81_FR_77113 81 FR 76899 - Medicare and Medicaid Programs; Fire Safety Requirements for Certain Dialysis Facilities

81 FR 76899 - Medicare and Medicaid Programs; Fire Safety Requirements for Certain Dialysis Facilities

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 214 (November 4, 2016)

Page Range76899-76904
FR Document2016-26583

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.

Federal Register, Volume 81 Issue 214 (Friday, November 4, 2016) 
[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Proposed Rules]
[Pages 76899-76904]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Proposed Rules 76899 Additionally, EPA is proposing to • are not economically significant DEPARTMENT OF HEALTH AND determine that the BRNA has met the regulatory actions based on health or HUMAN SERVICES criteria under CAA section 107(d)(3)(E) safety risks subject to Executive Order for redesignation from nonattainment to 13045 (62 FR 19885, April 23, 1997); Centers for Medicare & Medicaid attainment for the 2008 ozone NAAQS. Services • are not significant regulatory On this basis, EPA is proposing to actions subject to Executive Order 42 CFR Part 494 approve Louisiana’s redesignation request for the BRNA. If finalized, 13211 (66 FR 28355, May 22, 2001); approval of the redesignation request • are not subject to requirements of [CMS–3334–P] would change the official designation of section 12(d) of the National RIN 0938–AS94 the portion of BRNA, as found at 40 CFR Technology Transfer and Advancement part 81, from nonattainment to Act of 1995 (15 U.S.C. 272 note) because Medicare and Medicaid Programs; Fire attainment for the 2008 ozone NAAQS. application of those requirements would Safety Requirements for Certain X. Statutory and Executive Order be inconsistent with the CAA; and Dialysis Facilities Reviews • do not provide EPA with the AGENCY: Centers for Medicare & Under the CAA, redesignation of an discretionary authority to address, as Medicaid Services (CMS), HHS. area to attainment and the appropriate, disproportionate human ACTION: Proposed rule. accompanying approval of a health or environmental effects, using maintenance plan under section practicable and legally permissible SUMMARY: This proposed rule would 107(d)(3)(E) are actions that affect the methods, under Executive Order 12898 update fire safety standards for status of a geographical area and do not (59 FR 7629, February 16, 1994). Medicare and Medicaid participating impose any additional regulatory In addition the SIP is not approved to ESRD facilities, adopt the 2012 edition requirements on sources beyond those apply on any Indian reservation land or of the Life Safety Code and eliminate imposed by state law. A redesignation to in any other area where EPA or an references in our regulations to all attainment does not in and of itself Indian tribe has demonstrated that a earlier editions of the Life Safety Code create any new requirements, but rather and adopt the 2012 edition of the Health tribe has jurisdiction. In those areas of results in the applicability of Care Facilities Code, with some Indian country, the proposed rule does requirements contained in the CAA for exceptions. areas that have been redesignated to not have tribal implications and will not impose substantial direct costs on tribal DATES: To be assured consideration, attainment. Moreover, the Administrator comments must be received at one of is required to approve a SIP submission governments or preempt tribal law as specified by Executive Order 13175 (65 the addresses provided below, no later that complies with the provisions of the than 5 p.m. on January 3, 2017. Act and applicable Federal regulations. FR 67249, November 9, 2000). ADDRESSES: In commenting, please refer See 42 U.S.C. 7410(k); 40 CFR 52.02(a). List of Subjects Thus, in reviewing SIP submissions, to file code CMS–3334–P. Because of EPA’s role is to approve state choices, 40 CFR Part 52 staff and resource limitations, we cannot provided that they meet the criteria of accept comments by facsimile (FAX) the CAA. Accordingly, these proposed Environmental protection, Air transmission. actions merely propose to approve state pollution control, Incorporation by You may submit comments in one of law as meeting Federal requirements reference, Intergovernmental relations, four ways (please choose only one of the and do not impose additional Nitrogen dioxide, Ozone, Reporting and ways listed): requirements beyond those imposed by recordkeeping requirements, Volatile 1. Electronically. You may submit state law. For this reason, these organic compounds. electronic comments on this regulation proposed actions: to http://www.regulations.gov. Follow 40 CFR Part 81 the ‘‘Submit a comment’’ instructions. • Are not a significant regulatory action subject to review by the Office of 2. By regular mail. You may mail Environmental protection, Air Management and Budget under written comments to the following pollution control. Executive Orders 12866 (58 FR 51735, address ONLY: Centers for Medicare & October 4, 1993) and 13563 (76 FR 3821, Authority: 42 U.S.C. 7401 et seq. Medicaid Services, Department of January 21, 2011); Dated: October 27, 2016. Health and Human Services, Attention: • do not impose an information Samuel Coleman, CMS–3334–P, P.O. Box 8010, Baltimore, collection burden under the provisions MD 21244–8010. Acting Regional Administrator, Region 6. Please allow sufficient time for mailed of the Paperwork Reduction Act (44 [FR Doc. 2016–26584 Filed 11–3–16; 8:45 am] comments to be received before the U.S.C. 3501 et seq.); • are certified as not having a BILLING CODE 6560–50–P close of the comment period. significant economic impact on a 3. By express or overnight mail. You substantial number of small entities may send written comments to the under the Regulatory Flexibility Act (5 following address ONLY: Centers for U.S.C. 601 et seq.); Medicare & Medicaid Services, • do not contain any unfunded Department of Health and Human rmajette on DSK2TPTVN1PROD with PROPOSALS mandate or significantly or uniquely Services, Attention: CMS–3334–P, Mail affect small governments, as described Stop C4–26–05, 7500 Security in the Unfunded Mandates Reform Act Boulevard, Baltimore, MD 21244–1850. of 1995 (Public Law 104–4); 4. By hand or courier. Alternatively, • do not have Federalism you may deliver (by hand or courier) implications as specified in Executive your written comments ONLY to the Order 13132 (64 FR 43255, August 10, following addresses prior to the close of 1999); the comment period: VerDate Sep<11>2014 11:53 Nov 03, 2016 Jkt 241001 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 E:\FR\FM\04NOP1.SGM 04NOP1

76900 Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Proposed Rules a. For delivery in Washington, DC— I. Background requirements to dialysis facilities either Centers for Medicare & Medicaid located adjacent to industrial high A. Overview Services, Department of Health and hazard areas, and those that did not Human Services, Room 445–G, Hubert The Life Safety Code (LSC) is a provide one or more exits to the outside H. Humphrey Building, 200 compilation of fire safety requirements at grade level from the patient treatment Independence Avenue SW., for new and existing buildings, and is area level. However, we inadvertently Washington, DC 20201 updated and published every 3 years by neglected to include updated provisions the National Fire Protection Association for dialysis facilities in our proposed (Because access to the interior of the (NFPA), a private, nonprofit update to the Life Safety Code Hubert H. Humphrey Building is not organization dedicated to reducing loss provisions for CMS providers and readily available to persons without of life due to fire. The Medicare and suppliers, ‘‘Medicare and Medicaid Federal government identification, Medicaid regulations have historically Programs; Fire Safety Requirements for commenters are encouraged to leave incorporated these requirements by Certain Health Care Facilities; Proposed their comments in the CMS drop slots reference, along with Secretarial waiver Rule’’ (79 FR 21552, April 16, 2014). located in the main lobby of the authority. The statutory basis for Therefore, we are proposing these building. A stamp-in clock is available incorporating NFPA’s LSC into the provisions now, with some for persons wishing to retain a proof of regulations we apply to Medicare and, modifications to address the unique filing by stamping in and retaining an as applicable, Medicaid providers and needs of dialysis facilities. The extra copy of the comments being filed.) suppliers is the Secretary of the proposed update would apply only to b. For delivery in Baltimore, MD— Department of Health and Human dialysis facilities that do not provide Centers for Medicare & Medicaid Services’ (the Secretary) authority to one or more exits to the outside at grade Services, Department of Health and stipulate health, safety and other level from the treatment area level (for Human Services, 7500 Security regulations for each type of Medicare instance, in upper floors of a mid-rise or Boulevard, Baltimore, MD 21244–1850. and (if applicable) Medicaid- high-rise building). We would not participating facility. Specifically, require other dialysis facilities to If you intend to deliver your section 1881(b)(1)(A) of the Social comply with NFPA 99® 2012 edition of comments to the Baltimore address, call Security Act (the Act) provides for the Health Care Facilities Code (NFPA telephone number (410) 786–9994 in payments for ‘‘providers of services and 99) and NFPA 101® 2012 edition of the advance to schedule your arrival with renal dialysis facilities which meet such Life Safety Code (NFPA 101) because we one of our staff members. requirements as the Secretary shall by believe that patients in dialysis facilities Comments erroneously mailed to the regulation prescribe for institutional are generally capable of unhooking addresses indicated as appropriate for dialysis services and supplies . . . . ’’ themselves from dialysis machines and hand or courier delivery may be delayed Under this statutory authority, the self-evacuating without additional and received after the comment period. Secretary has set out ‘‘Conditions for assistance in the event of an emergency. Coverage,’’ including LSC compliance We believe that in all facilities with at- For information on viewing public requirements, at 42 CFR part 494, grade exits, patients would be able to comments, see the beginning of the subpart B. Our current LSC provisions evacuate the building in a timely SUPPLEMENTARY INFORMATION section. are set out at § 494.60(e). fashion. Consequently, we believe that FOR FURTHER INFORMATION CONTACT: In implementing the LSC provisions, state and local requirements are Kristin Shifflett, (410) 786–4133. we have given ourselves the discretion sufficient to protect these patients and to waive specific provisions of the LSC staff in the event of an emergency. In SUPPLEMENTARY INFORMATION: for facilities if application of our rules accordance with NFPA 101 sections Inspection of Public Comments: All would result in unreasonable hardship 20.1.3.7 and 21.1.3.7, we would prohibit comments received before the close of for the facility, and if the health and Medicare-approved dialysis facilities the comment period are available for safety of its patients would not be from being located adjacent to industrial viewing by the public, including any compromised by such waiver. For high hazard facilities. ‘‘Adjacent to’’ is personally identifiable or confidential dialysis facilities, that authority is set defined as sharing a wall, ceiling or business information that is included in out at § 494.60(e)(4). In addition, the floor, with a facility. a comment. We post all comments Secretary may accept a State’s fire and safety code instead of the LSC if the Defining ‘‘Exit to the Outside at Grade received before the close of the Level From the Patient Treatment Area comment period on the following Web Centers for Medicare & Medicaid Services (CMS) determines that the Level’’ site as soon as possible after they have protections of the State’s fire and safety The phrase ‘‘exit to the outside at been received: http:// code are equivalent to, or more stringent grade level from the patient treatment www.regulations.gov. Follow the search than, the protections offered by the LSC; area level’’ applies to dialysis facilities instructions on that Web site to view dialysis facility provisions to that effect that are on the ground or grade level of public comments. are set out at § 494.60(e)(3). These a building where patients do not have Comments received timely will also flexibilities mitigate the potential to traverse up or down stairways within be available for public inspection as unnecessary burdens of applying the the building to evacuate to the outside. they are received, generally beginning requirements of the LSC to all affected Accessibility ramps in the exit area that approximately 3 weeks after publication health care facilities. provide an ease of access between the rmajette on DSK2TPTVN1PROD with PROPOSALS of a document, at the headquarters of On May 12, 2012, we published a patient treatment level and the outside the Centers for Medicare & Medicaid final rule in the Federal Register, ground level are not considered Services, 7500 Security Boulevard, entitled ‘‘Medicare and Medicaid stairways. Baltimore, Maryland 21244, Monday Program; Regulatory Provisions to A dialysis facility which provides one through Friday of each week from 8:30 Promote Program Efficiency, or more exits to the outside at grade a.m. to 4 p.m. To schedule an Transparency, and Burden Reduction’’ level from patient treatment level and appointment to view public comments, (77 FR 29002). In that final rule, we which has a patient exit path to the phone 1–800–743–3951. limited the application of LSC outside (which may include an VerDate Sep<11>2014 11:53 Nov 03, 2016 Jkt 241001 PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 E:\FR\FM\04NOP1.SGM 04NOP1

Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Proposed Rules 76901 accessibility ramp that is compliant compliance with the LSC does not CMS will publish a document in the with NFPA and the Americans with ensure compliance with the Federal Register to announce those Disabilities Act (ADA)) would be requirements of the ADA. State and changes. exempt from compliance with the local government programs and D. Ambulatory Health Care applicable provisions of NFPA 99 and services, including health care facilities, Occupancies NFPA 101. are required to comply with Title II of the ADA. Private entities that operate According to our memorandum, II. Provisions of the Proposed ‘‘Survey & Certification: 13–47–LSC/ Regulations public accommodations such as nursing homes, hospitals, and social service ESRD,’’ issued July 12, 2013, dialysis In this rule, we are proposing to center establishments are required to facilities that are subject to the LSC update our requirements for dialysis comply with Title III of the ADA. provisions must meet the requirements facilities that do not provide one or Entities that receive federal financial of the Ambulatory Health Care more exits to the outside at grade level assistance from the Department of Occupancy chapters 20 and 21 of the from the patient treatment area level, by Health and Human Services, including LSC. Dialysis facilities that are not incorporating by reference the 2012 Medicare and Medicaid, are also subject to our LSC regulations must edition of NFPA 101 and NFPA 99. required to comply with section 504 of continue to meet State and local fire These facilities are already required to the Rehabilitation Act of 1973. The codes. (See https://www.cms.gov/ meet the 2000 edition of the LSC; other same accessibility standards apply Medicare/Provider-Enrollment-and- provider types affected by the LSC are regardless of whether health care Certification/ now required to meet the 2012 edition facilities are covered under Title II or SurveyCertificationGenInfo/Downloads/ of the NFPA 101 and the NFPA 99 (LSC Title III of the ADA or section 504 of the Survey-and-Cert-Letter-13–47.pdf.) final rule published May 4, 2016 at 81 Rehabilitation Act of 1973.1 For more The following are key provisions in FR 26872). The 2012 edition of the LSC the 2012 edition of the LSC from information about the ADA’s includes new provisions that we believe Chapter 20, ‘‘New Ambulatory Health requirements, see the Department of are vital to the health and safety of all Care Occupancies’’ and Chapter 21, Justice’s Web site at http://www.ada.gov patients and staff. Our intention is to ‘‘Existing Ambulatory Health Care or call 1–800–514–0301 (voice) or 1– ensure that patients and staff continue Occupancies.’’ We have provided the 800–514–0383 (TTY). to experience the highest degree of fire LSC citation and a description of the safety possible. C. Incorporation by Reference requirement. The NFPA 101 2012 edition of the The 2012 edition of the LSC defines This proposed rule would incorporate LSC provides minimum requirements, an ‘‘Ambulatory Health Care by reference the NFPA 101® 2012 with due regard to function, for the Occupancy’’ as a facility capable of edition of the LSC, issued August 11, design, operation and maintenance of treating 4 or more patients 2011, and all Tentative Interim buildings and structures for safety to life simultaneously on an outpatient basis. Amendments issued prior to April 16, We believe that dialysis facilities that do from fire. Its provisions also aid life 2014; and the NFPA 99® 2012 edition of safety in similar emergencies. not provide one or more exits to the the Health Care Facilities Code, issued outside at grade level from the patient The NFPA 99 2012 edition of the August 11, 2011, and Tentative Interim Health Care Facilities Code provides treatment area should also be required Amendments issued prior to April 16, to meet the provisions applicable to minimum requirements for health care 2014 in § 494.60(g). facilities for the installation, inspection, Ambulatory Health Care Occupancy These materials have been previously Chapters, regardless of the number of testing, maintenance, performance, and incorporated by reference for other safe practices for facilities, material, patients served, as a matter of health provider types by a final rule titled and safety of patients receiving services equipment, and appliances. ‘‘Medicare and Medicaid Programs; Fire in these facilities. In the burden B. 2012 Edition of the Life Safety Code Safety Requirements for Certain Health reduction final rule, published in the The 2012 edition of the LSC includes Care Facilities’’ published on May 4, Federal Register on May 12, 2012 new provisions that we believe are vital 2016 (81 FR 26872). entitled, ‘‘Medicare and Medicaid to the health and safety of all patients The materials that are incorporated by Program; Regulatory Provisions to and staff. Our intention is to ensure that reference can be found for interested Promote Program Efficiency, patients and staff continue to experience parties and are available for inspection Transparency, and Burden Reduction’’ the highest degree of fire safety possible. at the CMS Information Resource (77 FR 29002), we removed the We do review each edition of the NFPA Center, 7500 Security Boulevard, provision’s applicability to dialysis 101 and NFPA 99 every 3 years to see Baltimore, MD 21244, or from the facilities with at-grade exits directly if there are any significant provisions National Fire Protection Association, 1 from the treatment area because, in our that we need to adopt. CMS will Batterymarch Park, Quincy, MA 02269. view, there was, and continues to be, an continue to review revisions to ensure If any changes to this edition of the extremely low risk of fire in dialysis we meet proper standards for patient Code are incorporated by reference, facilities. Medicare-approved dialysis safety. We have reviewed the 2015 1 Facilities newly constructed or altered after facilities that provide exits to the edition of the NFPA 101 and NFPA 99 March 15, 2012 must comply with the 2010 outside at grade level would continue to and do not believe that there are any Standards for Accessible Design (2010 Standards). be required to follow State and local fire significant provisions that need to be Facilities newly constructed or altered between codes, which we believe provide for rmajette on DSK2TPTVN1PROD with PROPOSALS addressed at this time. Newer buildings September 15, 2010 and March 15, 2012 had the sufficient patient protection in the event option of complying with either the 1991 Standards are typically built to comply with the for Accessible Design (1991 Standards) or the 2010 of an emergency. If a facility’s exits were newer versions of the LSC because state Standards. Facilities newly constructed between located above or below grade, patients and local jurisdictions often adopt and January 26, 1993 and September 15, 2010, or altered would require more time to evacuate. enforce newer versions of the LSC as between January 26, 1992 and September 15, 2010 Consequently, we believe that the LSC were required to comply with the 1991 Standards they become available. under Title III and either the 1991 Standards or the would still be required due to the CMS must emphasize that the LSC is Uniform Federal Accessibility Standards under additional risk entailed in longer exit not an accessibility code, and Title II. times. VerDate Sep<11>2014 11:53 Nov 03, 2016 Jkt 241001 PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 E:\FR\FM\04NOP1.SGM 04NOP1

76902 Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Proposed Rules Sections 20.3.2.1 and 21.3.2.1—Doors compilation of documents that have likely to cause injury to patients or This provision requires all doors to been developed over a 40-year period by caregivers, but can cause patient hazardous areas be self-closing or close NFPA, and is intended to be used by discomfort. . . .’’ Section 4.1.4 automatically. those persons involved in the design, describes Category 4 as, ‘‘Facility construction, inspection, and operation systems in which failure of such Sections 20.3.2.6 and 21.3.2.6—Alcohol of health care facilities, and in the equipment would have no impact on Based Hand Rubs design, manufacture, and testing of patient care. . . .’’ This provision explicitly allows appliances and equipment used in Section 4.2 requires that each facility aerosol dispensers, in addition to gel patient care areas of health care that is a health care or ambulatory hand rub dispensers. The aerosol facilities. It provides information on occupancy define its risk assessment dispensers are subject to limitations on subjects, for example, medical gas and methodology, implement the size, quantity, and location, just as gel vacuum systems, electrical systems, methodology, and document the results. dispensers are limited. Automatic electrical equipment, and gas We did not propose to require the use dispensers are also now permitted in equipment. The NFPA 99 applies of any particular risk assessment ambulatory care facilities, provided, specific requirements in accordance procedure. However, if future situations among other things, that—(1) they do with the results of a risk-based indicate the need to define a particular not release contents unless they are assessment methodology. A risk-based risk assessment procedure, we would activated; (2) the activation occurs only approach allows for the application of pursue that through a separate notice when an object is within 4 inches of the requirements based upon the types of and comment rulemaking. sensing device; (3) any object placed in treatment and services being provided to patients or residents rather than the Chapter 5—Gas and Vacuum Systems the activation zone and left in place must not cause more than one type of facility in which they are being The hazards addressed in Chapter 5 activation; (4) the dispenser must not performed. In order to ensure the include the ability of oxygen and dispense more than the amount required minimum level of protection afforded nitrous oxide to exacerbate fires, safety for hand hygiene consistent with the by NFPA 99 is applicable to all patient concerns from the storage and use of label instructions; (5) the dispenser is and resident care areas within a health pressurized gas, and the reliance upon designed, constructed and operated in a care facility, we are proposing adoption medical gas and vacuum systems for way to minimize accidental or of the 2012 edition of NFPA 99, with the patient care. Chapter 5 does not malicious dispensing; and (6) all exception of chapters 7—‘‘Information mandate the installation of any systems; dispensers are tested in accordance with Technology and Communications rather, if they are installed or are the manufacturer’s care and use Systems for Health Care Facilities’’; 8— required to be installed, the systems will instructions each time a new refill is ‘‘Plumbing’’; 12—‘‘Emergency be required to comply with NFPA 99. installed. The provision further defines Management’’; and 13—‘‘Security Chapter 5 covers the performance, prior language regarding ‘‘above or Management’’. The first three chapters maintenance, installation, and testing of adjacent to an ignition source’’ as being of the NFPA 99 address the the following: ‘‘within 1 inch’’ of the ignition source. administration of the NFPA 99, the • Nonflammable medical gas systems referenced publications, and definitions. with operating pressure below a gauge Sections 20.3.5 and 21.3.5— Short descriptions of some of the more pressure of 300 psi; Extinguishment Requirements important provisions of NFPA 99 • Vacuum systems in health care This provision is related to sprinkler follow: facilities; system requirements and requires the • Waste anesthetic gas disposal Chapter 4—Fundamentals evacuation of a building or the systems (WAGD); and instituting of an approved fire watch Chapter 4 provides guidance on how • Manufactured assemblies that are when a sprinkler system is out of to apply NFPA 99 requirements to intended for connection to the medical service for more than 10 hours in a 24- health care facilities based upon gas, vacuum, or WAGD systems. hour period until the system has been ‘‘categories’’ determined when using a risk-based methodology. Chapter 6—Electrical Systems returned to service. A facility must evacuate the building or portion of the There are four categories utilized in The hazards addressed in Chapter 6 building affected by the system outage the risk assessment methodology, are related to the electrical power until the system is back in service, or depending on the types of treatment and distribution systems in health care establish a fire watch until the system services being provided to patients or facilities, and address issues such as is back in service. residents. Section 4.1.1 of NFPA 99 electrical shock, power continuity, fire, describes Category 1 as, ‘‘Facility electrocution, and explosions that might E. 2012 Edition of the Health Care systems in which failure of such be caused by faults in the electrical Facilities Code equipment or system is likely to cause system. Chapter 6 also covers the The 2012 edition of the NFPA 99, major injury or death of patients or performance, maintenance, and testing ‘‘Health Care Facilities Code,’’ addresses caregivers. . . .’’ Section A.4.1.1 of the electrical systems in health care requirements for both health care provides examples of what a major facilities. occupancies and ambulatory care injury could include, such as occupancies, and serves as a resource amputation or a burn to the eye. Section Chapter 9—Heating, Ventilation, and for those who are responsible for 4.1.2 describes Category 2 as, ‘‘Facility Air Conditioning (HVAC) rmajette on DSK2TPTVN1PROD with PROPOSALS protecting health care facilities from fire systems in which failure of such Chapter 9 requires HVAC systems and associated hazards. The purpose of equipment is likely to cause minor serving spaces or providing health care this Code is to provide minimum injury to patients or caregivers. . . .’’ functions to be in accordance with the requirements for the installation, Section A.4.1.2 describes a minor injury American Society of Heating, inspection, testing, maintenance, as one that is not serious or involving Refrigeration and Air-Conditioning performance, and safe practices for risk of life. Section 4.1.3 describes Engineers (ASHRAE) Standard 170— health care facility materials, equipment Category 3 as, ‘‘Facility systems in Ventilation of Health Care Facilities and appliances. This Code is a which failure of such equipment is not (2008 edition) (http://www.ashrae.org). VerDate Sep<11>2014 11:53 Nov 03, 2016 Jkt 241001 PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 E:\FR\FM\04NOP1.SGM 04NOP1

Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Proposed Rules 76903 Chapter 9 does not apply to existing facilities. Issues addressed in this this preamble, and, when we proceed HVAC systems, but applies to the chapter range from the use of flammable with a subsequent document, we will construction of new health care liquids in an operating room to special respond to the comments in the facilities, and the altered, renovated, or sprinkler protection. These fire preamble to that document. modernized portions of existing systems protection requirements are V. Regulatory Impact Statement or individual components. Chapter 9 independent of the risk-based approach, ensures minimum levels of heating, as they are applicable to all patient care We have examined the impact of this ventilation and air conditioning areas in both new and existing facilities. rule as required by Executive Order performance in patient and resident care Chapter 15 has several sections taken 12866 on Regulatory Planning and areas. Some of the issues discussed in directly from the NFPA 101, including Review (September 30, 1993), Executive Chapter 9 are as follows: requirements for the following: Order 13563 on Improving Regulation • HVAC system energy conservation; • Construction and and Regulatory Review (January 18, • Commissioning; compartmentalization of health care 2011), the Regulatory Flexibility Act • Piping; facilities. (RFA) (September 19, 1980, Pub. L. 96– • Ductwork; • Laboratories. 354), section 1102(b) of the Social • Acoustics; • Utilities. Security Act, section 202 of the • Requirements for the ventilation of • Heating, ventilation and air Unfunded Mandates Reform Act of 1995 medical gas storage and trans-filling conditioning systems. (March 22, 1995; Pub. L. 104–4), areas; • Elevators. Executive Order 13132 on Federalism • Waste anesthetic gases; • Escalators. (August 4, 1999) and the Congressional • Plumes from medical procedures; • Conveyors. Review Act (5 U.S.C. 804(2). • Emergency power system rooms; • Rubbish Chutes. Executive Orders 12866 and 13563 and • Incinerators. direct agencies to assess all costs and • Ventilation during construction. • Laundry Chutes. benefits of available regulatory • Fire detection, alarm and alternatives and, if regulation is Chapter 10—Electrical Equipment communication systems. necessary, to select regulatory Chapter 10 covers the performance, • Automatic sprinklers and other approaches that maximize net benefits maintenance, and testing of electrical extinguishing equipment. (including potential economic, equipment in health care facilities. • Compact storage including mobile environmental, public health and safety Much of this chapter applies to storage and maintenance. effects, distributive impacts, and requirements for portable electrical • Testing of water based fire equity). A regulatory impact analysis equipment in health care facilities, but protection systems. (RIA) must be prepared for major rules there are also requirements for fixed- These sections have requirements for with economically significant effects equipment and information on inspection, testing and maintenance ($100 million or more in any 1 year). administrative issues. which apply to all facilities, as well as This rule does not reach the economic specific requirements for existing threshold and thus is not considered a Chapter 11—Gas Equipment systems and equipment that also apply major rule. The hazards addressed in Chapter 11 to all facilities. The RFA requires agencies to analyze relate to general fire, explosions, and The prospective timeline for options for regulatory relief of small mechanical issues associated with gas applicability of these requirements entities. For purposes of the RFA, small equipment, including compressed gas would be 60 days after the publication entities include small businesses, cylinders. of the final rule in the Federal Register. nonprofit organizations, and small We are soliciting comments on the governmental jurisdictions. Most Chapter 14—Hyperbaric Facilities hospitals and most other providers and proposal of the adoption of the 2012 Chapter 14 addresses the hazards NFPA 101 and the 2012 NFPA 99 for suppliers are small entities, either by associated with hyperbaric facilities in dialysis facilities that do not provide nonprofit status or by having revenues health care facilities, including one or more exits to the outside at grade of less than $7.5 million to $38.5 electrical, explosive, implosive, as well level from the treatment area level. million in any 1 year. Individuals and as fire hazards. Chapter 14 sets forth States are not included in the definition minimum safeguards for the protection III. Collection of Information of a small entity. We are not preparing of patients and personnel administering Requirements an analysis for the RFA because we have hyperbaric therapy and procedures. This document does not impose determined, and the Secretary certifies, Chapter 14 contains requirements for information collection requirements, that this proposed rule would not have hyperbaric chamber manufacturers, that is, reporting, recordkeeping or a significant economic impact on a hyperbaric facility designers, and third-party disclosure requirements. substantial number of small entities. personnel operating hyperbaric Consequently, there is no need for In addition, section 1102(b) of the facilities. It also contains requirements review by the Office of Management and Social Security Act (the Act) requires us related to construction of the hyperbaric Budget under the authority of the to prepare a regulatory impact analysis chamber itself and the equipment used Paperwork Reduction Act of 1995 (44 if a rule may have a significant impact for supporting the hyperbaric chamber, U.S.C. 3501 et seq.). on the operations of a substantial as well as administration and number of small rural hospitals. This rmajette on DSK2TPTVN1PROD with PROPOSALS IV. Response to Comments analysis must conform to the provisions maintenance. Many requirements in this chapter are applicable only to new Because of the large number of public of section 603 of the RFA. For purposes construction and new facilities. comments we normally receive on of section 1102(b) of the Act, we define Federal Register documents, we are not a small rural hospital as a hospital that Chapter 15—Features of Fire Protection able to acknowledge or respond to them is located outside of a Metropolitan Chapter 15 covers the performance, individually. We will consider all Statistical Area for Medicare payment maintenance, and testing of fire comments we receive by the date and regulations and has fewer than 100 protection equipment in health care time specified in the DATES section of beds. We are not preparing an analysis VerDate Sep<11>2014 11:53 Nov 03, 2016 Jkt 241001 PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 E:\FR\FM\04NOP1.SGM 04NOP1

76904 Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Proposed Rules for section 1102(b) of the Act because paragraphs (e)(5), (f), and (g) to read as (g) Incorporation by reference. The we have determined, and the Secretary follows: standards incorporated by reference in certifies, that this proposed rule would this section are approved for § 494.60 Condition: Physical environment. not have a significant impact on the incorporation by reference by the operations of a substantial number of * * * * * Director of the Office of the Federal small rural hospitals. (e) * * * (1) Except as provided in paragraph Register in accordance with 5 U.S.C. Section 202 of the Unfunded 552(a) and 1 CFR part 51. You may Mandates Reform Act of 1995 also (e)(2) of this section, dialysis facilities that do not provide one or more exits to inspect a copy at the CMS Information requires that agencies assess anticipated Resource Center, 7500 Security costs and benefits before issuing any the outside at grade level from the patient treatment area level must Boulevard, Baltimore, MD or at the rule whose mandates require spending comply with provisions of the 2012 National Archives and Records in any 1 year of $100 million in 1995 edition of the Life Safety Code of the Administration (NARA). For dollars, updated annually for inflation. In 2016, that threshold is approximately National Fire Protection Association information on the availability of this $146 million. This rule will have no (NFPA 101 and Tentative Interim material at NARA, call 202–741–6030, consequential effect on State, local, or Amendments TIA 12–1, TIA 12–2, TIA or go to: http://www.archives.gov/ tribal governments or on the private 12–3, and TIA 12–4 applicable to federal_register/code_of_federal_ sector. Ambulatory Health Care Occupancies regulations/ibr_locations.html. If any Executive Order 13132 establishes (which is incorporated by reference in changes in this edition of the Code are certain requirements that an agency paragraph (g) of this section), regardless incorporated by reference, CMS will must meet when it promulgates a of the number of patients served. publish a document in the Federal proposed rule (and subsequent final * * * * * Register to announce the changes. rule) that imposes substantial direct (4) In consideration of a (1) National Fire Protection requirement costs on State and local recommendation by the State survey agency or at the discretion of the Association, 1 Batterymarch Park, governments, preempts State law, or Quincy, MA 02169, www.nfpa.org, 1– otherwise has Federalism implications. Secretary, the Secretary may waive, for periods deemed appropriate, specific 617–7470–3000. Since this regulation does not impose any costs on State or local governments, provisions of the Life Safety Code, (i) NFPA 99, Standard for Health Care the requirements of Executive Order which would result in unreasonable Facilities Code of the National Fire 13132 are not applicable. hardship upon an ESRD facility, but Protection Association 99, 2012 edition, We do not know how many, if any, only if the waiver will not adversely issued August 11, 2011. dialysis facilities would be affected by affect the health and safety of the (ii) TIA 12–2 to NFPA 99, issued this adoption of the 2012 editions of the patients. August 11, 2011. NFPA 101 and NFPA 99. However, we (5) No dialysis facility may operate in anticipate that the impact of this rule a building that is adjacent to an (iii) TIA 12–3 to NFPA 99, issued would be less than $1,000 for each industrial high hazard area, as described August 9, 2012. facility, and that is if they are not in sections 20.1.3.7 and 21.1.3.7 of the (iv) TIA 12–4 to NFPA 99, issued already meeting the requirements of the 2012 edition of the Health Care March 7, 2013. 2012 editions of the NFPA 101 and Facilities Code of the National Fire Protection Association (NFPA 99), (v) TIA 12–5 to NFPA 99, issued NFPA 99. Twenty states have already August 1, 2013. adopted the 2012 editions, so if there incorporated by reference in paragraph are facilities in those States, they are (g) of this section. (vi) TIA 12–6 to NFPA 99, issued already following the 2012 (f) Standard: Building safety. (1) March 3, 2014. requirements. In accordance with the Dialysis facilities that do not provide (vii) NFPA 101, Life Safety Code, provisions of Executive Order 12866, one or more exits to the outside at grade 2012 edition, issued August 11, 2011. this regulation was reviewed by the level from the patient treatment area level must meet the applicable (viii) TIA 12–1 to NFPA 101, issued Office of Management and Budget. provisions of the 2012 edition of the August 11, 2011. List of Subjects in 42 CFR Part 494 Health Care Facilities Code of the (ix) TIA 12–2 to NFPA 101, issued Health facilities, Incorporation by National Fire Protection Association October 30, 2012. reference, Kidney diseases, Medicare, (NFPA 99 and Tentative Interim (x) TIA 12–3 to NFPA 101, issued Reporting and recordkeeping Amendments TIA 12–2, TIA 12–3, TIA October 22, 2013. requirements. 12–4, TIA 12–5, and TIA 12–6), For the reasons set forth in the regardless of the number of patients (xi) TIA 12–4 to NFPA 101, issued preamble, the Centers for Medicare & served. October 22, 2013. Medicaid Services proposes to amend (2) A copy of the Code is available for (2) [Reserved] 42 CFR chapter IV as set forth below: inspection at the CMS Information Resource Center, 7500 Security Dated: September 7, 2016. PART 494—CONDITIONS FOR Boulevard, Baltimore, MD. Andrew M. Slavitt, COVERAGE FOR END-STAGE RENAL (3) Chapters 7, 8, 12, and 13 of the Acting Administrator, Centers for Medicare DISEASE FACILITIES NFPA 99 2012 Health Care Facilities & Medicaid Services. rmajette on DSK2TPTVN1PROD with PROPOSALS Code do not apply to a dialysis facility. Dated: October 17, 2016. ■ 1. The authority citation for part 494 (4) If application of the NFPA 99 continues to read as follows: Sylvia M. Burwell, would result in unreasonable hardship for the dialysis facility, CMS may waive Secretary, Department of Health and Human Authority: Secs. 1102 and 1871 of the Services. Social Security Act (42 U.S.C. 1302 and specific provisions of the Health Care 1395(hh)). Facilities Code for such facility, but [FR Doc. 2016–26583 Filed 11–3–16; 8:45 am] ■ 2. Amend § 494.60 by revising only if the waiver does not adversely BILLING CODE 4120–01–P paragraphs (e)(1) and (4) and adding affect the health and safety of patients. VerDate Sep<11>2014 11:53 Nov 03, 2016 Jkt 241001 PO 00000 Frm 00028 Fmt 4702 Sfmt 9990 E:\FR\FM\04NOP1.SGM 04NOP1


Document Created: 2018-02-14 08:26:03
Document Modified: 2018-02-14 08:26:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesTo be assured consideration, comments must be received at one of
ContactKristin Shifflett, (410) 786-4133.
FR Citation81 FR 76899 
RIN Number0938-AS94
CFR AssociatedHealth Facilities; Incorporation by Reference; Kidney Diseases; Medicare and Reporting and Recordkeeping Requirements
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