N.Y. Comp. Codes R. & Regs. tit. 10, § 709.8 – Bone marrow transplantation (BMT) services.

(a) This methodology will be utilized to evaluate certificate of need applications involving the initiation of allogeneic bone marrow 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 bone marrow transplantation services. The goals and objectives of the methodology expressed herein are expected to insure that an adequate number of BMT 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 allogeneic BMT services shall include, but not be limited to, the following:
1. (1) The need for BMT services shall be planned on a statewide basis.
2. (2) Based on the current status of BMT technology, the number of people expected to be candidates for BMT therapy is 13.2 per million population per year. This will be reviewed on an annual basis to determine if any adjustment is indicated.
3. (3) The capacity of each BMT bed is six patients/year.
4. (4) A BMT service shall have a minimum of four beds.
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 BMT service must meet the following standards:
  1. (i) Each applicant must demonstrate the availability of a bone marrow transplant team under the direction of a full-time medical director with training in immunology or hematology who had advanced training and experience in bone marrow transplantation.
  2. (ii) The bone marrow transplant team shall include specialists in the following areas: chemotherapy, radiation therapy, social work, nursing, infectious disease control, immunology, oncology, hematology, and expertise in intensive cardiopulmonary medicine.
  3. (iii) The transplant program shall be supported by a blood bank with a capacity to support four to six patients/day. This requires the availability of a blood separator, a central blood repository, and an irradiator for blood products.
  4. (iv) The bone marrow transplantation program shall provide or make arrangements for the harvesting of bone marrow.
  5. (v) The services of an immunogeneticist and a cytogeneticist shall be available to the transplant program.
  6. (vi) The transplant program shall have available clinical laboratories possessing permits issued under article 5, title 5 of the Public Health Law, in the categories of: virology, diagnostic immunology, bacteriology, mycology, mycobacteriology, parasitology, cytogenetics, cellular immunology and histocompatibility.
  7. (vii) There shall be an organized follow-up program for transplant patients following discharge, including data management resources to maintain records on the long-term survival of transplant patients.
  8. (viii) Each facility providing BMT services shall agree to provide annual reports to the Department of Health on utilization levels and patient origin data.