Section 68-11-1607 - [Effective 12/1/2029] Certificate of need - Applications - Exemptions - Registration of equipment - Critical access hospital designation(a) A person shall not perform the following actions in this state, except after applying for and receiving a certificate of need for the action: (1) The construction, development, or other establishment of a type of healthcare institution as described in this part;(2) In the case of a healthcare institution, a change in the bed complement, regardless of cost, that:(A) Increases by one (1) or more the number of nursing home beds;(B) Redistributes beds from any category to acute, rehabilitation, or long-term care, if at the time of redistribution, the healthcare institution does not have beds licensed for the category to which the beds will be redistributed; or(C) Relocates beds to another facility or site;(3) Initiation of the following healthcare services: (A) [Deleted by 2024 amendment.](B) [Deleted by 2024 amendment.](C) [Deleted by 2024 amendment.](D) Organ transplantation;(E) Cardiac catheterization;(F) [Deleted by 2024 amendment.](I) Opiate addiction treatment provided through a nonresidential substitution-based treatment center for opiate addiction;(4)(A) Except as provided in subdivision (a)(4)(D), a change in the location of existing or certified facilities providing healthcare services and healthcare institutions. However, the executive director may issue an exemption for the relocation of existing healthcare institutions and approved services if the executive director determines that:(i) At least ninety-five percent (95%) of patients to be served are reasonably expected to reside in the same zip codes as the existing patient population;(ii) The relocation will not reduce access to consumers, particularly those in underserved communities; those who are uninsured or underinsured; women and racial and ethnic minorities; TennCare or medicaid recipients; and low-income groups; and(iii) The payor mix will not include an increase in commercial insurance;(B) The executive director must notify the commission of an exemption granted pursuant to subdivision (a)(4)(A) at the next regularly scheduled commission meeting;(C) An exemption granted or denied by the executive director pursuant to subdivision (a)(4)(A) is subject to commission review in the same manner as described in § 68-11-1606(g) and (h) [repealed effective July 1, 2024]; and(D) The relocation of the principal office of a home health agency or hospice within its licensed service area does not require a certificate of need; and(5) [Deleted by 2024 amendment.](6) Except as provided in subsections (x) and (y), the establishment of a satellite emergency department facility or a satellite inpatient facility by a hospital at a location other than the hospital's main campus.(7) [Deleted by 2024 amendment.](b) An agency of this state, or of a county or municipal government, shall not approve a grant of funds for, or issue a license to, a healthcare institution for a portion or activity of the healthcare institution that is established, modified, relocated, changed, or resumed, or that constitutes a covered healthcare service, in violation of this part. If an agency of this state, or of a county or municipal government, approves a grant of funds for, or issues a license to, a person or institution for which a certificate of need was required but was not granted, then the license is void and the person or institution shall refund the funds to the state within ninety (90) days. The health facilities commission has the authority to impose civil penalties and petition a circuit or chancery court having jurisdiction to enjoin a person who is in violation of this part.(c)(1) For each application, a letter of intent must be filed between the first day of the month and the fifteenth day of the month prior to the application's submission. At the time of filing, the applicant shall cause the letter of intent to be published in a newspaper of general circulation in the proposed service area of the project. The published letter of intent must contain a statement that any: (A) Healthcare institution wishing to oppose the application must file written notice with the commission no later than fifteen (15) days before the commission meeting at which the application is originally scheduled; and(B) Other person wishing to oppose the application may file a written objection with the commission at or prior to the consideration of the application by the commission, or may appear in person to express opposition.(2) Persons desiring to file a certificate of need application seeking a simultaneous review regarding a similar project for which a letter of intent has been filed shall file with the commission a letter of intent between the sixteenth day of the month and the last day of the month of publication of the first filed letter of intent. A copy of a letter of intent filed after the first letter of intent must be mailed or delivered to the first filed applicant and must be published in a newspaper of general circulation in the proposed service area of the first filed applicant. The health facilities commission shall consider and decide the applications simultaneously. However, the commission may refuse to consider the applications simultaneously if it finds that the applications do not meet the requirements of "simultaneous review" under the rules of the commission.(3) Applications for a certificate of need, including simultaneous review applications, must be filed by the first business day of the month following the date of publication of the letter of intent.(4) If there are two (2) or more applications to be reviewed simultaneously in accordance with this part and the rules of the commission, and one (1) or more of those applications are not deemed complete by the deadline to be considered at the next commission meeting, then the other applications that are deemed complete by the deadline must be considered at the next commission meeting. The application or applications that are not deemed complete by the deadline to be considered at the next commission meeting will not be considered with the applications deemed complete by the deadline to be considered at the next commission meeting.(5) Review cycles begin on the fifteenth day of each month. Review cycles are thirty (30) days. The first meeting at which an application can be considered by the commission is the meeting following the application's review cycle. If an application is not deemed complete within sixty (60) days after initial written notification is given to the applicant by commission staff that the application is deemed incomplete, then the application is void. If the applicant decides to resubmit the application, then the applicant shall comply with all procedures as set out by this part and pay a new filing fee when submitting the application. Prior to deeming an application complete, the executive director shall ensure independent review and verification of information submitted to the commission in applications, presentations, or otherwise. The purpose of the independent review and verification is to ensure that the information is accurate, complete, comprehensive, timely, and relevant to the decision to be made by the commission. The independent review and verification must be applied, but not necessarily be limited, to applicant-provided information as to the number of available beds within a region, occupancy rates, the number of individuals on waiting lists, the demographics of a region, the number of procedures, and other critical information submitted or requested concerning an application; and staff examinations of data sources, data input, data processing, and data output, and verification of critical information.(6) An application filed with the commission must be accompanied by a nonrefundable examination fee fixed by the rules of the commission. The examination fee may be applied to a second application for the same project if the letter of intent for the first application is voided for non-compliance with law or rule by the executive director, the commission, or a court. The second application must be filed with the commission within ninety (90) days of the voiding of the first letter of intent for the examination fee to be applied.(7) Information provided in the application or information submitted to the commission in support of an application must be true and correct. Substantive amendments to the application, as defined by rule of the commission, are not allowed.(8) An applicant shall designate a representative as the contact person for the applicant and shall notify the commission, in writing, of the contact person's name, address, and telephone number. The applicant shall immediately notify the commission in writing of a change in the identity or contact information of the contact person. In addition to other methods of service permitted by law, the commission may serve by registered or certified mail a notice or other legal document upon the contact person at the person's last address of record in the files of the commission. Notwithstanding a law to the contrary, service in the manner specified in this subdivision (c)(8) constitutes actual service upon the applicant.(9)(A) Within ten (10) days of the filing of an application for a nonresidential substitution-based treatment center for opiate addiction with the commission, the applicant shall send a notice to the county mayor of the county in which the facility is proposed to be located; the state representative and senator representing the house district and the senate district in which the facility is proposed to be located; and the mayor of the municipality, if the facility is proposed to be located within the corporate boundaries of a municipality, by certified mail, return receipt requested, informing those officials that an application for a nonresidential substitution-based treatment center for opiate addiction has been filed with the commission by the applicant.(B) If an application involves a healthcare facility in which a county or municipality is the lessor of the facility or real property on which it sits, then, within ten (10) days of filing the application, the applicant shall notify the chief executive officer of the county or municipality of the filing, by certified mail, return receipt requested.(C) An application subject to the notification requirements of this subdivision (c)(9) is not complete if the applicant has not provided proof of compliance with this subdivision (c)(9) to the commission.(d) Communications with the members of the commission are not permitted once the letter of intent initiating the application process is filed with the commission. Communication between commission members and commission staff is not prohibited. Communication received by a commission member from a person unrelated to the applicant or party opposing the application must be reported to the executive director, and a written summary of the communication must be made part of the certificate of need file.(e) For purposes of this part, commission action is the same as administrative action defined in § 3-6-301.(f)(1) Notwithstanding this section to the contrary, Tennessee state veterans' homes under title 58, chapter 7, are not required to obtain a certificate of need pursuant to this section.(2) Notwithstanding this section to the contrary, the beds located in a Tennessee state veterans' home pursuant to title 58, chapter 7, must not be considered by the health facilities commission when granting a certificate of need to a healthcare institution due to a change in the number of licensed beds, redistribution of beds, or relocation of beds pursuant to this section.(g) After a person holding a certificate of need has completed the actions for which the certificate of need was granted, the time to complete activities authorized by the certificate of need expires.(h) The owners of the following types of equipment shall register the equipment with the health facilities commission: computerized axial tomographers, magnetic resonance imagers, linear accelerators, and positron emission tomography. The registration must be in a manner and on forms prescribed by the commission and must include ownership, location, and the expected useful life of the equipment. Registration must occur within ninety (90) days of acquisition of the equipment. All such equipment must be filed on an annual inventory survey developed by the commission. The survey must include, but not be limited to, the identification of the equipment and utilization data according to source of payment. The survey must be filed no later than thirty (30) days following the end of each state fiscal year. The commission may impose a penalty not to exceed fifty dollars ($50.00) for each day the survey is late.(i) Notwithstanding this section to the contrary, an entity, or its successor, that was formerly licensed as a hospital, and that has received from the executive director a written determination that it will be eligible for designation as a critical access hospital under the medicare rural hospital flexibility program, is not required to obtain a certificate of need to establish a hospital qualifying for that designation, if it meets the requirements of this subsection (i). In order to qualify for the exemption set forth in this subsection (i), the entity proposing to establish a critical access hospital shall publish notice of its intent to do so in a newspaper of general circulation in the county where the hospital will be located and in contiguous counties. The notice must be published at least twice within a fifteen-day period. The written determination from the executive director and proof of publication required by this subsection (i) must be filed with the commission within ten (10) days after the last date of publication. If no healthcare institution within the same county or contiguous counties files a written objection to the proposal with the commission within thirty (30) days of the last publication date, then the exemption set forth in this subsection (i) applies. However, this exemption applies only to the establishment of a hospital that qualifies as a critical access hospital under the medicare rural flexibility program and not to another activity or service. If a written objection by a healthcare institution within the same county or contiguous counties is filed with the commission within thirty (30) days from the last date of publication, then the exemption set forth in this subsection (i) does not apply.(j)(1) Notwithstanding subdivision (a)(2)(A) or (a)(4), a nursing home may increase its total number of licensed beds by the lesser of ten (10) beds or ten percent (10%) of its licensed capacity no more frequently than one (1) time every three (3) years without obtaining a certificate of need. The nursing home shall provide written notice of the increase in beds to the commission on forms provided by the commission prior to the request for licensing by the board for licensing healthcare facilities.(2) For new nursing homes, the ten-bed or ten-percent increase cannot be requested until one (1) year after the date all of the new beds were initially licensed.(3) When determining projected county nursing home bed need for certificate of need applications, all notices filed with the commission pursuant to subdivision (j)(1) must be considered with the total of licensed nursing home beds, plus the number of beds from approved certificates of need, but yet unlicensed.(k) This part does not require a certificate of need for a home care organization that is authorized to provide only professional support services as defined in § 68-11-201.(l) Except as provided in subsection (v), a home care organization may only initiate hospice services after applying for and receiving a certificate of need for providing hospice services.(m)(1) A person who provides magnetic resonance imaging services shall file with the commission an annual report no later than thirty (30) days following the end of each state fiscal year that details the mix of payers by percentage of cases for the prior calendar year for its patients, including private pay, private insurance, uncompensated care, charity care, medicare, and medicaid.(2) A person who initiates magnetic resonance imaging services shall notify the commission in writing that imaging services are being initiated and shall indicate whether magnetic resonance imaging services will be provided to a patient who is fourteen (14) years of age or younger on more than five (5) occasions per year.(n)(1) An application for a certificate of need for organ transplantation must separately:(A) Identify each organ to be transplanted under the application; and(B) State, by organ, whether the organ transplantation recipients will be adult patients or pediatric patients.(2) After an initial application for transplantation has been granted, the addition of a new organ to be transplanted or the addition of a new recipient category requires a separate certificate of need. The application must: (A) Identify the organ to be transplanted under the application; and(B) State whether the organ transplantation recipients will be adult patients or pediatric patients.(3)(A) For the purposes of certificate of need approval for organ transplantation programs under this part, a program submitted to the United Network for Organ Sharing (UNOS) by January 1, 2017, is not required to obtain a certificate of need.(B) If the organ transplantation program ceases to be a UNOS-approved program, then a certificate of need is required.(o)(1) Within two (2) years after the date of receiving a certificate of need, an outpatient diagnostic center must become accredited by the American College of Radiology in the modalities provided by that facility as a condition of receiving the certificate of need.(2) An outpatient diagnostic center that fails to comply with the accreditation requirement of subdivision (o)(1) is subject to licensure sanction under § 68-11-207 as a violation of part 2 of this chapter or of the rules, regulations, or minimum standards issued pursuant to part 2 of this chapter.(p)(1) Notwithstanding this title to the contrary, a certificate of need is not required for a hospital to operate a nonresidential substitution-based treatment center for opiate addiction if the treatment center is located on the same campus as the operating hospital and the hospital is licensed under title 33 or this title.(2) For purposes of this subsection (p), "campus" has the same meaning as defined in 42 CFR 413.65.(q)(1) This part does not require a certificate of need for actions in a county that: (A) Is designated as an economically distressed eligible county by the department of economic and community development pursuant to § 67-6-104, as updated annually; and(B) Has no hospital that is actively licensed under this title located within the county.(2)(A) A person that provides positron emission tomography services or magnetic resonance imaging services pursuant to this subsection (q) must be accredited by The Joint Commission or the American College of Radiology in the modalities provided by that person and submit proof of the accreditation to the commission within two (2) years of the initiation of service.(B) A person that provides positron emission tomography services or magnetic resonance imaging services pursuant to this subsection (q) and that fails to comply with the accreditation requirement of subdivision (q)(2)(A) is subject to licensure sanction under § 68-11-207 as a violation of part 2 of this chapter or of the rules, regulations, or minimum standards issued pursuant to part 2 of this chapter.(3) A person that provides a service other than those described in subdivision (q)(2), or establishes a healthcare institution shall submit proof of accreditation by an appropriate external peer-review organization for the service or facility to the commission within two (2) years of the date of initiation of service or licensure of the healthcare institution.(r)(1) This part does not require a certificate of need to establish a home health agency limited to providing home health services under the federal Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) (42 U.S.C. § 7384, et seq.), or a subsequent amendment, revision, or modification to the EEOICPA. A license issued by the commission pursuant to this subsection (r) for services under the EEOICPA must be limited to the provision of only those services. A home health agency providing home health services without a certificate of need pursuant to this subsection (r) must be accredited by The Joint Commission, the Community Health Accreditation Partner, or the Accreditation Commission for Health Care and submit proof of such accreditation to the commission within two (2) years of the initiation of service.(2) A home health agency that provides home health services without a certificate of need pursuant to this subsection (r) and that fails to comply with the accreditation requirement of subdivision (r)(1) is subject to licensure sanction under § 68-11-207 as a violation of part 2 of this chapter or of the rules, regulations, or minimum standards issued pursuant to part 2 of this chapter.(s)(1) This part does not require a certificate of need to establish a home health agency limited to providing home health services to patients less than eighteen (18) years of age. A license issued by the commission pursuant to this subsection (s) for the provision of home health services to patients under eighteen (18) years of age must be limited to the provision of only those services.(2) The commission may permit a home health agency providing home health services to patients under eighteen (18) years of age to continue providing home health services to the patient until the patient reaches twenty-one (21) years of age if: (A) The patient received home health services from the home health agency prior to the date the patient reached eighteen (18) years of age; and(B) The home health services are provided under a TennCare program.(3)(A) A home health agency that provides home health services without a certificate of need pursuant to this subsection (s) must, within two (2) years of the initiation of service, be accredited by and submit proof to the commission of the accreditation from:(i) An accrediting organization with deeming authority from the federal centers for medicare and medicaid services;(ii) The Joint Commission;(iii) The Community Health Accreditation Partner; or(iv) The Accreditation Commission for Health Care.(B) A home health agency that provides home health services without a certificate of need pursuant to this subsection (s) and that fails to comply with the accreditation requirement of subdivision (s)(3)(A) is subject to licensure sanction under § 68-11-207 as a violation of part 2 of this chapter or of the rules, regulations, or minimum standards issued pursuant to part 2 of this chapter.(t) This part does not require a certificate of need in order for an existing hospital licensed by the department of mental health and substance abuse services to become licensed by the commission as a satellite of an affiliated general acute care hospital as provided by § 33-2-403(b)(8)(B).(u)(1) A provider of positron emission tomography established without a certificate of need must become accredited by the American College of Radiology and provide to the commission proof of the accreditation within two (2) years of the date of licensure.(2) A provider of positron emission tomography established without a certificate of need that fails to comply with the accreditation requirement of subdivision (u)(1) is subject to licensure sanction under § 68-11-207 as a violation of part 2 of this chapter or of the rules or minimum standards issued pursuant to part 2 of this chapter.(v)(1) This part does not require a certificate of need to establish a home care organization or residential hospice limited to providing hospice services, as defined in § 68-11-201, to patients under the care of a healthcare research institution, as defined in § 68-11-1901.(2) A license issued by the commission pursuant to the exception created by subdivision (v)(1) must be limited to the provision of services only to the patients of the healthcare research institution, as defined in § 68-11-1901, or the patients of a hospital or clinic that has its principal place of business located in this state and that is affiliated with the healthcare research institution.(3) A home care organization or residential hospice that provides hospice services without a certificate of need pursuant to subdivision (v)(1) must, within twelve (12) months of the date the home care organization is granted a license by the commission, be accredited by The Joint Commission, the Community Health Accreditation Partner (CHAP), DNV GL Healthcare, or the Accreditation Commission for Health Care (ACHC), in order to continue to qualify for the exception created by subdivision (v)(1).(w) No later than July 1, 2023, the commission shall implement and make available for use by applicants an electronic certificate of need application system.(x)(1) Except as provided in subdivision (x)(2), and subject to subdivision (x)(3), this part does not require a certificate of need for actions in a county that has no acute care hospital that is actively licensed under this title located within the county.(2) The exception created by subdivision (x)(1) does not apply to: (A) A rehabilitation facility;(B) A home care organization other than a home care organization described in subsection (r) or (s);(D) Opiate addiction treatment provided through a nonresidential substitution-based treatment center for opiate addiction;(F) Organ transplantation.(3) If the action to be taken pursuant to subdivision (x)(1) is the establishment by a hospital of a satellite emergency department facility at a location other than such affiliate hospital's main campus, then the satellite emergency department facility must be at least ten (10) miles away from any actively licensed acute care hospital or satellite emergency department facility located in another county.(y) In a county other than a county described in subdivision (q)(1) or subdivision (x)(1), this part does not require a certificate of need for a hospital to establish a satellite emergency department facility at a location that is within ten (10) miles of such affiliate hospital's main campus; provided, that such location is ten (10) miles or more from another actively licensed acute care hospital or satellite emergency department facility.(z) If, on June 30, 2025, the initiation or provision of a service or the establishment or operation of a facility was subject to the requirement to obtain a certificate of need pursuant to this part but was not subject to the requirement to obtain a license pursuant to part 2 of this chapter or title 33, chapter 2, and, on or after July 1, 2025, the initiation or provision of such service or the establishment or operation of such facility becomes subject to the requirement to obtain both a certificate of need pursuant to this part and a license pursuant to part 2 of this chapter or title 33, chapter 2, then a person may begin initiating or providing the service or establishing or operating the facility upon receiving the certificate of need or obtaining the license, whichever occurs first.(aa) This part does not require a certificate of need to establish or operate a long-term care hospital.Amended by 2024 Tenn. Acts, ch. 985,s 16, eff. 12/1/2029.Amended by 2024 Tenn. Acts, ch. 985,s 14, eff. 12/1/2027.Amended by 2024 Tenn. Acts, ch. 985,s 13, eff. 12/1/2027.Amended by 2024 Tenn. Acts, ch. 985,s 7, eff. 12/1/2025.Amended by 2024 Tenn. Acts, ch. 985,s 6, eff. 12/1/2025.Amended by 2024 Tenn. Acts, ch. 985,s 5, eff. 12/1/2025.Amended by 2024 Tenn. Acts, ch. 985,s 2, eff. 7/1/2025.Amended by 2024 Tenn. Acts, ch. 985,s 1, eff. 7/1/2025.Amended by 2024 Tenn. Acts, ch. 985,s 19, eff. 7/1/2024.Amended by 2022 Tenn. Acts, ch. 1119, s 129, eff. 7/1/2022.Amended by 2021 Tenn. Acts, ch. 557, s 1, eff. 10/1/2021.Amended by 2021 Tenn. Acts, ch. 557, s 6, eff. 5/26/2021.Amended by 2016 Tenn. Acts, ch. 1043, s 6, s 7, s 8, s 9, s 10, s 11, s 12, s 13 eff. 7/1/2016.Amended by 2016 Tenn. Acts, ch. 1043, s 5, eff. 7/1/2016.Amended by 2015 Tenn. Acts, ch. 505, s 1, s 2 eff. 5/20/2015.Acts 2002, ch. 780, § 4; 2003 , ch. 69, §§ 1, 2; 2003 , ch. 90, § 2; 2004, ch. 649, § 1; 2004, ch. 942, §§ 4, 5; 2008 , ch. 1120, § 6; 2009 , ch. 323, § 2; 2010 , ch. 1100, § 117; 2011 , ch. 494, §§ 3, 4; 2012 , ch. 575, § 1.See Executive Order No. 36 (5/12/2020), which suspended the provisions of Tennessee Code Annotated, T.C.A. 68-11-1607, to the extent necessary to allow hospitals that would otherwise be subject to certificate of need requirements to temporarily increase their number of licensed hospital beds at any location or temporarily establish hospital and diagnostic services at any location, if necessary for the treatment of COVID-19 patients, as well as to the extent necessary to facilitate activity authorized by the provisions of this Order and any subsequent order concerning COVID-19. This section is set out more than once due to postponed, multiple, or conflicting amendments.