N.H. Admin. Code § He-Hea 2202.05

Current through Register No. 50, December 12, 2024

Section He-Hea 2202.05 - New or Additional Robotic Assisted Surgery System Services

(a) Applicants for each new or additional robotic assisted surgery system service shall demonstrate that the proposed volume of service shall not be detrimental to the existing health care system of the state.

(b) Applicants shall demonstrate that the proposed volume of services will not be detrimental to the state's health care system by providing a statistical report in its application that compares the applicant's current program operation to proposed project increases, including the following elements:

(1) Utilization;

(2) Patient charges;

(3) Market share;

(4) Physician referral patterns; and

(5) Personnel resources.

(c) Applicants shall provide a report with the application that supports the need for new or expanded robotic assisted surgery system service in terms of:

(1) Referrals from area health care providers as evidenced by letters of support;

(2) Historical trends in case volume;

(3) Changes in market share;

(4) The addition of new services with different market patterns;

(5) The addition of specialized services with different market patterns; and

(6) Any other causes presented to support the anticipated need for robotic assisted surgery system services.

(d) The applicant shall demonstrate that the robotic assisted surgery system service shall be supported by a quality assurance plan by providing a report with the application indicating how the service is or will be established in order to:

(1) Establish protocols for surgeon credentialing for the operation of robotic assisted surgery systems at the facility, including the methods of training in the operation of such systems, as evidenced by:

a. Physician residency training;

b. Fellowship training;

c. Robotic assisted surgery system manufacturer training; or

d. Other comparable training program that includes, at a minimum, proctoring, observation, or both; and

e. Participation in in-services training whenever such systems are replaced or upgraded;

(2) Establish protocols governing surgical evaluation of robotic assisted surgery system patients;

(3) Establish and review a list of indications and contraindications to govern patient selection for robotic system surgery;

(4) Review morbidity and mortality rates and other indicators of patient outcomes, compared with regional or national averages; and

(5) Establish mechanisms for follow-up surveillance of discharged patients.

N.H. Admin. Code § He-Hea 2202.05

Derived From Volume XXXV Number 49, Filed December 10, 2015, Proposed by #10978, Effective 11/20/2015, Expires 11/20/2025.