Final Ruling

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LegalImpact

Centers for Medicare & Medicaid Services publishes final rule on emergency preparedness.

By Paul J. Welk, PT, JD

On September 16, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (“Rule”) providing for emergency preparedness requirements for certain Medicare- and Medicaid-participating providers and suppliers.1 The Rule went into effect on November 16, 2016; however, those health care providers and suppliers affected by the Rule2 are not required to be in compliance with the regulations until November 16, 2017, one year after the effective date. The Rule seeks in part to promote consistency and coordination among providers, the community, and others, and to address concerns regarding a lack of adequate preparation in response to recent man-made and natural disasters including tornadoes, hurricanes, and influenza outbreaks. The Rule specifically applies to seventeen (17) Medicare and Medicaid providers and suppliers, including Comprehensive Outpatient Rehabilitation Facilities (CORFs); Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (“Organizations”), Long Term Care Facilities; Hospitals; and Home Health Agencies.

While the compliance requirements for a specific provider or supplier vary somewhat under the Rule, there are key common elements identified in the Rule that the regulated entities are required to address. Initially, the Rule requires a provider or supplier to perform and document a global risk assessment. The Rule describes the risk assessment as an “all hazards” approach that focuses on capacities and capabilities critical to be prepared for a broad spectrum of emergencies and disasters. The risk assessment should cover all natural and man-made disasters that may occur in the specific region. The assessment addresses situations such as power failures, destruction of facilities, and loss of communication. The commentary to the Rule notes that CMS expects that a risk assessment will require the involvement of the organization’s administrator and a therapist, and it is expected that, among other tasks, each of these individuals will attend an initial meeting, review the current assessment, develop comments and recommendations for changes to the assessment, attend a follow-up meeting, perform a final review, and approve the risk assessment.

Based on the outcome of the risk assessment, an emergency preparedness plan must be developed. Once developed, the Rule requires that the plan be updated annually. A specific form of emergency plan is not provided for in the Rule, but rather, when surveyed, a facility must be able to provide documentation of requirements of the plan and show where the plan is located.3 The plan for an Organization must address the patient population, including the type of services the Organization has the ability to provide in an emergency, and address the continuity of operations, including delegations of authority, in the event of an emergency. The plan for Organizations must also include the process for cooperation and collaboration with emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation.

Next, the provider or supplier is required to develop and implement policies and procedures based on the emergency plan and the enterprise risk assessment. Policies and procedures for Organizations must address items such as safe evacuation, including staff responsibilities and the needs of patients; a means to shelter in place the patients, staff, and volunteers; and having a system of medical documentation that preserves patient information and protects confidentiality. The Rule further requires that facilities develop a communication plan in compliance with applicable federal and state law. The communication plan must include names and contact information for varying individuals including staff and patients’ physicians, alternate means for communicating with staff and emergency management agencies, a method for sharing patient documentation with other health care providers, and a means of providing information about needs and the ability to provide assistance to appropriate authorities. The communication plan must also address coordination among health care providers, state and local emergency management agencies, and health departments in recognition of the fact that patients may have to be moved in connection with certain emergency situations.

Finally, the Rule requires providers and suppliers to establish a training and testing program. The training component includes staff training on policies and procedures and requires a demonstrated knowledge of emergency procedures. The training program must include both initial training as well as annual trainings. Facilities are granted discretion to determine the appropriate level of training for different individuals based on their role within the organization. The Rule also requires certain provider types to perform community- and facility-based testing exercises.

From a compliance-monitoring perspective, State Survey Agencies, Accreditation Organizations, and CMS Regional Offices will all have roles in monitoring for compliance. Guidance from the Survey & Certification Group notes that there will be no exceptions for the requirements, and noncompliance will follow the same process as for noncompliance with any other Conditions of Participation and Conditions for Coverage for the facility.

While the compliance deadline is not until November 15, 2017, those providers and suppliers to whom this Rule applies should begin to consider the key elements described in the Rule and consider an appropriate timeline for implementation. In fact, CMS has recognized the amount of time that providers and suppliers may need to come into compliance with the Rule in setting the compliance date. From a resources perspective, a Frequently Asked Questions4 document has been published by the Survey & Certification Group and will be updated on a continuous basis, the Assistant Secretary for Preparedness and Response has developed information to assist facilities in planning for the continuity of operations,5 and CMS has developed a chart so that providers can determine what, if any, their obligations are under the Rule. By utilizing these resources and dedicating appropriate time for implementation of action items, affected providers and suppliers can get a head start on satisfying their obligations under the Rule.

Please note that this article is not intended to, and does not, serve as legal advice to the reader but is for general information purposes only.

REFERENCES

1. Medicare and Medicaid programs; emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers. Final Rule available at https://www.gpo.gov/fdsys/pkg/FR-2016-09-16/pdf/2016-21404.pdf. Accessed November 13, 2016.

2. Note that the Rule does not apply to all physical therapy practice settings. The resources cited in this article provide the guidance necessary to determine if a particular practice setting is subject to the requirements of the Rule. Those practice settings not directly subject to the Rule may nonetheless be affected by the regulations through their relationships with regulated providers and suppliers, for example, through a contractual arrangement with a regulated long-term care facility.

3. Frequently asked questions emergency preparedness regulation. www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/Frequently-Asked-Questions-FAQs.pdf. Accessed November 14, 2016.

4. Frequently asked questions emergency preparedness regulation.

5. Health Care COOP and Recovery Plan – Concepts, Principles, Templates & Resources. Available at: www.phe.gov/Preparedness/planning/hpp/reports/Documents/hc-coop2-recovery.pdf. Accessed November 14, 2016.

6. Centers for Medicare & Medicaid Services (CMS) emergency preparedness requirements by provider type. Available at www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/EP-Rule-Table-Provider-Type.pdf. Accessed November 14, 2016.

Paul J. Welk, PT, JD, is a Private Practice Section member and an attorney with Tucker Arensberg where he frequently advises physical therapy private practices in the areas of corporate and health care law. He can be reached at pwelk@tuckerlaw.com.

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