N.Y. Comp. Codes R. & Regs. tit. 10, § 709.7 – Liver transplantation services.

(a) This methodology will be utilized to evaluate certificate of need applications involving the initiation of liver transplantation services. 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 liver transplantation services. The goals and objectives of the methodology expressed herein are expected to insure that an adequate number of liver transplantation services 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 liver transplantation services shall include, but not be limited to, the following:
1. (1) The need for liver transplantation services will be planned for on a statewide basis based on an incidence rate of candidates for liver transplantation of 10 persons per one million population per year.
2. (2) There shall be one liver transplantation service center per five million population.
3. (3) Each applicant for a liver transplantation service must present evidence that a minimum of 20 transplants per year shall be achieved within two years of initial operation.
4. (4) There shall be no additional liver transplantation services approved until each existing transplantation service is performing 50 transplantations per year.
5. (5) Priority consideration will be given to applicants that propose to provide this service within the facility's current capacity.
6. (6) Where public need is established herein, priority consideration will be given to applicants that agree to serve the medically indigent and patients regardless of the source of payment.
7. (7) In addition, each applicant applying to initiate a liver transplantation service must meet the following standards:
  1. (i) Each applicant must demonstrate the availability of a liver transplantation surgeon with board certification in general surgery or have equivalent experience and demonstrate the ability to perform liver transplantation as evidenced by clinical experience in an existing liver transplantation program.
  2. (ii) Each applicant must demonstrate the availability of a liver transplantation team that includes qualified specialists in gastroenterology, hepatology, infectious disease, pulmonary medicine, immunology, hematology, pediatrics, neurology, neurosurgery and nephrology.
  3. (iii) Each applicant must demonstrate its participation in a donor organ procurement system, or a donor organ harvesting program, or a written affiliation agreement with an existing approved or registered donor organ procurement or harvesting agency.