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Certificate of Need Definitions

Agency – Agency and Health Services and Development Agency (HSDA or Agency) is the agency created by T.C.A. §68-11-1601. "Tennessee Health Services and Planning Act of 2002." [Acts 2002, ch. 780, §4.] to administer the certificate of need program and related activities.

Certificate of Need – A permit granted by the health services and development agency to any person for the establishment or modification of a health care institution, facility, or covered health service, at a designated location.

Certificate of Need Criteria – The criteria as defined in the HSDA’s Rules 0720-11-.01(1)(2) and (3) General Criteria for Certificate of Need required for approval of a Certificate of Need (on pages 11 and 12).

Conflict of Interest – Any matter before the agency in which the member or employee of the agency has a direct or indirect interest that is in conflict or gives the appearance of conflict with the discharge of the member's or employee's duties;

     (A) "Direct interest" is a pecuniary interest in the persons involved in a matter before the agency. This interest applies to the agency member or employee, the agency member's or employee's relatives or an individual with whom or business in which the member or employee has a pecuniary interest. For the purposes of this part, a relative is a spouse, parent, child, stepparent, stepchild, grandparent, grandchild, brother, sister, half-brother, half-sister, aunt, uncle, niece, or nephew by blood, marriage or adoption; and

     (B) “Indirect interest” is a personal interest in the persons involved in a matter before the agency that is in conflict or gives the appearance of conflict with the discharge of the agency member’s or employee’s duties.

Consent Calendar – In accordance with T.C.A. §68-11-1601, et seq., as amended by Public Chapter 780--Upon request of the applicant and at the discretion of the Executive Director a project can be placed on the 30-day review cycle for CONSENT CALENDAR.  The project must meet all the CON criteria and be un-opposed.

Ex parte Communications – Communications with the HSDA’s Board Members is in violation of T.C.A. §68-11-1607(d)(1)(2) or §4-5-304.

Facility – Any real property or equipment owned, leased, or used by a health care institution for any purpose, other than as an investment.

Health Care Institution – Any agency, institution, facility or place, whether publicly or privately owned or operated, that provides health services and that is one (1) of the following: nursing home; recuperation center; hospital; ambulatory surgical treatment center; birthing center; mental health hospital; intellectual disability institutional habilitation facility; home care organization or any category of service provided by a home care organization for which authorization is required under part 2 of this chapter; outpatient diagnostic center; rehabilitation facility; residential hospice; or non-residential substitution-based treatment center for opiate addiction.

     The definition of T.C.A. §68-11-1602(7)(B)(i-vi) is provided as follows:

     (B) "Health care institution" does not include:

          (i) Ground ambulances;

          (ii) Homes for the aged;

          (iii) Any premises occupied exclusively as the professional practice office of a physician licensed pursuant to title 63, chapter 6, part 2 and title 63, chapter 9, or dentist licensed by the state and controlled by such physician or dentist;

          (iv) Administrative office buildings of public agencies related to health care institutions;

          (v) Christian Science sanatoriums operated, or listed and certified, by the First Church of Christ Scientist, Boston, Massachusetts; or

         (vi) A mental health residential treatment facility.

Health Service – Clinically related (i.e., diagnostic, treatment, or rehabilitation) services and includes those services specified as requiring a certificate of need under §68-11-1607.

Home Care Organization – Any entity licensed as such by the department that is staffed and organized to provide "home health services," or "hospice services" as defined by §68-11-201, to patients in either their regular or temporary place of residence.

Letter of Intent – The form prescribed by the agency which shall require a brief project description, location, estimated project cost, owner of the project and description of services to be performed.

Licensed Beds – The number of beds licensed by the agency having licensing jurisdiction over the facility.

Major Medical Equipment – A single unit of medical equipment or a single system of components with related functions, that is used to provide medical and other health services and that costs more than the amounts determined under §68-11-1607(a); "major medical equipment" does not apply to any equipment not directly related to patient care.  Registration is required of certain medical equipment pursuant to Tennessee Code Annotated §68-11-1607(i), which states “The owners of the following types of equipment shall register such equipment with the health services and development agency: computerized axial tomographers, lithotripters, magnetic resonance imagers, linear accelerators and positron emission tomography.” …….“The survey shall include but not limited to the identification of the equipment and utilization data according to source of payment.”

Nonresidential Substitution-based Treatment Center for Opiate Addiction – Includes, but is not limited to, stand-alone clinics offering methadone, products containing buprenorphine such as Subutex and Suboxone, or products containing any other formulation designed to treat opiate addiction by preventing symptoms of withdrawal.

Planning Division – The State Health Planning Division of the Department of Health whose purpose is to develop the state health plan and to conduct other related studies.

Public Hearings – A fact-finding public hearing on an application held in the area in which the project is to be located per request by interested parties or at the direction of the Executive Director.

Progress Reports – The Health Services and Development Agency Rules require that an Annual Progress Report be submitted each year and a Final Project Report form is to be submitted within ninety (90) days after completion of a project which shall include completion date, final costs, and other relevant information in regards to the project, pursuant to Public Acts 2002, Chapter No. 780, §16-11-1609(d).

Rehabilitation Facility – An inpatient or residential facility that is operated for the primary purpose of assisting in the rehabilitation of physically disabled persons through an integrated program of medical and other services that is provided under professional supervision.

Review Cycle – The timeframe set for the review and initial decision on applications for certificate of need applications that have been deemed complete. The first day of the month is the first day of the review cycle in accordance with T.C.A. §68-11-1601, et seq., as amended by Public Chapter 780, upon the CON application being deemed complete by the Agency.

The first sixty (60) calendar days of the cycle are assigned to the reviewing agency, during which time a public hearing may be held on your application.  You will be contacted by a representative from HSDA to establish the date, time and place of the hearing should one be requested.  At the end of the sixty (60) calendar day period, a written report from the reviewing agency’s representative will be forwarded to this office for HSDA review within the thirty (30) calendar day period immediately following.  You will receive a copy of their findings.

Consent Calendar projects have a thirty (30) calendar day review period.

Reviewing Agency(s) – Department of Health, the Department of Mental Health and Substance Abuse Services, and/or the Department of Intellectual and Developmental Disabilities.

State Health Plan – The plan that is developed by the State Health Planning Division containing clear statements of goals, objectives, criteria and standards for the purpose of guiding the development of health care programs administered or funded by the State of Tennessee through its departments, agencies and programs.  The State Health Plan provides guidance to the Tennessee Health Services and Development Agency (HSDA) when issuing Certificates of Need (CON).  [Acts 2002, ch. 780, §4.]