North Carolina § 131E-176 - Definitions.

§ 131E-176. Definitions.

The following definitions apply in this Article: Adult care home. - A facility with seven or more beds licensed under Part 1 of Article 1 of Chapter 131D of the General Statutes or under this Chapter that provides residential care for aged individuals or individuals with disabilities whose principal need is a home which provides the supervision and personal care appropriate to their age and disability and for whom medical care is only occasional or incidental. Air ambulance. - Aircraft used to provide air transport of sick or injured persons between destinations within the State. Ambulatory surgical facility. - A facility designed for the provision of a specialty ambulatory surgical program or a multispecialty ambulatory surgical program. An ambulatory surgical facility serves patients who require local, regional, or general anesthesia and a period of post-operative observation. An ambulatory surgical facility may only admit patients for a period of less than 24 hours and must provide at least one designated operating room or gastrointestinal endoscopy room and at least one designated recovery room, have available the necessary equipment and trained personnel to handle emergencies, provide adequate quality assurance and assessment by an evaluation and review committee, and maintain adequate medical records for each patient. An ambulatory surgical facility may be operated as a part of a physician or dentist's office, provided the facility is licensed under Part 4 of Article 6 of this Chapter, but the performance of incidental, limited ambulatory surgical procedures which do not constitute an ambulatory surgical program and which are performed in a physician's or dentist's office does not make that office an ambulatory surgical facility. Ambulatory surgical program. - A formal program for providing on a same-day basis those surgical procedures which require local, regional, or general anesthesia and a period of post-operative observation to patients whose admission for more than 24 hours is determined, prior to surgery or gastrointestinal endoscopy, to be medically unnecessary. Bed capacity. - Space used exclusively for inpatient care, including space designed or remodeled for licensed inpatient beds even though temporarily not used for such purposes. The number of beds to be counted in any patient room shall be the maximum number for which adequate square footage is provided as established by rules of the Department except that single beds in single rooms are counted even if the room contains inadequate square footage. The term "bed capacity" also refers to the number of dialysis stations in kidney disease treatment centers, including freestanding dialysis units. Bone marrow transplantation services. - The process of infusing bone marrow into persons with diseases to stimulate the production of blood cells. Burn intensive care services. - Services provided in a unit designed to care for patients who have been severely burned. Campus. - The adjacent grounds and buildings, or grounds and buildings not separated by more than a public right-of-way, of a health service facility and related health care entities. Capital expenditure. - An expenditure for a project, including but not limited to the cost of construction, engineering, and equipment which under generally accepted accounting principles is not properly chargeable as an expense of operation and maintenance. Capital expenditure includes, in addition, the fair market value of an acquisition made by donation, lease, or comparable arrangement by which a person obtains equipment, the expenditure for which would have been considered a capital expenditure under this Article if the person had acquired it by purchase. Repealed by Session Laws 2005-325, s. 1, effective for hospices and hospice offices December 31, 2005. Cardiac catheterization equipment. - The equipment used to provide cardiac catheterization services. Cardiac catheterization services. - Those procedures, excluding pulmonary angiography procedures, in which a catheter is introduced into a vein or artery and threaded through the circulatory system into the heart specifically to diagnose abnormalities in the motion, contraction, and blood flow of the moving heart or to perform surgical therapeutic interventions to restore, repair, or reconstruct the coronary blood vessels of the heart. Certificate of need. - A written order which affords the person so designated as the legal proponent of the proposed project the opportunity to proceed with the development of the project. Repealed by Session Laws 1993, c. 7, s. 2. Change in bed capacity. - Any of the following: Any relocation of health service facility beds, or dialysis stations from one licensed facility or campus to another. Any redistribution of health service facility bed capacity among the categories of health service facility bed. Any increase in the number of health service facility beds, or dialysis stations in kidney disease treatment centers, including freestanding dialysis units. Chemical dependency treatment facility. - A public or private facility, or unit in a facility, which is engaged in providing 24-hour a day treatment for chemical dependency or a substance use disorder. This treatment may include detoxification, administration of a therapeutic regimen for the treatment of individuals with chemical dependence or substance use disorders, and related services. The facility or unit may be any of the following: A unit within a general hospital or an attached or freestanding unit of a general hospital licensed under Article 5 of this Chapter. A unit within a psychiatric hospital or an attached or freestanding unit of a psychiatric hospital licensed under Article 1A of former Chapter 122 of the General Statutes or Article 2 of Chapter 122C of the General Statutes. A freestanding facility specializing in treatment of individuals with chemical dependence or substance use disorders that is licensed under Article 1A of former Chapter 122 of the General Statutes or Article 2 of Chapter 122C of the General Statutes. The facility may be identified as "chemical dependency, substance abuse, alcoholism, or drug abuse treatment units," "residential chemical dependency, substance use disorder, alcoholism or drug abuse facilities," or by other names if the purpose is to provide treatment of individuals with chemical dependence or substance use disorders. The term, however, does not include social setting detoxification facilities, medical detoxification facilities, halfway houses, or recovery farms. Chemical dependency treatment beds. - Beds that are licensed for the inpatient treatment of chemical dependency. Residential treatment beds for the treatment of chemical dependency or substance use disorder are chemical dependency treatment beds. Chemical dependency treatment beds do not include beds licensed for detoxification. Department. - The North Carolina Department of Health and Human Services. Develop. - When used in connection with health services, means to undertake those activities which will result in the offering of institutional health service or the incurring of a financial obligation in relation to the offering of such a service. Diagnostic center. - A freestanding facility, program, or provider, including but not limited to, physicians' offices, clinical laboratories, radiology centers, and mobile diagnostic programs, in which the total cost of all the medical diagnostic equipment utilized by the facility which cost ten thousand dollars ($10,000) or more exceeds five hundred thousand dollars ($500,000). In determining whether the medical diagnostic equipment in a diagnostic center costs more than five hundred thousand dollars ($500,000), the costs of the equipment, studies, surveys, designs, plans, working drawings, specifications, construction, installation, and other activities essential to acquiring and making operational the equipment shall be included. The capital expenditure for the equipment shall be deemed to be the fair market value of the equipment or the cost of the equipment, whichever is greater. Expedited review. - The status given to an application's review process when the applicant petitions for the review and the Department approves the request based on findings that all of the following are met: The review is not competitive. The proposed capital expenditure is less than five million dollars ($5,000,000). A request for a public hearing is not received within the time frame defined in G.S. 131E-185. The agency has not determined that a public hearing is in the public interest. Gamma knife. - Equipment which emits photon beams from a stationary radioactive cobalt source to treat lesions deep within the brain and is one type of stereotactic radiosurgery. Gastrointestinal endoscopy room. - A room used for the performance of procedures that require the insertion of a flexible endoscope into a gastrointestinal orifice to visualize the gastrointestinal lining and adjacent organs for diagnostic or therapeutic purposes. , (9) Repealed by Session Laws 1987, c. 511, s. 1. Health service. - An organized, interrelated activity that is medical, diagnostic, therapeutic, rehabilitative, or a combination thereof and that is integral to the prevention of disease or the clinical management of an individual who is sick or injured or who has a disability. "Health service" does not include administrative and other activities that are not integral to clinical management. Health service facility. - A hospital; long-term care hospital; psychiatric facility; rehabilitation facility; nursing home facility; adult care home; kidney disease treatment center, including freestanding hemodialysis units; intermediate care facility for individuals with intellectual disabilities; home health agency office; chemical dependency treatment facility; diagnostic center; hospice office, hospice inpatient facility, hospice residential care facility; and ambulatory surgical facility. Health service facility bed. - A bed licensed for use in a health service facility in the categories of (i) acute care beds; (ii) psychiatric beds; (iii) rehabilitation beds; (iv) nursing home beds; (v) intermediate care beds for individuals with intellectual disabilities; (vi) chemical dependency treatment beds; (vii) hospice inpatient facility beds; (viii) hospice residential care facility beds; (ix) adult care home beds; and (x) long-term care hospital beds. Provides or otherwise makes available to enrolled participants health care services, including at least the following basic health care services: usual physician services, hospitalization, laboratory, X ray, emergency and preventive services, and out-of-area coverage. Is compensated, except for copayments, for the provision of the basic health care services listed in sub-subdivision a. of this subdivision to enrolled participants by a payment which is paid on a periodic basis without regard to the date the health care services are provided and which is fixed without regard to the frequency, extent, or kind of health service actually provided. Provides physicians' services primarily (i) directly through physicians who are either employees or partners of such organizations, or (ii) through arrangements with individual physicians or one or more groups of physicians organized on a group practice or individual practice basis. Heart-lung bypass machine. - The equipment used to perform extra-corporeal circulation and oxygenation during surgical procedures. Home health services. - Items and services furnished to an individual by a home health agency, or by others under arrangements with such others made by the agency, on a visiting basis, and except for sub-subdivision e. of this subdivision, in a place of temporary or permanent residence used as the individual's home as follows: Part-time or intermittent nursing care provided by or under the supervision of a registered nurse. Physical, occupational, or speech therapy. Medical social services, home health aid services, and other therapeutic services. Medical supplies, other than drugs and biologicals and the use of medical appliances. Any of the items and services listed in this subdivision which are provided on an outpatient basis under arrangements made by the home health agency at a hospital or nursing home facility or rehabilitation center and the furnishing of which involves the use of equipment of such a nature that the items and services cannot readily be made available to the individual at home, or which are furnished at the facility while the individual is there to receive any such item or service, but not including transportation of the individual in connection with any such item or service. Hospice. - Any coordinated program of home care with provision for inpatient care for terminally ill patients and their families. This care is provided by a medically directed interdisciplinary team, directly or through an agreement under the direction of an identifiable hospice administration. A hospice program of care provides palliative and supportive medical and other health services to meet the physical, psychological, social, spiritual, and special needs of patients and their families, which are experienced during the final stages of terminal illness and during dying and bereavement. Hospice inpatient facility. - A freestanding licensed hospice facility or a designated inpatient unit in an existing health service facility which provides palliative and supportive medical and other health services to meet the physical, psychological, social, spiritual, and special needs of terminally ill patients and their families in an inpatient setting. For purposes of this Article only, a hospital which has a contractual agreement with a licensed hospice to provide inpatient services to a hospice patient as defined in G.S. 131E-201(4) and provides those services in a licensed acute care bed is not a hospice inpatient facility and is not subject to the requirements in sub-subdivision (5)b. of this section for hospice inpatient beds. Hospice residential care facility. - A freestanding licensed hospice facility which provides palliative and supportive medical and other health services to meet the physical, psychological, social, spiritual, and special needs of terminally ill patients and their families in a group residential setting. Intermediate care facility for individuals with intellectual disabilities. - Facilities licensed pursuant to Article 2 of Chapter 122C of the General Statutes for the purpose of providing health and habilitative services based on the developmental model and principles of normalization for individuals with intellectual disabilities, autism, cerebral palsy, epilepsy or related conditions. Repealed by Session Laws 1991, c. 692, s. 1. Reserved for future codification. Repealed by Session Laws 2001-234, s. 2, effective January 1, 2002. Kidney disease treatment center. - A facility that is certified as an end-stage renal disease facility by the Centers for Medicare and Medicaid Services, Department of Health and Human Services, pursuant to 42 C.F.R. § 405. "Legacy Medical Care Facility" means a facility that meets all of the following requirements: Is not presently operating. Has not continuously operated for at least the past six months. Within the last 24 months: Was operated by a person holding a license under G.S. 131E-77; and Was primarily engaged in providing to inpatients or outpatients, by or under supervision of physicians, (i) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons or (ii) rehabilitation services for the rehabilitation of injured, disabled, or sick persons. Linear accelerator. - A machine used to produce ionizing radiation in excess of 1,000,000 electron volts in the form of a beam of electrons or photons to treat cancer patients. Reserved for future codification. Lithotriptor. - Extra-corporeal shock wave technology used to treat persons with kidney stones and gallstones. Reserved for future codification. Long-term care hospital. - A hospital that has been classified and designated as a long-term care hospital by the Centers for Medicare and Medicaid Services, Department of Health and Human Services, pursuant to 42 C.F.R. § 412. Reserved for future codification. Magnetic resonance imaging scanner. - Medical imaging equipment that uses nuclear magnetic resonance. Main campus. - All of the following for the purposes of G.S. 131E-184(f) and (g) only: The site of the main building from which a licensed health service facility provides clinical patient services and exercises financial and administrative control over the entire facility, including the buildings and grounds adjacent to that main building. Other areas and structures that are not strictly contiguous to the main building but are located within 250 yards of the main building. Major medical equipment. - A single unit or single system of components with related functions which is used to provide medical and other health services and which costs more than seven hundred fifty thousand dollars ($750,000). In determining whether the major medical equipment costs more than seven hundred fifty thousand dollars ($750,000), the costs of the equipment, studies, surveys, designs, plans, working drawings, specifications, construction, installation, and other activities essential to acquiring and making operational the major medical equipment shall be included. The capital expenditure for the equipment shall be deemed to be the fair market value of the equipment or the cost of the equipment, whichever is greater. Major medical equipment does not include replacement equipment. Multispecialty ambulatory surgical program. - A formal program for providing on a same-day basis surgical procedures for at least three of the following specialty areas: gynecology, otolaryngology, plastic surgery, general surgery, ophthalmology, orthopedic, or oral surgery. Neonatal intensive care services. - Those services provided by a health service facility to high-risk newborn infants who require constant nursing care, including but not limited to continuous cardiopulmonary and other supportive care. The construction, development, or other establishment of a new health service facility. Except as otherwise provided in G.S. 131E-184(e), the obligation by any person of a capital expenditure exceeding two million dollars ($2,000,000) to develop or expand a health service or a health service facility, or which relates to the provision of a health service. The cost of any studies, surveys, designs, plans, working drawings, specifications, and other activities, including staff effort and consulting and other services, essential to the acquisition, improvement, expansion, or replacement of any plant or equipment with respect to which an expenditure is made shall be included in determining if the expenditure exceeds two million dollars ($2,000,000). Any change in bed capacity. The offering of dialysis services or home health services by or on behalf of a health service facility if those services were not offered within the previous 12 months by or on behalf of the facility. A change in a project that was subject to certificate of need review and for which a certificate of need was issued, if the change is proposed during the development of the project or within one year after the project was completed. For purposes of this subdivision, a change in a project is a change of more than fifteen percent (15%) of the approved capital expenditure amount or the addition of a health service that is to be located in the facility, or portion thereof, that was constructed or developed in the project. The development or offering of a health service as listed in this subdivision by or on behalf of any person: Bone marrow transplantation services. Burn intensive care services. Neonatal intensive care services. Open-heart surgery services. Solid organ transplantation services. Lithotriptor. Magnetic resonance imaging scanner. Positron emission tomography scanner. Simulator. to k. Repealed by Session Laws 1987, c. 511, s. 1. Nursing care. - Any of the following: Skilled nursing care and related services for residents who require medical or nursing care. Rehabilitation services for the rehabilitation of individuals who are injured or sick or who have disabilities. Health-related care and services provided on a regular basis to individuals who because of their mental or physical condition require care and services above the level of room and board, which can be made available to them only through institutional facilities. Nursing home facility. - A health service facility whose bed complement of health service facility beds is composed principally of nursing home facility beds. Repealed by Session Laws 2005-325, s. 1, effective for hospices and hospice offices December 31, 2005. Open-heart surgery services. - The provision of surgical procedures that utilize a heart-lung bypass machine during surgery to correct cardiac and coronary artery disease or defects. Operating room. - A room used for the performance of surgical procedures requiring one or more incisions and that is required to comply with all applicable licensure codes and standards for an operating room. Positron emission tomography scanner. - Equipment that utilizes a computerized radiographic technique that employs radioactive substances to examine the metabolic activity of various body structures. Replacement equipment. - Equipment that costs less than two million dollars ($2,000,000) and is purchased for the sole purpose of replacing comparable medical equipment currently in use which will be sold or otherwise disposed of when replaced. In determining whether the replacement equipment costs less than two million dollars ($2,000,000), the costs of equipment, studies, surveys, designs, plans, working drawings, specifications, construction, installation, and other activities essential to acquiring and making operational the replacement equipment shall be included. The capital expenditure for the equipment shall be deemed to be the fair market value of the equipment or the cost of the equipment, whichever is greater. Service area. - The area of the State, as defined in the State Medical Facilities Plan or in rules adopted by the Department, which receives services from a health service facility. Simulator. - A machine that produces high quality diagnostic radiographs and precisely reproduces the geometric relationships of megavoltage radiation therapy equipment to the patient. Reserved for future codification. Solid organ transplantation services. - The provision of surgical procedures and the interrelated medical services that accompany the surgery to remove an organ from a patient and surgically implant an organ from a donor. Reserved for future codification. Specialty ambulatory surgical program. - A formal program for providing on a same-day basis surgical procedures for only the specialty areas identified on the ambulatory surgical facility's 1993 Application for Licensure as an Ambulatory Surgical Center and authorized by its certificate of need. (10) Health maintenance organization (HMO). - A public or private organization which has received its certificate of authority under Article 67 of Chapter 58 of the General Statutes and which either is a qualified health maintenance organization under Section 1310(d) of the Public Health Service Act or satisfies all of the following: (11) Repealed by Session Laws 1991, c. 692, s. 1. (12) Home health agency. - A private organization or public agency, whether owned or operated by one or more persons or legal entities, which furnishes or offers to furnish home health services. (13) Hospital. - A public or private institution which is primarily engaged in providing to inpatients, by or under supervision of physicians, diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. The term includes all facilities licensed pursuant to G.S. 131E-77 , except long-term care hospitals. (14) Repealed by Session Laws 1987, c. 511, s. 1. (15) Repealed by Session Laws 1987, c. 511, s. 1. (16) New institutional health services. - Any of the following: 2a. Cardiac catheterization services, except cardiac catheterization services provided on equipment furnished by a person authorized to operate the equipment in North Carolina pursuant to either a certificate of need issued for mobile cardiac catheterization equipment or a settlement agreement executed by the Department for provision of cardiac catheterization services. f1. The acquisition by purchase, donation, lease, transfer, or comparable arrangement of any of the following equipment by or on behalf of any person: 1. Air ambulance. 2. Repealed by Session Laws 2005-325, s. 1, effective for hospices and hospice offices December 31, 2005. 3. Cardiac catheterization equipment. 4. Gamma knife. 5. Heart-lung bypass machine. 5a. Linear accelerator. l . The purchase, lease, or acquisition of any health service facility, or portion thereof, or a controlling interest in the health service facility or portion thereof, if the health service facility was developed under a certificate of need issued pursuant to G.S. 131E-180 . m. Any conversion of nonhealth service facility beds to health service facility beds. n. The construction, development or other establishment of a hospice, hospice inpatient facility, or hospice residential care facility; o. The opening of an additional office by an existing home health agency or hospice within its service area as defined by rules adopted by the Department; or the opening of any office by an existing home health agency or hospice outside its service area as defined by rules adopted by the Department. p. The acquisition by purchase, donation, lease, transfer, or comparable arrangement by any person of major medical equipment. q. The relocation of a health service facility from one service area to another. r. The conversion of a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or the addition of a specialty to a specialty ambulatory surgical program. s. The furnishing of mobile medical equipment to any person to provide health services in North Carolina, which was not in use in North Carolina prior to the adoption of this provision, if the equipment would otherwise be subject to review in accordance with sub-subdivision f1. of this subdivision or sub-subdivision p. of this subdivision if it had been acquired in North Carolina. t. Repealed by Session Laws 2001-242, s. 4, effective June 23, 2001. u. The construction, development, establishment, increase in the number, or relocation of an operating room or gastrointestinal endoscopy room in a licensed health service facility, other than the relocation of an operating room or gastrointestinal endoscopy room within the same building or on the same grounds or to grounds not separated by more than a public right-of-way adjacent to the grounds where the operating room or gastrointestinal endoscopy room is currently located. v. The change in designation, in a licensed health service facility, of an operating room to a gastrointestinal endoscopy room or change in designation of a gastrointestinal endoscopy room to an operating room that results in a different number of each type of room than is reflected on the health service facility's license in effect as of January 1, 2005. (17) North Carolina State Health Coordinating Council. - The Council that prepares, with the Department of Health and Human Services, the State Medical Facilities Plan. These are services which are not primarily for the care and treatment of mental diseases. (18) Offer. - In connection with health services, the act by a person of holding out as capable of providing, or as having the means to provide, specified health services. (19) Person. - An individual; a trust or estate; a partnership; a corporation, including associations, joint stock companies, and insurance companies; the State; or a political subdivision or agency or instrumentality of the State. (20) Project or capital expenditure project. - A proposal to undertake a capital expenditure that results in the offering of a new institutional health service. A project, or capital expenditure project, or proposed project may refer to the project from its earliest planning stages up through the point at which the specified new institutional health service may be offered. In the case of facility construction, the point at which the new institutional health service may be offered must take place after the facility is capable of being fully licensed and operated for its intended use, and at that time it shall be considered a health service facility. (21) Psychiatric facility. - A public or private facility licensed pursuant to Article 2 of Chapter 122C of the General Statutes and which is primarily engaged in providing to inpatients, by or under the supervision of a physician, psychiatric services for the diagnosis and treatment of individuals with mental illnesses. (22) Rehabilitation facility. - A public or private inpatient facility which is operated for the primary purpose of assisting in the rehabilitation of individuals with disabilities through an integrated program of medical and other services which are provided under competent, professional supervision. (23) Repealed by Session Laws 1991, c. 692, s. 1. (24) Repealed by Session Laws 1993, c. 7, s. 2. (25) State Medical Facilities Plan. - The plan prepared by the Department of Health and Human Services and the North Carolina State Health Coordinating Council, and approved by the Governor. In preparing the Plan, the Department and the State Health Coordinating Council shall maintain a mailing list of persons who have requested notice of public hearings regarding the Plan. Not less than 15 days prior to a scheduled public hearing, the Department shall notify persons on its mailing list of the date, time, and location of the hearing. The Department shall hold at least one public hearing prior to the adoption of the proposed Plan and at least six public hearings after the adoption of the proposed Plan by the State Health Coordinating Council. The Council shall accept oral and written comments from the public concerning the Plan. (26) Repealed by Session Laws 1983 (Regular Session, 1984), c. 1002, s. 9. (27) Repealed by Session Laws 1987, c. 511, s. 1. History (1977, 2nd Sess., c. 1182, s. 2; 1981, c. 651, ss. 1, 2; c. 1127, ss. 24-29; 1983, c. 775, s. 1; 1983 (Reg. Sess., 1984), c. 1002, ss. 1-9; c. 1022, ss. 2, 3; c. 1064, s. 1; c. 1110, ss. 1, 2; 1985, c. 589, ss. 42, 43(a); c. 740, ss. 1, 2, 6; 1985 (Reg. Sess., 1986), c. 1001, s. 2; 1987, c. 34; c. 511, s. 1; 1991, c. 692, s. 1; c. 701, s. 1; 1993, c. 7, s. 2; c. 376, ss. 1-4; 1997-443, s. 11A.118(a); 2000-135, ss. 1, 2; 2001-234, s. 2; 2001-242, ss. 2, 4; 2003-229, s. 13; 2003-390, ss. 1, 2; 2005-325, s. 1; 2005-346, s. 6(a)-(d); 2009-145, s. 2; 2009-462, s. 4(k); 2013-360, s. 12G.3(a); 2015-288, s. 1; 2018-81, s. 3(a); 2019-76, s. 19.) 1915(b)/(c) Medicaid Waivers. - Session Laws 2011-102, s. 2, provides: "The Department of Health and Human Services shall implement additional capitated 1915(b)(c) Medicaid waivers during the 2011-2012 fiscal year through a Request for Application (RFA) process for LME applicants who prove readiness. The Department shall consult with stakeholders during the approval process. The waiver program shall include all Medicaid-covered mental health, developmental disabilities, and substance abuse services. Expansion of the waiver is contingent upon approval by the Centers for Medicare and Medicaid Services." Session Laws 2011-264, s. 1, as amended by Session Laws 2012-151, s. 13, provides: "(a) The Department of Health and Human Services (Department) shall proceed with statewide restructuring of the management responsibilities for the delivery of services for individuals with mental illness, intellectual and developmental disabilities, and substance abuse disorders through expansion of the 1915(b)/(c) Medicaid Waiver. It is the intent of the General Assembly that expansion of the 1915(b)/(c) Medicaid Waiver will be completed by July 1, 2013, and will result in the establishment of a system that is capable of managing all public resources that may become available for mental health, intellectual and developmental disabilities, and substance abuse services, including federal block grant funds, federal funding for Medicaid and Health Choice, and all other public funding sources. In implementing the restructuring and expansion authorized in this section, the Department shall do all of the following: "(1) Establish accountability for the development and management of a local system that ensures easy access to care, the availability and delivery of necessary services, and continuity of care for consumers in need of mental health, intellectual and developmental disabilities, and substance abuse services. "(2) Maintain fidelity to the Piedmont Behavioral Health (PBH) demonstration model, a proven system for the operation of all public resources for mental health, developmental disabilities, and substance abuse services. "(3) Designate an area authority for mental health, developmental disabilities, and substance abuse services to assume responsibility for all aspects of Waiver management. The following operational models are acceptable: "a. Merger model: A single larger LME is formed from the merger of two or more LMEs. "b. Interlocal agreement among LMEs: A single LME is identified as the leader for all Waiver operations, financial management, and accountability for performance measures. "(4) Use managed care strategies, including care coordination and utilization management, to reduce the trend of escalating costs in the State Medicaid program while ensuring medically necessary care and deploy a system for the allocation of resources based on the reliable assessment of intensity of need. The Department shall design these strategies to efficiently direct consumers to appropriate services and to ensure that consumers receive no more and no less than the amount of services determined to be medically necessary and at the appropriate funding level. "(5) As the 1915(b)/(c) Medicaid Waiver expands statewide, phase out the current CAP-MR/DD Waiver as well as the utilization management functions currently performed by public and private contractors. "(6) Design the Innovations Waiver in such a way as to serve the maximum number of individuals with intellectual and developmental disabilities within aggregate funding. "(7) Require LMEs approved to operate a 1915(b)/(c) Medicaid Waiver to do all of the following: "a. Maintain a local presence in order to respond to the unique needs and priorities of localities. "b. Implement a process for feedback end exchange of information and ideas to ensure communication with consumers, families, providers, and stakeholders regarding disability-specific and general Waiver operations. "c. Establish and maintain systems for ongoing communication and coordination regarding the care of individuals with mental illness, intellectual and developmental disabilities, and substance abuse disorders with other organized systems such as local departments of social services, Community Care of North Carolina, hospitals, school systems, the Department of Juvenile Justice, and other community agencies. "d. Comply with the following operational requirements: "1. Maintain disability specific infrastructure and competency to address the clinical, treatment, rehabilitative, habilitative, and support needs of all disabilities covered by the 1915(b)/(c) Medicaid Waiver. "2. Maintain administrative and clinical functions, including requirements for customer service, quality management, due process, provider network development, information systems, financial reporting, and staffing. "3. Maintain full accountability for all aspects of Waiver operations and for meeting all contract requirements specified by the Department. The Department shall not require LMEs to subcontract any managed care functions or nonservice activities to other entities. However, LMEs that choose to subcontract managed care functions to other entities will be limited to the following: "I. Information systems. "II. Customer service (including call center) operations. "III. Claims processing. "IV. Provider, enrollment, credentialing, and monitoring. "V. Professional services. "VI. Treatment Plan development. "VII. Referral to services. "(b) By August 1, 2011, the Department shall select LMEs that have been assessed to meet minimum criteria for Waiver operations according to the requirements of RFA #2011-261 issued on April 1, 2011. "(c) The Department shall require LMEs that have not been approved by the Department to operate a 1915(b)/(c) Medicaid Waiver by January 1, 2013, to merge with or be aligned through an interlocal agreement with an LME that has been approved by the Department to operate a 1915(b)/(c) Medicaid Waiver. If any LME fails to comply with this requirement, or fails to meet performance requirements of an approved contract with the Department to operate a 1915(b)/(c) Medicaid Waiver, the Department shall assign responsibility for management of the 1915(b)/(c) Medicaid Waiver on behalf of the noncompliant LME to an LME that is successfully operating the Waiver and successfully meeting performance requirements of the contract with the Department. Those LMEs approved to operate the 1915(b)/(c) Medicaid Waiver under an interlocal agreement must have a single LME entity designated as responsible for all aspects of Waiver operations and solely responsible for meeting contract requirements. "(d) County governments are not financially liable for overspending or cost overruns associated with an area authority's operation of a 1915(b)/(c) Medicaid Waiver. County governments are not financially liable for overspending or cost overruns of Medicaid services associated with a county program or multicounty program's operation of a 1915(b)/(c) Medicaid Waiver beyond the county program or multicounty program's Medicaid risk reserve and Medicaid fund balance amounts. "(e) Providers of targeted case management under the CAP-MR/DD Waiver are qualified to provide the 1915(c) service known as Community Guide under the Innovations Waiver. During the first year of assuming responsibility for Waiver operations, LMEs shall offer to contract with providers that were previously approved to provide targeted case management to individuals with intellectual and developmental disabilities under the CAP-MR/DD Waiver, for the provision of Community Guide services. "(f) By December 31, 2011, the Department shall determine the feasibility of adding habilitation services to the State Medicaid Plan through the 1915(i) Option as a strategy to address the needs of Medicaid enrollees with IDD who are not enrolled in the Innovations Waiver and are not residing in an intermediate care facility for the mentally retarded (ICF-MR facility). "(g) The Department shall consider the impact on ICF-MR facilities included in the 1915(b)/(c) Medicaid Waiver to determine and, to the extent possible, minimize potential inconsistencies with the requirements of G.S. 131E-176 and G.S. 131E-178 without negatively impacting the viability and success of the 1915(b)/(c) Medicaid Waiver programs. "(h) The Department shall discontinue the pilot program to administer the Supports Intensity Scale to people with intellectual and developmental disabilities in non-Waiver LMEs. "(i) The Department shall establish written policies ensuring alignment of objectives and operational coordination of the 1915(b)/(c) Medicaid Waiver and the care of individuals with mental illness, intellectual and developmental disabilities, and substance abuse disorders with other organized systems under the auspices of the Department, including Community Care of North Carolina. "(j) In the development of the budget for the 2013-2015 fiscal biennium and subsequent biennia, the General Assembly shall consider a reinvestment of at least fifteen percent (15%) of the total projected State savings for that biennium from the operation of the 1915(b)/(c) Waiver, for the purpose of expanding the number of consumers served by the Innovations 1915(c) Medicaid Waiver, or for the purpose of expanding other services that are designed to meet the needs of individuals with intellectual and developmental disabilities. "(k) By October 1, 2011, the Department, in coordination with the Division of Mental Health, Developmental Disabilities, and Substance Abuse Services, the Division of Medical Assistance, LMEs, PBH, and with stakeholder input, shall submit to the appropriate Oversight Committee of the General Assembly a strategic plan delineating specific strategies and agency responsibilities for the achievement of the objectives and deadlines set forth in this Act. "( l ) The Department shall submit status reports to the General Assembly on the restructuring and expansion authorized in this section on January 1, 2012, April 1, 2012, October 1, 2012, February 1, 2013, and October 1, 2013." For provisions pertaining to actions by the Secretary to ensure effective management of behavioral health services under the 1915(b)/(c) Medicaid Waiver, see G.S. 122C-124.2 , as added by Session Laws 2013-85, s. 2, effective June 12, 2013. Session Laws 2012-171, ss. 1-3, provide: "SECTION 1. Qualified provider. - The Department of Health and Human Services (Department) shall ensure that Critical Access Behavioral Health Agencies (CABHAs) are the only providers of the following Medicaid services: (i) Community Support Team; (ii) Intensive In-Home; and (iii) Child and Adolescent Day Treatment. CABHAs shall provide these services in accordance with all of the following: "(1) State statutory requirements regulating the provision of mental health and substance abuse services in Chapter 122C of the General Statutes. "(2) Chapters 21 through 25 and Chapter 27 of Title 10A of the North Carolina Administrative Code. "(3) Clinical policy requirements specified in Medicaid Clinical Coverage Policy, Section 8, and in the 1915(b) MH/DD/SAS Health Plan Waiver. "(4) Federal Medicaid policy as outlined in 42 C.F.R. Chapter IV, Subchapter C. "SECTION 2. Required services. - Each CABHA shall, at a minimum, provide comprehensive clinical assessment, medication management, outpatient therapy, and at least two of the following listed services within an age and disability-specific continuum: "(1) Intensive In-Home. "(2) Community Support Team. "(3) Child and Adolescent Day Treatment. "(4) Substance Abuse Intensive Outpatient Program. "(5) Substance Abuse Comprehensive Outpatient Treatment. "(6) Child and Adolescent Residential Treatment Level II - Family and Program Type, Level III, or Level IV (provision of multiple residential service levels counts as one service). "(7) Psychosocial Rehabilitation. "(8) Assertive Community Treatment Team. "(9) Multi-Systemic Therapy. "(10) Partial Hospitalization. "(11) Substance Abuse Medically Monitored Community Residential Treatment. "(12) Substance Abuse Non-Medical Community Residential Treatment. "(13) Outpatient Opioid Treatment. "(14) Any other mental health or substance abuse service required to be delivered by a CABHA as set forth in the North Carolina State Plan of Medical Assistance as approved by the Centers for Medicare and Medicaid Services (CMS) or in a waiver approved by CMS pursuant to 42 U.S.C. § 1915(b). "SECTION 3. Staffing. - In accordance with the North Carolina State Plan of Medical Assistance, the Department shall ensure each CABHA meet the following staffing requirements: "(1) A medical director who is a medical doctor licensed in North Carolina, enrolled as a provider, and in good standing with the Division of Medical Assistance. The medical director shall provide medical, clinical, and quality management oversight of the agency's CABHA services described in Section 2 of this act. "(2) A clinical director who shall be one of the following licensed or certified providers: "a. Licensed medical doctor. "b. Licensed psychologist. "c. Licensed clinical social worker. "d. Licensed psychological associate. "e. Licensed professional counselor. "f. Licensed marriage and family therapist. "g. Licensed nurse practitioner. "h. Licensed clinical addiction specialist. "i. Certified clinical supervisor. "(3) A quality managementraining director who shall have any training or experience in quality management or training." Editor's Note. - Session Laws 1987, c. 511, s. 3, provided that the act, which amended this section, would become effective July 1, 1987, and would apply to all new institutional health services that are proposed on and after that date, but would not apply to applications for certificates of need which begin review, or to projects for which certificates of need were issued, before that date. Section 3 of Session Laws 1987, c. 511 further provided that the act would supersede all previous acts that were to become effective at any time after the effective date of the act (July 1, 1987). Thus an amendment by Session Laws 1985, c. 589, s. 43(b), which would have deleted "Article 1A of General Statutes Chapter 122 " following "licensed under" in paragraph (5a)b and (5a)c, and was scheduled to become effective on January 1, 1988, was superseded and did not go into effect. Session Laws 2001-242, s. 5, provides: "This act is effective when it becomes law [June 23, 2001]. This act shall not apply to any project which was not a new institutional health service as defined in G.S. 131E-176(16) prior to the effective date of this act and for which there has been a capital expenditure exceeding fifty thousand dollars ($50,000) or there was a legally binding obligation for a capital expenditure exceeding fifty thousand dollars ($50,000) in effect on or before the effective date of this act and which was reasonably expected to be completed by December 31, 2002. A facility or office that was not licensed as an ambulatory surgical facility prior to the effective date of this act shall not become an ambulatory surgical facility by virtue of the amendment set forth in Sections 1 and 2 of this act [which amended G.S. 131E-146 and 131E-176] and may not be licensed as an ambulatory surgical facility under Part D of Article 6 of Chapter 131E of the General Statutes without a certificate of need." Chapter 122 , referred to in this section, has been repealed. See now Chapter 122C . The definitions contained in this section have been set out in the order above at the direction of the Revisor of Statutes. Former subdivisions (1), (1a), and (1b) in this section were redesignated as present subdivisions (1a), (1b), and (1c), at the direction of the Revisor of Statutes to preserve alphabetical order of the definitions. The reference to G.S. 131E-180 , in sub-subdivision (16) l has been repealed by Session Laws 2005-325, s. 2, effective August 26, 2005. Session Laws 2005-325, s. 6, provides: "G.S. 131E-176(2f) and (2g), as enacted in this act, shall not preclude the furnishing of cardiac catheterization equipment or the provision of cardiac catheterization services by a person authorized to furnish this equipment or provide these services pursuant to a settlement agreement between the person and the Department of Health and Human Services prior to the effective date of this act." Session Laws 2005-325, s. 7, provides: G.S. 131E-176 , as amended by Section 1 of this act, becomes effective for hospices and hospice offices December 31, 2005. The remainder of this act is effective when it becomes law. Session Laws 2005-346, s. 9, provides: "Nothing in Sections 2 through 10 of this act shall be construed to represent legislative intent as to circumstances under which Medicare or Medicaid certification may be obtained for a provider of ambulatory surgery services." Session Laws 2011-145, s. 10.49A, as amended by Session Laws 2011-391, s. 26A, provides: "Beginning July 1, 2011, and for a period of three years thereafter, the Department of Health and Human Services shall not issue any licenses for home care agencies as defined in G.S. 131E-136(2) that intend to offer in-home aide services. The prohibition shall not restrict the Department from issuing licenses to certified home health agencies as defined in G.S. 131E-176(12) that intend to offer in-home aide services or to agencies that need a new license for an existing home care agency being acquired. The Secretary may at any time license a new home care agency in any area of the State if access to care becomes an issue during the time frame set forth above. Companion and Sitter services are exempt from this restriction. All completed applications that include the applicable fee received in the Division of Health Service Regulation prior to July 1, 2011, may be processed for licensure." Session Laws 2011-145, s. 1.1, provides: "This act shall be known as the 'Current Operations and Capital Improvements Appropriations Act of 2011.'" Session Laws 2011-145, s. 32.2, provides: "Except for statutory changes or other provisions that clearly indicate an intention to have effects beyond the 2011-2013 fiscal biennium, the textual provisions of this act apply only to funds appropriated for, and activities occurring during, the 2011-2013 fiscal biennium." Session Laws 2011-145, s. 32.5, is a severability clause. Session Laws 2013-360, s. 12G.3(b), made subdivision (14n), as added by Session Laws 2014-360, s. 12G.3(a), applicable to replacement equipment purchased, and capital expenditures for replacement facilities incurred, on or after July 26, 2013. Session Laws 2013-360, s. 1.1, provides: "This act shall be known as the 'Current Operations and Capital Improvements Appropriations Act of 2013.'" Session Laws 2013-360, s. 38.5, is a severability clause. Session Laws 2019-76, s. 33, provides: "Parts I and II of this act do not affect the coverage, eligibility, rights, responsibilities, or provision of State or federal services or benefits for individuals who have been diagnosed with mental retardation and whose diagnosis has not been changed to a diagnosis of intellectual disability." Session Laws 2019-76, s. 34, made the amendments by Session Laws 2019-76, s. 19 effective October 1, 2019, and applicable to proceedings commenced or services rendered on or after that date. Effect of Amendments. - Session Laws 2005-325, s. 1, effective for hospices and hospice offices December 31, 2005, repealed subdivisions (2e), (16)f1.2., and (18a); added subdivisions (2g), (14e), (14g), (14k), (16)f.2a., (16)f1.5a., (16)f1.9., and (24b); rewrote subdivisions (2f); in subdivision (9b), inserted "long-term care hospital" and "office" following "hospice," and deleted "oncology treatment center" following "diagnostic center"; in subdivision (9c), added clause (x) and made minor stylistic changes; added the exception at the end of subdivision (13); and in subdivision (16)o., inserted "or hospice" twice. Session Laws 2005-346, ss. 6(a) through 6(d), effective August 31, 2005, in subdivision (1b), inserted "or gastrointestinal endoscopy room, as defined in Article 5 Part 1 and Article 6, Part 4 of this Chapter" and substituted "(1c) of this section" for "(1b)" in the second sentence; and substituted "surgery or gastrointestinal endoscopy" for "surgery" at the end of subdivision (1c); added new subdivision (7d); in subdivision (16)u., substituted "gastrointestinal endoscopy room in a licensed health service facility" for "operating rooms" "gastrointestinal endoscopy room" for "operating rooms" and "or gastrointestinal endoscopy room is" for "is or operating rooms are"; and added subdivisions (16)v. and (18c). Session Laws 2009-145, s. 2, effective June 19, 2009, added "Except as otherwise provided in G.S. 131E-184(e) " at the beginning of subdivision (16)b. Session Laws 2009-462, s. 4(k), effective October 1, 2009, substituted "Part 1 of Article 1 of Chapter 131D of the General Statutes" for "G.S. 131D-2" in subdivision (1). Session Laws 2013-360, s. 12G.3(a), effective July 1, 2013, added subdivision (14n). For applicability, see Editor's note. Session Laws 2015-288, s. 1, effective October 29, 2015, added subdivision (14f). Session Laws 2018-81, s. 3(a), effective June 25, 2018, substituted "a facility" for "an institution" in subsection (14f), and "inpatients or outpatients," for "inpatients," in subdivision (14f)c.2. Session Laws 2019-76, s. 19, rewrote the section. For effective date and applicability, see editor's note.