SUBCHAPTER 14C CERTIFICATE OF NEED REGULATIONS SECTION GENERAL

Transcription

1 SUBCHAPTER 14C CERTIFICATE OF NEED REGULATIONS SECTION GENERAL 10A NCAC 14C.0101 DEFINITIONS (a) The definitions in G.S. 131E-176 shall apply to all the rules of this Subchapter. (b) "Home health agency office", as that phrase is used in G.S. 131E-176(9b) and G.S. 131E-176(16)o, means: (1) any site that is marketed or advertised as a place from which home health services are provided or for which a physical address or phone number for home health services is listed in the yellow or white pages of any telephone directory, any directory of home health agencies, any inventory of home health services, any promotional material, any agency letterhead, or any other documents distributed to the public; or (2) any site at which patients are accepted for home health services and regulatory responsibility and authority are assumed for organizing, implementing and evaluating a plan of care to meet the medical, nursing and social needs of the patient; or (3) any site at which staff are based to serve home health patients, excluding sites of a third party with which the home health agency subcontracts or private residences of employees; or (4) any site at which original client service records or patient medical records of current clients are maintained or stored. (c) "In use", as that phrase is used in G.S. 131E-176(16)s, means frequent, regular, periodic, or recurrent use of equipment and not occasional, sporadic, isolated, or incidental use of equipment. Authority G.S. 131E-177; Eff. January 1, 1990; Amended Eff. November 1, A NCAC 14C.0102 LOCATION OF THE AGENCY As used in this Subchapter, the agency is the Certificate of Need Section in the Division of Health Service Regulation, North Carolina Department of Health and Human Services. The location of the agency is 809 Ruggles Drive, Raleigh, North Carolina, The mailing address of the agency is Certificate of Need Section, Division of Health Service Regulation, 2704 Mail Service Center, Raleigh, NC The telephone number of the agency is Authority G.S. 131E-177; Eff. November 1, 1996; Amended Eff. January 1, 2013; January 1, A NCAC 14C.0103 STATE MEDICAL FACILITIES PLAN Authority G.S. 131E-176(25); 131E-177(1); 131E-183(1); 42 U.S.C. 300K-2; Eff. June 19, 1979; Temporary Amendment Eff. January 1, 1983 for a Period of 120 Days to Expire on May 1, 1983; Amended Eff. November 1, 1989; January 1, 1989; February 1, 1988; January 1, 1987; Repealed Eff. October 1, SECTION.0200 APPLICATION AND REVIEW PROCESS 10A NCAC 14C.0201 LETTER OF INTENT Authority G.S. 131E-177; Eff. October 1, 1981; Amended Eff. November 1, 1996; January 1, 1990; November 1, 1989; Repealed Eff. October 1, A NCAC 14C.0202 DETERMINATION OF REVIEW

2 (a) After receipt of a letter of intent, the agency shall determine whether the proposed project requires a certificate of need. (b) When any of the equipment listed in G.S. 131E-176(16)(f1) or (p) is acquired in parts or piecemeal fashion, the acquisition shall be determined to require a certificate of need on the date that the components are assembled. (c) If the agency determines that the project requires a certificate of need, the agency shall determine the appropriate review category or categories for the proposed project, the type or types of application forms to be submitted, the number of separate applications to be submitted, the applicable review period for each application, and the deadline date for submitting each application, as contained in this Subchapter. (d) Copies of the application forms may be obtained from the agency. (e) Proposals requiring review shall be reviewed according to the categories and schedule set forth in the duly adopted State Medical Facilities Plan in effect at the time the scheduled review period commences, as contained in this Subchapter. (f) Applications are competitive if they, in whole or in part, are for the same or similar services and the agency determines that the approval of one or more of the applications may result in the denial of another application reviewed in the same review period. Filed as a Temporary Amendment Eff. September 1, 1993 for a period of 180 days or until the permanent rule Authority G.S. 131E-177; Eff. October 1, 1981; Amended Eff. November 1, 1996; January 4, 1994; January 1, 1990; January 1, 1987; Temporary Amendment Eff. January 1, 2000; Amended Eff. April 1, A NCAC 14C.0203 FILING APPLICATIONS (a) A certificate of need application shall not be reviewed by the Certificate of Need Section until it is filed in accordance with this Rule. (b) An original and a copy of the application shall be file-stamped as received by the agency no later than 5:30 p.m. on the 15th day of the month preceding the scheduled review period. In instances when the 15th of the month falls on a weekend or holiday, the filing deadline is 5:30 p.m. on the next business day. An application shall not be included in a scheduled review if it is not received by the agency by this deadline. Each applicant shall transmit, with the application, a fee to be determined according to the formula as stated in G.S. 131E-182(c). (c) After an application is filed, the agency shall determine whether it is complete for review. An application shall not be considered complete if: (1) the requisite fee has not been received by the agency; or (2) a signed original and copy of the application have not been submitted to the agency on the appropriate application form. (d) If the agency determines the application is not complete for review, it shall mail notice of such determination to the applicant within five business days after the application is filed and shall specify what is necessary to complete the application. If the agency determines the application is complete, it shall mail notice of such determination to the applicant prior to the beginning of the applicable review period. (e) Information requested by the agency to complete the application must be received by the agency no later than 5:30 p.m. on the last working day before the first day of the scheduled review period. The review of an application shall commence in the next applicable review period that commences after the application has been determined to be complete. Authority G.S. 131E-177; 131E-182; Eff. October 1, 1981; Amended Eff. January 1, 1982; Temporary Amendment Eff. July 15, 1983, for a Period of 118 Days, to Expire on November 10, 1983; Amended Eff. November 1, 1990: January 1, 1990; December 1, 1989; January 1, 1987; October 1, 1984; November 10, 1983; Temporary Amendment Eff. August 11, 1993, for a period of 180 days or until the permanent rule Amended

3 Temporary Amendment Eff. August 12, 1994, for a period of 180 days or until the permanent rule Amended Eff. December 1, 1994; Temporary Amendment Eff. January 1, 2000; Amended Eff. April 1, 2001; Temporary Amendment Eff. February 16, 2004; Amended Eff. August 1, 2004; Temporary Amendment Eff. February 1, 2006; Amended Eff. November 1, 2006; Temporary Amendment Eff. January 1, 2008; Amended Eff. July 1, A NCAC 14C.0204 AMENDMENTS TO APPLICATIONS An applicant may not amend an application. Responding to a request for additional information made by the agency after the review has commenced is not an amendment. Authority G.S. 131E-177; 131E-182; Eff. October 1, 1981; Amended Eff. January 1, 1990; January 1, A NCAC 14C.0205 REVIEW PERIOD (a) The review of an application for a certificate of need shall be completed within 90 days from the beginning date of the review period for the application, except as provided in Paragraph (b) of this Rule. (b) Except in the case of an expedited review, the period for review may be extended for up to 60 days by the agency if it determines that, for one or more of the following reasons, it cannot complete the review within 90 days: (1) the extension is necessary to consider conflicting, contradictory, or otherwise relevant matters; (2) the total number of applications assigned to the project analyst for review, including those in other review periods, preclude the project analyst from completing the review within 90 days; (3) the complexity of the application or applications to be reviewed make it necessary to extend the review period; (4) the review of an applicant's response to the agency's request for additional information has not been completed; (5) the timing of the public hearing which was held for the application or applications under review does not allow sufficient time to consider the information presented; (6) extension of previous reviews necessitated that the project analyst delay the commencement of the review; or (7) the unavailability of the project analyst due to illness, annual leave, litigation associated with other reviews, or other duties and responsibilities. (c) In the case of an expedited review, the review period may be extended only if the Agency has requested additional substantive information from the applicant in accordance with G.S. 131E-185(c). (d) Applicants will be provided written notice of the extension of the review period after the agency determines that an extension is necessary. Failure to receive such notice prior to the last day of the scheduled review period, however, does not entitle an applicant to a certificate of need nor authorize an applicant to proceed with a project without one. Filed as a Temporary Amendment Eff. September 1, 1993 for a period of 180 days or until the permanent rule Authority G.S. 131E-177; 131E-185; Eff. October 1, 1981; Amended January 1, 1990; January 1, A NCAC 14C.0206 EXPEDITED REVIEW (a) An applicant which desires an expedited review shall submit a petition for an expedited review with the Certificate of Need Section when the application is submitted. (b) The Certificate of Need Section shall review the petition within 15 days from the beginning of the review and shall notify the applicant if the Agency has determined that a public hearing is in the public interest.

4 (c) If the Certificate of Need Section decides that it is not in the public interest to hold a public hearing, a final determination on the request for an expedited review shall not be issued until after the thirty day written comment period has expired. (d) If a request for a public hearing is received by the Agency during the 30 day written comment period, which is defined in G.S. 131E-185, the request for an expedited review shall be denied. (e) After the thirty day written comment period, the Certificate of Need Section shall notify the applicant that its petition for an expedited review is approved or denied. Filed as a Temporary Adoption Eff. September 1, 1993 for a period of 180 days or until the permanent rule Authority G.S. 131E-177(1); Eff. January 4, A NCAC 14C.0207 AGENCY DECISION (a) The agency shall determine whether a proposal is consistent with the review criteria set forth in G.S. 131E-183 and the standards, plans, and criteria promulgated thereunder in effect at the time the review commences. The agency shall determine which standards, plans, and criteria are applicable to the proposal. If a proposal is consistent with all applicable standards, plans, and criteria, the agency decision shall be to issue the certificate of need. If a proposal is not consistent with all applicable standards, plans, and criteria, the agency decision shall be to either not issue the certificate of need or issue one subject to those conditions necessary to insure that the proposal is consistent with applicable standards, plans, and criteria. The agency may only impose conditions which relate directly to applicable standards, plans, and criteria. (b) The written agency decision shall include the following: (1) the basis for the decision; (2) the findings regarding the extent to which the proposal meets the criteria set forth in G.S. 131E-183; (3) the time when the service or equipment is to be available or the project completed and the timetable to be followed; and (4) the approved capital expenditure for the project. (c) The agency decision and findings shall be sent to the applicant. The agency decision shall be sent to aggrieved persons as required under N.C.G.S. 150B-23. Any other person may obtain a copy of an agency decision and findings by requesting them from the agency, for which there will be a charge to cover the cost of reproducing the document. Authority G.S. 131E-177; 131E-189; Eff. October 1, 1981; Amended Eff. January 1, A NCAC 14C.0208 ISSUANCE OF A CERTIFICATE OF NEED (a) A certificate shall not be issued until 30 days after the date of the final decision under 10A NCAC 14C If no request for a contested case hearing is received by the agency within that time, the agency shall issue the certificate. If a request for a contested case hearing is received within that time, the certificate shall not be issued until the final agency decision from the contested case hearing has been issued. (b) The certificate, or attachments, shall specify: (1) the scope of the project; (2) the physical location of the project; (3) the person to whom the certificate was issued; (4) the maximum capital expenditure, if any, which may be obligated under the certificate; (5) the timetable to be followed in making the service or equipment available or in completing the project; and (6) when the first progress report under 10A NCAC 14C.0209 is due. (c) The effective date of the issuance of a certificate shall be the first day after the 30 day appeal period expires, the date the agency receives notice of withdrawal of the request for a contested case hearing, the date of the Department's final decision made in accordance with G.S. 131E-188(a), or the date the agency determines that the conditions of approval are satisfied, whichever is latest. Authority G.S. 131E-177;

5 Eff. October 1, 1981; Amended Eff. January 1, 1990; February 1, A NCAC 14C.0209 PROGRESS REPORTS (a) The holder of a certificate of need shall submit a report on the progress made in making the service or equipment available or in completing the project. These reports shall also include information as to the total dollar amount of capital expenditures which have been obligated under the certificate, and any changes in amounts of proposed or previously obligated capital expenditures. These reports will be made on a form provided by the agency and will be due on the date or dates indicated by the agency on the Certificate of Need and in subsequent correspondence. (b) The agency may also request additional reports as often as necessary in order to determine: (1) if the timetable specified in the certificate is being met; (2) if the scope of the project is being completed as described on the certificate and in the application for the certificate of need; (3) if the amount of the capital expenditure or expenditures obligated under the certificate has exceeded or can be expected to exceed the maximum under the certificate; and (4) if the condition(s) of approval have been satisfactorily met. Authority G.S. 131E-177; 131E-189; Eff. October 1, 1981; Amended Eff. January 1, 1990; February 1, SECTION EXEMPTIONS 10A NCAC 14C.0301 RESEARCH ACTIVITY (a) Under G.S. 131E-179 a health care facility may apply to the agency for an exemption from obtaining a certificate of need for any of the following if they are to be used solely for research: (1) acquisition of major medical equipment; (2) the offering of institutional health services; or (3) the incurring of the obligation of a capital expenditure. If any of the foregoing is used to provide patient care on an occasional and irregular basis and not as a part of the research program, the agency will not deny any request for an exemption solely on that basis. (b) The exemption shall be granted if notice is filed in accordance with this Rule and if the notice shows that the proposed new institutional health service will not: (1) affect the charges of the health care facility for the provision of medical or other patient care services other than the services which are included in research; (2) substantially change the bed capacity of the facility; or (3) substantially change the medical or other patient care services of the facility. (c) The notice required by G.S. 131E-179 shall be given on a form "Notice of Proposed Research Activity." This form may be obtained by contacting the agency at the address and telephone number stated in 10A NCAC 14C (d) The notice must be completed and delivered to the agency before the new institutional health service is offered or developed. The notice is not filed in accordance with this Rule until the notice is deemed complete. (e) The agency shall promptly acknowledge in writing receipt of the notice. The notice shall be deemed complete unless the agency, within seven days after receipt, mails a letter to the person submitting the notice which states that the notice was incomplete and specifies what information is necessary to make it complete. As soon as the requested information is delivered to the agency, the notice shall be deemed complete and filed in accordance with this Rule. (f) Within 30 days after receipt of a completed notice, the agency shall notify the health care facility submitting the notice whether the agency has granted the exemption. If the exemption has been granted, the health care facility may proceed to offer and develop the new institutional health service. If a certificate of need is required, the notice and review under this Rule shall be deemed to be in compliance with 10A NCAC 14C (g) Any affected person, as defined in G.S. 131E-188(c), may obtain a contested case hearing on a decision of the agency under this Rule by following procedures set forth in G.S. 150B and G.S. 131E-188. Authority G.S. 131E-177; 131E-179; Eff. January 1, 1982; Amended Eff. February 1, 2000; January 1, 1990; November 1, 1989; February 1, 1986.

6 10A NCAC 14C.0302 HEALTH MAINTENANCE ORGANIZATIONS Authority G.S. 131E-177; 131E-180; Eff. January 1, 1982; Amended Eff. November 1, 1996; January 1, 1990; November 1, 1989; February 1, 1986; Temporary Amendment Eff. January 1, 2000; Amended Eff. April 1, 2001; Repealed Eff. January 1, A NCAC 14C.0303 REPLACEMENT EQUIPMENT (a) The purpose of this Rule is to define the terms used in the definition of "replacement equipment" set forth in G.S. 131E-176(22a). (b) "Activities essential to acquiring and making operational the replacement equipment" means those activities which are indispensable and requisite, absent which the replacement equipment could not be acquired or made operational. (c) "Comparable medical equipment" means equipment which is functionally similar and which is used for the same diagnostic or treatment purposes. (d) Replacement equipment is comparable to the equipment being replaced if: (1) it has the same technology as the equipment currently in use, although it may possess expanded capabilities due to technological improvements; and (2) it is functionally similar and is used for the same diagnostic or treatment purposes as the equipment currently in use and is not used to provide a new health service; and (3) the acquisition of the equipment does not result in more than a 10% increase in patient charges or per procedure operating expenses within the first twelve months after the replacement equipment is acquired. (e) Replacement equipment is not comparable to the equipment being replaced if: (1) the replacement equipment is new or reconditioned, the existing equipment was purchased secondhand, and the replacement equipment is purchased less than three years after the acquisition of the existing equipment; or (2) the replacement equipment is new, the existing equipment was reconditioned when purchased, and the replacement equipment is purchased less than three years after the acquisition of the existing equipment; or (3) the replacement equipment is capable of performing procedures that could result in the provision of a new health service or type of procedure that has not been provided with the existing equipment; or (4) the replacement equipment is purchased and the existing equipment is leased, unless the lease is a capital lease; or (5) the replacement equipment is a dedicated PET scanner and the existing equipment is: (A) a gamma camera with coincidence capability; or (B) nuclear medicine equipment that was designed, built, or modified to detect only the single photon emitted from nuclear events other than positron annihilation. Authority G.S. 131E-177(1); Amended Eff. April 1, 1999; November 1, 1996; Temporary Amendment Eff. June 3, 2002; Amended Eff. April 1, A NCAC 14C.0304 PSYCHIATRIC BED CONVERSIONS If psychiatric beds are established pursuant to G.S. 131E-184(c), those beds shall remain psychiatric beds only as long as the contract required in G.S. 131E-184(c) remains in effect. If that contract is terminated, then the facility shall: (1) obtain a certificate of need to convert the psychiatric beds back to acute care beds prior to termination of the contract, or (2) terminate the provision of psychiatric services in the beds.

7 Authority G.S. 131E-177; Eff. November 1, SECTION.0400 CERTIFICATE OF NEED APPEAL PROCESS 10A NCAC 14C.0401 PETITION FOR A HEARING Authority G.S. 131E-177; 131E-188; Eff. October 1, 1981; Amended Eff. January 1, 1990; November 1, 1989; February 1, 1986; Repealed Eff. October 1, A NCAC 14C.0402 ISSUES The correctness, adequacy, or appropriateness of criteria, plans, and standards shall not be an issue in a contested case hearing. Authority G.S. 131E-177; 131E-188; Eff. October 1, 1981; Amended Eff. February 1, 1986; October 1, A NCAC 14C.0403 CONTESTED CASE HEARINGS Authority G.S. 131E-177; 131E-188; Eff. January 1, 1990; Repealed Eff. October 1, SECTION.0500 ENFORCEMENT AND SANCTIONS 10A NCAC 14C.0501 ASSESSMENT OF CIVIL PENALTY (a) In determining the amount of a penalty assessed for a violation in accordance with G.S. 131E-190(f), the Agency may consider, but is not limited to, the following factors in evaluating the degree and extent of harm and the cost of rectifying the damage caused by the violation: (1) the amount of revenues derived as a consequence of offering the service; and (2) the amount of the unauthorized capital expenditure; and (3) the amount expended in excess of 115 percent of the approved capital expenditure of a certificate of need; and (4) the person's record of compliance with the Certificate of Need Law and with the terms and conditions of any other certificate of need issued to that person; and (5) the degree of completion of the project; and (6) the number of patients served as a consequence of the violation; and (7) the number of procedures performed or treatments offered as a consequence of the violation; and (8) the number of days a service is offered as a consequence of the violation; and (9) whether the violation duplicates an existing or approved health service capability or facility; and (10) whether the conduct violated any judicial or administrative order, injunction, decree, or decision; and (11) whether the person impeded or attempted to obstruct the Department's investigation of the current violation; and (12) whether the development ceased prior to the offering of a new institutional health service; and (13) whether the person voluntarily terminated the project prior to the Department's investigation of the violation; and (14) whether the person voluntarily and truthfully cooperated with the Department's investigation of the violation. (b) Payment of the penalty shall be due within 60 days from the date of notification of the penalty. Authority G.S. 131E-177(1); 131E-190(f);

8 Eff. November 1, A NCAC 14C.0502 WITHDRAWAL OF A CERTIFICATE (a) Before the agency withdraws a certificate of need, pursuant to G.S. 131E-189, it shall give the holder an opportunity to demonstrate why the certificate of need should not be withdrawn. (b) Ownership of a certificate of need is transferred when any person acquires a certificate from the holder by purchase, donation, lease, trade, or any comparable arrangement, except that ownership of a certificate of need is not transferred when: (1) the holder of the certificate is a corporation and the identity of the holder changes because of a corporate reorganization; or (2) the holder of the certificate is a partnership and the identity of the holder changes because the same partners reorganize as a new partnership. (c) Control of a certificate of need is transferred when any person acquires a majority interest in the facility, project or holder or any parent entity of the facility, project or holder. (d) "Parent entity" means any person that directly or indirectly controls the facility, project or holder of a certificate. (e) A transfer of ownership or control of a facility, project, or certificate shall not be grounds for the withdrawal of the certificate of need, pursuant to G.S. 131E-189, if the transfer occurs after the completion of the project or the operation of the facility. Filed as a Temporary Amendment Eff. October 10, 1990, for a Period of 142 Days to Expire on February 28, 1991; Authority G.S. 131E-177; 131E-189; Eff. October 1, 1981; Amended Eff. November 1, 1996; March 1, 1991; January 1, SECTION.0600 RESERVED FOR FUTURE CODIFICATION SECTION.0700 RESERVED FOR FUTURE CODIFICATION SECTION.0800 RESERVED FOR FUTURE CODIFICATION SECTION.0900 RESERVED FOR FUTURE CODIFICATION SECTION.1000 RESERVED FOR FUTURE CODIFICATION SECTION.1100 CRITERIA AND STANDARDS FOR NURSING FACILITY OR ADULT CARE HOME SERVICES 10A NCAC 14C.1101 Authority G.S. 131E-175; 131E-176; 131E-177(1); 131E-183(b); S.L. 2001, c. 234; Eff. November 1, 1996; Temporary Amendment Eff. January 1, 2003; January 1, 2002; Amended Eff. August 1, 2004; April 1, 2003; 10A NCAC 14C.1102 PERFORMANCE STANDARDS (a) An applicant proposing to add nursing facility beds to an existing facility, except an applicant proposing to transfer existing certified nursing facility beds from a State Psychiatric Hospital to a community facility, shall not be approved unless the average occupancy, over the nine months immediately preceding the submittal of the application, of the total number of licensed nursing facility beds within the facility in which the new beds are to be operated was at least 90 percent. (b) An applicant proposing to establish a new nursing facility or add nursing facility beds to an existing facility, except an applicant proposing to transfer existing certified nursing facility beds from a State Psychiatric Hospital to a community facility, shall not be approved unless occupancy is projected to be at least 90 percent for the total number of nursing

9 facility beds proposed to be operated, no later than two years following the completion of the proposed project. All assumptions, including the specific methodologies by which occupancies are projected, shall be clearly stated. (c) An applicant proposing to add adult care home beds to an existing facility shall not be approved unless the average occupancy, over the nine months immediately preceding the submittal of the application, of the total number of licensed adult care home beds within the facility in which the new beds are to be operated was at least 85 percent. (d) An applicant proposing to establish a new adult care home facility or add adult care home beds to an existing facility shall not be approved unless occupancy is projected to be at least 85 percent for the total number of adult care home beds proposed to be operated, no later than two years following the completion of the proposed project. All assumptions, including the specific methodologies by which occupancies are projected, shall be stated. Authority G.S. 131E-175; 131E-176; 131E-177(1); 131E-183(b); S.L. 2001, c. 234; Eff. November 1, 1996; Temporary Amendment Eff. January 1, 2002; Amended Eff. April 1, SECTION.1200 CRITERIA AND STANDARDS FOR INTENSIVE CARE SERVICES 10A NCAC 14C.1201 DEFINITIONS The definitions in this Rule shall apply to all rules in this Section: (1) "Intensive care services" means those services provided by an acute care hospital to patients with a wide variety of illnesses of a life-threatening nature, including patients with highly unstable conditions which require sophisticated medical and surgical intervention and a high level of nursing care and those patients which require continuous, comprehensive observation. (2) "Intensive care unit" means a separate self-sufficient entity which has all supplies, equipment, and staff necessary to offer intensive care services twenty-four hours a day, seven days a week. The term does not include post-operative recovery rooms, post-delivery rooms, or emergency observation units. Eff. January 4, A NCAC 14C.1202 Amended Eff. November 1, 1996; Temporary Amendment Eff. February 1, 2010; Amended Eff. November 1, 2010; 10A NCAC 14C.1203 PERFORMANCE STANDARDS (a) The applicant shall demonstrate that the proposed project is capable of meeting the following standards: (1) the overall average annual occupancy rate of all intensive care beds in the facility, excluding neonatal and pediatric intensive care beds, over the 12 months immediately preceding the submittal of the proposal, shall have been at least 70 percent for facilities with 20 or more intensive care beds, 65 percent for facilities with intensive care beds, and 60 percent for facilities with 1-9 intensive care beds; and (2) the projected occupancy rate for all intensive care beds in the applicant's facility, exclusive of neonatal and pediatric intensive care beds, shall be at least 70 percent for facilities with 20 or more intensive care beds, 65 percent for facilities with intensive care beds, and 60 percent for facilities with 1-9 intensive care beds, in the third operating year following the completion of the proposed project. (b) All assumptions and data supporting the methodology by which the occupancy rates are projected shall be provided. Eff. January 4, 1994.

10 10A NCAC 14C A NCAC 14C.1205 SUPPORT SERVICES 131E-183(b); Amended Eff. November 1, 1996; SECTION CRITERIA AND STANDARDS FOR PEDIATRIC INTENSIVE CARE SERVICES 10A NCAC 14C.1301 DEFINITIONS The definitions in this Rule shall apply to all rules in this Section: (1) "Pediatric intensive care service area" means a geographic area defined by the applicant from which the patients to be admitted to the unit will originate. (2) "Pediatric intensive care services" means those services provided by an acute care hospital to children with a wide variety of illnesses of a life-threatening nature, including children with highly unstable conditions requiring sophisticated medical and surgical intervention, children requiring a high level of nursing care and those children requiring continuous, comprehensive observation. (3) "Pediatric intensive care unit" means a separate self-sufficient entity that contains supplies and equipment essential to provide treatment on a 24-hour basis to children who need pediatric intensive care services. It does not include post-operative recovery rooms, post-delivery rooms, or emergency observation units. Eff. January 4, A NCAC 14C.1302 Amended Eff. November 1, 1996; 10A NCAC 14C.1303 PERFORMANCE STANDARDS (a) An applicant proposing to develop a new pediatric intensive care unit or to add a bed to an existing pediatric intensive care unit shall demonstrate that the following standards are met: (1) the overall average annual occupancy rate of the number of beds in the applicant's existing pediatric intensive care unit for the twelve months immediately preceding the submittal of the application shall have been at least 70 percent in units with 20 or more pediatric intensive care beds, 65 percent in units with pediatric intensive care beds, and 60 percent in units with 1-9 pediatric intensive care beds; and (2) the projected annual occupancy rate of the applicant's new or expanded pediatric intensive care unit in the third year of operation following completion of the proposed project shall be at least 70 percent in units with 20 or more pediatric intensive care beds, 65 percent in units with pediatric intensive care beds, and 60 percent in units with 1-9 pediatric intensive care beds. (b) The applicant shall document all assumptions and provide data supporting the methodology used for each of the projections required in this Rule. Amended Eff. November 1, A NCAC 14C A NCAC 14C.1305 SUPPORT SERVICES

11 Amended Eff. November 1, 1996; SECTION.1400 CRITERIA AND STANDARDS FOR NEONATAL SERVICES 10A NCAC 14C.1401 DEFINITIONS The definitions in this Rule shall apply to all rules in this Section: (1) "Approved neonatal service" means a neonatal service that was not operational prior to the beginning of the review period. (2) "Existing neonatal service" means a neonatal service in operation prior to the beginning of the review period. (3) "High-risk obstetric patients" means those patients requiring specialized services provided by an acute care hospital to the mother and fetus during pregnancy, labor, delivery and to the mother after delivery. The services are characterized by specialized facilities and staff for the intensive care and management of high-risk maternal and fetal patients before, during, and after delivery. (4) "Level I neonatal services" means services provided by an acute care hospital to full term and pre-term neonates that are stable, without complications, and may include neonates that are small for gestational age or large for gestational age. (5) "Level II neonatal service" means services provided by an acute care hospital in a licensed acute care bed to neonates and infants that are stable without complications but require special care and frequent feedings; infants of any weight who no longer require Level III or Level IV neonatal services, but still require more nursing hours than normal infants; and infants who require close observation in a licensed acute care bed. (6) "Level III neonatal service" means services provided by an acute care hospital in a licensed acute care bed to neonates or infants that are high-risk, small (approximately 32 and less than 36 completed weeks of gestational age) but otherwise healthy, or sick with a moderate degree of illness that are admitted from within the hospital or transferred from another facility requiring intermediate care services for sick infants, but not intensive care. Level III neonates or infants require less constant nursing care than Level IV services, but care does not exclude respiratory support. (7) "Level IV neonatal service" means neonatal intensive care services provided by an acute care hospital in a licensed acute care bed to high-risk medically unstable or critically ill neonates (approximately under 32 weeks of gestational age) or infants requiring constant nursing care or supervision not limited to continuous cardiopulmonary or respiratory support, complicated surgical procedures, or other intensive supportive interventions. (8) "Neonatal bed" means a licensed acute care bed used to provide Level II, III or IV neonatal services. (9) "Neonatal intensive care services" shall have the same meaning as defined in G.S. 131E-176(15b). (10) "Neonatal service area" means a geographic area defined by the applicant from which the patients to be admitted to the service will originate. (11) "Neonatal services" means any of the Level I, Level II, Level III or Level IV services defined in this Rule. (12) "Obstetric services" means any normal or high-risk services provided by an acute care hospital to the mother and fetus during pregnancy, labor, delivery and to the mother after delivery. (13) "Perinatal services" means services provided during the period shortly before and after birth. Amended Eff. November 1, 1996; Temporary Amendment Eff. March 15, 2002; Amended Eff. April 1, A NCAC 14C.1402

12 Amended Eff. November 1, 1996; Temporary Amendment Eff. March 15, 2002; Amended Eff. April 1, 2003; Temporary Amendment Eff. February 1, 2010; Amended Eff. November 1, 2010; 10A NCAC 14C.1403 PERFORMANCE STANDARDS (a) An applicant shall demonstrate that the proposed project is capable of meeting the following standards: (1) if an applicant is proposing to increase the total number of neonatal beds (i.e., the sum of Level II, Level III and Level IV beds), the overall average annual occupancy of the combined number of existing Level II, Level III and Level IV beds in the facility is at least 75 percent, over the 12 months immediately preceding the submittal of the proposal; (2) if an applicant is proposing to increase the total number of neonatal beds (i.e., the sum of Level II, Level III and Level IV beds), the projected overall average annual occupancy of the combined number of Level II, Level III and Level IV beds proposed to be operated during the third year of operation of the proposed project shall be at least 75 percent; and (3) The applicant shall document the assumptions and provide data supporting the methodology used for each projection in this rule. (b) If an applicant proposes to develop a new Level III or Level IV service, the applicant shall document that an unmet need exists in the applicant's defined neonatal service area, unless the State Medical Facilities Plan includes a need determination for neonatal beds in the service area. The need for Level III and Level IV beds shall be computed for the applicant's neonatal service area by: (1) identifying the annual number of live births occurring at all hospitals within the proposed neonatal service area, using the latest available data compiled by the State Center for Health Statistics; (2) identifying the low birth weight rate (percent of live births below 2,500 grams) for the births identified in (1) of this Paragraph, using the latest available data compiled by the State Center for Health Statistics; (3) dividing the low birth weight rate identified in (2) of this Paragraph by.08 and subsequently multiplying the resulting quotient by four; and (4) determining the need for Level III and Level IV beds in the proposed neonatal service area as the product of: (A) the product derived in (3) of this Paragraph, and (B) the quotient resulting from the division of the number of live births in the initial year of the determination identified in (1) of this Paragraph by the number Temporary Amendment Eff. March 15, 2002; Amended Eff. April 1, 2003; Temporary Amendment Eff. February 1, 2009; Amended Eff. November 1, 2009; Temporary Amendment Eff. February 1, 2010; Amended Eff. November 1, A NCAC 14C A NCAC 14C.1405 SUPPORT SERVICES

13 Temporary Amendment Eff. March 15, 2002; Amended Eff. April 1, 2003; SECTION CRITERIA AND STANDARDS FOR HOSPICES 10A NCAC 14C.1501 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Bereavement counseling" means counseling provided to a hospice patient's family or significant others to assist them in dealing with issues of grief and loss. (2) "Caregiver" means the person whom the patient designates to provide the patient with emotional support, physical care, or both. (3) "Care plan" means a plan as defined in 10A NCAC 13K.0102 of the Hospice Licensing Rules. (4) "Continuous care" means care as defined in 42 CFR , the Hospice Medicare Regulations. (5) "Homemaker services" means services provided to assist the patient with personal care, maintenance of a safe and healthy environment and implementation of the patient's care plan. (6) "Hospice" means any coordinated program of home care as defined in G.S. 131E-176(13a). (7) "Hospice inpatient facility" means a facility as defined in G.S. 131E-176(13b). (8) "Hospice services" means services as defined in G.S. 131E-201(5b). (9) "Hospice staff" means personnel as defined in 10A NCAC 13K.0102 of the Hospice Licensing Rules. (10) "Interdisciplinary team" means personnel as defined in G.S. 131E-201(6). (11) "Palliative care" means treatment as defined in G.S. 131E-201(8). (12) "Respite care" means care provided as defined in 42 CFR Authority G.S. 131E-177(1); Eff. July 1, 1994; Temporary Amendment Eff. January 1, 2003; Amended Eff. August 1, 2004; Temporary Amendment Eff. February 1, 2006; Amended Eff. November 1, A NCAC 14C.1502 Eff. July 1, 1994; Amended Eff. November 1, 1996; Temporary Amendment Eff. January 1, 2003; Amended Eff. August 1, 2004; Temporary Amendment Eff. February 1, 2006; Amended Eff. November 1, 2006; 10A NCAC 14C.1503 PERFORMANCE STANDARDS An applicant proposing to develop a hospice shall demonstrate that no less than 80 percent of the total combined number of days of hospice care furnished to Medicaid and Medicare patients will be provided in the patients' residences in accordance with 42 CFR (f)(2). Authority G.S. 131E-177(1); Eff. July 1, 1994; Temporary Amendment Eff. January 1, 1999; Temporary Eff. January 1, 1999 Expired on October 12, 1999;

14 Temporary Amendment Eff. January 1, 2000; Temporary Amendment effective January 1, 2000 amends and replaces a permanent rulemaking originally proposed to be effective August 2000; Amended Eff. April 1, 2001; Temporary Amendment Eff. January 1, 2003; Amended Eff. August 1, 2004; Temporary Amendment Eff. February 1, 2006; Amended Eff. November 1, A NCAC 14C A NCAC 14C.1505 SUPPORT SERVICES Eff. July 1, 1994; Amended Eff. November 1, 1996; Temporary Amendment Eff. February 1, 2006; Amended Eff. November 1, 2006; SECTION.1600 CRITERIA AND STANDARDS FOR CARDIAC CATHETERIZATION EQUIPMENT AND CARDIAC ANGIOPLASTY EQUIPMENT 10A NCAC 14C.1601 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Approved" means the equipment was not in operation prior to the beginning of the review period and had been issued a certificate of need. (2) "Capacity" of an item of cardiac catheterization equipment means 1500 diagnostic-equivalent procedures per year. One therapeutic cardiac catheterization procedure is valued at 1.75 diagnostic-equivalent procedures. One cardiac catheterization procedure performed on a patient age 14 or under is valued at two diagnostic-equivalent procedures. All other procedures are valued at one diagnostic-equivalent procedure. (3) "Cardiac catheterization equipment" shall have the same meaning as defined in G.S. 131E-176(2f). (4) "Cardiac catheterization procedure," for the purpose of determining utilization in a certificate of need review, means a single episode of diagnostic or therapeutic catheterization which occurs during one visit to a cardiac catheterization room, whereby a flexible tube is inserted into the patient's body and advanced into the heart chambers to perform a hemodynamic or angiographic examination or therapeutic intervention of the left or right heart chamber, or coronary arteries. A cardiac catheterization procedure does not include a simple right heart catheterization for monitoring purposes as might be done in an electrophysiology laboratory, pulmonary angiography procedure, cardiac pacing through a right electrode catheter, temporary pacemaker insertion, or procedures performed in dedicated angiography or electrophysiology rooms. (5) "Cardiac catheterization room" means a room or a mobile unit in which there is cardiac catheterization or cardiac angioplasty equipment for the performance of cardiac catheterization procedures. Dedicated angiography rooms and electrophysiology rooms are not cardiac catheterization rooms. (6) "Cardiac catheterization service area" means a geographical area defined by the applicant, which has boundaries that are not farther than 90 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 45 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures; except that the cardiac catheterization service area of an academic medical center teaching hospital designated in 10A NCAC 14B shall not be limited to 90 road miles. (7) "Cardiac catheterization services" means the provision of diagnostic cardiac catheterization procedures or therapeutic cardiac catheterization procedures performed utilizing cardiac catheterization equipment in a cardiac catheterization room. (8) "Comprehensive cardiac services program" means a cardiac services program which provides the full range of clinical services associated with the treatment of cardiovascular disease including community

15 outreach, emergency treatment of cardiovascular illnesses, non-invasive diagnostic imaging modalities, diagnostic and therapeutic cardiac catheterization procedures, open heart surgery and cardiac rehabilitation services. Community outreach and cardiac rehabilitation services shall be provided by the applicant or through arrangements with other agencies and facilities located in the same city. All other components of a comprehensive cardiac services program shall be provided within a single facility. (9) "Diagnostic cardiac catheterization procedure," for the purpose of determining utilization in a certificate of need review, means a cardiac catheterization procedure performed for the purpose of detecting and identifying defects or diseases in the coronary arteries or veins of the heart, or abnormalities in the heart structure, but not the pulmonary artery. (10) "Electrophysiology procedure" means a diagnostic or therapeutic procedure performed to study the electrical conduction activity of the heart and characterization of atrial ventricular arrhythmias. (11) "Existing" means the equipment was in operation prior to the beginning of the review period. (12) "High-risk patient" means a person with reduced life expectancy because of left main or multi-vessel coronary artery disease, often with impaired left ventricular function and with other characteristics as referenced in the American College of Cardiology/ Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards (June 2001) report. (13) "Mobile equipment" means cardiac catheterization equipment and transporting equipment which is moved to provide services at two or more host facilities. (14) "Percutaneous transluminal coronary angioplasty (PTCA)" is one type of therapeutic cardiac catheterization procedure used to treat coronary artery disease in which a balloon-tipped catheter is placed in the diseased artery and then inflated to compress the plaque blocking the artery. (15) "Primary cardiac catheterization service area" means a geographical area defined by the applicant, which has boundaries that are not farther than 45 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 23 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures; except that the primary cardiac catheterization service area of an academic medical center teaching hospital designated in 10A NCAC 14B shall not be limited to 45 road miles. (16) "Therapeutic cardiac catheterization procedure," for the purpose of determining utilization in a certificate of need review, means a cardiac catheterization procedure performed for the purpose of treating or resolving anatomical or physiological conditions which have been determined to exist in the heart or coronary arteries or veins of the heart, but not the pulmonary artery. Eff. January 1, 1987; Temporary Amendment Eff. September 1, 1993 for a period of 180 days or until the permanent rule Amended Eff. November 1, 1996; February 1, 1994; Temporary Amendment Eff. January 1, 1999; Temporary Eff. January 1, 1999 Expired on October 12, 1999; Temporary Amendment Eff. January 1, 2000; Temporary Amendment effective January 1, 2000 amends and replaces a permanent rulemaking originally proposed to be effective August 1, 2000; Temporary Amendment Eff. January 1, 2001; Temporary Amendment effective January 1, 2001 amends and replaces a permanent rulemaking originally proposed to be effective April 1, 2001; Amended Eff. August 1, 2002; Temporary Amendment Eff. February 1, 2006; Amended Eff. November 1, A NCAC 14C.1602 Eff. January 1, 1987;

16 Temporary Amendment Eff. September 1, 1993 for a period of 180 days or until the permanent rule Amended Eff. November 1, 1996; February 1, 1994; Temporary Amendment Eff. January 1, 2005; Amended Eff. November 1, 2005; Temporary Amendment Eff. February 1, 2006; Amended Eff. November 1, 2006; 10A NCAC 14C.1603 PERFORMANCE STANDARDS (a) An applicant proposing to acquire cardiac catheterization equipment shall demonstrate that the project is capable of meeting the following standards: (1) each proposed item of cardiac catheterization equipment, including mobile equipment but excluding shared fixed cardiac catheterization equipment, shall be utilized at an annual rate of at least 60 percent of capacity excluding procedures not defined as cardiac catheterization procedures in 10A NCAC 14C.1601(5), measured during the fourth quarter of the third year following completion of the project; (2) if the applicant proposes to perform therapeutic cardiac catheterization procedures, each of the applicant's therapeutic cardiac catheterization teams shall be performing at an annual rate of at least 100 therapeutic cardiac catheterization procedures, during the third year of operation following completion of the project; (3) if the applicant proposes to perform diagnostic cardiac catheterization procedures, each diagnostic cardiac catheterization team shall be performing at an annual rate of at least 200 diagnostic-equivalent cardiac catheterization procedures by the end of the third year following completion of the project; (4) at least 50 percent of the projected cardiac catheterization procedures shall be performed on patients residing within the primary cardiac catheterization service area; (b) An applicant proposing to acquire mobile cardiac catheterization equipment shall: (1) demonstrate that each existing item of cardiac catheterization equipment, excluding mobile equipment, located in the proposed primary cardiac catheterization service area of each host facility shall have been operated at a level of at least 80 percent of capacity during the 12 month period reflected in the most recent licensure form on file with the Division of Health Service Regulation; (2) demonstrate that the utilization of each existing or approved item of cardiac catheterization equipment, excluding mobile equipment, located in the proposed primary cardiac catheterization service area of each host facility shall not be expected to fall below 60 percent of capacity due to the acquisition of the proposed mobile cardiac catheterization equipment; (3) demonstrate that each item of existing mobile equipment operating in the proposed primary cardiac catheterization service area of each host facility shall have been performing at least an average of four diagnostic-equivalent cardiac catheterization procedures per day per site in the proposed cardiac catheterization service area in the 12 month period preceding the submittal of the application; (4) demonstrate that each item of existing or approved mobile equipment to be operating in the proposed primary cardiac catheterization service area of each host facility shall be performing at least an average of four diagnostic-equivalent cardiac catheterization procedures per day per site in the proposed cardiac catheterization service area in the applicant's third year of operation; and (5) provide documentation of all assumptions and data used in the development of the projections required in this Rule. (c) An applicant proposing to acquire cardiac catheterization equipment excluding shared fixed and mobile cardiac catheterization shall: (1) demonstrate that its existing items of cardiac catheterization equipment, except mobile equipment, located in the proposed cardiac catheterization service area operated at an average of at least 80 percent of capacity during the twelve month period reflected in the most recent licensure renewal application form on file with the Division of Health Service Regulation; (2) demonstrate that its existing items of cardiac catheterization equipment, except mobile equipment, shall be utilized at an average annual rate of at least 60 percent of capacity, measured during the fourth quarter of the third year following completion of the project; and (3) provide documentation of all assumptions and data used in the development of the projections required in this Rule.