WASHINGTON—Medicare is proposing to ease federal fire safety regulations after finding the extra structural requirements would impose large costs on already fire-safe dialysis facilities.
There have been no recorded patient injuries or deaths due to fires in the 40-year history of the Medicare ESRD program, according to CMS. In fact, The Federal Emergency Management Agency ranked ESRD facilities the lowest (0.1 percent) in fire incidence among all healthcare facilities.
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In 2009, CMS updated the ESRD Conditions for Coverage (CfC) to include Federal Life Safety Code (LSC) provisions, which called for additional structural requirements in dialysis facilities. These included chapters 20 and 21 of the National Fire Protection Agency’s (NFPA) 101 LSC, 2000 Edition.
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In researching the issue, CMS found that the federal LSC provisions also duplicated many of the existing local and state fire safety codes covering dialysis clinics. In addition, the government originally estimated the additional requirements would cost dialysis facilities approximately $1,960. However, after receiving feedback from dialysis clinic owners, CMS learned the actual costs far exceeded the original number.
In June, owners of 3,756 of 5,600 existing certified dialysis facilities responded to the CMS request for cost projections on four specific requirements: smoke compartment barriers, occupancy separations, hazardous area separations, and upgraded fire alarms. The responders represented approximately 70 percent of existing dialysis facilities, including hospital-owned facilities and those owned by small, medium, and large dialysis organizations.
The data collected showed that approximately 50 percent (an estimated 2, 800) of the existing ESRD facilities would require renovations or upgrading of at least one of the four elements. CMS pointed out that the primary reason for the 50-percent compliance was the pervasive inconsistency in knowledge, interpretation, and application of the regulations.
There was a high variability in the cost estimates submitted, ranging from a low of $23,500 to a high of $222,000 for an existing facility which needed to renovate, construct and upgrade all four components. The average per facility cost estimates submitted for the additional structural requirements are as follows:
- Smoke compartments:$32,544
- Occupancy separation:$28,139
- Hazardous areas separation: $16,976
The total average cost for a facility to meet all three would be $77,659. Although there is a wide array of facility characteristics, such as age and size, CMS estimated if 50 percent or 2,800 facilities required only renovation for hazardous area separation, the savings would be $47.5 million. If 2,800 facilities required renovation for all three structural requirements, the total savings from the burden reduction at the average estimate for all three would be $217 million.
“These amounts represent a significant financial burden on facilities, with little or no improvement in patient safety from fire for a majority of them,” CMS wrote. “Expenditures of this magnitude would likely divert resources away from areas which do affect dialysis patient safety, such as infection control and prevention.”
Therefore, CMS has concluded that the fire safety regulation adds costs “out of proportion to any added protection that they may afford in dialysis facilities which are not at higher risk of fire penetration from adjacent industrial ‘high hazard’ occupancies and where swift, unencumbered evacuation to the outside is available.”
As a result, “…we propose revising §494.60(e)(1) to restrict mandatory compliance with the NFPA 101 LSC to those ESRD facilities located adjacent to ‘high hazardous’ occupancies and those facilities whose patient treatment areas are not located at grade level with direct access to the outside.”
The change was part of a larger proposed rule, which aims to reform certain regulations that the Centers for Medicare & Medicaid Services (CMS) has identified as unnecessary, obsolete, or excessively burdensome on healthcare providers and beneficiaries.
However, CMS did say these additional structural requirements could improve patients’ fire safety in “specific dialysis facilities that pose a higher risk for life safety from fire by their proximity to a potential fire source or their barriers to prompt evacuation from fire.” These higher risk locations are those dialysis facilities that are adjacent to occupancies that contain “industrial high hazard contents” and those facilities that do not have a readily available exit to the outside for swift, unencumbered evacuation.
CMS is also proposing which ESRD facilities must use sprinkler-equipped buildings: those housed in multi-story buildings of lesser fire protected construction types (Types II(000), III(200), or V(000), as defined in NFPA 101), which were constructed after Jan. 1, 2008; and those housed in high rise buildings over 75 feet in height. Dialysis facilities participating in Medicare as of Oct. 14, 2008, may continue to use non-sprinklered buildings if such buildings were constructed before Jan. 1, 2008, and state law so permits.
Dialysis clinics would still be required to comply with state and local fire codes. The ESRD CfCs also address other topics related to fire and building safety that will remain in place under the proposed revision. These existing CfC requirements include specific rules on how to handle chemicals related to the dialysis process, as well as general requirements for appropriate training in emergency preparedness for the staff and patients, including provisions for instructions on disconnecting from the dialysis machine during an emergency and instructions on emergency evacuation.