emotionally disturbed children and adolescents who are not in an acute phase of illness that requires the services of a psychiatric hospital, but who need restorative residential treatment services. “Emotionally disturbed” in this context means a condition exhibiting certain characteristics over a long period of time and to a marked degree. The Criteria and Standards section of this chapter describes these facilities more fully. Table 3-3 shows facilities are in operation with a total of 314 PRTF beds. Map 3-3 presents the location of the private psychiatric residential treatment facilities throughout the state. Children and adolescents who need psychiatric residential treatment beyond the scope of these residential treatment centers are served in acute psychiatric facilities or sent out of the state to other residential treatment facilities. DMH operates a specialized thirty-two (32) bed treatment facility (ICF/IID) in Brookhaven for youth with an intellectual and/or developmental disability who are thirteen (13) years, but less than twenty- one (21) years of age. A similar facility, licensed as a psychiatric residential treatment facility, is located in Harrison County for youth who have also been diagnosed with a mental disorder. Adolescents appropriate for admission are thirteen (13) years, but less than twenty-one (21) years of age, who present with a diagnosis of a severe emotional disturbance and need psychiatric residential care. Alcohol and Substance Abuse Disorder Services 305.1 Alcohol and Substance Abuse Disorders Alcohol and other drug problems cause pervasive effects: biological, psychological, and social consequences for the user; psychological and social effects on family members and others; increased risk of injury and death to self, family members, and others (especially by accidents, fires, or violence); and derivative social and economic consequences for society at large. The location of facilities with alcohol and substance use programs is shown on Maps 3-4 and 3-5. Each of the fourteen (14) regional community health centers provide a variety of alcohol and drug services, including residential and transitional treatment programs, along with recovery support services. Tables 3-4 and 3-5 show the utilization of these facilities for adult and adolescent chemical dependency services, respectively. The community mental health centers (CMHCs) with whom DMH contracts are the foundation and primary service providers of the public substance use disorders services delivery system. Each CMHC serves a designated number of Mississippi counties. There are sixty‐seven (67) community‐based satellite centers throughout the state which allow greater access to services by the area’s residents. The goal is for each CMHC to have a full range of treatment options available for citizens in its region. Other nonprofit service agencies/organizations, which make up a smaller part of the service system, also receive funding through the DMH to provide community‐based services. Many of these free‐standing nonprofit organizations receive additional funding from other sources such as grants from other state agencies, community service organizations, donations, etc. Substance use disorder services usually include: (1) alcohol, tobacco, and other drug prevention services; (2) general outpatient treatment including individual, group, and family counseling; (3) recovery support (continuing care) planning and implementation services; (4) primary residential treatment services (including withdrawal management); (5) transitional residential treatment services; (6) vocational counseling and employment seeking assistance; (7) emergency services (including a 24‐ hour hotline); (8) educational programs targeting recovery from substance use disorders which include understanding the disease, the recovery process, relapse prevention, and anger management; (9) recreational and social activities presenting alternatives to continued substance use and emphasizing the positive aspects of recovery; (10) 10-15 week intensive outpatient treatment programs for individuals who are in need of treatment but are still able to maintain job or school responsibilities; (11) community‐based residential substance use disorders treatment for adolescents; (12) specialized women's services; (13) priority treatment for pregnant/parenting women; (14) services for individuals with a co‐occurring disorder of substance use disorder and serious mental illness; and, (15) employee assistance programs. Certificate of Need Criteria and Standards for Acute Psychiatric, Chemical Dependency, and/or Psychiatric Residential Treatment Facility Beds/Services Should MSDH receive a CON application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until MSDH has developed and adopted CON criteria and standards. If MSDH has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. 306.1 Policy Statement Regarding Certificate of Need Applications for Acute Psychiatric, Chemical Dependency, and Psychiatric Residential Treatment Facility Beds/Services 1. Indigent/Charity Care: An applicant must provide a “reasonable amount” of indigent/charity care as described in Chapter 1 of this Plan. 2. Mental Health Planning Areas: MSDH shall use the state as a whole to determine the need for acute psychiatric beds/services, chemical dependency beds/ services, and psychiatric residential treatment beds/services. Tables 3-6, 3-7, and 3-8 give the statistical need for each category of beds. 3. Public Sector Beds: Because DMH is a public entity and directly operates facilities providing acute psychiatric, chemical dependency, and psychiatric residential treatment facility beds, the number of licensed beds operated by DMH shall not be counted in the bed inventory used to determine statistical need for additional acute psychiatric, chemical dependency, and psychiatric residential treatment facility beds. 4. Comments from DMH: MSDH shall solicit and take into consideration comments received from DMH regarding any CON application for the establishment or expansion of inpatient acute psychiatric, chemical dependency, and/or psychiatric residential treatment facility beds. 5. Separation of Adults and Children/Adolescents: Child and adolescent patients under eighteen (18) years of age must receive treatment in units that are programmatically and physically distinct from adult (18 plus years of age) patient units. A single facility may house adults as well as adolescents and children if both physical design and staffing ratios provide for separation. 6. Separation of Males and Females: Facilities must separate males and females age thirteen (13) and over for living purposes (e.g., separate rooms and rooms located at separate ends of the halls, etc.). 7. Patients with Co-Occurring Disorders: It is frequently impossible for a provider to totally predict or control short-term deviation in the number of patients with mixed psychiatric/ addictive etiology to their illnesses. Therefore, MSDH will allow deviations of up to twenty- five percent (25%) of the total licensed beds as "swing-beds" to accommodate patients having diagnoses of both psychiatric and substance abuse disorders. However, the provider must demonstrate to the Division of Licensure and Certification that the “swing- bed” program meets all applicable licensure and certification regulations for each service offered, i.e., acute psychiatric, chemical dependency, and psychiatric residential treatment facility services, before providing such "swing-bed" services. 8. Comprehensive Program of Treatment: Any new mental health beds approved must provide a comprehensive program of treatment that includes, but is not limited to, inpatient, outpatient, and follow-up services, and in the case of children and adolescents, includes an educational component. The facility may provide outpatient and appropriate follow-up services directly or through contractual arrangements with existing providers of these services. 9. Medicaid Participation: An applicant proposing to offer acute psychiatric, chemical dependency, and/or psychiatric residential treatment facility services or to establish, expand, and/or convert beds under any of the provisions set forth in this section or in the service specific criteria and standards shall affirm in the application that: a. The applicant shall seek Medicaid certification for the facility/program at such time as the facility/program becomes eligible for such certification; and b. The applicant shall serve a reasonable number of Medicaid patients when the facility/program becomes eligible for reimbursement under the Medicaid Program. The application shall affirm that the facility will provide MSDH with information regarding services to Medicaid patients. 10. Licensing and Certification: All acute psychiatric, chemical dependency treatment, co- occurring disorders beds/services, and psychiatric residential treatment facility beds/services must meet all applicable licensing and certification regulations of the Division of Health Facilities Licensure and Certification. If licensure and certification regulations do not exist at the time the application is approved, the program shall comply with such regulations following their effective date. 11. Psychiatric Residential Treatment Facility: A psychiatric residential treatment facility (PRTF) is a non-hospital establishment with permanent licensed facilities that provides a twenty-four (24) hour program of care by qualified therapists including, but not limited to, duly licensed mental health professionals, psychiatrists, psychologists, psychotherapists, and licensed certified social workers, for emotionally disturbed children and adolescents referred to such facility by a court, local school district, or the Department of Human Services, who are not in an acute phase of illness requiring the services of a psychiatric hospital and who are in need of such restorative treatment services. For purposes of this paragraph, the term “emotionally disturbed” means a condition exhibiting one or more of the following characteristics over a long period of time and to a marked degree, which adversely affects educational performance: a. An inability to learn which cannot be explained by intellectual, sensory, or health factors; b. An inability to build or maintain satisfactory relationships with peers and teachers; c. Inappropriate types of behavior or feelings under normal circumstances; d. A general pervasive mood of unhappiness or depression; or e. A tendency to develop physical symptoms or fears associated with personal or school problems. An establishment furnishing primarily domiciliary care is not within this definition. 12. Certified Educational Programs: Educational programs certified by the Department of Education shall be available for all school age patients. Also, sufficient areas suitable to meet the recreational needs of the patients are required. 13. Preference in CON Decisions: Applications proposing the conversion of existing acute care hospital beds to acute psychiatric and chemical dependency beds shall receive preference in CON decisions provided the application meets all other criteria and standards under which it is reviewed. 14. Dedicated Beds for Children's Services: It has been determined that there is a need for specialized beds dedicated for the treatment of children less than fourteen (14) years of age. Therefore, of the beds determined to be needed for child/adolescent acute psychiatric services and psychiatric residential treatment facility services, twenty-five (25) beds under each category, for a total of fifty (50) beds statewide, shall be reserved exclusively for programs dedicated to children under the age of fourteen (14). 15. CON Authority: Effective April 12, 2002, no healthcare facility shall be authorized to add any beds or convert any beds to another category of beds without a CON under the authority of Section 41-7-191(1)(c). 16. Delicensed/Relicensed Beds: Effective March 4, 2003, if a healthcare facility has voluntarily delicensed some of its existing bed complement, it may later relicense some or all of its delicensed beds without the necessity of having to acquire a CON. MSDH shall maintain a record of the delicensing healthcare facility and its voluntarily delicensed beds and continue counting those beds as part of the state’s total bed count for health care planning purposes. 17. Reopening a Facility: A healthcare facility has ceased to operate for a period of sixty (60) months or more shall require a CON prior to reopening. 18. Medicaid Participation (DeSoto County): Notwithstanding any prior Medicaid participation restrictions or conditions, and pursuant to House Bill 3 from the 2026 Legislative Session (effective February 4, 2026), there shall be no prohibition or restrictions on participation in the Medicaid program for the forty-bed (40) psychiatric residential treatment facility (PRTF) located in DeSoto County that would not otherwise apply to any other such facility in the state. 306.2 General Certificate of Need Criteria and Standards for Acute Psychiatric, Chemical Dependency, and Psychiatric Residential Treatment Facility Bed/Services The Mississippi State Department of Health will review applications for a Certificate of Need for the establishment, offering, or expansion of acute psychiatric, chemical dependency treatment, and/or psychiatric residential treatment beds/services under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the policies in this Plan; the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the general and service specific criteria and standards listed below. The offering of acute psychiatric, chemical dependency treatment, and/or psychiatric residential treatment facility services is reviewable if the proposed provider has not offered those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered. The construction, development, or other establishment of a new healthcare facility to provide acute psychiatric, chemical dependency treatment, and/or psychiatric residential treatment services requires CON review regardless of capital expenditure. Need Criterion 1: Bed Need Requirements A. New/Existing Acute Psychiatric, Chemical Dependency, and/or Psychiatric Residential Treatment Facility Beds/Services: The applicant shall document a need for acute psychiatric, chemical dependency, and/or psychiatric residential treatment facility beds using the appropriate bed need methodology as presented in this section under the service specific criteria and standards. B. Projects that do not involve the Addition of Acute Psychiatric, Chemical Dependency, and/or Psychiatric Residential Treatment Facility Beds: The applicant shall document the need for the proposed project. Documentation may consist of, but is not limited to, citing of licensure or regulatory code deficiencies, institutional long-term plans duly adopted by the governing board, recommendations made by consultant firms, and deficiencies cited by accreditation agencies (JCAHO, CAP, etc.). C. Projects that Involve the Addition of Beds: The applicant shall document the need for the proposed project. Exception: Notwithstanding the service specific statistical bed need requirements as stated in "a" above, MSDH may approve additional beds for facilities which have maintained an occupancy rate of at least eighty percent (80%) for the most recent twelve (12) month licensure reporting period or at least seventy percent (70%) for the most recent two (2) years. D. Child Psychiatry Fellowship Program: Notwithstanding the service specific statistical bed need requirements as stated in “A” above, MSDH may approve a fifteen (15) bed acute child psychiatric unit at the University of Mississippi Medical Center for children aged four (4) to twelve (12) to provide a training site for psychiatric residents. E. Establishment or Addition of Programs for the Exclusive Treatment of Adults for Primary Psychiatric Diagnosis of Post Traumatic Stress Disorder (PTSD): Notwithstanding the service specific statistical bed need requirements as stated in "a" above, MSDH may approve service and/or beds for the exclusive treatment of adults eighteen years of age and older with a primary psychiatric diagnosis of PTSD. The applicant shall document the need for the proposed project and justify the number of inpatient beds to be dedicated for such purpose. Need Criterion 2: Data Requirements The application shall affirm that the applicant will record and maintain, at a minimum, the following information regarding charity care and care to the medically indigent and make such information available to MSDH within fifteen (15) business days of request: A. Source of patient referral; B. Utilization data (e.g., number of indigent admissions, number of charity admissions, and inpatient days of care); C. Demographic/patient origin data; D. Cost/charges data; and E. Any other data pertaining directly or indirectly to the utilization of services by the medically indigent or charity patients that MSDH request. Need Criterion 3: Referral/Admission of Charity/Indigent Patients A CON applicant desiring to provide or to expand chemical dependency, psychiatric, and/or psychiatric residential treatment facility services shall provide copies of signed memoranda of understanding with Community Mental Health Centers and other appropriate facilities within their patient service area regarding the referral and admission of charity and medically indigent patients. Need Criterion 4: Letters of Commitment Applicants should also provide letters of comment from the Community Mental Health Centers, appropriate physicians, community and political leaders, and other interested groups that may be affected by the provision of such care. Need Criterion 5: Non-Discrimination Provision The application shall document that within the scope of its available services, neither the facility nor its participating staff shall have policies or procedures which would exclude patients because of race, color, age, sex, ethnicity, or ability to pay. Need Criterion 6: Charity/Indigent Care The application shall document that the applicant will provide a reasonable amount of charity/indigent care as provided for in Chapter 1 of this Plan. 306.3 Service Specific Certificate of Need Criteria and Standards for Acute Psychiatric, Chemical Dependency and/or Residential Treatment Facility Beds/Services 306.3.1 Acute Psychiatric Beds for Adults Need Criterion 1: Statistical Need for Adult Psychiatric Beds MSDH shall base statistical need for adult acute psychiatric beds on a ratio of 0.21 beds per 1,000 population aged eighteen (18) and older for 2025 in the state as a whole as projected by the Division of Health Planning and Resource Development. Table 3-6 presents the statistical need for adult psychiatric beds. Need Criterion 2: Proposed Size of Facility/Unit The applicant shall provide information regarding the proposed size of the facility/unit. Acute psychiatric beds for adults may be located in either freestanding or hospital-based facilities. Freestanding facilities should not be larger than sixty (60) beds. Hospital units should not be larger than thirty (30) beds. Patients treated in adult facilities and units should be eighteen (18) years of age or older. Need Criterion 3: Staffing The applicant shall provide documentation regarding the staffing of the facility. Staff providing treatment should be specially trained for the provision of psychiatric and psychological services. The staff should include both psychiatrists and psychologists and should provide a multi-discipline psychosocial medical approach to treatment. Acute Psychiatric Beds for Children and Adolescents. 306.3.2 Acute Psychiatric Beds for Children & Adolescents Need Criterion 1: Statistical Need for Child/Adolescent Beds MSDH shall base statistical need for child/adolescent acute psychiatric beds on a ratio of 0.55 beds per 1,000 population aged five (5) to seventeen (17) for 2025 in the state as a whole as projected by the Division of Health Planning and Resource Development. Table 3-6 presents the statistical need for child/adolescent psychiatric beds. Of the specified beds needed, twenty- five (25) beds are hereby set aside exclusively for the treatment of children less than fourteen (14) years of age. Need Criterion 2: Proposed Size of Facility/Unit The applicant shall provide information regarding the proposed size of the facility/unit. Acute psychiatric beds for children and adolescents may be located in freestanding or hospital-based units and facilities. A facility should not be larger than sixty (60) beds. All units, whether hospital- based or freestanding, should provide a homelike environment. Ideally, a facility should provide cottage-style living units housing eight (8) to ten (10) patients. Because of the special needs of children and adolescents, facilities or units which are not physically attached to a general hospital are preferred. For the purposes of this Plan, an adolescent is defined as a minor who is at least fourteen (14) years old but less than eighteen (18) years old, and a child is defined as a minor who is at least five (5) years old but less than fourteen (14) years old. Need Criterion 3: Staffing The applicant shall provide documentation regarding the staffing of the facility. Staff should be specially trained to meet the needs of adolescents and children. Staff should include both psychiatrists and psychologists and should provide a multi-discipline, psychosocial medical approach to treatment. The treatment program must involve parents and/or significant others. Aftercare services must also be provided. Need Criterion 4: Structural Design of Facility – Separation of Children and Adolescents The applicant shall describe the structural design of the facility in providing for the separation of children and adolescents. In facilities where both children and adolescents are housed, the facility should attempt to provide separate areas for each age grouping. 306.3.3 Chemical Dependency Beds for Adults Need Criterion 1: Statistical Need for Adult Chemical Dependency Beds MSDH shall base statistical need for adult chemical dependency beds on a ratio of 0.14 beds per 1,000 population aged eighteen (18) and older for 2025 in the state as a whole as projected by the Division of Health Planning and Resource Development. Table 3-7 presents the statistical need for adult chemical dependency beds. Need Criterion 2: Proposed Size of Facility/Unit The applicant shall provide information regarding the proposed size of the facility/unit. Chemical dependency treatment programs may be located in either freestanding or hospital- based facilities. Facilities should not be larger than seventy-five (75) beds, and individual units should not be larger than thirty (30) beds. The bed count also includes detoxification beds. Staff should have specialized training in the area of alcohol and substance abuse treatment, and a multi-discipline psychosocial medical treatment approach that involves family and significant others. Need Criterion 3: Aftercare/Follow-Up Services Provided The applicant shall describe the aftercare or follow-up services proposed for individuals leaving the chemical dependency program. Chemical dependency treatment programs should include extensive aftercare and follow-up services. Need Criterion 4: Type of Clients to be Treated at Facility The applicant shall specify the type of clients to be treated at the proposed facility. Freestanding chemical dependency facilities and hospital-based units should provide services to substance abusers as well as alcohol abusers. 306.3.4 Chemical Dependency Beds for Children & Adolescents Need Criterion 1: Statistical Need for Child/Adolescent Chemical Dependency Beds MSDH shall base statistical need for child/adolescent chemical dependency beds on a ratio of 0.44 beds per 1,000 population aged five (5) to seventeen (17) for 2025 in the state as a whole as projected by the Division of Health Planning and Resource Development. Table 3-7 presents the statistical need for child/adolescent chemical dependency beds. Need Criterion 2: Proposed Size of Facility/Unit The applicant shall provide information regarding the proposed size of the facility/unit. Chemical dependency beds may be located in either freestanding or hospital-based facilities. Because of the unique needs of the child and adolescent population, facilities shall not be larger than sixty (60) beds. Units shall not be larger than twenty (20) beds. The bed count of a facility or unit shall include detoxification beds. Need Criterion 3: Provision of Home-Like Environment Facilities or units, whether hospital-based or freestanding, should provide a home-like environment. Ideally, facilities should provide cottage-style living units housing eight (8) to ten (10) patients. Because of the special needs of children and adolescents, facilities or units which are not physically attached to a general hospital are preferred. Need Criterion 4: Staffing The applicant shall provide documentation regarding the staffing of the facility. Staff should be specially trained to meet the needs of adolescents and children. Staff should include both psychiatrists and psychologists and should provide a multi-discipline, psychosocial medical approach to treatment. The treatment program must involve parents and significant others. Aftercare services must also be provided. Need Criterion 5: Structural Design of Facility – Separation of Children and Adolescents The applicant shall describe the structural design of the facility in providing for the separation of children and adolescents. Child and adolescent patients shall be separated from adult patients for treatment and living purposes. Need Criterion 6: Aftercare/Follow-Up Services Provided The applicant shall describe the aftercare or follow-up services proposed for individuals leaving the chemical dependency program. Extensive aftercare and follow-up services involving the family and significant others should be provided to clients after discharge from the inpatient program. Chemical dependency facilities and units should provide services to substance abusers as well as alcohol abusers. 306.3.5 Psychiatric Residential Treatment Facility Beds/Services Need Criterion 1: Statistical Need for Psychiatric Residential Treatment Beds MSDH shall base statistical need for psychiatric residential treatment beds on a ratio of 0.5 beds per 1,000 population aged five (5) to nineteen (19) for 2023 in the state as a whole as projected by the Division of Health Planning and Resource Development. Table 3-8 presents the statistical need for psychiatric residential treatment facility beds. Need Criterion 2: Age Group to be Served The application shall state the age group that the applicant will serve in the psychiatric residential treatment facility and the number of beds dedicated to each age group (5 to 13, 14 to 17, and 18 to 21). Need Criterion 3: Structural Design of Facility The applicant shall describe the structural design of the facility for the provision of services to children less than fourteen (14) years of age. Of the beds needed for psychiatric residential treatment facility services, twenty-five (25) beds are hereby set aside exclusively for the treatment of children less than fourteen (14) years of age. An applicant proposing to provide psychiatric residential treatment facility services to children less than fourteen (14) years of age shall make provision for the treatment of these patients in units which are programmatically and physically distinct from the units occupied by patients older than thirteen (13) years of age. A facility may house both categories of patients if both the physical design and staffing ratios provide for separation. Need Criterion 4: Bed Count as Authorized by the Legislature This criterion does not preclude more than twenty-five (25) psychiatric residential treatment facility beds being authorized for the treatment of patients less than fourteen (14) years of age. However, MSDH shall not approve more psychiatric residential treatment facility beds statewide than specifically authorized by legislation (Miss. Code Ann. § 41-7-191 et. seq). This authorization is limited to 334 beds for the entire state. Pursuant to House Bill 3 (2026), the 334-bed cap is maintained; however, any facility-specific Medicaid participation restrictions previously established by the Department for the 40-bed facility in DeSoto County are hereby removed. (NOTE: the 314 licensed and CON approved beds indicated in Table 3-8 were the result of both CON approval and legislative actions). Need Criterion 5: Proposed Size of Facility/Unit The applicant shall provide information regarding the proposed size of the facility/unit. A psychiatric residential treatment facility should provide services in a homelike environment. Ideally, a facility should provide cottage-style living units not exceeding fifteen (15) beds. A psychiatric residential treatment facility should not be larger than sixty (60) beds. Need Criterion 6: Staffing The applicant shall provide documentation regarding the staffing of the facility. Staff should be specially trained to meet the treatment needs of the age category of patients being served. Staff should include both psychiatrists and psychologists and should provide a multi-discipline, psychosocial medical approach to treatment. The treatment program must involve parents and/or significant others. Aftercare/follow-up services must also be provided. Private Distinct-Part Geriatric Psychiatric Services During 2020, twenty-one (21) Mississippi hospitals operated certified distinct-part geriatric psychiatric units (Geropsych DPU) with a total of 331 beds. Geropsych units receive Medicare certification as a distinct-part psychiatric unit but are licensed as short-term acute hospital beds. These Geropsych units served a total of 53,962 inpatient days of psychiatric services to patients aged fifty-five (55) and older. The industry standard formula for determining Geropsych DPU bed need is 0.5 beds per 1,000 population aged fifty-five (55) and over. The State Data Center of Mississippi under the University of Mississippi Center for Population Studies, projects Mississippi will have 943,320 persons aged fifty- five (55) and older by 2025. This population will need a total of 472 Geropsych DPU beds. The optimum unit size of a Geropsych unit is twelve (12) to twenty-four (24) beds. Table 3-9 shows the state’s twenty-one (21) distinct-part geriatric psychiatric units. County population projections can be found in Chapter 1 of this Plan. The following facilities received approval through a Determination of Reviewability for the establishment of a Geriatric Psychiatric Distinct Part (Geriatric-Psychiatric DPU or Gero-psych) Unit/Service: • Garden Park Medical Center (Add 8 beds) - Approved on 12/15/2017; • Garden Park Medical Center (Amendment to add 1 bed) - Approved on 10/19/2018; • Merit Health Wesley (Add 2 beds) - Approved on 3/15/2019; • Tippah County Hospital (Add 10 beds) – Approved on 12/23/2019; and • Trace Regional Hospital (Add 8 beds) - Approved on 4/9/2020. Chapter 4 Perinatal Natality Statistics Mississippi experienced 36,634 live births in 2019. Of these live births, 49.8 percent (18,248) were white non-Hispanic, 42.9 percent (15,702) were black non-Hispanic, 2.7 percent (976) were other non-Hispanic and 4.7 percent (1708) were Hispanic. A physician attended 97.8 percent of all in- hospital live births delivered in 2019 (36,449). Nurse midwife deliveries accounted for 690 live births. More than 99 percent of the live births occurred to women 15 to 44 years of age. Births to unmarried women made up 54.9 percent (20,106) of all live births in 2019; 80.6 percent (12,656) of births to black non- Hispanic women were to unmarried women. The rate for other race/ethnicity groups were 33.3 percent (6,069) for white non-Hispanic women, 43.0 percent (420) for other non- Hispanic women and 56.3 percent (961) for Hispanic women. Women under the age of fifteen (15) gave birth to forty-two (42) children: twenty-seven (27) were black non-Hispanic and nine (9) were white non-Hispanic five (5) were Hispanic, and one (1) was other non-Hispanic. The birth rate in 2019 was 12.3 live births per 1,000 population; the general fertility rate was 62.6 live births per 1,000 women aged 15-44 years. Mississippi reported 349 fetal deaths in 2019. The black non-Hispanic fetal death ratio, which is the number of fetal deaths per 1000 live births to women in the specified age group, was more than two times that of non-Hispanic white women, with a ratio of 14.3 per 1,000 live births compared to 6.1 for non-Hispanic white women. Women aged 40 and older, had the highest fetal death ratio at 15.3 per 1,000 live births, followed by women aged 20-24 with a ratio of 10.2. MSDH requires the reporting of fetal deaths with gestation of twenty (20) or more weeks or fetal weight of 350 grams or more. MSDH does not report fetal death rates for an age group if there are less than 100 births within that age group. The number of maternal deaths between 2016-2018 which occurred while pregnant or within forty- two (42) days of the end of a pregnancy are twenty-one (21) or on average about seven (7) maternal deaths each year. Maternal Death is defined as a death of a woman while pregnant or within forty-two (42) days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes. The Maternal Mortality Rate is calculated as the number of maternal deaths per 100,000 live births and it is used to measure trends and make national/international comparisons. Maternal death data for the last three (3) years is presented in Table 4-1 (this data was generated using information from the MMRIA system). Infant Mortality Infant mortality remains a critical concern in Mississippi. There was an increase in the infant mortality rate to 8.8 in 2019 from 8.4 in 2018. Table 4-2 shows the infant, neonatal, and post- neonatal mortality rates for non-Hispanic black infants were all substantially above the rates for non-Hispanic white and Hispanic infants. Table 4-3 displays Mississippi’s infant mortality rates from 2005 to 2019, along with the rates for the United States. Map 4-1 shows the five-year average infant mortality rate by county for the period 2015 to 2019. Many factors contribute to Mississippi’s high infant mortality rate including: a high incidence of preterm birth and low birthweight, young and advanced maternal age, lack of education, poverty, lack of access for planned delivery services, and lack of adequate perinatal and acute medical care. More than 97 percent of expectant mothers received some level of prenatal care in 2019. More than 75.9 percent (27,795) of mothers began prenatal care in the first trimester; 17.4 percent (6,371) began in the second trimester, and 3.9 percent (1,440) during the third trimester. Only 1.3 percent (486) of expectant mothers received no prenatal care prior to delivery. The Kessner Index measures prenatal care adequacy based on the month in which prenatal care began, the number of prenatal visits, and the length of gestation. In Mississippi, 8.1 percent of women have inadequate prenatal care (white women account for 6.5 percent, black women account for 10.1 percent, and women of other races account for 8.4 percent). In 2019, 12.3 percent of births were low birthweight (less than 5.5 pounds or 2,500 grams) and 14.6 percent were premature (gestational age less than 37 weeks). These indicators differ markedly by maternal race: 8.7 percent of non-Hispanic white births were low birthweight compared to 17.3 percent for non- Hispanic black births. The low birthweight rate for Hispanics was 7.8 percent. The premature birth rate was 10.4 percent for Hispanic women, 12.4 percent for non-Hispanic white women and 17.8 percent for non- Hispanic black women. A total of 2,911 Mississippi teenagers (under 20 years of age) gave birth in 2019 — 7.9 percent of the state's 36,634 live births. Teenage births increased each year from 2005 until 2007 but decreased steadily through 2018. There was a slight (2.6%) increase in the number of births to teenagers between 2018 and 2019. In 2019, 13.9 percent of teenage births were low birthweight and 13.7 percent were premature. There are several factors that could create a high-risk pregnancy condition. These factors include: • Existing health conditions (e.g., high blood pressure, heart or blood disorders, renal conditions, thyroid disease, diabetes, asthma, autoimmune diseases, epilepsy, obesity, sexually transmitted infections, stress, depression, anxiety, etc.); • Age (young age or over 35 years of age); • Lifestyle factors (e.g., substance use/substance use disorders including alcohol and tobacco); • Short interpregnancy intervals [Interpregnancy care. Obstetric Care Consensus No. 8. American College of Obstetricians and Gynecologists. Obstet. Gynecol. 2019;133:e51– 72.]; and • Conditions of pregnancy (e.g., multiple gestation, preeclampsia and eclampsia, gestational diabetes, previous preterm birth, birth defects or genetic conditions of the fetus). Physical Facilities for Perinatal Care In Fiscal Year 2019, fifty-nine (59) hospitals reported at least one live birth. Forty-three (43) of these hospitals handled deliveries on a regular basis while sixteen (16) hospitals performed deliveries in cases where the mother could not reach a hospital with obstetrical services in time. Three (3) of these hospitals reported more than 2,000 obstetrical deliveries in Fiscal Year 2019, accounting for 7,095 deliveries or 20.1 percent of the state's total hospital deliveries: Forest General Hospital with 2,516 deliveries, North Mississippi Medical Center with 2,322 deliveries, and the University of Mississippi Medical Center with 2,2,257 deliveries. These hospitals with a large number of deliveries are strategically located in north, central and south Mississippi. Map 4- 2 shows the Perinatal Planning Areas. Certificate of Need Criteria and Standards for Obstetrical Services Should the Mississippi State Department of Health receive a Certificate of Need application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until the Department of Health has developed and adopted CON criteria and standards. If the Department has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of the Mississippi State Department of Health. 403.1 Policy Statement Regarding Certificate of Need Applications for the Offering of Obstetrical Services 1. Indigent/Charity Care: An applicant is required to provide a reasonable amount of indigent/charity care as described in Chapter 1 of this Plan. 2. Perinatal Planning Areas (PPA): MSDH shall determine the need for obstetrical services using the Perinatal Planning Areas as outlined on Map 4-2 at the end of this chapter. 3. Travel Time: Obstetrical services should be available within one (1) hour normal travel time of ninety-five percent (95%) of the population in rural areas and within thirty (30) minutes normal travel time in urban areas. 4. Preference in CON Decisions: The MSDH shall give preference in CON decisions to applications that propose to improve existing services and to reduce costs through consolidation of two basic obstetrical services into a larger, more efficient service over the addition of new services or the expansion of single service providers. 5. Patient Education: Obstetrical service providers shall offer an array of family planning and related maternal and child health education programs that are readily accessible to current and prospective patients. 6. Levels of Care: All hospitals providing obstetric and newborn services will be designated a perinatal level of care by MSDH, based upon its functional capabilities to provide risk- appropriate care for pregnant women and neonates. The levels of care will be divided into four levels defined in accordance with the 2012 policy statement by the American Academy of Pediatrics, (PEDIATRICS Vol. 130, No. 3, September 2012) and maternal standards set forth by the American College of Obstetricians and Gynecologists with modifications approved by MSDH. The levels are: • Level I- Basic Care, Well newborn nursery • Level II- Specialty Care, Special care nursery • Level III- Sub-specialty Care, Neonatal Intensive Care Unit • Level IV- Regional Care Details of the levels are outlined in section 405.03 of the State Health Plan. 7. An applicant proposing to offer obstetrical services shall be equipped to provide perinatal services in accordance with the guidelines contained in the Minimum Standards of Operation for Mississippi Hospitals § 130, Obstetrics and Newborn Nursery. All hospitals offering obstetric and newborn care shall conform to the practice guidelines of the American Academy of Pediatrics, Policy Statement, Levels of Care and professional standards established in the Guidelines for the Operations of Perinatal Units. 8. An applicant proposing to offer obstetrical services shall agree to provide an amount of care to Medicaid mothers/babies comparable to the average percentage of Medicaid care offered by other providers of the requested service within the same, or most proximate, geographic area. 403.2 Certificate of Need Criteria and Standards for Obstetrical Services The Mississippi State Department of Health will review applications for a Certificate of Need to establish obstetric services under the statutory requirements of Miss. Code Ann. §§ 41-7-173, 41- 7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. The establishment or expansion of Level I-basic or Level II-specialty perinatal services shall require approval under the Certificate of Need statute if the $10,000,000.00 capital expenditure threshold is crossed. Any hospital proposing to establish or expand existing services to become a Level III-subspecialty or Level IV-regional perinatal center shall require approval under the Certificate of Need statute. Provision for individual units should be consistent with the regionalized perinatal care system involved. Those facilities desiring to provide obstetric services shall meet the Basic facility minimum standards as listed under Guidelines for the Operation of Perinatal Units found at the end of this Chapter. Need Criterion 1: Minimum Procedures The application shall demonstrate how the applicant can reasonably expect to deliver a minimum of 150 babies the first full year of operation and 250 babies by the second full year. In this demonstration, the applicant shall document the number of deliveries performed in the proposed perinatal planning area (as described in Section 403.1, Policy Statement 2, by hospital). Need Criterion 2: Perinatal Services The application shall document that the facility will provide one of the three types of perinatal services: Basic, Specialty, or Subspecialty. Need Criterion 3: Staffing Requirements The facility shall provide full-time nursing staff in the labor and delivery area on all shifts. Nursing personnel assigned to nursery areas in Basic Perinatal Centers shall be under the direct supervision of a qualified registered nurse with extra training such as Neonatal Resuscitation Program (NRP) certification and the S.T.A.B.L.E program. Need Criterion 4: Policies Any facility proposing the offering of obstetrical services shall have written policies delineating responsibility for immediate newborn care, resuscitation, transfer to higher-level of care, selection and maintenance of necessary equipment, and training of personnel in proper techniques. Need Criterion 5: Staff Required for Medical Emergency The application shall document that the nurse, anesthesia, neonatal resuscitation, and obstetric personnel required for emergency cesarean delivery shall be in the hospital or readily available at all times. Need Criterion 6: Travel Time The application shall document that the proposed services will be available within one (1) hour normal driving time of 95 percent of the population in rural areas and within 30 minutes normal driving time in urban areas. Need Criterion 7: Transfer of Patients in Medical Emergency The applicant shall affirm that the hospital will have protocols for the transfer of medical care of the neonate in both routine and emergency circumstances. Need Criterion 8: Data Requirements The application shall affirm that the applicant will record and maintain, at a minimum, the following information regarding charity care and care to the medically indigent and make it available to the Mississippi State Department of Health within fifteen (15) business days of request: A. Source of patient referral; B. Utilization data (e.g., number of indigent admissions, number of charity admissions, and inpatient days of care); C. Demographic/patient origin data; D. Cost/charges data; and E. Any other data pertaining directly or indirectly to the utilization of services by medically indigent or charity patients, which the Department may request. Need Criterion 9: Non-Discrimination Provision The applicant shall document that within the scope of its available services, neither the facility nor its participating staff shall have policies or procedures, which would exclude patients because of race, age, sex, ethnicity, or ability to pay. Certificate of Need Criteria and Standards for Neonatal Special Care Services Should the Mississippi State Department of Health receive a Certificate of Need application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until the Department of Health has developed and adopted CON criteria and standards. If the Department has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. 404.1 Policy Statement Regarding Certificate of Need Applications for the Offering of Neonatal Special Care Services 1. Indigent/Charity Care: An applicant is required to provide a reasonable amount of indigent/charity care as described in Chapter 1 of this Plan. 2. Perinatal Planning Areas (PPA): MSDH shall determine the need for neonatal special care services using the Perinatal Planning Areas as outlined on Map 4-2. 3. Bed Limit: The total number of neonatal special care beds is not to exceed eight (8) per 1,000 live births in a specified PPA as defined below: a. Two (2) intensive care beds per 1,000 live births; and b. Six (6) intermediate care beds per 1,000 live births. 4. Size of Facility: A single neonatal special care unit (Subspecialty) Level 3 or greater facility should contain a minimum of fifteen (15) beds. 5. Levels of Care: MSDH shall determine the perinatal level of care designation of the facility based upon its functional capabilities to provide risk-appropriate care for pregnant women and neonates. Facilities shall be designated as one of four levels of care as outlined in Section 405.03 of the State Health Plan. • Level I- Basic Care, Well Newborn Nursery • Level II- Specialty Care, Special Care Nursery • Level III- Sub-Specialty Care, Neonatal Intensive Care Unit • Level IV- Regional Care 6. Medicaid Care: An applicant proposing to offer neonatal special care services shall agree to provide an amount of care to Medicaid babies comparable to the average percentage of Medicaid care offered by other providers of the requested services. 404.2 Certificate of Need Criteria and Standards for Neonatal Special Care Services The Mississippi State Department of Health will review applications for a Certificate of Need to establish neonatal special care services under the statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. The MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. All neonatal intensive care units providing subspecialty care are reviewable under the Certificate of Need law based upon the addition/conversion of hospital beds required to establish such units. Those facilities desiring to provide neonatal special care services shall meet the capacity and levels of neonatal care for the specified facility (Specialty, Subspecialty or Regional) as outlined by the American Academy of Pediatrics, Policy Statement, Levels of Neonatal Care (PEDIATRICS Vol. 130, No. 3, September 2012). Need Criterion 1: Minimum Procedures The application shall demonstrate that the Perinatal Planning Area (PPA) wherein the proposed services are to be offered had a minimum of 3,600 deliveries for the most recent 12-month reporting period. MSDH shall determine the need for neonatal special care services based upon the following: A. Two (2) neonatal intensive (subspecialty) care bed per 1,000 live births in a specified Perinatal Planning Area for the most recent 12-month reporting period; and B. Six (6) neonatal intermediate (specialty) care beds per 1,000 live births in a specified Perinatal Planning Area for the most recent 12-month reporting period. Neonatal intensive care beds can only be housed within a hospital designated as a Level III facility. Neonatal intermediate or specialty care beds can be housed within either a Level II, Level III or Level IV facility. Applications submitted by existing providers of neonatal special care services, which seek to expand capacity by adding or converting neonatal special care beds must document the need for the proposed project. The applicant shall demonstrate that the facility in question has maintained an occupancy rate for neonatal special care services of at least seventy percent (70%) for the most recent two (2) years or maintained an eighty percent (80%) neonatal special care services occupancy rate for the most recent year, notwithstanding the neonatal special care bed need outlined in Table 4-5 below. The applicant may be approved for additional or conversion of neonatal special care beds to meet projected demand balanced with optimum utilization rate for the Perinatal Planning Area. Need Criterion 2: Minimum Bed Requirement for Single Neonatal Special Care Unit A single neonatal special care unit (Subspecialty or Regional) that is Level III or greater should contain a minimum of fifteen (15) beds (neonatal intensive care and/or neonatal intermediate care). An adjustment downward may be considered for a specialty unit when travel time to an alternate unit is a serious hardship due to geographic remoteness. Need Criterion 3: Travel Time The application shall document that the proposed services will be available within one (1) hour normal driving time of ninety-five percent (95%) of the population in rural areas and within thirty (30) minutes normal driving time in urban areas. Need Criterion 4: Referral Networks The application shall document that the applicant has established referral networks to transfer infants requiring more sophisticated care than is available in less specialized facilities. Need Criterion 5: Data Requirement The application shall affirm that the applicant will record and maintain, at a minimum, the following information regarding charity care and care to the medically indigent and make it available to the Mississippi State Department of Health within fifteen (15) business days of request: A. Source of patient referral; B. Utilization data (e.g., number of indigent admissions, number of charity admissions, and inpatient days of care); C. Demographic/patient origin data; D. Cost/charges data; and E. Any other data pertaining directly or indirectly to the utilization of services by medically indigent or charity patients which the Department may request. Need Criterion 6: Non-Discrimination Provision The applicant shall document that within the scope of its available services, neither the facility nor its participating staff shall have policies or procedures which would exclude patients because of race, age, sex, ethnicity, or ability to pay. 404.3 Neonatal Special Care Services Bed Need Methodology The determination of need for neonatal special care beds/services in each Perinatal Planning Area will be based on eight (8) beds per 1,000 live births as defined below. 1. Two (2) neonatal intensive care beds per 1,000 live births in the most recent 12- month reporting period. 2. Six (6) neonatal intermediate care beds per 1,000 live births in the most recent 12- month reporting period. Guidelines for the Operation of Perinatal Units (Obstetrics and Newborn Nursery) 405.1 Organization Obstetrics and newborn nursery services shall be under the direction of a member of the staff of physicians who has been duly appointed for this service and who has experience in maternity and newborn care. There shall be a qualified professional registered nurse responsible at all times for the nursing care of maternity patients and newborn infants. Provisions shall be made for pre-employment and annual health examinations for all personnel on this service. Physical facilities for perinatal care in hospitals shall be conducive to care that meets the normal physiologic and psychosocial needs of mothers, neonates and their families. The facilities provide for deviations from the norm consistent with professionally recognized standards/guidelines. The perinatal service should have facilities for the following components: 1. Antepartum care and testing 2. Fetal diagnostic services 3. Admission/observation/waiting 4. Labor 5. Delivery/cesarean birth 6. Newborn nursery 7. Newborn special care unit (Level II- Specialty) 8. Newborn Intensive Care Unit (Level III Subspecialty and Level IV –Regional care only 9. Recovery and postpartum care 10. Visitation. 405.2 Staffing The facility must be staffed to meet its patient care commitments based upon its designated level of care, consistent with the American Academy of Pediatrics, Policy Statement, Levels of Care and professional guidelines. Hospitals with Neonatal Intensive Care Units providing subspecialty care must include appropriately trained personnel (neonatologists, neonatal nurses, and respiratory therapists) and equipment to provide life support for as long as necessary. 405.3 Perinatal Levels of Care Level 1- Basic Care, Well Newborn Nursery Neonatal Guidelines 1. Provide neonatal resuscitation at every delivery. 2. Evaluate and provide postnatal care to stable term newborn infants. 3. Stabilize and provide care for infants born at 35-37 weeks gestation who remain physiologically stable. 4. Stabilize newborn infants who are ill and those born at less than 35 weeks gestation until transfer to a facility that can provide the appropriate level of care. 5. Maintain a staff of providers including pediatricians, family physicians, nurse practitioners with newborn training, registered nurses with newborn training, including being current with Neonatal Resuscitation Program Certification and S.T.A.B.L.E. Maternal Guidelines 1. Surveillance and care of all patients admitted to the obstetric service, with an established triage system for identifying high-risk patients who should be transferred to a facility that provides specialty or sub-specialty care. 2. Capability to begin an emergency cesarean delivery within 30 minutes of the decision to do so. 3. Mothers that are stable and likely to deliver before 35 weeks gestation or have a fetus that is likely to require specialty services and mothers who themselves are likely to require specialty services should be transferred prior to delivery, when possible. 4. Proper detection and supportive care of known maternal conditions and unanticipated maternal-fetal problems that occur during labor and delivery. 5. Care of postpartum conditions. 6. Maintain a staff of providers certified to perform normal and operative vaginal deliveries and cesarean sections including obstetricians and family physicians with advanced training in obstetrics, providers certified to perform normal vaginal deliveries including certified nurse midwives, and registered nurses with training in labor and delivery, post-partum care or inpatient obstetrics. Hospital Resources 1. Availability of anesthesia, radiology, ultrasound, blood bank and laboratory services available on a 24-hour basis. 2. Consultation and transfer agreement with specialty and/or subspecialty perinatal centers. 3. Parent-sibling-neonate visitation. 4. Data collection and retrieval. 5. Quality improvement programs, maximizing patient safety. Level II- Specialty Care, Special Care Nursery Neonatal Guidelines 1. Performance of all basic care services as described above. 2. Provide care for infants born at more than 32 weeks and weighing more than 1500g who have physiological immaturity or who are moderately ill with problems that are expected to resolve rapidly and are not anticipated to need subspecialty services on an urgent basis. 3. Provide for infants’ convalescent care after intensive care. 4. Provide mechanical ventilation for brief duration (less than 24 hours) and/or continuous positive airway pressure. 5. Stabilize infants born before 32 weeks gestation and weighing less than 1500 grams until transfer to a Level III or Level IV neonatal intensive care facility. 6. Maintain a staff of providers including those listed in Basic Care plus pediatric hospitalists, neonatologist, and neonatal nurse practitioners. 7. Referral to a higher level of care for all infants when needed for pediatric surgical or medical subspecialty intervention. Level II nurseries must have equipment (e.g., portable x-ray machine, blood gas analyzer) and personal (e.g., physicians, specialized nurses, respiratory therapists, radiology technicians and laboratory technicians) to provide ongoing care of admitted infants as well as to address emergencies. Maternal Guidelines 1. Perform all basic maternal services listed above. 2. Mothers that are stable and likely to deliver before 32 weeks gestation or have a neonate that is likely to require sub-specialty services, or mothers who themselves are likely to require sub-specialty services should be transferred prior to delivery, when possible. 3. Access to maternal fetal medicine consultation and antenatal diagnosis technology including fetal ultrasound. Level III- Sub-Specialty Care/Neonatal Intensive Care Unit Neonatal Guidelines 1. Provision of all Level I and Level II services. 2. Level III NICUs are defined by having continuously available personnel (neonatologists, neonatal nurses, and respiratory therapists) and equipment to provide life support for as long as necessary. 3. Provide comprehensive care for infants born less than 32 weeks gestation and weighing less than1500 grams and infants born at all gestational ages and birth weights with critical illness. 4. Provide prompt and readily available access to a full range of pediatric medical subspecialists, pediatric surgical specialists, pediatric anesthesiologists or anesthesiologists with experience in neonatal surgical care and pediatric ophthalmologists, on site or by prearranged consultative agreements. 5. Provide a full range of respiratory support and physiologic monitoring that may include conventional and/or high-frequency ventilation and inhaled nitric oxide. 6. Perform advanced imaging with interpretation on an urgent basis, including computed tomography, MRI and echocardiography. 7. Social and family support including social services and pastoral care. 8. If geographic constraints for land transportation exist, the Level III facility should ensure availability of rotor and fixed-wing transport services to transfer infants requiring subspecialty intervention from other regions and facilities. 9. Consultation and transfer agreements with both lower-level referring hospitals and regional centers, including back-transport agreements. 10. Prompt diagnosis and appropriate referral of all conditions requiring surgical intervention. Major surgery should be performed by pediatric surgical specialists (including anesthesiologists with pediatric expertise) on site within the hospital or at a closely related institution, ideally in close geographic proximity if possible. Level III facilities should be able to offer complete care, management, and evaluation for high-risk neonates 24 hours a day. A neonatologist should be available either in-house or on call with the capacity to be in-house in a timely manner, 24 hours a day. 11. Level III facilities should maintain a sufficient volume of infants less than 1500 grams to meet professionally accepted guidelines to achieve adequate experience and expertise. 12. Enrollment in the Vermont Oxford Network to report and monitor data regarding outcomes of infants born less than 32 weeks and weighing less than 1500 grams. 13. Participation in and evaluation of quality improvement initiatives. Maternal Guidelines 1. Manage complex maternal and fetal illnesses before, during and after delivery. 2. Maintain access to consultation and referral to Maternal-Fetal Medicine specialists. Level IV- Regional Care Neonatal Guidelines 1. All level III capabilities listed above. 2. Located within an institution with the capability to provide surgical repair of complex congenital or acquired conditions. 3. Maintain a full range of pediatric medical subspecialists, pediatric surgical subspecialists and pediatric anesthesiologists at the site. 4. Facilitate transport and provide outreach education including community taught NRP and S.T.A.B.L.E. classes. Maternal Guidelines 1. All level III capabilities listed above. 2. Maintain a full range of surgical and medical specialists including Maternal-Fetal Medicine specialists at the site. 3. Facilitate maternal transport and provide outreach education. 405.4 Perinatal Care Services Antepartum Care There should be policies for the care of pregnant patients with obstetric, medical, or surgical complications and for maternal transfer. Intra-Partum Services: Labor and Delivery Intra-partum care should be both personalized and comprehensive for the mother and fetus. There should be written policies and procedures regarding: 1. Assessment 2. Admission 3. Medical records (including complete prenatal history and physical) 4. Consent forms 5. Management of labor including assessment of fetal well-being: a. Term patient b. Preterm patients c. Premature rupture of membranes d. Preeclampsia/eclampsia e. Third trimester hemorrhage f. Pregnancy Induced Hypertension (PIH) 6. Patient receiving oxytocic or tocolytics 7. Patients with stillbirths and miscarriages 8. Pain control during labor and delivery 9. Management of delivery 10. Emergency cesarean delivery (capability within 30 minutes) 11. Assessment of fetal maturity prior to repeat cesarean delivery or induction of labor 12. Vaginal birth after cesarean delivery 13. Assessment and care of neonate in the delivery room 14. Infection control in the obstetric and newborn areas 15. A delivery room shall be kept that will indicate: a. The name of the patient b. Date of delivery c. Sex of infant d. Apgar e. Weight f. Name of physician g. Name of person assisting h. What complications, if any, occurred i. Type of anesthesia used j. Name of person administering anesthesia k. Maternal transfer 16. Immediate postpartum/recovery care 17. Housekeeping Newborn Care There shall be policies and procedures for providing care of the neonate including: 1. Immediate stabilization period 2. Neonate identification and security 3. Assessment of neonatal risks 4. Cord blood, Coombs, and serology testing 5. Eye care 6. Subsequent care 7. Administration of Vitamin K 8. Neonatal screening 9. Circumcision 10. Parent education 11. Visitation 12. Admission of neonates born outside of facility 13. Housekeeping 14. Care of or stabilization and transfer of high-risk neonates Postpartum Care There shall be policies and procedures for postpartum care of mother: 1. Assessment 2. Subsequent care (bed rest, ambulation, diet, care of the vulva, care of the bowel and bladder functions, bathing, care of the breasts, temperature elevation) 3. Postpartum sterilization 4. Immunization: RHIG and Rubella 5. Discharge planning. 405.5 Hospital Evaluation & Level of Care Designation MSDH maintains the authority to evaluate hospitals offering obstetric and newborn services and designate a level of care based upon its clinical services and capacity. References • American Academy of Pediatrics, Committee on Fetus and Newborn and American College of Obstetricians and Gynecologists Committee on Obstetric Practice, Edited by Kilpatrick, S, Papile, L., Macones, G. Guidelines for Perinatal Care, 8th Edition, Published 2017. • American Academy of Pediatrics, Committee on fetus and Newborn; Levels of Neonatal Care. Pediatrics 2012; 130;587 DOI:10.1542/peds.2012-1999. Chapter 5 Acute Care Mississippi had ninety-two (92) non-federal medical/surgical hospitals in FY 2020, with a total of 10,534 licensed acute care beds (plus 558 beds held in abeyance by MSDH). This total also excludes long-term acute care (LTAC), rehabilitation, psychiatric, chemical dependency, and other special purpose beds. In addition, numerous facilities provide specific health care services on an outpatient basis. Some of these facilities are freestanding, others are closely affiliated with hospitals. Such facilities offer an increasingly wider range of services, many of which were once available only in inpatient acute care settings. Examples include diagnostic imaging, therapeutic radiation, and ambulatory surgery. General Medical/Surgical Hospitals When calculating the occupancy rate using total licensed bed capacity, the overall occupancy rate drops to 36.26 percent. Table 5-1 shows the licensed Mississippi hospital beds by service areas. These statistics indicate an average daily census in Mississippi hospitals of 3,819.87. Seventy-four (74) of the state's hospitals reported occupancy rates of less than forty percent (40%) during FY2020. Mississippi requires Certificate of Need (CON) review for all projects that increase the bed complement of a healthcare facility or exceed a capital expenditure threshold of $10 million for clinical services or $20 million for non-clinical services. The law requires CON review regardless of capital expenditure for the construction, development, or other establishment of a new healthcare facility, including a replacement facility; the relocation of a healthcare facility or any portion of the facility which does not involve a capital expenditure and is more than 5,280 feet from the main entrance of the facility; and a change of ownership of an existing healthcare facility, unless the MSDH receives proper notification at least thirty (30) days in advance. A healthcare facility that has ceased to treat patients for a period of sixty (60) months or more must receive CON approval prior to reopening. A CON is required for major medical equipment purchase if the capital expenditure exceeds $3,000,000.00 and is not a replacement of existing medical equipment. A statewide glut of licensed acute care beds complicates planning for community hospital services. There are far more hospital beds than needed. The average use of licensed beds has been less than fifty percent (50% percent) in recent years. With few exceptions, the surplus is statewide. The continued presence of surplus hospital beds in all planning districts, and in nearly all counties with acute care hospitals, raises a number of basic planning questions: • Does the “carrying cost” of maintaining unused beds raise operating cost unnecessarily? • Do the surpluses, and any associated economic burdens, retard the introduction of new and more cost-effective practices and services? • Do existing services providers maintain unwarranted surpluses to shield themselves from competition, as argued by some potential competitors? • Should the space allocated to surplus beds be converted to other uses, particularly if doing so would avoid construction of new space, or facilities, to accommodate growing outpatient caseloads? • Do the large surpluses mask need for additional services and capacity in some regions and reduce the sensitivity and responsiveness of planners and regulators to these legitimate community needs? • Do the continuing surpluses, and the view of them by stakeholders and other interested parties, create an environment that invites policy intervention by legislators and other responsible parties? These questions are unusually difficult to answer definitively. The fact they arise frequently suggests the importance of reducing excess capacity where it is possible to do so and is not likely to result in problematic consequences. MSDH urges each hospital to voluntarily reduce the licensed bed capacity to equal its average daily census plus a confidence factor that will assure an unused hospital bed will be available on any given day. Hospital Outpatient Services Table 5-2 shows the number of visits to hospital emergency rooms and hospital outpatient clinics in FY 2020. These statistics represent an increase over 2016’s total of 5,629,572 visits to hospitals with emergency departments and hospital outpatient clinics. Certificate of Need Criteria and Standards for General Acute Care Facilities Should MSDH receive a CON application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until MSDH has developed and adopted CON criteria and standards. If MSDH has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. 502.1 Policy Statement Regarding Certificate of Need Applications for General Acute Care Hospitals & General Acute Care Beds 1. Need in Counties Without a Hospital: Ten counties in Mississippi do not have a hospital: Amite, Benton, Carroll, Humphreys, Issaquena, Itawamba, Prentiss Quitman, Smith and Tunica. Most of these counties do not have a sufficient population base to indicate a potential need for the establishment of a hospital, and all appear to receive sufficient inpatient acute care services from hospitals in adjoining counties. 2. Expedited Review: MSDH may consider an expedited review for CON applications that address only license code deficiencies, project cost overruns, and relocation of facilities or services. 3. Capital Expenditure: For the purposes of CON review, transactions which are separated in time but planned to be undertaken within twelve (12) months of each other and which are components of an overall long-range plan to meet patient care objectives shall be reviewed in their entirety without regard to their timing. For the purposes of this policy, the governing board of the facility must have duly adopted the long-range plan at least twelve (12) months prior to the submission of the CON application. 4. Addition or Conversion of Beds: No healthcare facility shall be authorized to add any beds or convert any beds to another category of beds without a CON. 5. Beds in Abeyance: If a healthcare facility has voluntarily delicensed some of its existing bed complement, it may later relicense some or all of its delicensed beds without the necessity of having to acquire a CON. MSDH shall maintain a record of the delicensing healthcare facility and its voluntarily delicensed beds and continue counting those beds as part of the state’s total bed count for health care planning purposes. 6. Break in Services: A healthcare facility that has ceased to operate for a period of sixty (60) months or more shall require a CON prior to reopening. 502.2 Certificate of Need Criteria and Standards for the Establishment of a General Acute Care Hospital MSDH will review applications for a CON to construct, develop, or otherwise establish a new hospital under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for a Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. Need Criterion 1: Acute Care Hospital Need Methodology With the exception of psychiatric, chemical dependency, and rehabilitation hospitals, MSDH will use the following methodologies to project the need for general acute care hospitals: A. Counties Without a Hospital MSDH shall determine hospital need by multiplying the state’s average annual occupied beds per 1,000 population (1.41 in FY 2013) by the estimated 2023 county population to determine the number of beds the population could utilize. A hospital with a maximum of 100 beds may be considered if the following three conditions are met: (i) the number of beds needed is 100 or more; (ii) there is strong community support for a hospital; and (iii) a hospital can be determined to be economically feasible. B. Counties With Existing Hospitals MSDH shall use the following formula to determine the need for an additional hospital in a county with an existing hospital: 𝐴𝐷𝐶+ 𝐾 𝐴𝐷𝐶 ADC = Average Daily Census K = Confidence Factor of 2.57 The formula is calculated for each facility within a given General Hospital Service Area (GHSA); then beds available and beds needed under the statistical application of the formula are totaled and subtracted to determine bed need or excess within each GHSA. Map 5-1 delineates the GHSAs. A hospital with a maximum of 100 beds may be considered if the following three conditions are met: (i) the number of beds needed is 100 or more; (ii) there is strong community support for a hospital; and (iii) a hospital can be determined to be economically feasible. C. Counties with Existing Hospitals Located in an Underdeveloped General Hospital Service Area and With a Rapidly Growing Population If the need methodology in “B” above shows a need does not exist in that county, an Applicant may further demonstrate need for an acute care hospital not to exceed one hundred (100) beds if the county has a population in excess of 140,000 people; the county projects a population growth rate in excess of ten percent (10%) over the next ten (10) year period; and the county’s GHSA does not presently exceed a factor of three (3) beds per 1,000 population. Further, any person proposing a new hospital under this criterion must meet the following conditions: 1. Provide an amount of indigent care in excess of the average of the hospitals in the General Hospital Service Area as determined by the State Health Officer; 2. Provide an amount of Medicaid care in excess of the average of the hospitals in the General Hospital Service Area as determined by the State Health Officer; and 3. If the proposed hospital will be located in a county adjacent to a county or counties without a hospital, the applicant must establish outpatient services in the adjacent county or counties without a hospital; 4. Fully participate in the Trauma Care System at a level to be determined by the MSDH for a reasonable number of years to be determined by the State Health Officer. Fully participate means play in the Trauma Care System as provided in the Mississippi Trauma Care System Regulations and the new hospital shall not choose or elect to pay a fee not to participate or participate at a level lower than the level specified in the CON; and 5. The new hospital must also participate as a network provider in the State and School Employees’ Health Insurance Plan as defined in Miss. Code Ann. §§ 25-15-3 and 25-15-9. Need Criterion 2: Indigent/Charity Care The applicant shall affirm that the applicant will provide a “reasonable amount” of indigent/charity care as described in Chapter 1 of this Plan. 502.3 Certificate of Need Criteria and Standards for Construction, Renovation, Expansion, Capital Improvements, Replacement of Healthcare Facilities, & Addition of Hospital Beds MSDH will review applications for a Certificate of Need for the addition of beds to a healthcare facility and projects for construction, renovation, expansion, or capital improvement involving a capital expenditure in excess of $10,000,000.00 (for clinical health services) or $20,000,000.00 (for nonclinical health services). MSDH will further review applications under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of the MSDH; and the specific criteria and standards listed below. The construction, development, or other establishment of a new healthcare facility, the replacement and/or relocation of a healthcare facility or portion thereof, and changes of ownership of existing healthcare facilities are reviewable regardless of capital expenditure. Need Criterion 1: Acute Care Bed Need A. Projects Which Do Not Involve the Addition of Any Acute Care Beds The applicant shall document the need for the proposed project. Documentation may consist of, but is not limited to, citing of licensure or regulatory code deficiencies, institutional long-term plans (duly adopted by the governing board), recommendations made by consultant firms, and deficiencies cited by accreditation agencies (JCAHO, CAP, etc.). In addition, for projects which involve construction, renovation, or expansion of emergency department facilities, the applicant shall include a statement indicating whether the hospital will participate in the statewide trauma system and describe the level of participation, if any. B. Projects Which involve the Addition of Acute Care Beds The applicant shall document the need for the proposed project. In addition to the documentation required as stated in Need Criterion (1) (A), the applicant shall document the facility in question has maintained an occupancy rate of at least sixty percent (60%) for the most recent two (2) years or has maintained an occupancy rate of at least seventy percent (70%) for the most recent two (2) years according to the below formula: # Observation Patient Days/365/Licensed Beds + Inpatient Occupancy Rate NOTE: An observation patient day is a patient that has NOT been admitted as an inpatient but occupies an acute care bed (observation bed) and is provided observation services in a licensed, acute care hospital. Hospitals shall follow strict guidelines set forth by The Centers for Medicare & Medicaid Services, health insurance companies, and others in reporting observation bed data to the Department. For definitions that correspond with the above-referenced item, please refer to the Glossary included in the Plan. Need Criterion 2: Bed Service Transfer/Reallocation/Relocation Applications proposing the transfer, reallocation, and/or relocation of a specific category or sub- category of bed/service from another facility as part of a renovation, expansion, or replacement project shall document that the applicant will meet all regulatory/licensure requirements for the type of bed/service being transferred/reallocated/relocated. Need Criterion 3: Charity/Indigent Care The application shall affirm the applicant will provide a “reasonable amount” of indigent/charity care as described in Chapter 1 of this Plan. Need Criterion 4: Cost of Project The application shall demonstrate the cost of the proposed project, including equipment, is reasonable in comparison with the cost of similar projects in the state. A. The applicant shall document that the cost per square foot (per bed if applicable) does not exceed the median construction costs, as determined by MSDH, for similar projects in the state within the most recent twelve-month (12) period by more than fifteen percent (15%). The Glossary of this Plan provides the formulas to be used by MSDH staff in calculating the cost per square foot for construction and/or construction/renovation projects. B. If equipment costs for the project exceed the median costs for equipment of similar quality by more than fifteen percent (15%), the applicant shall provide justification for the excessive costs. The median costs shall be based on projects submitted during the most recent six-month period and/or estimated prices provided by acceptable vendors. Need Criterion 5: Project Specifications The applicant shall specify the floor areas and space requirements, including the following factors: A. The gross square footage of the proposed project in comparison to state and national norms for similar projects. B. The architectural design of the existing facility if it places restraints on the proposed project. C. Special considerations due to local conditions. Need Criterion 6: Renovation/Expansion Justification If the cost of the proposed renovation or expansion project exceeds eighty-five percent (85%) of the cost of a replacement facility, the applicant shall document their justification for rejecting the option of replacing said facility. Need Criterion 7: Need for Service The applicant shall document the need for a specific service (i.e. perinatal, ambulatory care, psychiatric, etc.) using the appropriate service specific criteria as presented in this and other sections of the Plan. Long-Term Acute Care Hospitals A Long-Term Acute Care (LTAC) hospital is a freestanding, Medicare-certified acute care hospital with an average length of inpatient stay greater than twenty-five (25) calendar days, which is primarily engaged in providing chronic or long-term medical care to patients who do not require more than three (3) hours of rehabilitation or comprehensive rehabilitation per day, and has a transfer agreement with an acute care medical center and a comprehensive medical rehabilitation facility. As of FY 2020, seven (7) long-term acute care hospitals were in operation. The following table lists specific LTAC information. Certificate of Need Criteria and Standards for Long-Term Acute Care Hospitals/Beds Should MSDH receive a CON application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until MSDH has developed and adopted CON criteria and standards. If MSDH has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. 504.1 Policy Statement Regarding Certificate of Need Applications for Long- Term Acute Care Hospitals & Long-Term Acute Care Hospital Beds 1. Restorative Care Admissions: Restorative care admissions shall be identified as patients with one or more of the following conditions or disabilities: a. Neurological Disorders i. Head Injury ii. Spinal Cord Trauma iii. Perinatal Central Nervous System Insult iv. Neoplastic Compromise v. Brain Stem Trauma vi. Cerebral Vascular Accident vii. Chemical Brain Injuries b. Central Nervous System Disorders i. Motor Neuron Diseases ii. Post Polio Status iii. Developmental Anomalies iv. Neuromuscular Diseases (e.g. Multiple Sclerosis) v. Phrenic Nerve Dysfunction vi. Amyotrophic Lateral Sclerosis c. Cardio-Pulmonary Disorders i. Obstructive Diseases ii. Adult Respiratory Distress Syndrome iii. Congestive Heart Failure iv. Respiratory Insufficiency v. Respiratory Failure vi. Restrictive Diseases vii. Broncho-Pulmonary Dysplasia viii. Post Myocardial Infarction ix. Central Hypoventilation d. Pulmonary Cases i. Presently Ventilator-Dependent/Weanable ii. Totally Ventilator-Dependent/Not Weanable iii. Requires Assisted or Partial Ventilator Support iv. Tracheostomy that Requires Supplemental Oxygen and Bronchial Hygiene. 2. Bed Licensure: All beds designated as long-term acute care hospital beds shall be licensed as general acute care. 3. Average Length of Stay: Patients’ average length of stay in a long-term acute care hospital must be twenty-five (25) calendar days or more. 4. Size of Facility: Establishment of a long-term acute care hospital shall not be for less than twenty (20) beds. 5. Long-Term Medical Care: A long-term acute care hospital shall provide chronic or long- term medical care to patients who do not require more than three (3) hours of rehabilitation or comprehensive rehabilitation per day. 6. Transfer Agreement: A long-term acute care hospital shall have a transfer agreement with an acute care medical center and a comprehensive medical rehabilitation facility. 7. Addition or Conversion of Beds: Effective July 1, 1994, no healthcare facility shall be authorized to add any beds or convert any beds to another category of beds without a CON under the authority of Section 41-7-191(1)(c), unless there is a projected need for such beds in the planning district in which the facility is located. 8. Harrison County LTAC Medicaid Status: Notwithstanding any prior certification conditions or crossover provider restrictions, and pursuant to House Bill 3 from the 2026 Legislative Session (effective February 4, 2026), the eighty-bed (80) long-term care (LTC) hospital located in Harrison County is authorized to participate in the Medicaid program as a crossover provider. In accordance with HB 3, this authorization is applied retroactively to July 1, 2023. 504.2 Certificate of Need Criteria and Standards for the Establishment of a Long-Term Acute Care Hospital & Addition of Long-Term Acute Care Hospital Beds MSDH will review applications for a CON for the construction, development, or otherwise establishment of a long-term acute care hospital and bed additions under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193, Mississippi Code 1972. MSDH will also review applications for CON according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. Need Criterion 1: Projected Need The applicant shall document a minimum of 450 clinically appropriate restorative care admissions with an average length of stay of twenty-five (25) days. Need Criterion 2: Financial Feasibility A projection of financial feasibility by the end of the third year of operation. Need Criterion 3: Bed Licensure The applicant shall document that any beds which are constructed/converted will be licensed as general acute care beds offering long-term acute care hospital services. Need Criterion 4: Licensure Applicants proposing the transfer/reallocation/relocation of a specific category or sub-category of bed/service from another facility as part of a renovation, expansion, or replacement project shall document that they will meet all regulatory and licensure requirements for the type of bed/service proposed for transfer/reallocation/relocation. Need Criterion 5: Indigent/Charity Care The application shall affirm that the applicant will provide a “reasonable amount” of indigent/charity care as described in Chapter 1 of this Plan. Need Criterion 6: Project Cost The application shall demonstrate that the cost of the proposed project, including equipment, is reasonable in comparison with the cost of similar projects in the state. The applicant shall document that the cost per square foot (per bed if applicable) does not exceed the median construction costs, as determined by the MSDH, for similar projects in the state within the most recent twelve (12) month period by more than fifteen percent (15%). The Glossary of this Plan provides the formulas MSDH staff shall use to calculate the cost per square foot of space for construction and/or construction-renovation projects. Need Criterion 7: Floor Area and Space Requirements The applicant shall specify the floor areas and space requirements, including the following factors: A. The gross square footage of the proposed project in comparison to state and national norms for similar projects. B. The architectural design of the existing facility if it places restraints on the proposed project. C. Special considerations due to local conditions. Need Criterion 8: Transfer Agreement The applicant shall provide copies of transfer agreements entered into with an acute care medical center and a comprehensive medical rehabilitation facility. Swing-Bed Programs & Extended Care Services Federal law allows rural hospitals with fewer than 100 hospital beds to utilize its beds as “swing beds” to provide post-acute extended care services. 42 C.F.R. § 482.58. Hospitals must have a Medicare provider agreement and meet several eligibility and skilled nursing facility service requirements to be granted CMS approval to provide post-hospital extended care services and to be reimbursed as a swing-bed hospital. Swing-bed hospitals have the same Medicare coverage requirements and coinsurance provisions as nursing facilities. In addition to meeting acute care standards, swing-bed hospitals must also substantially comply with the eight (8) skilled nursing facility services standards listed in 42 C.F.R.§ 482.58(b). These standards include: resident rights, admission, transfer, and discharge rights; freedom from abuse, neglect, and exploitation; dental services, specialized rehabilitative services, social services, patient activities, and discharge planning. Because many patients, particularly elderly patients, no longer need acute hospital care but are not well enough to go home, swing-beds enable the hospital to provide nursing care, rehabilitation, and social services with a goal of returning patients to their homes. Many of these patients would become nursing home residents without the extended period of care received in a swing-bed. Swing-beds provide a link between inpatient acute care and home or community-based services in a continuum for the elderly and others with long-term needs. If it is not possible for the patient to return home, the swing-bed hospital assists the patient and their family with nursing home placement. Ideally, the swing-bed concept should help alleviate low utilization problems in small rural hospitals and provide a new revenue source with few additional expenses while also more efficiently utilizing hospital staff during periods of low acute care occupancy. 505.1 Swing Bed Utilization Fifty (50) Mississippi hospitals and one (1) specialty hospital participated in the swing bed program during Fiscal Year2020. They reported 9,496 discharges from their swing beds and an average length of stay of 17.70 days. 505.2 Certificate of Need Criteria and Standards for Swing-Bed Services MSDH will review applications for a CON to establish swing-bed services under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for CON according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of the MSDH; and the specific criteria and standards listed below. Need Criterion 1: Federal Requirements The application shall document that the hospital will meet all federal regulations regarding the swing-bed concept. However, a hospital may have more licensed beds or a higher average daily census (ADC) than the maximum number specified in federal regulations for participation in the swing-bed program. Need Criterion 2: Resolution Adopted for Proposed Participation The applicant shall provide a copy of the Resolution adopted by its governing board approving the proposed participation. Need Criterion 3: Hospitals Proposing Beds over the Maximum allowed by Federal Law If the applicant proposes to operate and staff more than the maximum number of beds specified in federal regulations for participation in the swing-bed program, the application shall give written assurance that only private pay patients will receive swing-bed services once the federal threshold is met. Need Criterion 4: Medicare Recipients The application shall affirm upon receiving CON approval and meeting all federal requirements for participation in the swing-bed program, the applicant shall render services provided under the swing-bed concept to any patient eligible for Medicare (Title XVIII of the Social Security Act) who is certified by a physician to need such services. Need Criterion 5: Limitation on Medicare/Medicaid Patients The application shall affirm upon receiving CON approval and meeting all federal requirements for participation in the swing-bed program, the applicant shall not permit any patient who is eligible for both Medicaid and Medicare or is eligible only for Medicaid to stay in the swing-beds of a hospital for more than thirty (30) days per admission unless the hospital receives prior approval for such patient from the Division of Medicaid. Need Criterion 6: Hospitals with More Licensed Beds or a Higher Average Daily Census The application shall affirm that if the hospital has more licensed beds or a higher average daily census than the maximum number specified in federal regulations for participation in the swing- bed program, the applicant will develop a procedure to ensure, before a patient is allowed to stay in the swing-beds of the hospital, there are no vacant nursing home beds available within a fifty (50) mile radius (geographic area) of the hospital. The applicant shall also affirm that if the hospital has a patient staying in the swing-beds of the hospital and the hospital receives notice from a nursing home located within a fifty (50) mile radius that there is a vacant bed available for that patient, the hospital shall transfer the swing-bed patient to the nursing home within five (5) days, exclusive of holidays and weekends, unless the patient's physician certifies the transfer is not medically appropriate. Need Criterion 7: Transfer Agreements The applicant shall provide copies of transfer agreements entered into with each nursing facility within the applicant's geographic area. Need Criterion 8: Failure to Comply An applicant subject to the conditions stated in Need Criterion 5 shall affirm in the application that they will be subject to suspension from participation in the swing-bed program for a reasonable period of time by MSDH, after a hearing complying with due process, MSDH, determines that the hospital has failed to comply with any of those requirements. Therapeutic Radiation Services Therapeutic radiation services include the treatment of cancer and other diseases using ionizing radiation consisting of high-energy photons (x-rays or gamma rays) or charged particles (electrons, protons, or heavy nuclei). Radiation therapy is intended to destroy, control, or inhibit the growth of abnormal cells while minimizing injury to surrounding healthy tissue. Therapeutic radiation may be used to cure or control cancer, or to alleviate some of the symptoms associated with cancer (palliative care). Radiation therapy services do not include low energy, superficial, external beam x-ray treatment of superficial skin lesions. Radiation therapy is frequently administered over a period of several days or weeks and can be directed specifically to the area requiring treatment, thereby minimizing radiation exposure to surrounding healthy tissues. This repetitive treatment is called fractionation because a small fraction of the total dose is given each treatment. External beam radiation therapy is commonly delivered using linear accelerator (LINAC) technology, proton beam systems, or other approved radiation therapy technologies. Conventional external beam radiation therapy generally delivers radiation throughout the treatment field encompassing the tumor and surrounding tissues at risk for microscopic disease. Certain disease processes may be appropriately treated using stereotactic radiosurgery, which is discussed separately in this Chapter. Therapeutic radiation services may also include brachytherapy, which involves placement of a radioactive source directly within or adjacent to the target tissue. 506.1 General Therapeutic Radiation Services General Therapeutic Radiation Services utilize ionizing radiation to treat cancer and certain non- malignant conditions. Radiation therapy may be delivered using high-energy photons (x-rays or gamma rays) or charged particles (electrons) generated by specialized radiation therapy equipment. The objective of radiation therapy is to damage the genetic material of abnormal cells, thereby preventing continued growth and reproduction while minimizing injury to surrounding healthy tissues. External beam radiation therapy is the most commonly utilized form of therapeutic radiation and is typically delivered using linear accelerator (LINAC) technology. Modern radiation therapy techniques may include three-dimensional conformal radiation therapy (3D-CRT), intensity- modulated radiation therapy (IMRT), image-guided radiation therapy (IGRT), volumetric modulated arc therapy (VMAT), and other advanced treatment modalities designed to improve precision and reduce radiation exposure to normal tissues. Therapeutic radiation is commonly administered through a process known as fractionation, whereby the total prescribed radiation dose is divided into multiple treatment sessions delivered over several days or weeks. Fractionation allows normal tissues time to recover between treatments while maximizing the therapeutic effect on the targeted disease process. Another form of therapeutic radiation utilized in Mississippi is brachytherapy. Unlike external beam radiation therapy, in which radiation is generated by a machine outside the body and directed toward the treatment area, brachytherapy involves placement of a radioactive source directly within or adjacent to the target tissue. General Therapeutic Radiation Services do not include stereotactic radiosurgery or proton therapy, which are addressed separately in this chapter. 506.2 Stereotactic Radiosurgery Despite its name, Stereotactic Radiosurgery is a non-surgical procedure that uses highly focused x-rays (or in some cases, gamma rays) to treat certain types of tumors, inoperable lesions, and as a post-operative treatment to eliminate any leftover tumor tissue. Stereotactic Radiosurgery treatment involves the delivery of a single high-dose—or in some cases smaller multiple doses— of radiation beams that converge on the specific area of the brain where the tumor or other abnormality resides. Stereotactic Radiosurgery was once limited to the GammaKnife® for treating intra-cranial lesions and functional issues. With the introduction of CyberKnife® and other LINAC-based radiosurgery systems, there has been rapid growth in total-body radiosurgery. The modified LINAC radiosurgery modality is now being used to treat lung, liver, pancreas, prostate, and other body areas. Some modified full-body LINAC models use full-body frames as a guiding tool and others do not. Therefore, the term “Stereotactic Radiosurgery” will refer to radiosurgery regardless of whether a full-body frame is used or not. A full course of radiosurgery requires only one (1) to five (5) treatments versus thirty (30) to forty (40) for radiotherapy. Three (3) basic types of Stereotactic Radiosurgery are in common use, each of which uses different instruments and sources of radiation: • Cobalt 60 Based (Gamma Knife®) uses 201 beams of highly focused gamma rays. The Gamma Knife is commonly used to treat small to medium-sized intracranial lesions due to its ability to deliver highly focused radiation while minimizing exposure to surrounding healthy tissue. • Linear Accelerator (LINAC) Based machines, prevalent throughout the world, deliver high-energy X-ray photons or electrons in curving paths around the patient’s head. The linear accelerator can perform radiosurgery on larger tumors in a single session or during multiple sessions (fractionated stereotactic radiotherapy). Examples of LINAC-based radiosurgery systems include CyberKnife®, Novalis®, TomoTherapy®, and other approved radiosurgery platforms. Multiple manufacturers produce Stereotactic Radiosurgery systems capable of delivering highly precise radiation treatment to intracranial and extracranial targets. Certain systems utilize robotic guidance and image- guided treatment technologies to deliver radiation with a high degree of accuracy while minimizing exposure to surrounding healthy tissues. • Particle Beam (photon) or Cyclotron Based machines are in limited use in North America. Table 5-5 presents facilities offering megavoltage therapeutic radiation therapy in Mississippi. 506.3 Proton Therapy Proton therapy is an advanced form of external beam radiation therapy that utilizes accelerated proton particles rather than conventional photon (X-ray) radiation to treat cancer and certain other diseases. Proton therapy employs specialized accelerator technology to generate and direct proton beams with a high degree of precision to the targeted treatment area. Unlike conventional photon radiation, proton particles deposit the majority of their energy at a specific depth within tissue, commonly referred to as the Bragg Peak. This characteristic allows radiation oncologists to deliver highly conformal radiation doses to tumors while reducing radiation exposure to surrounding healthy tissues and critical organs. Proton therapy may be particularly beneficial for selected pediatric cancers, tumors located near critical structures such as the brain, spinal cord, or optic system, skull-based tumors, ocular tumors, and other conditions for which minimizing radiation exposure to normal tissue is clinically important. Patient selection should be based upon accepted clinical guidelines, evidence-based medical practice, and physician judgment. Proton therapy is typically delivered on an outpatient basis and, similar to conventional radiation therapy, may be administered in a single treatment or in multiple fractions over a period of days or weeks depending upon the disease being treated and the prescribed treatment plan. Proton therapy requires substantial capital investment, highly specialized equipment, dedicated facility infrastructure, and specialized clinical expertise. As a result, proton therapy services are generally provided on a regional or statewide basis rather than as a routine community-level radiation therapy service. Diagnostic Imaging Services Diagnostic imaging equipment and services, except for magnetic resonance imaging, positron emission tomography, and invasive digital angiography, are reviewable under the state’s Certificate of Need law only when the capital expenditure for the acquisition of the equipment and related costs exceeds $3,000,000.00. The provision of invasive diagnostic imaging services (i.e. invasive Digital Angiography, Positron Emission Tomography, and Magnetic Resonance Imaging) require a Certificate of Need if the proposed provider has not offered the services on a regular basis within twelve (12) months prior to the time the services would be offered, regardless of the capital expenditure. Equipment in this category includes, but is not limited to, ultrasound equipment, diagnostic nuclear medicine equipment, digital radiography equipment, digital angiography equipment, computed tomographic (CT) scanning equipment, magnetic resonance imaging (MRI) equipment, and positron emission tomography (PET) equipment. 507.1 Computed Tomographic (CT) Scanning Computed Tomographic (CT) scanning is a diagnostic imaging modality that utilizes X-rays and computerized image reconstruction to produce detailed cross-sectional images of internal organs, tissues, and anatomical structures. CT technology plays an important role in the diagnosis, evaluation, treatment planning, and monitoring of a wide variety of medical conditions. 507.2 Magnetic Resonance Imaging (MRI) Magnetic Resonance Imaging (MRI) is a diagnostic imaging technique that employs magnetic and radio-frequency fields to produce images of the body non-invasively. MRI is similar to CT scanning in that it produces cross-sectional and digital images without potentially harmful ionizing radiation, producing an image not distorted by bone mass. The equipment and its operational specifications continue to be refined. Ninety (91) facilities (hospitals and free-standing) in Mississippi operated fixed or mobile based MRI units in FY 2020. These facilities performed a total of 253,198 MRI procedures during the year. Table 5-6 presents the location, type (fixed or mobile), number of units per facility, and utilization of MRI equipment throughout the state in fiscal years 2019 and 2020. 507.3 Invasive Digital Angiography (DA) Invasive Digital Angiography (DA) is a diagnostic and catheter based therapeutic intravascular intervention imaging procedure that combines a digital processing unit with equipment similar to that used for standard fluoroscopic procedures. Most invasive DA studies are appropriate as outpatient procedures in a freestanding facility, where proper protocols are met. 507.4 Positron Emission Tomography (PET) Positron Emission Tomography (PET) is a minimally invasive imaging procedure in which positron-emitting radionuclides, produced either by a cyclotron or by a radio-pharmaceutical producing generator, and a gamma camera are used to create pictures of organ function rather than structure. PET scans provide physicians a crucial assessment of the ability of specific tissues to function normally. PET can provide unique clinical information in an economically viable manner, resulting in a diagnostic accuracy that affects patient management. PET scans provide diagnostic and prognostic patient information regarding cognitive disorders; for example, identifying the differences between Alzheimer’s, Parkinson's, dementia, depression, cerebral disorders, and mild memory loss. PET scans also provide information regarding psychiatric disease, brain tumors, epilepsy, cardiovascular disease, movement disorders, and ataxia. Research shows that clinical PET may obviate the need for other imaging procedures. PET installations generally take one of two forms: a scanner using only generator-produced tracers (basic PET unit) or a scanner with a cyclotron (enhanced PET unit). The Rubidium-82 is the only generator approved by the FDA to produce radiopharmaceuticals. Rubidium limits PET services to cardiac perfusion imaging. A PET scanner supported by a cyclotron can provide the capabilities for imaging a broader range of PET services, such as oncology, neurology, and cardiology. Manufacturers of PET equipment are providing more user-friendly cyclotrons, radiopharmaceutical delivery systems, and scanners which have drastically reduced personnel and maintenance requirements. These changes have made the cost of PET studies comparable to those of other high-technology studies. Cardiology Associates of North Mississippi located in Tupelo, Mississippi (Lee County) has a fixed PET unit and performs Cardiac/PET procedures (PET scans/imaging of the heart). For FY2020, Cardiology Associates of North Mississippi performed 1,170 procedures. Table 5-7 presents the location, type (fixed or mobile), and utilization of PET equipment throughout the state in 2020. Certificate of Need Criteria and Standards for Therapeutic Radiation Services Should MSDH receive a CON application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until MSDH has developed and adopted CON criteria and standards. If MSDH has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. 508.1 General Therapeutic Radiation Equipment & Services 508.1.1 Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of General Therapeutic Radiation Equipment and/or the Offering of General Therapeutic Radiation Services 1. Service Areas: MSDH shall determine the need for General Therapeutic Radiation services equipment using the General Hospital Service Areas as presented in this chapter of the Plan. MSDH shall determine the need for General Therapeutic Radiation services and equipment within a given service area independently of all other service areas. Map 5-1 shows the General Hospital Service Areas. 2. Equipment to Population Ratio: The need for General Therapeutic Radiation units (as defined) is determined to be one unit per 117,380 population (see Methodology in Section 508.1 of the Plan). MSDH will consider out-of-state population in determining need only when the applicant submits adequate documentation acceptable to MSDH, such as valid patient origin studies. 3. Limitation of New Services: When the General Therapeutic Radiation unit-to-population ratio reaches one to 117,380 in a given general hospital service area, no new General Therapeutic Radiation services may be approved unless the utilization of all the existing machines in a given hospital service area averaged 8,000 treatments or 320 patients per year for the two most recent consecutive years as reported on the “Renewal of Hospital License and Annual Hospital Report.” For purposes of this policy, Cesium-137 teletherapy units, Cobalt-60 teletherapy units designed for use at less than 80 cm SSD (source-to-skin distance), old betatrons and van de Graaf Generators unsuitable for modern clinical use shall not be counted in the inventory of General Therapeutic Radiation units located in a hospital service area. 4. Expansion of Existing Services: MSDH may consider a CON application for the acquisition or otherwise control of an additional General Therapeutic Radiation unit by an existing provider of such services when the applicant’s existing equipment has exceeded the expected level of patient service (i.e. 320 patients per year or 8,000 treatments per year for the two most recent consecutive years) as reported on the facility’s “Renewal of Hospital License and Annual Hospital Report.” 5. Equipment Designated for Backup: General Therapeutic Radiation equipment designated by an applicant as “backup” equipment shall not be counted in the inventory for CON purposes. Any treatments performed on the “backup” equipment shall be attributed to the primary equipment for CON purposes. “Backup” equipment should only be utilized when the primary equipment is deemed out of service. 6. Definition of a Treatment: For health planning and CON purposes a patient “treatment” is defined as one individual receiving radiation therapy during a visit to a facility which provides megavoltage radiation therapy regardless of the complexity of the treatment or the number of “fields” treated during the visit. 7. Use of Equipment or Provision of Service: Before the equipment or service can be utilized or provided, the applicant desiring to provide the General Therapeutic Radiation equipment or service shall have CON approval or written evidence that the equipment or service is exempt from CON approval, as determined by MSDH through a Determination of non- Reviewability. 8. Review Threshold: Notwithstanding any prior language in this section, and pursuant to House Bill 3 from the 2026 Legislative Session (effective February 4, 2026), Certificate of Need review for the acquisition or otherwise control of Therapeutic Radiation equipment is required only if the total acquisition cost as defined in Section 1.14 of the CON Review Manual exceeds Three Million Dollars ($3,000,000.00). 508.1.2 Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of General Therapeutic Radiation Equipment and/or the Offering of General Therapeutic Radiation Services MSDH will review CON applications for the acquisition or otherwise control of General Therapeutic Radiation equipment and/or the offering of General Therapeutic Radiation services under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7- 193. MSDH will also review applications for CON according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. The acquisition or otherwise control of General Therapeutic Radiation equipment is reviewable if the equipment cost exceeds $3,000,000.00. The offering of General Therapeutic Radiation services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure. Need Criterion 1: Project Need The applicant shall document a need for General Therapeutic Radiation equipment/services by complying with any one of the following methodologies: A. The need methodology as presented in this section of the Plan; B. Demonstrating that all existing machines in the service area in question have averaged 8,000 treatments per year or all machines have treated an average of 320 patients per year for the two most recent consecutive years; or C. Demonstrating that the applicant’s existing General Therapeutic Radiation equipment has exceeded the expected level of patient service (i.e. 320 patients per year/unit or 8,000 treatments per year/unit for the two most recent consecutive years). Need Criterion 2: Presence of Readily Available Services The applicant must document that access to diagnostic x-ray, CT scan, and ultrasound services is readily available within fifteen (15) minutes normal driving time of the General Therapeutic Radiation unit’s location. Need Criterion 3: Staffing Requirements An applicant shall document the following: A. The service will have at a minimum the following full-time dedicated staff: 1. One board-certified radiation oncologist-in-chief, 2. One dosimetrist, 3. One certified radiation therapy technologist certified by the American Registry of Radiation Technologists, and 4. One registered nurse. B. The service will have at a minimum access to a radiation physicist certified or eligible for certification by the American Board of Radiology. NOTE: One individual may act in several capacities. However, the application shall affirm that when a staff person acts in more than one capacity that staff person shall meet, at a minimum, the requirements for each of the positions he/she fills. Need Criterion 4: Access to Additional Staff The applicant shall affirm that access will be available as needed to Brachytherapy staff, treatment aides, social workers, dietitians, and physical therapists. Need Criterion 5: Physician Location Applicants shall document that all physicians who are responsible for General Therapeutic Radiation services in a facility, including the radiation oncologist-in-chief, shall reside within sixty (60) minutes normal driving time of the facility. Need Criterion 6: Access to a Modern Stimulator The application shall affirm that the applicant will have access to a modern simulator capable of precisely producing the geometric relationships of the treatment equipment to a patient. This simulator must produce high quality diagnostic radiographs. The applicant shall also affirm that the following conditions will be met regarding use of the simulator: A. If the simulator is located at a site other than where the General Therapeutic Radiation equipment is located, protocols will be established which will guarantee that the radiation oncologist who performs the patient’s simulation will also be the same radiation oncologist who performs the treatments on the patient. B. If the simulator uses fluoroscopy, protocols will be established to ensure that the personnel performing the fluoroscopy have received appropriate training in the required techniques related to simulation procedures. NOTE: X-rays produced by diagnostic x-ray equipment and photon beams produced by megavoltage therapy units are unsuitable for precise imaging of anatomic structures within the treatment volume and do not adequately substitute for a simulator. Need Criterion 7: Access to Computerized Treatment Planning System The application shall affirm that the applicant will have access to a computerized treatment planning system with the capability of simulation of multiple external beams, display isodose distributions in more than one plane, and performing dose calculations for brachytherapy implants. NOTE: It is highly desirable that the system has the capability of performing CT-based treatment planning. Need Criterion 8: Supervision of Treatment The applicant shall affirm that all treatments will be under the control of a board-certified or board- eligible radiation oncologist. Need Criterion 9: MSDH Division of Radiological Health Approval The applicant shall affirm that the proposed site, plans, and equipment shall receive approval from the MSDH Division of Radiological Health before service begins. Need Criterion 10: Quality Assurance Program The application shall affirm that the applicant will establish a quality assurance program for the service as follows: A. The General Therapeutic Radiation program shall meet, at a minimum, the physical aspects of quality assurance guidelines established by the American College of Radiology (ACR) within twelve (12) months of initiation of the service. B. The service shall establish a quality assurance program which meets, at a minimum, the standards established by the American College of Radiology. Need Criterion 11: Failure to Comply The applicant shall affirm understanding and agreement that failure to comply with Need Criterion 10 (A) and (B) may result in revocation of the CON (after due process) and subsequent termination of authority to provide General Therapeutic Radiation services. 508.1.3 General Therapeutic Radiation Equipment/Services Need Methodology 1. Treatment/Patient Load: A realistic treatment/patient load for a General Therapeutic Radiation unit is 8,000 treatments or 320 patients per year. 2. Incidence of Cancer: The American Cancer Society (ACS) estimates that Mississippi will experience 18,750 new cancer cases in 2021. Based on a population of 3,095,026 (year 2025) as estimated by the State Data Center of Mississippi (University of Mississippi Center for Population Studies), the Mississippi Cancer Incidence Rate is 6.06 cases per 1,000 population. 3. Patients to Receive Treatment: The number of cancer patients expected to receive General Therapeutic Radiation treatment is set at forty-five percent (45%). 4. Population to Equipment Ratio: Using the above-stated data, a population of 100,000 will generate 606 new cancer cases each year. Assuming that forty-five percent (45%) will receive radiation therapy, a population of 117,380 will generate approximately 320 patients who will require radiation therapy. Therefore, a population of 117,380 will generate a need for one General Therapeutic Radiation unit. 508.1.4 General Therapeutic Radiation Equipment Need Determination Formula 1. Project Annual Number of Cancer Patients: General Hospital Service Area Population × 6.06 cases*/1,000 population = New Cancer Cases *Mississippi Cancer Incidence Rate 2. Project Annual Number of Radiation Therapy Patients: New Cancer Cases ×45% = Patients Who Will Likely Require Radiation Therapy 3. Estimate Number of Treatments to Be Performed Annually: Radiation Therapy Patients × 25 Treatments per Patient (Avg.) = Estimated # of Treatments 4. Project Number of Megavoltage Radiation Therapy Units Needed: Estimated # of Treatments/8,000 Treatments per Unit = Projected # of Units Needed 5. Determine Unmet Need (if any): Projected # of Units Needed - # of Existing Units = # of Units Required (Excess) 508.2 Stereotactic Radiosurgery Equipment & Services 508.2.1 Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of Stereotactic Radiosurgery Equipment and/or the Offering of Stereotactic Radiosurgery 1. Service Areas: MSDH shall determine the need for Stereotactic Radiosurgery services and equipment by using the actual Stereotactic Radiosurgery provider’s service area. 2. Unit to Population Ratio: The need for Stereotactic Radiosurgery units is determined to be the same as for radiotherapy, for 2023 a population of 3,138,145. The General Therapeutic Radiation Equipment Need Determination formula is outlined in Section 508.1.4 above. 3. Accessibility: Nothing contained in these CON criteria and standards shall preclude the University of Mississippi School of Medicine from acquiring and operating Stereotactic Radiosurgery equipment, provided the acquisition and use of such equipment is justified by the School’s teaching and/or research mission and complies with the teaching exception as outlined in Section 102.1 of this Plan. However, the requirements listed under the section regarding the granting of “appropriate scope of privileges for access to the stereotactic radiosurgery equipment to any qualified physician” must be met. 4. Expansion of Existing Services: MSDH may consider a CON application for the acquisition or otherwise control of an additional Stereotactic Radiosurgery unit by an existing provider of such services when the applicant’s existing equipment has exceeded the expected level of patient service (i.e. 900 treatments per year for the two most recent consecutive years) as reported on the facility’s “Renewal of Hospital License and Annual Hospital Report.” 5. Addition of Services: Facilities requesting approval to add Stereotactic Radiosurgery services should have an established neurosurgery program and must be able to demonstrate previous radiosurgery service experience. 6. Discharge Planning Policy: All Stereotactic Radiosurgery services should have written procedures and policies for discharge planning and follow-up care for the patient and family as part of the institution’s overall discharge planning program. 7. Referral Policy: All Stereotactic Radiosurgery services should have established protocols for referring physicians to ensure adequate post-operative diagnostic evaluation for radiosurgery patients. 8. Service Cost Comparison: The total cost of providing Stereotactic Radiosurgery services projected by prospective providers should be comparable to the cost of other similar services provided in the state. 9. Patient Cost Comparison: The usual and customary charge to the patient for Stereotactic Radiosurgery should be commensurate with cost. 508.2.2 Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Stereotactic Radiosurgery Equipment and/or the Offering of Stereotactic Radiosurgery MSDH will review CON applications for the acquisition or otherwise control of Stereotactic Radiosurgery equipment and/or the offering of Stereotactic Radiosurgery services under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. The acquisition or otherwise control of Stereotactic Radiosurgery equipment is reviewable if the equipment cost exceeds $3,000,000.00. The offering of Stereotactic Radiosurgery services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure. Need Criterion 1: Minimum Procedures The applicant shall document a need for Stereotactic Radiosurgery equipment/services by reasonably projecting that the proposed new service will perform at least 900 Stereotactic Radiosurgery treatments in the third year of operation. No additional new Stereotactic Radiosurgery services should be approved unless the number of Stereotactic Radiosurgery treatments performed with existing units in the state average 900 treatments or more per year. Need Criterion 2: Staffing Requirements A. The radiosurgery programs must be established under the medical direction of two co- directors, one with specialty training and board certification in neurosurgery and the other with specialty training and board certification in radiation oncology, with experience in all phases of Stereotactic Radiosurgery. B. In addition to the medical co-directors, all Stereotactic Radiosurgery programs should have a radiation physicist who is certified in radiology, or who holds an advanced degree in physics with two to three years of experience working under the direction of a radiation oncologist, and a registered nurse present for each Stereotactic Radiosurgery performed. C. The applicant shall document that the governing body of the entity offering Stereotactic Radiosurgery services will grant an appropriate scope of privileges for access to the Stereotactic Radiosurgery equipment to any qualified physician who applies for privileges. For this criterion, “Qualified Physician” means a Doctor of Medicine or Osteopathic Medicine licensed by the State of Mississippi who possesses training in Stereotactic Radiosurgery and other qualifications established by the governing body. Need Criterion 3: Equipment A. Facilities providing Stereotactic Radiosurgery services should have dosimetry and calibration equipment and a computer with the appropriate software for performing Stereotactic Radiosurgery. B. The facility providing Stereotactic Radiosurgery services should also have access to Magnetic Resonance Imaging, Computed Tomography, and Angiography services. 508.3 Proton Therapy Equipment & Services The Mississippi State Department of Health recognizes that proton accelerator technology represents a highly specialized form of radiation therapy requiring substantial capital investment, specialized clinical expertise, and long-term operational sustainability. The Department further recognizes that Proton Therapy may provide clinical benefit for certain patient populations while also representing one of the most resource-intensive forms of radiation oncology services. The Department finds that proton accelerator services should be developed in a manner that: • Promotes access for Mississippi residents; • Avoids unnecessary duplication of highly specialized services; • Supports clinical quality and patient safety; • Demonstrates long-term financial viability; and • Ensures efficient utilization of health care resources. The purpose of this section is to establish criteria for review of Certificate of Need applications proposing the establishment, acquisition, expansion, or relocation of proton accelerator services. 508.4 Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of Proton Therapy Equipment and/or the Offering of Proton Therapy Services 1. Definitions: For purposes of this Policy Statement and the Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Proton Therapy Equipment and/or the Offering of Proton Therapy Services, the following definitions shall apply: a. “Proton Accelerator Service” means a healthcare service utilizing proton beam therapy technology for the treatment of cancer or other medically appropriate conditions. 2. Planning Area: The planning area for proton accelerator services shall be statewide. 3. Limitation on Duplication: Until sufficient utilization data are available to support development of a numerical planning methodology, no additional proton accelerator service shall be approved unless the Department determines that: a. The existing proton accelerator service has operated at or above eighty percent (80%) of practical treatment capacity for two (2) consecutive years; or b. Exceptional circumstances demonstrate a substantial unmet statewide need that cannot reasonably be addressed through the existing service. 4. Annual Review: The Department shall periodically evaluate utilization data and may revise this methodology as additional information becomes available. 508.5 Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Proton Therapy Equipment and/or the Offering of Proton Therapy Services The Mississippi State Department of Health will review applications for a Certificate of Need for the acquisition or otherwise control of Proton Therapy equipment and/or the offering of Proton Therapy services under the applicable statutory requirements of Miss. Code Ann. §§ 41- 7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures and plans of MSDH; and the specific criteria and standards listed below. The acquisition or otherwise control of Proton Therapy equipment is reviewable if the equipment costs exceed $3,000,000.00. The offering of Proton Therapy services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered. Need Criterion 1: Demonstration of Need The applicant shall demonstrate a need for the proposed proton accelerator service through documentation including: A. The estimated number of Mississippi residents currently receiving proton therapy services; B. The locations where Mississippi residents currently receive proton therapy services; C. Referral patterns from Mississippi physicians and hospitals; D. Clinical conditions and patient populations expected to utilize the service; and E. Projected annual patient volumes. Need Criterion 2: Clinical Appropriateness The applicant shall demonstrate that the proposed service will utilize evidence-based patient selection criteria consistent with nationally recognized standards and clinical practice guidelines. Need Criterion 3: Access The applicant shall demonstrate that the proposed service will be reasonably accessible to patients throughout Mississippi. At a minimum, the applicant shall: A. Accept Medicare beneficiaries; B. Participate in Mississippi Medicaid if otherwise eligible; C. Maintain charity care policies consistent with those applicable to the applicant’s facility; and D. Accept referrals regardless of physician or hospital affiliation. Criterion 4: Financial Feasibility The applicant shall demonstrate: A. The financial feasibility of the proposed service; B. Availability of sufficient capital resources; C. Projected operating sustainability; and D. Reasonable utilization assumptions. Criterion 5: Staffing and Clinical Resources A. The applicant shall demonstrate the availability of: B. Qualified radiation oncologists; C. Qualified medical physicists; D. Radiation therapy personnel; E. Appropriate support staff; and F. Comprehensive oncology support services. Criterion 6: Integration with Existing Cancer Services The applicant shall demonstrate coordination with existing oncology providers and continuity of care for patients receiving proton therapy. Criterion 7: Data Reporting As a condition of approval, the provider shall submit annual reports to the Department for a period of five (5) years following initiation of services. The reports shall include: A. Number of patients treated; B. Mississippi resident utilization; C. Payer mix; D. Referral sources; E. Charity care provided; and F. Other information required by the Department. Need Criterion 8: MSDH Division of Radiological Health Approval The applicant shall affirm that the proposed site, plans, and equipment shall receive approval from the MSDH Division of Radiological Health before service begins. 508.6 Proton Therapy Equipment/Service Methodology The Department finds that insufficient Mississippi-specific utilization data currently exists to support a numerical planning formula for proton accelerator services. Accordingly, need shall be determined through consideration of the criteria established in this section and evaluation of the applicant’s demonstration of statewide need, projected utilization, access, financial feasibility, and clinical appropriateness. Certificate of Need Criteria and Standards for Diagnostic Imaging Services Should MSDH receive a CON application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until MSDH has developed and adopted CON criteria and standards. If MSDH has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. 509.1 Computed Tomographic (CT) Scanning Should the capital expenditure for the acquisition of fixed or mobile CT scanning services, equipment, and related costs exceed $3,000,000.00, the CON proposal will be reviewed under the general review criteria outlined in the most recent Certificate of Need Review Manual adopted by the Mississippi State Department of Health and the following utilization standards: 1. A proposed unit must be able to generate a minimum of 2,000 HECTs by the second year of operation. See Table 5-6 for HECT conversion table. 2. Providers desiring CT capability must be properly utilizing 20,000 general radiographic imaging procedures per year. 509.2 Digital Angiography Equipment & Services 509.2.1 Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of Digital Angiography Equipment and/or the Offering of Invasive DA Services Digital Angiography Equipment and Services in Ambulatory Surgery Centers: Applicants proposing the acquisition or otherwise control of Digital Angiography equipment and/or the offering of invasive Digital Angiography services in a single specialty ambulatory surgery center must apply for a certificate of need before providing such services. 509.2.2 Certificate of Need Criteria and Standards for Invasive Digital Angiography in a Hospital MSDH will review applications for a CON for the acquisition or otherwise control of Digital Angiography (DA) equipment and associated costs under the applicable statutory requirements of Miss. Code. Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. CON review is required when the capital expenditure for the purchase of Digital Angiography equipment and associated costs exceed $3,000,000.00, or when the equipment is to be used for invasive procedures (i.e. the use of catheters). The offering of diagnostic and therapeutic intravascular intervention imaging services of an invasive nature (i.e. invasive Digital Angiography) is reviewable if those services have not been provided on a regular basis by the proposed provider of such services within the period of twelve (12) months prior to the time such services would be offered regardless of the capital expenditure. Need Criterion 1: Staffing Requirements The applicant for invasive DA services shall demonstrate that proper protocols for screening and medical specialty backup are in place before services are rendered by personnel other than those with specialized training. For example, if a radiologist without specialized training in handling cardiac arrhythmia is to perform a procedure involving the heart, a cardiologist/cardiosurgeon must be available for backup. The protocols shall include, but are not limited to, having prior arrangements for backup from: A. A cardiologist/cardiosurgeon for procedures involving the heart; B. A neurologist/neurosurgeon for procedures involving the brain; and C. A vascular surgeon, cardiologist, radiologist or nephrologist credentialed and accredited for interventional peripheral vascular procedures. Need Criterion 2: CON Exemption Before utilizing or providing the equipment or service, the applicant desiring to provide the Digital Angiography equipment or invasive DA services shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by MSDH through a Determination of Reviewability. 509.2.3 Certificate of Need Criteria and Standards for Invasive Digital Angiography in a Freestanding Facility Need Criterion 1: Staffing Requirements A. The applicant for invasive DA services shall demonstrate that proper protocols for screening and medical specialty backup are in place before services are rendered by personnel other than those with specialized training. The protocols shall include, but are not limited to, having prior arrangements for consultation/backup from a vascular surgeon, cardiologist, radiologist or nephrologist credentialed and accredited for interventional peripheral vascular procedures. B. Identify physicians in the group and state which physicians(s) will perform intravascular interventions using DA. Certify that: 1. Each physician will maintain medical staff privileges at a full-service hospital; or 2. At least one member of the physician group has staff privileges at a full-service hospital and will be available at the facility or on call within a 30-minute travel time of the full-service hospital during the hours of operation of the facility. Need Criterion 2: Types of Procedures A. Procedures in a freestanding facility are generally non-emergent nor life threatening in nature and require a patient stay of less than twenty-four (24) consecutive hours. The procedures shall not be of a type that: 1. Generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; 2. Require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures, except for laparoscopic procedures; or 3. Involve Major Blood Vessels. a. Major Blood Vessels are defined as the group of critical arteries and veins including the aorta, coronary arteries, pulmonary arteries, superior and inferior vena cava, pulmonary veins, carotid arteries, and any intra- cerebral artery or vein. Percutaneous endovascular interventions of the peripheral vessels not excluded in subsection A.1.a. above are permitted to be performed in a freestanding facility. These procedures are defined as procedures performed without open direct visualization of the target vessel, requiring only needle puncture of an artery or vein followed by insertion of catheters, wires, or similar devices which are then advanced through the blood vessels using imaging guidance. Once the catheter reaches the intended location, various maneuvers to address the diseased area may be performed which include, but are not limited to, injection of contrast for imaging, ultrasound of the vessel, treatment of vessels with angioplasty, artherectomy, covered or uncovered stenting, intentional occlusion of vessels or organs (embolization), and delivering of medications, radiation, or other energy such as laser, radiofrequency, or cryo. Need Criterion 3: Transfer Agreement The applicant must certify that the proposed facility will have a formal transfer agreement with a full-service hospital to provide services which are required beyond the scope of the freestanding facility’s programs. Need Criterion 4: CON Exemption Before utilizing or providing the equipment or service, the applicant desiring to provide the digital angiography equipment or invasive DA services shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by MSDH through a Determination of Reviewability. 509.3 Magnetic Resonance Imaging Equipment & Services 509.3.1 Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of Magnetic Resonance Imaging Equipment and/or the Offering of MRI Services 1. CON Review Requirements: The CON process regarding the acquisition or otherwise control of MRI equipment and/or the offering of MRI services involves separate requirements for CON review: (a) an entity proposing to acquire or otherwise control MRI equipment must obtain a CON to do so if the capital expenditure for the MRI unit and related equipment exceeds $3,000,000.00; and (b) an entity proposing to offer MRI services which has not provided the service on a regular basis within the last twelve (12) months must obtain a CON before providing such services, regardless of the capital expenditure. 2. CON Approval Preference: MSDH shall give preference to those applicants proposing to enter into joint ventures utilizing mobile and/or shared equipment. However, the applicant must meet the applicable CON criteria and standards provided herein and the general criteria and standards contained in the currently approved Mississippi Certificate of Need Review Manual. 3. Mobile MRI: For purposes of this Plan, a mobile MRI unit is defined as an MRI unit operating at two or more host sites and that has a central service coordinator. The mobile MRI unit shall operate under a contractual agreement for the provision of MRI services at each host site on a regularly scheduled basis. 4. Conversion to Fixed: The conversion from mobile MRI service to fixed MRI service is considered the establishment of a new MRI service and requires CON review. 5. Utilization of Existing Units: No new MRI services shall be approved unless all existing MRI service in the applicant’s defined service area performed an average of 1,700 MRI procedures per existing and approved MRI scanner during the most recent twelve (12) month reporting period and the proposed new services would not reduce the utilization of existing providers in the service area. 6. Population-Based Formula: MSDH shall use a population-based formula as presented at the end of this chapter when calculating MRI need. Also, the formula will use historical and projected use rates by service area and patient origin data. The population-based formula is based on the most recent population projections prepared by the State Data Center (University of Mississippi Center for Population Studies). The applicant shall project a reasonable population base to justify the provision of 2,700 procedures (or 1,700 procedures for rural hospitals) by the second year of operation. 7. Mobile Service Volume Proration: The required minimum service volumes for the establishment of services and the addition of capacity for mobile services shall be prorated on a “site by site” basis based on the amount of time the mobile services will be operational at each site. 8. Addition of a Healthcare Facility: An equipment vendor who proposes to add a healthcare facility to an existing or proposed route must notify MSDH through the filing of a Determination of Reviewability of any proposed changes (i.e. additional healthcare facilities or route deviations, from those presented in the Certificate of Need application prior to such change). 9. Review Threshold: Notwithstanding any prior language in this section, and pursuant to House Bill 3 from the 2026 Legislative Session (effective February 4, 2026), Certificate of Need review for the acquisition or otherwise control of MRI equipment is required only if the total acquisition cost as defined in the CON Review Manual exceeds Three Million Dollars ($3,000,000.00). 509.3.2 Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Magnetic Resonance Imaging Equipment and/or the Offering of MRI Services Need Criterion 1: Minimum Procedures/Population The entity desiring to acquire or otherwise control the MRI equipment shall demonstrate a minimum of 2,700 procedures per year by the end of the second year of operation; provided, however, that MRI equipment exclusively servicing rural hospitals (those located outside U.S. Census Bureau Metropolitan Statistical Areas with 75 or less beds) shall be required to demonstrate a minimum of 1,700 procedures per year by the end of the second year of operation. This criterion includes both fixed and mobile MRI equipment. The applicant must show the methodology used for the projections. A. Applicants for non-hospital-based MRI facilities may submit affidavits from referring physicians. MRI procedures projected in affidavits shall be based on actual MRI procedures referred during the year. B. The applicant shall document a reasonable population base to document that a minimum of 2,700 procedures will be performed per proposed MRI unit (or 1,700 procedures per year for a mobile MRI route exclusively serving rural hospitals). C. The applicant shall demonstrate that all existing units within its defined service area have performed an average of 1,700 procedures for the most recent 12-month period. It is recognized that an applicant desiring to acquire or otherwise control an MRI unit may make or propose to make the MRI unit available to more than one provider of MRI services, some of which may be located outside of Mississippi. In such cases all existing or proposed users of the MRI unit must jointly meet the required service volume of 2,700 (or 1,700 for mobile MRI route exclusively serving rural hospitals) procedures annually. If the MRI unit in question is presently utilized by other providers of MRI services, the actual number of procedures performed by them during the most recent twelve (12) month period and/or documented projections of physician referrals may be used. Need Criterion 2: Equipment Requirements In order to receive CON approval to acquire or otherwise control MRI equipment, the applicant shall provide a copy of the proposed contract and document the following: A. The equipment is FDA approved; B. Only qualified personnel will be allowed to operate the equipment; and C. If the equipment is to be rented, leased, or otherwise used by other qualified providers on a contractual basis, no fixed/minimum volume contracts will be permitted. Need Criterion 3: Data Requirements Applicants shall provide written assurance that they will record and maintain, at a minimum, the following information and make it available to MSDH: A. All facilities which have access to the equipment; B. Utilization by each facility served by the equipment (e.g., days of operation, number of procedures, and number of repeat procedures); C. Financial data (e.g., copy of contracts, fee schedule, and cost per scan); and D. Demographic and patient origin data for each facility. In addition, if required by the Department, the above referenced information and other data pertaining to the use of MRI equipment will be made available to the MSDH within fifteen (15) business days of request. The required information may also be requested for entities outside of Mississippi that use the MRI equipment in question. Need Criterion 4: Business Registration The entity desiring to acquire or otherwise control the MRI equipment must be a registered entity authorized to do business in Mississippi. Need Criterion 5: CON Approval/Exemption for MRI Equipment Before the specified equipment can be utilized, the applicant desiring to provide the MRI equipment shall have CON approval or written evidence that the equipment is exempt from CON approval, as determined by MSDH through a Determination of Reviewability. Each specified piece of equipment must be exempt from or have CON approval. 509.3.3 Certificate of Need Criteria and Standards for Acquisition or Otherwise Control of MRI Equipment MSDH will review applications for a CON for the acquisition or otherwise control of MRI equipment and/or the offering of MRI services under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans MSDH; and the specific criteria and standards listed below. The acquisition or otherwise control of MRI equipment is reviewable if the equipment cost is in excess of $3,000,000.00; if the equipment and/or service is relocated; and if the proposed provider of MRI services has not provided such services on a regular basis within the period of twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure. 509.3.4 Certificate of Need Criteria and Standards for the Offering of Fixed or Mobile MRI Services An entity proposing to offer MRI services shall obtain Certificate of Need (CON) approval before offering such services. Need Criterion 1: Minimum Procedures/Population The entity desiring to offer MRI services must document that the equipment shall perform a minimum of 2,700 procedures (or 1,700 procedures for rural hospitals) by the end of the second year of operation. This criterion includes both fixed and mobile MRI equipment. The applicant must show methodology used for the projections. A. Applicants for non-hospital-based MRI facilities may submit affidavits from referring physicians. MRI procedures projected in affidavits shall be based on actual MRI procedures referred during the year. B. The applicant shall document a reasonable population within its service area to justify 2,700 procedures per year per proposed MRI unit (1,700 procedures per year per proposed mobile MRI unit on a route exclusively serving rural hospitals). C. The applicant shall demonstrate that all existing units within its defined service area have performed an average of 1,700 procedures for the most recent 12-month period. It is recognized that a particular MRI unit may be utilized by more than one provider of MRI services, some of which may be located outside of Mississippi. In such cases all existing or proposed providers of MRI services must jointly meet the required service volume of 2,700 (or 1,700 for mobile MRI route exclusively serving rural hospitals) procedures annually by the end of the second year of operation. If the MRI unit in question is presently utilized by other providers of MRI services, the actual number of procedures performed by them during the most recent 12- month period and/or documented projection of physician referrals may be used instead of the formula projections. Need Criterion 2: Availability of Diagnostic Imaging Modalities An applicant desiring to offer MRI services must document that a full range of diagnostic imaging modalities for verification and complementary studies will be available at the time MRI services begin. These modalities shall include, but not be limited to, computed tomography (full body), ultrasound, angiography, nuclear medicine, and conventional radiology. Need Criterion 3: Non-Discrimination All applicants proposing to offer MRI services shall give written assurance that, within the scope of its available services, neither the facility where the service is provided nor its participating medical personnel shall have policies nor procedures which would exclude patients because of race, color, age, sex, ethnicity, or ability to pay. Need Criterion 4: Staffing Requirements The applicant must document that the following staff will be available: A. Director - A full-time, board eligible radiologist or nuclear medicine imaging physician, or other board eligible licensed physician whose primary responsibility during the prior three years has been in the acquisition and interpretation of clinical images. The Director shall have knowledge of MRI through training, experience, or documented post-graduate education. The Director shall document a minimum of one week of full-time training with a functional MRI facility. B. One full-time MRI technologist radiographer or a person who has had equivalent education, training, and experience, who shall be on-site at all times during operating hours. This individual must be experienced in computed tomography or other cross-sectional imaging methods, or must have equivalent training in MRI spectroscopy. Need Criterion 5: Experimental Procedures The applicant shall document that when an MRI unit is to be used for experimental procedures with formal/approved protocols, a full-time medical physicist or MRI scientist (see definition in Glossary) with at least one year of experience in diagnostic imaging shall be available in the facility. Need Criterion 6: Data Requirements The applicant shall provide assurances that the following data regarding its use of the MRI equipment will be kept and made available to MSDH upon request: A. Total number of procedures performed, B. Number of inpatient procedures, C. Number of outpatient procedures, D. Average MRI scanning time per procedure, E. Average cost per procedure, F. Average charge per procedure, G. Demographic/patient origin data, and H. Days of operation. In addition to the above data recording requirements, the facility should maintain the source of payment for procedures and the total amounts charged during the fiscal year when it is within the scope of the recording system. Need Criterion 7: CON Approval/Exemption for MRI Equipment Before the service can be provided, the CON applicant desiring to offer MRI services shall provide written evidence that the specified MRI equipment provider has received CON approval or is exempt from CON approval as determined by MSDH through a Determination of Reviewability. Each specified piece of equipment must be exempt from or have CON approval. 509.3.5 Population-Based Formula for Projection of MRI Service Volume X(Y) ÷1,000 = V Where: X = Applicant’s Defined Service Area Population Y = Mississippi MRI Use Rate* V = Expected Volume *Use Rate shall be based on information in the State Health Plan. 509.4 Positron Emission Tomography Equipment & Services 509.4.1 Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of a Positron Emission Tomography Scanner and Related Equipment Including Cardiac-Only PET Scanner 1. CON Review Requirements: Applicants proposing the acquisition or otherwise control of a PET scanner shall obtain a CON to do so if the capital expenditure for the scanner and related equipment exceeds $3,000,000.00. 2. Indigent/Charity Care: An applicant shall be required to provide a "reasonable amount" of indigent/charity care as described in Chapter 1 of this Plan. 3. Service Areas: The state as a whole shall serve as a single service area in determining the need for a PET scanner. In the case of Cardiac only PET Scanner, the service area will be the General Hospital Service Areas. 4. Equipment-to-Population Ratio: The need for a PET scanner is estimated to be one scanner per 300,000 population. MSDH will consider out-of-state population in determining need only when the applicant submits adequate documentation acceptable to MSDH, such as valid patient origin studies. In the case of Cardiac only PET Scanner, this policy will not apply. 5. Access to Supplies: Applicants must have direct access to appropriate radio- pharmaceuticals. 6. Services and Medical Specialties Required: The proposed PET units must function as a component of a comprehensive inpatient or outpatient diagnostic service. The proposed PET unit must have the following modalities (and capabilities) on-site or through contractual arrangements: a. Computed Tomography – (whole body) b. Magnetic Resonance Imaging – (brain and whole body) c. Nuclear Medicine – (cardiac, SPECT) d. Conventional Radiography e. The following medical specialties during operations hours: i. Cardiology ii. Neurology iii. Neurosurgery iv. Oncology v. Psychiatry vi. Radiology. 7. Hours of Operation: PET facilities should have adequate scheduled hours to avoid an excessive backlog of cases. 8. CON Approval Preference: MSDH may approve applicants proposing to enter ventures utilizing mobile and/or shared equipment. 9. CON Requirements: The criteria and standards contained herein pertain to both fixed and/or mobile PET scanner equipment. 10. CON Exemption: Nothing contained in these CON criteria and standards shall preclude the University of Mississippi School of Medicine from acquiring and operating a PET scanner and a Cardiac only PET Scanner, provided the acquisition and use of such equipment is justified by the School’s teaching and/or research mission and complies with the teaching exception as outlined in Section 102. 2 of this Plan. However, the requirements listed under the section regarding the granting of “appropriate scope of privileges for access to the scanner to any qualified physician” must be met. MSDH shall not consider utilization of equipment/services at any hospital owned and operated by the state or its agencies when reviewing CON applications. 11. Addition to a Healthcare Facility: An equipment vendor who proposes to add a healthcare facility to an existing or proposed route must notify MSDH by submitting a Determination of Reviewability for any proposed changes from those presented in the CON application prior to such change (i.e. additional healthcare facilities or route deviations). 12. Equipment Registration: The applicant must provide the Department with the registration/serial number of the CON-approved PET scanner. 13. Certification: If a mobile PET scanner, the applicant must certify that only the single authorized piece of equipment and related equipment vendor described in the CON application will be utilized for the PET service by the authorized facility/facilities. 14. Conversion from Mobile to Fixed Service: The conversion from a mobile PET service site to a fixed PET service site will not be considered the establishment of a new service and will not require CON review under Section 509.2.4; provided, however, that the facility submit an application for a determination of non-reviewability prior to converting the service. 15. Applicants with an Accredited Cancer Center: Applicants seeking to acquire and operate a fixed PET scanner as part of a Cancer Center accredited by the Commission on Cancer, a program of the American College of Surgeons, shall be exempt from the requirements set forth in Policy Statement number 4 (Equipment-to-Population Ratio). 16. Review Threshold: Notwithstanding any prior language in this section, and pursuant to House Bill 3 from the 2026 Legislative Session (effective February 4, 2026), Certificate of Need review for the acquisition or otherwise control of PET equipment (including PET/CT) is required only if the total acquisition cost as defined in Section 1.14 of the CON Review Manual exceeds Three Million Dollars ($3,000,000.00). 509.4.2 Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of a Positron Emission Tomography Scanner and Related Equipment Including Cardiac-Only PET Scanner MSDH will review applications for a Certificate of Need for the acquisition or otherwise control of a PET scanner and related equipment under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general review criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. The acquisition or otherwise control of a PET scanner and related equipment is reviewable if the equipment cost is in excess of $3,000,000.00 or if the equipment is relocated. The offering of PET services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure. Need Criterion 1: Minimum Procedures/Population A. The entity desiring to acquire or to otherwise control the PET scanner must project a minimum of 1,000 clinical procedures per year and must show the methodology used for the projection. B. The applicant shall document a minimum population of 300,000 per PET scanner unit. The Office of Health Planning and Resource Development population projections shall be used. In the case of Cardiac only PET Scanner, this Criterion will not apply. Need Criterion 2: Business Registration The entity desiring to acquire or otherwise control the PET equipment must be a registered entity authorized to do business in Mississippi. Need Criterion 3: Approval of Additional PET Equipment MSDH will approve additional PET equipment in a service area with existing equipment only when it is demonstrated that the existing PET equipment in that service area is performing an average of 1,500 clinical procedures per PET unit per year (six clinical procedures per day x 250 working days per year). For purposes of this Criterion, PET and Cardiac-Only PET are to be evaluated separately. Need Criterion 4: Division of Radiological Health Approval The application shall affirm that the applicant shall receive approval from the Division of Radiological Health for the proposed site, plans, and equipment before service begins. Need Criterion 5: Data Requirements The applicant shall provide assurances that the following data regarding the PET equipment will be kept and made available to MSDH upon request: A. Total number of procedures performed; B. Total number of inpatient procedures (indicate type of procedure); C. Total number of outpatient procedures (indicate type of procedure); D. Average charge per specific procedure; E. Hours of operation of the PET unit; F. Days of operation per year; and G. Total revenue and expense for the PET unit for the year. Need Criterion 6: Fixed/Minimum Value Contracts The applicant shall provide a copy of the proposed contract and document that if the equipment is to be rented, leased, or otherwise used by other qualified providers on a contractual basis, no fixed/minimum volume contracts will be permitted. Need Criterion 7: CON Approval/Exemption for PET Equipment Before the specified equipment can be utilized, the applicant desiring to provide the PET equipment shall have CON approval or written evidence that the equipment is exempt from CON approval as determined by MSDH through a Determination of Reviewability. Each specified piece of equipment must be exempt from or have CON approval. Need Criterion 8: Applicants with an Accredited Cancer Center Applicants seeking to acquire and operate a fixed PET scanner as part of a Cancer Center accredited by the Commission on Cancer, a program of the American College of Surgeons, shall be exempt from the requirements set forth in Need Criterion 1B (Minimum Procedures/Populations) and Need Criterion 3 (Approval of Additional PET Equipment). 509.4.3 Certificate of Need Criteria and Standards for the Offering of Fixed or Mobile Positron Emission Tomography Services Including Cardiac-Only PET Scanner The offering of Fixed or Mobile PET services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered. Need Criterion 1: Minimum Procedures The entity desiring to offer PET services must document that the equipment shall perform a minimum of 1,000 clinical procedures per year and must show the methodology used for the projection. Need Criterion 2: PET Equipment Utilized by Multiple Providers It is recognized that a particular PET unit may be utilized by more than one provider of PET services, some of which may be located outside of Mississippi. In such cases all existing or proposed providers of PET services utilizing the same PET unit must jointly meet the required service volume of 1,000 procedures annually. If the PET unit in question is presently utilized by other providers of PET services, the actual number of procedures performed by them during the most recent 12-month period may be used. Need Criterion 3: Quality Control and Environmental Requirements An applicant proposing to provide new or expanded PET services must include written assurances in the application that the service will be offered in a physical environment that conforms to federal standards, manufacturer’s specifications, and licensing agencies’ requirements. The following areas are to be addressed: A. Quality control and assurance of radiopharmaceutical production of generator or cyclotron- produced agents; B. Quality control and assurance of PET tomograph and associated instrumentation; C. Radiation protection and shielding; and D. Radioactive emissions to the environment. Need Criterion 4: Division of Radiological Health Approval The application shall affirm that the applicant shall receive approval from the Division of Radiological Health for the proposed site, plans, and equipment before service begins. Need Criterion 5: Provision of On-Site Medical Cyclotron The applicant shall document provision of an on-site medical cyclotron for radionuclide production and a chemistry unit for labeling radiopharmaceuticals; or an on-site rubidium-82 generator; or access to a supply of cyclotron-produced radiopharmaceuticals from an off-site medical cyclotron and a radiopharmaceutical production facility within a two-hour air transport radius. Need Criterion 6: Staffing Requirements Applicants for PET shall document that the necessary qualified staff are available to operate the proposed unit. The applicant shall document the PET training and experience of the staff. The following minimum staff shall be available to the PET unit: A. If operating a fixed PET unit, one or more nuclear medicine imaging physician(s) available to the PET unit on a full-time basis (e.g., radiologist, nuclear cardiologist) who have been licensed by the state for the handling of medical radionuclides and whose primary responsibility for at least a one-year period prior to submission of the CON application has been in acquisition and interpretation of tomographic images. This individual shall have knowledge of PET through training, experience, or documented postgraduate education. The individual shall also have training with a functional PET facility. B. If operating a cyclotron on site, a qualified PET radiochemist or radiopharmacist personnel, available to the facility during PET service hours, with at least one year of training and experience in the synthesis of short-lived positron emitting radiopharmaceuticals. The individual(s) shall have experience in the testing of chemical, radiochemical, and radionuclidic purity of PET radiopharmaceutical syntheses. C. Qualified engineering and physics personnel, available to the facility during PET service hours, with training and experience in the operation and maintenance of the PET equipment. Engineering personnel are not required on-site for mobile PET units. D. Qualified radiation safety personnel, available to the facility at all times, with training and experience in the handling of short-lived positron emitting nuclides. If a medical cyclotron is operated on-site, personnel with expertise in radiopharmacy, radiochemistry, and medical physics would also be required. E. Certified nuclear medicine technologists with expertise in computed tomographic nuclear medicine imaging procedures, at a staff level consistent with the proposed center's expected PET service volume. F. Other appropriate personnel shall be available during PET service hours which may include certified nuclear medicine technologists, computer programmers, nurses, and radio- chemistry technicians. Need Criterion 7: Management of Medical Emergencies The applicant shall demonstrate how medical emergencies within the PET unit will be managed in conformity with accepted medical practice. Need Criterion 8: Accommodating Referred Patients The applicant shall affirm that, in addition to accepting patients from participating institutions, facilities performing clinical PET procedures shall accept appropriate referrals from other local providers. These patients shall be accommodated to the extent possible by extending the hours of service and by prioritizing patients according to standards of need and appropriateness rather than source of referral. Need Criterion 9: Medical Necessity The applicant shall affirm that protocols will be established to ensure that all clinical PET procedures performed are medically necessary and cannot be performed as well by other, less expensive, established modalities. Need Criterion 10: Notification of Procedures Offered Applicants will be required to maintain current listings of appropriate PET procedures for use by referring physicians. Need Criterion 11: Data Requirements The applicant shall provide assurances that the following data regarding the PET service will be kept and made available to MSDH upon request: A. Total number of procedures performed; total number of inpatient procedures (indicate type of procedure); B. Total number of outpatient procedures (indicate type of procedure); C. Average charge per specific procedure; D. Hours of operation of the PET unit; E. Days of operation per year; and F. Total revenue and expense for the PET unit for the year. Need Criterion 12: CON Approval/Exemption for PET Equipment Before the specified service can be provided, the applicant desiring to offer the PET service shall provide written evidence that the specified PET equipment provider has CON approval or written evidence that the equipment is exempt from CON approval as determined by MSDH through a determination of reviewability. Each specified piece of equipment must be exempt from or have CON approval. Cardiac Catheterization Cardiac Catheterization is an integral part of cardiac evaluation and brings together two disciplines: Cardiac Catheterization (the evaluation of cardiac function) and angiography (x-ray demonstration of cardiac anatomy). Cardiac Catheterization includes various therapeutic interventions, including but not limited to, percutaneous coronary interventions (PCI), thrombolysis of coronary clots in evolving myocardial infarctions, electrical ablation of abnormal conduction pathways, and closure of patent ductus arteriosus in infants. Any facility performing diagnostic Cardiac Catheterizations without open-heart surgery capability must maintain formal referral agreements with a nearby facility to provide emergency cardiac services, including open-heart surgery. Such a facility must also delineate the steps it will take to ensure that high-risk patients are not catheterized in the facility. Additionally, a facility without open-heart surgery capability must document that more complex procedures, except for percutaneous coronary interventions (PCI) as provided herein, are not performed in the facility. Such procedures include, but are not limited to: transseptal puncture, transthoracic left ventricular puncture, myocardial biopsy, trans catheter aortic valve replacement (TAVR), and left atrial occlusion devices. Section 41-7-191(1)(d), Mississippi Code 1972, as amended, requires Certificate of Need review for the establishment and/or offering of Cardiac Catheterization services if the proposed provider has not offered such services on a regular basis within twelve (12) months prior to the time the services would be offered. Table 5-8 presents the utilization of cardiac catheterization services in Fiscal Years 2019 and 2020. Certificate of Need Criteria and Standards for Cardiac Catheterization & Open- Heart Surgery Services Should the Mississippi State Department of Health receive a Certificate of Need application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until the Department of Health has developed and adopted CON criteria and standards. If the Department has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of the Mississippi State Department of Health. 511.1 Joint Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of Cardiac Catheterization Equipment and/or the Offering of Cardiac Catheterization Services and/or the Acquisition of Open-Heart Surgery Equipment and/or the Offering of Open-Heart Surgery Services Heart disease remains the leading cause of death in Mississippi. However, it should be noted that the State has seen a decrease in mortality rates in the last few years. From 2004 to 2013, the mortality rate for African American women decreased by 25% per 100,000 and the total mortality rate decreased by 19.6% per 100,000. Studies show that minorities have a higher cardiovascular death rate than whites and are less likely to receive cardiac catheterization and open-heart surgery services than are whites. The disproportionate impact on minorities' health status in general is recognized elsewhere in this State Health Plan. Innovative approaches to address these problems in the cardiac area are needed. It has been shown that statistical methods, such as population base and optimum capacity at existing providers, are not accurate indicators of the needs of the underserved, nor do they address the accessibility of existing programs to the underserved. The goal of these revisions to the State Health Plan is to improve access to cardiac care and to encourage the establishment of additional cardiac catheterization and open-heart surgery programs within the state that can serve the poor, minorities, and the rural population in greater numbers. MSDH also adopted a provision that it shall not consider utilization of equipment/services at any hospital owned and/or operated by the state or its agencies when reviewing CON applications. MSDH further adopted standards requiring an applicant to report information regarding catheterization and open-heart programs to monitor the provision of care to the medically underserved and the quality of that care. MSDH shall interpret and implement all standards in this Plan in recognition of the stated findings and so as to achieve the stated goal. 511.2 Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of Cardiac Catheterization Equipment and/or the Offering of Cardiac Catheterization Services 1. Cardiac Catheterization Services: For purposes of the following CON criteria and standards the term “cardiac catheterization services” or “catheterization services” shall include three levels of cardiac catheterization services an applicant may provide: Diagnostic Cardiac Catheterization services, Percutaneous Coronary Intervention (PCI) services in a hospital without on-site cardiac surgery, or Therapeutic Cardiac Catheterization services. a. Diagnostic Cardiac Catheterization services are defined as, and refer to, cardiac catheterization services which are performed for the purpose of diagnosing, identifying, or evaluating cardiac related illness or disease. Diagnostic Cardiac Catheterization services include, but are not limited to, left heart catheterizations, right heart catheterizations, left ventricular angiography, coronary procedures, and other cardiac catheterization services of a diagnostic nature. b. Percutaneous Coronary Intervention (PCI) services in a hospital without on-site cardiac surgery are defined as, and refer to, those Therapeutic Cardiac Catheterization services involving primary and elective PCIs but not involving transseptal puncture, transthoracic left ventricular puncture, myocardial biopsy, and any other procedure that is currently defined as a structural heart disease procedure. c. Therapeutic Cardiac Catheterization services are defined as, and refer to, cardiac catheterization services which are performed for the purpose of actively treating, as opposed to merely diagnosing, cardiac-related illness or disease. Therapeutic Cardiac Catheterization services include, but are not limited to, all PCIs (including primary and elective), transseptal puncture, transthoracic left ventricular puncture, myocardial biopsy, and any procedure that is currently defined as a structural heart disease procedure. 2. Open-Heart Surgery Capability: MSDH shall not approve CON applications for the establishment of Therapeutic Cardiac Catheterization services at any facility that does not have open-heart surgery capability (i.e. new Therapeutic Cardiac Catheterization services may not be established, and existing Therapeutic Cardiac Catheterization services may not be extended without approved and operational open-heart surgery services in place). This policy does not preclude approval of a Certificate of Need application proposing the concurrent establishment of both Therapeutic Cardiac Catheterization and open-heart surgery services. This policy also does not preclude approval of a Certificate of Need application to perform Percutaneous Coronary Intervention (PCI) services in a hospital without on-site cardiac surgery or in a Cardiac Ambulatory Surgical Facility as defined in Section 511.7. 3. Service Areas: The State has nine designated Cardiac Catheterization/Open-Heart Surgery Planning Areas (CC/OHSPAs) presented in the Open-Heart Surgery section of this chapter of the Plan. Map 5-2 shows the CC/OHSPAs. 4. Pediatric Cardiac Catheterization: Because the number of pediatric patients requiring study is relatively small, the provision of cardiac catheterization for neonates, infants, and young children shall be restricted to those facilities currently providing the service. National standards indicate that a minimum of 150 cardiac catheterization cases should be done per year and that catheterization of infants should not be performed in facilities which do not have active pediatric cardiac surgical programs. 5. Present Utilization of Cardiac Catheterization Equipment/Services: MSDH shall consider utilization of existing equipment/services and the presence of valid CONs for equipment/services within a given CC/OHSPA when reviewing CON applications. MSDH shall not consider utilization of equipment/services at any hospital owned and/or operated by the state or its agencies when reviewing CON applications. MSDH may collect and consider any additional information it deems essential, including information regarding access to care, to render a decision regarding any application. 6. Minimum Caseload: Applicants for a Diagnostic Cardiac Catheterization Certificate of Need must be able to project a caseload of at least 300 diagnostic catheterizations per year by the end of the third year of operation. Applicants for a Therapeutic Cardiac Catheterization Certificate of Need must be able to project a caseload of at least 450 catheterizations, diagnostic and therapeutic, per year by the end of the third year of operation. Applicants for a Certificate of Need to provide PCI services in a hospital without on-site cardiac surgery must be able to project a caseload of at least 300 catheterizations, diagnostic and PCI, with at least 100 being PCIs, per year by the end of the third year of operation. 7. Residence of Medical Staff: Cardiac catheterizations must be under the control of and performed by personnel living and working within the specific hospital area. No site shall be approved for the provision of services by traveling teams. 8. Hospital-Based: All cardiac catheterizations and open-heart surgery services shall be located in acute care hospitals or in a Cardiac Ambulatory Surgical Facility, subject to the policy statements, and need criteria and standards set forth in Sections 511.3 and 511.4 of this Plan. 9. Conversion of Existing Therapeutic Cardiac Catheterization Services to PCI Services in a Hospital without On-Site Cardiac Surgery Capabilities: A hospital currently providing Therapeutic Cardiac Catheterization services may convert their cardiac catheterization program to provide PCI services in the hospital without on-site cardiac surgery capability without Certificate of Need review; provided, however, that the facility shall submit a Determination of Reviewability application prior to eliminating on-site cardiac surgery. The hospital must attest in the Determination of Reviewability application that it will meet the CON Criteria and Standards set out in Section 511.4 of this Plan. If the hospital goes twelve (12) consecutive months of providing PCI services without on-site cardiac surgery and wants to convert back to a Therapeutic Cardiac Catheterization program, the hospital must submit a Certificate of Need application for review. 511.3 Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Cardiac Catheterization Equipment and/or the Offering of Cardiac Catheterization Services The Mississippi State Department of Health will review applications for a Certificate of Need for the acquisition or otherwise control of diagnostic cardiac catheterization equipment and/or the offering of diagnostic cardiac catheterization services under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures and plans of the Mississippi State Department of Health; and the specific criteria and standards listed below. The acquisition or otherwise control of diagnostic cardiac catheterization equipment is reviewable if the equipment costs exceed $3,000,000.00. The offering of diagnostic cardiac catheterization services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure. Need Criterion 1: Minimum Procedures An applicant proposing the establishment of diagnostic cardiac catheterization services only shall demonstrate that the proposed equipment/service utilization will be a minimum of 300 diagnostic cardiac catheterizations per year by its third year of operation. Need Criterion 2: Staffing Standards The applicant shall document that it has, or can obtain, the ability to administer the proposed services, provide sufficiently trained and experienced professional staff, and evaluate the performance of the programs. Need Criterion 3: Recording and Maintenance of Data Applicants shall provide, as required under licensure standards, written assurance that they will record and maintain utilization data for diagnostic cardiac catheterization procedures (e.g., morbidity data, number of diagnostic cardiac catheterization procedures performed, and mortality data, all reported by race, sex, and payor status) and make such data available to the Mississippi State Department of Health annually. Need Criterion 4: Referral Agreement An applicant proposing the establishment of diagnostic cardiac catheterization services only shall document that a formal referral agreement with a facility for the provision of emergency cardiac services (including open-heart surgery) will be in place and operational at the time of the inception of cardiac catheterization services. Need Criterion 5: Patient Selection An applicant proposing to provide diagnostic cardiac catheterization services must (a) delineate the steps which will be taken to insure that high risk patients are not catheterized in the facility, and (b) certify that therapeutic cardiac catheterization services and/or PCI services in a hospital without on-site cardiac surgery will not be performed in the facility unless and until the applicant has received CON approval to provide said services. Need Criterion 6: Regulatory Approval Before utilizing or providing the equipment or service, the applicant desiring to provide the diagnostic cardiac catheterization equipment or service shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by the Mississippi State Department of Health. Each specified piece of equipment must be exempt from or have CON approval. 511.4 Certificate of Need Criteria and Standards for the Acquisition or Other Control of Therapeutic Cardiac Catheterization Equipment for the Performance of PCI Services in a Hospital without On-Site Cardiac Surgery and/or the Offering of PCI Services in a Hospital without On-Site Cardiac Surgery The Mississippi State Department of Health will review applications for a Certificate of Need for the acquisition or otherwise control of Therapeutic Cardiac Catheterization equipment for the performance or offering of PCI services in a hospital without on-site cardiac surgery under the applicable statutory requirements of Miss. Code. Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures and plans of MSDH; and the specific criteria and standards listed below. The acquisition or otherwise control of Therapeutic Cardiac Catheterization equipment for the performance of PCI services in a hospital without on-site cardiac surgery is reviewable if the equipment costs exceed $3,000,000.00. The offering of PCI services in a hospital without on-site cardiac surgery is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure. Need Criterion 1: Minimum Procedures An applicant proposing the establishment of PCI services in a hospital without on-site cardiac surgery shall demonstrate that the proposed equipment/service utilization will be a minimum of 300 cardiac catheterizations, both diagnostic and PCI, with at least 100 being total PCIs, per year by its third year of operation. Applicants must certify they will submit volume data to demonstrate and verify the utilization of the service at a minimum of every three (3) years. Need Criterion 2: Staffing Requirements The applicant shall document that it has, or can obtain, the ability to administer the proposed services, provide sufficiently trained and experienced professional staff, and evaluate the performance of the programs. Need Criterion 3: Staff Residency The applicant shall certify that medical staff performing PCI procedures shall be onsite within thirty (30) minutes. Need Criterion 4: Recording and Maintenance of Data In addition to the certification in Need Criterion 1, applicants shall provide, as required under licensure standards, written assurance that they will record and maintain separate utilization data for diagnostic and PCI catheterization procedures (e.g., morbidity data, number of diagnostic cardiac catheterization and PCI procedures performed and mortality data, all reported by race, sex and payor status) and make that data available to the Mississippi State Department of Health annually. Need Criterion 5: Open-Heart Surgery An applicant proposing the establishment of PCI services without on-site cardiac surgery shall: A. Document that Open-Heart Surgery services will be available through a formal emergency transfer agreement to a hospital providing open heart surgery. Such transfer must be done at a minimum of less than 120 minutes to accomplish transfer from the onset of PCI complications to cardiopulmonary bypass. Transporting of the patient to the receiving hospital must include the capability to provide an intra-aortic balloon pump (IABP). B. Programs must project and annually perform a minimum of 100 total PCIs per year to include at a minimum twelve (12) primary PCIs per year by the end of the third year of operation. New programs should have three years to reach the absolute minimum volume, but after that, programs failing to reach this volume for two consecutive years should not remain open. MSDH has the discretion under a finding of rare or unique circumstances to grant an exception to the above based on a finding of need of access and quality of care by the program. C. Certify that the proposed primary operators for the service have a lifetime experience of greater than 150 total PCIs with acceptable outcomes as primary operators after completing a cardiology fellowship. Successful completion of an Interventional Cardiology fellowship is considered adequate certification. D. New and Existing Programs must actively participate in the STEMI (“ST”-Segment Elevation Myocardial Infarction) Network, including, but not limited to, the submission of data to the STEMI databank. E. At the present time, there is no justification for a PCI program without on-site surgery to perform only elective procedures or not provide availability to primary PCI 24 hours/365 days per year. The Mississippi State Department of Health has the discretion under a finding of rare or unique circumstances to grant exception to the above based on a finding of need of access and quality of care by the program. F. Certify that the applicant will provide educational programs to underserved patient populations (low income, racial and ethnic minorities, women, Medicaid eligible, and handicapped persons) with the goal of decreasing cardiac mortality rates in such populations. G. Certify that the applicant will provide a reasonable amount of charity care. H. Certify that the applicant will hold monthly multi-disciplinary meetings to evaluate patient outcomes, review quality improvement data, and to identify and implement solutions for any operational issues. I. Certify that the following guideline from the Society of Cardiovascular Angiography and Interventions (SCAI)-ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention or such sections’ update(s), if applicable, at the time of filing the certificate of need application will be met: 1. Certify the applicant will have available in the catheterization lab the equipment in Section 4.1.1 entitled “Equipment” and that such will be routinely tested; 2. Certify the availability of adequate staff in the catheterization lab as set forth in Section 4.1.2 entitled “Staffing” and that such staff will be certified on both basic life support and advanced cardiovascular life support; 3. Certify that “time-out” procedures will be implemented as discussed in Section 4.1.3 entitled “‘Time-Out’ Procedures”; and 4. Certify that the applicant will operate a quality improvement program and participate in a national PCI registry as discussed in Section 7.1 entitled “Quality Performance: Recommendations”. Need Criterion 6: Applicants for PCI Services in a Hospital without On-Site Cardiac Surgery Capabilities Currently Providing Diagnostic Catheterization Services In addition to Need Criteria 1-5, an applicant proposing the establishment of PCI services in a hospital without Open-Heart Surgery capabilities, who is already an existing provider of diagnostic catheterization services, shall demonstrate that its diagnostic cardiac catheterization unit has been utilized for a minimum of 300 procedures per year for the two most recent years as reflected in the data supplied to and/or verified by the Mississippi State Department of Health or that its primary operators for the service have a life-time experience of greater than 250 total procedures (including both diagnostic catheterizations and PCIs) with acceptable outcomes after completing a cardiology fellowship. Successful completion of an Interventional Cardiology fellowship is considered adequate certification. Need Criterion 7: Regulatory Approval Before utilizing or providing the equipment or service, the applicant desiring to provide the Cardiac Catheterization equipment or service shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by the Mississippi State Department of Health through a Determination of Reviewability. Each specified piece of equipment must be exempt from or have CON approval. 511.5 Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Therapeutic Cardiac Catheterization Equipment and/or the Offering of Therapeutic Cardiac Catheterization Services The Mississippi State Department of Health will review applications for a Certificate of Need for the acquisition or otherwise control of therapeutic cardiac catheterization equipment and/or the offering of therapeutic cardiac catheterization services under the applicable statutory requirements of Miss. Code Ann. §§ 41- 7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures and plans of MSDH; and the specific criteria and standards listed below. The acquisition or otherwise control of therapeutic cardiac catheterization equipment is reviewable if the equipment costs exceed $3,000,000.00. The offering of therapeutic cardiac catheterization services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered. Need Criterion 1: Minimum Procedures An applicant proposing the establishment of therapeutic cardiac catheterization services shall demonstrate that the proposed equipment/service utilization will be a minimum of 450 cardiac catheterizations, both diagnostic and therapeutic, of which at least 100 should be PCIs, per year by its third year of operation. Need Criterion 2: Staffing Standards The applicant shall document that it has, or can obtain, the ability to administer the proposed services, provide sufficiently trained and experienced professional staff, and evaluate the performance of the programs. Need Criterion 3: Staff Residency The applicant shall certify that medical staff performing therapeutic cardiac catheterization procedures shall be onsite within thirty (30) minutes. Need Criterion 4: Recording and Maintenance of Data Applicants shall provide, as required under licensure standards, written assurance that they will record and maintain separate utilization data for diagnostic and therapeutic cardiac catheterization procedures (e.g., morbidity data, number of diagnostic and therapeutic cardiac catheterization procedures performed and mortality data, all reported by race, sex and payor status) and make that data available to the Mississippi State Department of Health annually. Need Criterion 5: Open-Heart Surgery An applicant proposing the establishment of therapeutic cardiac catheterization services shall document that Open-Heart Surgery services are available or will be available on-site where the proposed therapeutic Cardiac Catheterization services are to be offered before such procedures are performed. Need Criterion 6: Regulatory Approval Before utilizing or providing the equipment or service, the applicant desiring to provide the cardiac catheterization equipment or service shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by the Mississippi State Department of Health. Each specified piece of equipment must be exempt from or have CON approval. Need Criterion 7: Applicants for Therapeutic Cardiac Catheterization Currently Providing Diagnostic Catheterization Services or PCI Services in a Hospital without On-Site Cardiac Surgery In additional to Need Criteria 1-6, an applicant proposing the establishment of therapeutic cardiac catheterization services, who is already an existing provider of diagnostic catheterization services and/or PCI services in a hospital without on-site cardiac surgery, shall demonstrate that it has provided a minimum of 300 procedures (including both diagnostic catheterizations and PCIs) per year for the two most recent years as reflected in the data supplied to and/or verified by the Mississippi State Department of Health. 511.6 Policy Statement Regarding Certificate of Need Applications for the Establishment of Cardiac Ambulatory Surgical Facilities 1. Definitions: For purposes of this Policy Statement and the Certificate of Need Criteria and Standards for the Establishment of Cardiac Ambulatory Surgical Facilities, the following definitions shall apply. a. “Cardiac Ambulatory Surgical Facility (CASF)” means an ambulatory surgical facility which is established and operated for the purpose of providing Cardiac Catheterization procedures. A JV-CASF (as defined below) is a type of CASF. b. “Joint Venture Cardiac Ambulatory Surgical Facility (JV-CASF)” means a CASF which is jointly owned by (i) an acute care hospital which offers Cardiac Catheterization services and PCI services, and (ii) one or more cardiologists who are licensed to practice medicine by the Mississippi State Board of Medical Licensure, or a group practice comprised of such cardiologists. 2. Offering of Cardiac Catheterization Services: Cardiac Catheterization services may be performed only in (a) an acute care hospital, (b) a hospital-owned CASF, or (c) JV-CASF. Exception: MSDH may consider an application for a CASF which does not have hospital ownership if the applicant obtains and provides MSDH a written letter of support for the proposed project from all acute care hospitals which offer Cardiac Catheterization services and/or PCI services and are located within a 25-mile radius of the proposed facility. A CASF must maintain appropriate third-party accreditation. A CASF must be located within twenty-five (25) miles of an acute care hospital that provides Cardiac Catheterization services and PCI services. In order to encourage local ownership and operation of joint ventures and CASFs, a CASF with hospital ownership must be located within a 25-mile radius of the main campus of the acute care hospital that has an ownership interest in the JV-CASF and/or the hospital-owned CASF. 3. Types of Procedures: A CASF or JV-CASF may perform only those Cardiac Catheterization procedures which have been approved by the federal Centers for Medicare and Medicaid Services (CMS) for Medicare payment in an ambulatory surgical center. Primary (i.e. acute infarct) PCIs shall not be performed in a CASF. A PCI-only hospital may perform any procedure that is allowed in a CASF or JV-CASF. 4. Multispecialty and Single-Specialty Ambulatory Surgical Facilities: Cardiac Catheterization procedures may be performed in a multispecialty ambulatory surgical facility, or in a single-specialty ambulatory surgical facility if they meet the need criteria and standards for the establishment of a CASF (as set forth in Policy Statement 2). The multispecialty ambulatory surgical facility or single-specialty ambulatory surgical facility which proposes to offer Cardiac Catheterization services, and which does not have hospital ownership must be located within twenty-five (25) miles of an acute care hospital that provides Cardiac Catheterization services and PCI services. MSDH may consider an application to offer Cardiac Catheterization services by a multispecialty ambulatory surgical facility or a single-specialty ambulatory surgical facility which does not have hospital ownership if the applicant obtains and provides MSDH a written letter of support for the proposed project from all hospitals which offer Cardiac Catheterization services and PCI services and are located within a 25-mile radius of the proposed project. 5. CON-Exempt Single-Specialty CASFs Prohibited: MSDH shall not approve any Determination of Reviewability that exempts a single-specialty cardiac ambulatory surgical facility from Certificate of Need review. All single-specialty CASFs must obtain a Certificate of Need from the MSDH prior to the commencement of operations or services. 6. Application of Policy Statement: In reviewing CON applications for the establishment of a CASF, MSDH shall apply the policies set forth in Section 511.2 of this Plan (Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of Cardiac Catheterization Equipment and/or the Offering of Cardiac Catheterization Services). 511.7 Certificate of Need Criteria and Standards for the Establishment of Cardiac Ambulatory Surgical Facilities The Mississippi State Department of Health will review applications for a Certificate of Need for the establishment of Cardiac Ambulatory Surgical Facilities (CASFs and JV-CASFs) under the applicable statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193, MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures and plans of MSDH; and the specific criteria and standards listed below. Need Criterion 1: Minimum Procedures An applicant proposing the establishment of a CASF shall demonstrate that the proposed service utilization will be a minimum of 300 Cardiac Catheterization procedures, diagnostic and therapeutic, per year, by the third year of operation. Applicants must certify they will submit volume data to demonstrate and verify the utilization of the service at a minimum of every three (3) years. Need Criterion 2: Minimum Population The applicant must document that the proposed Cardiac Catheterization/Open-Heart Surgery Planning Area (Map 5-2) has a population base of at least 60,000 within thirty (30) minutes travel time of the facility. Need Criterion 3: Minimum Number of Procedure Rooms All CASFs shall establish and have available for service no fewer than two (2) procedure rooms used exclusively for Cardiac Catheterization and PCI services. Need Criterion 4: Financial Feasibility The applicant must provide documentation that the CASF will be economically viable within two (2) years of commencement of services. Need Criterion 5: Letters of Support The applicant must show support from the cardiologists who will be expected to utilize the CASF. Need Criterion 6: Staffing Standards The applicant shall document that it has, or can obtain, the ability to administer the proposed services, provide sufficiently trained and experienced professional staff, and evaluate the performance of the programs. The applicant shall also certify that all cardiologists and providers who perform Cardiac Catheterization and/or PCI procedures in the CASF will maintain active medical staff and clinical privileges at an acute care hospital with which the facility has a formal emergency transfer agreement (as required by Need Criterion 8). Need Criterion 7: Recording and Maintenance of Data In addition to the certification in Need Criterion 1, applicants shall provide, as required under licensure standards, written assurance that they will record and maintain separate utilization data for diagnostic Cardiac Catheterization and PCI procedures (e.g., morbidity data, number of diagnostic Cardiac Catheterization and PCI procedures performed and mortality data, all reported by race, sex and payor status) and make that data available to the Mississippi State Department of Health annually. Need Criterion 8: Service Specific An applicant proposing the establishment of a CASF shall: A. Document that Open-Heart Surgery services will be available through a formal emergency transfer agreement to a hospital providing open heart surgery. Such transfer must be done at a minimum of less than 120 minutes to accomplish transfer from the onset of PCI complications to cardiopulmonary bypass. Transporting of the patient to the receiving hospital must include the capability to provide a ventricular support devise, such as an intra-aortic balloon pump (IABP), or an Impella. B. Certify that the proposed primary operators performing PCI’s have a lifetime experience of greater than 150 total PCIs with acceptable outcomes as primary operators after completing a cardiology fellowship. Successful completion of an Interventional Cardiology fellowship is considered adequate certification. C. The CASF shall participate in and submit quality data to the appropriate Cardiac Catheterization registries. D. Certify that the applicant will hold quarterly multi-disciplinary meetings to evaluate patient outcomes, review quality improvement data, and to identify and implement solutions for any operational issues. E. Certify that the following guideline from the Society of Cardiovascular Angiography and Interventions (SCAI)-ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention or such sections’ update(s), if applicable, at the time of filing the certificate of need application will be met: 1. Certify the applicant will have available in the catheterization lab the equipment in Section 4.1.1 entitled “Equipment” and that such will be routinely tested; 2. Certify the availability of adequate staff in the catheterization lab as set forth in Section 4.1.2 entitled “Staffing” and that such staff will be certified on both basic life support and advanced cardiovascular life support; 3. Certify that “time-out” procedures will be implemented as discussed in Section 4.1.3 entitled “‘Time-Out’ Procedures”; and 4. Certify that the applicant will operate a quality improvement program and participate in a national PCI registry as discussed in Section 7.1 entitled “Quality Performance: Recommendations”. Need Criterion 9: Medicaid Participation All CASFs shall participate in the Mississippi Medicaid program. Need Criterion 10: Indigent/Charity Care The applicant shall certify that the CASF will provide care to Medicaid patients. Also, the applicant shall certify that the CASF will provide indigent/charity care, including care to underinsured patients, of no less than five percent (5%) of the total volume of procedures performed at the CASF. Each approved facility shall report the total volume of indigent/charity care to the Office of Health Planning and Resource Development annually and shall publish their indigent/charity care policy to their facility website. Need Criterion 11: Regulatory Approval Before utilizing the equipment or providing the service, the applicant desiring to establish a CASF shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by the Mississippi State Department of Health through a Determination of Reviewability. Each specified piece of equipment must be exempt from or have CON approval. Open-Hear Surgery Open-Heart Surgery, defined as any surgical procedure in which a heart-lung machine is used to maintain cardiopulmonary functioning, involves a few procedures, including valve replacement, repair of cardiac defects, coronary bypass, heart transplantation, and artificial heart implant. Mississippi Code Ann. § 41-7-191(1)(d), requires Certificate of Need review for the establishment and/or offering of Open-Heart Surgery services if the proposed provider has not offered such services on a regular basis within twelve (12) months prior to the time the services would be offered. Table 5-9 presents the utilization of existing facilities. Map 5-2 in the Open-Heart Surgery criteria and standards section shows the Cardiac Catheterization/Open-Heart Surgery Planning Areas (CC/OHSPAs) and the location of existing services. 512.1 Policy Statement Regarding Certificate of Need Applications for the Acquisition of Open-Heart Surgery Equipment and/or the Offering of Open-Heart Surgery Services 1. Service Areas: The need for Open-Heart Surgery equipment/services shall be determined using the nine designated Cardiac Catheterization/Open-Heart Surgery Planning Areas (CC/OHSPAs) presented in this chapter of the Plan. Map 5-2 shows the CC/OHSPAs. 2. CC/OHSPA Need Determination: The need for Open-Heart Surgery equipment/services within a given CC/OHSPA shall be determined independently of all other CC/OHSPAs. 3. Pediatric Open-Heart Surgery: Because the number of pediatric patients requiring open- heart surgery is relatively small, the provision of open-heart surgery for neonates, infants, and young children shall be restricted to those facilities currently providing the service. 4. Present Utilization of Open-Heart Surgery Equipment/Services: MSDH shall consider utilization of existing Open-Heart Surgery equipment/ services and the presence of valid CONs for Open-Heart Surgery equipment/services within a given CC/OHSPA when reviewing CON applications. MSDH shall not consider utilization of equipment/services at any hospital owned and/or operated by the state or its agencies when reviewing CON applications. MSDH may collect and consider any additional information it deems essential, including information regarding access to care, to render a decision regarding any application. 5. CON Application Analysis: At its discretion, MSDH may use market share analysis and other methodologies in the analysis of a CON application for the acquisition or otherwise control of open-heart surgery equipment and/or the offering of open-heart surgery services. The Department shall not rely upon market share analysis or other statistical evaluations if they are found inadequate to address access to care concerns. 6. Minimum CC/OHSPA Population: A minimum population base of 100,000 in a CC/OHSPA (as projected by the Office of Health Planning and Resource Development) is required before such equipment/services may be considered. The total population within a given CC/OHSPA shall be used when determining the need for services. Population outside an applicant’s CC/OHSPA will be considered in determining need only when the applicant submits adequate documentation acceptable to MSDH, such as valid patient origin studies. 7. Minimum Caseload: Applicants proposing to offer adult Open-Heart Surgery services must be able to project a caseload of at least 150 open-heart surgeries per year. 8. Residence of Medical Staff: Open-Heart Surgery must be under the control of and performed by personnel living and working within the specific hospital area. No site shall be approved for the provision of services by traveling teams. 9. Review Threshold: Notwithstanding any prior language in this section, and pursuant to House Bill 3 from the 2026 Legislative Session (effective February 4, 2026), Certificate of Need review for the acquisition or otherwise control of equipment for the provision of Open-Heart Surgery services is required only if the total acquisition cost as defined in the CON Review Manual exceeds Three Million Dollars ($3,000,000.00). 512.2 Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Open-Heart Surgery Equipment and/or the Offering of Open-Heart Surgery Services MSDH will review applications for a CON for the acquisition or otherwise control of open-heart surgery equipment and/or the offering of open-heart surgery services under the applicable statutory requirements of Sections 41-7-173, 41-7-191, and 41-7-193, Mississippi Code 1972, as amended. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures and plans of MSDH; and the specific criteria and standards listed below. The acquisition or otherwise control of open-heart surgery equipment is reviewable if the equipment cost more than $3,000,000.00. The offering of open-heart surgery services is reviewable if the proposed provider has not provided those services on a regular basis within twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure. Need Criterion 1: Minimum Population The applicant shall document a minimum population base of 100,000 in the CC/OHSPA where the proposed open-heart surgery equipment/service is to be located. Division of Health Planning and Resource Development population projections shall be used. Need Criterion 2: Minimum Procedures The applicant shall demonstrate that it will perform a minimum of 150 open-heart surgeries per year by its third year of operation. Need Criterion 3: Impact on Existing Providers An applicant proposing to acquire or otherwise control open-heart surgery equipment and/or offer open-heart surgery services shall document that each facility offering open-heart surgery services which is (a) in the CC/OHSPA and (b) within forty-five (45) miles of the applicant, has performed a minimum of 150 procedures per year for the two most recent years as reflected in data supplied to and/or verified by MSDH. No hospital owned and/or operated by the state or its agencies shall be considered an existing unit in the CC/OHSPA under this section. MSDH may collect and consider any additional information it deems essential, including information regarding access to care, to render a decision regarding any application. Need Criterion 4: Staffing Requirements The applicant shall document that it has, or can obtain, the ability to administer the proposed services, provide sufficiently trained and experienced professional staff, and evaluate the performance of the programs. MSDH staff shall use guidelines presented in Optimal Resources for Examination of the Heart and Lungs: Cardiac Catheterization and Radiographic Facilities, published under the auspices of the Inter-Society Commission for Heart Disease Resources, and Guidelines and Indications for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Coronary Artery Bypass Graft Surgery), published under the auspices of the American College of Cardiology, as resource materials when reviewing these items in an application. Need Criterion 5: Staff Residency The applicant shall certify that medical staff performing open-heart surgery procedures shall reside within forty-five (45) minutes normal driving time of the facility. The applicant shall document that proposed open-heart surgery procedures shall not be performed by traveling teams. Need Criterion 6: Data Requirements Applicants shall provide, as required under licensure standards, written assurance that they will record and maintain utilization data for open-heart surgeries (e.g., morbidity data, number of open- heart surgeries performed and mortality data, all reported by race, sex, and payor status) and make such data available to MSDH annually. Need Criterion 7: CON Approval/Exemption for Open-Heart Surgery Equipment/Service Before utilizing or providing the equipment or service, the applicant desiring to provide the open- heart surgery equipment or service shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by MSDH through a determination of reviewability. Each specified piece of equipment must be exempt from or have CON approval. Systems of Care There are three systems of care: the Trauma Care System, the ST-Elevation Myocardial Infarction (STEMI) System, and the Stroke System. Mississippi is one of only six states that has multiple acute systems of care and is the only state that has statewide systems for trauma, STEMI, and stroke. Each system of care has five key components: an organizational structure, protocols for the transport and transfer of patients, an advisory group process, a performance/quality improvement process, and a data collection system. These components work together to accomplish the ultimate goal of the systems – to deliver the right patient to the right hospital the first time, an approach shown to improve outcomes. Emergency Medical Services In Mississippi, the Emergency Medical Services (EMS) system is extraordinary in that ninety-nine percent (99%) of the state’s population is covered by paramedic level agencies. EMS provides services not only to certified pre-hospital personnel but also provides the highest standards of pre- hospital healthcare to the citizens and visitors of Mississippi ensuring patients are delivered to the right hospital the first time. 514.1 Organization The Emergency Medical Services Act of 1973 (Miss. Code Ann. § 63-13-11) establishes standards for the organization of emergency services. Prior to 1974, government involvement in emergency medical services was primarily limited to providing an emergency department in the public hospital. Private operators, predominantly funeral homes, provided emergency transportation. Within MSDH, the Bureau of Emergency Medical Services organizes, regulates, and maintains a statewide program to improve emergency medical care. Further, it coordinates agency resources in “all-hazard” planning and in response to disasters. This includes incidents involving weapons of mass destruction as well as natural disasters, from hurricanes on the coast to ice storms in the Delta. EMS Services are typically provided in response to a medical emergency reported through the 9- 1-1 system. A 9-1-1 call placed from any telephone is automatically routed to the appropriate designated Public Safety Answering Point (PSAP). Once the call is received, the nature of the medical emergency is determined, the call is prioritized, appropriate personnel and equipment are dispatched, and pre-arrival instructions are given if appropriate. The dispatcher may ask a few questions to help assess the nature and severity of the injury or illness. At times the dispatcher may give the caller specific patient care instructions to maximize the success of the injury or illness outcome. 514.2 Protocols When EMS professionals are called, the injured or ill person is often transported to the hospital in an ambulance. EMS professionals work under protocols approved by physicians designated as Offline Medical Control. The physician oversees the care of patients in EMS systems and is knowledgeable about out-of-hospital patient care interventions and delivery systems. Typically, the physicians work in conjunction with local EMS managers to assure quality patient care. EMS may be provided by a fire department, a private ambulance service, a county or government-based service, a hospital-based service, or a combination of the above. EMS professionals may be paid or serve as volunteers in the community. 514.3 Advisory Council In accordance with Miss. Code Ann. § 41-59-7, the Emergency Medical Services Advisory Council (EMSAC) was created, with membership appointed by the Governor. 514.4 Performance Improvement The Medical Directors’ Training and Quality Assurance (MDTQA) Committee provides performance improvement review of the EMS system and develops model protocols for adoption by EMS services. The committee is chaired by the State EMS Medical Director, a board-certified emergency physician, and membership includes physicians who provide medical control to EMS services, and EMS practitioners. 514.5 Data System The Mississippi EMS Information System (MEMSIS) uses a web-based system hosted by ImageTrend. The ImageTrend EMS State Bridge is a pre-hospital emergency data collection, analysis, and reporting system. EMS State Bridge integrates information across the entire emergency medical community, whether in the ambulance, the local station, or state offices. With the EMS State Bridge, ambulance services can satisfy reporting requirements easily, without major investment and without learning complex new technology. The system provides for: • Data collection based upon the NHTSA V2.2.1 data set. Data will be migrated to the NHTSA V3.4 data set in FY2018. • The aggregation of information from various units and services with the possibility of sharing secured data with other systems and agencies. • Electronic transport of information to improve communications. • Standard and ad hoc reporting for using data to support evidence-based practices. • Easy expansion through its open architecture as needs grow and evolve. • Scalability to conform to the needs of small, medium and large services as required. Additionally, the system is HIPAA compliant and sensitive to medical data security issues. The application meets and exceeds state and federal data privacy requirements. Mississippi Trauma Care System Trauma is the leading cause of death for all age groups in Mississippi from birth to age forty-four (44). Serious injury and death resulting from trauma events such as vehicle crashes, falls, and firearms claim 500 lives and disable 6,000 Mississippians each year. Trauma victims require immediate, expert attention. 515.1 Organization Mississippi Code Ann. § 41-59-5 (5) establishes MSDH as the lead agency to develop a uniform, non- fragmented, inclusive statewide Trauma Care System, that provides excellent patient care. Through the State Trauma Plan, MSDH has designated seven trauma care regions; each incorporated as a 501c-3 organization which contracts with MSDH to administer the plan within their respective region. The State Trauma Plan includes the seven regional plans, allows for transfer protocols between trauma facilities, and for trauma patients to be transported to the “most appropriate” trauma facility for their injuries. To increase participation in the Trauma Care System, the Mississippi Legislature enacted legislation (House Bill 1405) in 2008, which required MSDH to develop regulations mandating all licensed acute-care facilities participate in the Mississippi Trauma Care System (“Play or Pay”). Hospitals must participate at a level commensurate with their capabilities or pay a non- participation fee to the Trauma Care Trust Fund. Each hospital’s capability to participate in the Trauma Care System is reviewed annually by their respective Trauma Care Region and MSDH, which determines the appropriate level of participation and any associated fee. Trauma facility designation levels set specific criteria and standards of care that guide hospital and emergency personnel in determining the level of care a trauma victim needs and whether that hospital can care for the patient or transfer the patient to a trauma center that can administer more definitive care. Level I Trauma Centers must have a full range of trauma capabilities, including an emergency department, a full-service surgical suite, intensive care unit, and diagnostic imaging. Level I centers must have a surgical residency program, ongoing trauma research, and provide 24-hour trauma service. These hospitals provide a variety of other services to comprehensively care for both trauma patients. Level I Trauma Centers act as referral facilities for Level II, III, and IV Trauma Centers. The University of Mississippi Medical Center (UMMC) in Jackson is the only Level I facility in the state. Two Level I Trauma Centers border the northern and southeastern part of the state and are in Tennessee and Alabama. Additionally, a “stand-alone” Tertiary Pediatric Trauma Center located in Tennessee participates in the system. Level II Trauma Centers must be able to provide comprehensive care to the severely injured patient. These facilities must have a full range of trauma capabilities, including an emergency department, a full-service surgical suite, an intensive care unit, and diagnostic imaging. Level II Trauma Centers act as referral facilities for Level III and IV Trauma Centers. Level III Trauma Centers must offer general/trauma surgery and orthopedic surgery and have the ability to manage the initial care of multi-system trauma patients. Transfer protocols must be in place with Level I and II Trauma Centers for patients that exceed the Level III Trauma Center’s resources. Level IV Trauma Centers provide initial evaluation and assessment of injured patients. Most patients will require transfer to facilities with more resources dedicated to providing optimal care for the injured patients. Level IV Trauma Centers must have transfer protocols in place with Level I, II, and III Trauma Centers. 515.2 Protocols The Trauma Care System has developed uniform trauma activation criteria for all hospitals participating in the system to ensure that patients receive appropriate care, regardless of locale. EMS Field Destination Guidelines, based on the Center for Disease Control (CDC) Field Triage Decision Scheme, provide for the transport of trauma patients to the most appropriate facility. The approved Trauma Activation Criteria, based on the publication Resources for Optimal Care of the Injured Patient, provide the criteria used by trauma center staff for trauma team activation. 515.3 Advisory Committee In accordance with Miss. Code Ann. § 41-59-7, the Mississippi Trauma Advisory Committee (MTAC) was created as a committee of the Emergency Medical Services Advisory Council (EMSAC). This committee is comprised of members of EMSAC, appointed by the Governor. The committee acts as the advisory body for trauma care system development and provides technical support to MSDH in all areas of trauma care system design, trauma standards, data collection and evaluation, continuous quality improvement, trauma care system funding, and evaluation of the trauma care system and trauma care programs. 515.4 Performance Improvement A systems approach to trauma care provides the best means to protect the public from pre-mature death and prolonged disability. The development of a statewide system of care for the injured must include a mechanism to monitor, measure, assess, and improve the processes and outcome of care. The process must be a continuous, multidisciplinary effort to reduce inappropriate variation in the care of trauma patients and improve the effectiveness of the system and its components, including pre-hospital care (communication, dispatch, medical control, triage, and transport), hospital care, inter-facility management, rehabilitative care, and mass casualty disaster response. Statewide Performance Improvement (PI) consists of multiple layers of continuous monitoring and evaluation of treatment processes to identify opportunities to optimize care and improve outcomes. The continuous cycle of evaluation extends from the PI programs of EMS providers and hospitals to review committees established at the regional and state levels. The State Trauma PI Committee is appointed by the MSDH Director of Health Protection. The committee is independent from MTAC and EMSAC. The PI Committee is chaired by the state Trauma System of Care Medical Director. Membership shall include, but may not be limited to, representatives from the following areas: • Emergency Medicine • State EMS PI Committee • Trauma Registry Committee • One representative from each Trauma Care Region • Nursing representative from each Trauma Center level • Tertiary Pediatric Trauma Center • Trauma Medical Directors from each Level I Trauma Center. The PI Committee establishes specific statewide performance measures. Subject Matter Experts (SME) participate in committee activities appropriate to their expertise. MSDH Division of Trauma provides administrative support to the PI Committee and all meetings of the Committee, PI Committee meetings are by invitation only and are not open to the public. 515.5 Data System There are four objectives of the trauma registry: performance improvement, enhanced hospital operations, injury prevention, and medical research. In July 2006, MSDH deployed "Collector" Trauma Registry software to all hospitals that participated in the Mississippi Trauma Care System. Today, every Mississippi licensed acute care facility (hospital) having an organized emergency service or department uses the Collector software to submit their data to the State Trauma Registry. Collector is a trauma registry system that helps users meet changing requirements of collection and evaluation of trauma data for quality assurance, accreditation, management, prevention, and research. Collector is a complete data management and report generating package which includes a user-friendly data entry and verification system, querying capabilities and integration with expert coding software. Collector offers coding, database, and analysis capabilities. In addition to its use as the trauma registry, Collector is also used as the state’s burn registry and the registry for Traumatic Brain and Spinal Cord Injuries (TBI/SCI). STEMI System of Care ST-Elevation Myocardial Infarction (STEMI) is a significant public health problem and carries a high risk of death and disability. The American Heart Association (AHA) estimates that as many as 400,000 people will suffer from a STEMI heart attack each year in the United States. Mississippi currently leads the nation in mortality and morbidity from cardiovascular disease. STEMI patients should be recognized as quickly as possible to identify those eligible for thrombolytic or primary PCI therapy. Research has shown that both morbidity and mortality can be reduced by the approach of rapid interventional reperfusion within ninety (90) minutes of hospital arrival. Additional research has demonstrated that in-the-field recognition by pre-hospital providers utilizing 12-lead ECG, coupled with pre-hospital notification of the receiving facilities, can further reduce time to reperfusion, resulting in improved outcomes. 516.1 Organization The STEMI System of Care is a voluntary system comprised of several separate components, which are organized and work together, as a system. The individual components and elements are described below: • STEMI Regions – This component facilitates system organization, coordination, and education requirements for both practitioners and the public. Each STEMI Region (North, Central, and South) will have a regional STEMI Coordinator, who will schedule and facilitate quarterly regional meetings. • Pre-Hospital Component – EMS units are an integral part of the STEMI System. All EMTs, Paramedics, on-line and off-line medical control physicians need to have a basic knowledge and awareness of the STEMI System Plan elements and system function. Specifically, this knowledge refers to the alert criteria (identification of a STEMI), and communication procedures. • Hospital Component – Hospitals may participate in the STEMI System on a voluntary basis but must meet the criteria prescribed in the STEMI Standards to be designated as a STEMI Receiving or STEMI Referral Center. • Program oversight is provided by MSDH’s Bureau of Acute Care Systems. Map 5-2 identifies those hospitals participating in the STEMI System. 516.2 Protocols Standard treatment protocols for both STEMI Receiving Centers and STEMI Referral Centers have been developed and published by the Mississippi Healthcare Alliance (MHCA), the practitioners’ organization which initiated the development of the system of care. The current protocols may be found on the MHCA website at https://mshealthcarealliance.org. 516.3 Advisory Committee The STEMI Advisory Committee meets quarterly. Membership is compromised of the following membership categories as prescribed by the STEMI System of Care Plan: • Cardiology Co-Chairman • Emergency Medicine Co-Chairman • Emergency Medicine Representative – Northern Region • Emergency Medicine Representative – Central Region • Emergency Medicine Representative – Southern Region • Emergency Nursing Representative – Northern Region • Emergency Nursing Representative – Central Region • Emergency Nursing Representative – Southern Region • Hospital Administration Representative – Northern Region • Hospital Administration Representative – Central Region • Hospital Administration Representative – Southern Region • Cardiology Representative – Northern Region • Cardiology Representative – Central Region • Cardiology Representative – Southern Region • STEMI Nursing Representative – Northern Region • STEMI Nursing Representative – Central Region • STEMI Nursing Representative – Southern Region • Southern Regional STEMI Coordinator • Registry Representative – Northern Region • Registry Representative – Central Region • Registry Representative – Southern Region • EMS Provider Representative – Northern Region • EMS Provider Representative – Central Region • EMS Provider Representative – Southern Region • EMS Administration Representative – Northern Region • EMS Administration Representative – Central Region • EMS Administration Representative – Southern Region • Northern Regional STEMI Coordinator • Central Regional STEMI Coordinator • Southern Regional STEMI Coordinator • American Heart Association Representative. 516.4 Performance Improvement Statewide Performance Improvement (PI) consists of multiple layers of continuous monitoring and evaluation of treatment processes to identify opportunities to optimize care and improve outcomes. The continuous cycle of evaluation extends from the PI programs of EMS providers and hospitals to review committees established at the regional and state levels. The STEMI PI Committee meets quarterly. Membership is comprised of the following: • Cardiology Chair • Emergency Medicine Vice Chair • Cardiologist (one from each region) • Emergency Department Physician (one from each region) • Representative from each PCI hospital (minimum of one per region) • Non-PCI hospital representative (minimum of one per region) • EMS Representatives (minimum of three). The PI Committee establishes specific system-wide performance measures. Subject Matter Experts (SME) participate in committee activities appropriate to their expertise. The MSDH Bureau of Acute Care Systems provides administrative support to the PI Committee and all meetings of the Committee. PI committee meetings are by invitation only and are not open to the public. 516.5 Data System The data system for the STEMI System of Care is the ACTION Registry-GWTG (Get with The Guidelines) system. The ACTION Registry-GWTG is a risk-adjusted, outcomes-based quality improvement program that focuses exclusively on high-risk STEMI/NSTEMI patients. It helps hospitals apply American College of Cardiology (ACC) and American Heart Association (AHA) clinical guideline recommendations in their facilities and provides invaluable tools to measure care and achieve quality improvement goals. Use of the ACTION Registry-GWTG is a requirement for participation in the STEMI System of Care. Acute Ischemic Stroke System of Care Mississippi ranks fourth (4th) in the nation in occurrence of death from the immediate and long- term effects of stroke. Moreover, stroke continues to be the fifth leading cause of death and a leading cause of disability in Mississippi. However, eighty-three percent (83%) of stroke occurrences in Calendar Year 2015 were potentially treatable ischemic strokes. The primary goal of the Mississippi Stroke System of Care is to get the patient suffering from a stroke to an appropriate hospital so that patients who are candidates for thrombolytic and interventional therapies may receive appropriate care in a timely manner. This approach is supported by research that shows early thrombolytics for ischemic stroke and interventional therapy for large vessel occlusion improve outcomes in patients suffering from these types of strokes. Therefore, the Stroke System of Care has focused on early recognition of strokes by educating individuals to call 911 when a stroke occurs, minimizing door to CT-times and ensuring early administration of thrombolytics. In Mississippi, most of the specialty physicians, like neurologists, are in select large medical centers; therefore, access to a stroke specialist is a primary concern in stroke care. Unlike trauma and STEMI systems of care, where it is essential to get the patient to a specialty facility in the shortest amount of time, stroke care can be initiated at a rural facility in conjunction with input from a nurse practitioner trained in stroke care, either by telephone or telemedicine. A careful patient history and examination, laboratory analysis, and a head CT can be done at “Stroke-Ready” hospitals, allowing the timely decision to treat the patient with thrombolytic therapy at that hospital before transfer to a “Stroke Center” (“Drip and Ship”) if needed for neurological, neurosurgical, or neuro-interventional support. 517.1 Organization The Stroke System of Care is a voluntary system comprised of several separate components, which are organized and work together, as a system. The individual components and elements are described below: • Stroke Regions – This component facilitates system organization, coordination, and education requirements for both practitioners and the public. Each Stroke Region (North, Central, and South) will have a regional Coordinator, who will schedule and facilitate quarterly regional meetings. • Pre-Hospital Component – EMS units are an integral part of the STEMI System. All EMTs and paramedics need to have a basic knowledge and awareness of the Stroke System elements and system function. Specifically, this knowledge refers to entry criteria (identification of an acute ischemic stroke), triage and destination guidelines, and communication procedures. On-line and off-line medical control physicians will also need to be involved with the Stroke System elements and system function. • Hospital Component – Hospitals may participate in the Stroke System on a voluntary basis. • Program oversight is provided by MSDH’s Bureau of Acute Care Systems. 517.2 Protocols Standard treatment protocols for Stroke Ready and Non-Stroke hospitals have been developed and published by the Mississippi Healthcare Alliance (MHCA), the practitioners’ organization which initiated the development of the system of care. The current protocols may be found on the MHCA website at: https://mshealthcarealliance.org/. The protocols are centered on the “Drip and Ship” model, where outlying hospitals identify the presence of an acute ischemic stroke through a head CT and initiate thrombolytic therapy (tPA- Alteplase) prior to transferring the patient to a Stroke Center. EMS protocols include the use of the Cincinnati Stroke Scale to identify potential stroke victims, and their delivery to a Stroke Ready hospital for diagnosis. 517.3 Advisory Committee The Stroke Advisory Committee meets quarterly. Membership is compromised of the following as prescribed in the Stroke System of Care Plan: • Chairperson • Emergency Medicine Representative – Northern Region • Emergency Medicine Representative – Central Region • Emergency Medicine Representative – Southern Region • Emergency Nursing Representative – Northern Region • Emergency Nursing Representative – Central Region • Emergency Nursing Representative – Southern Region • Hospital Administration Representative – Northern Region • Hospital Administration Representative – Central Region • Hospital Administration Representative – Southern Region • Neurology Representative – Northern Region • Neurology Representative – Central Region • Neurology Representative – Southern Region • Stroke Nursing Representative – Northern Region • Stroke Nursing Representative – Central Region • Stroke Nursing Representative – Southern Region • Registry Representative – Northern Region • Registry Representative – Central Region • Registry Representative – Southern Region • EMS Provider Representative – Northern Region • EMS Provider Representative – Central Region • EMS Provider Representative – Southern Region • EMS Administration Representative – Northern Region • EMS Administration Representative – Central Region • EMS Administration Representative – Southern Region • Northern Regional STROKE Coordinator • Central Regional STROKE Coordinator • Southern Regional STROKE Coordinator • American Heart Association Representative. 517.4 Performance Improvement Statewide Performance Improvement (PI) consists of multiple layers of continuous monitoring and evaluation of treatment processes to identify opportunities to optimize care and improve outcomes. The continuous cycle of evaluation extends from the PI programs of EMS providers and hospitals to review committees established at the regional and state levels. The Stroke PI Committee meets quarterly and is appointed by the State Health Officer. Membership is comprised of the following: • Neurology Chair • Emergency Medicine Vice Chair • Neurologist (one from each region) • One Emergency Department Physician (one from each region) • Representative from each stroke participating hospital (minimum of one per region) • EMS representative (minimum of three). Subject Matter Experts (SME) participate in committee activities appropriate to their expertise. The MSDH Bureau of Acute Care Systems provides administrative support to the PI Committee and all meetings of the Committee. PI Committee meetings are by invitation only and are not open to the public. 517.5 Data System The American Heart Association/American Stroke Association GWTG (Get with The Guidelines) – Stroke Program is a performance improvement program for hospitals that uses a stroke registry to support its aims. GWTG-Stroke collects patient level data on characteristics, diagnostic testing, treatments, adherence to quality measures, and in-hospital outcomes on patients hospitalized with stroke and transient ischemic attack (TIA). Collection of comprehensive, continuous stroke data supports data analysis and the development of interventions to improve stroke care. The primary goal of GWTG-Stroke program is to improve the quality of care and outcomes for patients hospitalized with stroke and TIA. The GWTG-Stroke registry helps achieve this goal in a variety of ways, including: • Enabling high caliber stroke research. • Promoting stroke center designation. • Supporting hospital level quality improvement. • Driving the creation of a regional stroke system. Chapter 6 Comprehensive Medical Rehabilitation Services Comprehensive Medical Rehabilitation Services Comprehensive medical rehabilitation (CMR) services are intensive care services that treat patients with severe physical disabilities by providing a coordinated multidisciplinary approach that requires an organized program of integrated services. Level I facilities offer a full range of CMR services to treat disabilities such as spinal cord injury, brain injury, stroke, congenital deformity, amputations, major multiple trauma, polyarthritis, fractures of the femur, and neurological disorders. Level II facilities offer CMR services to treat disabilities other than spinal cord injury, congenital deformity, and brain injury. The bed capacity, number of discharges, average length of stay, and occupancy rates for Level I and Level II CMR facilities are listed in Tables 6-1 and 6-2, respectively. The Need for Comprehensive Medical Rehabilitation Services A total of 241 Level I and 85 Level II rehabilitation beds were operational in Mississippi during FY 2020 (the Singing River Hospital bed conversion is reflected in the total numbers mentioned previously; therefore, the totals reflected in the tables may not match). Map 6-3 at the end of this chapter shows the location of all CMR facilities in the state. The state as a whole serves as a single service area when determining the need for comprehensive medical rehabilitation beds/services. Based on the bed need formula found in the criteria and standards section of this chapter, Mississippi currently needs seven (7) Level I beds and ninety-four (94) additional Level II CMR beds. The Need for Children’s Comprehensive Medical Rehabilitation Services No universally accepted methodology exists for determining the need of children’s comprehensive medical rehabilitation services. The bed need methodology in the previous section addresses need for all types of comprehensive medical rehabilitation beds, including those for children. Certificate of Need Criteria and Standards for Comprehensive Medical Rehabilitation Beds/Services 603.1 Policy Statement Regarding Certificate of Need Criteria and Standards for Comprehensive Medical Rehabilitation Beds/Services 1. Definition: Comprehensive Medical Rehabilitation (CMR) Services provided in a freestanding CMR hospital or a CMR distinct part unit are defined as an intensive care service providing a coordinated multidisciplinary approach to patients with severe physical disabilities that require an organized program of integrated services. These disabilities include stroke, spinal cord injury, congenital deformity, amputation, major multiple trauma, fractures of the femur (hip fracture), brain injury, polyarthritis, including rheumatoid arthritis, or neurological disorders, including multiple sclerosis, motor neuron disease, polyneuropathy, muscular dystrophy, and Parkinson’s Disease. 2. Planning Areas: The state as a whole shall serve as a single planning area for determining the need of CMR beds/services. 3. CMR Services: Level I - Level I CMR providers may provide treatment services for all rehabilitation diagnostic categories. Level II - Level II CMR providers may provide treatment services for all rehabilitation diagnostic categories except: (1) spinal cord injuries, (2) congenital deformity, and (3) brain injury. 4. CMR Need Determination: MSDH shall determine the need for Level I CMR beds/services based upon a formula of 0.08 beds per 1,000 population for the state as a whole. MSDH shall determine the need for Level II CMR beds/services based upon a formula of 0.0623 beds per 1,000 population for the state as a whole. Table 6-3 shows the current need for CMR beds. 5. Present Utilization of Rehabilitation Services: When reviewing CON applications, MSDH shall consider the utilization of existing services and the presence of valid CONs for services. 6. Minimum Sized Facilities/Units: Hospital-based Level I CMR units shall not contain less than twenty (20) beds. If the established formula reveals a need for more than ten (10) beds, MSDH may consider a twenty (20) bed (minimum sized) unit for approval. Hospital-based Level II CMR facilities are limited to a maximum of thirty (30) beds. 7. Expansion of Existing CMR Beds: Before any additional CMR beds, for which CON review is required, are approved for any facility presently having CMR beds, the currently licensed CMR beds at said facility shall have maintained an occupancy rate of at least eighty percent (80%) for the most recent twelve (12) month licensure reporting period or at least seventy percent (70%) for the most recent two (2) years. 8. Priority Consideration: When reviewing two or more competing CON applications, MSDH shall use the following factors in the selection process, including, but not limited to, a hospital having a minimum of 160 licensed acute care beds as of January 1, 2000; the highest average daily census of the competing applications; proposed comprehensive range of services; and the patient base needed to sustain a viable CMR service. 9. Children’s Beds/Services: Should a CON applicant intend to serve children, the application shall include a statement to that effect. 10. Other Requirements: Applicants proposing to provide CMR beds/services shall meet all requirements set forth in CMS regulations as applicable, except where additional or different requirements as stated in the State Health Plan or in the licensure regulations are required. Level II CMR units are limited to a maximum size of thirty (30) beds. 11. Enforcement: In any case in which MSDH finds a Level II provider has failed to comply with the diagnosis and admission criteria as set forth above, the provider shall be subject to the sanctions and remedies as set forth in Section 41-7-209 of the Mississippi Code 1972, as amended, and other remedies available to MSDH in law or equity. 12. Addition/Conversion of Beds: Effective July 1, 1994, no healthcare facility shall be authorized to add any beds or convert any beds to another category of beds without a CON under the authority of Section 41-7-191(1)(c) of the Mississippi Code1972, as amended, unless there is a projected need for such beds in the planning district in which the facility is located. 13. Delicensed Beds: Effective March 4, 2003, if a healthcare facility has voluntarily delicensed some of its existing bed complement, it may later relicense some or all of its delicensed beds without the necessity of having to acquire a CON. MSDH shall maintain a record of the delicensing healthcare facility and its voluntarily delicensed beds and continue counting those beds as part of the state’s total bed count for health care planning purposes. 603.2 Certificate of Need Criteria and Standards for Comprehensive Medical Rehabilitation Beds/Services MSDH will review applications for a CON for the establishment, offering, or expansion of comprehensive medical rehabilitation beds and/or services under the statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193. MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual, all adopted rules, procedures, and plans of MSDH, and the specific criteria and standards listed below. In addition, comprehensive rehabilitation services are reviewable if the proposed provider has not provided such services on a regular basis within twelve (12) months prior to the time such services would be offered. The twenty (20) bed hospital-based comprehensive medical rehabilitation facilities which were operational or approved on January 1, 2001, are grandfathered and shall not be required to obtain a Certificate of Need as long as the services are provided continuously by those facilities and are limited to the diagnoses set forth below for Level II comprehensive medical rehabilitation facilities. Need Criterion 1: Projected Need A. New/Existing CMR Beds/Services: The need for Level I CMR beds in the state shall be determined using a methodology of 0.08 beds per 1,000 population. The state as a whole shall be considered as a single planning area. The need for Level II CMR beds in the state shall be determined using a methodology of 0.0623 comprehensive medical rehabilitation beds per 1,000 population. The state as a whole shall be considered a planning area. B. Projects which do not Involve the Addition of any CMR Beds: The applicant shall document the need for the proposed project. Documentation may consist of, but is not necessarily limited to, citing of licensure or regulatory code deficiencies, institutional long- term plans (duly adopted by the governing board), recommendations made by consultant firms, and deficiencies cited by Accreditation Agencies (JCAHO, CAP). C. Projects which Involve the Addition of CMR Beds: The applicant shall document the need for the proposed project. Exception: Notwithstanding the service specific need requirements as stated in "a" above, MSDH may approve additional beds for facilities which have maintained an occupancy rate of at least eighty percent (80%) for the most recent twelve (12) month licensure reporting period or at least seventy percent (70%) for the most recent two (2) years. D. Level II Trauma Centers: The applicant shall document the need for the proposed CMR project. Exception: MSDH may approve the establishment of a twenty (20) bed Level II CMR unit for any hospital without CMR beds which held a Level II Trauma care designation on July 1, 2003, as well as on the date the CON application is filed. E. Conversion of Level II CMR Beds to Level I CMR Beds: Notwithstanding any other policy statement, standard or criterion, including, but not limited to, Need Criterion 1(a) above, an existing Level II CMR unit may convert no more than eight (8) beds to Level I CMR status if the Level II facility meets the following requirements: 1. The Level II CMR unit demonstrates high utilization by documenting that it has maintained an occupancy rate of at least eighty percent (80%) for the most recent twelve (12) month licensure reporting period or at least seventy percent (70%) for the most recent two (2) years, as reported in the Mississippi State Health Plan. 2. The Level II CMR unit establishes the need for Level I CMR status for no more than eight (8) beds by documenting that the facility expects to have a minimum of sixty (60) patient admissions annually with one (1) or more of the following rehabilitation diagnostic categories: spinal cord injuries, congenital deformity, and/or brain injury. This documentation may include, without limitation, the Level II CMR unit’s patient data or any other data or documentation acceptable to MSDH. 3. The Level II CMR unit shall document compliance with the standards for Level I CMR units set forth below in Criterion 2 (Treatment and Programs) and Criterion 3 (Staffing and Services). 4. The Department shall assess the potential of the project on any adverse impact on any Level I CMR facilities operating in the state and such assessment shall be continually reviewed by the Department. The Department may revoke or suspend any Level II CMR unit operating a Level I program for non-compliance or finding of adverse impact to any Level I CMR units or programs in the state. Need Criterion 2: Level 1 CMR Services Applicants proposing to establish Level I CMR services shall provide treatment and programs for one (1) or more of the following conditions: A. Stroke B. Spinal cord injury C. Congenital deformity D. Amputation E. Major multiple trauma F. Fractures of the femur (hip fracture) G. Brain injury H. Polyarthritis, including rheumatoid arthritis, or neurological disorders, including multiple sclerosis, motor neuron disease, polyneuropathy, muscular dystrophy, and Parkinson's Disease. Applicants proposing to establish Level II CMR services shall be prohibited from providing treatment services for the following rehabilitation diagnostic categories: (1) spinal cord injury, (2) congenital deformity, and (3) brain injury. Facilities providing Level I and Level II CMR services shall include on their Annual Report of Hospitals submitted to MSDH the following: total admissions, average length of stay by diagnosis, patient age, sex, race, zip code, payor source, and length of stay by diagnosis. Need Criterion 3: Staffing and Services A. Freestanding Level I Facilities 1. Shall have a Director of Rehabilitation who: a. Provides services to the hospital and its inpatient clientele on a full-time basis; b. Is a Doctor of Medicine or Osteopathy licensed under state law to practice medicine or surgery; and c. Has had, after completing a one (1) year hospital internship, at least two (2) years of training in the medical management of inpatients requiring rehabilitation services. 2. The following services shall be provided by full-time designated staff: a. Speech therapy b. Occupational therapy c. Physical therapy d. Social services 3. Other services shall be provided as required but may be by a consultant or on a contractual basis. B. Hospital-Based Units 1. Both Level I and Level II hospital-based units shall have a Director of Rehabilitation who: a. Is a Doctor of Medicine or Osteopathy licensed under state law to practice medicine or surgery; b. Has had, after completing a one (1) year hospital internship, at least two (2) years of training or experience in the medical management of inpatients requiring rehabilitation services; and c. Provides services to the unit and its inpatients for at least twenty (20) hours per week. 2. The following services shall be available full-time by designated staff: a. Physical therapy b. Occupational therapy c. Social services 3. Other services shall be provided as required but may be by a consultant or on a contractual basis. 603.3 Certificate of Need Criteria and Standards for Children’s Comprehensive Medical Rehabilitation Beds/Services Until such time as specific criteria and standards are developed, the MSDH will review CON applications for the establishment of children's CMR services under the general criteria and standards listed in the Mississippi Certificate of Need Review Manual in effect at the time of submission of the application, and the preceding criteria and standards listed. 603.4 Comprehensive Medical Rehabilitation Bed Need Methodology The determination of need for Level I CMR beds/services will be based on 0.08 beds per 1,000 population in the state as a whole for the year 2025. Table 6-3 presents Level I CMR bed need. The determination of need for Level II CMR beds/services will be based on 0.0623 beds per 1,000 population in the state as a whole for the year 2025. Table 6-3 presents Level II CMR bed need. Certificate of Need Criteria and Standards for Comprehensive Medical Residential Medical Rehabilitation Beds/Services for Patients with Traumatic Brain Injury (CRMR-TBI) 604.1 Policy Statement Regarding Certificate of Need Applications for Comprehensive Medical Residential Medical Rehabilitation Beds/Services for Patients with Traumatic Brain Injury 1. Definitions: a. Comprehensive Residential Medical Rehabilitation Services (CRMR) for Patients with a Traumatic Brain Injury (TBI) are defined as a place which is devoted to the provision of residential treatment and rehabilitative care in a transitional living program or a lifelong living program for periods of twenty-four (24) hours or longer for persons who have traumatic brain injury. b. A transitional living program is treatment and rehabilitative care delivered to traumatic brain injury patients who require education and training for independent living with a focus on compensation for skills which cannot be restored; such care prepares clients for maximum independence, teaches necessary skills for community interaction, works with clients pre-vocational and vocational training and stresses cognitive, speech, and behavioral therapies structured to the individual needs of patients. c. Lifelong living programs are treatment and rehabilitative care for traumatic brain injury patients who have been discharged from advanced treatment and rehabilitation facilities, but who cannot live at home independently, and who require on-going lifetime support and rehabilitation. d. A TBI is traumatic harm to the brain and its related parts resulting in organic damage thereto that may cause physical, intellectual, emotional, social, and/or vocational changes in a person. 2. Planning Areas: The state as a whole shall serve as a single planning area for determining the need of CRMR beds/services for patients with a TBI. 3. Any application for a CRMR-TBI shall document the need for such a program in the state. Any application for an expansion through the addition of beds at a CRMR-TBI shall document an occupancy rate in excess of seventy percent (70%) for the most recent two (2) years. 4. Present Utilization of Rehabilitation Services: When reviewing CON applications for CRMR- TBI, MSDH shall consider the utilization of existing services and the presence of valid CONs for services. 5. Minimum Size Facilities/Units: CRMR-TBI facilities shall contain not less than six (6) beds and no more than thirty (30) beds. MSDH shall give a preference for CRMR-TBI facilities that are not located within a forty-five (45) mile radius of any other CRMR-TBI facility. 6. Children’s Beds/Services: Should a CON applicant intend to serve children, the application shall include a statement to that effect. 7. Other Requirements: Applicants proposing to provide CRMR-TBI beds/services shall meet all requirements set forth in CMS regulations as applicable, except where additional or different requirements, as stated in the State Health Plan or in the licensure regulations, are required. 8. Effective July 1, 1994, no healthcare facility shall be authorized to add any beds or convert any beds to another category of beds without a CON under the authority of §41-7- 191(1)(c), unless there is a projected need for such beds in the planning district in which the facility is located. 9. Effective March 4, 2003, if a healthcare facility has voluntarily delicensed some of its existing bed complement, it may later relicense some or all of its delicensed beds without the necessity of having to acquire a CON. MSDH shall maintain a record of the delicensing healthcare facility and its voluntarily delicensed beds and continue counting those beds as part of the state’s total bed count for health care planning purposes. 604.2 Certificate of Need Criteria and Standards for Comprehensive Medical Residential Medical Rehabilitation Beds/Services for Patients with Traumatic Brain Injury (CRMR-TBI) MSDH will review applications for a CON for the establishment, offering, or expansion of CRMR beds and/or services for patients with TBI under the statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193, MSDH will also review applications for Certificate of Need according to the general criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. In addition, comprehensive rehabilitation services are reviewable if the proposed provider has not provided such services on a regular basis within twelve (12) months prior to the time such services would be offered. Need Criterion 1: Projected Need A. New/Existing CRMR Beds/Services for Patients with TBI: shall be determined considering the current and projected population of the state as whole and the current and projected incidence of TBIs. The state as a whole shall be considered a planning area. B. Projects which do Not Involve the Addition of any CRMR-TBI beds: The applicant shall document the need for the proposed project. Documentation may consist of, but is not necessarily limited to, citing of licensure or regulatory code deficiencies, institutional long- term plans (duly adopted by the governing board), recommendations made by consultant firms, and deficiencies cited by Accreditation Agencies (JCAHO, CAP). C. Projects which Involve the Addition of Beds: The applicant shall document the need for the proposed project. MSDH may approve additional beds for facilities, which have maintained an occupancy rate of at least seventy percent (70%) for the most recent two (2) years. Need Criterion 2: Federal/State Requirements Applicants proposing to establish CRMR services for patients with TBI shall demonstrate the ability to meet all CMS and state licensure requirements. Chapter 7 Other Health Services Other ambulatory health services consist of primary, specialty, and supportive medical services provided on an outpatient basis, in contrast to services provided in the home or to persons who are inpatients. The term ambulatory care implies that patients must travel to a location outside the home to receive services that do not require an overnight hospital stay. This chapter describes several organizations which provide ambulatory care in Mississippi. In addition, this chapter discusses home health services in Mississippi. Ambulatory Surgery Services During FY 2020, the state’s medical/surgical hospitals reported a total of 225,867 general surgical procedures. This number included 150,178 outpatient surgeries, almost a 19.40 percent decrease of the 186,324 surgeries performed in hospitals during 2016. The percentage of surgeries performed on an outpatient basis in hospitals has decreased from 67.2 percent in 2016 to 66.49 percent in 2020. Table 7-1 displays hospital affiliated surgery data by general hospital service area. Mississippi licenses eighteen (18) freestanding ambulatory surgery facilities. Table 7-2 shows the distribution of facilities and related ambulatory surgery data. The eighteen (18) facilities reported 66,789 procedures during fiscal year 2020. Total outpatient surgeries (hospitals and freestanding facilities combined) comprised 74.11 percent of all surgeries performed in the state. The number of procedures performed in freestanding facilities was 22.81 percent of total surgeries in 2020. Certificate of Need Criteria and Standards for Ambulatory Surgery Services Should MSDH receive a CON application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until MSDH has developed and adopted CON criteria and standards. If MSDH has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. 701.1 Policy Statement Regarding Certificate of Need Applications for Ambulatory Surgery Services 1. Ambulatory Surgery Planning Areas (ASPAs): MSDH shall use the Ambulatory Surgery Planning Areas as outlined on Map 7-1 of this Plan for planning and CON decisions. The need for ambulatory surgery facilities in any given ASPA shall be calculated independently of all other ASPAs. 2. Ambulatory Surgery Facility Service Areas: An applicant's Ambulatory Surgery Facility Service Area must have a population base of approximately 60,000 within thirty (30) minutes normal driving time or twenty-five (25) miles, whichever is greater, of the proposed/established facility. Note: Licensure standards require a freestanding facility to be within fifteen (15) minutes traveling time of an acute care hospital and a transfer agreement with said hospital must be in place before a CON may be issued. Additionally, the ambulatory surgery facility service area must have a stable or increasing population. 3. Definitions: The Glossary of this Plan includes the definitions in the state statute regarding ambulatory surgery services. 4. Surgeries Offered: MSDH shall not approve single service ambulatory surgery centers. Only multi-specialty ambulatory surgery center proposals may be approved for a CON. 5. Minimum Surgical Operations: The minimum of 1,000 surgeries required to determine need is based on five (5) surgeries per operating room per day times five (5) days per week x times fifty (50) weeks per year times eighty percent (80%) utilization rate. 6. Present Utilization of Ambulatory Surgery Services: MSDH shall consider the utilization of existing services and the presence of valid CONs for services within a given ASPA when reviewing CON applications. 7. Optimum Capacity: The optimum capacity of an ambulatory surgery facility is 800 surgeries per operating room per year. MSDH shall not issue a CON for the establishment of an additional facility(ies) unless the existing facilities within the ASPA have performed in aggregate at least 800 surgeries per operating room per year for the most recent 12- month reporting period, as reflected in data supplied to and/or verified by MSDH. MSDH may collect additional information it deems essential to render a decision regarding any application. Optimum capacity is based on four (4) surgeries per operating room per day times five (5) days per week times fifty (50) weeks per year times eighty percent (80%) utilization rate. This Policy Statement 7 shall not apply to applications proposing the expansion of an existing and licensed ambulatory surgery facility. 8. Conversion of Existing Service: Applications proposing the conversion of existing inpatient capacity to hospital affiliated ambulatory surgical facilities located within the hospital shall receive approval preference over detached or freestanding ambulatory surgical facilities if the applicant can show that such conversion is less costly than new construction and if the application substantially meets other adopted criteria. 9. Construction/Expansion of Facility: Any applicant proposing to construct a new facility or major renovation to provide ambulatory surgery must propose to build/renovate no fewer than two (2) operating rooms. 10. Indigent/Charity Care: The applicant shall be required to provide a “reasonable amount” of indigent/charity care as described in Chapter 1 of this Plan. 11. Single-Specialty Ambulatory Surgery Facility: A single-specialty ambulatory surgical center (“ASC”) is not considered an integral part of an institutional health service if a hospital or hospital’s parent, subsidiary or affiliated entity directly or indirectly (i) employs or contracts with physicians, dentists, or health care professionals who own the ASC or practice at the ASC; (ii) owns, in whole or in part, the incorporated medical group that owns the ASC; (iii) jointly owns the ASC with physicians, dentists, or health care professionals, independently or by incorporated medical groups; or (iv) solely owns the ASC for credentialed physicians (whether employed, contracted or independent) to perform surgical procedures in the ASC that qualify for single-specialty status. The establishment of a single-specialty ASC does not require CON review; however, the facility must submit a Determination of Reviewability application prior to establishment of the single-specialty ASC. 701.2 Certificate of Need Criteria and Standards for Ambulatory Surgery Services MSDH will review applications for a CON for new ambulatory surgery facilities, as defined in Mississippi law, under the statutory requirements of Miss. Code Ann. §§ 41-7-173, 41-7-191, and 41-7-193, MSDH will also review applications submitted for CON in accordance with the rules and regulations in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. Ambulatory surgery services require CON review when the establishment or expansion of the services involves a capital expenditure in excess of $20,000,000.00. In addition, the offering of ambulatory surgery services is reviewable if the proposed provider has not provided those services on a regular basis within twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure. Need Criteria 1: Minimum Surgeries A. An applicant proposing the establishment of a new ambulatory surgery facility shall demonstrate that the proposed ambulatory surgery facility shall perform a minimum average of 1,000 surgeries per operating room per year. B. An applicant proposing the expansion of an existing and licensed ambulatory surgery facility through the addition of operating rooms shall demonstrate that the applicant’s facility has performed in aggregate at least 800 surgeries per operating room per year for the most recent twelve (12) month reporting period, as reflected in data supplied to and/or verified by MSDH. Need Criteria 2: Minimum Population The applicant must document that the proposed Ambulatory Surgery Facility Service Area has a population base of approximately 60,000 within 30 minutes travel time. Need Criteria 3: Present Utilization of Ambulatory Surgery Services The applicant proposing to offer ambulatory surgery services shall document that the existing facilities in the ambulatory surgery planning area have been utilized for a minimum of 800 surgeries per operating room per year for the most recent 12-month reporting period as reflected in data supplied to and/or verified by MSDH. MSDH may collect additional information it deems essential to render a decision regarding any application. Need Criteria 4: Affirmation of Provision of Surgical Services The applicant must affirm that the proposed program shall provide a full range of surgical services in general surgery. Need Criteria 5: Financial Feasibility The applicant must provide documentation that the facility will be economically viable within two (2) years of initiation. Need Criteria 6: Letters of Support The proposed facility must show support from the local physicians who will be expected to utilize the facility. Need Criteria 7: Staffing Requirements Medical staff of the facility must live within a twenty-five (25) mile radius of the facility. Need Criteria 8: Transfer Agreements/Follow-Up Services The proposed facility must have a formal agreement with a full-service hospital to provide services which are required beyond the scope of the ambulatory surgical facility’s programs. The facility must also have a formal process for providing follow-up services to the patients (e.g., home health care, outpatient services) through proper coordination mechanisms. Need Criteria 9: Indigent/Charity Care The applicant shall affirm that the applicant will provide a “reasonable amount” of indigent/charity care by stating the amount of indigent/charity care the applicant intends to provide. Home Health Care Mississippi licensure regulations define a home health agency as: a public or privately owned agency or organization, or a subdivision of such an agency or organization, properly authorized to conduct business in Mississippi, which is primarily engaged in providing to individuals at the written direction of a licensed physician, in the individual's place of residence, skilled nursing services provided by or under the supervision of a registered nurse licensed to practice in Mississippi, and one or more of the following additional services or items: 1. Physical, occupational, or speech therapy, 2. Medical social services, 3. Home Health aide services, 4. Other services as approved by the licensing agency, 5. Medical supplies, other than drugs and biologicals, and the use of medical appliances, or 6. Medical services provided by a resident in training at a hospital under a teaching program of such hospital. All skilled nursing services and the services listed in items 1 through 4 must be provided directly by the licensed home health agency. For the purposes of this Plan, “directly” means either through an agency employee or by an arrangement with another individual not defined as a healthcare facility in Miss. Code Ann. § 41-7-173(h). The requirements of this paragraph do not apply to healthcare facilities which had contracts for the above services with a home health agency on January 1, 1990. 702.1 Home Health Status The 2016 Report on Home Health Agencies (the latest available) indicated that 56,051 Mississippians received home health services during the year. The reported noted there were 2,024,397 home health care visits made in 2016 in Mississippi. Each patient (all payor sources) received an average of thirty-four (34) visits. Certificate of Need Criteria and Standards for Home Health Agencies/Services Should MSDH receive a CON application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until MSDH has developed and adopted CON criteria and standards. If MSDH has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. In the event a statutory or regulatory moratorium applicable to a particular health care service is judicially invalidated or otherwise rendered unenforceable, and existing Certificate of Need (CON) criteria and standards for that particular service have not been applied or evaluated due to the moratorium, MSDH may temporarily defer final action on CON applications for that service for a period not to exceed 180 days to allow time for the development, adoption and implementation of well-conceived criteria and standards by which CON applications for the service may be reviewed. 703.1 Policy Statement Regarding Certificate of Need Applications for the Establishment of a Home Health Agency and/or the Offering of Home Health Services 1. 2026 Legislative Findings Regarding Continuation of Moratoria: Effective April 17, 2026, the Mississippi Legislature reaffirmed its determination that continuation of the moratorium on the issuance of Certificates of Need for new home health agencies remains in the public interest. The Legislature found that the state maintains a network of licensed home health agencies serving all geographic regions and that there is currently no comprehensive statewide demonstration of systemic service shortages or unmet need requiring additional home health agency licensure. The Legislature further found that expansion of provider supply in utilization-driven reimbursement systems may increase service volume and aggregate Medicaid expenditures. Accordingly, the Legislature determined that continuation of the moratorium is rationally related to preventing unnecessary expansion, avoiding duplication of services, cost containment, ensuring appropriate allocation of healthcare resources, and protecting the fiscal sustainability of publicly funded healthcare programs. 2. Service Areas: The need for home health agencies/services shall be determined on a county-by-county basis. 3. Determination of Need: A potential need for home health services may exist in a county if, for the most recent calendar year available, that county had fewer home health visits per 1,000 elderly (65+) population than the average number of visits received per 1,000 elderly (65+) in the ten-state region consisting of Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, and Tennessee. Because county- level datasets measuring Medicare-paid home health visits per 1,000 population age sixty- five (65) and older are no longer publicly available in a form that permits direct application of the historical methodology, county home health visits shall be estimated using current Centers for Medicare and Medicaid Services (CMS) fee-for-service (FFS) Medicare utilization data. The Department has adopted a reconstructed historical methodology that estimates county home health visits using current CMS fee-for-service utilization data and expresses utilization relative to the county population age sixty-five (65) and older, thereby preserving the core analytical framework of the historical State Health Plan methodology to the greatest extent practicable. The regional benchmark shall be calculated in accordance with Section 703.03 and reported in Table 7-3 using the most recent available data. 4. Unmet Need Determination: If it is determined that a potential need exists in a given county, the applicant shall document that the unmet need in that county is greater than or equal to fifty (50) home health patients. Unmet need shall be determined in accordance with the methodology contained in Section 703.3. 5. All CON applications for the establishment of a home health agency and/or the offering of home health services shall be considered substantive and will be reviewed accordingly. 703.2 Certificate of Need Criteria and Standards for the Establishment of a Home Health Agency and/or the Offering of Home Health Services If the present moratorium were removed or partially lifted, MSDH would review applications for a CON for the establishment of a home health agency and/or the offering of home health services under the applicable statutory requirements of Miss. Code Ann. § 41-7-173, 41-7-191, and 41-7- 193. MSDH will also review applications submitted for CON according to the general criteria as listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. The development or otherwise establishment of a home health agency requires CON. The offering of home health services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered. Need Criteria 1: Establishment of Need The applicant shall document that a possible need for home health services exists in each county proposed to be served using the methodology contained in this section of the Plan. Need Criteria 2: Home Health Service Area Boundaries The applicant shall state the boundaries of the proposed home health service area in the application. Need Criteria 3: Unmet Need The applicant shall document that each county proposed to be served has an unmet need equal to fifty (50) patients as determined by the methodology contained in Section 703.3, including calculation of HC, C, R, VR, and N. Need Criteria 4: Home Office of New Home Health Agency The applicant shall document that the home office of a new home health agency shall be located in a county included in the approved service area of the new agency. An existing agency receiving CON approval for the expansion of services may establish a sub-unit or branch office if such meets all licensing requirements of the Division of Licensure. Need Criteria 5: Application Requirements The application shall document the following for each county to be served: A. Letters of intent from physicians who will utilize the proposed services. B. Information indicating the types of cases physicians would refer to the proposed agency and the projected number of cases by category expected to be served each month for the initial year of operation. C. Information from physicians who will utilize the proposed service indicating the number and type of referrals to existing agencies over the previous twelve (12) months. D. Evidence that patients or providers in the area proposed to be served have attempted to find services and have not been able to secure such services. E. Projected operating statements for the first three years, including: 1. Total cost per licensed unit; 2. Average cost per visit by category of visit; and 3. Average cost per patient based on the average number of visits per patient. Need Criteria 6: Difference in Existing Services Already Provided Information concerning whether proposed agencies would provide services different from those available from existing agencies. 703.3 Statistical Need Methodology for Home Health Services The Department has adopted a reconstructed historical methodology that estimates county home health visits using current Centers for Medicare and Medicaid Services (CMS) fee-for-service utilization data and expresses utilization relative to the county population age sixty-five (65) and older, thereby preserving the core analytical framework of the historical State Health Plan methodology to the greatest extent practicable. The methodology used to calculate home health utilization rates and unmet need within the ten- state region consists of the following: 1. The ten-state region consists of Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, and Tennessee. 2. County and regional population age sixty-five (65) years and older shall be obtained from the United States Census Bureau Population Estimates Program, Population Estimates: Annual County and Puerto Rico Municipio Resident Population Estimates by Selected Age Groups and Sex, using the July 1 estimate for the most recent calendar year available. 3. Table 7-3 shall show estimated home health visits, home health users, average visits per patient, population age sixty-five (65) and older, and utilization rates for the ten-state region using the most recent Centers for Medicare and Medicaid Services (CMS) utilization data and United States Census Bureau population estimates available. Figure 7-1 shall show the corresponding utilization rates for the ten-state region. 4. Estimated county home health visits shall be calculated as follows: HC = (RC÷ 1,000) × BC where: ▪ HC= Estimated annual home health visits in the county; ▪ RC = County home health visits per 1,000 fee-for-service Medicare beneficiaries; and ▪ BC = County fee-for-service Medicare beneficiaries. The county utilization rate shall be calculated as follows: C = (HC ÷ PC) × 1,000 where: ▪ C = County utilization rate; and ▪ PC = County population age sixty-five (65) and older. The regional utilization rate shall be calculated as follows: R = (HR ÷ PR) × 1,000 where: ▪ R = Regional utilization rate; ▪ HR = Total annual home health visits in the ten-state region; and ▪ PR = Total population age sixty-five (65) and older in the ten-state region. A potential need for home health services may exist when: C < R The estimated visit deficit shall be calculated as follows: Visit Deficit: (R − C) × (PC÷ 1,000) The regional average number of visits per patient shall be calculated as follows: VR= HR ÷ Regional Home Health Users where: ▪ VR = Regional average visits per patient. Estimated unmet need shall be calculated as follows: N = [(R − C) × (PC ÷ 1,000)] ÷ VR where: ▪ N = Estimated unmet need expressed as patient equivalents. An unmet need exists if: N ≥ 50 NOTE: This methodology functions as a utilization-based planning methodology and does not constitute a direct measure of actual unmet need for home health services. Rather, the methodology estimates potential need by comparing relative utilization levels among geographic areas using available Medicare utilization data and population estimates. End Stage Renal Disease End-Stage Renal Disease (ESRD) describes the loss of kidney function from chronic renal failure to the extent that the remaining kidney function will no longer sustain life. The kidney’s function of filtering waste products from the blood and removing fluid and salts from the body is essential for life; consequently, if untreated, end-stage renal disease results in death. ESRD treatment generally consists of either a kidney transplant or dialysis. Dialysis treatment consists of either peritoneal dialysis or hemodialysis. Peritoneal dialysis uses a dialyzing fluid which is placed in the abdominal cavity through a plastic tube (catheter), and waste products (fluid and salts) exchange across the peritoneal membrane between the patient's blood and the dialyzing fluid. Hemodialysis is the process by which an artificial kidney machine "washes" metabolic waste products from the bloodstream and removes fluids and salts. Both hemodialysis and peritoneal dialysis mimic the function normally performed by the kidney. Dialysis can be done by the patient and an assistant in the home, in a facility, or by professional staff in a hospital or limited care facility. Mississippi has sixty-two (62) ESRD facilities and twenty-two (22) Satellite ESRD facilities providing maintenance dialysis services as of FY 2020. Map 7-1 shows the facility locations and Table 7-4 shows the number of existing and CON approved ESRD facilities by county. Kidney transplantation is the treatment of choice for most patients with end-stage renal failure. Unfortunately, suitable kidneys will probably never be available in the number that would be required to treat everyone with this mode of therapy. In kidney transplantation, a healthy kidney is removed from a donor and placed into an ESRD patient. Donors for kidney transplantation may come either from a close relative, such as a sibling or parent, or from an emotionally connected donor, such as a spouse or close associate. Kidneys may also be obtained from cadaver donors who have the closest matching tissue type. Living donors are preferred because they function longer than cadaver kidneys (i.e. thirty (30) years for a living donor versus fifteen (15) years for a cadaver kidney). The University of Mississippi Medical Center, the only kidney transplant program in the state, performed 114 cadaver and eleven (11) living-donor transplants during the calendar year 2020. It is certified by membership in the Organ Procurement and Transplant Network (OPTN) as managed by the United Network of Organ Sharing, a private agency under contract from the Health Resources and Services Administration. Transplant results are comparable to those with transplant programs with similar population basis and can be viewed on the Internet under the Scientific Registry for Transplant Recipients (SRTR) website at www.srtr.org. Approximately, seventy-five (75) additional transplants in Mississippi residents are performed in neighboring states. Certificate of Need Criteria and Standards for End-Stage Renal Disease (ESRD) Facilities If MSDH receives a CON application regarding the acquisition and/or otherwise control of major medical equipment or the provision of a service for which specific CON criteria and standards have not been adopted, the application shall be deferred until MSDH has developed and adopted CON criteria and standards. If MSDH has not developed CON criteria and standards within 180 days of receiving a CON application, the application will be reviewed using the general CON review criteria and standards presented in the Mississippi Certificate of Need Review Manual and all adopted rules, procedures, and plans of MSDH. 705.1 Policy Statement Regarding Certificate of Need Applications for the Establishment of End-Stage Renal Disease Facilities 1. Establishment of an ESRD Facility: The provision or proposed provision of maintenance dialysis services constitutes the establishment of an ESRD facility if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered. 2. Type of Review: CON applications for ESRD services shall be considered substantive as defined under the appropriate Mississippi State Health Plan. 3. ESRD Facility Service Area: An ESRD Facility Service Area is defined as the area within a thirty (30) mile radius of an existing or proposed ESRD facility. ESRD Facility Service Areas, including the Service Areas of existing facilities which overlap with the proposed Service Area, shall be used for planning purposes. 4. Utilization Definitions: These utilization definitions are based upon three (3) shifts per day six (6) days per week, or eighteen (18) shifts per week. Only equipment (peritoneal or hemodialysis) that requires staff assistance for dialysis and is in operation shall be counted in determining the utilization rate. Utilization of equipment in operation less than twelve (12) months shall be prorated for the period of time in actual use. a. Full Utilization: For planning and CON purposes, full (100 percent) utilization is defined as an average of 936 dialyses per station per year. b. Optimum Utilization: For planning and CON purposes, optimum (65 percent) utilization is defined as an average of 608 dialyses per station per year. c. Need Utilization: For planning and CON purposes, need (80 percent) utilization is defined as an average of 749 dialyses per station per year. 5. Outstanding CONs: ESRD facilities that have received CON approval but are not operational shall be considered to be operating at 50 percent, which is the minimum utilization rate for a facility the first year of operation. 6. Utilization Data: The Department may use any source of data, subject to verification by the Department, it deems appropriate to determine current utilization or projected utilization of services in existing or proposed ESRD facilities. The source of data may include, but is not limited to, Medicare Certification records maintained by the Division of Licensure and Certification, ESRD Network #8 data, and Centers for Medicare and Medicaid Services (CMS) data. 7. Minimum Expected Utilization: It is anticipated that a new ESRD facility may not be able to reach optimum utilization (65 percent) of ten (10) ESRD stations during the initial phase of operation. Therefore, for the purposes of CON approval, an application must demonstrate how the applicant can reasonably expect to have 50 percent utilization of a minimum of ten ESRD stations by the end of the first full year of operation and 65 percent utilization by the end of the third full year of operation. 8. Minimum Size Facility: No CON application for the establishment of a new ESRD facility shall be approved for less than ten (10) stations. 9. Expansion of Existing ESRD Facilities: Existing ESRD facilities may add ESRD stations as follows: a. An existing ESRD facility with a CMS star rating of 1 or 2, may add ESRD stations without certificate of need review as long as the facility does not add, over the period of one (1) year, more than four (4) stations. b. An existing ESRD facility with a CMS star rating of 3, may add ESRD stations without certificate of need review as long as the facility does not add, over the period of one (1) year, more than six (6) stations. c. An existing ESRD facility with a CMS star rating of 4 or 5, may add ESRD stations without certificate of need review, as long as the facility does not add, over the period of one (1) year, more than eight (8) stations. NOTE: An ESRD facility that has not yet been given a CMS star rating may add ESRD stations without certificate of need review as long as the facility does not add, over the period of one(1) year, more than four (4) stations. 10. Home Dialysis Training Programs: Each existing ESRD facility may establish or relocate a Home Dialysis Training Program to any location within a 10-mile radius of the existing facility without Certificate of Need review; provided, however, that the facility shall submit a Determination of Reviewability prior to the establishment of the Home Dialysis Training Program. If such established or relocated Home Dialysis Training Program is a freestanding program, the freestanding Home Dialysis Training Program shall document that it has a back-up agreement for the provision of any necessary dialysis services with the existing ESRD facility. If an existing ESRD facility wants to create, either through establishment or relocation, more than two (2) Home Dialysis Training Programs, the project shall be subject to CON review as the establishment of a new ESRD facility. Existing freestanding Home Dialysis Training Programs may add home training stations as follows: a. An existing freestanding Home Dialysis Training facility with a CMS star rating of 1 or 2, may add home training stations without Certificate of Need review as long as the facility does not add, over the period of one (1) year, more than four (4) stations. b. An existing freestanding Home Dialysis Training facility with a CMS star rating of 3, may add home training stations without Certificate of Need review as long as the facility does not add, over the period of one (1) year, more than six (6) stations. c. An existing freestanding Home Dialysis Training facility that has not yet been given a CMS star rating may add home training stations without Certificate of Need review as long as the facility does not add, over the period of one (1) year, more than eight (8) stations. d. An existing ESRD facility with a CMS star rating of 4 or 5, may add home training stations without Certificate of Need review, as long as the facility does not add, over the period of one (1) year, more than eight (8) stations. 11. Individual Home Dialysis Stations/Equipment: Dialysis stations or dialysis equipment located in an individual patient’s home or residence and used solely for the treatment of that individual patient shall not be considered an ESRD facility, Satellite ESRD facility, or Home Dialysis Training Program for purposes of Certificate of Need review and shall not be subject to Certificate of Need review under this Section. Nothing herein shall be construed to exempt from Certificate of Need review the establishment, relocation, expansion, or operation of an ESRD facility, Satellite ESRD facility, Home Dialysis Training Program, or Home Training Program operated by or affiliated with an ESRD provider. 12. Establishment of Satellite ESRD Facilities: Any existing ESRD facility which reaches a total of thirty (30) ESRD stations, may establish a ten (10) station satellite facility. If a proposed Satellite ESRD facility is to be located more than one (1) mile from the existing facility, a Certificate of Need must be obtained by the facility prior to the establishment of the satellite facility. 13. Non-Discrimination: An applicant shall affirm that within the scope of its available services, neither the facility nor its staff shall have policies or procedures which would exclude patients because of race, color, age, sex, or ethnicity. 14. Indigent/Charity Care: An applicant shall be required to provide a “reasonable amount” of indigent/charity care as described in Chapter 1 of this Plan. 15. Staffing: The facility must meet, at a minimum, the requirements and qualifications for staffing as contained in 42 CFR § 494.140. In addition, the facility must meet all staffing requirements and qualifications contained in the service specific criteria and standards. 16. Federal Definitions: The definitions contained in 42 CFR § 494.10 shall be used as necessary in conducting health planning and CON activities. 17. Affiliation with a Renal Transplant Center: ESRD facilities shall be required to enter into a written affiliation agreement with a renal transplant center. 18. Small Community Hospital Pilot Program — ESRD Exemption: Notwithstanding the standard statistical need methodologies governing the establishment of ESRD facilities, the State Health Officer is authorized to issue a Certificate of Need exemption to operate an ESRD facility for not more than eight (8) qualifying Small Community Hospitals statewide in accordance with applicable law and the Mississippi Certificate of Need Manual. Operational Parameters: a. No more than two (2) such exempted ESRD facilities may be located within each of the four (4) Public Health Regions designated by the Department as of January 1, 2026. b. In the event that more than two (2) eligible hospitals within a single Public Health Region apply, preference and issuance shall be granted to those Small Community Hospitals located in areas most remote from existing dialysis units. c. Any exemption obtained under this pilot shall be counted toward the Small Community Hospital’s General Pilot Program Exemption allotment as set for in the Mississippi Certificate of Need Manual. 705.2 Certificate of Need Criteria and Standards for End-Stage Renal Disease Facilities MSDH will review applications for a CON for the establishment of an ESRD facility under the applicable statutory requirements of Miss. Code Ann. § 41-7-173, 41-7-191, and 41-7-193, MSDH will also review applications for CON according to the general criteria as listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below. When a provider proposes to offer ESRD services in an ESRD facility service area where he does not currently provide services or proposes to transfer an existing ESRD unit(s) from a current location into a different ESRD facility service area, it will constitute the establishment of a new ESRD healthcare facility. NOTE: The transfer of dialysis stations from an existing ESRD facility to any other location is a relocation of a healthcare facility or portion thereof and requires CON review. Likewise, new dialysis stations placed into service at a site separate and distinct from an existing ESRD facility constitutes the establishment of a new healthcare facility and requires CON review. For purposes of determining reviewability, individual home dialysis equipment shall be governed by ESRD Policy Statement 11. 705.2.1 Establishment of End-Stage Renal Disease (ESRD) Facility Need Criterion 1: For Establishment of New ESRD Facilities An applicant proposing the establishment of a limited care renal dialysis facility or the relocation of a portion of an existing ESRD facility’s dialysis stations to another location shall demonstrate, subject to verification by the Mississippi State Department of Health, that each individual existing ESRD facility in the proposed ESRD Facility Service Area has maintained a minimum annual utilization rate of eighty percent (80%). Need Criterion 2: For Expansion of Existing ESRD Facilities A. Expansion of Existing ESRD Facilities – Non-Satellite: If an existing ESRD facility, other than a satellite facility that has operated for two (2) years or less, proposes to add stations in excess of the limits established in ESRD Policy Statement 9, the facility shall obtain a Certificate of Need. The applicant shall demonstrate either: (a) that the facility maintained a minimum annual utilization rate of sixty-five percent (65%) during the twelve (12) months immediately preceding submission of the CON application; or (b) that the facility is reasonably projected to achieve and maintain a minimum annual utilization rate of sixty- five percent (65%). Evidence supporting a projected utilization rate may include, but is not limited to, historical utilization trends, patient demand, physician referral patterns, population growth, or other relevant evidence. NOTE: ESRD Policy Statement 3 and Need Criteria 1 are inapplicable to applications for the expansion of existing ESRD facilities. B. Expansion of Existing ESRD Facilities – Satellite: If an existing ESRD facility that has operated as a satellite facility for two (2) years or less proposes to add stations in excess of the limits established in ESRD Policy Statement 9, the facility shall obtain a Certificate of Need. The applicant shall demonstrate that the facility has maintained, or is reasonably projected to maintain, a minimum annual utilization rate of sixty-five percent (65%). Such demonstration may include, but is not limited to, patient support letters, documentation regarding the distance between patients’ residences or transportation sources and the facility, transportation-related concerns, patient access considerations, or other evidence supporting the projected utilization rate. NOTE: ESRD Policy Statement 3 and Need Criteria 1 are inapplicable to applications for the expansion of existing ESRD facilities. Need Criterion 3: For Establishment of ESRD Satellite Facilities In order for a thirty (30) station ESRD facility to be approved for the establishment of a ten (10) station satellite facility through the transfer and relocation of existing stations within a five-mile radius or less from the existing facility, the facility must (a) document that it has maintained a minimum annual utilization rate of fifty-five percent (55%) for the twelve (12) months immediately preceding submission of the CON application; (b) justify the need for the project, which may include, but is not limited to, physical or space limitations at the existing facility; and (c) document that it is more cost effective to establish a satellite facility than to expand the existing facility. If the proposed satellite facility will be established at a location within a radius of five to thirty (30) miles of the existing facility, the facility must (a) document that it has maintained a minimum annual utilization rate of fifty-five percent (55%) for the twelve (12) months prior to the submission of the CON application; (b) justify the need for the project, which may include, but is not limited to, physical or space limitations at the existing facility; and (c) document that it is more cost effective to establish a satellite facility than to expand the existing facility; and (d) demonstrate that the proposed satellite facility’s location is not within thirty miles of an existing facility without obtaining the existing facility’s written support. NOTE: ESRD Policy Statements 2, 4, 5 and 6, and Need Criterion 1, are inapplicable to applications for the establishment of ESRD Satellite facilities. An ESRD Satellite facility established under this Need Criterion 3 shall not be used or considered for purposes of establishing or determining an ESRD Facility Service Area. Need Criterion 4: Number of Stations The applicant shall state the number of ESRD stations that are to be located in the proposed facility. No new facility shall be approved for less than ten (10) dialysis stations. Need Criterion 5: Minimum Utilization The application shall demonstrate that the applicant can reasonably expect to meet the minimum utilization requirements as stated in ESRD Policy Statement 10. Need Criterion 6: Minimum Services The application shall affirm that the facility will provide, at a minimum, social, dietetic, and rehabilitative services. Rehabilitative services may be provided on a referral basis. Need Criterion 7: Access to Needed Services The application shall affirm that the applicant will provide for reasonable access to equipment/facilities for such needs as vascular access and transfusions required by stable maintenance ESRD patients. Need Criterion 8: Access to Needed Services The application shall affirm that the applicant will provide for reasonable access to equipment/facilities for such needs as vascular access and transfusions required by stable maintenance ESRD patients. Need Criterion 9: Home Dialysis Training Program The application shall affirm that the applicant will make a Home Dialysis Training Program available to those patients who are medically eligible and receptive to such a program. The application shall affirm that the applicant will counsel all patients on the availability of and eligibility requirements to enter the home/self-dialysis program. Need Criterion 10: Indigent/Charity Care The application shall affirm that the applicant will provide a “reasonable amount” of indigent/charity care. The application shall also state the amount of indigent/charity care the applicant intends to provide. Need Criterion 11: Facility Staffing The application shall describe the facility’s staffing by category (i.e. registered nurse, technologist, technician, technician, social worker, dietician) as follows: A. Qualifications (minimum education and experience requirements), B. Specific Duties, and C. Full-Time Equivalents (FTE) based upon expected utilization Need Criterion 12: Staffing Qualifications The applicant shall affirm that the staff of the facility will meet, at a minimum, all requirements and qualifications as stated in 42 CFR, Subpart D § 494.140. Need Criterion 13: Staffing Time A. The applicant shall affirm that when the unit is in operation, at least one (1) Registered Nurse (R.N.) will be on duty. There shall be a minimum of two (2) persons for each dialysis shift, one of whom must be an R.N. B. The applicant shall affirm that the medical director or a designated physician will be on- site or on call at all times when the unit is in operation. It is desirable to have one other physician to supplement the services of the medical director. C. The applicant shall affirm that when the unit is not in operation, the medical director or designated physician and a registered nurse will be on call. Need Criterion 14: Data Collection The application shall affirm that the applicant will record and maintain, at a minimum, the following utilization data and make this data available to the Mississippi State Department of Health as required. The time frame for the submission of the utilization data shall be established by the Department. A. Utilization data (e.g., days of operation, shifts, inventory and classification of all stations, number of patients in dialysis, transplanted, or expired). B. The number of charity/indigent patients (as defined in this Plan) served by the facility and the number of dialysis procedures provided to these patients free of charge or at a specified reduced rate. Need Criterion 15: Staff Training The application shall affirm that the applicant will provide an ongoing program of training in dialysis techniques for nurses and technicians at the facility. Need Criterion 16: Scope of Privileges The applicant shall affirm that the facility shall provide access to Doctors of Medicine or Osteopathic Medicine licensed by the State of Mississippi who possess qualifications established by the governing body of the facility. Need Criterion 17: Affiliation with a Renal Transplant Center The applicant shall affirm that within one year of commencing operation the facility will enter into an affiliation agreement with a transplantation center. The written agreement shall describe the relationship between the transplantation facility and the ESRD facility and the specific services that the transplantation center will provide to patients of the ESRD facility. The agreement must include at least the following: A. Time frame for initial assessment and evaluation of patients for transplantation; B. Composition of the assessment/evaluation team at the transplant center; C. Method for periodic re-evaluation; D. Criteria by which a patient will be evaluated and periodically re-evaluated for transplantation; and E. Signatures of the duly authorized persons representing the facilities and the agency providing the services. F. Furthermore, the application shall affirm that the applicant understands and agrees that failure to comply with this criterion may (after due process) result in revocation of the Certificate of Need. 705.2.2 Establishment of Renal Transplant Center Need Criterion 1: The applicant shall document that the proposed renal transplant center will serve a minimum population of 3.5 million people. Need Criterion 2: The applicant shall document that the proposed facility will provide, at a minimum, the following: A. Medical-surgical specialty services required for the care of ESRD transplant patients; B. Acute dialysis services; C. An organ procurement system; D. An organ preservation program; and E. A tissue typing laboratory. Need Criterion 3: The applicant shall document that the facility will perform a minimum of twenty-five (25) transplants annually. Glossary Accessibility — a measure of the degree to which the health care delivery system inhibits or facilitates an individual's ability to receive services, including geographic, architectural, transportation, social, time, and financial considerations. Ambulatory Surgery — surgical procedures that are more complex than office procedures performed under local anesthesia but less complex than major procedures requiring prolonged post-operative monitoring and hospital care to ensure safe recovery and desirable results. General anesthesia is used in most cases. The patient must arrive at the facility and expect to be discharged on the same day. Ambulatory surgery shall be performed only by physicians or dentists licensed to practice in the state of Mississippi. Examples of procedures performed include, but are not limited to: • Tonsillectomies and adenoidectomies • Nasal polypectomy • Submucosa resection • Some cataract procedures • Cosmetic procedures • Breast biopsy • Augmentation mammoplasty • Hand surgery • Cervical conization • Laparoscopy and tubal sterilization • Circumcision • Urethral dilation • Simple hernia repairs • Stripping and ligation of varicose veins Ambulatory Surgical Facility — a publicly or privately owned institution that is primarily organized, constructed, renovated, or otherwise established for the purpose of providing elective surgical treatment to outpatients whose recovery, under normal and routine circumstances, will not require inpatient care. Such facilities as herein defined do not include the offices of private physicians or dentists whether practicing individually or in groups but does include organizations or facilities primarily engaged in such outpatient surgery, whether using the name "ambulatory surgical facility" or a similar or different name. Such organization or facility, if in any manner considered to be operated or owned by a hospital or a hospital holding, leasing, or management company, either for-profit or not-for-profit, is required to comply with all Mississippi State Department of Health ambulatory surgical licensure standards governing a hospital-affiliated facility as adopted under Section 41-9-1 et seq., Mississippi Code of 1972, provided that such organization or facility does not intend to seek federal certification as an ambulatory surgical facility as provided for in 42 CFR, Parts 405 and 416. Further, if such organization or facility is to be operated or owned by a hospital or a hospital holding, leasing, or management company and intends to seek federal certification as an ambulatory facility, then such facility is considered to be freestanding and must comply with all Mississippi State Department of Health ambulatory surgical licensure standards governing a freestanding facility. If such organization or facility is to be owned or operated by an entity or person other than a hospital or hospital holding, leasing, or management company, then such organization or facility must comply with all Mississippi State Department of Health ambulatory surgical facility standards governing a freestanding facility. Bed Need Methodologies — quantitative approaches to determining present and future needs for inpatient beds. Capital Improvements — costs other than construction which will yield benefits over a period of years. Examples of capital improvements are painting, refurbishing, and land improvements, such as improving driveways, fences, parking lots, and sprinkler systems. Capitalized Interest — interest incurred during the construction period, which is included in debt borrowing. Construction Formulas — ▪ New Construction/Renovation (Prorated Project): Cost/square foot = A+C+D+(E+F+G(A%*)) New Const. Square Feet Cost/square foot = B+(E+F+G(B%))**+H Renov. Square Feet ▪ New Construction (No Renovation Involved): Cost/square foot = A+C+D+E+F+G Square Feet ▪ Renovation (No New Construction): Cost/square foot = B+C+E+F+G+H Square Feet When: A = New Construction E = Fees B = Renovation F = Contingency C = Fixed Equipment G = Capitalized Interest D = Site Preparation H = Capital Improvement *A% - refers to the percentage of square feet allocated to new construction. **B% - refers to the percentage of square feet allocated to renovation. Example: ABC Health Care's project for construction/renovation consists of 10,000 square feet of new construction and 9,000 square feet of renovation, for a total of 19,000 square feet. A% = 10,000 or 53% 19,000 B% = 9,000 or 47% 19,000 Continuing Care Retirement Community — a comprehensive, cohesive living arrangement for the elderly which is offered under a contract that lasts for more than one year or for the life of the resident and describes the service obligations of the CCRC and the financial obligations of the resident. The contract must obligate the CCRC to provide, at a minimum, room, board, and nursing care to an individual not related by consanguinity or affinity to the provider furnishing such care. The contract explicitly provides for full lifetime nursing home care as required by the resident. The resident may be responsible for the payment of some portion of the costs of his/her nursing home care, and the CCRC sponsor is responsible for the remaining costs as expressly set forth in the contract. Depletion of the contractee’s personal resources does not affect the contribution of the CCRC sponsor. Conversion — a major or proportional change that a healthcare facility undertakes in its overall mission, such as the change from one licensure category to another, from one organizational tax status to another, or from one type of healthcare facility to another. Cost Containment — maintaining control of expenses within the healthcare delivery system to prevent and reduce unnecessary spending. Criteria — guidelines or pre-determined measurement characteristics on which judgment or comparison of need, appropriateness, or quality of health services may be made. Distinct Part Skilled Nursing Unit- Medicare eligible certified units which are a “distinct part” (i.e. distinguishable from the larger institution and fiscally separate for cost reporting purposes) of an institution that is certified to provide Skilled Nursing Facility services as by the Centers for Medicare and Medicaid Services (CMS). Existing Provider — an entity that has provided a service on a regular basis during the most recent 12-month period. Facilities — collectively, all buildings constructed for the purpose of providing healthcare including hospitals, nursing homes, clinics, or health centers, but not including physician offices; encompasses physical plant, equipment, and supplies used in providing health services. Feasibility Study — a report prepared by the chief financial officer, CPA or an independently recognized firm of accountants demonstrating that the cash flow generated from the operation of the facility will be sufficient to complete the project being financed and to pay future annual debt service. The study includes the financial analyst’s opinion of the ability of the facility to undertake the debt obligation and the probable effect of the expenditure on present and future operating costs. Freestanding Ambulatory Surgical Facility — a separate and distinct facility or a separate and distinct organized unit of a hospital owned, leased, rented, or utilized by a hospital or other persons for the primary purpose of performing ambulatory surgery procedures. Such facility must be separately licensed as herein defined and must comply with all licensing standards promulgated by the Mississippi State Department of Health regarding a freestanding ambulatory surgical facility. Further, such facility must be a separate, identifiable entity and must be physically, administratively, and financially independent and distinct from other operations of any other health facility and shall maintain a separate organized medical and administrative staff. Furthermore, once licensed as a freestanding ambulatory surgical facility, such facility shall not become a component of any other health facility without securing a Certificate of Need to do so. Group Home — a single dwelling unit whose primary function is to provide a homelike residential setting for a group of individuals, generally 8 to 20 persons, who neither live in their own home nor require institutionalization. Group homes are used as a vehicle for normalization. Habilitation — the combined and coordinated use of medical, social, educational, and vocational measures for training individuals who are born with limited functional ability as contrasted with people who have lost abilities because of disease or injury. Home Health Agency — certain services must be provided directly by a licensed home health agency and must include all skilled nursing services; physical, occupational, or speech therapy; medical social services; part-time or intermittent services of a home health aide; and other services as approved by the licensing agency for home health agencies. In this instance, "directly" means either through an agency employee or by an arrangement with another individual not defined as a healthcare facility. Hospital Affiliated Ambulatory Surgical Facility — a separate and distinct organized unit of a hospital or a building owned, leased, rented, or utilized by a hospital and located in the same county in which the hospital is located for the primary purpose of performing ambulatory surgery procedures. Such facility is not required to be separately licensed and may operate under the hospital's license in compliance with all applicable requirements of Section 41-9-1 et seq. Limited Care Renal Dialysis Facility — a healthcare facility which provides maintenance or chronic dialysis services on an ambulatory basis for stable ESRD patients. The limited care renal dialysis facility is considered a substitute for home dialysis to be used by patients who cannot dialyze at home. The facility provides follow-up and back-up services for home dialysis patients. Magnetic Resonance Imaging (MRI) Scientist — a professional with similar skills and job qualifications as a medical physicist, who holds a comparable degree in an allied science, such as chemistry or engineering, and shows similar experience as the medical physicist with medical imaging and MRI imaging spectroscopy. Market Share — historical data used to define a primary or secondary geographic service area (i.e. patient origin study, using counties, zip codes, census tracts). Observation Bed — a licensed, acute care bed on the premise of a licensed, short-term, acute care facility. The hospital bed shall be used by a physician and/or nursing/medical staff to periodically monitor/evaluate a patient’s medical condition. A bed that is occupied by a patient who is admitted to the hospital for a period of 23 hours and 59 minutes or ≤ (less than) 48 hours will be counted as an observation bed. Also, the status of a patient will be documented by a physician as an outpatient. Observation Services — a well-defined set of specific, clinically appropriate services, which include ongoing short-term treatment, assessment, and reassessment, that are furnished while a decision is being made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital. Observation services begin at the clock time documented in the patient’s medical record, which coincides with the time that observation services are initiated in accordance with a physician’s order for observation services. In most cases, a beneficiary (patient) may not remain in observation status for more than 24 or 48 hours. The hospital status of a patient will be documented as an outpatient until the physician writes an order to admit a person as an inpatient. Billing and coding of physician services are expected to be billed consistent with the patient’s status as an outpatient or an inpatient. General standing orders for observation services following all outpatient surgery are not recognized. Hospitals should not report postoperative monitoring during a standard recovery period (e.g. 4-6 hours) as observation services because those hours may be considered recovery room services. Occupancy Rate — measure of average percentage of hospital beds occupied; determined by dividing available bed-days (bed capacity) by patient days actually used during a specified time period. Outpatient Facility — a medical institution designed to provide a limited or full spectrum of health and medical services (including health education and maintenance services, preventive services, diagnosis, treatment, and rehabilitation) to individuals who do not require hospitalization or institutionalization. Pediatric Skilled Nursing Facility — a pediatric skilled nursing facility is an institution or a distinct part of an institution that is primarily engaged in providing to inpatients skilled nursing care and related services for persons under 21 years of age who require medical, nursing care, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. Policy Statement — a definite course of action selected in light of given conditions to guide and determine present and future decisions. Positron Emission Tomography (PET) — a non-invasive imaging procedure in which positron- emitting radionuclides, that are produced either by a cyclotron or a radiopharmaceutical producing generator, and a nuclear camera are used to create pictures of organ function rather than structure. PET, therefore, has the potential for providing unique, clinically important information about disease processes. Key applications for PET are in coronary artery disease and myocardial infarction, epilepsy, cerebral gliomas, and dementia. Radiation Therapy — the use of ionizing radiations for the treatment of tumors. Renal Dialysis Center — a healthcare facility which provides dialysis services to hospital patients who require such services. The dialysis provided in a renal dialysis center functions primarily as a backup program for ESRD patients dialyzing at home or in a limited care facility who are placed in a hospital. A renal dialysis center may also serve as an initial dialysis setting for newly diagnosed ESRD patients who are in the hospital. A center may also provide acute dialysis services as needed. Renal Transplant Center — a healthcare facility which provides direct transplant and other medical-surgical specialty services required for the care of the ESRD transplant patient. Services provided include, but are not limited to, acute renal dialysis, organ procurement system, organ preservation program, and tissue typing laboratory. Standard — a quantitative level to be achieved regarding a particular criterion to represent acceptable performance as judged by the agency establishing the standard. Therapeutic Radiation Services — shall have the meaning set forth in Section 41-7-173, Mississippi Code of 1972, as amended. Appendix Table 7-3 Medicare Home Health Statistics – Ten-State Region January 1, 2023 – December 31, 2024 State Estimated HH Visits Population 65+ HH Users Avg. Visits/ Patient Visits per 1,000 Age 65+ Alabama 1,054,364 929,867 42,652 24.72 1,133.89 Arkansas 631,317 549,766 27,013 23.37 1,148.34 Florida 6,574,712 4,935,427 233,472 28.16 1,332.15 Georgia 1,329,390 1,697,554 58,197 22.84 783.12 Kentucky 714,306 805,637 32,619 21.90 886.64 Louisiana 1,135,809 793,190 38,301 29.65 1,431.95 Mississippi 1,139,553 517,325 40,340 28.25 2,202.78 North Carolina 1,468,645 1,908,545 71,461 20.55 769.51 South Carolina 1,108,231 1,036,937 55,056 20.13 1,068.75 Tennessee 1,415,405 1,240,957 52,667 26.87 1,140.58 REGION TOTAL 16,571,732 14,415,205 651,778 25.43 1,149.60