Medical Technology Demonstration Project: Proton Beam Therapy Questions and Answers as of June 11, 2010
Question: Assuming that the applicant is a not for profit corporation, must the member corporations of the not-for-profit applicant themselves be licensed Article 28 facilities?
A member corporation need not be a "facility;" however, if the member corporation will have decision-making authority over any of the powers set forth in section 405.1(c) of 10 NYCRR, it must be established as a co-operator of the not-for-profit applicant. If the member corporation will not assume any of these powers, it need not be established as a co-operator of the applicant.
If the parent will not exercise any of the 405.1(c) powers, but will satisfy the criteria that define a "third-party that will be involved in the operation of the proposed PBT facility," the parent must provide the information described in the Department's clarification issued as part of the Questions and Answers released on May 28, 2010. [See May 28, 2010 Questions and Answers.]
Question: If the applicant is a not-for-profit corporation, and the members are article 28 facilities, will each trustee of each member entity be required to be reviewed under the character and competence review process, or will it be possible to nominate a subset of the trustees of the member entity to serve as representatives, such that only the representatives will be required to be reviewed under the character and competence process?
If a member of the applicant will exercise any of the powers set forth in section 405.1(c) of 10 NYCRR, all of the trustees of the member are subject to character and competence review. If the member will not exercise any of the powers in section 405.1(c), the trustees of the member are not subject to character and competence review. However, if the member will satisfy the criteria that define a "third-party that will be involved in the operation of the proposed PBT facility," the parent must provide the information described in the Department's clarification issued as part of the Questions and Answers released on May 28, including, among other items, the Schedule 2A for every individual who is a director, officer, manager (of an LLC), controlling person, principal stockholder/member, partner or sole proprietor of the parent. [See May 28, 2010 Questions and Answers.]]
Question: What are the attributes of an academic medical center that would satisfy the Department's requirements that the proposed facility must be operated by, or in collaboration with, one or more academic medical centers licensed in New York State? Is a teaching hospital with medical residency programs an academic medical center?
For purposes of this demonstration program, an academic medical center is a health system or hospital that:
- Is affiliated with one or more New York State medical schools and serves as a major clinical site for clerkships or clinical rotations, in multiple specialties, for such medical school(s); and
- Includes on its staff medical school faculty who are engaged in undergraduate and graduate medical education, and in providing clinical services, at the hospital or health system's facilities; and
- Sponsors residency and fellowship programs in multiple specialties that are accredited by the ACGME and its Residency Review Committees; and
- Through its faculty and staff, engages in substantial clinical research.