N.Y. Comp. Codes R. & Regs. tit. 10, § 709.9 – Human heart transplantation services.

(a) This methodology will be utilized to evaluate certificate of need applications involving the initiation of human heart 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 human heart transplantation services. The goals and objectives of the methodology expressed herein are expected to insure that an adequate number of human heart 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 human heart transplantation services shall include, but not be limited to the following:
1. (1) The need for human heart transplantation services will be planned initially on a statewide basis, based upon the need for two human heart transplantation centers.
2. (2) Each applicant for a human heart transplantation service must present evidence that a minimum of 14 transplants per year shall be achieved within two years of initial operation.
3. (3) There shall be no additional human heart transplantation services approved until each existing transplantation service is performing at least 30 transplantations per year at which time additional applications will be accepted and reviewed by the department.
4. (4) Priority consideration will be given to applicants that propose to provide this service within the facility's current capacity.
5. (5) 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.
6. (6) In addition, each applicant applying to initiate a heart transplantation service must meet the following standards:
  1. (i) Each applicant must demonstrate the availability of a heart transplantation surgeon with the ability to perform heart transplantation as evidenced by clinical experience in an existing heart transplantation program.
  2. (ii) Each applicant must demonstrate the availability of a heart transplantation team that includes qualified specialists in cardiology, cardiovascular surgery, infectious disease, pulmonary medicine, pediatrics, neurosurgery, anesthesiology, psychiatry, immunologist, and pathologist.
  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.