Announcement: Medical Technology Demonstration Project Proton Beam Therapy

May 5, 2010

Regulations pursuant to Article 28 of the Public Health Law (10 NYCRR Part 705) allow the Commissioner of Health to authorize demonstration projects to evaluate the medical efficacy, cost-effectiveness, efficiency of, and public need for, new medical technologies. This announcement is to request the submission of applications for the operation of proton beam therapy (PBT) services in New York State on a demonstration basis, as authorized by Part 705 of 10 NYCRR.

In light of factors such as the emerging nature of proton beam therapy, the size and cost of a proton beam therapy facility, and the necessary organization and management structure to operate and finance such a facility, certificate of need (CON) approval is required for the construction and operation of such a facility. This demonstration is the only vehicle for submission of CON applications for proton beam therapy in New York State until further notice. The Department of Health may solicit additional rounds of demonstration project applications after the commencement of operation of the first round of approved projects, depending upon the findings of the approved project(s), demonstrated need, and the state of medical knowledge at that time.

Purpose of the Demonstration

The Commissioner of Health has determined that there is a need for the evaluation of proton beam therapy, to be conducted through a demonstration project, before this technology may be considered for routine review and approval pursuant to Section 2802 of the Public Health Law (PHL) and Part 710 of Title 10 (Health) of NYCRR. The purpose of the demonstration project is to assess the efficacy, safety, and cost-effectiveness of, and need for, PBT in New York State.

PBT has demonstrated efficacy for a number of relatively rare cancers and tumors that are not amenable to surgery or conventional forms of radiation. While it is believed that PBT's ability to maximize the dose and target it with high precision translates into better tumor control and fewer radiation-induced complications than photon therapy, definitive outcome studies comparing PBT to conventional radiation therapy are lacking.

Nevertheless, this medical technology continues to evolve, and the number of PBT centers in the United States, though still relatively small, is growing. Because the demand for, and availability of, PBT is likely to grow, this demonstration seeks to assess the promise of this medical technology in the treatment of cancers, other tumors, and similar conditions, such as arteriovenous malformations, that lack satisfactory treatment options, and to determine the terms on which PBT should be available and accessible to residents of New York State.

Duration of the Demonstration

Projects approved under this demonstration will be authorized for a period of up to ten years, provided that pending regulations are adopted that authorize the commissioner to approve a ten-year demonstration. Within that ten-year period, the Department may solicit additional rounds of applications, depending on the findings of the approved project(s), demonstrated need, and the state of medical knowledge at that time. During the course of the project, the operator will be required to submit written progress reports to the Department every six months, such other periodic reports as the Department specifies, and a final report upon completion of the project.

Upon completion of the demonstration project and a determination by the Commissioner that the PBT service meets an identifiable need, is cost-effective and efficient, and meets generally accepted medical standards for safety and effectiveness, medical facilities participating in the demonstration may then apply for full approval to provide PBT services, by filing a CON application pursuant to section 2802 of the Public Health Law and Part 710. Similarly, to the extent consistent with the findings of the demonstration, CON applications may be filed at that time by other entities for licensure to provide PBT services.

Application Review Process

Applications to participate in this demonstration project will be subject to Article 28 review consistent with the requirements of Part 710 et seq. of 10 NYCRR. Applications will be reviewed by a Technical Advisory Committee, to be appointed by the Commissioner, which will make recommendations to the Commissioner concerning the selection of demonstration projects. The State Hospital Review and Planning Council (SHRPC) and the local Health Systems Agency (HSA) will also have the opportunity to submit recommendations prior to a final decision by the Commissioner. Applications proposing a new Article 28 operator will be subject to establishment review, pursuant to 10 NYCRR Part 600 et seq., by the Public Health Council, in addition to review by the SHRPC.

Minimum Requirements

In addition to meeting applicable Article 28 requirements, applicants must satisfy the following requirements:

  • The proposed facility must be operated by, or in collaboration with, one or more academic medical centers licensed in New York State;
  • PBT facilities must comply with the most current National Council on Radiation Protection Standards applicable to Particle Beam Facilities, including but not limited to Report No. 144 – Radiation Protection for Particle Accelerator Facilities. In addition, PBT facilities must comply with the requirements set forth in 10 NYCRR Part 16 or Part 175 of the New York City Health Code (as applicable).
  • Applicants must commit to engage in research concerning the effectiveness of PBT in comparison with other treatment modalities.

Evaluation Criteria

Applicants under this announcement will be assessed based on their ability to satisfy the applicable requirements under Article 28 of the Public Health Law (i.e., requirements relating to public need, character and competence, financial feasibility and compliance with architectural and engineering standards) and based on criteria specific to demonstration projects under Part 705 and proton beam therapy projects in particular.

Applications will be evaluated according to the following criteria set forth in Part 705:

  1. the extent to which an applicant's proposal meets the goals of the demonstration as set by the commissioner;
  2. the adequacy of the methodology proposed for the demonstration;
  3. the ability of the proposed demonstration to collect data required for an analysis of the project;
  4. the adequacy and appropriateness of the plan for organizing and carrying out the project;
  5. the technical qualifications of the principal investigator and the proposed project staff;
  6. the reasonableness of the proposed budget in relation to the proposed project;
  7. the adequacy of the facility and resources available to the applicant;
  8. where an application involves activities which could have an adverse health effect upon individuals participating in the demonstration, the adequacy of the proposed means for protecting against or minimizing such effects;
  9. the relevance and status of any approvals required by the Federal Food and Drug Administration for the subject of the demonstration project; and
  10. the number of applications to be approved.

The evaluation criteria specific to proton beam therapy include the applicant's capacity and commitment to:

  • conduct research into the efficacy of PBT and its effectiveness compared to other treatments, and into public need for PBT and the cost-effectiveness of PBT;
  • assure patient safety and quality of care in the delivery of PBT;
  • collect, store, transmit, and protect the security and integrity of data concerning the patients and conditions treated and short-term and long-term outcomes;
  • coordinate patient care with affiliated and non-affiliated facilities and health care providers;
  • provide PBT services to Medicaid clients and other underserved groups, including the uninsured; and
  • protect staff and members of the public from radiation exposure.

The time frame in which the proposed facility can be expected to commence operation will also be considered.

Preferential treatment will be given to applications that document the sharing of resources and active collaboration among multiple health care facilities in the operation of the proposed facility and in clinical research related to PBT.

Application Process

The application for a demonstration project under this announcement consists of two parts:

  1. All applicable CON schedules required for a full review for construction and, if a new operator will be established, for establishment (CON schedules are available at: http://www.nyhealth.gov/facilities/cons/more_information/#forms_schedules ); and
  2. Any other information that the applicant deems pertinent to the criteria set forth above. Such information must not exceed 25 pages in length (12-point type, single-spaced). Curricula vitae and similar attachments will not be counted toward the page limit.

In addition, the application should include the following:

Qualifications of Third-Parties Involved in the Operation of the Proposed Facility

The applicant must identify and describe the qualifications of any individual or entity that will:

  • Have an ownership interest in the premises in which the PBT services will be provided;
  • Have an ownership interest in, and/or maintain, the PBT fixtures and equipment (including but not limited to the PBT accelerator, treatment planning systems, computer technology and beam delivery systems);
  • Provide or arrange administrative or consulting services for the operator.

CON Schedule 2 must be completed by the directors, officers, controlling persons, principal stockholders, principal members, managers, partners or sole proprietors of any such third party.

Proton Beam System

Please provide a detailed description of the medical charged-particle radiation therapy system to be used.

  • Identify by trade name and manufacturer all particle beam production equipment (including the cyclotron or synchrotron, beam transport, degraders, range modulators), as well as particle beam delivery equipment and accessories (including gantries, nozzles, robotic treatment tables, signal analysis and display equipment, patient and equipment supports, treatment planning and other computer programs).
  • Identify the computed tomography system, PET system, or magnetic resonance imaging system that will be used as part of the treatment planning and verification process.
  • Identify all devices proposed to be used in the PBT facility that are not yet cleared by the FDA, including their FDA classification. Provide the type of clearance sought for each device, the date on which the application or notification was submitted to the FDA, the status of the clearance, and any other information relevant to FDA clearance of the PBT system.
  • Identify and describe all combinations of radiation therapy software and/or equipment to be used in the PBT facility that have not yet been cleared by the FDA to be used in such a combination. Provide the type of clearance sought for each, the date on which the application or notification was submitted to the FDA, the status of the clearance, and any other information relevant to FDA clearance of the PBT system.

Supply a list of all medical device reports required by 21 CFR Part 807 for medical charged-particle radiation therapy system equipment to be used.

Services to Underserved Populations, Medicaid Beneficiaries and the Uninsured

Please describe the commitment of the proposed facility and its affiliated physicians to serving underserved populations, Medicaid beneficiaries and the uninsured. How will the facility assure that physicians with privileges serve Medicaid beneficiaries and the uninsured and refer them to the facility if medically-necessary?

Documents to be Submitted for Legal Review

In addition to any documents otherwise required as part of a CON application under Parts 710 or 600 of NYCRR (e.g., documents required by Schedule 3), please provide the following:

  • Organizational chart for the proposed licensed operator;
  • PBT facility organizational chart (if different from the licensed operator);
  • PBT facility contract of sale, deed or lease agreement (if not already included with CON schedules);
  • All written agreements signed or to be signed by the PBT facility operator that relate to the following: PBT facility staffing; PBT facility finance; clinical, consulting and administrative services; the acquisition and/or maintenance of PBT fixtures and equipment (including, but not limited to the PBT accelerator, treatment planning systems, computer technology and beam delivery systems); the use of the PBT facility premises;
  • Anti-kickback statement (if not already included with CON application documents);
  • A photocopy of all licenses to operate radiation oncology installations pursuant to 10 NYCRR Part 16 or Part 175 of the New York City Health Code, or federal regulation (if the installation is located out of state) held by:
    • the licensed operator, its clinical affiliates, and any person/entity having an ownership or controlling interest in the licensed operator; and
    • any third party that owns the premises in which the PBT services will be provided, owns and/or maintains the PBT fixtures and equipment, or provides or arranges administrative or consulting services for the operator.

In accordance with the requirements of Part 705, applications must be received by the Department within 45 days of the date of this announcement, and no later than June 21, 2010 at 3:00 p.m. Late applications will not be accepted1. Applications will not be accepted via FAX or e-mail.

Applications should be submitted to

  • Bureau of Project Management
    Division of Health Facility Planning
    433 River Street
    6th Floor
    Troy, NY 12180

Further information concerning this demonstration and the application process may be obtained by contacting via e-mail at pbtdemo@health.state.ny.us. Questions should be submitted by May 14. Written answers to all questions raised will be posted by May 28 on the DOH website.

Notes

  1. It is the applicant's responsibility to see that applications are delivered to the address above prior to the date and time specified. Late applications due to a documentable delay by the carrier may be considered at the Department of Health's discretion.