As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2022, which is no later than the 3rd year after the year in which this rule is being adopted.

Public comments were submitted to the New York State Department of Health (Department) in response to the proposed regulation. The public comment period for this regulation ended on December 17, 2018. The Department received comments from physicians, health care associations and legislators. The comments and the Department’s responses are summarized below.

COMMENT: A commenter recommended that section 405.34(g)(2) be amended to clarify that a hospital will not be prohibited from becoming a designated stroke center if it does not seek to become certified in the two-year period following the adoption of the regulations. The commenter expressed concern that hospitals may be discouraged from applying for certification if they do not apply within the two-year transition period.

RESPONSE: The intent of the proposed regulation at section 405.34(g) is to offer a transition period for hospitals that are currently recognized as stroke centers in NYS. Section 405.34(g)(1) states that hospitals currently recognized as designated stroke centers by the Department prior to the effective date of this section shall have two years from the effective date of the regulation to initiate the stroke center certification process with a Department approved certifying organization. In the event that a hospital currently recognized as a stroke center does not initiate the process within two years of the effective date of the regulation, the hospital will lose its designation but could be designated in the future as provided in this regulation. The Department will continue to work to make transition period details clear to all hospitals in NYS. No changes to the proposed regulations were made as a result of these comments.

COMMENT: A commenter noted that the Regulatory Impact Statement associated with the proposed regulations listed the Primary, Thrombectomy-Capable and Comprehensive Stroke programs as the levels hospitals may apply for in the proposed Stroke Services program in NYS, but the nationally-available Acute Stroke Ready (ASR) level was not included in the description.

RESPONSE: The Department spent considerable time engaging stakeholders prior to proposing regulations to understand whether there would be interest from hospitals in pursuing the ASR level. The Department will continue to engage hospitals to gauge the need for and interest in the ASR level and will make it available should need and interest be identified. No changes to the proposed regulations were made as a result of these comments.

COMMENT: A commenter recommended that the Department streamline the proposed application process, which requires a hospital to submit a request for designation to the Department after the hospital has been certified by a certifying organization. The commenter suggested that a hospital approved by the certifying organization should be recognized by the Department without a separate application process.

RESPONSE: Section 405.34(d)(2) requires hospitals seeking stroke center designation to apply to the Department with a copy of the certifying organization’s certification and supporting documents. This section allows the Department to perform a final review to ensure that all standards have been satisfied by the hospital prior to designation and to review for, at a minimum, potential investigations by federal or State oversight agencies that may preclude the Department from designating the hospital. This step will also trigger internal Department processes which include notifying the NYS Bureau of Emergency Medical Services (EMS) of a new stroke designation and updates to internal and public systems acknowledging the new hospital designation as a destination for EMS providers transporting patients. No changes to the proposed regulations were made as a result of these comments.

COMMENT: A commenter urged the Department to streamline, align and focus on the performance measures that are the most meaningful for improving stroke care. The commenter stated that performance measures should be consistent with the Accrediting Organizations (AOs) approved to certify NYS hospitals for stroke services and that two measures currently collected by the Department are not required by the AOs: dysphagia screening and smoking cessation. The commenter also noted that at least one of the AOs leverages sampling for stroke measures which reduces the burden of reporting without losing data validity.

RESPONSE: The Department will continue its ongoing efforts to capture meaningful data to advance the goals of making high-quality stroke care available in a timely manner to patients suffering from a suspected stroke. To that end, the Department, in collaboration with the Stroke Advisory Committee, has been developing reporting requirements that allow robust evaluation of hospital and stroke system of care performance while minimizing the burden of excessive reporting. The Department will take these comments under advisement when finalizing reporting requirements for the program. No changes to the proposed regulations were made as a result of these comments.

COMMENT: Multiple commenters shared concern over the potential burden for hospitals of reporting data to the Department and the AO. One commenter stated that most hospitals submit stroke quality measures to the American Heart Association (AHA) Get With The Guidelines (GWTG) program and that, to fulfill the Department’s requirements, hospitals that submit to GWTG but select an AO other than The Joint Commission/AHA may be forced to double-report the same measures to the AO they select, thereby causing an undue reporting burden on these hospitals. One commenter commended the Department for allowing hospitals to select from multiple AOs to become certified in the proposed program, but shared concern that the potential for double-reporting could undermine the Department’s efforts to allow for multiple AOs. A separate commenter urged the Department to ensure that hospitals can report to both the AO and the Department through a single data submission to streamline data collection and submission to reduce burden and to enable hospitals to dedicate their limited resources to quality and patient safety.

RESPONSE: The Department engaged numerous stakeholders to assess potential issues surrounding data collection and the barriers associated with the available stroke registries. The Department has continuously emphasized the importance of data collection for the purposes of performance monitoring and quality improvement to foster a successful program that provides the highest quality care to suspected stroke patients. To that end, the Department has specifically not required any single data collection tool or stroke registry in the proposed regulations to avoid administrative burden or additional costs to hospitals. The Department will only require that hospitals submit performance measurement data to the Department; however, the Department is aware that AOs have varying data requirements, with some requiring no data submission and others requiring extensive data reporting. The Department will take these comments under advisement and will continue working with AOs that become certifying organizations and hospitals to minimize double-reporting of performance measurement data. No changes to the proposed regulations were made as a result of these comments.

COMMENT: A commenter noted that the proposed program will require regions to adopt new stroke patient triage protocols, processes and agreements across hospitals so that patients are appropriately transported to the closest stroke designated center based on an assessment of their stroke acuity. The commenter stated that regions will also need to ensure that their EMS services are adequately trained and EMTs are appropriately scoring and triaging patients. The commenter further stated that some regions, including New York City (NYC), have already approved ambulance triage and transport protocols and have begun implementation of these protocols. While the commenter offered support for the proposed three-year transition period, the commenter stated that questions have been raised about whether the transition period applies to NYC and other regions and whether hospitals need to move more quickly. The commenter urged the Department and the State Emergency Medical Advisory Committee (SEMAC) to monitor and ensure a level of uniformity, particularly with respect to allowing hospitals time to transition and train EMTs as the regulations are implemented. Another commenter stated that as NYS moves from a single-tiered stroke program to tiered certifications the Department should work closely with EMS to monitor potential disruptions to the healthcare system to ensure that patients continue to receive timely, expert stroke care in NYS.

RESPONSE: The Department has worked extensively over the last year to engage critical stakeholders, including the Regional Emergency Medical Advisory Committees (REMACs) and the SEMAC, on issues related to developing guidelines for regions that are developing and implementing stroke systems of care that include all levels of NYS stroke facility designation. The Department has also clarified in numerous live and virtual presentations that the proposed regulations will apply to all regions in NYS, including NYC, at the time of adoption. The Department is committed to continuing to work with the REMACs and the SEMAC to establish a framework and guidelines for the development and implementation of regional stroke systems of care. The proposed regulation does not require regions to adopt new triage protocols. Additional information and written guidance will be made available by the Department to address the change from a single tiered stroke program to a tiered certification system. No changes to the proposed regulations were made as a result of these comments.

COMMENT: Multiple commenters wrote in support of modifications to the proposed regulations to address EMS triage and transport plans, as well as hospital transfer plans, to address and support patients with a specific type of severe ischemic stroke called an emergent large vessel occlusion (ELVO), as patients with ELVO have a significantly higher rate of mortality and disability. Commenters stated that a newly developed procedure called mechanical thrombectomy has provided a vastly more successful treatment for ELVO patients. Commenters stated that EMS protocol and transport plans should ensure that patients are receiving proper treatment in a timely fashion and the proposed regulations should address the ELVO patient group to ensure that those within the regional systems of care (including hospitals, EMS providers, REMACs, the SEMAC) throughout NYS address this need by continuously updating their system based on data that supports direct transport of ELVO patients to hospitals capable of performing mechanical thrombectomy whenever necessary. Commenters noted that ensuring patients are sent to the most appropriate medical centers depending on the severity of their stroke, the Department will be doing what has already been done for patients suffering heart attacks or trauma.

RESPONSE: These comments are noted. The Department is developing guidance in consultation with the Stroke Advisory Committee to address the rapid triage and transport of suspected stroke patients to the most appropriate hospital setting based on hospital capability. The guidance will highlight requirements for transfer agreements between hospitals to address the need for transportation to appropriate settings depending on patient acuity and will be part of certification standards. In light of the comments, the Department will include guidance specific to the ELVO patient population to address the need for EMS protocol and stroke center transport plans for patients with ELVO. The Department is committed to continuing to work with the REMACs and the SEMAC to develop and implement guidelines and protocols to address the appropriate triage of patients. The changes proposed by the commenters are beyond the scope of the proposed regulations as the Department is not seeking to amend the regulations in section 405.19 as they relate to EMS providers. No changes to the proposed regulations were made as a result of these comments.

COMMENT: Several commenters wrote in support of the proposed regulations. One commenter noted that while stroke outcomes in New York State (NYS) are among the best in the country, the proposed regulations will enable NYS to improve and better coordinate stroke care across all providers regionally, based on a patient’s needs and acuity. Another commenter thanked the Department for leading stroke experts around NYS with the common goal of improving patient care and outcomes. Several commenters noted the proposed updates to stroke services in NYS are encouraging and a move in the right direction.

RESPONSE: These comments in support are noted by the Department. No changes to the proposed regulations were made as a result of these comments.