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The National Emergency Management Association has regularly published a report on state emergency management since Mainstays in the report include information on state emergency management budgets, agency organizational structures, disaster funding mechanisms and how states pay for their share of federal disaster assistance programs. As more states established homeland security offices — often combined with the emergency management department — the report incorporated data on this important function.

In addition, topical issues are identified and addressed as needed in each report. This played out at the state level as well, with gubernatorial emergencies, which was 38 percent more than the reported in the NEMA Biennial Survey. There were also events that required a significant commitment of state resources, but which did not result in a declared state of emergency. This was percent increase from the FY survey when it was As a result of 27 new governors taking office in , 17 states appointed new state emergency directors. In addition, a few commenters noted that certain facilities, mainly rural and small facilities, may be at a disadvantage because they have not participated in national emergency preparedness planning efforts or because they lack the necessary resources to implement emergency preparedness plans.

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A few commenters drew a distinction between accredited and non-accredited facilities and recommended that hospitals implement the requirements within a year or 2 after publication of the final rule. Several of these commenters also stated that hospitals that need more time for implementation should be able to propose to CMS a reasonable period of time to comply. A few commenters stated that the emergency preparedness proposal is unlike the standards utilized by the TJC and that enforcement of these requirements should be at a later date for both accredited and non-accredited facilities.

A commenter recommended that CMS set a later implementation date for the requirements and provide a flexible implementation timeframe based on provider type and resources. A few commenters recommended that CMS phase-in implementation on a standard-by-standard basis. A commenter recommended that LTC facilities implement the requirements 12 to 18 months after hospitals. Furthermore, the commenter recommended an 18 to 24 month phase-in of emergency systems and a 24 to 38 month phase-in for the training and testing requirements. Another commenter recommended that facilities be allowed to comply with the initial planning requirements within 2 years, and then be allowed to comply with the subsistence and infrastructure requirements in years 3 and 4.

The commenters varied in their recommendations on the timeframe CMS should use for the implementation date. These recommendations ranged from 6 months to 5 years, with a few commenters recommending even longer periods. Furthermore, a commenter noted that a phased in approach would help to alleviate the cost burden on facilities that would need to create an emergency plan and train and test staff. Response: We appreciate the commenters' feedback. We considered a phased-in approach in a number of ways.

We looked at phasing in the implementation of various providers and suppliers; and phasing in the various standards of the regulation. We concluded that this approach would be too difficult to implement, enforce, and evaluate. Also, this would not allow communities to have a comprehensive approach to emergency preparedness.

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However, we agree that there should be a later implementation date for the emergency preparedness requirements. However, we do not believe that a targeted or phased-in approach to implementation is appropriate. One thing we proposed and are now finalizing to address this concern is extending the implementation timeframe for the requirements to 1 year after the effective date of this final rule see section section II, Provisions of the Proposed Rule and Responses to Public Comments, part B, Implementation Date.

We believe it is imperative that each provider thinks in terms broader than their own facility, and plan for how they would serve similar and other healthcare facilities as well as the whole community during and surrounding an emergency event. To encourage providers to develop a comprehensive and coordinated approach to emergency preparedness, all providers need to adopt the requirements in this final rule at the same time. Nearly all hospitals However, we also believe that other facilities will be ready to begin implementation of these rules at the same time as hospitals.

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We believe that most facilities already have some basic emergency preparedness requirements that can be built upon to meet the requirements set out in this final rule. We note that we have modified or eliminated some of our proposed requirements for certain providers and suppliers, as discussed later in this final rule, which should ease concerns about implementation. Therefore, we believe that all affected providers and suppliers will be able to comply with these requirements 1 year after the final rule is published.

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We do not believe a period of non-enforcement is appropriate as it will further prolong the implementation of necessary and life-saving emergency preparedness planning requirements by facilities. A later implementation date will leave the most vulnerable patient populations and unprepared facilities without a valuable, life-saving emergency preparedness plan should an emergency arise.

We have not received comments that persuaded us that a later implementation date for these requirements of more than 1 year is beneficial or appropriate for providers and suppliers or their patients. In response to commenters that opposed our proposal to implement the requirements 1 year after the final rule was published and recommended that we afford facilities more time to implement the requirements, we do not believe that the requirements will be overly burdensome or overly costly to providers and suppliers.

We note, as we have heard from many commenters, that many facilities already have established emergency preparedness plans, as required by accrediting organizations. However, we acknowledge that there may be a significant amount of work that small facilities and those with limited resources will need to undertake to establish an emergency preparedness plan that conforms to the requirements set out in this regulation.

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However, we believe that prolonging the requirements in this final rule by 1 year will provide sufficient time for implementation among the various facilities to meet the emergency preparedness requirements. We encourage facilities to engage and collaborate with their local partners and healthcare coalitions in their area for assistance. Facilities may also access ASPR's TRACIE web portal, which is a healthcare emergency preparedness information gateway that helps stakeholders at the federal, state, local, tribal, non-profit, and for-profit levels have access to information and resources to improve preparedness, response, recovery, and mitigation efforts.

We encourage facilities to engage and collaborate with their local partners and healthcare coalitions in their area for technical assistance as they include local experts and can provide regional information that can inform the requirements as set forth. Comment: Some commenters recommended that CMS implement all of the emergency preparedness requirements 1 year after the final rule is published.

Other commenters recommended that CMS implement the requirements as soon as the final rule is published or set an implementation date that is less than 1 year from the effective date of this final rule. A few of these commenters, including a major beneficiary advocacy group, stated that implementation should begin as soon as practicable, or immediately after the final rule is published and cautioned against a later implementation date that may leave facilities without important emergency preparedness plans during an emergency.

Some of these commenters stated that hospitals in particular already have emergency preparedness plans in place and are well equipped and prepared to implement the requirements set out in these regulations over the course of a year. Some commenters noted that most hospitals are fully aware of the 4 emergency preparedness requirements set out in the proposed rule through current accreditation standards.

Furthermore, the commenters noted that these four requirements would not impose any additional burdens on hospitals. A few commenters acknowledged that some hospitals are not under the purview of an accrediting agency and therefore may need up to 1 year to implement the requirements. We agree with the commenters' view that implementation of the requirements should occur 1 year after the final rule is published for all 17 types of providers and suppliers. We believe that an implementation date for these requirements that is 1 year after the effective date of this final rule will allow all facilities to develop an emergency preparedness plan that meets all of the requirements set out within these regulations.

While we understand why some commenters would want these requirements to be implemented shortly after publication of the final rule, we also understand some commenters' concerns about that timeframe. We believe that facilities will need a period of time after the final rule is published to plan, develop, and implement the emergency preparedness requirements in the final rule. Accordingly, we believe that 1 year is a sufficient amount of time for facilities to meet these requirements. Comment: A few commenters recommended that CMS include a provision that would allow facilities to apply for additional time extensions or waivers for implementation.

A commenter recommended that CMS allow facilities to rely on their existing policies if the facility can demonstrate that the existing policies align with the emergency preparedness plan requirements and achieve a similar outcome. Response: We do not agree with including a provision that will allow for facilities to apply for extensions or waivers to the emergency preparedness requirements. We believe that an implementation date that is beyond 1 year after the effective date of this final rule for these requirements is inappropriate and leaves the most vulnerable facilities and patient populations without life-saving emergency preparedness plans.

However, we do understand that some facilities, especially smaller and more rural facilities, may experience difficulties developing their emergency preparedness plans. Therefore, we believe that setting an implementation date of 1 year after the effective date of this final rule for these requirements will give these and other facilities Start Printed Page sufficient time for compliance. As stated earlier, we encourage facilities to form coalitions in their area for assistance in meeting these requirements.

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We also encourage facilities to utilize the many resources we have included in the proposed and final rule. We appreciate that some facilities have existing emergency preparedness plans. However, all facilities will be required to develop and maintain an emergency preparedness plan based on an all-hazards approach and address the four major elements of emergency preparedness in their plan that we have identified in this final rule. Each facility will be required to evaluate its current emergency preparedness plan and activities to ensure that it complies with the new requirements.

A few commenters noted that this implementation data should include a period of engagement with hospitals and other providers and suppliers, a period to allow for the development and testing of surveyor tools, and a readiness review of state survey agencies that is complete and publicly available.

A commenter recommended that facilities implement the requirements 5 years after the IGs have been published. Another commenter recommended that CMS phase-in implementation in terms of enforcement and roll out, allowing time for full implementation and assistance to facilities and state surveyors.

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  7. A few commenters recommended that providers be allowed a period of time where they are held harmless during a transitional planning period, where providers may be allotted more time to plan and implement the emergency preparedness requirements. Response: We disagree with the commenter's recommendations that we should implement this regulation after the IGs have been published. Additionally, we disagree with the recommendation that CMS phase in enforcement or hold facilities harmless for a period of time while the requirements are being implemented, and we do not believe that it is appropriate to implement the CoPs after the IGs are established.

    The IGs are subregulatory guidelines which establish our expectations for the function states perform in enforcing the regulatory requirements. Facilities do not require the IGs in order to implement the regulatory requirements. We note that CMS historically releases IGs for new regulations after the final rule has been published. This EP rule is accompanied by extensive resources that providers and suppliers can use to establish their emergency preparedness programs.

    The Web site will contain the link to the final rule and will also include templates, provider checklists, sample emergency preparedness plans, disaster specific information and lessons learned. We will also continue to communicate with providers and other stakeholders about these requirements through normal channels. For example we will communicate with surveyors via Survey and Certification memoranda and provide information to facilities via, provider forums, press releases and Medicare Learning Network publications.

    We continue to believe that setting a later implementation date for the enforcement of these requirements will leave the most vulnerable patient populations and unprepared facilities without valuable, life-saving emergency preparedness plans should an emergency arise. One year is a sufficient amount of time for facilities to meet these requirements.

    Comment: Several commenters, including national and local organizations, and providers, supported using a transparent process in the development of interpretive guidelines for state surveyors. They suggested consulting with industry experts, healthcare organizations, accrediting bodies and state survey agencies in the development of clear and concise interpretation and application of the IGs nationwide.

    One provider suggested that CMS post the draft guidance electronically for a period of time and provide an email address for stakeholders to offer comments. Furthermore, this provider suggested that the guidance be pilot-tested and revised prior to adoption.

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    Response: We thank the commenters for their suggestions. We also note that surveyors will be provided training on the emergency preparedness requirements so that enforcement of the rule will be based on the regulations set forth here. While comments on the process for developing the interpretive guidelines is outside the scope of this proposed rule, we agree that consistency and conciseness in the IGs is critical in the evaluation process for providers and suppliers in meeting these emergency preparedness requirements.

    Comment: A few commenters recommended that CMS allow multiple facility types that are administered by the same owner to obtain waivers of specific requirements or have a single multi-facility plan approved, if they can collectively adopt a functionally equivalent strategy based on the requirements that may apply to one of their facility types.

    The commenters note that operation of more than one facility type is not uncommon among Tribal health programs.