[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Proposed Rules]
[Pages 76899-76904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26583]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 494

[CMS-3334-P]
RIN 0938-AS94


Medicare and Medicaid Programs; Fire Safety Requirements for 
Certain Dialysis Facilities

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would update fire safety standards for 
Medicare and Medicaid participating ESRD facilities, adopt the 2012 
edition of the Life Safety Code and eliminate references in our 
regulations to all earlier editions of the Life Safety Code and adopt 
the 2012 edition of the Health Care Facilities Code, with some 
exceptions.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on January 3, 2017.

ADDRESSES: In commenting, please refer to file code CMS-3334-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3334-P, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3334-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:

[[Page 76900]]

    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Kristin Shifflett, (410) 786-4133.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

A. Overview

    The Life Safety Code (LSC) is a compilation of fire safety 
requirements for new and existing buildings, and is updated and 
published every 3 years by the National Fire Protection Association 
(NFPA), a private, nonprofit organization dedicated to reducing loss of 
life due to fire. The Medicare and Medicaid regulations have 
historically incorporated these requirements by reference, along with 
Secretarial waiver authority. The statutory basis for incorporating 
NFPA's LSC into the regulations we apply to Medicare and, as 
applicable, Medicaid providers and suppliers is the Secretary of the 
Department of Health and Human Services' (the Secretary) authority to 
stipulate health, safety and other regulations for each type of 
Medicare and (if applicable) Medicaid-participating facility. 
Specifically, section 1881(b)(1)(A) of the Social Security Act (the 
Act) provides for payments for ``providers of services and renal 
dialysis facilities which meet such requirements as the Secretary shall 
by regulation prescribe for institutional dialysis services and 
supplies . . . . '' Under this statutory authority, the Secretary has 
set out ``Conditions for Coverage,'' including LSC compliance 
requirements, at 42 CFR part 494, subpart B. Our current LSC provisions 
are set out at Sec.  494.60(e).
    In implementing the LSC provisions, we have given ourselves the 
discretion to waive specific provisions of the LSC for facilities if 
application of our rules would result in unreasonable hardship for the 
facility, and if the health and safety of its patients would not be 
compromised by such waiver. For dialysis facilities, that authority is 
set out at Sec.  494.60(e)(4). In addition, the Secretary may accept a 
State's fire and safety code instead of the LSC if the Centers for 
Medicare & Medicaid Services (CMS) determines that the protections of 
the State's fire and safety code are equivalent to, or more stringent 
than, the protections offered by the LSC; dialysis facility provisions 
to that effect are set out at Sec.  494.60(e)(3). These flexibilities 
mitigate the potential unnecessary burdens of applying the requirements 
of the LSC to all affected health care facilities.
    On May 12, 2012, we published a final rule in the Federal Register, 
entitled ``Medicare and Medicaid Program; Regulatory Provisions to 
Promote Program Efficiency, Transparency, and Burden Reduction'' (77 FR 
29002). In that final rule, we limited the application of LSC 
requirements to dialysis facilities either located adjacent to 
industrial high hazard areas, and those that did not provide one or 
more exits to the outside at grade level from the patient treatment 
area level. However, we inadvertently neglected to include updated 
provisions for dialysis facilities in our proposed update to the Life 
Safety Code provisions for CMS providers and suppliers, ``Medicare and 
Medicaid Programs; Fire Safety Requirements for Certain Health Care 
Facilities; Proposed Rule'' (79 FR 21552, April 16, 2014). Therefore, 
we are proposing these provisions now, with some modifications to 
address the unique needs of dialysis facilities. The proposed update 
would apply only to dialysis facilities that do not provide one or more 
exits to the outside at grade level from the treatment area level (for 
instance, in upper floors of a mid-rise or high-rise building). We 
would not require other dialysis facilities to comply with NFPA 
99[supreg] 2012 edition of the Health Care Facilities Code (NFPA 99) 
and NFPA 101[supreg] 2012 edition of the Life Safety Code (NFPA 101) 
because we believe that patients in dialysis facilities are generally 
capable of unhooking themselves from dialysis machines and self-
evacuating without additional assistance in the event of an emergency. 
We believe that in all facilities with at-grade exits, patients would 
be able to evacuate the building in a timely fashion. Consequently, we 
believe that state and local requirements are sufficient to protect 
these patients and staff in the event of an emergency. In accordance 
with NFPA 101 sections 20.1.3.7 and 21.1.3.7, we would prohibit 
Medicare-approved dialysis facilities from being located adjacent to 
industrial high hazard facilities. ``Adjacent to'' is defined as 
sharing a wall, ceiling or floor, with a facility.
Defining ``Exit to the Outside at Grade Level From the Patient 
Treatment Area Level''
    The phrase ``exit to the outside at grade level from the patient 
treatment area level'' applies to dialysis facilities that are on the 
ground or grade level of a building where patients do not have to 
traverse up or down stairways within the building to evacuate to the 
outside. Accessibility ramps in the exit area that provide an ease of 
access between the patient treatment level and the outside ground level 
are not considered stairways.
    A dialysis facility which provides one or more exits to the outside 
at grade level from patient treatment level and which has a patient 
exit path to the outside (which may include an

[[Page 76901]]

accessibility ramp that is compliant with NFPA and the Americans with 
Disabilities Act (ADA)) would be exempt from compliance with the 
applicable provisions of NFPA 99 and NFPA 101.

II. Provisions of the Proposed Regulations

    In this rule, we are proposing to update our requirements for 
dialysis facilities that do not provide one or more exits to the 
outside at grade level from the patient treatment area level, by 
incorporating by reference the 2012 edition of NFPA 101 and NFPA 99. 
These facilities are already required to meet the 2000 edition of the 
LSC; other provider types affected by the LSC are now required to meet 
the 2012 edition of the NFPA 101 and the NFPA 99 (LSC final rule 
published May 4, 2016 at 81 FR 26872). The 2012 edition of the LSC 
includes new provisions that we believe are vital to the health and 
safety of all patients and staff. Our intention is to ensure that 
patients and staff continue to experience the highest degree of fire 
safety possible.
    The NFPA 101 2012 edition of the LSC provides minimum requirements, 
with due regard to function, for the design, operation and maintenance 
of buildings and structures for safety to life from fire. Its 
provisions also aid life safety in similar emergencies.
    The NFPA 99 2012 edition of the Health Care Facilities Code 
provides minimum requirements for health care facilities for the 
installation, inspection, testing, maintenance, performance, and safe 
practices for facilities, material, equipment, and appliances.

B. 2012 Edition of the Life Safety Code

    The 2012 edition of the LSC includes new provisions that we believe 
are vital to the health and safety of all patients and staff. Our 
intention is to ensure that patients and staff continue to experience 
the highest degree of fire safety possible. We do review each edition 
of the NFPA 101 and NFPA 99 every 3 years to see if there are any 
significant provisions that we need to adopt. CMS will continue to 
review revisions to ensure we meet proper standards for patient safety. 
We have reviewed the 2015 edition of the NFPA 101 and NFPA 99 and do 
not believe that there are any significant provisions that need to be 
addressed at this time. Newer buildings are typically built to comply 
with the newer versions of the LSC because state and local 
jurisdictions often adopt and enforce newer versions of the LSC as they 
become available.
    CMS must emphasize that the LSC is not an accessibility code, and 
compliance with the LSC does not ensure compliance with the 
requirements of the ADA. State and local government programs and 
services, including health care facilities, are required to comply with 
Title II of the ADA. Private entities that operate public 
accommodations such as nursing homes, hospitals, and social service 
center establishments are required to comply with Title III of the ADA. 
Entities that receive federal financial assistance from the Department 
of Health and Human Services, including Medicare and Medicaid, are also 
required to comply with section 504 of the Rehabilitation Act of 1973. 
The same accessibility standards apply regardless of whether health 
care facilities are covered under Title II or Title III of the ADA or 
section 504 of the Rehabilitation Act of 1973.\1\ For more information 
about the ADA's requirements, see the Department of Justice's Web site 
at http://www.ada.gov or call 1-800-514-0301 (voice) or 1-800-514-0383 
(TTY).
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    \1\ Facilities newly constructed or altered after March 15, 2012 
must comply with the 2010 Standards for Accessible Design (2010 
Standards). Facilities newly constructed or altered between 
September 15, 2010 and March 15, 2012 had the option of complying 
with either the 1991 Standards for Accessible Design (1991 
Standards) or the 2010 Standards. Facilities newly constructed 
between January 26, 1993 and September 15, 2010, or altered between 
January 26, 1992 and September 15, 2010 were required to comply with 
the 1991 Standards under Title III and either the 1991 Standards or 
the Uniform Federal Accessibility Standards under Title II.
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C. Incorporation by Reference

    This proposed rule would incorporate by reference the NFPA 
101[supreg] 2012 edition of the LSC, issued August 11, 2011, and all 
Tentative Interim Amendments issued prior to April 16, 2014; and the 
NFPA 99[supreg] 2012 edition of the Health Care Facilities Code, issued 
August 11, 2011, and Tentative Interim Amendments issued prior to April 
16, 2014 in Sec.  494.60(g).
    These materials have been previously incorporated by reference for 
other provider types by a final rule titled ``Medicare and Medicaid 
Programs; Fire Safety Requirements for Certain Health Care Facilities'' 
published on May 4, 2016 (81 FR 26872).
    The materials that are incorporated by reference can be found for 
interested parties and are available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD 
21244, or from the National Fire Protection Association, 1 Batterymarch 
Park, Quincy, MA 02269. If any changes to this edition of the Code are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce those changes.

D. Ambulatory Health Care Occupancies

    According to our memorandum, ``Survey & Certification: 13-47-LSC/
ESRD,'' issued July 12, 2013, dialysis facilities that are subject to 
the LSC provisions must meet the requirements of the Ambulatory Health 
Care Occupancy chapters 20 and 21 of the LSC. Dialysis facilities that 
are not subject to our LSC regulations must continue to meet State and 
local fire codes. (See https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-47.pdf.)
    The following are key provisions in the 2012 edition of the LSC 
from Chapter 20, ``New Ambulatory Health Care Occupancies'' and Chapter 
21, ``Existing Ambulatory Health Care Occupancies.'' We have provided 
the LSC citation and a description of the requirement.
    The 2012 edition of the LSC defines an ``Ambulatory Health Care 
Occupancy'' as a facility capable of treating 4 or more patients 
simultaneously on an outpatient basis. We believe that dialysis 
facilities that do not provide one or more exits to the outside at 
grade level from the patient treatment area should also be required to 
meet the provisions applicable to Ambulatory Health Care Occupancy 
Chapters, regardless of the number of patients served, as a matter of 
health and safety of patients receiving services in these facilities. 
In the burden reduction final rule, published in the Federal Register 
on May 12, 2012 entitled, ``Medicare and Medicaid Program; Regulatory 
Provisions to Promote Program Efficiency, Transparency, and Burden 
Reduction'' (77 FR 29002), we removed the provision's applicability to 
dialysis facilities with at-grade exits directly from the treatment 
area because, in our view, there was, and continues to be, an extremely 
low risk of fire in dialysis facilities. Medicare-approved dialysis 
facilities that provide exits to the outside at grade level would 
continue to be required to follow State and local fire codes, which we 
believe provide for sufficient patient protection in the event of an 
emergency. If a facility's exits were located above or below grade, 
patients would require more time to evacuate. Consequently, we believe 
that the LSC would still be required due to the additional risk 
entailed in longer exit times.

[[Page 76902]]

Sections 20.3.2.1 and 21.3.2.1--Doors
    This provision requires all doors to hazardous areas be self-
closing or close automatically.
Sections 20.3.2.6 and 21.3.2.6--Alcohol Based Hand Rubs
    This provision explicitly allows aerosol dispensers, in addition to 
gel hand rub dispensers. The aerosol dispensers are subject to 
limitations on size, quantity, and location, just as gel dispensers are 
limited. Automatic dispensers are also now permitted in ambulatory care 
facilities, provided, among other things, that--(1) they do not release 
contents unless they are activated; (2) the activation occurs only when 
an object is within 4 inches of the sensing device; (3) any object 
placed in the activation zone and left in place must not cause more 
than one activation; (4) the dispenser must not dispense more than the 
amount required for hand hygiene consistent with the label 
instructions; (5) the dispenser is designed, constructed and operated 
in a way to minimize accidental or malicious dispensing; and (6) all 
dispensers are tested in accordance with the manufacturer's care and 
use instructions each time a new refill is installed. The provision 
further defines prior language regarding ``above or adjacent to an 
ignition source'' as being ``within 1 inch'' of the ignition source.
Sections 20.3.5 and 21.3.5--Extinguishment Requirements
    This provision is related to sprinkler system requirements and 
requires the evacuation of a building or the instituting of an approved 
fire watch when a sprinkler system is out of service for more than 10 
hours in a 24-hour period until the system has been returned to 
service. A facility must evacuate the building or portion of the 
building affected by the system outage until the system is back in 
service, or establish a fire watch until the system is back in service.

E. 2012 Edition of the Health Care Facilities Code

    The 2012 edition of the NFPA 99, ``Health Care Facilities Code,'' 
addresses requirements for both health care occupancies and ambulatory 
care occupancies, and serves as a resource for those who are 
responsible for protecting health care facilities from fire and 
associated hazards. The purpose of this Code is to provide minimum 
requirements for the installation, inspection, testing, maintenance, 
performance, and safe practices for health care facility materials, 
equipment and appliances. This Code is a compilation of documents that 
have been developed over a 40-year period by NFPA, and is intended to 
be used by those persons involved in the design, construction, 
inspection, and operation of health care facilities, and in the design, 
manufacture, and testing of appliances and equipment used in patient 
care areas of health care facilities. It provides information on 
subjects, for example, medical gas and vacuum systems, electrical 
systems, electrical equipment, and gas equipment. The NFPA 99 applies 
specific requirements in accordance with the results of a risk-based 
assessment methodology. A risk-based approach allows for the 
application of requirements based upon the types of treatment and 
services being provided to patients or residents rather than the type 
of facility in which they are being performed. In order to ensure the 
minimum level of protection afforded by NFPA 99 is applicable to all 
patient and resident care areas within a health care facility, we are 
proposing adoption of the 2012 edition of NFPA 99, with the exception 
of chapters 7--``Information Technology and Communications Systems for 
Health Care Facilities''; 8--``Plumbing''; 12--``Emergency 
Management''; and 13--``Security Management''. The first three chapters 
of the NFPA 99 address the administration of the NFPA 99, the 
referenced publications, and definitions. Short descriptions of some of 
the more important provisions of NFPA 99 follow:
Chapter 4--Fundamentals
    Chapter 4 provides guidance on how to apply NFPA 99 requirements to 
health care facilities based upon ``categories'' determined when using 
a risk-based methodology.
    There are four categories utilized in the risk assessment 
methodology, depending on the types of treatment and services being 
provided to patients or residents. Section 4.1.1 of NFPA 99 describes 
Category 1 as, ``Facility systems in which failure of such equipment or 
system is likely to cause major injury or death of patients or 
caregivers. . . .'' Section A.4.1.1 provides examples of what a major 
injury could include, such as amputation or a burn to the eye. Section 
4.1.2 describes Category 2 as, ``Facility systems in which failure of 
such equipment is likely to cause minor injury to patients or 
caregivers. . . .'' Section A.4.1.2 describes a minor injury as one 
that is not serious or involving risk of life. Section 4.1.3 describes 
Category 3 as, ``Facility systems in which failure of such equipment is 
not likely to cause injury to patients or caregivers, but can cause 
patient discomfort. . . .'' Section 4.1.4 describes Category 4 as, 
``Facility systems in which failure of such equipment would have no 
impact on patient care. . . .''
    Section 4.2 requires that each facility that is a health care or 
ambulatory occupancy define its risk assessment methodology, implement 
the methodology, and document the results. We did not propose to 
require the use of any particular risk assessment procedure. However, 
if future situations indicate the need to define a particular risk 
assessment procedure, we would pursue that through a separate notice 
and comment rulemaking.
Chapter 5--Gas and Vacuum Systems
    The hazards addressed in Chapter 5 include the ability of oxygen 
and nitrous oxide to exacerbate fires, safety concerns from the storage 
and use of pressurized gas, and the reliance upon medical gas and 
vacuum systems for patient care. Chapter 5 does not mandate the 
installation of any systems; rather, if they are installed or are 
required to be installed, the systems will be required to comply with 
NFPA 99. Chapter 5 covers the performance, maintenance, installation, 
and testing of the following:
     Nonflammable medical gas systems with operating pressure 
below a gauge pressure of 300 psi;
     Vacuum systems in health care facilities;
     Waste anesthetic gas disposal systems (WAGD); and
     Manufactured assemblies that are intended for connection 
to the medical gas, vacuum, or WAGD systems.
Chapter 6--Electrical Systems
    The hazards addressed in Chapter 6 are related to the electrical 
power distribution systems in health care facilities, and address 
issues such as electrical shock, power continuity, fire, electrocution, 
and explosions that might be caused by faults in the electrical system. 
Chapter 6 also covers the performance, maintenance, and testing of the 
electrical systems in health care facilities.
Chapter 9--Heating, Ventilation, and Air Conditioning (HVAC)
    Chapter 9 requires HVAC systems serving spaces or providing health 
care functions to be in accordance with the American Society of 
Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE) Standard 
170--Ventilation of Health Care Facilities (2008 edition) (http://www.ashrae.org).

[[Page 76903]]

    Chapter 9 does not apply to existing HVAC systems, but applies to 
the construction of new health care facilities, and the altered, 
renovated, or modernized portions of existing systems or individual 
components. Chapter 9 ensures minimum levels of heating, ventilation 
and air conditioning performance in patient and resident care areas. 
Some of the issues discussed in Chapter 9 are as follows:
     HVAC system energy conservation;
     Commissioning;
     Piping;
     Ductwork;
     Acoustics;
     Requirements for the ventilation of medical gas storage 
and trans-filling areas;
     Waste anesthetic gases;
     Plumes from medical procedures;
     Emergency power system rooms; and
     Ventilation during construction.
Chapter 10--Electrical Equipment
    Chapter 10 covers the performance, maintenance, and testing of 
electrical equipment in health care facilities. Much of this chapter 
applies to requirements for portable electrical equipment in health 
care facilities, but there are also requirements for fixed-equipment 
and information on administrative issues.
Chapter 11--Gas Equipment
    The hazards addressed in Chapter 11 relate to general fire, 
explosions, and mechanical issues associated with gas equipment, 
including compressed gas cylinders.
Chapter 14--Hyperbaric Facilities
    Chapter 14 addresses the hazards associated with hyperbaric 
facilities in health care facilities, including electrical, explosive, 
implosive, as well as fire hazards. Chapter 14 sets forth minimum 
safeguards for the protection of patients and personnel administering 
hyperbaric therapy and procedures. Chapter 14 contains requirements for 
hyperbaric chamber manufacturers, hyperbaric facility designers, and 
personnel operating hyperbaric facilities. It also contains 
requirements related to construction of the hyperbaric chamber itself 
and the equipment used for supporting the hyperbaric chamber, as well 
as administration and maintenance. Many requirements in this chapter 
are applicable only to new construction and new facilities.
Chapter 15--Features of Fire Protection
    Chapter 15 covers the performance, maintenance, and testing of fire 
protection equipment in health care facilities. Issues addressed in 
this chapter range from the use of flammable liquids in an operating 
room to special sprinkler protection. These fire protection 
requirements are independent of the risk-based approach, as they are 
applicable to all patient care areas in both new and existing 
facilities.
    Chapter 15 has several sections taken directly from the NFPA 101, 
including requirements for the following:
     Construction and compartmentalization of health care 
facilities.
     Laboratories.
     Utilities.
     Heating, ventilation and air conditioning systems.
     Elevators.
     Escalators.
     Conveyors.
     Rubbish Chutes.
     Incinerators.
     Laundry Chutes.
     Fire detection, alarm and communication systems.
     Automatic sprinklers and other extinguishing equipment.
     Compact storage including mobile storage and maintenance.
     Testing of water based fire protection systems.
    These sections have requirements for inspection, testing and 
maintenance which apply to all facilities, as well as specific 
requirements for existing systems and equipment that also apply to all 
facilities.
    The prospective timeline for applicability of these requirements 
would be 60 days after the publication of the final rule in the Federal 
Register. We are soliciting comments on the proposal of the adoption of 
the 2012 NFPA 101 and the 2012 NFPA 99 for dialysis facilities that do 
not provide one or more exits to the outside at grade level from the 
treatment area level.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

V. Regulatory Impact Statement

    We have examined the impact of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
This rule does not reach the economic threshold and thus is not 
considered a major rule.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
less than $7.5 million to $38.5 million in any 1 year. Individuals and 
States are not included in the definition of a small entity. We are not 
preparing an analysis for the RFA because we have determined, and the 
Secretary certifies, that this proposed rule would not have a 
significant economic impact on a substantial number of small entities.
    In addition, section 1102(b) of the Social Security Act (the Act) 
requires us to prepare a regulatory impact analysis if a rule may have 
a significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 603 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a Metropolitan Statistical Area for Medicare payment regulations and 
has fewer than 100 beds. We are not preparing an analysis

[[Page 76904]]

for section 1102(b) of the Act because we have determined, and the 
Secretary certifies, that this proposed rule would not have a 
significant impact on the operations of a substantial number of small 
rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2016, that 
threshold is approximately $146 million. This rule will have no 
consequential effect on State, local, or tribal governments or on the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on State 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    We do not know how many, if any, dialysis facilities would be 
affected by this adoption of the 2012 editions of the NFPA 101 and NFPA 
99. However, we anticipate that the impact of this rule would be less 
than $1,000 for each facility, and that is if they are not already 
meeting the requirements of the 2012 editions of the NFPA 101 and NFPA 
99. Twenty states have already adopted the 2012 editions, so if there 
are facilities in those States, they are already following the 2012 
requirements. In accordance with the provisions of Executive Order 
12866, this regulation was reviewed by the Office of Management and 
Budget.

List of Subjects in 42 CFR Part 494

    Health facilities, Incorporation by reference, Kidney diseases, 
Medicare, Reporting and recordkeeping requirements.
    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE 
FACILITIES

0
1. The authority citation for part 494 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395(hh)).

0
2. Amend Sec.  494.60 by revising paragraphs (e)(1) and (4) and adding 
paragraphs (e)(5), (f), and (g) to read as follows:


Sec.  494.60  Condition: Physical environment.

* * * * *
    (e) * * *
    (1) Except as provided in paragraph (e)(2) of this section, 
dialysis facilities that do not provide one or more exits to the 
outside at grade level from the patient treatment area level must 
comply with provisions of the 2012 edition of the Life Safety Code of 
the National Fire Protection Association (NFPA 101 and Tentative 
Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4 
applicable to Ambulatory Health Care Occupancies (which is incorporated 
by reference in paragraph (g) of this section), regardless of the 
number of patients served.
* * * * *
    (4) In consideration of a recommendation by the State survey agency 
or at the discretion of the Secretary, the Secretary may waive, for 
periods deemed appropriate, specific provisions of the Life Safety 
Code, which would result in unreasonable hardship upon an ESRD 
facility, but only if the waiver will not adversely affect the health 
and safety of the patients.
    (5) No dialysis facility may operate in a building that is adjacent 
to an industrial high hazard area, as described in sections 20.1.3.7 
and 21.1.3.7 of the 2012 edition of the Health Care Facilities Code of 
the National Fire Protection Association (NFPA 99), incorporated by 
reference in paragraph (g) of this section.
    (f) Standard: Building safety. (1) Dialysis facilities that do not 
provide one or more exits to the outside at grade level from the 
patient treatment area level must meet the applicable provisions of the 
2012 edition of the Health Care Facilities Code of the National Fire 
Protection Association (NFPA 99 and Tentative Interim Amendments TIA 
12-2, TIA 12-3, TIA 12-4, TIA 12-5, and TIA 12-6), regardless of the 
number of patients served.
    (2) A copy of the Code is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD.
    (3) Chapters 7, 8, 12, and 13 of the NFPA 99 2012 Health Care 
Facilities Code do not apply to a dialysis facility.
    (4) If application of the NFPA 99 would result in unreasonable 
hardship for the dialysis facility, CMS may waive specific provisions 
of the Health Care Facilities Code for such facility, but only if the 
waiver does not adversely affect the health and safety of patients.
    (g) Incorporation by reference. The standards incorporated by 
reference in this section are approved for incorporation by reference 
by the Director of the Office of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy at the 
CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD 
or at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If any changes in this 
edition of the Code are incorporated by reference, CMS will publish a 
document in the Federal Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1-617-7470-3000.
    (i) NFPA 99, Standard for Health Care Facilities Code of the 
National Fire Protection Association 99, 2012 edition, issued August 
11, 2011.
    (ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011.
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

    Dated: September 7, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: October 17, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-26583 Filed 11-3-16; 8:45 am]
 BILLING CODE 4120-01-P