10A NCAC 14C .1803. INFORMATION REQUIRED OF APPLICANT

(a)  An applicant proposing to establish a new diagnostic center or to expand an existing diagnostic center shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant shall also provide the following additional information:

(1)           the number, type, cost, condition, useful life and depreciation schedule of all medical diagnostic equipment that either is proposed to be acquired or is currently owned or operated by the applicant, and will be part of the diagnostic center following completion of the project;

(2)           other than the equipment listed in Subparagraph (b)(1) of this Rule, a list of all equipment and related components which are necessary to perform the proposed procedures and services;

(3)           the maximum number of procedures that each piece of medical diagnostic equipment in the diagnostic center is capable of performing and the assumptions used to project capacity;

(4)           a list of all existing and approved health service facilities that operate or have been approved to operate medical diagnostic equipment and diagnostic suites by type and location in the proposed medical diagnostic equipment service area;

(5)           the hours of operation of the proposed diagnostic center and each proposed diagnostic service;

(6)           the patient origin by percentage by county of residence for each diagnostic service provided by the applicant in the 12 month period immediately preceding the submittal of the application;

(7)           the projected patient origin by percentage by county of residence for each service proposed, and all the assumptions and data supporting the methodology used for the projections;

(8)           drawings or schematics of the proposed diagnostic center that identifies a distinct, identifiable area for each of the proposed services; and

(9)           a three year capital budget.

(c)  An applicant proposing to establish a new mobile diagnostic program shall also provide the following information:

(1)           the number, type and cost of all proposed mobile medical diagnostic equipment including the cost of the transporting equipment;

(2)           other than the equipment listed in Subparagraph (b)(1) of this Rule, a list of all equipment and related components which are necessary to perform the proposed procedures and services;

(3)           the number and type of all existing and approved mobile diagnostic equipment in the proposed mobile diagnostic center service area;

(4)           the maximum number of procedures that each proposed piece of medical diagnostic equipment is capable of performing and the assumptions used to project capacity;

(5)           the name, address and hours of service at each host facility that is proposed to be served by the mobile diagnostic program; and

(6)           copies of letters of intent from, and proposed contracts with, all of the proposed host facilities of the mobile diagnostic program.

(d)  An applicant shall demonstrate that all equipment, supplies and pharmaceuticals proposed for the diagnostic center have been certified for clinical use by the U.S. Food and Drug Administration or will be operated or used under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations.

(e)  An applicant proposing to establish a new diagnostic center or to expand an existing diagnostic center shall provide:

(1)           the projected number of patients to be served, classified by diagnosis for each of the first twelve calendar quarters following completion of the project; and

(2)           the projected number of patients to be served by county of residence for each of the first twelve calendar quarters following completion of the project; and

(3)           the projected number and type of diagnostic procedures proposed to be provided by CPT code or ICD-9-CM procedure code for each of the first twelve calendar quarters following completion of the project.

 

History Note:        Filed as a Temporary Adoption Eff. September 1, 1993 for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;

Authority G.S. 131E-177(1); 131E-183;

Eff. January 4, 1994;

Amended Eff. November 1, 1996.