10A NCAC 14C .1903       PERFORMANCE STANDARDS

(a)  An applicant proposing to acquire a linear accelerator shall demonstrate that each of the following standards will be met:

(1)           an applicant's existing linear accelerators located in the proposed radiation therapy service area performed at least 6,750 ESTV treatments per machine or served at least 250 patients per machine in the twelve months prior to the date the application was submitted;

(2)           each proposed new linear accelerator will be utilized at an annual rate of 250 patients or 6,750 ESTV treatments during the third year of operation of the new equipment; and

(3)           an applicant's existing linear accelerators located in the proposed radiation therapy service area are projected to be utilized at an annual rate of 6,750 ESTV treatments or 250 patients per machine during the third year of operation of the new equipment.

(b)  A linear accelerator shall not be held to the standards in Paragraph (a) of this Rule if the applicant provides documentation that the linear accelerator has been or will be used exclusively for clinical research and teaching.

(c)  An applicant proposing to acquire radiation therapy equipment other than a linear accelerator shall provide the following information:

(1)           the number of patients who are projected to receive treatment from the proposed radiation therapy equipment, classified by type of equipment, diagnosis, treatment procedure, and county of residence; and

(2)           the maximum number and type of procedures that the proposed equipment is capable of performing.

(d)  The applicant shall document all assumptions and provide data supporting the methodology used to determine projected utilization as required in this Rule.

 

History Note:        Authority G.S. 131E-177(1); 131E-183(b);

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996

Temporary Amendment Eff. January 1, 1999;

Temporary Amendment effective January 1, 1999 expired October 12, 1999;

Temporary Amended Eff. January 1, 2000;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

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. March 15, 2002; January 1, 2002; Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Temporary Amendment Eff. February 1, 2009;

Amended Eff. November 1, 2009.