N.Y. Comp. Codes R. & Regs. tit. 10, § 709.6 – Extracorporeal shockwave lithotripters.

(a) This methodology will be utilized to evaluate certificate of need applications involving the acquisition of extracorporeal shockwave lithotripters (ESWL). It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decisionmaking tools for directing the distribution of extracorporeal shockwave lithotripters. The goals and objectives of the methodology expressed herein are expected to insure that an adequate number of ESWL units are available to provide access to care and avoid the unnecessary duplication of resources.
(b) The factors and methodology for determining the public need for ESWL units shall include, but not be limited to the following:
1. (1) There shall be one ESWL unit for each 2.5 million residents within a health system agency's geographic area with a minimum of one unit in each health systems agency's geographic area.
2. (2) Each applicant must present evidence that an annual minimum utilization of 750 procedures shall be achieved within two years of initial operation, except those applicants located in a health systems agency whose geographic area contains less than 2.5 million residents.
3. (3) In addition, each applicant applying to acquire an ESWL unit must meet the following standards:
  1. (i) Each applicant must demonstrate the availability of urologists who meet the definition of a qualified specialist. The applicant must also have competence in the provision of diagnostic, metabolic, and surgical services to patients with kidney stone disease. This shall include experience in the performance of renal surgery, percutaneous procedures and ureteroscopy for the removal of urinary calculi.
  2. (ii) Each applicant must submit a plan to develop referral agreements with all facilities in the relevant service area.
  3. (iii) Each applicant must submit a plan to evaluate ESWL compared to alternative therapeutic modalities in terms of clinical efficacy, utilization and costs.
  4. (iv) Where public need is established herein, priority consideration will be given to applicants that agree to serve the medically indigent and patients regardless of source of payment.