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Comment Letter to CMS on Proposed Rule on Emergency Preparedness Conditions of Participation

March 27, 2014   

Marilyn Tavenner
Acting Administrator
Centers for Medicare & Medicaid Services
Attention: CMS-1599-P
P.O. Box 8011
Baltimore, MD 21244-8013

RE: CMS–3178–P, Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers

Dear Ms. Tavenner:

On behalf of The Hospital & Healthsystem Association of Pennsylvania (HAP), which represents approximately 240 member institutions, including 125 stand-alone hospitals and another 120 hospitals that comprise 32 health systems across the state, we appreciate this opportunity to comment about the proposed rule on emergency preparedness conditions of participation.

HAP’s main concerns regarding the proposed rule are the cost burdens and strict time constraints for achieving compliance.  HAP strongly believes that CMS’ projections of burden and cost for compliance with this proposed rule are greatly underestimated.

HAP agrees with CMS’ efforts to align the framework for the proposed conditions of participation and conditions for coverage, with CMS’ national emergency preparedness requirements. This will enable Medicare- and Medicaid-participating providers and suppliers to adequately plan for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It also would ensure that these providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations.

There are four key areas in the proposed rule:   

  • Risk assessment and planning
  • Policies and procedures
  • Communications plan
  • Training and testing

These are the foundation of current Joint Commission standards and federal guidance and grants for emergency preparedness. Hospitals that have participated in federal grant programs such as the U.S. Department of Health and Human Services’ (HHS) Hospital Preparedness Program, and currently are accredited by the Joint Commission, will have established processes, programs, and systems to address most, but not all, elements of the proposed regulations.

However, providers, such as rural health clinics, that have not been as engaged in national preparedness efforts will face greater difficulty in implementing the proposed rule, and therefore we recommend that the requirements be phased in over a period of time.

Despite ongoing hospital preparedness and accreditation initiatives, during this time of unprecedented financial strain on health care providers, certain additional requirements that exceed current grant and accreditation requirements may place an undue hardship on hospitals.

HAP offers the following specific comments:

  • 482.15 (a) The requirement for each facility to have a separate plan will be inefficient and ineffective for health care systems with multiple provider types. Instead, the final rule should encourage system-level plans that delineate the specific roles, capabilities, and limitations of each provider entity within that health care system.
  • 482.15 (a) (1-2) The requirement for risk assessment and identification followed by an all-hazards approach is laudable. Specifically, the requirement to focus on functions and capabilities rather than specific hazards increases efficient and effective planning. The proposed language would benefit from further clarification requiring identification and focus on the top internal and external incidents that have the highest probability of occurrence, or have the highest risk for significant medical surge or other negative health outcomes.
  • 482.15(b) (1) (ii) D The requirement for hospitals to establish alternate sources of energy to maintain sewage and waste disposal should be identified as a best practice as indicated, rather than a regulated requirement.   
  • 482.15 (b) (2) A system to track the location of staff and patients in the hospital’s care should be required “until disposition.” Further, we recommend that CMS encourage HHS, the U.S. Department of Defense, and the U.S. Department of Homeland Security to align federal tracking systems and support their expansion into the state, local, and private sectors.
  • 482.15 (b) (3-4) The requirement for the safe evacuation of patients from the hospital to include the identification of evacuation locations is appropriate. However, alternate care sites for purposes of medical surge require resources and coordination from multiple public and private entities, and thus should not be a specific responsibility for a sole provider.
  • 482.15 (c) (4) The requirement for back-up of electronic information to be stored within and outside of the geographic area where the hospital is located requires further clarification of the definition of “geographic area.”
  • 482.15 (c) (4-7) The requirements pertaining to a method or means for sharing information should include timelines for submission of said information.
  • 482.15 (d) The requirement to train staff consistent with their expected role and validate their knowledge is a reasonable requirement with some clarification and modification:
  1. 482.15 (d) (1) (i) The term “volunteer” is vague and requires considerable clarification. Also, as real-world disasters clearly have demonstrated, self-deployed volunteers present in every disaster. The requirement to demonstrate knowledge for a broad range of emergency preparedness topics in addition to validating licensure and credentials is not practical nor feasible.
  2. 482.15 (d) (1) (ii) Providing emergency preparedness training at least annually should be expanded to define the minimum requirement for this training. We recommend that training requirements align with the National Incident Management System, including IS-100.HCB: Introduction to the Incident Command System (ICS 100) for Healthcare/Hospitals.
  3. 482.15 (d) (1) (iv) Demonstration of skill connotes skills labs or other methods of physical validation requiring exhaustive resources if all staff and volunteers must comply. The projected costs and time required are overly burdensome. Rather, the regulation should require annual validation of knowledge through written testing, demonstration, or real-world response based on plans and policies.
  • 482.15(e) (1) The Emergency and Standby Power Systems requirement as proposed will impose significant costs on hospitals. It simply is not feasible to require that every provider with inpatients ensure current generator systems are relocated to comply with these regulations, and are able to maintain HVAC temperature. Rather, it is recommended that all existing systems be grandfathered into compliance and be required to meet, but not exceed, current National Fire Protection Association standards with any major renovation, expansion, or new construction.

Finally, we strongly recommend that CMS consult with industry leaders in developing interpretive guidelines for these regulations to ensure surveyors have a full understanding of the complexities and variations of these requirements by provider group to avoid time financial burden.

Thank you for the opportunity to review and comment about this proposed rule. If you have any questions, please feel free to contact me at (717) 561-5344, or Brian Smith, director, clinical compliance and quality, at (717) 561-5356.

Sincerely,     

PAULA A. BUSSARD
Senior Vice President
Policy and Regulatory Services

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