Comment Letter to CMS on Proposed Rule on Emergency Preparedness Conditions of Participation
for Medicare & Medicaid Services
Medicare and Medicaid Programs; Emergency Preparedness Requirements for
Medicare and Medicaid Participating Providers and Suppliers
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.
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
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
are four key areas in the proposed rule:
- Risk assessment and planning
- Policies and procedures
- Communications plan
- Training and testing
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.
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.
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.
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
- 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
- 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.
(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.
(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.
(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.
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
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.
and Regulatory Services