Three public comments were submitted to the NYS Department of Health ("DOH") in response to this regulation. One comment was received from the Health Care Association of New York State (HANYS), the second was from Orange Regional Medical Center and the third was from the Greater New York Hospital Association (GNYHA). A fourth letter was received after the public comment period for this regulation ended.

HANYS

HANYS expressed overall support for the proposed rule, noting that the proposed regulatory changes would allow the DOH to focus on the most substantial and complex projects, while allowing health care facilities to perform routine maintenance and repair and upgrades either outside of CON or with a simplified review process. HANYS also noted that the proposed rule streamlines the review of health information technology projects. HANYS noted that although they have sought a more aggressive package of reforms through legislation, they are fully supportive of the proposed rule.

Orange Regional Medical Center

Orange Regional Medical Center (ORMC) also submitted comments on the proposed amendments to Part 705 (New Medical Technology and Health Services Demonstration Projects). ORMC did not comment directly on the proposed rule, but rather used the publication of the rule as an opportunity to comment on how the proposed regulatory changes governing demonstration projects may impact proton beam therapy demonstration projects. ORMC commented that proton beam therapy services belong in an academic medical center environment where research is a primary focus and the efficacy, safety, cost-effectiveness of, and need for, this technology can be evaluated. The comment strongly supported the CON process as the only way to allow proton beam therapy centers into New York, and supported the proposed changes to 705 as a way for the Department to initiate a demonstration project to review proton beam therapy applications. Finally, ORMC expressed a desire to allow community providers to comment on demonstration project applications.

GNYHA

GNYHA expressed "strong support" for the proposed rule, mentioning that it increases review thresholds, consolidates certain levels of review, and adds flexibility to the Department's demonstration project authority. Support for the creation of an electronic CON application, which is currently under design, was also mentioned, as well as further reforms that would streamline the CON process and increase the threshold review levels beyond what is proposed through these amendments.

American Shared Hospital Services (ASHS)

Comments from a California-based healthcare company (ASHS) were received after the public comment period ended. ASHS used the publication of the proposed amendments to Part 705 as an opportunity to comment on the Department's announcement of a proton beam therapy (PBT) demonstration project which authorizes the approval of PBT facilities for a period of ten years. ASHS expressed concern that this would limit access to PBT in New York State. The Department notes that at this time PBT has demonstrated efficacy only for certain relatively rare cancers and that the PBT demonstration project announcement authorizes the approval of additional PBT facilities within the 10-year period, "depending on the findings of the approved project(s), demonstrated need, and the state of medical knowledge at that time."