Federal Register, Volume 73 Issue 73 (Tuesday, April 15, 2008)

[Federal Register Volume 73, Number 73 (Tuesday, April 15, 2008)]
[Rules and Regulations]
[Pages 20370-20484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1102]

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Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 405, 410, 413 et al.

Medicare and Medicaid Programs; Conditions for Coverage for End-Stage
Renal Disease Facilities; Final Rule

Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 413, 414, 488, and 494

[CMS-3818-F]
RIN 0938-AG82

Medicare and Medicaid Programs; Conditions for Coverage for End-
Stage Renal Disease Facilities

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

ACTION: Final rule.

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SUMMARY: This rule finalizes the February 4, 2005 proposed rule
entitled ``Medicare Program; Conditions for Coverage for End-Stage
Renal Disease Facilities.'' It establishes new conditions for coverage
that dialysis facilities must meet to be certified under the Medicare
program. This final rule focuses on the patient and the results of care
provided to the patient, establishes performance expectations for
facilities, encourages patients to participate in their plan of care
and treatment, eliminates many procedural requirements from the
previous conditions for coverage, preserves strong process measures
when necessary to promote meaningful patient safety, well-being, and
continuous quality improvement. This final rule reflects the advances
in dialysis technology and standard care practices since the
requirements were last revised in their entirety in 1976.

DATES: The provisions of this final rule are effective October 14,
2008. Compliance with Sec. 494.30(a)(1)(i) and Sec. 494.60(e)(1) is
not required until February 9, 2009. In addition, the compliance with
Sec. 494.180(h) is effective on February 1, 2009. The incorporation by
reference of certain publications listed in the regulations is approved
by the Director of the Federal Register as of October 14, 2008.

FOR FURTHER INFORMATION CONTACT: Lynn Riley, (410) 786-1286, Stefan
Miller, (410) 786-6656, Lauren Oviatt, (410) 786-4683, Judith Kari,
(410) 786-6829, (Survey and Certification), Teresa Casey, (410) 786-
7215, (Issues related to Quality Assessment Performance Improvement).

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
A. Introduction
B. Legislative History
C. Existing ESRD Regulations
D. The Establishment of Central Requirements
II. Summary of the Proposed Provisions and Response to Comments on
the February 4, 2005 Proposed Rule
A. Part 414--Payment for Part B Medical and Other Health
Services; Payment for Home Dialysis Equipment, Supplies, and Support
Services (Proposed Sec. 414.330)
B. Part 488--Survey, Certification, and Enforcement Procedures;
Special Procedures for Approving End-Stage Renal Disease Facilities
(Proposed Sec. 488.60)
C. Part 494--Conditions for Coverage for End-Stage Renal Disease
Facilities
1. Subpart A--General Provisions
a. Basis and Scope (Proposed Sec. 494.1)
b. Definitions (Proposed Sec. 494.10)
c. Compliance With Federal, State, and Local Laws and
Regulations (Proposed Sec. 494.20)
2. Subpart B--Patient Safety
a. Infection Control (Proposed Sec. 494.30)
b. Water and Dialysate Quality (Proposed Sec. 494.40)
c. Reuse of Hemodialyzers and Bloodlines (Proposed Sec. 494.50)
d. Physical Environment (Proposed Sec. 494.60)
3. Subpart C--Patient Care
a. Patients' Rights (Proposed Sec. 494.70)
b. Patient Assessment (Proposed Sec. 494.80)
c. Patient Plan of Care (Proposed Sec. 494.90)
d. Care at Home (Proposed Sec. 494.100)
e. Quality Assessment and Performance Improvement (Proposed
Sec. 494.110)
f. Special Purpose Renal Dialysis Facilities (Proposed Sec.
494.120)
g. Laboratory Services (Proposed Sec. 494.130)
4. Subpart D--Administration
a. Personnel Qualifications (Proposed Sec. 494.140)
b. Responsibilities of the Medical Director (Proposed Sec.
494.150)
c. Relationship With the ESRD Network (Proposed Sec. 494.160)
d. Medical Records (Proposed Sec. 494.170)
e. Governance (Proposed Sec. 494.180)
D. Other Proposed Changes and Issues
1. Proposed Cross-Reference Changes
2. Proposed Additions to Part 488
E. Survey & Certification Comments
F. Impact Analysis Comments
III. Provisions of the Final Rule
IV. Effective Dates for the Final Rule
V. Reference Materials
A. Provisions of Part 494
B. ESRD Crosswalk
VI. Collection of Information Requirement
VII. Regulatory Impact Analysis
Regulations Text

Acronym List

AAMI Association for the Advancement of Medical Instrumentation
ACLS Advanced Cardiac Life Support
ADA American Dietetic Association
AED Automated external defibrillator
AIA American Institute of Architects
AHA American Heart Association
ALT Alanine Aminotransferase
APA Administrative Procedures Act
ANSI American National Standards Institute
BMI Body mass index
BONENT Board of Nephrology Nursing Examiners Nursing and Technology
BSW Bachelor's degree social worker
CADE Commission on Accreditation for Dietetics Education
CAHPS Consumer Assessment of Health Plans Survey
CCHT Certified Clinical Hemodialysis Technician
CDC Centers for Disease Control and Prevention
CEO Chief executive officer
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare and Medicaid Services
CNSW Council of Nephrology Social Workers
CPG Clinical practice guidelines
CPM Clinical performance measures
CRAFT CROWN Responsiveness and Feedback Tree
CROWNWeb Consolidated Renal Operations in a Web-enabled Network
DFC Dialysis Facility Compare
DHHS Department of Health and Human Services
DOPPS Dialysis Outcomes and Practice Patterns Study
DOQI Disease Outcomes Quality Initiative
DTR Dietetic Technician, Registered
EDI Electronic Data Interchange
EMS Emergency medical system
ESRD End-Stage renal disease
FDA Food and Drug Administration
HBsAg Hepatitis B surface antigen
HIPAA Health Insurance Portability and Accountability Act 1996
HBV Hepatitis B virus
HCV Hepatitis C virus
HICPAC Healthcare Infection Control Practices Advisory Committee
HMO Health Maintenance Organization
ICC International Code Council
ICH In-center hemodialysis
IOM Institute of Medicine
KCP Kidney Care Partners
KDOQI Kidney Disease Outcomes Quality Initiative
K/DOQI Kidney Disease Outcomes Quality Initiative
LAL Amoebocyte lysate
LDO Large dialysis organization
LPN Licensed practical nurse
LVN Licensed vocational nurse
LSC Life Safety Code
MedPAC Medicare Payment Advisory Commission
MNT Medical nutrition therapy
MPD Mission and Priority Document
MSW Master's degree social worker
NCD National Coverage Determination
NF Nursing Facility
NKF National Kidney Foundation
NKF-KDOQI National Kidney Foundation's Kidney Disease Outcomes
Quality Initiative
NNCC Nephrology Nursing Certification Commission
NNCO National Nephrology Certification Organization
NQF National Quality Forum
NTTAA National Technology Transfer and Advancement Act of 1995
OIG Office of the Inspector General
PA Physician assistant

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PCT Patient care technician
QAPI Quality assessment and performance improvement
QIS Quality Infrastructure Report
RD Registered dietitian
RN Registered nurse
REMIS Renal Management Information System
RO Reverse osmosis
RPA Renal Physicians Association
SGA Subjective global assessment
SHEA Society for Healthcare Epidemiology of America
SNF Skilled nursing facility
SOW Scope of work
STIC Safe and Timely Immunization Coalition
TEP Technical Expert Panel
VISION Vital Information System to Improve Outcomes in Nephrology

I. Background

A. Introduction

End-Stage Renal Disease (ESRD) is a kidney impairment that is
irreversible and permanent and requires either a regular course of
dialysis or kidney transplantation to maintain life. Dialysis is the
process of cleaning the blood and removing excess fluid artificially
with special equipment when the kidneys have failed. Our existing ESRD
services conditions for coverage were originally adopted in 1976 (41 FR
22502). In our existing requirements for dialysis facilities at 42 CFR
part 405, subpart U, we emphasize the policies and procedures that must
be in place to support good patient care, and we focus on a facility's
capacity to furnish quality care. To determine if a facility meets ESRD
conditions for coverage, the State survey agency performs an on-site
survey of the facility. If a survey indicates that a facility is in
compliance with the conditions, and all other Federal requirements are
met, we then certify the facility as qualifying for Medicare payment.
Medicare payment for outpatient maintenance dialysis is limited to
facilities meeting these conditions. We have made several changes to
our ESRD requirements since they were first adopted in 1976. However,
they have not been comprehensively revised since that time.
On February 4, 2005, we published in the Federal Register a
proposed rule entitled ``Conditions for Coverage for End-Stage Renal
Disease Facilities'' (70 FR 6183). In that rule, we proposed revisions
to the requirements that ESRD dialysis facilities must meet in order to
be certified under the Medicare program.
Our decision to propose major changes to the existing conditions
was based on several considerations. Revising the ESRD requirements is
part of our effort to modernize regulations and improve the
availability of quality-of-care information; to promote transparency;
and to move toward a patient outcome-based system that focuses on
quality assessment and performance improvement. We believe that
revising the conditions for coverage would encourage improvement in
outcomes of care for beneficiaries. We wish to incorporate the most
recent medical and scientific guidelines and recommendations for
dialysis facilities from the Centers for Disease Control and Prevention
(CDC), the Association for the Advancement of Medical Instrumentation
(AAMI), and recognize current practice guidelines and professional
standards of practice such as the National Kidney Foundation's Kidney
Disease Outcomes Quality Initiative (NKF-K/DOQI) clinical practice
guidelines (CPGs).

B. Legislative History

Section 299I of the Social Security Amendments of 1972 (Pub. L. 92-
603) originally extended Medicare coverage to insured individuals,
their spouses, and their dependent children with ESRD who require
dialysis or transplantation. The ESRD program became effective July 1,
1973, and initially operated under interim regulations published in the
Federal Register on June 29, 1973 (38 FR 17210). In the July 1, 1975
Federal Register (40 FR 27782), we published a proposed rule that
revised sections of the ESRD requirements. On June 3, 1976 the final
rule was published in the Federal Register (41 FR 22501). Subsequently,
the ESRD Amendments of 1978 (Pub. L. 95-292), amended title XVIII of
the Social Security Act (the Act) by adding section 1881. Sections
1881(b)(1) and 1881(f)(7) of the Act further authorize the Secretary to
prescribe health and safety requirements (known as conditions for
coverage) that a facility providing dialysis and transplantation
services to dialysis patients must meet to qualify for Medicare
payment. In addition, section 1881(c) of the Act establishes ESRD
Network areas and Network organizations to assure that dialysis
patients are provided appropriate care.
We know, based on comments, that many in the community support the
overall shift in the ESRD conditions for coverage from an emphasis on
process-oriented requirements to a more patient-centered, outcome-
oriented approach. Further, we believe that virtually all members of
the community support a quality assessment and performance improvement
requirement and the development of a comprehensive data set that will
contain information including the characteristics of ESRD facilities,
their patient populations, as well as outcome measures of patient care.
The fundamental principles that guided us during this collaborative
effort to develop new conditions were as follows:
Ensure that patients' rights and physical safety are
protected;
Stress continuous quality assessment and performance
improvement, incorporating, to the greatest extent possible, outcome-
oriented, data-driven measures;
Facilitate flexibility in how dialysis facilities meet our
performance requirements;
Eliminate unnecessary administrative policies. Process-
oriented standards are only included where we believe they are
essential to protect patient health and safety;
Focus on the continuous, interdisciplinary, integrated
care system that a dialysis patient experiences, centered around
patient assessment, care planning, service delivery, and quality
assessment and performance improvement; and
Stress patient satisfaction and ongoing patient
involvement in the development of the care plan and treatment.
Finally, in order for the ESRD facility conditions for
coverage to move from a process and structure orientation toward a more
patient-centered, outcome-oriented approach, individual patient and
facility-specific outcome measures must be identified and evaluated, or
in the absence of existing measures, they must be developed and
validated with community input to ensure they are clinically meaningful
and reflect current scientific knowledge.

C. Existing ESRD Regulation

The requirements from section 1881(b), (c), and (f)(7) of the Act
are implemented in regulations at 42 CFR part 405, subpart U,
``Conditions for Coverage of Suppliers of End-Stage Renal Disease
(ESRD) Services.''
The existing regulations describe the health and safety
requirements that dialysis facilities must meet to furnish care to
Medicare beneficiaries. The regulations in part 405, subpart U also
include the provision that dialysis facilities be organized into
Network areas and describe the role that Networks play in the ESRD
program. Networks are defined at Sec. 405.2110 as ``CMS designated
ESRD Networks in which the approved ESRD facilities collectively
provide the necessary care for ESRD patients.''

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The purpose of the existing conditions for coverage (also known as
conditions) is to protect dialysis patients' health and safety and to
ensure that quality care is furnished to all patients in Medicare-
approved dialysis facilities.
The ESRD conditions for coverage (health and safety provisions for
dialysis facilities) will be moved from existing 42 CFR part 405,
subpart U, to a new 42 CFR part 494, where they will follow regulations
establishing standards for other Medicare providers, such as the
conditions of participation for hospitals (42 CFR part 482), long-term
care facilities (42 CFR part 483), and home health agencies (42 CFR
part 484). The termination of Medicare coverage and alternative
sanctions conditions at Sec. 405.2180 through Sec. 405.2184 will be
recodified at Sec. 488.604 through Sec. 488.610. Since many of the
existing ESRD conditions will be revised, consolidated with other
conditions, or deleted, we are renumbering and reorganizing the
requirements.

D. The Establishment of Central Requirements

Our 2005 proposed rule proposed new conditions for coverage for
ESRD facilities that revise or eliminate many of the existing
requirements and establish critical central requirements. The central
requirements of this rule were grouped into three broad categories: (1)
Patient safety; (2) patient care; and (3) administration. Subpart A
contained general provisions, for example, statutory authority,
definitions, and requirements for compliance with Federal, State and
local laws and regulations. Subpart B (Patient Safety), and subpart C
(Patient Care) of the proposed conditions for coverage focused on the
actual care delivered to the patients, the performance of the dialysis
facility, and the impact of the treatment furnished by the dialysis
facility on the health status of its patients. Subpart D contained
personnel, ESRD Network, medical records and governance requirements.
In subpart B (Patient Safety), we proposed to retain and strengthen
some process-oriented patient safety provisions that we believe remain
highly predictive of ensuring desired outcomes and preventing harmful
outcomes. Accordingly, the proposed patient safety requirements
incorporated current CDC infection control procedures, retained and
updated our incorporation by reference of the AAMI standards and
guidelines for water quality and dialysate, hemodialyzer reuse
practices, and incorporated by reference applicable current Life Safety
Code (LSC) provisions.
Subpart C (Patient Care) included provisions: (1) Emphasizing a
dialysis facility's fundamental responsibility to respect and promote
the rights of each patient (patient rights); (2) requiring a facility
to perform a comprehensive assessment to determine appropriate
treatments and achieve desired health outcomes (Patient Assessment);
(3) requiring an interdisciplinary team approach to providing dialysis
services to patients; and specifying the process by which the
interdisciplinary team would achieve effective patient health outcomes
(Patient Plan of Care); (4) requiring a quality assessment and
performance improvement program which would charge each dialysis
facility with carrying out a program of its own design to continually
improve quality outcomes and patient satisfaction; and (5)
consolidating various aspects of home dialysis care into a single
condition (Care at home).
Subpart D (Administration) covered the operation of the dialysis
facility in a patient outcome-oriented environment, including: (1)
Minimum personnel qualifications; (2) the role of the medical director;
(3) the facility's relationship with its servicing ESRD Network; (4)
medical recordkeeping; and (5) minimum operating responsibilities of
the facility, including data collection and reporting requirements
(Governance).
On August 22, 2006, President Bush signed Executive Order 13410,
entitled ``Promoting Quality and Efficient Health Care in Federal
Government Administered or Sponsored Health Care Programs' (71 FR
51089, August 28, 2006). In order to empower Americans to find better
health care value and better health care, they should know their health
care options in advance. Patients need access to information regarding
the quality of doctors, hospitals, dialysis facilities and other
providers in their area, as well as the costs of various medical
procedures. The August 2006 executive order directs agencies to
increase transparency in pricing by sharing pricing information with
patients; to increase transparency in quality by sharing information
with patients on the quality of services provided by doctors,
hospitals, ESRD facilities, and other health care providers; to
encourage the adoption of health information technology systems that
meet recognized interoperability standards; and to provide patients
with options that promote quality and efficiency in health care, by
developing and identifying approaches that facilitate high quality and
efficient care. Building on efforts of quality alliances that include a
broad range of healthcare stakeholders, we will work collaboratively to
improve quality and cost information. Patients will be able to access
this information from a variety of potential sources, including
insurance companies, employers, and Medicare sponsored Web sites. In
order to help dialysis patients make more informed health care
decisions and to increase transparency, this final rule promotes a
patient-centered approach and focuses on disclosing relevant
information regarding care to patients.
We believe that transparency will also be improved by the
implementation of an electronic Web-based data collection system,
Consolidated Renal Operations in a Web-enabled Network (CROWNWeb),
which is designed to collect clinical performance measures (CPMs) data
from dialysis facilities. CPM data are used to monitor the performance
of Medicare-certified dialysis facilities on a national and local
level. These data are also used to provide information to individuals
who have or may develop ESRD and their caregivers to assist them in
making health care decisions; to allow the identification of
opportunities for quality improvement at a national, regional, or
dialysis facility-level; and to calculate case-mix adjustments and the
potential future use of value based purchasing.
Dialysis Facility Compare (DFC) is an online tool at http://www.medicare.gov available for dialysis patients and their caregivers,
which serves to enhance public accountability in healthcare by
increasing transparency regarding the quality of dialysis facility
care. DFC allows patients and caregivers to find and compare
information about the services and quality of care provided at dialysis
facilities in any State. Important information and resources regarding
chronic kidney disease is also available on the DFC Web site.

II. Summary of the Proposed Provisions and Response to Comments on the
February 4, 2005 Proposed Rule

The comment period for the February 4, 2005 proposed rule was 90
days, and closed on May 5, 2005. We received over 3,000 public
comments, but many were form letters, so that the total number of
discrete comments was approximately 315. Interested parties that
commented included the American Association of Kidney Patients, the
American Kidney Fund, the American Nephrology Nurses Association, the
American Society of Nephrology, the American Healthcare Association,
the Association of Dialysis Advocates, the

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Association for the Advancement of Medical Instrumentation, the
American Society of Pediatric Nephrology, the American Dietetic
Association, DaVita, Inc., Dialysis Centers Inc., Fresenius Medical
Care North America, Gambro Healthcare, Kidney Care Partners, Life
Options Rehabilitation Advisory Council, the National Kidney
Foundation, the National Renal Administrator's Association, the
National Association of Nephrology Technicians, the Renal Care Group,
the Renal Physicians Association, the Renal Support Network, Medical
Education Institute, Inc., state survey agencies, ESRD Networks and the
Forum of ESRD Networks, healthcare professionals, administrators,
academics, dialysis patients, pharmaceutical and dialysis product
companies, and hospital-based and non-hospital-based dialysis
providers. Many commenters applauded the long overdue modernization of
the ESRD conditions for coverage, even though they may have disagreed
with a specific requirement or concept. Below we provide a brief
summary of each proposed provision, a summary of the public comments we
received, and our responses to the comments.
We received several comments on issues outside of the scope of this
final rule, which we will not address. Please note, that in this final
rule we have revised the title of subpart U from ``Conditions for
Coverage for Suppliers of End-Stage Renal Disease'' to read
``Requirements for End-Stage Renal Disease Facilities.'' We are
changing this final rule because the ``Hospital Conditions of
Participation: Requirements for Approval and Re-approval of Transplant
Centers to Perform Organ Transplants'', published on March 30, 2007 (72
FR 15198) updated and recodified the kidney transplant center
conditions for coverage and the remaining provisions only apply to the
ESRD Networks.

A. Part 414--Payment for Part B Medical and Other Health Services;
Payment for Home Dialysis Equipment, Supplies, and Support Services
(Proposed Sec. 414.330)

We proposed a new Sec. 414.330(a)(2)(iii)(C) that would require
the patient's home dialysis medical equipment supplier to report to the
facility, every 30 days, all services and items furnished to the
beneficiary, so that the information could be documented in the
patient's medical record.
Comment: Two commenters supported the proposed requirement for a
30-day reporting timeframe for durable medical equipment suppliers who
provide support services to home dialysis patients. Several other
commenters suggested that the 30-day timeframe was inappropriate and
restrictive and recommended we allow 45 days in the final rule.
Response: We agree with both sets of comments because we believe
that all information showing what supplies and services were provided
to the patient and when each was provided should be reported to the
ESRD facility on a regular basis. However, we agree with the second
group of commenters that the 30-day timeframe is restrictive.
Therefore, to allow greater flexibility, we have modified the final
rule at Sec. 414.330(a)(2)(iii)(C) to allow durable medical equipment
suppliers to report to the ESRD facility providing support services at
least once every 45 days.

B. Part 488--Survey, Certification, and Enforcement Procedures; Special
Procedures for Approving End-Stage Renal Disease Facilities (Proposed
Sec. 488.60)

We proposed to retain the procedures for approving ESRD facilities
as specified at Sec. 488.60. We received one public comment pertaining
to the procedures for approving ESRD facilities. The comment and
response are found at the end of this section. We have recodified Sec.
405.2180, Sec. 405.2181, Sec. 405.2182, and Sec. 405.2184 as Sec.
488.604, Sec. 488.606, Sec. 488.608, and Sec. 488.610, respectively.
These provisions were relocated without any modifications. Comments
pertaining to hemodialyzer reuse sanctions are addressed in the Sec.
494.50, ``Reuse of hemodilayzers and bloodlines'' discussion, later in
this preamble.
Comment: One commenter expressed concern regarding the
certification process for ESRD facilities. The commenter remarked that
facilities applying for initial approval may not have all of the data
required by the conditions for coverage in accordance with Sec.
488.60(a).
Response: Although we understand the commenter's concern that a new
provider may not have all of the required data available, data are
important for use in improving quality outcomes and play an important
part in the management and oversight of the ESRD facilities. Therefore,
we are retaining the provisions of Sec. 488.60(a) as proposed. In
addition, the absence of data would not necessarily result in the
denial of certification. If an ESRD facility is unable to supply all of
the data required in Sec. 488.60(a), the facility could be cited at a
standard deficiency level, thus emphasizing the importance of the data,
but not precluding the ESRD facility from receiving approval to operate
in the Medicare program.

C. Part 494--Conditions for Coverage for End-Stage Renal Disease
Facilities

1. Subpart A (General Provisions)
a. Basis and Scope (Proposed Sec. 494.1)
We proposed a new organizational format for the conditions for
coverage, which permitted the elimination of almost all of Sec.
405.2100, Scope of subpart. This section consists largely of a
description of the contents of the existing ESRD conditions for
coverage. We proposed at Sec. 494.1 to identify the statutory
authority for the revised regulations, and to state that provisions of
part 494 would serve as the basis for survey activities for determining
whether a dialysis facility met the conditions for coverage under the
Medicare program. We received no comments on this section.
b. Definitions (Proposed Sec. 494.10)
We proposed to recodify Sec. 405.2102 as Sec. 494.10, with an
abbreviated set of definitions. While Sec. 405.2102 defined 32 terms,
we proposed to define only 7 terms at Sec. 494.10. We proposed to
eliminate several terms that were self-evident and others that would
not be utilized in these revised conditions. In addition, we did not
believe it would be appropriate to have substantive requirements
contained within definitions, so we proposed to move definitions that
contained qualification requirements, such as the term
``interdisciplinary team,'' to the appropriate conditions in the final
rule.
Comment: A few commenters suggested revisions to the proposed
definition for ``dialysis facility.'' One commenter recommended we
adopt the phrase ``chronic kidney dialysis facility'' and two other
commenters suggested the addition of ``self-care dialysis'' to the
current list of services provided by the facility.
Response: Adding the word ``chronic,'' we believe, would add no
value to the term ``dialysis facility'' since kidney disease requiring
outpatient dialysis is chronic by nature. The proposed definition for
``dialysis facility'' does recognize self-care dialysis. Self-care
dialysis is a modality described in section 1881 of the Act. We believe
the proposed definition of ``dialysis facility'' is sufficient.
Therefore, we adopt this definition as proposed.
Comment: Two commenters suggested adding language to clarify that a
facility that taught a patient how to self-cannulate would not need to
obtain

[[Page 20374]]

certification as a self-dialysis unit exclusively because of such
instruction.
Response: We agree with the commenters that any dialysis facility
that is Medicare-certified to provide outpatient dialysis services may
include instruction in self-cannulation in its dialysis program. We do
not require any additional certifications, nor is a separate ``self-
dialysis'' certification category available. Dialysis facilities
receive Medicare certification to provide in-center dialysis or home
dialysis training and support services, or both. We are not adding a
regulatory statement regarding the absence of a self-dialysis
certification category to this final rule.
Comment: One commenter requested additional clarification regarding
what would constitute ``discharge'' (for example, ``30 days after
departure from a facility for any reason'').
Response: Our intent was to describe the cessation or end of
patient care services for patients who either voluntarily leave the
facility or for patients who are discharged for reasons listed at Sec.
494.180(f). To address the commenter's concern, we have added
clarifying language at Sec. 494.10 to read, ``Discharge means the
termination of patient care services by a dialysis facility or the
patient voluntarily terminating dialysis when he or she no longer wants
to be dialyzed by that facility.''
Comment: We requested comments regarding whether to reference
nursing facilities (NFs) and skilled nursing facilities (SNFs) in the
definition for ``home dialysis.'' We received many comments regarding
the definition of ``home dialysis.'' Some commenters questioned the
definition of ``home,'' while others commented that nursing homes and
other institutional settings were appropriate for home dialysis. Yet
others stated that nursing homes and other institutional settings were
inappropriate for home dialysis. One commenter expressed concern
regarding permanent versus temporary residence status within a nursing
facility. One commenter suggested we adopt a new term, ``institutional
home dialysis,'' to describe patients in a nursing home setting. Other
commenters suggested a separate definition for dialysis provided in a
nursing home setting that would be distinct from ``home dialysis.''
Many commenters noted the nursing home setting is different from
the typical dialysis facility setting, and that the needs of the NF/SNF
patient population are unique. One commenter proposed the term ``staff
assisted nursing home dialysis'' be used. Other topics of concern
included training course specifications, recommendations about
peritoneal dialysis and hemodialysis modalities, and the burden
associated with including NFs and SNFs in the definition.
Some commenters believed that neither short nor long-term stays in
NFs/SNFs should be considered a patient's home for purposes of home
dialysis, while others took the opposite view. Other commenters
responded that only a long-term stay in a NF/SNF should be considered a
patient's home for purposes of home dialysis. Major dialysis
associations and a major nursing home association urged Centers for
Medicare and Medicaid Services (CMS) not to classify NF/SNF as the
patient's ``home'' in this final rule, but to convene an expert panel
to study this complex issue and then address it in a separate rule at a
later date.
Response: We understand the concerns of commenters. Currently a SNF
may be considered a patient's home for self-dialysis, as noted in the
Medicare Claims Processing Manual, which can be found at http://www.cms.hhs.gov/manuals/downloads/clm104c20.pdf and as noted in the
Program Integrity Manual, Chapter 5 at http://www.cms.hhs.gov/manuals/downloads/pim83c05.pdf.
We recognize that the provision of hemodialysis to nursing home
patients presents unique challenges, given this frail population. We
note that there was no consensus within either the renal community or
the medical community at large as to the inclusion of SNFs or NFs in
the definition of ``home dialysis.'' A more detailed discussion of this
issue can be found later in this preamble under the ``Care at home''
condition (Sec. 494.100). Given the variety of differing comments, we
believe that a regulation regarding NF/SNF dialysis would be premature.
Therefore, we will consider addressing this issue at a later date, and
the current guidance for dialysis in a nursing home environment will
remain in effect at this time.
Comment: Three commenters suggested that the definition for
``interdisciplinary team'' use the same language as that of Sec.
494.80, and that the definitions be cross-referenced throughout the
text.
Response: The composition of the interdisciplinary team is a
minimum requirement of this final rule. We are not including
requirements in the definition section. We are defining the
``interdisciplinary team'' in the ``Patient assessment'' condition
opening paragraph at Sec. 494.80. We have also added the requirement
to the ``Patient plan of care'' condition at Sec. 494.90, to include
the same language describing the composition of the team. The
definition for ``interdisciplinary team'' appearing under Sec. 494.10
in the proposed rule has been removed from this final rule.
Comment: We received several comments regarding the definition of
``self-dialysis.'' Two commenters suggested changing the definition
from ``dialysis performed with little or no professional assistance''
to ``dialysis performed with limited or no professional assistance * *
*.'' Some commenters stated the definition should not reference the
training requirement at Sec. 494.100(a) since such requirement would
not apply to all self-dialysis, and that many patients would perform
some level of self-care in the facility. One commenter recommended that
we issue interpretive guidelines to address the issue of patients that
would perform self-care dialysis in a facility. Another commenter
suggested dropping ``self-dialysis'' terminology from the definition
section of this final rule.
Response: ``Self-dialysis'' is addressed in section 1881 of the Act
and the Secretary has the discretion to define ``self-dialysis
services'' in regulations. We are retaining the proposed language,
which contains the term ``little'' because we believe ``limited'' may
imply the necessity of a potentially higher degree of professional
assistance for self-dialysis patients than envisioned by the statute.
Interpretive guidelines will be developed to instruct the surveyors how
to review facilities for compliance with the requirement.
Comment: Several commenters requested clarifications of terminology
and additional definitions in the final rule such as: New patient;
first dialysis; direct supervision; and grievance.
Response: The terms ``first dialysis'' and ``new patient'' are
clarified in the section in which the terms are used. For example,
``new patient'' is now clarified in the ``Patient assessment''
condition at Sec. 494.80(b). The term ``direct supervision'' has been
deleted from the final rule, as explained in the preamble discussion
for ``Personnel qualifications'' at Sec. 494.140(e)(3). ``Grievance''
is discussed in the preamble for ``Patients' rights'' at Sec. 494.70.
Comment: A renal association recommended that we define the term
``standards'' in the final rule since we used that term in the preamble
of the proposed rule. The commenter noted that the use of the term
``standards'' is significant and should be explicitly defined to ensure
consistency throughout the regulation. The commenter also noted that
each of the NKF's clinical practice guidelines

[[Page 20375]]

contains a disclaimer stating that guideline is ``not intended to
define a standard of care, and should not be construed as one.''
Response: The term ``standards'' appears throughout the regulation,
as it is used to identify levels of requirements within each condition
for coverage. Historically, our conditions of participation and
conditions for coverage are written in hierarchical form of conditions,
with standards and elements (or factors) contained within the
conditions. For the most part they are written as individual,
surveyable requirements. Merriam-Webster's Collegiate Dictionary
defines ``standards'' as ``something established by authority, custom,
or general consent as a model or example.'' This definition matches how
the term ``standards'' is used in this final rule. When using the term
``standards'' as applied to care of patients, we expect that
professionals would rely upon principles and practices of care that
are, for example, widely used and supported by professional
organizations, academic institutions, and recognized standard-setting
organizations. We recognize that professionals may vary in their use of
particular ``standards.'' We assume the commenter is concerned about
the use of the terms ``standards'' as used in the preamble discussion
of facility-wide standards to be used for enforcement. Any facility-
level standards for Medicare participation developed subsequent to
publication of this final rule, will be developed in accordance with
the National Technology Transfer and Advancement Act of 1995 (NTTAA)
process adopted by the Secretary, as discussed in the ``Governance''
condition at Sec. 494.180.
c. Compliance With Federal, State, and Local Laws and Regulations
(Proposed Sec. 494.20)
We proposed a slightly broader version of Sec. 405.2135 in our
February 2005 proposed rule. While Sec. 405.2135 specifies applicable
laws and regulations pertaining to licensure, fire safety, equipment,
and other relevant health and safety requirements with which a facility
had to comply, we proposed that, additionally, facilities specifically
comply with State and local building codes, and any laws regulating
drugs and medical device usage.
Comment: Several commenters suggested deleting the reference to
``drugs'' at proposed Sec. 494.20. Commenters are concerned that this
reference to drugs would restrict physicians' use of Medicare Part B
covered drugs for ``off label'' use.
Response: We agree with the commenters. The reference to ``drugs''
has been removed from Sec. 494.20 of the regulation text. Medicare
contractors may make reasonable and necessary determinations regarding
off-label uses of drugs pursuant to instructions published in program
manuals.
Additionally, we removed the phrase ``staff licensure and other
personnel staff qualifications'' from Sec. 494.20, as this requirement
may be found in ``Personnel qualifications'' at Sec. 494.140. We
removed the phrase ``fire safety, equipment, building codes'' from
Sec. 494.20, as these issues are addressed in the ``Physical
environment'' condition at Sec. 494.60. In addition, we removed the
phrase ``medical device usage'' from Sec. 494.20, as it is covered
under the condition for ``Water and dialysate quality'' at Sec.
494.40, the condition for ``Reuse of hemodialyzers and bloodlines'' at
Sec. 494.50, the ``Physical environment'' condition at Sec.
494.60(b), and in the ``Care at home'' condition at Sec. 494.100.
Comment: A commenter stated that water treatment systems are
``medical devices'' and fall under Food and Drug Administration (FDA)
regulations. The commenter stated that the proposed rule preamble
suggests that water systems would have to meet FDA guidance document
requirements even if installed before May 1997. The commenter is
concerned that replacement of water systems with ``510(k) cleared''
systems would incur needless expense.
Response: As explained above, we have removed the words
``equipment'' and ``medical device usage'' from Sec. 494.20 and do not
single out these categories of law. Facilities are expected to comply
with all Federal, State and local laws regarding health and safety.
Under current FDA regulations, all water treatment systems installed
after May 30, 1997 must meet review requirements under section 510(k)
of the Food, Drug, and Cosmetic Act (21 U.S.C. sec. 360(k)) as
described in Guidance for the Content of Premarket Notifications for
Water Purification Components and Systems for Hemodialysis (http://www.fda.gov/cdrh/ode/hemodial.pdf). This document is intended to
provide guidance in the preparation of a regulatory submission and
reflects the current FDA review guidance for water purification
components and systems for hemodialysis. Water purification systems
installed before May 30, 1997 are not affected by this guidance;
however, all systems installed after this date must meet FDA
requirements. Regardless of when a water purification system was
installed, the system must yield water and dialysate that meets AAMI
standards and must be monitored and maintained in accordance with the
AAMI RD52 guidelines, which are incorporated by reference in this final
rule at Sec. 494.40.
Comment: A number of commenters recommended we include a reference
to the Americans with Disabilities Act of 1990 (Disabilities Act)
within this condition. The rationale is that patients must be
accommodated for mobility, hearing, vision, or other disabilities or
language barriers.
Response: A specific reference to the Disabilities Act is not
necessary since ESRD facilities must comply with all applicable
Federal, State, and local laws, including the Disabilities Act. The
Department of Justice, Civil Rights Division, is charged with oversight
and enforcement of the Disabilities Act. We would also continue to
support the enforcement of the Disabilities Act provisions through the
survey process under Sec. 494.20.
2. Subpart B--Patient Safety
a. Infection Control (Proposed Sec. 494.30)
We proposed a separate condition for coverage for infection control
requirements, to update the provisions currently found at Sec.
405.2140(b) and Sec. 405.2140(c). We proposed incorporating by
reference ``Recommended Infection Control Practices for Hemodialysis
Units at A Glance'' precautions found in the CDC publication
``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients'' (DHHS/CDC, pages 20-21), with the
exception of the screening recommendations for hepatitis C. We proposed
that dialysis facilities implement appropriate procedures for patient
isolation; for the handling, storage, and disposal of waste; and the
disinfection of surfaces, devices, and equipment. We proposed the
appointment of an infection control officer registered nurse (RN) to
ensure oversight of the facility's infection control program,
maintenance of current infection control information, reporting of
infection control issues to the facility chief executive officer (CEO)
or administrator and the facility improvement committee, and the
development of facility infection control improvement recommendations.
We also proposed monitoring and reporting standards that would require
the facility to analyze and document the incidence of infection to
identify trends, establish baselines, take action to reduce future
infection control incidents, and report incidences of communicable
diseases as

[[Page 20376]]

required by Federal, State, and local regulations.
Comment: We received numerous comments on Sec. 494.30 ``Infection
control'' condition. Many commenters agreed with the inclusion of the
CDC infection control precautions for hemodialysis settings. Some
commenters recommended that we incorporate in the final rule the entire
CDC (RR05) document entitled, ``Recommendations for Preventing
Transmission of Infections Among Chronic Hemodialysis Patients''
(published on April 27, 2001), rather than only the ``At A Glance''
section.
A number of commenters referenced particular infection control
precautions included in the ``At A Glance'' section and requested
clarification or raised issues related to the cost or logistics of
implementing the specific precaution in a hemodialysis facility. The
precautions referred to in these comments include: use of disposable
items, use of cloth-covered blood pressure cuffs, use of leak-proof
containers for used hemodialyzers, specifications for medication carts,
carrying supplies or medications in the pockets of staff, and isolation
room requirements. Some commenters stated that there was no need for
every new dialysis unit to have an isolation room. Two commenters
supported having separate staff to care for hepatitis B-positive
patients, but other commenters stated the cost of separate staff for
this would be prohibitive.
Response: We appreciate the support for inclusion of the CDC
hemodialysis infection control precautions in this final rule. Based on
the comments, it is apparent that clarifications are needed for the
``At A Glance'' guidelines, which are an abbreviated version of the CDC
RR05 ``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients.'' The majority of comments concerning
specific precautions are addressed in the CDC narrative section
entitled ``Recommendations'' on pages 18 through 28 of
``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients.'' In order to better clarify the
requirements of the infection control precautions, we are expanding our
RR05 incorporation by reference to include the entire
``Recommendations'' narrative section of the document (pages 18-28) in
the final rule, with one exception (hepatitis C screening), as
discussed below. The introduction and background sections of the RR05
document (pages 1-17) provide the evidentiary basis for the recommended
precautions. The entire CDC RR05 document provides rich background
information and rationale for the recommended practices; we encourage
facilities to use the entire document as a resource.
The RR05 CDC infection control precautions state that items taken
into the dialysis station should be disposed of, dedicated for use only
on a single patient, or cleaned and disinfected before being taken to a
common clean area or used on another patient. Items that cannot be
cleaned and disinfected (for example, adhesive tape, cloth-covered
blood pressure cuffs) should be dedicated for use only on a single
patient. Blood pressure cuff covers may be more cost-effective and may
be used for blood pressure cuffs that cannot be decontaminated easily
between patients. In contrast, rolls of tape cannot be decontaminated
and can serve as a source of contamination for both facility personnel
and patients. Tape rolls must be dedicated to a single patient, or
disposed of after patient use.
Hemodialyzers carried to the reuse area should always be in a leak-
proof container. We wish to prevent a blood-contaminated item from
potentially contaminating the treatment (and clean) areas as it is
carried from a patient's station. A container could be a plastic bag.
We believe that the practice of carrying a contaminated hemodialyzer to
the reuse room without the use of a leakproof container does not
adequately prevent contamination.
Although one commenter stated that banning a medication cart and
taping medication to the hemodialysis machine would ``waste'' RN time,
the CDC has made clear that patient safety is best protected and risk
of cross-contamination reduced when medications are prepared and
distributed from a centralized clean area dedicated to that purpose.
Another commenter argued that staff should have immediate access to
gloves for times when a patient suddenly starts to bleed, and that
staff members should be allowed to carry extra gloves in their pockets.
The CDC precautions do not allow this practice. Instead, the facility
should have gloves strategically placed so that staff has adequate
access to them for both routine and emergency use.
Regarding the treatment of hepatitis B-positive patients, many
commenters provided alternative isolation room recommendations and
requested clarification of the isolation room requirement for new units
as well as for existing units. The ``At A Glance'' page states (under
``Management of HBsAg-Positive Patients'') that the dialysis facility
should dialyze hepatitis B surface antigen (HBsAg) positive patients in
a separate room using separate machines, equipment, instruments, and
supplies; and that staff members caring for HBsAg-positive patients
should not care for hepatitis B virus (HBV) susceptible patients at the
same time (for example, during the same shift or during patient change-
over). CDC language from page 27 of the CDC RR05 document states, ``For
existing units in which a separate room is not possible, HBsAg-positive
patients should be separated from HBV-susceptible patients in an area
removed from the mainstream of activity and should undergo dialysis on
dedicated machines. If a machine that has been used on an HBsAg-
positive patient is needed for an HBV-susceptible patient, internal
pathways of the machine can be disinfected using conventional protocols
and external surfaces cleaned using soap and water or a detergent
germicide.'' Therefore, we are incorporating this section by reference
into the ``Infection control'' condition at Sec. 494.30, as it is
found in the ``Recommendations'' narrative section of the CDC ``At A
Glance'' infection control precautions. However, we are allowing
dialysis facilities extra time to come into compliance with the
provision requiring a separate isolation room (recommendation found on
pages 27 and 28 under the ``HBV-Infected Patient'' section header of
RR05), since in some cases the provision would require that a facility
retrofit its building, which would necessitate project development,
architectural design, contractor bids, building permits, and time to
complete the job. Therefore, we are allowing dialysis facilities 300
days after the publication of this final rule in the Federal Register
to comply with the requirements of this provision. In addition, any
HBsAg-positive patient in an existing dialysis facility should be
separated from hepatitis B-susceptible patients either by a buffer zone
of hepatitis B-immune patients or by a demarcated physical space at
least equal to the width of one dialysis station. Separate dedicated
supplies and equipment must be used to provide care to the HBsAg-
positive patient. Note that ``separate equipment'' includes
glucometers. Use of an ``end of row'' hemodialysis station can
facilitate the separation of the area from the mainstream of the
dialysis facility's activities and decreases the number of adjacent
dialysis stations. If this space is needed for both HBsAg-positive as
well as HBsAg-negative patients on other shifts, the space may be
disinfected using conventional protocols and used for both types of
patients at different

[[Page 20377]]

times. If a facility does not have any HBsAg-positive patients, this
space may be used by non-HBsAg-positive patients on a normal basis.
Every facility must have the capacity to separate HBsAg-positive
patients in the facility.
In response to comments that not every new unit should be required
to have an isolation room due to the low incidence of hepatitis B in
hemodialysis patients, we have added a waiver provision at Sec.
494.30(a)(1)(ii) that states, ``When dialysis isolation rooms as
required by (a)(1)(i) are available locally that sufficiently serve the
needs of patients in the geographic area, a new dialysis facility may
request a waiver of such requirement. Such waivers are at the
discretion of and subject to such additional qualifications as may be
deemed necessary by the Secretary.''
The CDC infection control precautions specifically call for
separate staff to care for hepatitis B-positive patients to prevent
infection of susceptible dialysis patients. According to the CDC, using
separate staff is a very effective method to reduce the spread of HBV.
One staff person may care for a HBsAg-positive patient and immune
patients at the same time, but may not simultaneously care for
hepatitis B-susceptible patients. Section 494.30 requires dialysis
facilities to implement this infection control precaution.
Comment: Two commenters pointed out that the RR05 ``At A Glance''
section uses the word ``should'' and seems to allow less than full
compliance with the infection control precautions.
Response: We recognize that the RR05 CDC document uses the word
``should'' when describing implementation of the infection control
precautions, for example, ``clean areas should be clearly designated
for the preparation, handling and storage of medications * * *'' The
CDC document is written as guidelines and therefore guideline language
is used. For purposes of these Conditions for Coverage, the CDC
infection control precautions, which are incorporated by reference, are
mandatory and must be adhered to and demonstrated within the dialysis
facility. The regulation states, ``the facility must demonstrate that
it follows standard infection control precautions' by implementing the
CDC hemodialysis infection control practices found in the RR05
document. The guidelines incorporated by reference will be deemed
mandatory in the survey process.
Comment: One commenter asked whether a reverse isolation negative
pressure room would be required.
Response: The RR05 CDC recommended infection control practices
incorporated by reference address the unique needs of a hemodialysis
unit and include contact precautions. When airborne pathogens are
discovered within the dialysis unit, the CDC infection control
recommendations regarding airborne pathogens should be consulted and
the proper measures taken to protect patients and staff from exposure.
This could mean that the affected patient is transferred to a setting
that provides the necessary isolation precautions for the pathogen. The
facility may want to have an agreement with a hospital if the facility
discerns that this is necessary; however, we are not incorporating this
provision into the Medicare ESRD conditions for coverage.
Comment: One commenter asked whether staff cover gowns are
required.
Response: Staff scrubs or uniforms are sufficient attire within the
dialysis unit, except for times when one might expect to be exposed to
a blood spattering. Cover gowns primarily serve to protect a staff
member from exposure to blood within the dialysis unit. This is
addressed on page 22 of RR05 CDC document.
Comment: We received more than a dozen comments regarding the CDC
RR05 recommendation for hepatitis C screening of dialysis patients.
Most of the comments supported the CDC recommendation and several
suggested that Medicare pay for hepatitis C screenings. Commenters
stated that hepatitis C is an important pathogen for dialysis patients,
screening would allow for early detection, and would alert the facility
to significant breaks in use of infection control precautions. Some
commenters did not support hepatitis C screening by the dialysis
facility, and one noted that a positive diagnosis would not change
treatment or patient care within the dialysis facility.
Response: In the proposed rule, we specified an exemption for
hepatitis C screening, since Medicare only covers diagnostic hepatitis
C testing when indicated, and does not cover general screening for
hepatitis C. A patient with a hepatitis C positive test is treated in
the dialysis facility with the same protocols as a patient who is not
positive for hepatitis C. However, transmission of hepatitis C serves
as a marker to evaluate the adequacy of infection control practices
within a dialysis facility. Medicare generally covers preventive care
and screenings if stipulated in law, including diagnostic testing. We
will continue to omit from our incorporation by reference the CDC RR05
sections that specify hepatitis C screening.
On December 14, 2005, we published a coverage decision memo (CAG-
00304N) that allows Medicare coverage of hepatitis panel testing when
there is an elevation of liver enzyme levels. The memo title is
``Decision Memo for Addition of ICD-9-CM code 790.4, Nonspecific
Elevation of Levels of Transaminase or Lactic Acid Dehydrogenase, as a
Covered Indication for the Hepatitis Panel/Acute Hepatitis Panel
National Coverage Determination'' and may be found at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=173. Elevated liver
enzymes, with or without other signs or symptoms of hepatitis, is a
covered indication for the hepatitis panel. Most hemodialysis patients
with newly acquired Hepatitis C virus (HCV) infection have elevated
serum transaminase levels. Elevations in serum transaminase levels
often precede anti-HCV seroconversion. Monthly serum ALT (a
transaminase) determination is included in the composite payment to
renal dialysis facilities. Consequently, if a beneficiary has an
elevated ALT, the provider may order a diagnostic hepatitis panel,
which includes a hepatitis C antibody test as part of the panel. The
hepatitis panel National Coverage Determination (NCD) does not require
the physician to order all of its constituent component tests. Thus, a
provider may order a hepatitis C antibody test when the beneficiary's
serum ALT, ordered and covered for monthly testing in the composite
rate, is elevated.
Comment: A few commenters referred to the CDC guidelines regarding
injectable medications and disagreed with the established protocol that
allows re-entry of single-use medication vials.
Response: The April 27, 2001/50 (RR05); 1-43 CDC infection control
guidelines, ``Recommendations for Preventing Transmission of Infections
Among Chronic Hemodialysis Patients'' (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm) state: ``Intravenous medication vials labeled
for single use, including erythropoietin, should not be punctured more
than once (196,197). Once a needle has entered a vial labeled for
single use, the sterility of the product can no longer be guaranteed.
Residual medication from two or more vials should not be pooled into a
single vial.''
We have retained the intent of this policy and the proposed
requirement at Sec. 494.30(b)(2), regarding current infection control
information including the most current CDC guidelines for the proper
techniques in the use of vials and ampules containing medication.
However, we have modified the wording slightly because we have

[[Page 20378]]

removed the proposed infection control officer requirement, as
discussed below.
Under the ``Oversight'' standard at Sec. 494.30(b)(2) we are
requiring the clinical staff to ``demonstrate compliance with current
aseptic technique when dispensing and administering intravenous
medications from vials and ampules.''
Comment: Several comments were submitted in response to our
solicitation as to whether we should incorporate by reference the
Healthcare Infection Control Practices Advisory Committee's (HICPAC)
``Hand Hygiene in Healthcare Settings'' guidelines and the ``Guideline
for Preventing Intravascular Device-Related Infections.'' Comments were
evenly divided regarding incorporation of the hand hygiene guidelines.
Two of the commenters stated there is no consensus between HICPAC hand
hygiene guidelines and guidelines developed by Society for Healthcare
Epidemiology of America (SHEA) regarding standards of care for
preventing nosocomial transmission of staph aureus and enterococcus.
While one commenter did not support incorporation of the intravascular
device guidelines, there was some support for their inclusion, notably
from the American Nephrology Nurses Association.
Response: We would expect that dialysis facilities demonstrate
adherence to professional standards of practice for infection control,
which include adherence to hand hygiene guidelines. This expectation is
included in the stem statement of the infection control condition:
``The dialysis facility must provide and monitor a sanitary environment
to minimize the transmission of infectious agents within and between
the unit and any adjacent hospital or other public areas.'' The
expectation of acceptable hand hygiene extends to all healthcare
providers. We will not specifically incorporate by reference the HICPAC
hand hygiene standards, but we do expect compliance to the hand hygiene
professional standards of practice.
We do not agree that the guidelines developed by SHEA regarding
standards of care for preventing nosocomial transmission of staph
aureus and enterococcus conflict with the HICPAC hand hygiene
standards. We note that the SHEA guidelines are not specific to
dialysis facilities where contact precautions are recommended, but
address infection control issues in the hospital setting. The SHEA
guidelines reflect the general lack of adherence by health care workers
to hand hygiene standards and recommend additional measures, such as
surveillance cultures, to prevent and monitor cross-contamination.
Facilities have the flexibility to use appropriate resources to assist
in the development and implementation of their hand hygiene infection
control and prevention program.
Catheter infections continue to be a concern in hemodialysis
facilities and lead to hospitalizations. HICPAC states in its
``Guidelines for the Prevention of Intravascular Catheter-Related
Infections'' RR-10 document (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5110a1.htm) (page 11), that the use of catheters for hemodialysis is
the most common factor contributing to bacteremia in dialysis patients
and the relative risk for bacteremia in patients with dialysis
catheters is sevenfold the risk for patients with primary arteriovenous
fistulas. In Sec. 494.30(a)(2) we are incorporating by reference the
pertinent hemodialysis catheter use sections (pages 13-14, and 17-18)
of RR-10, 2002, ``Guidelines for the Prevention of Intravascular
Catheter-Related Infections.'' These guidelines describe appropriate
health-care worker education and training, surveillance, hand hygiene
(I-III, page 16), aseptic technique (IV, page 16), hemodialysis
catheter exit site care (section III-V, page 21), and catheter-site
dressing regimens (section VI, C, page 22), and are the nursing
standard of practice for catheter care. We expect that incorporation of
these guidelines will increase staff awareness of the protections
needed for hemodialysis patients with catheters and lead to reduced
catheter infections.
Comment: Few commenters responded to our solicitation for comment
regarding whether we should incorporate by reference the American
Institute of Architects (AIA) Guidelines for Design and Construction of
Hospitals and Health Care Facilities, which outline building
requirements pertinent to dialysis facilities. Comments were split
between supporting and rejecting AIA guidelines, and incorporation by
reference if adopting the guidelines.
Response: We have not incorporated the AIA building standards in
our final rule. However, facilities must comply with all State and
local building codes/requirements.
Comment: Several commenters addressed our proposed infection
control officer requirement at Sec. 494.30(b)(2). Some supported
having an RN assume the role of the infection control officer. Others
believed that a staff member other than an RN should assume the role.
Some commenters stated this role was not the best use of RN time, and a
few cited cost concerns. Several commenters stated that oversight of
infection control should be performed by the medical director or that
the medical director should be notified of infection control issues at
proposed Sec. 494.30(b)(2)(ii) instead of our proposed notification of
the chief executive officer or administrator and the quality
improvement committee.
Response: We understand that dialysis facilities may face a
shortage of RNs and that in many facilities RNs must be used to perform
duties that only an RN can perform. While comments supported infection
control to protect patient safety, several alternatives to an RN
infection control officer were suggested. In response to comments and
in order to increase facility flexibility in assigning staff roles, we
have removed the infection control officer requirement from Sec.
494.30(b)(2), and added infection control to the quality assessment and
performance improvement (QAPI) condition at Sec. 494.110(a)(2)(ix) as
a required topic. This change requires that infection control be
addressed within the action-oriented, data-driven QAPI program, which
is under the direction of the medical director and requires RN and
interdisciplinary team participation.
In response to comments we have also modified the proposed
requirement at Sec. 494.30(b)(2)(ii) (now Sec. 494.30(b)(3)), to
require that clinical staff report infection control issues to the
dialysis facility's medical director and the quality improvement
committee instead of the chief executive officer or administrator. The
medical director has a critical role in addressing infection control
issues in the dialysis facility and Sec. 494.150(c)(2)(i) now requires
the medical director to ensure that staff adhere to infection control
policies and procedures.
Comment: We received a few comments regarding the role of the
patient and patient perceptions of infection control practices in
dialysis facilities. One patient stated that patients should be fully
informed about infection control so they can protect themselves and be
aware of staff infection control violations. Another patient's
observation was that facility staff has no training regarding infection
control and no one seems to worry about its ramifications.
Response: We agree that the dialysis patient has a role in
assisting the staff in preventing the spread of infection. It is
appropriate for the patient to be educated regarding infection control.
We have added ``infection prevention and personal care'' to the Patient
Education standard under Sec. 494.90(d) in

[[Page 20379]]

the ``Patient plan of care'' condition. The facility should provide
information to dialysis patients on topics including current infection
control precautions, the facility's infection control practices, and
the role of the patient in preventing the spread of infection. As
explained above, we have strengthened infection control by making it a
condition for coverage and expect that dialysis staff will comply with
the hemodialysis infection control precautions developed by the CDC and
required by this rule.
Comment: One commenter asked whether State surveyors could enforce
local regulations and laws pertaining to disposal of hazardous wastes.
Response: Surveyors make referrals regarding unlawful disposal of
hazardous wastes to the appropriate local authorities. If there is a
problem, it can be cited by the surveyor under Sec. 494.20,
``Compliance with Federal, State, and local laws and regulations,''
when local authorities confirm infringement.
Comment: It was suggested that the final rule require more
surveillance, include septicemia and infection data elements, include
an added CPM or standard for infection control, and require mandatory
reporting of such data on the DFC Web site.
Response: As stated above, the facility must address infection
control within the action-oriented, data-driven QAPI program.
Surveillance and use of infection data will be necessary components of
QAPI. We will consider the ``reporting'' as appropriate when developing
new CPMs and adding new measures to the DFC Web site. We are not
requiring new performance measures that have not been fully developed
in this regulation.
b. Water and Dialysate Quality (Proposed Sec. 494.40)
We proposed a separate condition for coverage to update the water
purity requirements that were incorporated by reference into part 405,
subpart U (Sec. 405.2140(a)(5)) in 1995. AAMI has since rescinded the
document from which the sections were incorporated (ANSI/AAMI RD5:1992,
Hemodialysis Systems, second edition) and published updated AAMI
guidelines in 2001. We proposed to incorporate sections from the new
AAMI document, ``Water Treatment Equipment for Hemodialysis
Applications'' (ANSI/AAMI RD62:2001), to update the bacterial and
chemical concentrations allowed in water used in hemodialysis. The new
AAMI guidelines established action levels for contaminants in addition
to merely identifying unsafe contaminant levels. At ``action levels,''
the facility must implement corrective actions to prevent contaminants
from reaching unsafe levels. We also proposed water treatment equipment
requirements and water testing frequency and sample sites that are
consistent with the new AAMI document, ``Dialysate for Hemodialysis''
(ANSI/AAMI RD52:2004). We proposed chlorine and chloramine testing
frequency, thresholds, and actions for unacceptable high levels to
prevent the occurrence of hemolytic anemia in patients. We proposed
corrective action plan and adverse event standards to further protect
patient safety. We additionally proposed that facilities use
bicarbonate dialysate, which has the potential for high levels of
bacterial contamination, within the timeframe specified by the
manufacturer.
Comment: We received many comments regarding Sec. 494.40 ``Water
quality'' condition. The comments were unanimous in supporting
incorporation of AAMI water quality guidelines. Several of the comments
recommended that the more recent 2004 ANSI/AAMI RD52 ``Dialysate for
hemodialysis'' guidelines, written for water treatment system users, be
incorporated by reference, rather than the 2001 ANSI/AAMI RD62 ``Water
treatment equipment for hemodialysis applications,'' which are
addressed primarily to the manufacturers of equipment. A commenter
associated with the AAMI Renal Disease and Detoxification Committee
stated that the 2001 ANSI/AAMI RD62 guidelines are slated to be revised
in the near future.
Response: We agree with the commenters that ANSI/AAMI RD52:2004
``Dialysate for hemodialysis'' is the more appropriate set of
guidelines to incorporate by reference into these conditions for
coverage. In fact, the RD52 guidelines addressing water purity
monitoring and equipment parameters are similar to the requirements we
proposed at Sec. 494.40(a), Sec. 494.40(b), and parts of Sec.
494.40(c). Therefore, we are incorporating the AAMI guidelines (ANSI/
AAMI RD 52:2004) by reference at Sec. 494.40(a). These RD52 guidelines
are compatible with the RD62 guidelines that we proposed to incorporate
by reference, and are the standard of practice in dialysis facilities.
We have removed the redundant sections of proposed Sec. 494.40(a)
through Sec. 494.40(c) from the regulation, since the ANSI/AAMI
RD52:2004 incorporation by reference addresses this issue. We are also
renaming this condition ``Water and dialysate quality'' to more closely
reflect the requirements of this condition.
Comment: One commenter recommended that we define ``established
pattern'' (as related to collecting cultures for new water systems)
(proposed Sec. 494.40(a)(2)(i)(B)), as being on a weekly basis until
an established pattern can be demonstrated.
Response: We agree. This issue is addressed in ANSI/AAMI RD52
(section 6.1--page 19; table 4), which, as discussed above, we are
incorporating by reference. This section states that cultures should be
drawn ``weekly until a pattern of consistent compliance with limits can
be demonstrated.'' We have removed proposed Sec. 494.40(a)(2)(i)(B).
Comment: One commenter stated that Sec. 494.40(a)(2)(ii)(C) and
(D) are redundant since the ``seasonal variations in source water''
specified as a trigger for chemical analysis at (C) will cause the
reverse osmosis (RO) rejection rate to fall below 90 percent, the
trigger listed at (D). A second commenter stated that RO is monitored
by both rejection rate and dissolved solids or resistivity, and all of
these types of monitoring should be indicated as acceptable.
Response: RO monitoring is addressed by ANSI/AAMI RD52 section
5.2.7 (page 10) and section 6.1 (pages 18-19), which we are
incorporating by reference. As explained above, we have removed the
redundant language from Sec. 494.40(a)(2)(ii)(C) and Sec.
494.40(a)(2)(ii)(D). Facilities also must follow the manufacturers'
instructions for feed water treatment and monitoring. In the absence of
manufacturer's recommendations, the AAMI guidelines require facilities
to monitor product water conductivity, total dissolved solids or
resistivity, and calculated rejection at a frequency and using
thresholds provided by the manufacturer.
Comments: Many commenters made recommendations or requested
clarification regarding carbon tank requirements at proposed Sec.
494.40(c)(1). Many commenters supported a two carbon tank requirement,
and some opposed it. A few commenters agreed with the 10-minute empty
bed contact time, while one commenter said that the ``adequate'' empty
bed contact time standard was too subjective. One commenter recommended
that we clarify that the second carbon tank is in series with the
first, and that we require the first tank to be replaced if test
results are above the specified permissible levels. A few commenters
pointed out that high chloramine levels may be mitigated with the use
of ascorbic acid.
Response: Section 5.2.1 of the ``Dialysate for hemodialysis'' ANSI/

[[Page 20380]]

AAMI RD:52 guidelines specify, ``Whether a device is included in a
particular water purification system will be dictated by local
conditions.'' Since comments overwhelmingly supported two carbon tanks
in series due to patient safety concerns and the fact that carbon tanks
also remove organic contaminants from water, we will require at least
two carbon tanks or equivalent components at Sec. 494.40(b)(1) of our
final rule (proposed Sec. 494.40(c)(1)). Section 5.2.5 of ANSI/AAMI
RD52 clarifies that two carbon tanks must be placed in series and that
the carbon bed must be replaced in the first tank when depleted. We
have added the phrase ``in series'' to our carbon tank requirement at
Sec. 494.40(b)(1), as suggested by the commenter. This RD52 section
also clarifies that empty bed contact time must be at least 5 minutes
in each bed. The empty bed contact time is an indicator of how much
water contact with the particles in the carbon bed occurs so that there
is adequate binding and removal of impurities.
AAMI does refer to use of ascorbic acid to correct chloramine/
chlorine levels in RD62 (section A.4.3.9), though only in reference to
portable water treatment systems. In RD52 (section 5.2.5 and appendix
section A.5.2.5), AAMI also acknowledges the supplementation of carbon
adsorption with other methods of chloramine removal.
In response to comments regarding an alternate means of correcting
chloramine/chlorine breakthrough that would permit the continuation of
hemodialysis, we have added a provision to the final rule at Sec.
494.40(b)(2)(ii)(A) to allow immediate corrective action, and confirm
through testing that the corrective action has been effective. We will
not limit the means by which chloramines/chlorine levels are brought
back into compliance at Sec. 494.40(b)(2)(ii)(A). This regulation
allows for use of other proven methods to remove chloramines including
ascorbic acid and new technologies that may be developed. When using
alternate methods to remove chloramines/chlorine, the facility must
perform the required testing to ensure the successful removal of
harmful chloramine/chlorine. After measures have been taken to resolve
the immediate problem of chloramine/chlorine breakthrough, the facility
must implement actions to maintain long-term compliance with acceptable
chloramines/chlorine levels. We have added a provision at Sec.
494.40(b)(2)(ii)(D), which requires facility action to ensure ongoing
compliance. This provision reads, ``The facility must * * * Take
corrective action to ensure ongoing compliance with acceptable chlorine
and chloramine levels as described in paragraph (b)(2)(i) of this
section.''
Comment: Many comments addressed our proposed requirement for
chlorine/chloramine testing (proposed Sec. 494.40(c)(2)) before each
patient shift or every 4 hours, whichever was shorter. The majority of
comments favored chlorine/chloramine testing only before every shift
and not every 4 hours. One commenter recommended we change the 4 hours
to 6 hours and retain the requirement, while another suggested we
delete the phrase ``whichever is shorter.'' A few commenters agreed
with the testing frequency of every 4 hours.
Response: According to ANSI/AAMI RD52, section 6.2.5 (page 20),
testing should be done at the beginning of the day and again before
each shift, and if there are no set shifts, then every 4 hours. We
refer to this section, which has been incorporated by reference, at
Sec. 494.40(b)(2)(i), and we believe it provides sufficient
clarification. We have deleted the proposed requirement at Sec.
494.40(c)(2).
Comment: One commenter stated the regulation should include maximum
carbon tank limits on usage time, flow, volume, and that testing for
iodine should be required.
Response: The AAMI guidelines call for chlorine/chloramine testing
every shift to monitor carbon tank performance. We are not aware of any
evidence suggesting that these precautions are insufficient. We believe
the commenter is suggesting that a minimum iodine number for the carbon
should be required. Section 5.2.5 of the AAMI RD52 document states that
``When granular activated carbon is used as the medium, it shall have a
minimum iodine number of 900.''
Comment: A few commenters stated that chlorine/chloramine testing
requirements should also allow the testing for total chlorine with a
limit of 0.10 mg/L.
Response: This suggestion corresponds with ANSI/AAMI RD52 section
6.1; table 4 (page 8) which allows total chlorine levels of less than
0.1 mg/L. This section is now incorporated by reference. We have
modified proposed Sec. 494.40(c)(2)(i), now Sec. 494.40(b)(2)(i) to
allow total chlorine testing with acceptable levels of less than 0.1
mg/L as an alternative to testing free chlorine and chloramine levels.
Comment: One commenter stated that chlorine/chloramine requirements
at proposed Sec. 494.40(c)(2)(ii) do not account for facilities with a
holding tank, and we should allow water in the holding tank to be used
if testing shows this water contains total chlorine < 0.1 mg/L.
Response: Water in the holding tanks may be used during failure of
carbon tanks only if testing indicates the holding tank water meets
AAMI chlorine/chloramines standards of < 0.1 mg/L total chlorine OR <
0.50 mg/L free chlorine AND < 0.1 mg/L chloramines and no additional
water is allowed to enter the tank. Revised Sec. 494.40(b)(2)(ii)(B)
(proposed (c)(2)(ii)) allows use of purified water in the holding tank
when it meets the AAMI standards at Sec. 494.40(b)(2)(i).
Comment: One commenter recommended that endotoxin levels be
measured in addition to blood and dialysis cultures when there is an
adverse event (proposed at Sec. 494.40(e)(1)), since cultures may be
negative even with high endotoxin levels.
Response: We agree with the commenter that measurement of dialysate
endotoxin levels should be performed along with dialysate cultures when
a suspected adverse event occurs. We note that the AAMI guidelines call
for dialysate bacterial cultures to be accompanied by endotoxin level
testing. The AAMI guidelines state that endotoxin testing, if performed
in the dialysis facility, can give results in about 1 hour, eliminating
the long delay between sampling and obtaining a result (ANSI/AAMI
RD52:2004, section A.1.4). We have added endotoxin testing to the blood
and dialysate culture requirement at Sec. 494.40(d)(1) (proposed Sec.
494.40(e)(1).
Comment: Two commenters requested that we clarify the language of
proposed Sec. 494.40(e) ``Adverse events'' (now Sec. 494.40(d)),
regarding the active surveillance of patient reactions during and
following dialysis. One commenter suggested that the word ``following''
be defined to mean ``after post-dialysis assessment with subsequent
discharge by nurse or caregiver.''
Response: We appreciate the comment; however, we believe that the
suggested definition is too narrow, since not every adverse advent will
be limited to the time period the patient is physically in the dialysis
unit. ``Following dialysis'' runs from the moment when the treatment
session ends through the time the patient leaves the unit and beyond.
In addition, when the patient calls and/or when the patient returns for
the next dialysis session, if there are symptoms that are correlated
with a water purity adverse event, then cultures and endotoxin testing
must be performed.

[[Page 20381]]

Comment: Many comments reflected concern regarding the proposed
requirement at Sec. 494.40(f) that mixed bicarbonate concentrate be
used within the timeframe specified by the manufacturer of the
concentrate, and the accompanying preamble statement that fresh
bicarbonate must not be mixed with other batches of fresh bicarbonate.
Several commenters stated that mixing batches of bicarbonate
concentrate may be unavoidable due to mixing processes and the use of
holding tanks. Two commenters agreed with limiting use of bicarbonate
to the time limit given by the manufacturer, while others stated that
it was only necessary to use bicarbonate the same day it was mixed.
Some commenters stated that bicarbonate is the most vulnerable part of
dialysis solutions.
Response: AAMI addresses procedures for bicarbonate concentrate in
ANSI/AAMI RD52, section 7.1 (page 24), stating, ``Storage times for
bicarbonate concentrate should be minimized, as well as the mixing of
fresh bicarbonate concentrate with unused portions of concentrate from
a previous batch.'' Section 5.4.4.3 (page 15), also states, ``Once
mixed, bicarbonate concentrate should be used within the time period
recommended by the manufacturer of the concentrate. The concentrate
shall be shown to routinely produce dialysate meeting the
recommendations of 4.3.2.1.'' ANSI/AAMI RD52 stipulates the use of
bicarbonate concentrate within the time period recommended by the
manufacturer and does not expressly prohibit the mixing of bicarbonate
concentrate. If the first batch of bicarbonate concentrate has not yet
expired, it could be mixed with a second batch, provided the first
batch had not expired in accordance with the manufacturer's time
limitations before it was used. We have removed the proposed water and
dialysate quality standard at Sec. 494.40(f), regarding unused
bicarbonate, since we are instead incorporating ANSI/AAMI RD52 by
reference.
Comment: We received many comments regarding whether we should
include requirements related to ultrapure dialysate. Although two
commenters (including a large patient organization) supported ultrapure
dialysate requirements, a number of commenters opposed such
requirements, citing a lack of evidence that supported the use of
ultrapure dialysate. One commenter stated that in light of new findings
showing that ultrapure dialysis could be beneficial to hemodialysis
patients, ultrapure dialysate should be strongly encouraged. Another
commenter, who was a national expert in the area of dialysis water
treatment systems, suggested that we require that all new water systems
installed after publication of the final rule be capable of delivering
ultrapure dialysate. This would allow facilities to provide ultrapure
dialysate in the future should an evidentiary basis be solidified. A
few comments suggested that if we require ultrapure dialysate, Medicare
should provide corresponding reimbursement.
Response: We appreciate the comments; however, we are not requiring
dialysis facilities to provide ultrapure dialysate in this final rule.
Current information shows promise of ultrapure dialysate, but we
believe that sufficient evidence is lacking. We will revisit this issue
in the future when more evidence is available, recognizing that
dialysis patients are in favor of a lower permissible level of
bacterial contamination in the dialysate. If additional evidence
supports the use of ultrapure dialysate, we may undertake the necessary
rulemaking to incorporate the requirement at a later date. Facilities
choosing to provide ultrapure dialysate must meet section 4.3.2.2 of
the ANSI/AAMI RD52 guidelines.
Comment: Some commenters suggested that we avoid codifying dates
and values in the regulations, as these may change before the
regulation changes.
Response: We believe that the avoidance of values and use of
general language for Medicare patient safety requirements may create
confusion and allow less than full compliance with these conditions for
coverage. There are currently clear thresholds and standards for
dialysis water purity, which we have included. Where necessary, we will
consider updating specific dates and values via future rulemaking, as
appropriate.
Comment: Two commenters pointed out that the AAMI guidelines for
bacteria and bacterial toxin sample sites were misquoted in the
proposed rule preamble bullets (70 FR 6195) as follows:
Outlet of the water storage tanks if used
Concentrate or from the bicarbonate concentrate mixing
tank.
Response: The commenters are correct. The bullets above do not
accurately reflect the guidelines. However, the language will not
appear in this final rule since the issue is covered in ANSI/AAMI RD52;
section 7.2.1 (page 25), incorporated by reference at Sec. 494.40(a)
in this final rule, which addresses collection sites for water/
dialysate samples.
Comment: One commenter stated that the final rule should require a
water quality technician who would be independent from the primary
caregivers.
Response: Provisions regarding the water treatment system
technicians are found at Sec. 494.140(f); water treatment system
technicians must complete a training program that has been approved by
the medical director and governing body. Section 9 of AAMI RD52 calls
for a training program that includes ``quality testing, the risks and
hazards of improperly prepared concentrate, and bacterial issues.''
Section 9 also states, ``Operators should be trained in the use of the
equipment by the manufacturer or should be trained using materials
provided by the manufacturer. The training should be specific to the
functions performed (that is, mixing, disinfection, maintenance, and
repairs). Periodic audits of the operators' compliance with procedures
should be performed. The user should establish an ongoing training
program designed to maintain the operator's knowledge and skills.'' The
dialysis facility has flexibility with staff assignments and the water
quality technician may or may not be independent of the primary
caregivers. As noted, we are incorporating these provisions by
reference.
Comment: One commenter objected to the RO/deionization component
requirement at Sec. 494.40(b), which it believed could preclude use of
new/improved technologies.
Response: We have removed this language from Sec. 494.40(b). At
Sec. 494.40(a), we have incorporated by reference ANSI/AAMI RD52,
which states in section 5, ``Equipment'' (page 8):

Since feed water quality and product water requirements may vary
from facility to facility, not all of the components described in
the following clauses will be necessary in every purification and
distribution system. Components must be included, which would allow
product water and dialysate to meet the AAMI standards specified at
4.1.2, 4.2.1, and 4.3.2.1.

Comment: One commenter objected to the requirement to assay
cultures within 24 hours since this may not be realistic on weekends.
The commenter suggested allowing a 48-hour time period for cultures.
Response: The proposed rule did not prescribe culture assay
timelines. However, the ANSI/AAMI RD52 guidelines at section 7.2.3
state that samples that cannot be cultured within 1-2 hours can be
refrigerated for up to 24 hours. Samples that are held longer than 24
hours do not accurately measure

[[Page 20382]]

the degree of contamination against the established AAMI standards. We
have incorporated ANSI/AAMI RD52 standards into this final rule by
reference at Sec. 494.40(a).
Comment: One comment stated that facilities should be able to
substitute a reuse water sample from the site where the dialyzer
connects to the reuse system for a sample taken from the entrance to
the reprocessing equipment (described at 70 FR 6195).
Response: AAMI specifies collection of water samples from the
outlets supplying the reuse equipment (ANSI/AAMI RD52 section 6.3.3,
page 22). We will adhere to this AAMI guideline. We have incorporated
ANSI/AAMI RD52 by reference at Sec. 494.40(a) in this final rule.
Comment: One commenter suggested the requirement for a water sample
at the outlet of the water storage tank be deleted, since this is only
necessary initially and when trouble-shooting.
Response: The commenter refers to proposed rule preamble language
(70 FR 6195) describing RD52 sample sites and is correct in observing
that samples are taken from the outlet of the water storage only
initially and when troubleshooting. This matter is addressed in section
7.2.1 of AAMI RD52, which we are incorporating into this final rule by
reference.
Comment: One commenter stated that when referring to water samples
from the distribution ``loop'' we should change our wording, as a
``loop'' has no ``beginning'' or ``end''.
Response: We refer the commenter to AAMI RD52 section 6.3.3 (page
22), which states that samples should be taken from the first and last
outlets of the water distribution loop and the outlets supplying the
reuse equipment and bicarbonate mixing tanks. We have incorporated
ANSI/AAMI RD52 by reference at Sec. 494.40(a) into this final rule. We
believe that the AAMI language is generally understood.
Comment: We received comments regarding the quality of home
hemodialysis water, recommending that there be separate water purity
standards for home dialysis systems due to the availability of new
technology and the cost burden associated with the proposed water
quality requirements.
Response: We acknowledge that the AAMI RD52 water and dialysate
purity guidelines were not intended by AAMI for home dialysis or
portable systems. However, in the absence of water purity guidelines
for home hemodialysis, we believe that the AAMI RD52 water and
dialysate purity guidelines offer the best protection for use in
preconfigured systems.
Therefore, the dialysis facility must monitor the quality of water
and dialysate used by home hemodialysis patients, and conduct an onsite
evaluation and testing of the water and dialysate system. The water and
dialysate monitoring must be in accordance with the system's
manufacturer instructions at Sec. 494.100(c)(1)(v)(A), and the
system's FDA approved labeling for preconfigured systems designed,
tested, and validated to meet AAMI quality (which includes standards
for chemical and chlorine/chloramine testing) water and dialysate. The
facility must meet testing and other requirements of AAMI RD52:2004 for
water and dialysate. In addition, bacteriological and endotoxin testing
must be performed at least quarterly, or on a more frequent basis, as
needed, to ensure that the water and dialysate are within AAMI
standards at Sec. 494.100(c)(1)(v)(B).
In cases where these new preconfigured hemodialysis machines are
used in a dialysis facility, the home dialysis requirements do not
apply. Therefore, we have added the following language at Sec.
494.40(e) to address in-center use of these machines: ``When using a
preconfigured, FDA-approved hemodialysis system designed, tested, and
validated to yield AAMI-quality (which includes standards for chemical
and chlorine/chloramine testing) water and dialysate, the system's FDA-
approved labeling must be adhered to for machine use and monitoring of
the water and dialysate quality. The facility must meet AAMI RD52:2004
requirements for water and dialysate. However, the facility must
perform bacteriological and endotoxin testing on a quarterly or more
frequent basis, as needed, to ensure that the water and dialysate are
within AAMI limits.''
Comment: One commenter recommended that we require facilities to
use only certified labs for analysis of bacteria growth and limulus
amoebocyte lysate (LAL) testing.
Response: We are aware that many facilities do their own water and
dialysate cultures and endotoxin testing on-site. The AAMI RD52
guidelines address the monitoring of water and dialysate systems for
bacteria and endotoxin levels. Section 7.2.3 states that ``Dip samplers
may be used for bacterial surveillance. However, they should be used
only in conjunction with a quality assurance program designed to ensure
their appropriate use.'' Section 7.2.4 addresses in-house testing for
endotoxin levels. We have not modified the requirements as the RD52
document provides guidance regarding cultures and endotoxin testing.
c. Reuse of Hemodialyzers and Bloodlines (Proposed Sec. 494.50)
We proposed to update our condition for coverage at Sec. 405.2150,
``Reuse of hemodialyzers and other dialysis supplies'', by replacing it
with a new condition for coverage at Sec. 494.50. The ANSI/AAMI
``Reuse of Hemodialyzers'' guidelines (ANSI/AAMI RD47: 1993, second
edition), incorporated by reference in 1995, were revised in 2002 and
amended in 2003. We proposed incorporation by reference of the third
edition of ``Reuse of Hemodialyzers'' (ANSI/AAMI RD47: 2002/A1: 2003).
We proposed that only hemodialyzers and bloodlines labeled for reuse
could be reprocessed and that reprocessing would have to meet the AAMI
guidelines and adhere to the manufacturer's recommendations, unless an
alternate method, documented to be safe and effective, was employed.
The prohibition on reuse of hemodialyzers for hepatitis B patients was
retained in the proposed rule, to protect staff from exposure to the
hepatitis B virus. The requirement that the facility use only one
germicide for each reprocessed hemodialyzer was retained in the
proposed rule, to ensure integrity of the dialyzer membrane; we added a
clarification that bleach would not be considered a germicide in this
context. We proposed monitoring, evaluation, and reporting requirements
to ensure surveillance for adverse patient reactions to reuse, and
proposed that the facility suspend reuse when a problem was suspected
or discovered. We also proposed that when required by law, adverse
outcomes would have to be reported to the FDA and other Federal, State,
or local government agencies.
We received more than two dozen comments on the Reuse condition.
The comments support inclusion of the updated 2002/2003 AAMI ``Reuse of
hemodialyzers'' guidelines.
Comment: Several commenters addressed the first provision of this
condition, which states, ``The dialysis facility that reuses
hemodialyzers or bloodlines must meet the requirements of this section.
Failure to meet any of these requirements constitutes grounds for
denial of payment for the dialysis treatment affected and termination
from participation in the Medicare program.'' Some of the commenters
suggested deletion of this statement, while others suggested stronger
penalties. One commenter stated this statement merely repeated proposed
Sec. 488.604, while another suggested the penalty was too drastic.
Response: The language regarding penalties for failure to meet the
reuse

[[Page 20383]]

requirements is consistent with section 1881(f)(7) of the Act, which
directly addresses dialyzer filter reuse. However, denial of payment
for discrete instances of reuse non-compliance, authorized by section
1881(f)(7)(C) of the Act, has not been implemented, due to
administrative difficulties associated with identifying which
particular treatments would be associated with any specific denial of
payment when there is a reuse problem. Currently, when a compliance
problem is identified, the surveyor cites the facility and the facility
must develop and implement a corrective action plan. If the facility
does not make the necessary corrections then the facility is put on a
termination track. This process has been effective in protecting
patient health and safety when hemodialyzers are reused and will
continue under this final rule. Therefore, we have removed the
undesignated paragraph ``Failure to meet any of these requirements
constitutes grounds for denial of payment for the dialysis treatment
affected and termination from participation in the Medicare program''
from Sec. 494.50.
We believe dialysis facility termination for reuse deficiencies and
non-compliance fulfills the statutory requirement at section
1881(f)(7)(C) of the Act, that CMS deny payment for hemodialyzer reuse
non-compliance. Under the current process, when a reuse problem is
confirmed by a surveyor, we require immediate corrective action, which
protects patient safety. If the reuse problem presented immediate
jeopardy to patient safety, we would shut down the reuse program
immediately until the facility could demonstrate that the problem had
been corrected. CMS also has the authority to withhold payment from a
facility when it has determined that there have been specific
violations of this provision. If the facility were to continue to
compromise patient safety, we would put the facility on a termination
track. We believe that termination procedures provide more incentive to
return to compliance than the denial of payment alternative sanction.
Comment: One commenter asked how the proposed rule ensures patient
consent for dialyzer reuse.
Response: Our requirement for patient consent for dialysis reuse is
located at Sec. 494.70(a)(9), which states the patient has the right
to be informed of facility policies regarding the reuse of dialysis
supplies, including hemodialyzers. Patients may want to discuss this
aspect of their medical treatment with their physician.
Comment: An organization representing kidney disease patients
expressed concern regarding the large number of times a hemodialyzer is
reused (up to 30 times), and requested that CMS convene a technical
expert panel to examine all facets of reuse and make recommendations to
improve current practice.
Response: We have added incorporation by reference the AAMI reuse
guidelines, ANSI/AAMI RD47:2002 & RD47:2002/A1:2003 ``Reuse of
hemodialyzers'' to this final rule at Sec. 494.50(b)(1). The AAMI
guidelines, which represent the consensus of technical experts, include
dialyzer performance measurements (that is, total cell volume) that
must be met in order for a dialyzer to be reused. Currently these
parameters do not include a maximum number of allowable reuses. We may
consider updates to this final rule through separate rulemaking when
AAMI updates its reuse guidelines.
Comment: A few commenters disagreed with some of the AAMI
hemodialyzer reuse guidelines. One commenter recommended that we
require immediate disinfection of dialyzers and not allow the
refrigeration of dialyzers; another commenter suggested that we ban the
reuse of bloodlines, since AAMI is withdrawing the bloodline reuse
guidelines. A third commenter recommended that dialyzer heat
disinfection be prohibited.
Response: We defer to the AAMI guidelines on each of these reuse
issues. Section 11 of the AAMI reuse guidelines, ANSI/AAMI RD47:2002 &
RD47:2002/A1:2003 ``Reuse of hemodialyzers,'' incorporated into this
final rule by reference, describes the approved processes for cleaning
and disinfecting dialyzers, including heat disinfection. The guidelines
also permit refrigeration of hemodialyzers that cannot be reprocessed
within 2 hours, in order to inhibit bacterial growth. The AAMI
guidelines allow disinfection procedures that have been shown to
accomplish at least high-level disinfection when tested in dialyzers
artificially contaminated with the relevant types of microorganisms.
The guidelines also state that the disinfection process shall not
adversely affect the integrity of the dialyzer. To date, AAMI has not
rescinded the bloodline reuse guidelines and this final rule requires
facilities that reuse bloodlines to follow them.
Comment: Two commenters recommended a further clarification of the
requirement we proposed at Sec. 494.50(b)(3), which stated that
facilities will ``Not expose hemodialyzers to more than one chemical
germicide, other than bleach, during the life of the dialyzer.'' One
suggestion was to insert a clarifying parenthetical phrase so that this
requirement would read, ``Not expose hemodialyzers to more than one
chemical germicide, other than bleach (used as a cleaner in this
application), during the life of the dialyzer.'' This commenter
suggested that without adding this phrase the statement would be
misleading, as it implied that bleach could be used as a disinfectant,
which could damage the dialyzer if used long-term in such a manner.
Response: We agree with the commenter. We have revised Sec.
494.50(b)(3) to clarify that bleach is considered a ``cleaner'' and not
a disinfectant in this context.
Comment: We received a few comments regarding Sec. 494.50(c),
``Monitoring, evaluation, and reporting requirements for the reuse of
hemodialyzers and bloodlines.'' Some commenters recommended clarifying
the phrase ``cluster of adverse patient reactions'' and two commenters
supported a requirement that a blood test be done whenever a febrile
reaction occurs, not just when there is a cluster. Another commenter
cited a 1987 study published in the Journal of the American Medical
Association that established a direct relationship between endotoxin
levels and febrile reactions caused by poor reuse reprocessing
techniques and recommended that endotoxins be measured in addition to
blood and dialysis cultures since cultures may be negative with high
endotoxin levels.
Response: ``A cluster of adverse patient reactions'' means a set of
undesirable events affecting the health of dialysis patients that could
be clinically related to dialyzer reuse practices. In such cases, the
physician responsible for the hemodialyzer reprocessing program must
act in accordance with the AAMI guidelines found at ANSI/AAMI RD47:2002
& RD47:2002/A1:2003. If a single patient has a suspected adverse
reaction, the physician should evaluate the incident and order testing
as appropriate in his or her clinical judgment.
The requirements of section 494.50(c) (regarding obtaining blood
and dialysate cultures and evaluation of dialyzer reprocessing and
water purification systems) would apply if a group of patients (that
is, a cluster) was suspected of having adverse reuse reactions. We
agree with the commenter that facility personnel should perform
dialysate endotoxin level tests along with dialysate cultures when a

[[Page 20384]]

suspected adverse event occurs; this is consistent with our requirement
in the ``Adverse events'' standard in the ``Water and dialysate
quality'' condition at Sec. 494.40. Therefore we have added endotoxin
testing requirements at Sec. 494.40(d)(1) and Sec. 494.50(c)(2)(i).
A dialysis facility that uses outside hemodialyzer reprocessing
services is responsible for fully protecting patient health and safety
and ensuring compliance with these conditions for coverage and AAMI
reuse guidelines as well as carrying out appropriate testing and
evaluation of reuse processing and water purification systems when a
cluster of adverse events occurs.
d. Physical Environment (Proposed Sec. 494.60)
We proposed to update the Sec. 405.2140 ``Physical environment''
requirements, which address facility building safety, equipment
maintenance, the patient care environment, emergency preparedness, and
fire safety, at new Sec. 494.60. The proposed rule was consistent with
part 405, subpart U provisions in requiring that a facility be
constructed, equipped, and maintained to provide dialysis patients,
staff, and the public a safe, functional, and comfortable environment.
The proposed rule further addressed patient comfort by requiring that
the facility temperature be comfortable for the majority of its
patients or that reasonable accommodations be offered. We proposed that
the dialysis facility implement processes and procedures to manage
medical and nonmedical emergencies (including fire, equipment or power
failures, care-related emergencies, water supply interruption, and
natural disasters) that are likely to threaten the health or safety of
the patients, the staff, or the public. The proposed rule would require
emergency preparedness training for staff and patients, and would
specify the emergency equipment that would have to be available in the
dialysis facility (including oxygen, airways, suction, defibrillator,
artificial resuscitator, and emergency drugs). The proposed fire safety
requirements called for facility compliance with applicable provisions
of the 2000 edition of the LSC of the National Fire Protection
Association. The LSC waiver provisions were included in the proposed
rule for those instances when, in the view of CMS, LSC compliance would
result in unreasonable hardship and patient health and safety would not
be adversely affected; or when a State had fire and safety codes that
adequately protected dialysis patients. For a detailed discussion of
our proposed physical environment provisions at Sec. 494.60, see the
February 4, 2005 proposed rule (70 FR at 6197).
Comment: Under the ``Equipment maintenance'' standard at Sec.
494.60(b), one commenter suggested that equipment be maintained
according to a regular maintenance schedule rather than the
manufacturer's recommendations. The commenter was concerned that the
manufacturer might overstate the amount of maintenance required.
Response: Our intent was to ensure that all dialysis facility
equipment was adequately maintained and working properly. We proposed
that ``The dialysis facility must implement and maintain a program to
ensure that all equipment (including emergency equipment, dialysis
machines and equipment, and the water treatment system) is maintained
and operated in accordance with the manufacturer's recommendations.''
It is expected that routine maintenance be performed so that the risk
of equipment malfunction is small. The facility will need to use the
manufacturer's recommendations as a reference and guide. We have
retained Sec. 494.60(b) as proposed.
Comment: While the majority of commenters support our proposed
requirement at Sec. 494.60(c)(2) (that the facility maintain a room
temperature that would be comfortable for patients, and make reasonable
accommodations for the patients who might not be comfortable at the
temperature that is comfortable for the majority), several commenters
disagreed with this requirement. Some thought the proposal was too
prescriptive, ignored the needs of staff (who are required to wear
protective clothing), and allowed patients to dictate staff working
conditions. Commenters noted that facilities already strive to keep
patients comfortable, and stated that patients should be educated as to
why body temperature drops during dialysis.
Response: Room temperature is a source of frequent tension in a
hemodialysis facility. Generally, the sedentary patients undergoing
treatment prefer a warmer room temperature, while staff who are engaged
in activity and wearing protective coverings prefer a cooler room
temperature. The proposed requirement would have tilted the room
temperature in favor of the patients without consideration of the needs
of the staff. In response to comments, we have modified the requirement
to acknowledge the room temperature needs of staff. The intent of the
new requirement is to have facilities arrive at a middle ground so that
the room temperature is at least marginally acceptable to both patients
and staff. Patients who continue to feel cold could use coverings or
blankets. Regardless of the room temperature, patients should not be
deprived of the ability to use covers or blankets. The dialysis
facility may allow patients to bring their own blanket or may opt to
provide a cover. In either case, adequate infection control precautions
must be taken considering the risk of blood spatter. Additionally, the
access sites and line connections should remain uncovered to allow
staff to visually monitor these areas to ensure patient safety. In
response to comments, we have revised Sec. 494.60(c)(2)(i) by removing
the phrase ``that is comfortable for the majority of its patients'' and
inserted the word ``comfortable'' earlier in the sentence. Section
Sec. 494.60(c)(2)(i) and Sec. 494.60(c)(2)(ii) now requires a
facility to maintain a comfortable temperature within the facility; and
make reasonable accommodations for the patients who are not comfortable
at this temperature.
Comment: Many commenters recommended that we add privacy
requirements to allow facility staff to conduct confidential interviews
with patients, and to ensure that facilities utilized physical barriers
whenever body exposure necessitated usual privacy. Commenters who
supported a confidential area for patient interviews cited the April
14, 2003 Health Insurance Portability and Accountability Act (HIPAA)
fact sheet (http://www.hhs.gov/news/facts/privacy.html) which outlines
patient information privacy protections, including the patient's right
to request confidential communications.
Response: HIPAA requirements protecting patient privacy apply to
dialysis facilities. Two provisions of the proposed rule would support
the patient's right to privacy. Proposed paragraph Sec. 494.70(a)(3)
stated that the patient would have the right to privacy and
confidentiality in all aspects of treatment. Likewise, proposed Sec.
494.70(a)(4), stated that the patient would have the right to privacy
and confidentiality in personal medical records. Our preamble
discussion of this requirement in the proposed rule (70 FR 6201)
clearly stated our belief that any staff discussion with dialysis
patients regarding treatment, the patient care plan, and medical
conditions should be held in private and kept confidential, using
reasonable precautions. We also pointed out that in situations when
there was patient body exposure, the staff would be instructed to
provide temporary screens, curtains, or blankets to protect patient
privacy. To respond to these comments and to further

[[Page 20385]]

strengthen the patient's right to physical privacy, we have added a new
provision at Sec. 494.60(c)(3), stating that ``The dialysis facility
must make accommodations to provide for patient privacy when patients
are examined or treated and body exposure is required.'' This provision
also protects those patients who do not wish to intrude on another
patient's privacy.
Comment: Several commenters objected to the deletion of the
centralized nursing monitoring station requirement in the proposed
rule, formerly at Sec. 405.2140(b)(3), as they believe a monitoring
station is needed to support adequate surveillance of patients
receiving dialysis. One commenter suggested that patient call buttons
be required. Another commenter suggested retaining the concept of the
nursing station requirement by adding the language, ``Patients should
be in view of staff at all times during treatment to ensure patient
safety.''
Response: We had proposed deleting the centralized nursing station
requirement in order to increase facility flexibility in designing the
clinical area. Patients undergoing hemodialysis require surveillance
and continuous monitoring. Without vigilant monitoring it is possible
for a dialysis needle to become dislodged, which could result in
patient death from blood loss in just minutes. The suggested call
button would place responsibility on the patient to alert staff to a
problem; however, we expect continual monitoring of the patient, which
would make a call button unwarranted. We are not restoring the
requirement for a ``nursing station'' to allow maximum facility
flexibility, but will require staff surveillance of in-center
hemodialysis patients during treatment. Therefore, we have added a new
provision at Sec. 494.60(c)(4), ``Patients must be in view of staff
during hemodialysis treatment to ensure patient safety (video
surveillance will not meet this requirement).''
Comment: We received several comments regarding ``Emergency
preparedness'' at Sec. 494.60(d). Two commenters objected to having
specific types of emergencies ``spelled out'' in regulation while
another commenter recommended that bioterrorism be added to the list of
emergencies for which facilities would be required to be prepared.
Response: In the proposed rule, the list of emergencies at Sec.
494.60(d) for which dialysis facilities must be prepared ``include, but
are not limited to, fire, equipment or power failures, care-related
emergencies, water supply interruption, and natural disasters likely to
occur in the facility's geographic area.'' This list clarifies for
facilities what types of emergencies must be addressed in the emergency
plans. Facilities may prepare for many types of emergencies, including
bioterrorism, which are identified as a risk after the performance of a
facility risk assessment. We are retaining the proposed list of
emergencies in this final rule.
Comment: Some commenters concurred with the standard as proposed.
Two commenters advocated for a back-up generator requirement. Others
requested clarification of proposed requirement for periodic training
of staff and patients.
Response: The proposed emergency preparedness standard was designed
to allow dialysis facilities maximum flexibility in meeting our
requirements, which could include a back-up generator or other means of
supplying needed power to the facility.
As for training, our final staff training requirements (Sec.
494.60(d)(1)) state that the dialysis facility must ``provide
appropriate training and orientation in emergency preparedness to the
staff. Staff training must be provided and evaluated at least annually
* * *.'' The regulation goes on to specify what topics must be included
in the training and the patients' instruction. The frequency of this
training must be sufficient so that staff and patients are able to
implement emergency procedures at any time. We are adopting Sec.
494.60(d) introductory text and Sec. 494.60(d)(1) introductory text as
proposed. We believe this addresses the commenter's concern.
Comment: After the tragic hurricane events of 2005 (Hurricanes
Katrina, Rita, and Wilma) we received some additional comments and
recommendations from the national ESRD disaster response workgroup
related to natural disaster preparedness, as these experiences led to
new ``lessons learned.'' One recommendation was to add a requirement
that would enable patients to contact their dialysis facility during a
disaster, such as requiring each facility to provide an emergency toll-
free phone number where patients could obtain critical medical
information. A second recommendation was to include evacuation
procedures in the disaster plan. A third recommendation was to require
not only a plan, but also to require facilities to have a procedure in
place to obtain back-up utilities, including agreements with utility
companies for water and energy. A fourth suggestion was to require
dialysis facilities to contact local disaster management officials at
least annually, to ensure that local disaster aid agencies were aware
of the dialysis facility's patients' needs in the event of an
emergency.
Response: The final emergency preparedness standard includes
requirements for the emergency preparedness of staff and patients and
addresses instructions that are provided to dialysis patients. We have
revised Sec. 494.60(d)(1)(i)(B) to require that staff inform patients
of where to go during an emergency, including evacuation instructions
for emergencies in which geographic area of the dialysis facility must
be evacuated.
We believe it is reasonable for dialysis facilities to provide an
alternate phone number if the phone is not being answered, and/or the
facility is not functioning during a disaster. We have added this
requirement at Sec. 494.60 (d)(1)(i)(C). This additional requirement
reads, ``This contact information must include an alternate emergency
phone number for the facility for instances when the dialysis facility
is unable to receive phone calls due to an emergency situation (unless
the facility has the ability to forward calls to a working phone number
under such emergency conditions) * * *.''
A disaster plan must include procedures and processes for use in
the event of power or water source loss, or a disaster that would make
the dialysis facility inoperable. We believe that it is reasonable for
a dialysis facility to establish at least annual contact with its local
disaster management agency to ensure that the agency is aware of the
dialysis facility's needs in the event of an emergency. This pre-
emptive contact could facilitate the meeting of dialysis patient needs
during a disaster. We have added a new provision, codified at Sec.
494.60(d)(4)(iii), requiring the dialysis facility to, ``Contact its
local disaster management agency at least annually to ensure that such
agency is aware of dialysis facility needs in the event of an
emergency.''
We did not modify the final rule in response to the disaster
response workgroup's recommendation that we require facilities to have
a procedure in place to obtain back-up utilities, including agreements
with utility companies for water and energy. This final rules requires
that dialysis facilities develop an emergency plan that addresses
emergency situations that may occur. These emergencies include power
failure and water supply problems. The dialysis facility has
flexibility in designing an emergency plan for these types of
emergencies. The plan may include agreements with utility companies or
alternative

[[Page 20386]]

interventions. We will not prescribe the methods that must be employed
in responding to the various types of emergencies. The emergency plan
must provide sufficient guidance to staff in preparing for emergencies
and carrying out the plan.
Comment: A few comments were specific to proposed Sec.
494.60(d)(1)(iii), requiring the facility to ensure that nursing staff
are properly trained in the use of emergency equipment and emergency
drugs. Two commenters objected to such nurse training, because it
``placed an emergency room-type burden on them.'' Other commenters
suggested that the relevant emergency drugs be specified, and that
suction devices be specifically excluded from the definition of
``emergency equipment.''
Response: We believe it is reasonable for dialysis facility nurses
to be trained and prepared to handle emergencies that are likely to
occur within the dialysis facility, and to require the facility to have
equipment available for treating these emergencies. Suction machines
are necessary medical devices used to clear a patient's airway of
secretions or vomit. In the absence of these medical devices, it is
possible that the patient's airway could not be cleared. Therefore, we
are not deleting this requirement. The specific emergency drugs that
are to be available should be determined by the medical director and
described in the facility's policies and procedures. We are making no
changes based on these comments.
Comment: We received many comments regarding the proposed
defibrillator requirement at Sec. 494.60(d)(3). The vast majority of
commenters support inclusion of a defibrillator requirement, but
recommended that an automated external defibrillator (AED) be an
acceptable option. Commenters stated that AEDs were preferable because
they are easy to use, more affordable, and do not require the extensive
Advanced Cardiac Life Support (ACLS) training and certification that a
non-automated defibrillator would require. Commenters did not support a
defibrillator exception for small rural dialysis facilities, stating
that these more remote facilities do not have nearby emergency medical
services (EMS) and have a greater need for an in-house AED. A few
commenters objected to the defibrillator requirement because they saw
this as an unfunded mandate. One commenter said defibrillators should
only be required if Medicare funds them, while another dissenting
commenter said the need for a defibrillator should be based on the
facility's proximity to EMS. The American Heart Association (AHA)
commented on this issue and strongly supported a defibrillator
requirement and AEDs in dialysis units, and suggested that AED training
be combined with cardiopulmonary resuscitation training. The AHA
pointed out that defibrillators have been shown to save lives in a
variety of settings including office buildings, airplanes, and
stadiums, where survival rates without AEDs are otherwise 1 percent.
The AHA also noted that cardiac disease accounts for 43 percent of
deaths in ESRD patients (United States Renal Data System 2003 Annual
Data Report). The AHA recommended no exemptions for small, rural units
but suggested a 1-year phase-in period for these types of dialysis
facilities.
Response: We received substantial support from commenters for
requiring a defibrillator, specifically an AED. In response to
comments, we will require a defibrillator or an automated external
defibrillator in our ``Emergency equipment'' standard at Sec.
494.60(d)(3). However, we are not allowing a ``1-year phase-in period''
for small, rural units as suggested by one commenter. This is because
we believe that a small, rural unit is likely to be further from
emergency services and/or ambulance services, and as such, we believe
that having a defibrillator or AED on hand would greatly increase the
chance of survival for a dialysis patient in the event of a cardiac
arrest. We believe that facilities will have sufficient time to
purchase a defibrillator or AED and to train staff, since this
regulation is effective 180 days after publication in the Federal
Register.
Comment: We received many comments on proposed Sec. 494.60(e)
``Fire safety.'' Several commenters concurred with the standard as
proposed. We received many comments objecting to the proposed LSC
provisions that require sprinklers and central monitoring systems in
dialysis facilities. The commenters felt that LSC provisions should
apply only to new facilities that are built after the effective date of
the final rule. Several commenters felt that requiring the installation
of sprinkler and a central monitoring system would be costly and
burdensome. Some stated this could impose excessive burdens on leased
dialysis facilities, building landlords, multi-story buildings and
multi-tenant buildings, where sprinkler systems would need to be
installed in a general retrofit for the entire structure. Commenters
stated that since existing dialysis facilities occupied buildings that
met the building codes in effect at the time of construction, they
should be grandfathered for the 2000 LSC requirements, as long as State
codes were met.
Response: The proposed LSC requirements provide significantly
greater protection to dialysis patients than the fire protection
provisions of part 405, subpart U at Sec. 405.2140(a) and Sec.
405.2140(c). Commenters objected most strongly to the LSC requirement
for a sprinkler system in certain existing buildings. The 2000 LSC only
requires buildings with certain structural configurations to have
sprinkler systems. Specifically, 2000 LSC requires that only Type II
(000) and ordinary constructed Type III (200) buildings, and Type V
(000) buildings of two or more stories must be protected throughout by
an approved, supervised automatic sprinkler system (2000 LSC section
21.1.6.3). We acknowledged in the proposed rule preamble that for some
existing dialysis facilities it could be overly burdensome to comply
with certain LSC requirements, and provided the sprinkler requirement
as an example (70 FR 6200). We indicated that this could be a situation
where a waiver might be warranted. However, the January 10, 2003 final
rule, ``Fire Safety Requirements for Certain Health Care Facilities,''
allowed the grandfathering of existing facilities for the sprinkler
systems requirement (as long as the facility was not undergoing
renovations), without the imposition of a waiver process (68 FR 1375).
Likewise, we will only apply the sprinkler provisions called for in the
2000 LSC to new dialysis facilities and existing facilities that are
undergoing extensive renovations. Therefore, in new Sec. 494.60(e)(2),
we are exempting dialysis facilities in operation on the effective date
of this rule and utilizing facilities built before January 1, 2008 from
installing sprinkler systems if State law so permits. However, no
dialysis facility may open and/or move to a location without a
sprinkler system after the effective date of this rule. All other 2000
LSC provisions found in chapters 20 and 21 (New and Existing Ambulatory
Health Care Occupancies) will be applied to dialysis facilities,
including the provisions regarding automatic notification-equipped fire
detection and alarm systems. However, in recognition of the possible
extra expense and time required to review current building leases and
fire codes, and if necessary, to make changes in the building
structure, we are allowing dialysis facilities 300 days after the
publication of this final rule in the Federal Register to comply with
the requirements found at Sec. 494.60(e)(1).

[[Page 20387]]

The stipulation at Sec. 494.60(e)(4) regarding the waiver process
for other provisions of the LSC has been retained in this final rule. A
dialysis facility may apply for a waiver after receiving a notice of
deficiency resulting from a survey by the State agency. The State
agency will review the request and may seek guidance from the State
fire marshal to make recommendations to the appropriate CMS Regional
office. Our regional office will review the request and all associated
documentation and make a final decision on the waiver.
Comment: Several commenters asked why ESRD facilities would have to
meet State and local fire codes along with Federal fire safety
standards. Many commenters requested waivers or extensions of the
implementation date and stated that if presented with an option, they
would prefer to follow State and local fire codes in lieu of the
Federal standards.
Response: This final rule provides for a statewide waiver of any
provision of the LSC (see Sec. 494.60(e)(3) through Sec.
494.60(e)(4)) that would not adversely affect patient health and
safety, if endorsed by State survey authorities and approved by CMS.
Any statewide waiver granted would apply to both new and existing
facilities in the state. Individual waivers can be requested by both
new and existing facilities. In States receiving a CMS-approved LSC
waiver, dialysis facilities will only need to meet State fire safety
provisions. Additionally, we have removed our proposed language at
Sec. 494.60(e)(2), which proposed that Chapter 5 of the 2000 edition
of the LSC would not apply to a dialysis facility. Use of Chapter 5 of
the LSC allows a dialysis facility a performance-based option for
meeting the LSC occupant protection, structural integrity, and systems
effectiveness goals and objectives. This change allows the design of a
LSC-compliant dialysis facility building using a performance-based
template that employs a computer-based methodology. This requirement is
consistent with our LSC provisions for other provider-types and
increases flexibility for dialysis facilities.
Comment: One commenter suggested that an emergency evacuation chair
should be required for dialysis facilities in multi-level buildings.
Response: We appreciate the comment; however, we do not agree that
an emergency evacuation chair should be required. We believe that LSC
protections at Sec. 494.60(e)(1) will provide an adequate level of
safety. Dialysis facilities should develop a disaster preparedness plan
as required at Sec. 494.60(d) that includes evacuation procedures.
Facilities may choose to have an emergency evacuation chair if
necessary.
Comment: Many commenters objected to removing patients from
dialysis equipment and evacuating them in order to comply with the fire
drill requirement. It was felt that this exercise was unreasonable and
medically unsafe. Many commenters preferred annual fire drills instead
of quarterly fire drills.
Response: We agree with the commenters regarding removal of
patients during fire drills. As we indicated in the preamble of the
proposed ESRD conditions for coverage (70 FR 6200), we are not going to
require that patients be physically removed during a fire drill. Fire
drills may be conducted using simulated patients or empty wheelchairs.
According to the LSC 2000, quarterly fire drills are not required.
Instead, section 4.7.2 of the LSC--Drill Frequency states, ``Emergency
egress and relocation drills, where required by chapters 11 through 42
or the authority having jurisdiction, shall be held with sufficient
frequency to familiarize occupants with the drill procedure and to
establish conduct of the drill as a matter of routine.''
3. Subpart C--Patient Care
a. Patients' Rights (Proposed Sec. 494.70)
We proposed to update the existing condition for coverage at Sec.
405.2138, ``Patients' rights,'' by replacing it with a new condition
for coverage at Sec. 494.70. We proposed that patients or their
designated representatives be informed of their rights and
responsibilities when beginning treatment in the facility. The essence
of the provisions in existing Sec. 405.2138 was retained in the new
condition for coverage under Sec. 494.70(a), ``Patients' rights.'' In
addition to these provisions, new Sec. 494.70(a)(6) states that
patients must be informed about their right to have advance directives.
Patients must also be informed of all modality choices, including home
hemodialysis. The provision that patients must be informed of facility
policies regarding patient care, including, but not limited to,
isolation of patients, was proposed at Sec. 494.70(a)(7). We also
proposed changes to the existing grievance mechanism requirements at
Sec. 405.2138(e). The proposed rule would require facilities to inform
patients of internal and external grievance processes, including how to
contact the ESRD Network and State survey agency.
Standard (a) also proposed that patients be informed that they
could file grievances personally, anonymously, or through a
representative, and could do so without reprisal or denial of services.
We also proposed a new standard at 494.70(b) to guarantee the patient's
right to be informed regarding the facility's discharge, transfer, and
discontinuation of services policies. This proposed standard also would
have required facilities to provide a written notice to patients 30
days in advance of the facility terminating care, but would provide
that in the case of immediate threats to the health and safety of
others, an abbreviated discharge procedure could be allowed. We also
proposed to require the facility to prominently display a copy of the
patients' rights in the facility where patients could easily see and
read it. We proposed that this posted information also include up-to-
date State agency and ESRD Network telephone complaint numbers.
The Children's Health Act amended the Public Health Service Act by
(among other things) adding a new section 591 (Pub. L. 106-310, section
3207; 42 U.S.C. 290ii); this section requires health care facilities to
protect and promote the rights of residents to be free from restraint
and seclusion imposed for purposes of discipline or convenience. The
law applies to any ``public or private general hospital, nursing
facility, intermediate care facility, or any other health care facility
that receive support in any form from any program supported in whole or
in part with funds appropriated to any Federal department or agency * *
*.'' Section 591(d)(1) of the Public Health Service Act defines
restraint as any mechanical or personal restriction that immobilizes or
reduces the ability of an individual to move freely or a drug or
medication that is used as a restraint to control behavior or restrict
freedom of movement. Seclusion is defined as any behavior control
technique involving locked isolation, not including a time out.
While we believe that section 591 of the Public Health Service Act
applies to Medicare-participating dialysis facilities, this final rule
does not address these specific restraint and seclusion provisions
because these issues are being considered under a separate rulemaking.
Therefore, the patient rights section does not contain any restraint or
seclusion requirements at this time.
Comment: We received many public comments regarding the rights of
patients. There was overall support for the condition as a whole, as
well as many recommendations and suggestions.
Some commenters recommended that we mandate that facilities inform

[[Page 20388]]

patients of their rights at the start of care or within 30 days after
the start of care. Others suggested that these rights be reviewed with
the patient at least annually, or more frequently depending on patient
need. One commenter suggested patient rights be reviewed during the
first dialysis treatment and reviewed in detail by a social worker
within the first month, while another suggested that a summary of
patient rights would be sufficient. A number of commenters suggested
the addition of language to mandate that facilities inform patients of
facility policies, including discharge policies.
Response: Patients are entitled to be informed of their rights at
the start of care, meaning within the first 3 treatments in the
facility, which, we believe, will allow patients to exercise their
rights and make choices regarding their care immediately. We are not
prescribing the level of detail for a patient's rights review, nor
which facility staff members must perform the review. The facility has
flexibility in meeting the intent of this provision, so long as the
facility sufficiently informs the patient so that he or she may
exercise his or her rights early in dialysis care. The professionals at
the dialysis facility should determine the most appropriate time for a
more detailed review of patient's rights (including discharge policy
information) according to individual patient's needs. Patients must
also be informed of dialysis facility discharge policies as required at
Sec. 494.70(b)(1), and we expect all information would be provided at
one time. We believe requiring a facility to provide patient's rights
information within 3 treatments is reasonable, given that dialysis is
normally performed 3 times per week for approximately 3 to 4 hours per
session.
Comment: We received several comments regarding possible
misinterpretations by State surveyors as to what is meant by patients
being ``informed'' of facility policies.
Response: The word ``inform'' simply means to communicate
knowledge. We have not dictated the mode of communication. Patient
rights information may be presented to patients in writing, orally, in
audiovisual form, etc. Since the means by which information is
communicated to the patient is not specified, facilities and their
staff have the necessary flexibility to comply within the intent of the
condition. Our interpretive guidelines for surveyors will reflect the
intent of the final rule.
Comment: We received several comments regarding discrimination and
harassment. Some commenters specifically recommended that we add
language that states patients have the right to be free from verbal,
physical, sexual abuse, intimidation, and harassment.
Response: The ``Patients' rights'' condition specifies the
patient's right to dignity and respect. Moreover, section 494.20 states
that facilities and staff must comply with applicable Federal, State,
and local laws, and these laws and protections apply to dialysis
patients. Illegal acts must not be tolerated in dialysis facilities and
should trigger notification of appropriate law enforcement officials.
We have not expanded ``Patients' rights'' as suggested by the
commenters; we believe sufficient safeguards, laws, and regulations are
already in place.
Comment: Two commenters suggested additional language for the
protection of patients' rights and dignity. The commenters explained
that some patients are disconnected from a dialysis machine only after
being made to sign a ``Leaving Against Medical Advice'' waiver of
liability, for such activities as using the restroom, taking pain
medications, or eating or drinking. The commenters suggested that the
``Patients' rights'' condition include protection for these patients
whose rights and dignity are being violated.
Response: At Sec. 494.70(a)(1) patients have the right to receive
respect for their personal needs. The intent of this standard is that
all facilities must respect patients and their individual
characteristics or unique needs. For instance, facilities may want to
develop policies for a variety of situations, such as patient restroom
use during a dialysis session, to ensure that their patients' rights
are protected. We do not expect that patient signatures on liability
waivers are necessary or appropriate in most cases. When a patient
needs to use the restroom, that time should not be deducted from the
dialysis treatment session. Facilities should schedule patients in such
a way so that patients are not forced to give up prescribed services
for which Medicare provides payment. In addition, CMS considers
facilities that fail to schedule patients appropriately and thus, force
patients to give up prescribed services, to be a serious matter of
program integrity.
Comment: Several commenters suggested that current subpart U
regulatory language, requiring a facility to use translators where a
significant number of patients exhibit language barriers, remain in the
final rule. Two commenters suggested language be added to specify that
a facility must make a clear, reasonable effort to provide information
in a language the patient can understand and to document such provision
in the patient's record. Two commenters suggested that facilities be
required to provide information in the appropriate language and in a
culturally sensitive manner. Additionally, several commenters suggested
that a facility confirm that patients understand the information they
receive.
Response: The intent of the proposed rule language was to provide
the facility with flexibility in meeting the requirement that it
provide information in a way the patient understands. If a facility
needs to obtain the use of a translator service to provide information
to a patient and respond to questions, then we expect the facility to
obtain that service. The suggestion to add language that requires
information to be provided in a culturally sensitive manner, as well as
in the appropriate language, would be redundant, since this is required
as part of Sec. 494.70(a)(2). The information required to be provided
under Sec. 494.70 would include all the information patients need to
understand their rights and participate in their care if they choose
(see Sec. 494.70(a)(5)).
Comment: One commenter suggested that specific language be added to
state that a social worker should have the ability to assess a
patient's psychological needs in a private environment.
Response: The intention of Sec. 494.70(a)(3) and Sec.
494.70(a)(4) is that all facilities must respect privacy and
confidentiality for all patients; therefore social worker-patient
interactions that require privacy should be conducted in private.
Comment: A number of commenters stated that patient participation
can optimize care. One commenter suggested language to specify that
patients and their family members participate in their care and
training. Several other commenters suggested we state that patients
have some obligation to take part in, and be accountable for their
care, and that patients must be fully aware of and engaged in their
course of treatment.
Response: The ``Patients' rights'' condition requires that patients
or their representatives be informed about patient rights and
responsibilities. Section 494.70(a)(5) states that patients have the
right to participate in all aspects of care. It may be desirable that
patients participate fully in their care; however, neither CMS nor a
facility can demand full patient participation. Additionally, we cannot
mandate the involvement of patient representatives in the care of
patients. We do require that patients have the opportunity to

[[Page 20389]]

participate in their care. Patients have the right to accept or decline
to participate.
Comment: Two commenters suggested that we add language to specify
that a patient has the right to attend care planning meetings and that
a patient also has the right to request a care conference that would
include his or her care team members. One commenter stated that there
was no regulatory language that provides that a patient has the right
to be involved in care planning, and that the language only required
the patient to be informed of care planning.
Response: Patients have the right to be involved in their care
planning as part of the interdisciplinary team, which is defined at
Sec. 494.80 and Sec. 494.90. Because patients have the right to be
part of the interdisciplinary team, they have the opportunity to
participate in all aspects of care, which includes, but is not limited
to, care planning. The language in the final rule allows for
flexibility in the way a facility demonstrates that a patient has had
sufficient opportunity to participate as part of the team. Care plan
meetings or conference calls that allow the patient to call in from
home would allow the patient to participate. The dialysis facility must
encourage patient participation in care planning.
Comment: Some commenters, including patients, suggested language be
added to state that a patient has the right to refuse cannulation by
specific nurses or patient care technicians (PCTs) if problems
cannulating his or her access site have occurred with that staff
member. Some patients have experienced situations causing them fear
and/or discomfort due to cannulation by specific members of a
facility's staff.
Response: Patients have the right to be informed of the right to
refuse treatment, as required at Sec. 494.70(a)(5). However, this
final regulation includes new minimum qualifications for PCTs, who
frequently cannulate patients during in-center hemodialysis sessions.
Dialysis facilities will now be required to employ trained and
certified patient care technicians. We have added ``proper cannulation
techniques'' as part of the technician training program at Sec.
494.140(e)(3)(iii). We would anticipate patients having less difficulty
with cannulation due to the more stringent technician training
requirements required for certification. Additionally, ``Fistula
First'' is a nationwide initiative that promotes the adoption of
recommended ``best practices,'' including cannulation methods, in
dialysis facilities. Facilities are encouraged to implement these
practices, including increased self-cannulation. The initiative
encourages self-cannulation with the appropriate course of training, as
part of an emphasis on broader patient involvement in care.
Comment: A number of comments reinforced the importance of advance
directives. Many comments support the inclusion of providing advance
directives information in the ``Patients' rights'' condition. A few
comments requested that the proposed advance directives language be
strengthened by adding discussion of ``end of life'' options. Another
commenter suggested the intent of the regulation text could be
clarified further by adding language to require that facilities provide
an advance directive planning process. One commenter remarked that
patients should not be required to have an advance directive on file.
Additionally, a few comments suggested that patients be educated about
advance directives rather than just informed.
Response: The large number of supportive comments regarding advance
directives is appreciated. We believe that it is important to include
this language in the final regulation for several reasons, not the
least of which is that while ESRD treatment has prolonged life, the
typical patient receiving dialysis treatment is often afflicted with
multiple co-morbidities. We are not mandating that facilities discuss
``end of life'' options, requiring units to provide advance directives
planning assistance, or requiring patients to complete advance
directive documents. We are requiring in the final rule at Sec.
494.70(a)(6) that facilities inform patients of their right to have
advance directives and inform patients of the facility's policies
regarding advance directives. While the actions suggested by commenters
might assist in the planning process, we believe requirements such as
these would extend beyond the scope of a facility's expertise and
responsibility, as well as beyond the scope and intent of these
regulations. Patients requiring assistance in advance directive
preparation should look to the facilities' social workers for guidance,
as social work professionals are trained to use their clinical judgment
to evaluate, provide information and make referrals if necessary.
Comment: Several commenters suggested that we strengthen and
clarify the advance directives language by adding specific requirements
to the regulation text. One commenter suggested that patients be
required to identify a preferred surrogate decision-maker, complete an
advance directive and durable power of attorney, as well as indicate
the amount of leeway for their chosen surrogates. Another commenter
suggested that the social worker be required to inform, encourage, and
assist in completion of advance directives.
Response: We appreciate the comments; however, we will not require
specific professionals to be responsible for encouraging patients to
complete advance directives. The dialysis facility staff must assess
individual patient needs, and determine if there is a need for further
clarification or discussion. They may suggest referral to a resource,
lawyer, or other appropriate professionals if indicated. Some patients
may desire to execute very detailed directions and advance directives
while other patients may not. We are not specifying patient advance
directive execution requirements in this final rule.
Comment: Many commenters suggested that we require a facility to
honor an advance directive, including ``do-not-resuscitate'' orders.
Two commenters suggested that the rule state that, if a facility could
not honor the wishes of an advance directive, the facility would have
to notify the patient and transfer patient to a facility that was able
to honor those wishes.
Response: The ``Patients' rights'' section of the proposed rule
would allow patients the right to be informed of their ability to
execute an advance directive. In response to comments, we have added a
provision stating that patients have the right to be informed of the
facility's policy regarding advance directives. The advance directive
language at Sec. 494.70(a)(5) in the proposed rule has been revised
and relocated. We have redesignated proposed Sec. 494.70(a)(6) through
Sec. 494.70(a)(16) as Sec. 494.70(a)(7) through Sec. 494.70(a)(17)
and have added a new Sec. 494.70(a)(6) to require facilities to ensure
that a patient is informed about his or her right to execute advance
directives and the facility's policy regarding advance directives. We
have also added language to the ``Medical records'' condition at Sec.
494.170(b)(2) to require that facilities document in the patient's
medical record whether or not an advance directive has been executed by
the patient. The facility should address advance directives in their
policies and procedures, which must be available to patients as
required in the ``Patients' rights'' condition. We expect facilities to
make patients aware of their policies regarding honoring properly
executed advance directives. If a facility does not honor advance
directives, we

[[Page 20390]]

expect it to make the patient aware of that policy. In addition, we
believe that the facility should develop a protocol for patient
transfer, if a facility does not intend to honor advance directives.
Some patients will opt to be treated in a facility that will honor
their advance directives.
Comment: One commenter suggested there is a need for national
guidelines for advance directives specific to dialysis services.
Response: Advance directive guidelines developed by national
organizations, such as the Renal Physicians Association (RPA) and the
National Kidney Foundation (NKF) already exist. Although we will not
require adherence to RPA and NKF advance directive guidelines, we
encourage facilities to use these valuable resources.
Comment: Many commenters concurred that information on all
modalities should be presented to all patients. One commenter remarked
that family members should also be presented with information on all
modalities. Another suggested we require facilities to inform patients
about all modalities at least annually.
Response: The ``Patients' rights'' condition at Sec. 494.70(a)(7)
requires that the patient or his or her representative be informed of
patient rights, including information about treatment modalities and
settings. Patients must decide what is in their best interest and they
should have the flexibility to include family members in their
decisions regarding dialysis modalities as they see fit. Patients are
periodically reassessed, as required under the condition for patient
assessment at Sec. 494.80(d). The patient's suitability for various
dialysis modalities and/or transplantation are assessed by the
interdisciplinary team, which may include the patient if desired, and
reviewed with the patient each year. Consequently, we believe it would
be redundant to add the suggested language under the ``Patients'
rights'' condition, since the requirement already exists elsewhere.
Comment: One commenter suggested that modality options be broader
to allow for new modalities, and that the facility offer an option for
``no treatment.''
Response: Individual patients always have the choice to not seek
treatment. As indicated at proposed Sec. 494.70(a)(5), patients have
the right to refuse treatment. If an individual is a patient of an ESRD
facility, then he or she has likely made the decision to treat his or
her illness. However, the patient's medical condition may change in
later months or years and there could be a time when the patient
decides that dialysis treatment is no longer appropriate. Therefore, in
response to this comment, we have modified our requirement so that a
patient must be informed of the right to discontinue as well as refuse
treatment.
Comment: One commenter suggested that the modality discussion
include the offer of transplant information and home dialysis
education.
Response: Transplant information and home dialysis education are
addressed under the condition ``Patient plan of care.'' The standard
for patient education and training at Sec. 494.90(d) mandates that the
plan of care include education and training in aspects of the dialysis
experience, dialysis management and transplantation, among other
things. Since transplant education for patients is captured as a
standard level requirement, it would be redundant to include the
language in the ``Patients' rights'' section.
Comment: One commenter suggested that all facilities be required to
offer home dialysis.
Response: While it may be ideal for every dialysis facility to
offer home dialysis, dialysis facilities have the flexibility to choose
which modalities to offer. However, patients must be informed of all
possible dialysis modalities, and where those modalities are offered.
We have revised Sec. 494.70(a)(7) to specify that facilities must
provide resource information about those modalities not offered in
their specific facilities. In addition, facilities must provide
information about alternative scheduling options for working patients
within and outside their own facility.
Comment: Many commenters suggested that facilities be required to
provide information on where all modalities may be obtained, including
home dialysis options. Some recommended that the regulation specify
that alternate dialysis locations be located within 120 miles of the
facility.
Response: As noted above, patients have the right to receive
resource information for modalities not offered in their facilities.
The facility may wish to create a resource information packet or
provide patients with an existing list from Medicare's DFC Web site.
This resource information may include giving the patient a handout, or
the DFC Web site information. Doing any of these things would meet the
requirement to provide the patient with resource information on where
they may obtain alternate care options. Requiring a facility to
identify dialysis options within a certain geographical limit would be
a burden without benefit, as the suggested 120 mile radius would likely
be too far for many patients. Those patients living in rural areas
might be more accustomed to traveling longer distances for services
than those residing in more urban areas and as such, we expect rural
dialysis facilities would consider this and make referrals as
appropriate.
Comment: A few commenters suggested that language be added to state
that a patient has the right to perform self-care after being trained.
Additionally, a number of comments suggested that we add specific
language to include self-cannulation and self-care to the list of
modalities at Sec. 494.70(a)(7).
Response: Some of the comments received on this issue were vague,
but we assume they generally refer to self-cannulation as an example of
self-care that may be performed by the patient in the dialysis facility
following training. Patients currently are allowed to self-cannulate
upon receiving the proper training and demonstrating competency. The
patient's right to participate in aspects of his or her care is
addressed at Sec. 494.70(a)(5), and as written, is flexible enough to
include self-cannulation as well as other forms of in-center self-care
and home dialysis.
Comment: Several commenters requested that language be added to
require dialysis facilities to inform patients about their right to
schedule treatments that can accommodate work and/or school schedules.
Others suggested that we add language at proposed Sec. 494.70(a)(7) to
specify that patients have a right to have access to a work-friendly
dialysis modality or schedule that accommodates work and/or school, and
if a schedule cannot be accommodated within that facility, the facility
must refer the patients to another facility that can meet the patients'
needs. Additionally, another commenter remarked that CMS should not
drop the existing requirement that a facility accommodate patients who
work.
Response: We believe that facilities should inform patients about
different modalities, and where to obtain them. This allows patients to
make a choice about what type of dialysis treatment is most convenient
for them. Working patients do have the option of home dialysis, which
may be more attractive because of the more flexible treatment schedule.
Facilities generally are willing to work with patients who have other
medical appointments that may affect their dialysis schedule.
Facilities with a full patient census may have limited ability to
change the dialysis schedule but will try to switch dialysis session

[[Page 20391]]

appointments when other patients are agreeable. Dialysis patients who
work or attend school should be encouraged to continue doing so and
dialysis facilities should recommend the most appropriate modality and
setting for dialysis. While we are not requiring a facility to provide
every modality or schedule to accommodate patients' unique schedules,
we are now requiring that facilities inform the patient where such
accommodations may be obtained. We have added new language at Sec.
494.70(a)(7), giving the patient the right to receive resource
information about dialysis modalities not offered by that facility,
including alternative scheduling options for working patients.
Accommodations for working patients may include, for example, home
hemodialysis, peritoneal dialysis, or extended facility hours.
Comment: One commenter objected to the proposal that facilities be
required to fully inform all patients about isolation, stating that the
regulation should ensure that patients have access to policies but not
require all policies be provided to all patients.
Response: This requirement is not a new mandate, but has been
retained from part 405, subpart U, the ESRD Conditions for Coverage.
Open communication between the facility staff and the patient, as well
as patient access to information, are both important for enhancing the
patient's participation in his or her care; this requirement will
remain in the final rule.
Comment: Two commenters recommended that the facility inform the
patient about the health and safety risks involved in reusing
dialyzers, provide accurate reuse data, provide the patient with
treatment options other than reuse, and notify the patient that reuse
is a patient choice. Another commenter stated that patients should have
the right to decline reuse and receive single use dialyzers in a
facility. One commenter questioned whether there should be a reuse
consent form, while another asked how patient choice would be
protected.
Response: Reuse is a safe practice when performed correctly. Reuse
language at proposed Sec. 494.50 was retained from existing regulation
and now requires ESRD facilities reusing hemodialyzers to meet the new
guidelines and standards adopted by AAMI. Additionally, section
1881(f)(7) of the Act directly addresses dialyzer reuse. Reuse is a
care decision that is to be made between the patient and his or her
physician. Patients also have the option to seek treatment in a
facility that exclusively uses new dialyzers.
Comment: One commenter suggested deletion of the requirement that
facilities inform patients of their own medical status. Another
suggested that we add broader language in the regulation text, which
would allow physicians, nephrologists, nurse practitioners or physician
assistants to provide patients with their own medical information.
Response: Providing the patient with his or her medical information
is an existing requirement and is found at Sec. 405.2138(a)(3). The
commenter provided no rationale for the deletion of this standard
language and thus, the language has been retained. We have added the
nurse practitioner, clinical nurse specialist and/or physician's
assistant treating the patient for ESRD to the list of authorized
personnel at Sec. 494.70(a)(10), which now states that patients have
the right to be informed by the physician, nurse practitioner, clinical
nurse specialist, or physician's assistant treating the patient for
ESRD of his or her own medical status as documented in his or her
medical record, unless the medical record contains a documented
contraindication. Individual facilities may determine policies and
procedures, in accordance with the State Boards of Practice, regarding
the practice of advance practice nurses and PAs in the facility.
Comment: A commenter objected to the requirement that facilities
fully inform patients about charges not covered by Medicare. Another
commenter suggested that trained and informed staff should explain non-
covered charges.
Response: The intent of the existing subpart U language at Sec.
405.2138(a)(2) was carried over into the proposed language at Sec.
494.70(a)(10), now redesignated as Sec. 494.70(a)(11) in this final
rule, which requires facilities to tell patients what services are
available in the facility, and inform them of charges for services not
covered under Medicare. Additionally, if a facility plans to bill a
patient for items and/or services which are usually covered by
Medicare, but which may not be considered reasonable and necessary for
a particular situation (according to section 1862 of the Act), an
advanced beneficiary notice must be given pursuant to section 1879 of
the Act.
Comment: A few commenters suggested that regulatory language
require that patients be given access to social work and psychological
services, psychosocial counseling, and nutritional counseling. Some
commenters suggested that language be added to the ``Patients' rights''
condition that specifies that patients would have access to, and
receive counseling from, a qualified social worker and a dietitian.
Some commenters recommended that patients have the right to receive a
referral for mental health services, physical or occupational therapy
and/or vocational rehabilitation, as needed. Another commenter
suggested the addition of language that would stipulate that patients
would have the right to receive necessary services, as authorized by
their insurance plan.
Response: The ``Patient assessment'' and the ``Patient plan of
care'' conditions for coverage (Sec. 494.80 and Sec. 494.90,
respectively), require input by an interdisciplinary team. This team of
professionals includes, at minimum, a registered nurse, physician,
social worker and dietitian. The team is responsible for properly
assessing and treating the patient, which would include identifying
additional treatment needs, such as psychosocial counseling, etc.
Therefore, we believe that expanding the language at Sec.
494.70(a)(12) to include social work and psychological services,
psychosocial counseling and nutritional counseling, as suggested by
these public comments, would be redundant under the final rule. Under
the final rule, following the comprehensive assessment required at
Sec. 494.80, a plan of care for each patient must be implemented,
which must include care and services deemed necessary by the
interdisciplinary team. The requirements for the provision of services
under the ``Plan of care'' condition at Sec. 494.90, do include
nutritional and social services, such as psychosocial and nutritional
counseling. Furthermore, the ``Patients' rights'' condition at Sec.
494.70(a)(11) requires facilities to inform patients of their right to
be informed of services available in the facility and the charges for
services not covered under Medicare. At Sec. 494.70(a)(12), patients
have the right to receive the necessary services outlined in the
patient plan of care. Therefore, we believe the concerns of commenters
are adequately addressed at Sec. 494.70, Sec. 494.80 and Sec.
494.90.
Comment: Some commenters suggested adding language to specify that
facilities must inform patients of their responsibilities, including
punctuality, following dietary/fluid restrictions, following treatment
regimens, exhibiting appropriate personal behavior, informing the team
of scheduling problems, and issues in filling prescriptions. Other
commenters stated that facilities should inform patients that the
patients have a responsibility to listen and ask

[[Page 20392]]

questions when they do not fully understand their rights or
responsibilities. Another commenter stated that CMS should clarify
patient responsibilities in the standard for patient rights.
Response: Patient responsibilities are addressed at Sec.
494.70(a)(13). We have retained the existing requirement found at Sec.
405.2138(a)(1), which states that patients must be informed of the
rules and expectations of the facility regarding patient conduct and
responsibilities. The proposed language has been retained in the final
rule. It is essential to recognize that positive patient behavior may
be encouraged but cannot be regulated.
Comment: One commenter suggested that we add regulatory language to
clarify that there needs to be a balance between providers' duties and
patient rights.
Response: Proposed section 494.70(a)(12), now Sec. 494.70(a)(13)
of this final rule, requires that the dialysis facility inform patients
of their rights, including rules and expectations regarding patient
conduct and responsibilities. Moreover, facilities must protect and
provide for the exercise of patient rights. Informing patients of their
responsibilities promotes and supports patient involvement in their
care. We will not attempt to address unique individual situations in
this regulation, but we expect that while facility staff informs
patients of their rights and responsibilities, we also expect patients
to try to adhere to facility rules and guidance from facility staff,
which would help patients maintain optimal health while receiving
facility services.
Comment: We received many comments in support of more patient-
protection requirements regarding facility internal grievance
processes. Commenters supported the proposed requirement for facilities
to post information on how to file a grievance. Some commenters
specifically supported requiring the posting of Network and State
Agency phone numbers and/or mailing addresses.
Response: We agree that it would be in the best interest of
patients that Network and State Agency mailing addresses and phone
numbers be posted. Posting the additional patient rights information
will not be a significant burden upon facilities. We have revised Sec.
494.70(c) to include ``mailing addresses.''
Comment: One commenter suggested that CMS establish a separate
definition of ``grievance.'' Another remarked that the term
``grievance'' should always be used carefully and with full
understanding of its seriousness. One commenter suggested that
facilities be required to review the grievance process with patients on
a regular basis. One commenter suggested adding language requiring a
facility to ``attempt to resolve'' grievances.
Response: We appreciate the comment, as well as the suggestions
regarding the grievance procedure. We believe the term ``grievance'' is
a commonly understood term and we did not receive substantial public
comment indicating this to be a particularly difficult concept to
understand within the renal community. We disagree with the commenter
and have not added a definition for the term ``grievance'' in the
``Patients' rights'' condition at Sec. 494.70. Whether patients use
the term ``complaint'' or ``grievance,'' they have the right to be
informed of and use established internal and external grievance
procedures. The proposed language was added to inform patients about
external mechanisms for filing a grievance and how to contact the ESRD
Network and State survey agency; the language strengthens the existing
requirements. We believe that it is imperative that all patients be
made aware of every grievance option available to them. Mandating
regular review of patient rights information with patients, we believe,
would be an unnecessary burden since patient rights information must be
prominently displayed within the dialysis facility, as required at
Sec. 494.70(c), and is thus available for review at any time. We
expect that the internal facility grievance procedures would aim to
resolve patient grievances. The provision at Sec. 494.180(e) requires
facility-level internal grievance processes.
Comment: One commenter sought clarification of the phrase
``appropriateness of discharge.'' Another commenter suggested that the
final rule clarify what we meant by stating that we would ``hold the
facility responsible'' for ensuring that patients were notified about
their rights.
Response: The phrase ``appropriateness of discharge'' did not
appear in the proposed rule text; however, clarification may be found
in the ``Governance'' condition at Sec. 494.180, which does address
the discharge procedure. This section specifies the acceptable
circumstances for an involuntary discharge or transfer of a patient, as
well as the required actions that must be completed by the
interdisciplinary team prior to ceasing treatment within the facility.
Regarding our intentions regarding the facility's involuntary discharge
responsibilities at Sec. 494.180(f), facilities are required to inform
patients of their rights and protect patients' rights; in the event a
facility fails to do so, the facility will be cited as being out of
compliance during a survey. In addition to the provision at Sec.
494.180(f), patients also have the ``right to be informed of the
facility's policies for transfer, routine or involuntary discharge, and
discontinuation of services to patients'' at Sec. 494.70(b).
Comment: Some commenters recommended the addition of language that
would require facilities to provide information on topical analgesics
for needle pain.
Response: Facilities have the flexibility to inform patients about
topical analgesics. We do not believe this should be a regulatory
requirement. We are not adopting this recommendation.
Comment: A commenter remarked on the issue of disruptive and
challenging dialysis patients and indicated that there is existing case
law regarding this topic, illustrating the inability of the law to
assist the abandoned patient who manifests extreme non-compliance. The
commenter specifically cited Payton v. Weaver, 131 Cal. App. 3d 38, 182
Cal. Rptr. 225 (1982), and Brown v. Bower, No. J86-0759(B) (S.D. Miss.,
Dec. 21, 1987). Another commenter suggested the addition of language to
specify that patients have a right to receive counseling and support
from the team in order to resolve behavioral issues and be informed of
appropriate/inappropriate behaviors, prior to being discharged from a
dialysis facility. There were a large number of comments regarding
discharge policies within the dialysis facility. Some comments
supported a 30-day notice for involuntary discharge. Several other
comments supported the proposed involuntary discharge guidelines
regarding an immediate threat. Many commenters suggested the addition
of language to specify that patients could not be involuntarily
discharged for noncompliant behaviors/non-adherence to medical
regimens. A few comments supported the waiver of discharge policies and
procedures in the face of an ``immediate threat.''
Response: We appreciate the comments regarding involuntary
discharge. While we appreciate the comment regarding Payton v. Weaver
and Brown v. Bower, the cases cited do not appear to be applicable to
this rulemaking. Patients are to be reassessed by the interdisciplinary
team, including a Master's degree social worker (MSW) at least monthly
when a patient exhibits significant changes in psychosocial

[[Page 20393]]

needs (as required at Sec. 494.80(d)(2)(iii)), manifested by, for
example, issues such as disruptive behavior, that could result in
discharge. In Sec. 494.180(f), we are requiring facilities to have
discharge policies and to manage involuntary discharge issues according
to facility protocols. Language at Sec. 494.180(f)(4)(i) through Sec.
494.180(f)(4)(v) responds to the ``disruptive'' or ``challenging''
patient issue. We have also added language to Sec. 494.70(b)(1) in
response to comments, to clarify that patients must be informed of
routine as well as involuntary discharge policies. As stated in the
proposed rule preamble, we do not expect that a patient should be
involuntarily discharged from a dialysis facility merely for failure to
follow the instructions of a facility staff member. However, we
recognize it may be necessary to discharge a disruptive patient in
order to protect the rights and safety of other patients and staff in
the facility. If, for instance, a patient physically harms or threatens
other patients and/or staff, brings weapons or illegal drugs into a
facility, or verbally abuses and disrupts the facility to a degree that
the facility is unable to operate effectively, then the 30-day
discharge notice policy could be abbreviated pursuant to Sec.
494.180(f)(5). This issue is further discussed later in this preamble
under the ``Governance'' condition.
Comment: One commenter noted that some facilities already have
policies in place regarding discharge and transfer policies as well as
policies regarding patient conduct, and questioned whether federal
requirements were needed.
Response: We are aware that some facilities already have policies
in place regarding discharge and transfer of patients. Many of these
facilities have established protocols regarding how staff must deal
with patient conduct. It is not our intent to create more prescriptive
requirements in this area, but to ensure that all dialysis facilities
review any established documentation and policies to make certain they
meet the minimum discharge and transfer requirements set forth at Sec.
494.180(f).
Comment: Two commenters recommended that we delete the phrase
``reducing or terminating ongoing care.'' The concern was that the
phrase was too indefinite.
Response: We agree that the wording in the proposed rule was
unclear. Therefore we have modified Sec. 494.70(b)(2) to require that
patients receive written notice 30 days in advance of an involuntary
discharge following the procedures described in Sec. 494.180(f)(4)(i).
Comment: One commenter recommended that we require posted patient
rights to be written in English at a 7th to 9th grade level and
translated into a patient's native language if possible. Many other
comments suggested that we require facilities to have an ``alternate
method'' to inform patients who cannot read posted information.
Response: The concerns raised in these comments have already been
addressed at Sec. 494.70(a)(2). The ``Patients' rights'' condition
requires that all patients receive information in a way they can
understand. Facilities have the flexibility to provide information to
patients in the most appropriate manner based upon patient needs. The
qualified professionals at the facility are capable of evaluating an
individual patient's level of understanding and making a determination
regarding the needs of that patient. We have retained the proposed
language.
Comment: One commenter suggested that the criteria for
transplantation be posted at the dialysis facility along with a copy of
the patient rights, which we proposed at 494.70(c).
Response: Dialysis facilities have the flexibility to post
transplant criteria within the facility. At Sec. 494.70(a)(7), it is
required that patients be informed about transplantation as a modality.
Additionally, the ``Plan of care'' condition at Sec. 494.90(d) of this
final rule requires that patients and caregivers be provided with
education and training on several topics, including transplantation.
These requirements will provide patients and their caregivers with
increased awareness of transplantation.
Comment: A commenter suggested that we add language that would
specifically state that patients have the right to know the identity of
their facility caregivers and the nature of their credentials. Another
commenter suggested that facility staff be required to wear nametags.
Response: The issue of staff nametags should be addressed in
facility-level policies and procedures. While it is desirable for staff
to wear nametags, we would like to allow flexibility within this health
and safety regulation. We would expect that facility staff introduce
themselves; however, we do not believe that it is necessary or
appropriate to add this prescriptive requirement to this final rule.
Comment: One commenter recommended that CMS use an ombudsman to
build relationships with ESRD patients and their families.
Response: Section 923 of the Medicare Prescription Drug Improvement
and Modernization Act of 2003 (Pub.L. 108-173)(MMA), mandated the
creation of the Medicare Beneficiary Ombudsman in section 1808(c) of
the Act, to ensure that people with Medicare get the information and
help they need to understand their Medicare options and to apply their
rights and protections. A Medicare Beneficiary Ombudsman Open Door
Forum has been established to provide an opportunity for beneficiaries,
their caregivers and advocates, to publicly interact with the Medicare
Beneficiary Ombudsman to discuss issues and concerns regarding ways to
improve the systems and processes within the Medicare program.
Information on the Office of the Medicare Ombudsman may be found at
http://www.cms.hhs.gov/center/ombudsman.asp.
Comment: One commenter suggested that the language in the final
rule include some mention of senile dementia and how it relates to
consent forms.
Response: Dialysis facilities employ professionals who must assess
whether a patient is competent to make medical decisions and assess
patients' mental capacities in general. This issue is present across
provider settings and we do not believe it is appropriate to implement
a new provision of this nature within these conditions for coverage.
Facilities may wish to address such issues and concerns in their own
policies.
b. Patient Assessment (Proposed Sec. 494.80)
We proposed to add a ``Patient assessment'' condition for coverage
at Sec. 494.80 that would make the ESRD facility, through the
patient's interdisciplinary team, responsible for providing each
patient with an individualized and comprehensive assessment of his or
her needs. This condition would define the interdisciplinary team to
include, at minimum, the patient (or patient designee), a registered
nurse, a physician, a qualified social worker, and a registered
dietitian. The proposed rule would expand the existing requirements to
specify the criteria that a facility must include in a comprehensive
patient assessment. We believe that these criteria would be necessary
in order to develop a specialized care plan that is based upon the
nature of the patient's illness, the treatment prescribed, and patient
needs. The frequency of patient assessment was also addressed in the
proposed rule. We proposed that the facility conduct an initial

[[Page 20394]]

comprehensive assessment within 20 calendar days of the first treatment
and that the facility conduct a follow up comprehensive assessment
within 3 months after the completion of the initial assessment. We also
proposed that the facility assess the adequacy of the treatment
prescription at least monthly for hemodialysis and at least every 4
months for peritoneal dialysis. Finally, we proposed patient
reassessment timeframes for both stable and unstable patients. We
proposed that the facility perform comprehensive assessments at least
annually when the patient is stable; if unstable, the facility must
reassess monthly. In addition, the proposed rule also added criteria to
specify which patients would be considered to be unstable.
We received more than 100 comments regarding the ``Patient
assessment'' condition at Sec. 494.80. Many commenters supported the
condition as proposed, while others supported the condition with minor
revisions.
Comment: A few commenters recommended we subsume standards (b), (c)
and (d) of proposed Sec. 494.80 ``Patient assessment'' condition into
the ``Patient plan of care'' condition at Sec. 494.90 and delete the
assessment criteria at Sec. 494.80(a). Some commenters opposed the
assessment criteria at standard (a), stating that it was unnecessary to
require assessment criteria because assessments using such criteria are
already being performed in their facilities.
Response: We appreciate the support for Sec. 494.80 ``Patient
assessment.'' We purposely linked the ``Patient assessment'' and
``Patient plan of care'' requirements, as evidenced by the inclusion of
both under subpart C ``Patient care.'' The ``Patient assessment''
condition provides a set of criteria for the evaluation of all ESRD
patients. The condition promotes an interdisciplinary approach to
evaluating and treating patients in order to achieve better outcomes.
Measuring patient outcomes of care is our goal, and outcome measures
are inherently linked to patient assessment tools. It is possible that
these dialysis patient assessment criteria will lead to the development
of a standardized assessment tool, which we hope that facilities would
use in the future to meet QAPI requirements. We expect that quality-
oriented facilities already are performing comprehensive patient
assessments that meet these new conditions.
We are retaining the proposed condition for coverage in the final
rule. A large number of commenters agreed that a comprehensive patient
assessment for each patient is critical to developing an appropriate
plan of care. The assessment criteria required at Sec. 494.80(a) are
necessary to ensure consistent assessments for all patients, ensuring
that all important assessment areas are addressed for every patient.
The comprehensive assessment is the tool used to develop a plan of care
based upon patient needs. In addition, the comprehensive assessment
criteria promote less fragmented care and will assist the facility's
QAPI program as a clinical data source.
Comment: Two commenters suggested CMS mandate that a physician or
an RN conduct the patient assessment. Other commenters suggested the
final rule allow nurse practitioners and physician's assistants to
conduct the physician portion of the assessment.
Response: The interdisciplinary team must include a physician and a
registered nurse, and these individuals are responsible, along with
other team members identified at Sec. 494.80, for providing each
patient with an individualized and comprehensive assessment. This final
rule retains the proposed requirement at Sec. 494.80 regarding the
composition of the interdisciplinary team. We expect every patient to
be assessed by the interdisciplinary team physician or ``physician
extender'' (that is, a nurse practitioner, clinical nurse specialist,
or a physician assistant (PA)), if a state practice act allows such
physician extenders to conduct the physician portion of the patient
assessment. Although a physician extender may conduct an assessment in
some states, the physician providing ESRD care must participate in the
assessment by reviewing and approving the assessment.
Comment: A few commenters recommended the addition of the term
``qualified,'' when referring to the social worker, and the term
``registered,'' when referring to the dietitian, who are members of the
interdisciplinary team as required in the first paragraph at Sec.
494.80.
Response: The dietitian and social worker specified under the
``Patient assessment'' and ``Patient plan of care'' conditions must
possess the professional qualifications set forth at Sec. 494.140(c)
and Sec. 494.140(d), respectively. We do not agree with the commenters
that further clarification is necessary regarding the qualifications of
the interdisciplinary team members. However, to further clarify the
dietitian and social worker duties required in the ``Patient
assessment'' condition, we have modified Sec. 494.80(a)(6) to require
that the assessment include evaluation of nutritional status by a
dietitian, and modified Sec. 494.80(a)(7) to require the assessment to
include evaluation of psychosocial needs by a social worker.
Comment: Two commenters suggested that we specify in the final rule
that the interdisciplinary team's nephrologist must be the facility
medical director or treating nephrologist. The commenters were
concerned that the proposed phrase at Sec. 494.80, which would require
``a nephrologist or the physician treating the patient for ESRD'' to be
a member of the interdisciplinary team was unclear. Commenters
suggested that this phrase could mean that any nephrologist, not
necessarily a nephrologist treating the patient, could participate on
the interdisciplinary team.
Response: Because the public may interpret the proposed language to
mean that any nephrologist may participate on the interdisciplinary
team, as opposed to the patient's treating nephrologist, we have
modified the introductory paragraph at Sec. 494.80 to include ``the
physician treating the patient'' and removed our reference to the
nephrologists, since the term ``physician'' includes nephrologists.
Comment: A few commenters suggested clarification regarding the
patient participation on the interdisciplinary team. The suggested
modification was ``the patient or the patient's designee (if the
patient chooses)'' in order to clarify that the patient not only has
the choice to participate, but also has the choice to have a designee
participate as part of the interdisciplinary team. Another commenter
suggested that facilities be required to document patient participation
and the reasons patients do not participate on the interdisciplinary
team.
Response: Patients have the right to be informed about and
participate, if desired, in all aspects of care, as required in the
``Patients' Rights'' condition at Sec. 494.70(a)(5). The ``Patient
assessment'' condition at Sec. 494.80 states that the
interdisciplinary team includes the patient or a patient designee if
chosen by the patient. Patients must have the option to participate in
the facility's interdisciplinary team. Conversely, the patient has the
right not to participate or to designate another individual to
participate on his or her behalf on the interdisciplinary team.
Although patient participation on the interdisciplinary team is
important and should be encouraged, we do not want to mandate patient
participation. We have modified the provision at Sec. 494.80, which
proposed to require that the facility provide every patient the
opportunity to participate with the

[[Page 20395]]

interdisciplinary team. The modified language in the first paragraph of
Sec. 494.80 clarifies that the patient may choose whether he or she
wants to identify a designee to participate in the interdisciplinary
team.
We note that the facility must demonstrate that the patient has
been provided the opportunity to participate in the interdisciplinary
team. The facility may develop policies and procedures regarding
standard documentation of patient participation and may document the
reasons for patient non-participation. If, for instance, a facility has
a low level of patient participation in the interdisciplinary team, the
facility may choose to document and monitor reasons for patient non-
participation as part of a quality assessment and performance
improvement plan.
Comment: We received two comments that suggested that the final
rule specify that individual assessments be conducted by all members of
the interdisciplinary team. Additionally, the commenters requested that
the final rule clarify that face-to-face meetings between the patient
and the interdisciplinary team would be required. Another commenter
recommended that we eliminate team assessment altogether and only
require use of individual assessments by each discipline.
Response: The entire interdisciplinary team is responsible for
ensuring that each patient is individually assessed and his or her
needs identified, as required at Sec. 494.80. We agree that in order
to conduct a clinical assessment, the patient must have face-to-face
contact with the other interdisciplinary team members. We expect all
professional members of the interdisciplinary team to complete the
portions of the comprehensive patient assessment that are within their
respective scopes of practice. It is not necessary for each
professional team member to individually complete the entire
comprehensive assessment and thereby duplicate efforts. Professional
interdisciplinary team members might choose to conduct one-on-one
interviews with patients to complete the assessments. The team may also
opt to set up team meetings, which would include the patient, in order
to collect the appropriate assessment information. We expect facilities
to determine the best way to manage this process, and create policies
and procedures to accurately and effectively collect patient assessment
information. The assessment information is used to develop the
patient's treatment plan and expectations for care, and thus it is
critical for the members of the interdisciplinary team to participate.
Comment: One commenter recommended that the final rule be modified
to include advance directive planning as part of the patient assessment
at Sec. 494.80(a).
Response: Patients are entitled to be informed about their right to
have an advance directive, as required at Sec. 494.70(a)(6).
Additionally, if a patient has an advance directive, this information
must be recorded in his or her medical record, as required at Sec.
494.170(b)(2). In some cases, it may be appropriate for a patient to be
assessed for advance directives and facilities should use their
professional judgment to evaluate and determine if such an assessment
is appropriate. We are not requiring advance directive planning as part
of the patient assessment, but are allowing facilities the flexibility
to include it in the patient assessment when deemed appropriate.
Comment: We received a comment recommending that language be added
to the final rule to ``allow the Secretary to modify or update these
`elements' with new technology and knowledge.''
Response: We believe the commenter is referring to the assessment
criteria found at Sec. 494.80(a), and we also believe the commenter
would like to see language that allows for updates without rulemaking.
We have not modified this final rule to allow for automatic updates for
assessment criteria because the Administrative Procedure Act (APA)
requires rulemaking with public notice and comment if and when new
regulatory requirements are proposed.
Comment: One commenter suggested the final rule at Sec.
494.80(a)(1) be modified specifically to include chest auscultation,
visual observance, gastrointestinal evaluation, access site evaluation,
and patient symptoms between treatments as part of the evaluation of
current health status and medical condition.
Response: Professional standards of practice require clinicians to
perform appropriate clinical assessments and use their clinical
judgment when caring for patients. The expectation is that these
standards of practice will be employed by all clinicians. We have
retained the proposed language at Sec. 494.80(a)(1). Evaluation of
current health status and medical condition, including co-morbid
conditions, would include the techniques, specific evaluations and
symptoms recommended by the commenter.
Comment: A few commenters recommended that the final rule include
an assessment criterion for cardiovascular disease.
Response: Dialysis patients are at risk for cardiovascular disease,
which is affected not only by individual risk factors, but also by
renal bone disease, blood pressure and fluid management. These patients
may have a number of co-morbid conditions and this final rule requires
the interdisciplinary team to assess the patient's medical history,
including any co-morbid conditions (Sec. 494.80(a)(1)). Since
cardiovascular disease is a co-morbid condition we expect it would be
assessed as appropriate for individual patients in order to comply with
Sec. 494.80(a)(1).
Comment: It was recommended by one commenter that ``intradialytic
symptom frequency, causes, prevention, and tracking symptoms'' be added
to this condition as new assessment criteria. Another commenter
suggested that dialysis adequacy be specifically referenced in the
assessment criteria.
Response: Patients must be assessed for the appropriateness of the
dialysis prescription, blood pressure and fluid management at Sec.
494.80(a)(2), which encompasses intradialytic symptoms and issues, such
as cramping, as well as dialysis adequacy.
Comment: Many commenters suggested minor edits to the ``Patient
assessment'' condition, but concurred with the condition as a whole and
agreed with our belief that systematic patient assessment is essential
to improving quality of care and patient outcomes. We received a
comment from the Safe and Timely Immunization Coalition (STIC), which
is facilitated by the Southeastern Kidney Council, Inc. (ESRD Network
6). This comment presented the benefits of immunization including
prevention of illness and hospitalizations. The commenter stated that
immunization is one of the most cost effective strategies to prevent
unnecessary hospitalizations and deaths, and that immunization is
currently a Government Performance and Results Act of 1993 (Pub. L.
103-62 (1993)) and Healthy People 2010 goal. According to the
commenter, the current rates of immunizations for influenza,
pneumococcal and hepatitis B immunizations nationwide are lower than 50
percent. STIC recommended adding influenza, pneumococcal, and hepatitis
requirements to this final rule. The suggested requirements are
consistent with the immunization requirements for long-term care
facilities. The recommended provisions address: (1) The offering of
influenza, pneumococcal and hepatitis B immunizations to the patient
(or legal representative) at appropriate times and

[[Page 20396]]

frequencies; (2) a process for patient immunization refusal; and (3)
documentation parameters.
Response: We agree with commenters that the systematic approach to
patient assessment is essential for improving quality of care and
patient outcomes.
We appreciate the work of STIC and their recommendations for
specific immunization requirements. In order to promote the
immunization initiative and the ongoing cooperative effort between CMS
and the dialysis industry to screen patients for their immunization
needs, we have modified the final rule at Sec. 494.80(a)(3) to include
immunization history as part of the assessment criteria. We believe it
is reasonable for facilities to include immunization history as part of
the comprehensive assessment at least annually so that immunization
needs may be identified. However, we have not added the extensive
provisions recommended by the commenter. If we determine that further
immunization requirements are warranted, we will undertake rulemaking
at a future date and provide the public the opportunity to comment on
any new proposed provisions.
Comment: One commenter recommended that erythropoietin not be
specifically referenced in the ``Patient assessment'' condition in the
final rule, so as not to limit the use of other erythropoiesis-
stimulating drugs.
Response: We agree with the commenter and in order to allow
flexibility for other medications that stimulate erythropoietin, as
well as new developments in the future, we have modified the final rule
to eliminate specific references to erythropoietin, and instead will
use the term erythropoiesis-stimulating agent(s).'' The new language at
Sec. 494.80(a)(4) reads: ``including administration of erythropoiesis-
stimulating agent(s).''
Comment: We received several comments suggesting that bone disease
be retained and added to the assessment criteria in the final rule.
Response: The proposed rule included bone disease as part of the
assessment criteria. The final rule will retain the language at Sec.
494.80(a)(5), which reads: ``Evaluation of factors associated with
renal bone disease.''
Comment: We received several comments regarding the evaluation of
nutritional status, which is required as part of the comprehensive
patient assessment. Two commenters suggested we modify the final rule
to add more specificity regarding nutritional status, suggesting the
use of K/DOQI guidelines, to insure uniformity in assessment. One
commenter suggested that serum albumin not be used as a sole indicator
and another commenter suggested specific nutritional parameters for
growth assessment for pediatric patients be added to the final rule.
Response: The K/DOQI guidelines are clinical practice guidelines
developed by the NKF via a technical expert workgroup and consensus
process (http://www.kidney.org/PROFESSIONALS/kdoqi/guidelines.cfm). In
order to allow for flexibility and professional clinical judgment we
are not adding specific criteria to the evaluation of nutritional
status requirement in this final rule at Sec. 494.80(a)(6). We discuss
``nutrition'' and nutritional indicators under the ``Patient plan of
care'' (Sec. 494.90(a)(2)) condition discussion in the preamble below.
Comment: We received many comments suggesting revisions to the
final rule regarding the evaluation of psychosocial needs. Many
commenters recommended the addition of a standardized survey tool to be
used in assessing the psychosocial status of dialysis patients, namely
the SF-36 or another instrument advocated by National Kidney Foundation
Life Options subgroup. One commenter suggested the final rule be
modified so that Sec. 494.80(a)(7) would specifically require
``evaluation of psychosocial needs, functioning and well-being using
the SF-36 or other standardized survey.'' Two commenters suggested the
final rule specify a list of psychosocial needs to be assessed, such as
mood changes and coping with chronic illness. We received suggestions
regarding additional forms that could be used for assessing
psychosocial status. One commenter suggested that ``depression'' be
added as a separate assessment criterion.
Response: In response to concern regarding the psychosocial status
of dialysis patients, we have modified the ``Patient assessment''
condition and strengthened the ``Patient plan of care'' condition. At
Sec. 494.80(a)(7) we have added the phrase ``by a social worker'' to
ensure that patients are being assessed by an MSW, as defined at Sec.
494.140(d). Additionally, we are requiring at Sec. 494.90(a)(6) that a
standardized tool, chosen by the MSW, be used to monitor patient
status, and that counseling be provided and referrals be made as
appropriate. There is further discussion of the standardized tool under
the ``Patient plan of care'' discussion below.
Comment: One commenter suggested that all patients be encouraged to
first consider home dialysis options when evaluating modality and
setting.
Response: We have emphasized increasing patient awareness of home
dialysis options in this final rule. In Sec. 494.70 we require that
the patient has the right to be informed about all treatment modalities
and settings, including home dialysis. We expect facilities to
encourage patients to consider home dialysis if it is a suitable
choice. In addition, we encourage the use of home dialysis under the
``Patient plan of care'' condition at Sec. 494.90(a)(7)(i).
Comment: A commenter suggested the comprehensive assessment include
an evaluation of self-care activities the patient performs. Another
commenter remarked that the evaluation of a patient's potential for
self-cannulation should be part of the assessment, and that
documentation in the patient record should be required if the patient
chooses not to participate. One commenter made a general observation
that patients are not treated as adults in the facility.
Response: All patients are to be encouraged to participate in their
own care, as ability and interest allows. Some patients may be able to
self-cannulate, while others may not. Some may be able to weigh
themselves or they may be charged with holding their access site to
stop bleeding after completion of a course of dialysis. Regardless of
the patient's level of participation, an evaluation of self-care
activities is encompassed within the comprehensive assessment
requirement at Sec. 494.80(a)(9), which requires ``Evaluation of the
patient's abilities, interests, preferences, and goals, including the
desired level of participation in the dialysis care process; the
preferred modality (hemodialysis or peritoneal dialysis) and setting
(for example, home dialysis), and the patient expectations for care
outcomes.''
Comment: We received many comments regarding the responsibility and
basis for transplantation referral of dialysis patients. Some
commenters remarked that ESRD facilities should not be responsible for
referring patients for transplantation. Commenters explained that often
dialysis units must cooperate with multiple transplantation centers
that may have varied criteria and some transplantation centers do not
have any criteria available on which a dialysis facility could base a
referral. Another commenter suggested that referral for transplantation
is the nephrologist's and patient's responsibility.

[[Page 20397]]

Response: The part 405, subpart U ESRD conditions for coverage
required facilities to evaluate patients for transplantation referral
as part of the long-term care program planning process. This final rule
does not require transplantation referral as an activity separate from
the short-term care plan, but rather, it is now encompassed within the
plan of care. Referrals will continue to be a facility-level
responsibility. We recognize the role of the physician as the leader of
the interdisciplinary team; however, these regulations apply to the
facility, and the interdisciplinary team is responsible for patient
referral for transplant.
It is important for dialysis facilities and transplantation centers
to make a concerted effort to communicate and cooperate. Two-way
communication is required not only in this final rule, but also within
the recently published Medicare Transplant Center conditions of
participation. The March 30, 2007 transplant center final rule
(``Hospital Conditions of Participation: Requirements for Approval and
Re-Approval of Transplant Centers to Perform Organ Transplants'' (72 FR
15276)) requires kidney transplant centers to make transplant referral
criteria available to any requesting dialysis center (see Sec.
482.90(a)(4)). The purpose of using transplant center criteria is to
remove and reduce the chances of referral bias and transplant referral
disparities.
Comment: One commenter suggested that the final rule require a
written agreement between transplant centers and dialysis facilities
and that such agreement contain the transplant center criteria for
patient referral.
Response: If a dialysis facility finds it useful to have a written
agreement with the transplant center regarding communication and
responsibilities of each entity, as well as transplant criteria, the
dialysis facility has the flexibility to do so, but we do not believe
we have sufficient cause to require such an agreement of all
facilities.
Comment: We received many comments regarding the proposed
requirement that the assessment include an evaluation of patient
physical activity level and rehabilitation status (Sec. 494.80(a)(12)
and Sec. 494.80(a)(13)). Some commenters agreed with the proposed
assessment criteria here, while others suggested modifications to the
final rule. Commenters remarked that the interdisciplinary team members
are not qualified or trained to assess a patient's physical activity
level or rehabilitation status. One commenter suggested we modify the
final rule to specify evaluation of developmental progress and
educational needs as part of the rehabilitative assessment for
pediatric patients.
Response: We agree with commenters that the proposed language at
Sec. 494.80(a)(13), which would require the facility to evaluate the
vocational and physical rehabilitation status and potential of
patients, is beyond the scope of a facility's responsibilities. The
professionals who are part of the interdisciplinary team do not have
complete knowledge and training necessary to accurately and fully
assess physical activity level or physical rehabilitation status and
potential. Therefore, we have modified the final rule at Sec.
494.80(a)(13) to require the interdisciplinary team to evaluate the
patient for referral to vocational and physical rehabilitation
services. Facilities are expected to evaluate whether the patient
should be referred for services as appropriate, not perform a complete
physical therapy or rehabilitation assessment in the facility.
Evaluation and referral of developmental progress and educational needs
may be appropriate for some patients; however, the final rule will not
be modified to require that these needs be evaluated for all patients.
If, during the assessment process, either of these issues is identified
by the interdisciplinary team, we expect the patient will be referred
to the appropriate professional for further evaluation.
Comment: One commenter suggested that the final rule require the
assessment elements laid out at Sec. 494.80(a)(11) through Sec.
494.80(a)(13) (support systems, physical activity level, and
rehabilitation services) be completed by a social worker using a
standardized assessment instrument that measures physical, social, and
emotional status.
Response: Facilities have the flexibility to designate staff with
the appropriate expertise to complete the comprehensive assessment. The
social worker may possess the greatest expertise related to these
areas; however, another team member might perform the physical activity
level assessment. At Sec. 494.80(a)(7), a social worker is required to
assess the psychosocial needs of patients, and Sec. 494.90(a)(6) of
the final rule requires the plan of care to address psychosocial status
using a standardized mental and physical assessment tool, chosen by the
qualified social worker. As discussed previously, we are not requiring
facilities to use any specific assessment tool.
Comment: A few commenters sought clarification on the meaning of
the phrase ``new patient'' at proposed Sec. 494.80(b), ``Frequency of
assessment for new patients.'' The commenters asked whether ``new
patient'' meant a patient new to dialysis or a patient new to a
particular dialysis unit. Another commenter asked if ``new patient''
referred to a patient receiving his or her first treatment in an
outpatient dialysis unit.
Response: In order to clarify the meaning of ``new patient,'' we
have modified the title of Sec. 494.80(b), so that it now reads:
``Frequency of assessment for patients admitted to the dialysis
facility.'' We intend for all dialysis patients new to any particular
outpatient dialysis facility be categorized as ``new patients'' and
have a comprehensive assessment within the specified 30-day timeframe
even if they are transferring from another dialysis facility. This
means a comprehensive assessment must be done on all transfer patients,
as well as those new to dialysis, within the first 30 days.
Comment: We received more than 50 comments regarding the frequency
of assessment and the timeframe for completion of patient assessments.
A few commenters agreed with the proposed timeframe for completing the
patient assessment; however, the majority of commenters were concerned
that the 20-day proposed timeframe did not allow enough time to
complete a thorough comprehensive assessment. Many commenters stated
that completion of the patient assessment within 20 days would be ideal
but is impractical for staff that often cover multiple units and/or
cover large geographical areas; such a requirement would be
particularly impractical in rural areas. Commenters also stated that
the proposed timeframe is unrealistic for MSWs carrying large patient
caseloads. Other commenters suggested 20 days would not be enough time
for all team members to participate, specifically those who work in
part-time positions. Other commenters were concerned that the 20-day
timeframe was inadequate for complete evaluation of all assessment
criteria, including nutritional status, physical activity level or
vocational or physical rehabilitation status. Commenters offered many
suggestions regarding the deadline to complete the assessment. Some
suggested alternatives that included time periods ranging from 30 to 60
days, and assessment timelines based on the number of dialysis sessions
ranging from 6 to 13 sessions. Other suggestions included a split
assessment with part 1 completed within 20 to 30 days or 9 sessions,
and part 2 at 3 months. Commenters also suggested completing

[[Page 20398]]

the assessment and plan of care within 30 days, or allowing medical
justification for the assessment time period to exceed 30 days.
Response: We agree with many of these commenters. A comprehensive
initial assessment is the basis for an effective plan of care and for
achieving desired patient outcomes. We also recognize dialysis
facilities may have difficulties when conducting assessments on
patients who face a wealth of challenges, including frequent
hospitalizations; however, these difficulties should not outweigh the
need to complete a comprehensive initial assessment within a reasonable
period of time. If a patient has received dialysis for a 1-month
period, or 13 hemodialysis treatments, that in-center patient has
likely been physically present in the facility for at least 40 hours.
We are therefore revising the deadline. We believe that, by allowing
facilities 30 days or 13 hemodialysis treatments to complete the
assessment (whichever is later), we are providing a reasonable
timeframe for every member of the interdisciplinary team to assess the
patient before developing the treatment plan. We have modified the
final rule at Sec. 494.80(b)(1) ``Patient assessment'' and at Sec.
494.90(b)(2) ``Patient plan of care'' so that the interdisciplinary
team has a timeframe of 30 days or 13 outpatient hemodialysis sessions,
whichever is later, for completion of the assessment and implementation
of the plan of care. Because some assessment criteria may take a longer
period of time to evaluate, such as nutritional status and vocational
and physical rehabilitation status, we expect that these areas would be
more fully covered during the follow-up comprehensive reassessment that
we are requiring for stable patients within 3 months after the
completion of the initial assessment, as required at Sec. 494.80(b)(2)
and discussed below.
Comment: We received more than 50 comments on the proposed 3-month
follow up comprehensive reassessment for dialysis patients. Half of the
commenters supported the requirement, arguing that a follow-up
assessment is necessary in order to evaluate the level of patient
adherence to the treatment plan, determine whether the care plan is
effective, and track the patient's overall adjustment to dialysis. One
commenter supported the 3-month timeframe, stating, ``many patients are
too sick and/or depressed to participate in life-altering decisions
regarding their care and treatment'' during the initial assessment. Two
commenters supported the 3-month reassessment but suggested that it be
a ``focused'' reassessment used exclusively to determine whether
changes would be needed in the plan of care.
The other half of the commenters opposed the proposed requirement,
stating that the requirement was redundant, burdensome and of
``questionable value.'' Some commenters suggested that follow-up
reassessments be completed after 6 months to relieve burden, especially
in rural areas. Some commenters suggested the 3-month reassessment
timeframe would be impractical because many new patients do not
stabilize for the first 6 months of dialysis. Some commenters suggested
that we modify the final rule to require a follow-up reassessment
within 36 hemodialysis treatments rather than within the proposed 3-
month timeframe. One commenter suggested that monthly progress notes
would eliminate the need for the 3-month follow-up reassessment.
Response: We recognize that patients who are new to dialysis need
time to adjust and adapt to the treatment. Initially, patients may
experience anxiety while learning self-care skills, modifying their
diet, changing their behavior, and perhaps dealing with access issues.
The 3-month comprehensive reassessment enables the interdisciplinary
team to evaluate, among other things, the patients' adherence to
treatment plans; the accuracy of the patient's plan of care; and the
patient's educational needs, rehabilitation needs, nutritional needs,
quality of life and adjustment to the dialysis regimen. We recognize
the burden this 3-month reassessment places on the interdisciplinary
team. However, the burden has been significantly reduced in this final
rule by eliminating the previous requirement that the team review the
care plans and associated patient assessments of all stable patients
every six months, which was previously required in part 405, subpart U.
This rule does not preclude facilities from performing an assessment 6
months after the initial assessment, if they desire.
Comment: We received several comments regarding the assessment of
the efficiency of the treatment prescription for hemodialysis and
peritoneal dialysis. One commenter believed that proposed Sec.
494.80(c) merely repeated Sec. 494.90(a)(1) and recommended that the
final rule combine the two.
Response: We disagree with the commenter regarding redundancy of
the ``Patient assessment'' and ``Patient plan of care'' provisions. The
requirement at Sec. 494.80(c) mandates the frequency of assessment of
the effectiveness of the treatment prescription for both hemodialysis
patients and peritoneal dialysis patients, while Sec. 494.90(a)(1)
requires the interdisciplinary team to develop a patient plan of care
to address the dose of dialysis and provide the necessary care and
services to achieve and sustain the prescribed dose of dialysis. These
conditions are also in keeping with our payment regulations (Medicare
Claims Processing Manual, Chapter 8, 50.1) (http://www.cms.hhs.gov/manuals/IOM/list.asp).
Comment: One commenter suggested Sec. 494.80(c), which addresses
the frequency of dialysis adequacy monitoring, be modified to require
facilities to ``monitor fluid status.'' The commenter cited a study
that argued Kt/V levels did not correlate with mortality or morbidity
and that better methods of measuring intravascular volume and related
blood pressure changes are needed.
Response: Proposed Sec. 494.80(a)(2) would require the
interdisciplinary team to evaluate fluid management needs. We have
retained this provision in this final rule. We have also added,
``manage the patient's volume status'' at Sec. 494.90(a)(1), under the
``Patient plan of care'' condition.
Comment: One commenter proposed that a Kt/V measurement should be
done every 2 months and that urea reduction rate could be used in
alternate months. The commenter argued that Kt/V measurement was
excessively burdensome for both patients and staff.
Response: Monthly monitoring of dialysis adequacy for hemodialysis
patients is consistent with current dialysis facility practice and
Medicare payment policies. We are not making any change to Sec.
494.80(c) based on this comment.
Comment: One commenter suggested the final rule be reworded at
Sec. 494.80(d)(1) to clarify what kind of annual reassessment must be
completed, as required in this condition.
Response: We appreciate the comment; however, Sec. 494.80(d)
states clearly that the reassessment must be completed in accordance
with the standards specified in paragraphs 494.80(a)(1) through
(a)(13). We do not believe that further clarification is needed. The
proposed language has been retained in the final rule.
Comment: We received a comment that suggested the final rule
require ``monthly reassessments for all stable patients using a simple
tool.'' Another commenter remarked that annual assessments for stable
patients are not enough and that co-morbid conditions

[[Page 20399]]

may necessitate assessments that are more frequent.
Response: While we are requiring stable patients to be
comprehensively reassessed at least annually, we recognize that
appropriate monitoring of patients may require ongoing assessments in
various areas. We expect that patients would be monitored on an ongoing
basis and expect progress notes would be entered in the patient's
medical record as needed. The interdisciplinary team has the
flexibility to use its professional judgment regarding on-going
monitoring methods as appropriate for their patients, as specified in
the patient plan of care.
Comment: We received many comments regarding the monthly
reassessments for unstable patients. Many commenters requested we
clarify what we meant by ``unstable patients'' and provide a definition
for ``unstable'' in the final rule, as well as identify what the
reassessment for such patients would specifically need to include. A
few commenters said ``unstable'' should be clarified to state that all
four criteria listed at Sec. 494.80(d)(2)(i) through Sec.
494.80(d)(2)(iv) must be present at once in order for the patient to be
considered ``unstable.'' Another commenter suggested Sec.
494.80(d)(2)(iv) be modified to add ``and/or'' so that presence of any
one of the three criteria listed in (iv) (poor nutritional status,
unmanaged anemia, and inadequate dialysis) would deem the patient
``unstable.'' A couple of commenters recommended modifying the final
rule to allow each facility to provide its own definition of
``unstable'' as part of their facility policies.
A few commenters recommended that nutritional status should not be
linked with anemia management or dialysis adequacy at Sec.
494.80(d)(2)(iv). One commenter suggested nutritional status should
stand alone, as should unmanaged anemia. One commenter recommended the
final rule clarify ``unmanaged anemia'' and defer to the most recent
KDOQI anemia clinical practice guidelines. A couple of commenters asked
whether the requirement at Sec. 494.80(d)(2)(iv) required all three
criteria to be present simultaneously. Another commenter strongly
recommended that the final rule clarify that all three parameters of
(iv), poor nutritional status, unmanaged anemia, and inadequate
dialysis be present to justify the determination that the patient was
``unstable.'' Another commenter suggested that ``poor nutrition''
should not be deemed a marker for instability, because facilities have
minimal influence over poor nutritional status, which is a chronic
problem.
We received many comments from social workers suggesting additional
assessment criteria which would indicate that patients were
``unstable,'' and therefore, trigger the requirement for monthly
reassessments. These suggestions included hemoglobin less than 11 gm/dL
for more than 8 weeks, frail patients, reduced physical and mental
component summary scores, physical debilitation, diminished emotional
well-being, loss of employment, intradialytic symptoms, blood pressure,
use of certain types of hypertensive medications, dry weight changes,
chronic heart failure admissions, depression, and significant change in
psychosocial needs.
Response: The comprehensive reassessment process can be seen as
part of a cycle. Through the use of patient assessment, accurate and
timely patient information is reflected in the plan of care. As the
assessment changes, the plan of care must be revised accordingly. Once
the patient is determined to be unstable, a monthly reassessment is
necessary to update the plan of care appropriately. Existing
regulations at part 405, subpart U required the professional care team
to review the plan of care for an unstable patient at least monthly.
The proposed rule aimed to add clarification and guidance as to how to
classify a patient as unstable, and we specified at Sec. 494.80(d)(2)
the minimum criteria necessary to consider a patient unstable. A
patient is unstable if he or she has had extended or frequent
hospitalizations, or a marked deterioration in health status, or a
significant change in psychosocial needs. In addition, a patient is
unstable when he or she is determined by the interdisciplinary team to
have poor nutritional status, unmanaged anemia, and inadequate dialysis
concurrently. Unstable patients must be reassessed in accordance with
Sec. 494.80(d), which specifies use of the assessment criteria at
Sec. 494.80(a)(1) through Sec. 494.80(a)(13). While a comprehensive
reassessment for patients classified as unstable is required, it is
possible that patient status may not change in all parts of the
assessment. Patient status, whether changed or unchanged, should be
clearly reflected in the new assessment.
This final rule allows facilities the flexibility to use their
professional judgment to develop more stringent policies regarding the
definition of ``unstable'' patient based on their unique patient
population and patient characteristics and to insert additional
assessment criteria, such as those offered by the commenters.
Comment: One commenter was concerned that facilities have
previously developed their own definitions of ``unstable patient'' that
ultimately classify very few patients as unstable. The commenter
suggested that this trend should be discouraged.
Response: The proposed rule at Sec. 494.80(d)(2) aimed to
specifically address these concerns by establishing minimum criteria by
which to identify patients considered ``unstable.'' As stated above,
facilities continue to have the flexibility to develop their own
policies and procedures with regards to how they define ``unstable''
patient, as long as that definition meets the minimum requirements put
forth in this final rule.
Comment: One commenter remarked that it is unclear how monthly
reassessments of stable patients coordinate with the ``monthly unstable
care plans.'' The commenter questioned if patients would be considered
``unstable'' if care plan goals were not met.
Response: Patients are considered unstable if they meet any of the
criteria listed at Sec. 494.80(d)(2). Implementation of the initial
and revised plan of care is discussed in the ``Patient plan of care''
section of the preamble below. The implementation of an updated plan of
care, which results from a new patient assessment, is addressed at
Sec. 494.90(b)(2).
c. Patient Plan of Care (Proposed Sec. 494.90)
We proposed a new condition for coverage entitled ``Patient plan of
care,'' which would require the interdisciplinary team to develop and
implement a written, individualized comprehensive plan of care that
specified the services necessary to address the patient's needs, as
identified by the comprehensive assessment and changes in the patient's
condition, and would have included measurable and expected outcomes and
estimated timetables to achieve these outcomes. Proposed components of
the patient plan of care included dose of dialysis, nutritional status,
anemia, vascular access, transplantation status, and rehabilitation
status. This proposed condition for coverage called for documentation
of a plan for transplantation, or, in the alternative, the patient's
decision not to accept transplant referral, or documentation of the
reason for the patient's nonreferral. We proposed implementation of the
plan of care within 10 days of completion of the initial or updated
patient assessment. We would no longer require the separate short-term
and

[[Page 20400]]

long-term care plans required, biannually and annually, respectively,
by part 405, subpart U of our rules. This proposed condition for
coverage would also have required that the facility would have to
adjust the plan of care if the expected outcome was not achieved. We
proposed that the dialysis facility would have to ensure that all
dialysis patients were seen by a physician providing the ESRD care at
least monthly, that this visit was documented, and occurred
periodically while the patient was receiving dialysis. Under the
proposed rule, the interdisciplinary team would have been required to
track the results of each kidney transplant center referral, monitor
patient status, and communicate with the transplant center at least
quarterly. The proposed ``Patient plan of care'' condition included a
patient education and training standard, which would have required, as
applicable, education and training for patients and facility members or
caregivers on the aspects of the dialysis experience, dialysis
management, quality of life, rehabilitation, and transplantation.
Further discussion of Sec. 494.90 provisions may be found in the
proposed rule (70 FR 6205).
We received more than 100 comments regarding the ``Patient plan of
care'' condition. The majority supported the proposed ``Patient plan of
care'' condition.
Comment: Dozens of commenters made recommendations regarding the
composition of the interdisciplinary team that would develop the plan
of care. Several commenters agreed with the proposed interdisciplinary
team definition and some suggested that the team definition wording at
Sec. 494.80 be carried over to Sec. 494.90. Two commenters supported
excluding the medical director from the interdisciplinary team, while
others thought the medical director team role should be retained from
part 405, subpart U, or changed to a team supervisory role. Commenters
disagreed as to whether the home dialysis physician role on the
interdisciplinary team should have been deleted in the proposed rule.
One commenter stated that some patients need a physical therapist and
psychiatrist on the interdisciplinary team. Another two commenters
stated it would be ideal to have a vascular access coordinator on the
interdisciplinary team, although this could be a cost issue. A number
of commenters suggested that a pharmacist be included as a member of
the interdisciplinary team.
Response: We are specifying the multidisciplinary team composition
in Sec. 494.90 of the final rule by cross-referencing the wording used
at the beginning of Sec. 494.80 (introductory text). The final rule
language at Sec. 494.80 reads as follows: ``The facility's
interdisciplinary team consists of, at a minimum, the patient or the
patient's designee (if the patient chooses), a registered nurse, a
physician treating the patient for ESRD, a social worker, and a
dietitian * * *.'' We do not agree there is a need to require that the
medical director, the home dialysis physician or other professional
staff be members of the interdisciplinary team. The medical director
role has been strengthened at Sec. 494.150 so that the medical
director is responsible for the delivery of patient care and outcomes
in the facility. In this role, the medical director may choose whether
to be a member of the interdisciplinary team and participate in
interdisciplinary team activities. The patient's right to be informed
about home dialysis was strengthened both in the ``Patients'' rights'
(Sec. 494.70(a)(7)) and ``Patient assessment'' (Sec. 494.80(a)(9))
conditions, so that the patient could be informed of home dialysis
options whether or not a home dialysis physician was included in the
multidisciplinary team.
Patients needing physical therapy or psychiatric services should be
referred for these services, as we would not necessarily expect the
dialysis facility to employ these professionals as staff members.
Facilities may want to have a vascular access coordinator. While we
encourage this, we will not mandate it, as dialysis facilities should
have the flexibility to use other approaches and staff as
interdisciplinary team members in ways that best meet the needs of
their patient population.
We have addressed comments related to a pharmacist's role at Sec.
494.140 ``Personnel qualifications'' discussion below. We have defined
in regulation the minimum staff that must be part of the team in order
to meet basic dialysis patient care needs. This regulation does not
preclude the use of an expanded interdisciplinary team, and dialysis
facilities always have the flexibility to add staff to the
interdisciplinary team.
Comment: Many commenters agreed with the proposed modification to
the provision specifying the role of the transplant surgeon in the
development of the patient's plan of care. A few commenters opposed
eliminating the requirement that the transplant surgeon's signature be
part of the plan of care, while some of the comments supported
transplant surgeon involvement via a designee.
Response: The previous ESRD conditions required a transplant
surgeon to participate in the long-term care program planning process.
The interpretive guidelines used by surveyors provided that a
transplant surgeon designee could be used, and this designee was often
a transplant nurse or the attending dialysis nephrologist. We proposed
that while the transplant surgeon would not be a required member of the
interdisciplinary team, the team must use criteria from the transplant
center to determine whether a patient was a transplant referral
candidate. The majority of comments supported this approach; therefore,
we will retain the proposed requirement, which does not include the
transplant surgeon. We are requiring use of transplant center criteria
for assessing potential transplant candidates (Sec. 494.80(a)(10)),
including transplantation status, as a component of the patient plan of
care (Sec. 494.90(a)(7)(ii)), and the transplantation referral
tracking standard (Sec. 494.90(c)).
Comment: A few commenters recommended further clarification of the
term ``current evidence-based community-accepted standards'' at
proposed Sec. 494.90, and some suggested that this be defined as the
K/DOQI standards. Some felt that the use of the word ``community''
could allow wide variation throughout the country as different
communities embraced different standards, some of which might not be
evidence-based.
Response: The first provision of the proposed ``Patient plan of
care'' condition required that the plan of care ``include measurable
and expected outcomes and estimated timetables to achieve these
outcomes.'' The outcomes specified in the ``Patient plan of care''
condition must allow the patient to achieve ``current evidence-based
community-accepted standards.'' The phrase ``community-accepted
standards'' was intended to mean nationally-accepted professional
standards of practice accepted by the renal community at large.
``Community'' was not intended to mean small local geographic groups of
people having standards unique to that group or area. We have modified
Sec. 494.90 to better clarify our meaning and have replaced the phrase
with new wording, ``current evidence-based professionally-accepted
clinical practice standards.''
Comment: One commenter recommended that a phrase be added to the
first paragraph in Sec. 494.90 of the ``Patient plan of care''
condition to clarify that community-accepted standards must reflect
joint decision-making between the patient and the

[[Page 20401]]

interdisciplinary team to individualize optimal goals for patient.
Response: We have designated the patient as a member of the
interdisciplinary team (if the patient desires) and expect that the
patient would share in the goal-setting team decisions. We do not agree
there is a need to modify the provision as suggested.
Comment: We received a few comments opposing the plan of care
timetables in Sec. 494.90 because commenters believed that the patient
response to therapy would be impossible to predict. A commenter
recommended that we clarify that the facility would not be responsible
for setting and meeting timetables for meeting the patient's medical
and psychosocial needs; the commenter argued that such policy would
constitute micromanagement that added no value to patient care. The
commenter stated there was no matrix (or method) in the literature that
allowed prediction of a patient's response time. A commenter stated it
was beyond the scope of practice for a dialysis center to set a
timetable for patients to achieve ``measurable and expected outcomes,''
especially those with ESRD for more than 1 year, since problems are
complex and professionals cannot predict how long they will take to
solve.
Response: It is common practice for a plan of care to include the
following elements for each patient problem or medical/nursing need
identified: Goal, action plan, and target date to either meet the goal
or check the patient's progress toward that goal. We recognize that
patient outcomes are determined in part by factors outside of the
dialysis facility's control, such as demographics, the systemic effects
of the underlying renal disease, and patient preferences and adherence.
Further, we recognize that health care delivery is dynamic and that not
all patients may be achieving, for example, the expected delivered dose
of dialysis at any specific point in time. If the patient is unable to
achieve the desired health outcomes, the plan of care should be
adjusted to reflect the patient's condition along with an explanation,
and any opportunities for improvement in the patient's health should be
identified. Care plans commonly include time frames and care plan goals
are more meaningful when the facility identifies a target date to
achieve a goal or reassess the patient's status. Therefore, we have
adopted the provision as proposed.
Comment: A few commenters were concerned about the patient's
ability to refuse to comply with the plan of care, which could nullify
team efforts to meet the plan of care goals. One commenter suggested
that CMS allow facilities to demonstrate that a patient's failure to
comply with the treatment regimen justified failure to meet criteria
within the plan of care. Another commenter recommended that the
dialysis adequacy regulatory language be more flexible to account for
patients who terminated treatment early, despite team intervention.
Response: These patient compliance concerns were discussed in the
February 4, 2005 proposed rule (70 FR 6209). As noted above, we
recognize that patient outcomes are determined in part by factors
outside of the dialysis facility's control. If the patient is unable to
achieve the desired health outcomes, the plan of care should be
adjusted to reflect the patient's condition along with an explanation
for the patient's inability to achieve the desired outcomes, and the
team must identify any opportunities to improve the patient's health.
This clarification has been added to the final rule at Sec.
494.90(b)(3).
The patient is part of the team and should be working to meet the
plan of care goals. We are requiring the interdisciplinary team to
adjust the patient's plan of care to achieve revised goals if initial
outcomes are not achieved. If a therapeutic goal is not met due to
patient non-compliance, then interventions must be implemented to
achieve better patient compliance. If reasonable measures have been
taken and lack of patient compliance still prevents the goal from being
met, the facility must document the interventions, the results of the
interventions, and the plan to preserve patient health and safety
within the limitations of poor patient compliance. Patient choices that
create barriers to meeting the targets should be documented and
addressed to a reasonable extent by the team. We are not requiring
patients to meet plan of care goals as a condition for coverage of
facility services.
Comment: We received several comments regarding Sec. 494.90(a)(1),
``Dose of dialysis.'' Most commenters recommended using the K/DOQI
adequacy standards for this requirement, and several, including the
National Kidney Foundation, recommended that we add the specific K/DOQI
guidelines as minimal standards to the plan of care requirements. Some
commenters suggested we include patient volume status (that is, a
measurement of body fluid removal) in the adequacy requirement. A few
commenters opposed establishing specific targets in the plan of care
requirement because they stated that would be too prescriptive and
rigid, future advances may outdate targets, facilities would have to
risk-adjust, and not all patients would be able to achieve 100 percent
of the targets. Commenters suggested alternatives, including using
guidelines of practice or consensus standards (like AAMI and CDC
guidelines), and encouraging, but not requiring, that specific targets
be met.
Response: The majority of commenters supported adding language to
Sec. 494.90(a)(1) to specify that the K/DOQI dialysis adequacy
guidelines must be targeted for all patients. We agree that the KDOQI
adequacy guidelines are the current evidence-based professionally-
accepted clinical practice standards. We have added to Sec.
494.90(a)(1) a reference to the 2006 KDOQI targets (that is, Kt/V of
1.2 for hemodialysis or weekly 1.7 for peritoneal dialysis); we are
also allowing dialysis facilities to meet ``an alternative equivalent
professionally-accepted clinical practice standard for adequacy of
dialysis that would allow for future advances in dialysis adequacy
measurement.
While there may be a need to risk-adjust when measuring facility-
wide performance, the ``Patient plan of care'' condition addresses
individual patient care and allows for unique patient characteristics
to be considered in the development of the plan of care goals,
alleviating the need to risk-adjust. As discussed previously in this
preamble, if a patient does not meet the plan of care goals,
appropriate interventions must be employed and if the patient still
cannot meet the goals, a proposed explanation of why goals were not met
must be entered into the plan of care. The rule does not require
patients to meet plan of care goals as a condition for coverage, but
facilities must demonstrate that they are attempting to meet those
goals to the extent possible.
Volume control, important to blood pressure management and cardiac
health, is an essential component of dialysis care that requires
ongoing attention from the care team. Therefore, we are incorporating
it into the ``dose of dialysis'' plan of care element. We have modified
Sec. 494.90(a)(1) to read, ``The interdisciplinary team must provide
the necessary care and services to manage the patient's volume status;
and achieve and sustain the prescribed dose of dialysis to meet a
hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V
of at least 1.7 or meet an alternative equivalent professionally-
accepted clinical practice standard for adequacy of dialysis.''

[[Page 20402]]

Comment: We received many comments regarding Sec. 494.90(a)(2),
the nutrition component of the ``Patient plan of care'' condition.
Several commenters supported the inclusion of nutrition as a plan of
care element. Two commenters objected to the use of serum albumin as a
marker of nutritional status, saying it was a poor indicator. Other
nutritional indicators favored by commenters include subjective global
assessment (SGA), normalized protein catabolic rate, weight, height and
appetite, body mass index (BMI), body surface area, lab values,
prealbumin and cholesterol, and the use of multiple nutrition measures,
and urea kinetic modeling. One commenter recommended that the nutrition
plan of care include target outcomes to meet/exceed the K/DOQI clinical
practice guidelines. Another commenter stated that if the target
albumin level was not met, alternate indicators (adequate dialysis and
normalized protein catabolic rate) should be allowed, as albumin is
affected by inflammation and chronic disease.
Response: Serum albumin levels are closely linked to morbidity and
mortality. According to the K/DOQI clinical practice guidelines (CPG),
serum albumin is a valid and clinically useful measure of protein-
energy nutritional status in maintenance dialysis patients, even though
it may fall in the presence of inflammation and stress. Several
commenters supported inclusion of BMI or body weight as a required
nutritional indicator. Dialysis patients are weighed at least 6 times
per week and inclusion of body weight does not increase burden to
facilities. A monthly assessment of body weight allows facilities to
calculate BMI (when the height is known), and track changes in body
mass.
We agree that the use of multiple markers is necessary to
adequately assess nutritional status. For example, the KDOQI CPG
encourages facilities to perform SGAs bi-annually as they are
considered to be a valid and clinically useful measure of protein-
energy nutritional status in dialysis patients (CPG 9). The CPGs also
state that catabolic rate or protein equivalent of total nitrogen
appearance are valid and clinically useful measures of net protein
degradation and protein intake in maintenance dialysis patients (K/DOQI
CPG 8). Serum cholesterol and serum prealbumin are valid and clinically
useful markers of protein-energy nutritional status in hemodialysis
patients (K/DOQI CPG 4 & 6). Facilities may use additional
markers and assessments as deemed appropriate by the registered
dietitian and physician. We are retaining in Sec. 494.90(a)(2) the
requirement that the interdisciplinary team monitor serum albumin (a
visceral protein) and body weight at least monthly as indicators of
nutritional status. In addition, we are adding language to Sec.
494.90(a)(2) to require that ``Additional evidence-based,
professionally-accepted nutrition indicators may be monitored, as
appropriate.''
Comment: Some commenters objected to the language in Sec.
494.90(a)(2) that requires the interdisciplinary team to ``provide the
necessary care and services to achieve and sustain an effective
nutritional status,'' because Medicare does not cover nutritional
supplements. One suggestion was to change the wording so that the
facility ``monitors'' the patient's nutritional status. Another
commenter suggested that facilities be allowed to give out supplements
without being cited for providing beneficiaries with an impermissible
``enticement.''
Response: Facilities must provide nutrition assessment, counseling,
and ongoing monitoring, and must review with the patient monthly
laboratory blood test results relating to the dialysis patient's
nutritional intake and nutritional status. The provision of nutritional
supplements by the dialysis facility is not expected or required. To
clarify this, we have revised the wording in Sec. 494.90(a)(2) to
read, ``provide the necessary care and counseling services * * *.''
Depending on the facts and circumstances of a particular case, a gift
of nutritional supplements by a provider to a beneficiary of a federal
health care program could violate the prohibition on beneficiary
inducements (section 1128A (a)(7) of the Social Security Act), 42
U.S.C. Sec. 1320a-7a(a)(7)) or the anti-kickback statute (1128B(b), 42
U.S.C. Sec. 1320a-7b(b)). Questions regarding whether a particular
arrangement may violate these statutes should be directed to the HHS
Office of Inspector General.
Comment: We received many comments regarding the anemia management
component of the ``Patient plan of care'' condition. While there was
some support for Sec. 494.90(a)(3) (now Sec. 494.90(a)(4)) as
written, many commenters recommended that we require that the KDOQI
anemia CPGs be plan of care targets. One commenter urged that we
consider having the healthcare team consider the new 2006 KDOQI CPGs as
they develop the plan of care. One commenter stated the hematocrit and
hemoglobin targets of 33.0 percent and 11 g/dl were too low and that a
hematocrit of 36 percent should be the minimum target.
Response: The proposed rule included references to the KDOQI
minimum target hemoglobin and hematocrit levels of 11 g/dL and 33
percent, respectively, at proposed Sec. 494.90(a)(3) (now Sec.
494.90(a)(4)). Although new 2006 KDOQI anemia CPGs modified the 2000
version, target hemoglobin and hematocrit CPGs continue to be evaluated
as new scientific evidence emerges. We note that the FDA issued a
November 16, 2006 alert to provide new safety information for
erythropoiesis-stimulating agents based on information reported in two
clinical studies in patients with chronic renal failure treated with an
unapproved regimen of erythropoiesis-stimulating agent(s). In addition,
on March 9, 2007, the FDA issued a stronger warning, entitled a ``Black
Box'' warning (see http://www.fda.gov/bbs/topics/NEWS/2007/NEW01582.html). Clinical research data continue to emerge and the FDA
continues to analyze this information.
In addition, the NKF convened a KDOQI workgroup in 2007 to review
new anemia management information and develop an update to the NKF-
KDOQI anemia management guidelines. The revised anemia management
guidelines were published on September 10, 2007 (see http://www.kidney.org/professionals/kdoqi/pdf/KDOQI_finalPDF.pdf or the
American Journal of Kidney Diseases, Vol. 50(3), September 2007: pp.
471-530) and included one clinical practice recommendation and one
clinical practice guideline for dialysis and nondialysis patients with
chronic kidney disease receiving erythropoiesis-stimulating agent(s)
therapy. They are as follows:
1. ``The selected Hgb target should generally be in the range of
11.0 to 12.0 g/dL;'' (clinical practice recommendation) and
2. ``The Hgb target should not be greater than 13.0 g/dL''
(clinical practice guideline).
The KDOQI recommendation and guideline also discussed the ``need to
maintain flexibility in medical decision making given the breadth of
variability between patients' individual needs, values, functional
status, disease burden, prognosis, and responsiveness to
erythropoiesis-stimulating agent(s) therapy.''
As such, the appropriate minimum hemoglobin/hematocrit targets for
dialysis patients may vary. Therefore, the interdisciplinary care team
must assess each patient to identify his or her unique needs for anemia
management,

[[Page 20403]]

considering renal community evidence-based professional standards of
practice, such as those published by the FDA or the NKF's KDOQI
guidelines.
Because the current science is evolving and it is probable that
more information regarding dialysis patient anemia management needs and
hemoglobin and hematocrit values will be forthcoming, we have not
included hemoglobin/hematocrit target levels in the final rule. The
plan of care must, however, reflect that individual patient anemia
management is consistent with current renal community evidence-based
professional standards of practice.
Comment: A few commenters stated that the proposed requirements for
anemia management in Sec. 494.90(a)(3) are not consistent with payment
policy, since physicians could not start Epogen until hematocrit was
below 30 percent. One commenter stated that the proposed requirement
would push hematocrits above 36 percent and add to reimbursement
problems (when the hematocrit goes above 37.5 percent). Another
commenter noted that payment affects hemoglobin/hematocrit targets.
Response: The final rule does not specify a specific hemoglobin
level. This change allows physicians and clinicians managing the
patient to determine the hemoglobin/hematocrit level appropriate for
each patient based upon the patient's comorbidities and clinical
characteristics. We note that the FDA labeling for erythropoiesis-
stimulating agent(s) (http://www.fda.gov/cder/foi/label/2007/103234s5122lbl.pdf) does not specify specific target hemoglobin, but
warns prescribers to use the lowest dose of erythropoiesis-stimulating
agent(s) to gradually increase the hemoglobin levels sufficient to
avoid the need for red blood cell transfusion. In addition, the anemia
management section in the final regulation decreases the focus on
erythropoiesis-stimulating agent(s) and instead, at Sec. 494.90(a)(4),
focuses on the patient's overall anemia management needs: ``The
interdisciplinary team must provide the necessary care and services to
achieve and sustain the clinically appropriate hemoglobin/hematocrit
level. The dialysis facility must conduct an evaluation of the
patient's anemia management needs.'' This evaluation would determine
whether the patient would benefit from supplemental iron,
erythropoiesis-stimulating agent(s), blood transfusions, or other
medical interventions.
Comment: One commenter stated hemoglobin levels should be used, and
not hematocrit levels, as the hemoglobin levels are more accurate and
are not affected by blood volume.
Response: The KDOQI CPGs do include a preference for hemoglobin
readings over hematocrit levels and many dialysis facilities have been
focusing on hemoglobin levels when managing anemia, rather than
hematocrit levels. Some facilities multiply the hemoglobin by three to
arrive at a comparable hematocrit level. Currently, Medicare payment
systems allow both hematocrit and/or hemoglobin levels to be reported.
Therefore, to allow flexibility in this health and safety rule, we will
allow use of either the hemoglobin or the hematocrit.
Comment: A commenter suggested that we remove specific references
to ``erythropoietin'' to allow for possible future advances in
technology. Another commenter recommended that anemia management be
individualized without the use of a range of parameters (that is, a
sliding scale) necessary for delivering medication.
Response: We agree with the commenter that a more general term
should be used rather than ``erythropoietin.'' We have revised Sec.
494.90(a)(4) by removing the term ``erythropoietin'' and adding the
term ``erythropoiesis-stimulating agents'' to allow for new technology
developments.
Standing physician orders are used in some dialysis units to
improve efficiency and responsiveness to changes in the patient's
anemia markers. We do not agree that there is a need to prevent
facilities from using these types of tools to manage anemia in dialysis
patients, provided the medication dose administered and lab tests
obtained are approved by the physician and are appropriate for the
individual patient. The physician is responsible for ordering
medications and laboratory tests and may or may not prescribe standing
orders or the use of an algorithm. However, medication type and
quantities billed to Medicare must be consistent with the physician's
orders.
Comment: We received many comments regarding the vascular access
component of the patient plan of care. While there was support for
including a vascular access plan of care component, several commenters
requested clarification of what type of vascular access monitoring
would be required. Some noted that a clinical physical exam, which
included observation, auscultation and palpation, would be different
from mechanical surveillance that could include transonic flow
measurements. The latter, according to commenters, would require a
change in payment policy. One commenter recommended referencing K/DOQI
Vascular Access CPGs 10, 11, and 12 for specifics regarding
monitoring, while the NKF suggested that monitoring include a clinical
physical exam at least monthly to detect problems or persistent
abnormalities that should prompt referral for access angiography.
Another commenter asked what CMS meant by its proposed requirement that
facilities ``provide necessary care and services to sustain vascular
access,'' and stated that a facility could only evaluate, monitor,
recommend, educate, and refer, but not provide all the services and
care that might be needed.
Response: The vascular access monitoring that must be included in
the patient plan of care is limited to a clinical physical exam, and we
expect that persistent abnormalities should prompt a referral, which is
in keeping with the K/DOQI Vascular Access CPGs. This physical
monitoring includes clinical observation, auscultation, and palpation
of the access. Additional information can be gained by comparing the
patient's expected Kt/V (given the current dialysis prescription) to
the actual Kt/V. When the actual Kt/V is significantly lower than the
expected Kt/V, the facility should investigate reasons for the
discrepancy, including the patency of the vascular access. The proposed
``necessary care and services'' provision in Sec. 494.90(a)(4) of our
regulation would be limited to those vascular access actions that are
reasonably expected within the dialysis facility, (generally, vascular
access monitoring, and appropriate and timely referral). We have
modified proposed Sec. 494.90(a)(4), now Sec. 494.90(a)(5), which now
reads in part, ``The interdisciplinary team must provide vascular
access monitoring and appropriate, timely referrals to achieve and
sustain vascular access.'' The current composite payment includes
payment for clinical access monitoring. When intervention is indicated,
Medicare covers certain diagnostic procedures.
Comment: A commenter stated that the plan of care should address
issues related to vascular access outcomes and the RN should be
responsible for access, initiating treatments and monitoring care. The
commenter also suggested that vascular access treatment should be
restricted to RNs or trained LPNs, because surgeons often complain of
vascular access problems in patients under their care, which they
believe is related to inadequate vascular access training and care.
Response: We appreciate the comment, however, it is not practical
to limit cannulation and all access care to

[[Page 20404]]

RNs and trained LPNs. In many units, PCTs perform vascular access tasks
under the direction of the licensed nursing personnel. We have
strengthened patient care dialysis technician certification and
training requirements at Sec. 494.140(e). Only PCTs with proven
cannulation competency should be inserting hemodialysis needles, under
the direction of the RN.
Comment: Two commenters suggested that we require a facility to
document the reason a fistula is not being used to provide vascular
access, as well as when applicable, a plan to place an arteriovenous
fistula in eligible patients.
Response: Current standards of practice recognize the health and
economical benefits of arteriovenous fistulas over catheters or grafts
used for hemodialysis. Vascular accesses must be patent over long
periods of time and efforts should be directed towards obtaining and
maintaining the most beneficial access type possible for each patient.
While not all patients may be able to obtain a viable arteriovenous
fistula, which generally lasts significantly longer than other access
types, each hemodialysis patient should be assessed for possible
arteriovenous fistula placement. To ensure adequate care planning for
arteriovenous fistulas, we have added a phrase to the vascular access
plan of care component at Sec. 494.90(a)(5), to require the facility
to evaluate ``whether the patient is a potential candidate for
arteriovenous fistula placement.'' The interdisciplinary team must
enter documentation into the medical record to demonstrate that this
requirement has been met; this documentation may include reasons why a
fistula is not being used in a particular patient's case.
Comment: A commenter recommended that evaluation of the
hemodialysis patient for the appropriate vascular access type should be
removed from the ``Patient plan of care'' condition, as this would be a
nephrologist's responsibility. Another commenter asked whether the
vascular surgeon's determination of what kind of access the patient
needs (per K/DOQI Vascular Access CPG 10) would meet the
patient plan of care requirement to evaluate the patient for the
appropriate vascular access type.
Response: The interdisciplinary team, led by the nephrologist, must
consider any vascular access determinations made by the vascular
surgeon, but the team may not abdicate its role of promoting the
placement of the safest access type possible for their patient.
Comment: Several commenters did not agree with the proposed role of
the dialysis facility interdisciplinary team as related to
transplantation referral. One commenter stated that transplant referral
should not be in the plan of care condition because it is a transplant
center responsibility. Several commenters stated that accountability
for transplant referral rests with the nephrologist. Two commenters
stated that the plan of care should simply include documentation of the
patient's transplant status. Another commenter stated that if an
eligible patient declines a transplant referral, this should be
documented in the plan of care as an informed decision.
Response: The proposed requirement regarding the role of the
dialysis facility interdisciplinary team in the transplant referral
process originated with the existing requirement in part 405, subpart U
(Sec. 405.2137(a)) that required the completion of a long-term care
program that addressed the selection of a suitable treatment modality
(that is, dialysis or transplantation) and dialysis setting for each
patient. The intent was to ensure each patient received the appropriate
modality of care and the appropriate care within that modality. The
professional team, not solely the nephrologist, has historically been
accountable for developing a plan of care that addresses whether the
patient was a transplant candidate.
We proposed to clarify what would have to be included in the plan
of care to include the plan for transplantation if the patient accepted
the referral, the patient's decision if an eligible patient declined
the transplantation referral, or reasons that the patient was not being
referred as a transplantation candidate, as determined during the
assessment. Many long-term care programs across the country address
these issues currently and it is reasonable that these topics be
addressed in any valid plan of care.
Facilities may want to develop their own policy identifying the
role of the interdisciplinary team members in performing the actual
transplant referral. The team member may be the nephrologist or another
team member. In any case, the facility will be held accountable for
ensuring that appropriate modalities are employed in treating chronic
kidney disease patients. We are adopting the proposed transplant
referral requirements at Sec. 494.90(a)(7)(ii) in this final rule.
Comment: We received many comments regarding the proposed
rehabilitation component of the ``Patient plan of care'' condition at
Sec. 494.90(a)(6), which read, ``The interdisciplinary team must
provide the necessary care and services for the patient to achieve and
sustain an appropriate level of productive activity, including
vocational, as desired by the patient, including the educational needs
of pediatric patients (patients under the age of 18 years).'' Many
commenters supported inclusion of rehabilitation in the plan of care,
while one commenter disagreed. Many commenters stated that the
provision of necessary care and services for rehabilitation was beyond
the scope of services offered by the dialysis facility. A few of these
commenters stated that a requirement to provide rehabilitation services
would constitute an unfunded mandate, and some commenters noted that
social workers are not trained to do rehabilitation. One commenter
recommended deletion of Sec. 494.90(a)(6) (now Sec. 494.90(a)(8)) and
suggested that rehabilitation referrals be addressed under social
services. Many commenters suggested a rewording of the requirement to
be more consistent with the capabilities of the dialysis facility, and
provided this wording: ``The interdisciplinary team must assist the
patient to achieve appropriate level of rehabilitation and refer the
patient to necessary services.''
Response: We concur with comments that the provision of the
necessary care and services for rehabilitation is beyond the range of
services offered by the majority of dialysis facilities. Physical
therapy, occupational therapy, and academic tutoring services (for
example) cannot realistically be provided by the facility staff.
Therefore, in response to comments, we have changed the wording of the
``rehabilitation status'' component, now at Sec. 494.90(a)(8), to
read, ``The interdisciplinary team must assist the patient in achieving
and sustaining an appropriate level of productive activity, as desired
by the patient, including the educational needs of pediatric patients
(patients under the age of 18 years), and make rehabilitation and
vocational rehabilitation referrals as appropriate.''
Comment: A few commenters suggested that a staff person be
identified who would be responsible for rehabilitation. One commenter
suggested that the social worker has a major role while another
commenter recommended that the medical director be responsible for
ensuring that the team assist patients in rehabilitation and in making
referrals.
Response: This final rule makes the interdisciplinary team
responsible for the patient plan of care, including rehabilitation.
Referrals may be made by the appropriate team member, which may be the
physician and/or the nurse or social worker. The role of the medical
director, as described in Sec. 494.150, is to

[[Page 20405]]

be responsible for the delivery of patient care and outcomes in the
facility; this would include rehabilitation outcomes.
Comment: One commenter suggested that rehabilitation referrals be
made before starting dialysis, when there is the most potential for
rehabilitation progress.
Response: While it may be desirable in some cases to provide a
rehabilitation referral to the patient before the start of dialysis,
this may not be possible because of patient illness associated with the
symptoms of uremia, as well as issues related to payment for
rehabilitation services.
Comment: A few commenters made suggestions regarding patient plan
of care rehabilitation outcomes. One commenter stated that the final
rule should clarify rehabilitation outcomes as broadly as possible, and
success should be defined differently for each patient. Another
commenter suggested adding sub-criteria for rehabilitation outcomes,
since the proposed rehabilitation requirements were not measurable as
written. A third commenter recommended that the optimum rehabilitation
outcome would be to return the patient to his or her former occupation.
Another commenter suggested that for pediatric patients, the
rehabilitation goal should be to help the patients get a high school
diploma/high school equivalency diploma (GED), and those interventions
and any reasons for a decline in rehabilitation potential should be
documented. A few commenters recommended that we add functional status
to the rehabilitation section. One commenter stated that a shift in
rehabilitation focus to functionality (activities of daily living)
would be more appropriate, because the age of many patients would
suggest that rehabilitation might not be realistic for them. Another
commenter suggested that we make maximizing physical/mental functioning
scores a rehabilitation goal, and aim to help patients maintain or
improve vocational status as measured annually, using the employment
categories on the CMS-2728 Medical Evidence form at http://www.cms.hhs.gov/cmsforms/downloads/cms2728.pdf.
Response: The introductory language to the ``Patient plan of care''
condition calls for the establishment of ``measurable and expected
outcomes and estimated timetables to achieve these outcomes.'' This
requirement will allow for individualized plans that lead to desirable
outcomes for patients in all care areas listed in the patient's plan of
care, including rehabilitation. Outcomes listed in the plan of care
could include such targets as the return of the patient to a former
occupation, attainment of a certification of education, return to
normal activities within the patient's household, a certain level of
functionality, or any another outcome that the team has determined is
appropriate for the patient. Dialysis facilities have the flexibility
to choose appropriate rehabilitation outcome targets, and we will not
narrowly define them in this final rule.
Comment: Two commenters stated that any rehabilitation services to
which a patient might be referred would be time-limited, and the
patient may not reach his or her full rehabilitation level; they stated
that the regulation would need to allow for this.
Response: If, while pursuing a rehabilitation goal, the team
encountered limits on the patient's eligibility for services (for
example, a limited number of physical therapy sessions), the plan,
goals and timetables would need to be adjusted and the reason noted in
the patient's record, as required at Sec. 494.90(b)(3).
Comment: One commenter suggested that the care team be required to
discuss with the patient whether to seek physical therapy, occupational
therapy, counseling or vocational rehabilitation referrals.
Response: The patient is a member of the interdisciplinary team
and, as such, should participate in team discussions regarding
rehabilitation potential and goals.
Comment: A commenter recommended that we require a separate
rehabilitation assessment initially and again every 3 to 6 months.
Response: The frequency of the rehabilitation assessment will be
the same as the frequency of the comprehensive assessment, since this
is a component of the assessment. (See Sec. 494.80(b).)
Comment: We received many comments suggesting modifications to the
components of the patient plan of care. Many commenters suggested that
we add ``mineral metabolism/bone disease'' as a required component of
the patient plan of care and referred to the NKF K/DOQI Clinical
Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney
Disease (American Journal of Kidney Disease 42:S1-S202, 2003
(supplement 3)). Two commenters specifically suggested that we
incorporate the K/DOQI CPGs for bone metabolism and disease in CKD
patients.
Response: In response to comments and evidence supporting the
importance of mineral metabolism management to the health of dialysis
patients, we will add mineral metabolism to the list of required
components of the plan of care by inserting the following language at
Sec. 494.90(a)(3): ``Provide the necessary care to manage mineral
metabolism and prevent or treat renal bone disease.'' Care and services
are limited to those normally provided by the dialysis facility and
would include appropriate referrals outside the dialysis facility when
appropriate. Current professional practice standards include management
of renal bone disease in dialysis patients, and we agree that mineral
metabolism and bone disease management is well within the purview of
the dialysis facility.
Comment: Many commenters supported adding a requirement for the
interdisciplinary team to document in the medical record or plan of
care the reasons a patient was not referred to home care, if
applicable. Other commenters suggested adding medication therapy
management and advance directives as additional plan of care
components.
Response: The patient must be assessed at least annually for
modality choice and level of participation in the dialysis care
process. We agree with commenters that it is appropriate to have a plan
of care component that corresponds with the treatment modality
assessment required at Sec. 494.80(a)(9) and Sec. 494.80(a)(10), and
it is appropriate to document the barriers to home dialysis. Therefore,
we have added home dialysis to Sec. 494.90(a)(7)(i), coupling home
dialysis with transplantation status (proposed Sec. 494.90(a)(5), now
Sec. 494.90(a)(7)(ii)) under a ``modality'' plan of care component.
This new ``Modality'' plan of care provision reads, ``Modality: (i)
Home dialysis. The interdisciplinary team must identify a plan for home
dialysis or explain why the patient is not a candidate for home
dialysis.'' This provision requires that, based on the most recent
assessment, the plan of care must be revised to reflect modalities for
which the patient is a candidate and the patient's preferences
regarding modality.
Advance directives were added under the ``Patient's rights'' and
``Medical records'' conditions and therefore we will not require
advance directives within the plan of care. Facilities have the
flexibility to address advance directives within the plan of care when
they deem it appropriate. Medication therapy management may be included
within the action plan for various components of the plan of care.
Comment: A commenter suggested that the plan of care address
cardiovascular health, and referred to the NKF K/DOQI Clinical Practice

[[Page 20406]]

Guidelines for Cardiovascular Disease in Chronic Kidney Disease
(American Journal of Kidney Disease 45:S1-S154, 2005 (supplement 3)).
The commenter stated that the NKF recommends that electrocardiograms be
performed in all patients at the initiation of dialysis, once patients
have achieved dry weight, and at 3 yearly intervals thereafter. In
addition, appropriate blood pressure management is an important part of
dialysis care and contributes directly to cardiovascular health.
Response: Cardiovascular disease is a concern for dialysis patients
and is affected by renal bone disease, blood pressure, and fluid
management as well as any other risk factors the patient may have.
Dialysis patients often have a number of co-morbidities. The patient's
medical history and co-morbidities are to be assessed as required at
Sec. 494.80(a)(1). Any problems identified by the comprehensive
assessment are to be addressed in the patient plan of care as required
at Sec. 494.90. Since very little support came from commenters
specifically to add a cardiovascular disease component to the plan of
care, we have not added this requirement. However, dialysis-related
cardiovascular health problems must be addressed in the plan of care
whenever it is appropriate for an individual patient, as determined by
the interdisciplinary team. Although core components of the plan of
care are listed in this final rule, the interdisciplinary team has
flexibility to add areas to the plan of care as identified in the
comprehensive assessment.
Comment: We received many comments regarding whether a social
services component should be required in the ``Patient plan of care''
condition. Most of the comments recommended that social services be
part of the plan of care and referred to current research regarding
social work services. Commenters stated that studies have shown that
social work intervention improves patients' quality of life, their
adherence to the ESRD treatment regimes and fluid restrictions, and
improves medication compliance. Another example of improved outcomes
provided by a commenter is that social work interventions can reduce
patients' blood pressure and anxiety levels.
Commenters suggested including emotional and social well-being
criteria in the final rule. Some commenters recommended including
functional status measures that they believe correlate with better
survival and hospitalization rates. Other commenters recommended
requirements that would specify psychosocial criteria along with MSW
tasks and responsibilities, and which would require that MSWs provide
information and training to patients. Some commenters suggested adding
specific language that would address measurable improvement in
physical, mental, and clinical health outcomes * * *,'' ``psychosocial
status and appropriate referral for services * * *,'' and would
``provide the necessary care and services to achieve and sustain
effective psychosocial status * * *.'' Many commenters suggested that
we require use of a tool to assist in measuring psychosocial status.
Tools suggested include the Zung Self-Assessment Depression Scale or
Hamilton Anxiety Scale, and a quality-of-life tool such as the SF-36,
or SF-12 (version 2.0 tool), that commenters state are used to measure
depression, functional status, and predict mortality and morbidity.
Commenters cited research supporting social work interventions that
they believe would contribute to meeting patient care team goals.
Response: In response to the large number of comments, and in light
of current academic research supporting social service interventions to
improve patient care, we are adding a social services component, called
``psychosocial status'' to the plan of care requirements at Sec.
494.90(a)(6). We are requiring that a standardized tool, chosen by the
social worker, be used to monitor patient status, and that counseling
be provided and referrals be made as appropriate. This new requirement
reads, ``The interdisciplinary team must provide the necessary
monitoring and social work interventions, including counseling and
referrals for social services, to assist the patient in achieving and
sustaining an appropriate psychosocial status as measured by a
standardized mental and physical assessment tool chosen by the social
worker, at regular intervals, or more frequently on an as-needed
basis.''
The standardized tool should be a professionally accepted, valid,
reliable tool, such as the SF-36, and should relate to the patient's
functional health and well-being. The tool must be used as a monitoring
aid that assists in determining the patient's psychosocial status. The
SF-36 model uses metrics that measure physical health as related to
functional level and presence of pain, and mental health as related to
social functioning, emotional and mental health. Reliability and
validity studies have been performed for this instrument. More
information about the SF-36 may be found in numerous articles or on the
Web at http://www.sf-36.org/tools/sf36.shtml. The SF-12 survey form
was derived from the SF-36 form and scales the 36 question survey down
to a 1-page, 2-minute version. However, we are not specifying which
tool must be used in order to allow flexibility and to limit the amount
of burden. The choice of which standardized tool to use is best left to
the facility social worker.
Comment: Although most comments recommended that social services be
part of the plan of care, two commenters disagreed, stating that social
workers have too big a caseload and are not capable of providing
professional counseling services. One commenter stated that until there
is consensus on outcomes, CMS should not include an outcomes-based
social service requirement in the plan of care. Commenters supporting
social services in the plan of care submitted a lengthy list of
references that highlight the importance of social services as related
to improved patient outcomes.
Response: In the previous conditions (Sec. 405.2162) as well as in
this final rule (Sec. 494.180(b)), dialysis facilities are required to
have adequate staff available to meet the care needs of their dialysis
patients. This requirement applies to the provision of social services
as well. Facilities may want to assess the caseloads of social workers
to ensure there are adequate staff to provide the appropriate level of
social services, including counseling. Social workers who meet the
qualifications at Sec. 494.140(d) are capable of providing counseling
services to dialysis patients. Furthermore, Medicare payment for social
worker counseling services is included in the dialysis facility
composite rate.
We are setting forth some process requirements within the ``Patient
plan of care'' condition because measurable outcomes in all areas are
not yet available. When evidence-based or consensus outcome measures
and standards become available, we may consider whether some process
requirements may be removed from the conditions for coverage in the
future.
Comment: We received a comment recommending that consistent
language be used for all plan of care elements so that for all care
plan areas the dialysis facility ``must provide the necessary care and
services to achieve and sustain an effective (treatment program).''
Response: Requiring the facility to provide all necessary care and
services for all elements of the patient plan of care may overstep the
facility's scope of practice in some areas, as pointed out by several
commenters.
Comment: One commenter questioned the need to list components of
the plan of care, since a qualified care team

[[Page 20407]]

would develop an appropriate plan, which would include measurable and
expected patient outcomes conforming to community-accepted standards.
The commenter stated this would not need to be mandated, nor should it.
Response: Although quality-oriented facilities may develop
meaningful plans of care that include measurable outcomes, we do not
agree that all facilities adequately develop and implement such a plan
of care. This patient-centered condition serves to protect the health
and safety of dialysis patients and to ensure that adequate patient
care services are provided.
Comment: A commenter suggested that when referring to the
interdisciplinary team implementing the plan of care at Sec.
494.90(b)(1)(i) the phrase ``inclusive of the patient'' be added.
Response: The interdisciplinary team definition specifically
includes the patient, and has been added to the first paragraph of this
condition. We have added the phrase ``including the patient if the
patient desires'' to Sec. 494.90(b)(1)(i) to clarify that we expect
that the patient will want to participate in devising the plan of care.
Comment: We received many comments regarding the proposed
requirement at Sec. 494.90(b)(1)(ii) suggesting that the patient sign
the plan of care. A few commenters recommended the plan of care be
signed by the patient's attending physician as well as the patient.
Response: The patient plan of care must be completed by the
interdisciplinary team (Sec. 494.90(b)(1)(i)). It is standard practice
for all team members, including the treating physician, that develop
the plan of care to sign it, as they would for any other entries into
the medical record. Therefore, we are changing the wording at Sec.
494.90(b)(1)(ii) to reflect that all team members must sign the plan of
care.
Comment: Commenters agreed with the proposed rule requirement that
the plan of care be signed by the patient or the patient's designee.
One commenter stated that at least one facility, to his or her
knowledge, limits patient involvement exclusively to signing the care
plan; the staff orders the patient to sign and the RN on-duty becomes
offended if the patient actually reads the care plan. The commenter
further noted that patients should be able to indicate the date they
signed the care plan. Another commenter noted that the proposed rule
did not require the patient to be involved in the development of the
care plan, but only to sign it. This commenter was concerned that only
paper compliance would be achieved with such a provision, and that
enforcement regarding patient involvement would be difficult. One
commenter recommended that facilities be required to conduct periodic
patient care conferences. The commenter further stated that deleting
survey tag V174 would be detrimental to quality of care and CMS should
prevent a ``pass around the paper'' meaningless care plan development
process.
Response: The role of the patient is central to providing quality
dialysis care. Paper compliance without substantive compliance is
unproductive. Specifically, the patient member of the interdisciplinary
team has a role in converting the comprehensive assessment into a
meaningful plan of care. Whenever possible, the patient (or designee)
should assist in the identification of goals and in formulating the
action plan to achieve these goals. The patient must be involved in
care planning and actively participate in care plan development and
review.
Survey tag V174, referred to by the commenter, required regularly
scheduled conferences, with participation by the staff involved in the
patient's care, to evaluate the progress each patient is making towards
the goals in their long-term care program and patient care plan.
However, this final rule also allows the facility flexibility to choose
the methods to ensure patient participation. One means of providing an
opportunity for participation is to have the patient attend the meeting
in which the plan of care is developed and updated. This final rule
makes very clear that the patient is part of the care team and can
participate in the assessment and the plan of care activities if the
patient desires to do so. While we have not required monthly care plan
meetings specifically, the facility must demonstrate that there is an
opportunity for patient involvement and participation. The facility has
the flexibility to design a process. The patient signature on the plan
of care is not sufficient to demonstrate patient participation. The new
interpretive guidelines for this regulation will include direction to
surveyors regarding enforcement of this provision.
Comment: A few commenters were concerned about dialysis facility
responsibility for patient participation in cases where the patient
chooses not to participate. Some commenters suggested that there be a
provision in this final rule for situations in which the patient
refused to sign the plan of care. The commenter suggested that in such
cases, documentation provided by the facility explain that the patient
had refused to provide a signature.
Response: We agree that as long as the patient has been provided
sufficient opportunity to participate with the interdisciplinary team,
the dialysis facility should not receive a citation for non-compliance
with these conditions when the patient has refused to participate or
sign the plan of care. We have modified the language at Sec.
494.90(b)(1)(ii) to indicate that the facility must document a
patient's refusal to sign the plan of care, along with the reason the
signature was not provided.
Comment: We received many comments regarding the time period for
commencing implementation of the patient plan of care (Sec.
494.90(b)(2)). The proposed rule specified that the plan of care would
have to be implemented within 10 days of any comprehensive assessment.
While there was some agreement with this proposal, many commenters
stated that 10 days was too short. Some commenters suggested that we
combine the assessment and plan of care time period to 30 days.
Commenters suggested a myriad of alternative timeframes for
implementing the plan of care, such as requiring implementation within
15 days of assessment completion, within 90 days of starting dialysis,
within a certain number of dialysis treatments (to allow for the
possibility of patient hospitalizations), or at the first team meeting
following completion of the assessment. The reasons facilities gave for
needing a longer plan of care implementation time included the shortage
of staff, needing time for referrals and schedule coordination, the
need for interpreters, accommodating monthly care plan meetings, and
the difficulties involved in bringing the multidisciplinary team
together monthly.
Response: We believe we must balance the health and safety needs of
the patient against the staffing limitations of the facilities. The
case loads of staff and constraints of facility processes should not
outweigh the need to develop and implement the plan of care within a
reasonable period of time. If a patient has received in-center dialysis
for a 1-month period or 13 (thrice-weekly) hemodialysis treatments,
that patient has likely been physically present in the dialysis
facility for at least 40 hours. We believe that this should provide
sufficient time for the interdisciplinary team to have completed an
assessment and developed a plan of care that is ready for
implementation. Thirty days is a reasonable timeframe for the initial

[[Page 20408]]

assessment and implementation of the plan of care in order to protect
the health and safety of patients and prevent harm. Facilities may want
to re-evaluate their processes, resources, and adequacy of staff if
they find the 30-day deadline to be too difficult to meet. We have
modified the requirement at Sec. 494.90(b)(2), so that the
interdisciplinary team has a timeframe of the latter of 30 days or 13
hemodialysis treatments from the date of admission to complete the
assessment and implement the plan of care. This provision now addresses
commenter concerns regarding time lapses when a patient is in the
hospital. Referrals are considered to be a part of the implementation
of the plan of care and would not be a reason to allow extended time
periods to complete and implement the plan of care. In addition, we
will allow a 15 day time period for the facility to implement any
patient plan of care revision due to completion of a monthly assessment
(done for unstable patients) or an annual assessment (completed for
stable patients) (Sec. 494.90(b)(2)).
Comment: Many comments addressed proposed Sec. 494.90(b)(4), which
would require the dialysis facility to ensure that the patients are
seen at least monthly by a physician providing ESRD care. Some
commenters supported this provision and a few suggested that the visit
could take place in the physician's office. Other commenters disagreed
with the requirement but agreed with the intent, saying that physicians
should see their dialysis patients at least monthly. Many commenters
strongly disagreed with the provision, stating that the facility should
not be accountable for physician visits. A few commenters stated that
the payment G-codes provided enough incentive for facilities and that
therefore this physician visit requirement was not needed. Other
commenters suggested there was no evidence of any benefits that could
be linked to monthly visits, and this would be especially burdensome
for rural dialysis facilities. One commenter recommended that an
exception be available for facilities in the Pacific Islands. Two
commenters suggested that CMS had no authority to mandate these monthly
physician visits according to section 1801 of the Social Security Act,
which prohibits the federal government from exercising any supervision
or control over the practice of medicine.
Response: We believe that it is in the best interest of the patient
for dialysis facilities to ensure that a physician (or other
practitioner, such as a PA, nurse practitioner, or clinical nurse
specialist) visits each month. The Dialysis Outcomes and Practice
Patterns Study (DOPPS) data demonstrate that physician contact
correlates with the quality of care. The G-codes, established in the
final rule, ``Medicare Program; Revisions to Payment Policies under the
Physician Fee Schedule for Calendar Year 2004'' published November 7,
2003 (68 FR 63196, 63216), provide payment to physicians in incremental
amounts depending on whether the patient was seen 1, 2-3, or 4 times
during a given month. Although the payment G-codes provide some
incentive for attending physicians to see their dialysis patients more
often, physicians may still choose not to see their patients for a
month or more. In this case, the patient still receives dialysis for
which the facility receives payment. We do not believe that requiring
monthly visits infringes on how physicians practice medicine and note
that physician organizations that provided comment on the proposed rule
supported the provision. We are retaining the proposed provision at
Sec. 494.90(b)(4) to ensure that patients receive face-to-face
physician (or, as discussed below, ``physician extender'') visits at
least monthly.
Comment: A few commenters suggested that physician assistants be
allowed to perform monthly visits, while one commenter favored allowing
a nurse practitioner to perform monthly visits.
Response: In response to comments, we have added nurse
practitioners, clinical nurse specialists, and physician assistants as
options for compliance with the provision requiring monthly visits by a
physician. CMS has previously issued instructions regarding physician
visits and payment via G-codes and these instructions clarify that a
physician assistant, clinical nurse specialist, or a nurse practitioner
may provide visits to dialysis patients instead of a physician.
Physicians may use nurse practitioners, physician assistants, and
clinical nurse specialists, who are able under the Medicare statute to
furnish services that would be physician services if furnished by a
physician and who are eligible to enroll in the Medicare program, to
deliver some of the visits during the month.
Comment: We received many comments regarding proposed Sec.
494.90(c), ``Transplantation referral tracking,'' which would require
the interdisciplinary team to track the results of each kidney
transplant center referral and monitor the status of any facility
patients who are on the transplant wait list. In addition, this
standard would require the team to communicate with the transplant
center regarding patient transplant status at least quarterly or more
frequently if necessary. Some commenters supported this standard as
proposed and many commenters stated the dialysis facility should not be
accountable for transplantation referral tracking once the referral has
been made. Commenters who disagreed with this proposed provision stated
that other parties have this tracking responsibility, including the
transplant center, the transplant candidate, and/or the physician. Two
commenters stated that this requirement creates a burden for dialysis
facilities.
Some commenters acknowledged that the proposed (now final)
transplantation center conditions of participation, published on March
30, 2007, included a proposed requirement for transplant centers to
communicate with dialysis centers regarding transplant candidate
status. A few commenters suggested that dialysis facility
responsibility be limited to maintaining a list of patients on the
transplant wait list. Several commenters stated that some transplant
centers did not communicate with the dialysis facility, or that it was
difficult to get information from the transplant center. One commenter
suggested penalties for transplant centers that did not communicate
with dialysis facilities, while another commenter suggested that
incentives be provided to transplant centers to share information
monthly on transplant candidates' work-up and listing status.
Response: Our intent is to ensure that the interdisciplinary team
is aware of where the patient is in the referral and transplant
evaluation process so that patients do not get ``lost'' along the way.
We do not expect that the transplant referral tracking responsibilities
borne by the dialysis facilities would be redundant with the
responsibilities of the transplant center. We would expect the
interdisciplinary team to be aware of whether the patient has completed
the evaluation process, is wait-listed, ineligible for wait listing, or
is awaiting living donation. Moreover, the dialysis facility is
expected to alert the transplant center about changes in the patient's
condition that would affect whether a patient was able to receive
kidney transplantation. The transplantation center conditions of
participation published on March 30, 2007 (72 FR 15198) require kidney
transplant centers to communicate transplant patient status to the
dialysis facility at Sec. 482.94(c)(1) and Sec. 482.94(c)(2) so that
there is two-way communication.
Comment: A few commenters who agreed that there was a need for
dialysis facility and transplant center communication did not agree
with the

[[Page 20409]]

proposed quarterly frequency of this communication. One suggestion was
to remove the ``quarterly'' language and replace it with ``when there
is a change.''
Response: We agree. In response to comments, we have changed the
frequency of required communication with the transplant center at Sec.
494.90(c)(3) so that the regulation will require the interdisciplinary
team to contact the transplant center ``at least annually, and when
there is a change in transplant candidate status.'' Although the
proposed ESRD conditions for coverage called for quarterly
communication with the transplantation center, the transplantation
center final rule (at Sec. 482.94(c)(1)and (2)) requires that the
transplant center notify the dialysis facility of the patient's
transplant status only when there are changes in such status (72 FR
15276). Our purpose here is to provide a means by which up-to-date
information can be made available to the transplant team so that
eligible patients are wait-listed and so that patients offered a donor
kidney are in a position to accept the transplantation. The dialysis
team also needs up-to-date information so that the team can choose the
most appropriate ESRD modality and setting for the patient and assist
the patient in understanding the process used to obtain kidney
transplantation.
Comment: Commenters made several additional transplant
recommendations. One commenter suggested that an RN with specific
transplant related duties is needed to act as transplant coordinator.
Response: While dialysis facilities may find it beneficial to have
an RN transplant coordinator assist in transplant referral tracking, we
do not believe it should be a requirement. We are allowing flexibility
so that the tracking may be done by staff members chosen by the
dialysis facility.
Comment: One commenter suggested that the dialysis facility and the
transplant center have a written agreement with each other.
Response: If a dialysis facility finds it useful to have a written
agreement with the transplant center, the dialysis facility has the
flexibility to pursue this, but we do not believe it is necessary and
will not require it.
Comment: One commenter suggested that there should be an internet
database to facilitate communication between transplant centers and
dialysis facilities.
Response: While there may be some benefit in having an internet
database to facilitate communication between transplant centers and
dialysis facilities, we will not burden dialysis facilities with
developing such an internet database. We believe an active and ongoing
communication and coordination process will suffice currently. As
electronic health records become a reality in the future, there is the
possibility that these records could facilitate dialysis facility and
kidney transplant center communications and exchange of information.
Comment: One commenter suggested that the transplantation
requirements should be consistent with the recommendations of the 2005
ESRD Network technical expert panel (TEP) that worked on developing
transplant referral clinical performance measures. Another commenter
stated that conditions for transplant center, physician and patient
communications should be based on the study and endorsement of the
American College of Physicians and physician organizations.
Response: The TEP referred to by the commenter was charged with
developing dialysis facility-specific kidney transplant referral
clinical performance measures. These measures would track steps in the
transplant referral process. TEP membership included transplant
surgeons, nephrologists, and dialysis facility representatives. The TEP
recommended that this final rule include the proposed transplantation
provisions at 494.90(c) in order to facilitate implementation of the
kidney transplant referral CPMs they developed. We have adopted the
proposed transplant provisions and believe this will alleviate the
concerns of the commenters.
Comment: A few commenters responded to our query as to whether we
should specify actions (that is, transplant referral activities and
monthly blood draws for antigen/antibody testing) that must be included
in the transplantation action plan. Two commenters stated that monthly
transplant blood drawing should not be the responsibility of the
dialysis facility. One commenter supported the concept that facilities
should support patients in the process of a work-up for a transplant,
which would include tracking tests, communication with transplant
coordinators/surgeons, etc.
Response: We will not specify actions that must be included in the
patient plan of care under the transplantation component, but encourage
dialysis facilities to assess the circumstances and include appropriate
actions in the plan of care as needed.
Comment: We received several comments supporting inclusion of the
``Patient education and training'' standard at Sec. 494.90(d). Some
commenters recommended the addition of other training topics, including
patient education regarding arteriovenous fistulas, advance directives,
and more. A commenter recommended that we require documentation in the
medical record that patients were informed of the risks and benefits of
various types of vascular access consistent with ``Fistula First'', and
provide funding for this if needed.
Response: We agree that it is a reasonable expectation that
dialysis patients be educated regarding the risks and benefits of
various access types due to the impact of a vascular access on the
patient's morbidity and mortality risks. Comments on this and other
sections of these conditions strongly support adding a requirement
ensuring that patients must be educated regarding the risks, benefits,
and outcomes of various access types. These comments are in keeping
with the National ``Fistula First'' quality initiative. Additionally,
the Institute of Medicine (IOM) has encouraged the empowerment of
patients to improve the quality of the healthcare system. Therefore, we
have added new language to the ``Patient plan of care'' condition at
Sec. 494.90(d), Patient education and training, requiring that the
plan of care include education and training on the benefits and risks
of various vascular access types. We have also added infection
prevention and personal care, and home dialysis and self-care training
to this provision in response to comments as discussed under the
``Infection control'' and ``Care at home'' sections of the preamble.
Comment: One commenter believes that education for all life changes
associated with dialysis is an unfunded mandate that will require
additional personnel skilled in this training. The commenter also
stated that patient education regarding employment, rehabilitation and
transplantation is beyond the scope of the dialysis center nurses and
technicians.
Response: Patient education is included in the Medicare composite
rate paid for dialysis. We expect that the interdisciplinary team has
the skills and expertise needed to educate dialysis patients about
aspects of the dialysis experience, dialysis management, quality of
life, rehabilitation, and transplantation.
d. Care at Home (Proposed Sec. 494.100)
We proposed a separate condition for coverage for care at home
requirements, which were previously located in four existing sections
of 42 CFR part 405, subpart U. The requirement that services to home
patients be at least equivalent to those provided to in-center patients
was retained from existing Sec. 405.2163. We addressed home

[[Page 20410]]

dialysis training in the proposed rule and proposed requiring the
interdisciplinary team to provide training to the patient and/or the
designated caregiver before the initiation of home dialysis. We
proposed that the home training be provided by a facility approved to
provide home dialysis services and that home and self-care training
would have to be conducted by an RN. The proposed training would have
to address specific needs of patients in several subject areas,
including the nature and management of ESRD, techniques associated with
the treatment modality, nutritional care plans, emotional and social
well-being, methods to detect, report and manage potential
complications, how to access and use available resources, how to self-
monitor health status, how to handle emergencies, infection control
precautions, and proper waste and disposal procedures. We also proposed
a home dialysis-monitoring standard, which would have required the
dialysis facility to document that the patient and/or caregiver
received and demonstrated adequate comprehension of the training;
retrieve and review self-monitoring data and other information at least
every two months; and maintain this information in the medical record.
We proposed to retain many of the existing regulations regarding home
dialysis support services; however, the proposed support services
standard was strengthened by requiring home dialysis patient
consultation with the interdisciplinary team. The team also would have
been held responsible for the development and periodic review of the
patient's plan of care based upon the comprehensive assessment, and for
addressing the patient's needs and achieving the expected outcomes of
care. The proposed rule also would have expanded existing requirements
to monitor the quality of water used by home hemodialysis patients. The
proposed rule specifically included onsite evaluation of the water
system, as well as adherence to applicable AAMI guidelines and
immediate correction of any problems with the water treatment system.
If problems could not be immediately corrected the facility would have
to arrange for backup dialysis until the home dialysis water quality
could be restored. At Sec. 494.100(c)(1)(vi), the proposed rule would
retain existing requirements that the dialysis facility be responsible
for ``Purchasing, delivering, installing, repairing and maintaining
medically necessary home dialysis supplies and equipment (including
supportive equipment) prescribed by the attending physician.'' The
proposed rule also would have required facilities to plan for and
arrange for emergency back-up dialysis services when needed. We also
proposed that the facility maintain record-keeping systems that ensured
continuity of care; this would have also been retained from existing
provisions found at Sec. 405.2163(e)(3).
Comment: Many commenters strongly supported the requirement that
home dialysis patients receive services that are at least equivalent to
those provided to patients in facilities. One patient remarked he felt
his peritoneal dialysis care was not equivalent to in-center
hemodialysis. Another commenter said home dialysis needs more attention
in the final rule.
Response: We appreciate the positive response from commenters. All
the ESRD conditions for coverage must be met regardless of whether the
setting is in-center or at home. We have added language to clarify this
in the first paragraph of Sec. 494.100, to require that dialysis
facilities meet all applicable conditions of this part. We would expect
that under these new regulations, dialysis facilities would make any
necessary changes to ensure that all patients receive the same quality
of care regardless of the location of the service. We have increased
the home dialysis focus of these conditions by making ``Care at home''
a separate condition for coverage.
Comment: A few commenters recommended that a new section be added
to our regulation, to address patients performing self-care dialysis in
the facility, and address policies and procedures for self-care in the
facility. These commenters believed that stringent regulation and
oversight was needed for self-care. One commenter suggested there
should be requirements for self-care training for both patients and
facility staff and that self-dialysis training should include treatment
monitoring, machine monitoring, needle procedures, and infection
control.
Response: We encourage self-care, both at home and within the
facility, whenever the patient has the ability. Self-care can be
supported in-center by Medicare-certified outpatient dialysis
facilities. Dialysis facilities that provide self-care must meet these
conditions for coverage and protect patient safety. We do not agree
that additional regulations are needed regarding self-care.
Comment: One commenter remarked that the requirements as written
would require all patient training to be completed before the
initiation of home dialysis, and the commenter suggested that this was
not practical because patients would lose interest in performing home
dialysis before the instruction was complete.
Response: As required at Sec. 494.100(a), the interdisciplinary
team must oversee the training provided to the home dialysis patient
and the designated caregiver before the initiation of home dialysis.
Patients should not begin home dialysis before adequate training is
complete and competency has been determined. We have maintained the
language of the proposed rule.
Comment: One commenter agreed that initial home training should be
conducted by a qualified RN. Some commenters remarked that the
requirement for an RN to train home dialysis patients was excessively
stringent and that an LPN was qualified to train these patients.
Another suggested that an RN be responsible for home training but still
have the ability to delegate parts of the training program to a trained
LPN or PCT. Two commenters suggested the final rule allow PCTs, under
the supervision of an RN, to provide patients with some or all home
care training, with a final review and evaluation done by an RN. One
commenter strongly opposed the provision at Sec. 494.100(a), which
required that the interdisciplinary team be responsible for providing
self-dialysis training to home patients.
Response: The existing requirement at Sec. 405.2162(c) mandates
that an RN be in charge of self-care training. We believe that an RN,
as an experienced health professional, fully understands the complexity
and rationale for the dialysis process, and is the best-suited expert
to conduct self-care training to patients. The requirement serves to
protect the health and safety of the patient. Therefore, we have
retained the proposed RN requirement in the final rule at Sec.
494.100(a)(2), which stipulates that the RN must conduct the home
training. The RN may use other members of the clinical dialysis staff
to assist in providing the home training. However, the RN is
responsible to ensure that the training is in accordance with the
requirements at Sec. 494.100.
In addition, we have modified the provision at proposed Sec.
494.100(a), which would have required that the interdisciplinary team
be responsible for providing the self-dialysis training to home
patients, to clarify that the role of the interdisciplinary team is to
oversee the home dialysis training.
Comment: Several commenters suggested that training topics should
be determined by the facility rather than regulation. Some commenters
suggested removing at least two of the proposed training topics
(proposed

[[Page 20411]]

Sec. 494.100(a)(3)(iii), implementation of a nutritional care plan,
and Sec. 494.100(a)(3)(iv), how to achieve and maintain emotional and
social well-being), since these topics are proposed to be covered in
the ``Patient plan of care'' condition.
Response: Patient education and training are addressed in the
``Patient plan of care'' condition, which now requires that the care
plan include education and training regarding home dialysis and self
care, as appropriate, at Sec. 494.90(d). All dialysis patients,
whether home or in-center, are to receive counseling regarding
nutrition and psychosocial well-being (Sec. 494.90(a)(2) and (6),
respectively). We concur with the comments and believe it is redundant
to include these topics under the self-care training standard at Sec.
494.100(a). Therefore, we have removed ``implementation of a
nutritional care plan'' at proposed Sec. 494.100(a)(3)(iii) and ``how
to achieve and maintain emotional and social well-being'' at proposed
Sec. 494.100(a)(3)(iv).
Comment: One commenter suggested removing the specific level of
hemoglobin and hematocrit and replacing it with reference to evidence-
based standards.
Response: We have modified the final rule at Sec.
494.100(a)(3)(ii) because the proposed language was redundant. The
``Patient plan of care'' condition at Sec. 494.90(a)(4) requires that
the interdisciplinary team develop a plan of care that addresses
anemia, and specifies the hemoglobin and hematocrit targets. In the
final rule at Sec. 494.100(a)(3)(ii), we have eliminated specific
numerical values for hematocrit and hemoglobin but require that the
patient be instructed on how to administer erythropoiesis-stimulating
agent(s) in order to achieve and maintain a target level hemoglobin or
hematocrit, as written in the patient's plan of care at Sec. 494.90.
Comment: A few commenters suggested that the 2-month timeframe for
monitoring home patients was excessively rigid and burdensome. Two of
those commenters suggested a quarterly reporting timeframe that would
coincide with monitoring. Two commenters suggested we change the
timeframe to require monthly reporting.
Response: The goal of the standard at Sec. 494.100(b)(2) is to
have facilities effectively monitor the care of home dialysis patients
to achieve desired outcomes. Monitoring patient records allows dialysis
facility staff to compare the prescribed regimen to actual dialysis
results. Home patients do not see facility staff as frequently as in-
facility patients do and so we believe the 2-month monitoring schedule
is reasonable.
Comment: One commenter agreed with the proposed rule but pointed
out that home patients do not always provide documentation regarding
their care at home. Another commenter remarked that non-compliant
patients may not provide the required data and other information
necessary for staff to carry out the mandatory review. This commenter
suggested we add language that would enable staff to be in compliance
on the basis of having made a ``good faith effort.''
Response: The home dialysis patient is part of the
interdisciplinary team and should be working to meet the home dialysis
plan of care goals. If home dialysis patients exhibit non-compliant
behavior and/or their care plan goals are not met, then facilities must
intervene. If facilities take reasonable measures and lack of patient
compliance remains a problem, then the interdisciplinary team must
document the interventions to address patient non-compliance, the
results of the interventions, and the plan to protect patient health
and safety within the limitations of poor patient compliance.
Comment: Several commenters remarked on the differences between
hemodialysis and peritoneal dialysis modalities in the home setting.
The commenters suggested that peritoneal dialysis visits only be
required when medically indicated, since the water treatment issues
associated with hemodialysis do not exist for these patients. Two
commenters suggested that home monitoring visits be at the discretion
of the interdisciplinary team. One commenter suggested that the
proposal be revised to allow home visits ``as appropriate.'' Another
commenter suggested that the final rule state whether the
interdisciplinary team would be required to perform an assessment at a
team meeting. Another commenter asked for clarification on whether the
staff must visit a patient's home periodically. A commenter suggested
that a physician be required to visit home patients only as medically
indicated, while another commenter asked whether the physician would be
required to see the home patient monthly. One commenter suggested we
add a requirement that the home consultation be with ``all'' of the
team members as needed. Two commenters suggested that ``periodic
monitoring'' include ``at least annually.'' Other commenters suggested
that the final rule specifically state that all home patients must be
visited in the home at least periodically after home training is
completed.
Response: Many of these concerns from commenters would be addressed
in the patient's plan of care at Sec. 494.90, which requires an
appropriate plan of care based upon medically indicated needs,
treatment, and services. Patient needs identified in the plan of care
should drive the frequency of home visits of the interdisciplinary team
members, including the physician. Regular contact with facility staff
offers the patient an ongoing support service and an avenue for
communicating questions and concerns. Our regulations require periodic
monitoring and home visits by a team member as part of the patient plan
of care; they are necessary in order to protect patient health and
safety. We would expect that each home care patient, in addition to
being visited, would have regular contact with dialysis facility staff.
The initial home visit allows dialysis facility staff to ensure that
the home patient has an acceptable environment in which to perform safe
dialysis, and ensure there is adequate storage of supplies, etc. The
dialysis facility should ensure that care being provided to home-care
patients be equivalent to care provided to other facility patients.
Comment: A commenter suggested that we require at Sec.
494.100(c)(1)(i) that home patient monitoring be completed as needed
and only if geographically feasible, in accordance with the patient's
plan of care. Another commenter remarked that facility staff should not
be required to make home visits if patients live in dangerous areas or
if it is unsafe for staff.
Response: Support services at standard (c) are required for all
home patients, regardless of the setting or geographical location. At
Sec. 494.100(c)(1)(i), dialysis facility staff are required to
periodically monitor the patient's home adaptation and visit the
patient's home setting in accordance with the plan of care. All
patients have the right to receive equal care that protects their
health and safety, and CMS cannot establish a mandate that would allow
discrimination in any form.
Comment: Two commenters remarked that while the proposed rule
provides a new level of protection for the patient, the requirements
would make home dialysis more expensive, which could be a deterrent for
dialysis facilities to offer home dialysis. One commenter noted that
weekly home hemodialysis water testing for new systems was too
expensive, as was monthly bacteria testing. The commenter remarked that
the final rule should recognize differences between hemodialysis and
peritoneal dialysis, and that it is not

[[Page 20412]]

necessary to monitor water quality/dialyzer reuse with certain new home
dialysis technologies. One commenter suggested that for preconfigured,
510(k) cleared systems designed, tested and validated to yield AAMI
quality water and dialysate, that we should merely require the facility
to monitor water quality in accordance with the systems' FDA-approved
labeling under Sec. 494.100(c)(1)(v). Another commenter remarked that
AAMI recommendations were never intended for home hemodialysis, stating
that home water quality should be monitored but not with the same
frequency as in a facility setting. One commenter also asked how the
conditions would stay current if the referenced guidelines were changed
or updated.
Response: The subject of water quality was addressed in our
discussion under Sec. 494.40, where all related issues, including home
dialysis issues, were thoroughly discussed. In accordance with that
discussion, we have revised the final rule at Sec. 494.100(c)(1)(v)(A)
and Sec. 494.100(c)(1)(v)(B), to require that the facility monitor the
quality of water and dialysate used by home hemodialysis patients and
conduct onsite evaluations and testing of the water system in
accordance with the recommendations specified in the manufacturers
instructions and the system's FDA-approved labeling for preconfigured
systems designed, tested and validated to yield AAMI quality water and
dialysate. Bacteriologic and endotoxin testing must be performed at
least quarterly, or on a more frequent basis as needed, to ensure that
the water and dialysate are within AAMI limits. We are requiring at
least quarterly cultures and endotoxin testing to ensure that as new
technologies come into use, the facility monitors home hemodialysis
water systems so that patient safety is protected. As data and
information become available regarding the long-term use and safety of
new technologies, we may, in the future, re-evaluate the required
frequency of water testing for these systems based on the scientific
evidence.
Comment: One commenter agreed with the proposed rule that the
dialysis facility should provide all support services regardless of
whether or not any durable medical equipment is provided by that
facility. Another commenter suggested adding the following language to
the final rule at Sec. 494.100(c) for Method I patients: ``The
dialysis facility must purchase or lease and deliver the necessary home
dialysis supplies and equipment.'' Two commenters remarked that
equipment rental should be included in the proposed list of
requirements at Sec. 494.100(c)(2)(iii), as some providers rent
dialysis equipment.
Response: We appreciate the positive comments regarding the need
for facilities to provide support services for the home patient. Home
dialysis patients who receive all equipment, supplies and support
services from their ESRD facility are considered ``Home Dialysis Method
I.'' Under ``Method II,'' a durable medical supply company provides all
necessary equipment and supplies to the home dialysis patient, and a
dialysis facility provides support services to the patient. In order to
be responsive to commenters, we have added the terms ``renting'' and
``leasing'' to the final rule at Sec. 494.100(c)(1)(vi), which now
requires services provided by the facility to include, ``Purchasing,
leasing, renting, delivering, installing, repairing and maintaining
medically necessary home dialysis supplies and equipment (including
supportive equipment) prescribed by the attending physician.''
Comment: One commenter suggested that we add a requirement that a
home dialysis provider have its own in-center facility within 35-50
miles of the patient's home, or an agreement with a designated backup
in-center provider, including on-call availability of a nurse to permit
a home patient to have access to care when equipment fails or in an
emergency.
Response: In the proposed rule at Sec. 494.100(c)(1)(vii),
facilities are required to identify a plan and arrange for emergency
back-up dialysis services in the event that they may be needed. We
believe this requirement addresses the commenter's concern, while
providing flexibility for facilities. Emergency preparedness is also
addressed in the final rule at Sec. 494.60(d), which requires
facilities to implement processes and procedures to manage medical and
non-medical emergencies that are likely to threaten the health or
safety of the patients, the staff, or the public.
Comment: One commenter stated that requiring facilities to deliver
supplies and equipment to home patients would give an unfair advantage
to Method II suppliers, especially for a clinic serving a large
geographic area. Another commenter recommended that we consider
allowing facilities to ``arrange'' for installation and maintenance of
supplies and equipment, as it is standard industry practice for the
manufacturer to install dialysis equipment.
Response: It appears these commenters may have misinterpreted some
of the proposed rule language at Sec. 494.100(c). The part 405,
subpart U requires self-dialysis support services to be furnished
either directly, under agreement or by arrangement with another ESRD
facility (Sec. 405.2163(e)). We have added language to Sec.
494.100(c)(1) of the final rule to clarify that, ``A home dialysis
training facility must furnish (either directly, under agreement or by
arrangement with another ESRD facility) home dialysis support services
regardless of whether dialysis supplies are provided by the dialysis
facility or a durable medical equipment company.''
As noted above, home dialysis patients who receive all equipment,
and supplies from one durable medical equipment supplier and all other
support services from their dialysis facility have opted for ``Home
Dialysis Method II.'' Facilities are accountable for arranging and
providing services and supplies to their patients as required. To allow
maximum flexibility for facilities to carry out this requirement,
facilities are permitted to determine the most effective and efficient
way for them to operate within the context of the final rule.
Comment: One commenter suggested the proposed rule at Sec.
494.100(c)(1)(vii) (identifying a plan and arranging for emergency
backup) be modified to require that emergency backup dialysis services
must be at a location convenient to the patient's home.
Response: We do not believe it would be beneficial to mandate
emergency back up dialysis services that are convenient to the
patient's home. The term ``convenient'' may have a wide range of
interpretations and depending on how it is interpreted, could become an
access to care barrier that reduces the availability of home dialysis.
Some patients choose home dialysis because they live in a remote area
where in-center dialysis is not available. If we required that back up
dialysis for all home patients must be ``convenient'', this may cause
dialysis facilities to discontinue home dialysis for patients who live
in these remote areas for whom there is no convenient dialysis
facility. We expect providers to work with patients, other providers
and ESRD Networks to best meet the needs of patients. Facilities must
have a reasonable emergency plan to deal with patients in need of
backup dialysis services.
Comment: Two commenters suggested we delete proposed Sec.
494.100(c)(1)(iii) through Sec. 494.100(c)(1)(vii) because most of the
requirements are already required of the facility with respect to all
patients receiving care and services through the facility.

[[Page 20413]]

Response: The support services provision in the proposed rule at
Sec. 494.100(c)(1)(i) through Sec. 494.100 (c)(1)(vi) would retain
and expand existing part 405, subpart U requirements, as discussed in
the ESRD proposed preamble (70 FR 6212). We also proposed the addition
of Sec. 494.100(c)(1)(vii), which would require the facility to plan
for and arrange for emergency backup dialysis services when needed.
Support services for home care patients are required by section 1881 of
the Act and are necessary to ensure proper care and support. We have
added a clarification to Sec. 494.100(c)(1) to state that any home
dialysis training facility must also ``furnish either directly, under
agreement, or by arrangement with another ESRD facility.''
Comment: Some commenters suggested that separate sections were
needed for home hemodialysis and peritoneal dialysis. One commenter
remarked that this was necessary due to water quality issues. Another
suggested that hemodialysis was more complex and that the proposed
rule, as written, would impose an undue burden on peritoneal dialysis
care.
Response: Hemodialysis water quality was addressed in the ``Care at
home'' condition at Sec. 494.100(c)(1)(v) in the proposed rule. The
language in the final rule has been modified and is now consistent with
the requirements in the ``Water and dialysate quality'' condition at
Sec. 494.40. The language at Sec. 494.100(c)(1)(v)(A) and Sec.
494.100(c)(1)(v)(B) requires that services include, ``Monitoring of the
quality of water and dialysate used by home hemodialysis patients,
including conducting an onsite evaluation and testing of the water and
dialysate system in accordance with: (A) The recommendations specified
in the manufacturers' instructions; and (B) the system's FDA-approved
labeling for preconfigured systems designed, tested, and validated to
yield AAMI quality water and dialysate; in addition, bacteriological
and endotoxin testing must be performed on a quarterly, or more
frequent basis as needed, to ensure that the water and dialysate are
within the AAMI limits.'' We have added a reference to dialysate in our
final rule to be consistent with the AAMI RD52 guidelines that we have
incorporated by reference. The interdisciplinary team is required to
educate the patients or caregivers about water quality problems as
required by Sec. 494.100(a)(3)(iii).
Comment: One commenter remarked that Medicare should ``cover
separately billable medication and biologicals for home patients, as it
does for in-center patients, to improve their clinical outcomes.''
Response: This regulation does not address payment issues. The
matter has been referred to the appropriate CMS coverage staff for
consideration.
Comment: One commenter recommended that CMS contract with a Network
to form a TEP to study current guidance for care at home and make
recommendations.
Response: A TEP was convened in Baltimore on January 20 and 21,
2006, after the close of the proposed rule's comment period, to assist
ESRD Network 9/10 in developing recommendations for providing staff-
assisted dialysis in a long-term care facility. TEP members, including
patients and professionals, represented various ESRD stakeholders
involved in or impacted by dialysis in the LTC facility. The TEP's
final recommendation to CMS was to suggest creation of a new model of
care for staff-assisted dialysis in long-term care facilities, as the
current method of home dialysis in such facilities did not
appropriately meet the need. The final report ``Delivery of Dialysis
Treatment Within the Long Term Care Facility'' can be found on The
Renal Network Web site at http://www.therenalnetwork.org/PF/LTC_feedback.html.
Comment: We received many public comments regarding the issue of
institutional dialysis or dialysis in a nursing home setting, which was
discussed in the proposed rule preamble. Dozens of members from the
renal, hospital, and nursing home industries commented and many were
opposed to the current existing (2004) nursing home dialysis policy,
which can be viewed at http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter04-24.pdf and http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter04-37.pdf.
The majority of commenters had major concerns with this issue and
expressed frustrations with existing payment systems. Commenters were
concerned with the financial feasibility of providing dialysis to these
patients at a certified dialysis facility within the nursing home or
under the home dialysis model. Commenters believe that the
reimbursement system should be adjusted for care provided in this
setting. Accountability is another concern, as commenters were not
clear regarding the division of responsibilities between the skilled
nursing facility and the ESRD facility. Still other commenters stated
that these patients should not be categorized as home-care patients
because the majority are frail and often elderly, cannot participate in
their own care, and cannot be trained. Many commenters suggested that
CMS convene a Technical Expert Panel to address the issue of dialysis
for nursing home residents and craft a separate rule following
publication of this final rule.
Response: The proposed rule solicited comment regarding ``whether
the current dialysis regulations need to be modified to protect this
vulnerable (nursing home) population * * *'' (70 FR 6213). Commenters
clearly believe that current regulations pertaining to the provision of
dialysis to nursing home patients need to be revised. However, it is
not clear now how we could best improve our health and safety
regulations to meet our goal of providing safe, high quality, efficient
dialysis care to vulnerable nursing home patients. Therefore, we are
not issuing nursing home dialysis regulations in this final rule. Given
the complex programmatic and fiscal issues associated with a new
nursing home dialysis model, we intend to consider rulemaking as well
as alternative actions in the future. Until that time the current
policy (S&C-04-24 and S&C-04-37) will remain in effect.
e. Quality Assessment and Performance Improvement (Proposed Sec.
494.110)
The February 4, 2005 proposed rule included a new condition that
would require dialysis facilities to develop, implement, maintain, and
evaluate an effective, data-driven, interdisciplinary QAPI program.
This ongoing internal quality oversight program would focus on
indicators related to improved health outcomes and the prevention and
reduction of medical errors. The QAPI program would include adequacy of
dialysis, nutritional status, anemia management, vascular access,
medical injuries and medical errors identification, hemodialyzer reuse,
(if applicable), and patient satisfaction and grievances. The dialysis
facility would be required, not only to monitor its performance, but
also to take actions that would result in sustained performance
improvements. Priorities would have to be set for performance
improvement activities, taking into consideration the prevalence and
severity of identified problems and affect on clinical outcomes or
patient safety. We proposed that any identified problems that
threatened the health and safety of patients would be immediately
corrected. We also proposed retaining the part 405, subpart U
requirement that dialysis facilities participate in ESRD Network
activities and pursue Network goals.

[[Page 20414]]

We received a large number of comments on the QAPI condition. The
comments generally supported a QAPI condition. One commenter applauded
the proposed requirement for prioritizing QAPI improvement activities
and requiring facilities to have a plan for immediate correction of
problems that might jeopardize patient health and safety.
Comment: A few commenters requested clarification of the term
``interdisciplinary team'' as used in subpart C.
Response: As stated earlier, we have clarified the meaning of
``interdisciplinary team'' under the ``Patient assessment'' (Sec.
494.80) and ``Plan of care'' (Sec. 494.90) conditions. The first
sentence of the QAPI condition in the proposed rule required an
``interdisciplinary'' QAPI program. We have modified this requirement
in the final rule to make clear that the professional members of the
interdisciplinary team (physician, RN, social worker, and dietitian)
must participate in the QAPI program. The facility has the option of
including facility patients when appropriate. The first sentence of
Sec. 494.110 now reads, ``The dialysis facility must develop,
implement, maintain, and evaluate an effective, data-driven quality
assessment and performance improvement program with participation by
the professional members of the interdisciplinary team.''
Comment: Two commenters were concerned that there was no mechanism
to update QAPI measures, and suggested that CMS develop such a
mechanism.
Response: QAPI measures were not proposed; however, QAPI topics
were proposed at Sec. 494.110(a)(2). Facilities may use indicators and
measures of their choice as appropriate and necessary to implement the
data driven QAPI program. We may update the QAPI topics as needed in
future revisions of the ESRD conditions for coverage. Facilities may
add topics to their QAPI program as needed to meet the unique needs of
their facility.
Comment: A commenter suggested that if face-to-face QAPI meetings
are expected, this should be specifically required in the regulation.
Response: The facility has the flexibility to develop and implement
QAPI via processes of their own choosing, as long as the efforts result
in a multidisciplinary, data-driven QAPI program that achieves
improvement and meets the criteria stated in Sec. 494.110. This might
include face-to-face meetings or additional and alternate activities.
We have not modified the regulatory language to specify processes or
face-to-face meetings.
Comment: Two commenters suggested that we consider increasing the
Network role in QAPI oversight.
Response: The Network role regarding the quality of ESRD care is
defined at section 1881(c) of the Act, and implemented at 42 CFR
405.2112 and in the ESRD Network contract. We expect the ESRD Networks
and the facilities to work collaboratively for the benefit of the
patients that are being served. These conditions for coverage do not
affect the ESRD Network role or requirements. The requirements
regarding dialysis facility cooperation with its ESRD Network have been
consolidated at Sec. 494.180(i), as discussed under that section of
this preamble.
Comment: A commenter stated that standard facility continuous
quality improvement programs should satisfy QAPI requirements.
Response: We expect that some quality-oriented dialysis facilities
already have in place effective full-scale quality improvement programs
that would meet QAPI requirements.
Comment: Many commenters suggested additional QAPI topics that
should be required, including: Infection control, renal bone disease,
psychosocial status, transplantation, mortality reviews, staffing
policy, errors, fluid status, staff education, home dialysis,
surveillance of water treatment, venous catheter use reduction, fistula
use, depression, hospitalizations, cardiovascular health, patient
suggestions for QI and safety, and growth and development for pediatric
patients under the age of 18. A large number of the comments supported
inclusion of infection control and renal bone disease. Two commenters
suggested that we omit the specific QAPI elements because while they
are currently appropriate, they should not be codified.
Response: The proposed QAPI elements included adequacy of dialysis,
nutritional status, anemia management, vascular access, medical
injuries and medical errors identification, hemodialyzer reuse program,
and patient satisfaction and grievances. The majority of comments
strongly supported the QAPI topics that we proposed to be included in
the facility QAPI program. We have added ``mineral metabolism and renal
bone disease'' to the list of QAPI topics in this final rule at Sec.
494.110(a)(2)(iii) due to its importance to quality dialysis care, its
association with cardiac health, and the strong support received from
commenters. Renal bone disease and mineral metabolism are routine
components of dialysis facility QI programs and are easily monitored
via lab values. CMS has recently pilot tested mineral metabolism/bone
disease clinical performance measures and has added these as new ESRD
clinical performance measures. We have also added ``infection control''
at Sec. 494.110(a)(2)(ix), as discussed above in connection with Sec.
494.30 ``Infection control'' condition. This QAPI component retains the
same specificity and detail provided in the proposed rule under Sec.
494.30. We believe that infection control is crucial to protecting
patient health and safety. We do not intend to understate the
importance of this issue simply because it was relocated in this final
rule.
Fistula use and reduction in venous catheter use is encompassed by
the vascular access topic, which is already included in the QAPI
required topics. Therefore, we are not making any additional changes.
Dialysis facilities should focus on the vascular access problems that
have been identified as a priority for their facility.
Surveillance of the water system is already required by this final
rule; the ANSI/AAMI RD 52 water purity guidelines, incorporated by
reference in the ``Water and dialysate quality'' condition for coverage
at Sec. 494.40(a), specify surveillance and quality assurance
procedures.
We encourage dialysis facilities to include social services and
other suggested QAPI topics in their program when appropriate, but are
not requiring these additional topics. The facility should identify
additional QAPI components when it prioritizes improvement activities
in accordance with standard Sec. 494.110(c). We expect the dialysis
facility to devote the needed resources to its QAPI program, which will
be based on such prioritization of facility needs.
Comment: We received several comments on various aspects of
proposed Sec. 494.110(b), which includes monitoring performance
improvement, taking actions that result in performance improvements,
and tracking performance to sustain improvements. One commenter stated
that when evaluating performance, new patients should be excluded for
the first 3 months. Another commenter suggested that the facility be
examined before requiring an improvement plan, in order for the
surveyor to evaluate patient characteristics and to decrease risk of
facilities ``cherry picking'' the healthiest patients. A commenter
stated that patients will not be able to meet targets for albumin and
anemia, and certain categories of patients should be excluded from the
quality measure patient population. One commenter

[[Page 20415]]

suggested that it should be sufficient that facilities address the
quality issues, while another stated that the facility can only address
actionable issues. Some commenters said a risk adjustment is needed,
but one commenter disagreed with a need for risk adjustment. Other
commenters stated that patient non-compliance is a factor in meeting
QAPI goals.
Response: The intent of Sec. 494.110(b) was explained in the
preamble of the proposed rule (70 FR 6217) where we stated, ``We will
specifically expect a facility whose treatment outcomes vary
significantly from accepted standards to identify the reasons for poor
outcomes and implement improvement projects to achieve expected
outcomes.'' The QAPI program is meant to have a facility-wide scope
that seeks opportunities for improvement, whereas the ``Patient plan of
care'' condition focuses on individual patient care. Since the QAPI
program is an internal facility function, facilities may use their own
risk adjustors and incident or prevalent patient designators within
their QAPI programs as needed. However, both adjusted and unadjusted
QAPI data must be available for our review. This QAPI condition does
not require facilities to report QAPI data, although information about
quality measurement and improvements would need to be available to the
surveyor who assesses whether the QAPI program met the requirements of
this condition. The risk adjustment aspect is discussed under the
``minimum facility-wide standards'' discussion below.
The QAPI requirement provides the facility with flexibility in
identifying the QAPI goals and actions to undertake. We would expect
the facility to undertake activities that are expected to improve
health outcomes, and prevent and reduce medical errors.
We recognize that patient adherence to the treatment plan can be a
factor in meeting facility QAPI goals. The issue of patient compliance
was discussed earlier in this document under the ``Patient plan of
care'' condition portion of the preamble. We addressed the need for
interventions when the plan of care goals are not met and the required
documentation of any barriers preventing the goals from being met. It
is possible that some facilities may find during their prioritization
of improvement activities that patient compliance trends need to be
addressed within the QAPI program.
Comment: Several commenters supported a requirement for dialysis
facilities to use a common patient experience of care or satisfaction
tool. They stated that this would allow comparable information and spur
improved performance, although one commenter stated this could be
costly and burdensome. Two commenters support the use of a common tool
that allows facilities to add unique facility-chosen questions. A few
commenters supported a patient satisfaction survey, but not use of a
common tool. While there was predominant support for the inclusion of
patient satisfaction in the QAPI program requirement, few commenters
specified their position on whether CMS should mandate the use of a
common survey tool (that is, In-Center Hemodialysis Consumer Assessment
of Healthcare Providers and Systems (ICH CAHPS)).
One commenter said that CMS should only specify that a survey be
done and within specified intervals. Another commenter, opposing a
common patient satisfaction tool requirement, stated regional
differences may skew results. A large dialysis organization (LDO)
stated they preferred their own patient satisfaction tool, which is
used to benchmark and allows modifications to the questions over time.
The LDO further stated that ICH CAHPS is not operational, and that
pilot tests need to be reviewed. A few commenters recommended that a
``quality of life'' aspect be included in a patient survey.
Response: We are requiring that dialysis facilities include patient
satisfaction as a component of their QAPI program. At this point in
time we are strongly encouraging facilities to use the standardized ICH
CAHPS tool to assess in-center hemodialysis patient experience of care,
but we are not requiring use of this instrument. As the renal community
becomes more experienced with using the ICH CAHPS instrument and
recognizes benefits associated with its use, we would expect to see
widespread voluntary use.
Providing patient experience-of-care information to beneficiaries
is a priority for CMS as a component of our transparency initiative.
Many of the questions in the Core ICH CAHPS Instrument are questions
that were taken directly from existing surveys used by dialysis
facilities that responded to our call for measures. A rigorously tested
instrument, based on input from stakeholders and facilities, would
supply valuable feedback to facilities for improving quality of
dialysis care.
Creation of a standardized patient experience-of-care survey for
dialysis patients is directly responsive to calls for CMS and the
Secretary to collect this type of information in a variety of reports.
The Office of the Inspector General (OIG) Report, entitled ``External
Review of Dialysis Facilities'' (June 2000), recommended that CMS
``require dialysis facilities to monitor patient satisfaction''
particularly, as a way of bringing forth patient concerns that may not
be captured by the current complaint systems. Likewise, in a Report to
the Congress entitled ``Improving Payment for End-Stage Renal Disease
Services'' (March 2000), the Medicare Payment Advisory Commission
(MedPAC) recommended that CMS collect and analyze information on a
regular basis on ESRD patients' satisfaction with the quality of and
access to care. This recommendation was reiterated in MedPAC's report
to the Congress ``Modernizing the Outpatient Dialysis Payment System''
(October 2003), which recommends that, ``The Secretary should also
monitor patient satisfaction with care and other access indicators to
determine whether patients face obstacles in obtaining needed care.''
Furthermore, the importance of a patient focus in the provision of
healthcare services was emphasized in the IOM 2001 report, ``Crossing
the Quality Chasm,'' that established patient-centered care as one of
the industry's six aims for quality improvement. The IOM dimensions of
patient-centered care include respect for patients' values,
preferences, and expressed needs; coordination and integration of care;
information, communication, and education; physical comfort; emotional
support; involvement of family and friends; continuity and transition;
and access to care. The ICH CAHPS survey instrument addresses all these
areas in either the Core Instrument or supplemental questions.
Consumer testing of the DFC Web site, conducted on behalf of CMS by
the Research Triangle Institute during 2002 and 2003, revealed that
consumers most frequently requested patient satisfaction information or
patient opinions about the care given in dialysis facilities to gauge
the quality of care provided in a dialysis facility. The data collected
from the core items in a common tool will allow consumers to make
``apples to apples'' comparisons among dialysis facilities. In
addition, such information would allow dialysis facilities to benchmark
their performance at local, regional, and national levels.
The ICH CAHPS core instrument and supplemental questions have been
placed in the public domain. Any hemodialysis facility interested in
using the survey should contact Charles Darby at
[email protected]. The Agency for Healthcare Research and
Quality welcomes input on experiences

[[Page 20416]]

that dialysis facilities may have in implementing the survey.
Comment: We received many comments regarding CMS use of facility-
specific standards for enforcement of the conditions for coverage.
While commenters supported CMS regulations that would hold facilities
accountable for their performance via clinical data, there was much
disagreement regarding the implementation approach.
Several commenters responded to our proposed rule preamble
discussion (70 FR 6218) regarding the use of NKF K/DOQI clinical
practice guidelines as the facility-specific minimum standards to be
used for enforcement. One commenter recommended that CMS adopt
evidence-based NKF-K/DOQI clinical practice guidelines for adequacy,
anemia, and vascular access as facility-wide targets for enforcement.
The commenter suggested that if problems were found, facilities could
be required to provide a plan to improve care with active Network
involvement. Two commenters supported minimum clinical standards using
K/DOQI, stating that this could provide a basis for quality improvement
and patient education on expected outcomes or goals. One commenter
supported facility-wide measures without risk adjusters, arguing that
no patient should be exempt from the coverage of evidence-based minimum
threshold values, and pointing out that the purpose of QAPI is to
identify and solve problems.
Most of the comments submitted on this minimum standards issue did
not support immediate implementation of facility-level standards and
thresholds in this final rule. The NKF communicated concerns about CMS
use of their K/DOQI guidelines for enforcement without addressing
factors such as case mix, effects of patient non-compliance, biologic
variability, third party reimbursement, large numbers of outliers, and
the inflexibility of the CMS regulation process. Another commenter
suggested that CMS should be careful to avoid overly prescriptive
language, requirements that create new indirect costs, and requirements
that hold units accountable for things they cannot control. A commenter
stated that some K/DOQI clinical practice guidelines are opinion-based,
and some requirements apply to non-reimbursable practices and that only
evidence-based criteria covered by Medicare should be considered for
inclusion in the conditions for coverage.
A few commenters stated that not all patients would be able to meet
the numerical outcome targets and should not be expected to meet them.
Other commenters were concerned about unintended consequences. A
commenter suggested that ``cherry-picking'' and other inadvertent
consequences will result without an effective case-mix adjuster to
avoid disadvantaging facilities that have a challenging case mix. The
commenter further stated that the current Medicare Modernization Act
case-mix adjuster (used to determine Medicare payment) is inadequate,
disadvantages frail elderly patients, and that minimum standards should
not be considered until an effective case-mix adjuster has been
developed. Many commenters objected to implementation of facility-level
performance standards without the use of case-mix adjusters and
objected to using clinical practice guidelines written for individual
patient care as facility-wide standards.
Some commenters noted that the NKF workgroups that developed the K/
DOQI clinical practice guidelines never intended that they would be
used for enforcement and pointed to the K/DOQI disclaimer regarding
appropriate use of the clinical practice guidelines. A commenter stated
that more study is needed to link existing evidence to intended
outcomes. Another commenter stated that CMS needs to differentiate
between standards and clinical guidelines. A commenter suggested that
``dynamic'' numerical standards do not belong in ``static'' federal
regulations. The commenter also noted that no methodology exists to
update numerical values, that serum albumin should not be a target
marker, and that these values are often out of the facility's control
for the majority of ESRD patients.
Commenters urged CMS to avoid direct extrapolation of standards
from existing guidelines until voluntary consensus organizations
develop real evidence-based standards and link a standard to a desired
outcome. Many commenters supported minimum facility-level clinical
performance standards development via a voluntary consensus process
that allowed input from the renal community at large. Several
commenters specifically supported the National Technology Transfer and
Advancement Act of 1995 (NTTAA) process proposed at Sec.
494.180(h)(3)(iv) as the voluntary consensus process to use. A
commenter urged CMS to develop flexible, evidence-based standards with
a methodology for periodic review. Another commenter endorsed the
concept of using commonly agreed upon clinical standards, but was very
concerned that frequent rulemaking would be required. One commenter
questioned the need for minimum standards in these conditions given the
difficulty of updating the conditions for coverage. Another commenter
also stated that CMS should not link QAPI expectations to ``static
standards.''
One commenter stated that the minimum facility standards proposal
is focused totally on lab-based outcomes and this focus ignores more
important clinical issues such as blood pressure treatment and
cardiovascular disease risks that are not tied intimately to
information technology systems and laboratory test outcomes. While
multiple laboratory results may be available, other important factors
such as the percentage of patients on ACE (angiotensin converting
enzymes) inhibitors or beta-blockers are not readily available. Another
commenter stated that there is an overdependence on K/DOQI in the
proposal.
Although commenters agreed that CMS should hold dialysis facilities
accountable for clinical outcomes and performance, the majority did not
agree with implementing facility-level clinical performance standards
based on the NKF K/DOQI clinical practice guidelines without a case-mix
adjuster and without recognition of other factors that affect clinical
outcomes.
Response: These conditions for coverage are an important component
of the overall CMS quality improvement strategy. We intend to hold
dialysis facilities accountable for the quality of care provided to
patients using performance measures and clinical data. Commenters
pointed out some factors that may impact a facility's ability to meet
K/DOQI targets for 100 percent of their patients. While certain
dialysis patient populations may have some unique characteristics,
efforts should be made by dialysis facilities to meet clinical practice
guidelines or come as close as possible to meeting those guidelines for
all patients. This is required by the ``Patient plan of care''
condition at Sec. 494.90. We do not intend for the implementation of
facility-level clinical performance standards to negatively impact
access to dialysis care and we do not hold facilities accountable for
outcomes beyond their control. Currently we do not have a case-mix
adjuster or other analytical means to ensure comparability between
facility performance levels. We would like to address the concerns
voiced by commenters before facility-level minimum standards are
implemented. In response to comments, we will develop facility-level
clinical performance standards via a voluntary consensus standards
process indicated at Sec. 494.180(h)(3)(iv). Once developed, these
facility-level clinical performance

[[Page 20417]]

standards will be published in the Federal Register as a proposed rule.
Comment: A few commenters responded to our preamble discussion (70
FR 6218) regarding how current NKF-K/DOQI clinical practice guidelines
could be used as minimum standards and what statistically-based
thresholds could be employed.
One commenter who was not in favor of using the K/DOQI guidelines
as minimum facility-level standards provided suggestions for possible
statistical methodologies: using 2 standard deviations below the mean;
or, using the 25th percentile for skewed distributions or alternatively
using percentiles; however, using a set percentage cut-off as a
standard would be arbitrary with no basis in science or evidence.
Another commenter suggested that facility-specific ``clinical care
measures should never appear on the oversight radar unless a certain
percentage of patients fail to meet a particular measure.'' Another
commenter recommended that facility-specific standards using K/DOQI be
identified as goals and expectations ``for more than 80 percent'' of
all patients. This commenter related concern about how minimum
standards would be applied when facilities are surveyed and stated that
the final rule must acknowledge that 100 percent of patients cannot
achieve K/DOQI target minimums.
One commenter suggested that CMS set minimum outcome goals, then
move up the thresholds incrementally, with annual readjustments.
Another commenter suggested that facilities could develop a corrective
action plan when a pre-determined portion of patients failed to meet
selected clinical standards. This could be percentile-based or some
other methodology but would have to be developed in collaboration with
the dialysis industry.
Another commenter recommended a focused review by the servicing
Network's Medical Review Board prior to implementation of a corrective
action plan, to determine whether there may have been reasonable
justification for poor performance. The focused review should be
consistent with population studies, which are statistically sound, and
not on percentile thresholds. A commenter suggested that K/DOQI
clinical practice guidelines were developed only to ``inform and
enhance decision-making,'' and believed that any process should include
a review by Network Medical Review Boards prior to CMS taking
enforcement action.
One commenter had a number of concerns. The first concern was that
it would be impossible to predict if patients could achieve clinical
outcomes. Another concern was that the proposal could create a
potential paperwork burden. A third concern was that no improvement
plan should apply unless a significant number of patients were
involved. Another concern was that the proposal ignored issues like
missed sessions and patient non-compliance. The commenter also
suggested that an improvement plan could not guarantee better outcomes,
and that the renal community should develop clinical standards and CMS
should then incorporate them by reference into its regulations.
A commenter stated that the minimum standards proposal confuses
process with outcomes. While a facility can order adequate dialysis,
Epogen, iron, etc., it could not guarantee that numerical targets would
be met. Documenting interventions and why goals were not met should be
sufficient, not the mandatory requirements proposed.
Response: According to the 2006 Annual Report, End-Stage Renal
Disease Clinical Performance Measures Project (http://www.cms.hhs.gov/CPMProject), which is based on data from October 2005 through December
2005 for hemodialysis patients and October 2005 through March 2006 for
peritoneal dialysis patients, reports national rates of meeting K/DOQI
based performance measures using a representative sample, 91 percent of
hemodialysis patients are meeting the dialysis adequacy target, and 81-
84 percent of dialysis patients have a hemoglobin of 11 g/dL or better
are meeting the anemia targets. In determining facility-level minimum
standards, we would not want to set our thresholds well below
established performance levels that could serve to undercut current
performance levels.
We have not included minimum facility-level clinical standards in
this final rule. We intend to develop minimum facility-level clinical
standards for enforcement using a voluntary consensus standards
process, as proposed at Sec. 494.180(h)(3)(iv).
f. Special Purpose Renal Dialysis Facilities (Proposed Sec. 494.120)
We proposed to retain with modifications the ``Special purpose
renal dialysis facilities'' condition from Sec. 405.2164. This
condition addresses the needs of patients who need dialysis on a short-
term basis because of emergency conditions, or because they are staying
at remote vacation camps. We proposed that such dialysis facilities
would be approved to furnish dialysis services at special locations and
that such vacation camps would have to be operated under the direction
of a certified renal dialysis facility that would assume full
responsibility for the care provided to patients. The proposed rule
retained the limited 8-month approval period and the service limitation
found at Sec. 405.2164. We proposed that a special purpose facility
would be approved as a vacation camp by demonstrating compliance with
proposed Sec. 494.30, most provisions of Sec. 494.40, Sec. 494.50,
Sec. 494.70(a) and Sec. 494.70(c), Sec. 494.100(c)(1)(v), Sec.
494.130, Sec. 494.150(c) and Sec. 494.150(d), and Sec. 494.170. We
also proposed that a special purpose facility certified due to
emergency circumstances could provide services only to those patients
who would otherwise be unable to obtain treatments in the geographical
areas served by the facility and was approved by demonstrating
compliance with specified proposed conditions for coverage that
included Sec. 494.20, Sec. 494.30, Sec. 494.40, Sec. 494.50, Sec.
494.60, Sec. 494.70(a) through Sec. 494.70(c), Sec. 494.130, Sec.
494.140, and Sec. 494.150, Sec. 494.170, and Sec. 494.180. The part
405, subpart U requirement, that a special purpose unit consult with
the patient's physician, was retained; we added a provision that this
consultation must occur before initiation of dialysis in a special
purpose unit. Additionally, we proposed to require the special purpose
unit to document care provided to the patient and forward that
documentation to the patient's regular dialysis facility within 30
days.
Comment: Many commenters submitted suggestions and recommendations
regarding requirements and/or certification for special purpose
dialysis facilities, and several commenters made positive remarks
regarding the proposed requirements and inclusion of vacation camps
within this condition, including the 8-month approval period for
special purpose facilities, as required at Sec. 494.120(a). A
commenter applauded the specific mention of vacation camps in this
regulation, but advised that these vacation camps should be certified
as ``safe environments'' for campers, while another commenter suggested
the deletion of vacation camps from the final rule. One commenter
suggested that the personnel requirements for the ESRD facility medical
director, for those furnishing nursing services, and for patient care
and water treatment technicians be met by the special purpose dialysis
facility vacation camp if on-site dialysis is performed.
Another commenter suggested that the final rule requirements also
address backup emergency care, and further suggested that the closest
hospital and/

[[Page 20418]]

or children's hospital be notified and a process for emergency
transportation be identified. One commenter suggested that ``certified
facilities not be held accountable for services provided outside their
domain.''
Response: We appreciate the positive comments on the proposed
language regarding special purpose dialysis facility vacation camps.
While we received a suggestion to delete vacation camps in the final
rule, the majority of comments regarding vacation camps were positive.
Thus, we will adopt vacation camp requirements in the final rule at
Sec. 494.120. We also received some positive remarks regarding the
approval period of 8 months, discussed at proposed Sec. 494.120(a),
which will also be adopted in the final rule. We agree with the
commenter that vacation camps should be a safe environment for campers.
The facilities must comply with the conditions for coverage set out at
Sec. 494.120(c) to ensure that the vacation camp environment protects
the health and safety of campers.
This condition addresses the possible needs of patients who,
because of emergency conditions, or because they are staying at a
remote vacation camp providing such services, need dialysis on a short-
term basis. The commenters' concerns regarding certain personnel
requirements, as well as responsibility and accountability for vacation
camps, is addressed at Sec. 494.120(c)(1). This standard mandates that
special purpose dialysis services, provided at a vacation camp
facility, be operated under the direction of a certified renal dialysis
facility. The certified renal dialysis facility assumes full
responsibility for the care provided to patients. Vacation camps must
demonstrate compliance with the conditions for coverage set out at
Sec. 494.120(c)(1)(i) through Sec. 494.120(c)(1)(viii), including
infection control, water and dialysate quality, reuse of hemodialyzers,
patients' rights, laboratory services, medical director
responsibilities, medical records, and home monitoring of water
quality. We agree with the commenter that it is important to take into
consideration emergency backup care in vacation camps. Vacation camps
will be held responsible for the care of their patients under Sec.
494.120(c)(1), including emergency care when required; however, we will
not specifically mandate that vacation camps notify hospitals and
develop emergency transportation plans in this final rule. We believe
that the requirement at Sec. 494.120(c)(1) provides adequate
protection for patients at vacation camps.
Comment: A commenter supported the requirements for emergency
circumstance facilities, noting that recent natural disasters
underscored the necessity for such facilities. Another commenter agreed
with changes in the proposed rule that would make access to care for a
patient in a disaster situation more readily available. One commenter
suggested the proposed language at Sec. 494.120(c)(2) was too
restrictive and that the final rule should be revised by requiring such
facilities to comply with the specified conditions ``where feasible.''
The commenter suggested that adding ``where feasible'' would be
necessary in the event of a large emergency affecting a broad
geographical area.
Another commenter suggested the requirement at Sec.
494.120(c)(2)(i) regarding compliance with Federal, State, and local
laws and regulations would be redundant for a facility that is quickly
converted to a special purpose facility under emergent circumstances.
The commenter suggested the adoption of State and local codes, as well
as the International Code Council (ICC) requirements, in lieu of the
LSC, would eliminate this problem of redundancy in many states. The ICC
is an association dedicated to building safety and fire prevention, and
they develop the codes used to construct residential and commercial
buildings, such as health care facilities. Most U.S. cities, counties
and states that adopt codes choose those codes developed by the ICC.
Response: In the event of a large disaster, section 1135 of the Act
gives the Secretary the authority to waive regulatory requirements
during national emergencies. During natural or man-made disasters, the
proposed regulation at Sec. 494.120(c)(2) allows for more flexibility
than part 405, subpart U of our previous regulations in managing
emergent circumstances. These facilities must comply with a condensed
number of conditions, which include: Sec. 494.20, compliance with
Federal, State and local laws and regulations; Sec. 494.60, physical
environment; abbreviated sections of Sec. 494.70, patient's rights;
Sec. 494.140, personnel qualifications; Sec. 494.150, medical
director; and Sec. 494.180, governance. While we expect that special
purpose facilities will comply with these requirements, we understand
that there may be instances where this may not be possible and a waiver
might need to be granted; however, we do not agree that the suggested
language ``where feasible'' should be added to the final rule.
Comment: Two commenters agreed that physician contact during a
disaster is ideal; however, they stated it may be impossible. These
commenters recommended the addition of a provision to allow another
physician to provide emergency care in extenuating circumstances at
Sec. 494.120(d). One commenter suggested we modify the requirement in
the final rule to indicate, ``Standing orders or the patient's current
orders may be followed until the time a physician may be reached.''
Another commenter suggested the wording in the final rule be changed to
require ``nephrologist contact'' as opposed to ``physician contact.''
Response: We agree that it may not be possible to consult with the
patient's physician during a disaster. To allow greater flexibility, in
the event of disasters or emergencies, we have modified the wording in
the final rule at Sec. 494.120(d) to indicate that the facility must
contact the patient's physician ``if possible'' prior to initiating
dialysis in the special purpose renal dialysis facility. Additionally,
we will retain the requirement for ``physician contact'' as proposed,
because we believe this language will allow more flexibility for
facilities.
Comment: It was suggested by a commenter that we modify the final
rule to require forwarding of documentation of care at the special
purpose facility to the patient's regular facility within 1 day of the
last scheduled treatment, as opposed to 30 days as proposed at Sec.
494.120(e). The rationale given was that hospitals as well as transient
dialysis clinics must transfer patient care records within one day.
Response: It is the responsibility of the special purpose facility
to communicate to the patient's permanent dialysis facility regarding
the patient's status, and we recognize that it would be most desirable
for this information to be forwarded in less than 30 days. However, we
must also keep in mind that some circumstances may prevent such
communication timeframes. For example, we have learned through recent
events, such as Hurricane Katrina in 2005, that 30 days may not allow
enough time for special purpose facilities to forward all documentation
to the patient's permanent facility. Because we recognize this possible
limitation, we have added language to allow greater flexibility for
facilities. At Sec. 494.120(e) the language has been modified in the
final rule to require information be forwarded ``if possible'' within
30 days.
g. Laboratory Services (Proposed Sec. 494.130)
We proposed to retain the existing requirements governing
laboratory services previously set out at

[[Page 20419]]

Sec. 405.2163(b), with minor revisions. The dialysis facility must
provide or make available laboratory services to meet the needs of
their patients, and these services must be furnished by or obtained
from a facility that meets the requirements for laboratory services in
accordance with 42 CFR part 493.
Comment: One commenter recommended that we add language in the
final rule to specify that facilities must have an agreement with a
primary or secondary laboratory that meets the Certified Laboratory
Improvement Amendments of 1988 (CLIA) requirement.
Response: CLIA certification is addressed at Sec. 494.130 by
reference to part 493. It states that all Medicare-certified
laboratories performing laboratory tests be certified under CLIA.
Therefore, we have adopted the language as proposed.
Comment: One commenter suggested the addition of language to the
final rule saying that to ``ensure that composite rate lab tests for
each ESRD beneficiary are accounted for in a single, centralized
database for proper application of ESRD laboratory billing rules,
composite rate lab tests performed by any other laboratory must be
billed through the primary laboratory.'' Another commenter suggested
adding language to specify that in the event a facility uses a
secondary laboratory, it must enter into an agreement with the facility
or the facility's primary laboratory to bill the facility or the
primary laboratory for laboratory tests that are subject to ESRD
laboratory billing rules. One commenter suggested we require a
facility's primary laboratory to be the single laboratory permitted to
bill Medicare for tests listed as composite rate laboratory tests.
Another commenter suggested that local laboratories (in close proximity
to an ESRD facility) should be able to bill for tests through a
``primary laboratory.'' One commenter remarked that the final
regulation should address problems with Health Maintenance
Organizations (HMOs) and mandate that required testing be conducted in
laboratories equipped to do such testing. The commenter stated that
HMOs often refuse referrals to properly equipped laboratories
affiliated with the patient's ESRD unit.
Response: The commenters' concerns are related to Medicare payment
for services and are therefore outside the scope of this rule. The
commenters' concerns have been forwarded to the appropriate officials
within CMS for consideration.
Comment: One commenter suggested the regulation require that
primary laboratories agree to furnish the dialysis facility with
laboratory test data electronically upon request so that the data can
be submitted to ESRD Networks.
Response: The ESRD Conditions for Coverage cover dialysis
facilities and do not extend to testing laboratories. Facilities must
provide for or make available laboratory services to meet the needs of
the ESRD patient. Laboratory services must be furnished by or obtained
from, a facility that meets the requirements for laboratory services
specified in part 493 of this chapter (Sec. 494.130). However,
dialysis facilities may enter into business agreements with
laboratories willing to provide requested data electronically.
Comment: One commenter stated ``convenience'' lab draws need to be
addressed in the final rule.
Response: We believe the commenter is referring to those laboratory
tests, such as histocompatability tests, ordered by a patient's outside
physician, which could be drawn in the ESRD facility while a patient is
undergoing dialysis treatment. Drawing additional laboratory tests
while the patient is undergoing treatment is convenient for the
patient; individual facilities have the flexibility to determine if
this is a service they wish to offer.
4. Subpart D (Administration)
a. Personnel Qualifications (Proposed Sec. 494.140)
To avoid placing substantive requirements within the definitions
section as written in part 405, subpart U (at Sec. 405.2102), we
proposed a separate condition to set forth requirements for dialysis
facility staff qualifications. We proposed that the dialysis facility
medical director be a physician who has completed a board approved
training program in nephrology and has at least 12 months experience
providing care to patients receiving dialysis. We did not retain
transplantation experience as a qualification, which was previously set
out at Sec. 405.2102(d), because this rule applies to dialysis centers
and not to transplantation centers. We proposed to carry forward the
part 405, subpart U waiver provision for instances when a physician
meeting the medical director qualifications is not available. We
proposed that the facility nurse manager be an RN and a full time
employee, as required under part 405, subpart U, and have at least 12
months of clinical nursing experience and an additional 6 months of
dialysis experience. We proposed that the self-care home dialysis
training nurse be an RN with at least 12 months of nursing experience
and an additional 3 months of dialysis experience in the modality for
which he or she would provide training. We proposed new qualifications
for the charge nurse, who would be required to be an RN or licensed
practical nurse (LPN) with 12 months of nursing experience, including 3
months of dialysis experience. We also proposed new qualifications for
the staff nurse, who would have to be an RN or LPN and meet the State
practice requirements. The proposed qualifications for the facility
dietitian included the registered dietitian (RD) credential and at
least one year of professional work experience as a RD. We proposed
social worker qualifications that would require the social worker to
have a master's degree in social work from a school of social work
accredited by the Council on Social Work Education. Our proposed social
worker qualifications did not include the grandfather clause (see Sec.
405.2102, ``Qualified personnel'' paragraph (f)(2)), which allowed non-
master's prepared social workers who were employed for at least two-
years as of September 1976 to hold dialysis facility social worker
positions when there was a consultative relationship with a master's
prepared social worker. We proposed to recognize patient care dialysis
technicians for the first time in the proposed conditions for coverage,
and set forth proposed qualifications. We proposed that patient care
dialysis technicians have a high school diploma or equivalency and at
least 3 months experience under the direct supervision of an RN, and
that they complete a training program that would include specified
topics and be approved by the medical director and governing body. We
proposed that the clinical staff meet State practice requirements
(Sec. 494.140) and be licensed according to State provisions (Sec.
494.20 and Sec. 494.140(e)(1)). We proposed new qualifications for the
water treatment system technicians, who would complete a training
program approved by the medical director and governing body. Personnel
qualifications that were not carried forward from part 405, subpart U,
included those for the chief executive officer, medical record
practitioner, and the transplantation surgeon.
We received more comments (more than 150) on the proposed
``Personnel qualifications'' condition for coverage at Sec. 494.140
than on any other condition.
Comment: A large number of commenters suggested that the title of
this condition be changed to ``Personnel qualifications and
responsibilities'' and

[[Page 20420]]

that the specific responsibilities of all members of the
interdisciplinary team be included. Commenters suggested that the
medical director and patient be excluded from assignment of
responsibilities under the ``Personnel qualifications'' condition. Some
commenters said that since medical director responsibilities were
included at Sec. 494.150, other team member responsibilities should be
listed in the regulation as well. Some commenters stated that it would
be helpful if clinical social worker responsibilities were listed in
regulation; they state that social workers are unable to provide
clinical social services to patients because they are often tasked with
clerical work that fills the majority of their time.
Response: We have sought to be less prescriptive in this rule in
order to allow dialysis facilities flexibility in meeting Medicare
requirements. We expect that as professional caregivers, members of the
interdisciplinary team are aware of their discipline's professional
standards of practice and provide quality care to their patients in
keeping with those standards. Under the ``Patient assessment'' and
``Patient plan of care'' conditions (Sec. 494.80 and Sec. 494.90), we
require that members of the interdisciplinary team complete a
comprehensive assessment followed by a plan of care that identifies
goals for patient care and the services that will be provided in order
to meet those goals. This includes psychosocial and nutrition services
to be provided by the social worker and the registered dietitian. The
assessment and plan of care requirements necessitate that the RN,
social worker, and dietitian provide appropriate professional care to
each patient. Specifically, the dialysis facility must ensure that the
social worker provides timely psychosocial assessments and social work
interventions in accordance with the plan of care in order to meet
these conditions for coverage. We are also requiring at Sec. 494.140
that the interdisciplinary team, which includes the RN, social worker,
and dietitian, play an active role in the QAPI program. This final rule
requires that the interdisciplinary team provide appropriate care to
dialysis patients and improve patient care on an ongoing basis. We do
not agree that all the responsibilities of the entire interdisciplinary
team need to be enumerated in regulation.
Comment: Many commenters objected to the change in medical director
qualifications, as proposed in standard Sec. 494.140(a), and
recommended that the medical director be board-eligible or board-
certified, as previously required at Sec. 405.2102(e). These
commenters included patient organizations, dialysis organizations, as
well as physicians. One commenter stated that nephrology is a
recognized sub-specialty, which requires specialized knowledge and
training and that removing the ``board eligible or board-certified''
requirement could affect the continued existence of this sub-specialty.
Another commenter said this ``board-certified'' requirement is the
accepted industry standard for evidence of proficiency in a specialty.
A commenter stated that to lower standards could jeopardize patient
care across the nation and that board eligibility and certification
needs to be recognized. Other commenters object to lowering of
standards for this important position, except on a case-by-case basis.
One commenter recommended that the medical director be required to be a
nephrologist. Two commenters supported our proposed medical director
qualifications.
Response: Many commenters communicated quality-of-care concerns
regarding our proposed deletion of the requirement under former Sec.
405.2102 that the facility medical director be ``board-eligible'' or
``board-certified'' in internal medicine or pediatrics. Our goal is to
improve quality of care via this final rule and to ensure that the
medical director has the appropriate qualifications. Therefore, in
response to comments, we have revised the proposed requirement in the
final rule, so that the medical director must be ``board-certified'' in
internal medicine or pediatrics by a nationally recognized professional
board at Sec. 494.140(a). We are not including the term board-
eligible,'' as it is no longer used, defined, or recognized by the
American Board of Internal Medicine (http://www.abim.org/cert/policies_ssneph.shtm). We have retained the proposed requirement that
the medical director complete a board-approved training program in
nephrology.
Comment: A commenter recommended that the time period during which
a physician is in a training program and providing care to dialysis
patients should satisfy the 12-month experience requirement for medical
directors. Another commenter requested clarification of whether or not
experience gained during a training program could count towards the 12
months of experience for medical director qualifications. The commenter
noted that if this time were not counted, then nephrologists completing
their training programs could not become a medical director for at
least 12 months.
Response: The required 12 months of experience caring for dialysis
patients may include experience gained while a physician is enrolled in
a nephrology-training program. This will be reflected in the
interpretive guidelines for this regulation.
Comment: A commenter requested further clarification of the process
that would allow a physician who does not meet the medical director
requirements at Sec. 494.140(a)(1) to serve as the medical director as
permitted at Sec. 494.140(a)(2).
Response: A physician who does not meet Sec. 494.140(a)(1)
requirements may only serve as the medical director when a qualified
physician is not available, and when approved by the Secretary as
required at Sec. 494.140(a)(2). This provision was retained from part
405, subpart U. A dialysis facility seeking to place an alternate
physician in the role of the medical director must contact their CMS
Regional Office to make a request for the Secretary's approval.
Comment: While most commenters supported the proposed RN
qualifications at Sec. 494.140(b), one commenter suggested an increase
in RN experience requirement, to 2 years of clinical and 1 year of
dialysis experience. Another suggested that the RN experience
qualification be reduced to 6 months. One commenter asked whether one
RN could fulfill all four roles listed under nursing services (Sec.
494.140(b)) if he or she met all the qualifications.
Response: Very few commenters disagreed with the proposed
experience qualifications for RNs; therefore, we will adopt the
requirement for 12 months of nursing experience and 3 to 6 months of
dialysis experience (depending on the role of the RN) in this final
rule. A single RN may fulfill multiple nursing roles in the dialysis
facility if he or she possesses the appropriate qualifications for each
role and if this does not jeopardize the facility's ability to meet the
staff requirement at Sec. 494.180(b)(1).
Comment: A few commenters suggested a revision of the
qualifications for the charge nurse. A commenter suggested that 12
months of experience for charge nurses be changed to 6 months because
the nursing shortage necessitates not eliminating new nursing graduates
from the hiring pool. Another commenter stated that 3 months of
dialysis experience should not include ``orientation time,'' as 3
months of experience is barely adequate. Two commenters stated that
they believe the 3 months of dialysis experience to be inadequate and
recommended that the requirement be changed to at least 6 months, since
some States, such as California, have no

[[Page 20421]]

minimum training requirements; the commenters believe that this
endangered patients.
Response: There was disagreement among commenters regarding the
proposed qualifications for charge nurses, with some commenters
advocating longer experience requirements and others suggesting shorter
experience requirements. Our goal for this provision is to ensure that
a qualified nurse who can adequately protect patient safety acts as the
charge nurse. We believe that the level of experience for charge nurses
as stated in the proposed rule (12 months experience in providing
nursing care, including 3 months of dialysis nursing care) is
reasonable. Given that there is disagreement among commenters and no
evidence was presented supporting a modification, we have adopted the
charge nurse experience requirements as proposed at Sec.
494.140(b)(3)(ii).
Comment: Many commenters objected to the proposed charge nurse
qualifications, which commenters state would allow a licensed practical
nurse to serve as a charge nurse, because state practice boards
generally do not allow an LPN to supervise an RN. Some commenters
stated that the level of responsibility for the charge nurse requires
an RN, and LPNs are not qualified for this position. Other commenters
stated that experienced dialysis LPNs are very capable individuals. Two
commenters stated that due to the nursing shortage, an LPN should be
allowed to act as the charge nurse only when an RN is not available.
Another commenter stated that the nursing shortage should not be used
to justify use of unqualified personnel. One commenter stated that LPNs
could function as charge nurses without any RN supervision on-site, and
another stated that the LPNs at her facility have more experience than
the RNs. One commenter noted that LPNs are used more frequently by
LDOs.
Response: We have revised the requirement formerly found at subpart
U (Sec. 405.2162), so that an RN must be present in the facility, and
an LPN could still act as a charge nurse if he or she met the proposed
qualifications. We did not intend for a LPN to supervise an RN, as
suggested by the commenters.
The RN must be present in the facility when patients are being
treated, as required at Sec. 494.180(b)(2). An LPN might act as the
charge nurse but would not necessarily be supervising an RN. All
dialysis nurses must adhere to their state practice requirements. We
have modified Sec. 494.140(b)(3)(iii) to clarify this by adding
language to indicate that, if the charge nurse is a licensed practical
nurse or licensed vocational nurse, that he/she must work under the
supervision of a registered nurse when required by the State nursing
practice act provisions.
Comment: A few commenters objected to proposed Sec.
494.140(b)(1)(i), which requires the nurse manager RN to be a full-time
employee of the facility, and recommended deletion of this requirement.
Two commenters said it was unrealistic to require the nurse manager to
be employed full-time because small rural units are only open part-
time. Some units share the same nurse manager. A commenter stated that
requiring a full-time employee as nurse manager would not be a good use
of a scarce resource.
Response: The full-time requirement is not a new provision (refer
to former Sec. 405.2162(a)). Dialysis facilities should already be
fully compliant with this provision. In the case of small dialysis
facilities that are not open for at least 40 hours per week the ``full-
time nurse'' would be employed at all times the facility is open. For
example, a dialysis facility that is only open for 24 hours per week
would only need to employ the nurse manager for 24 hours per week to
satisfy this requirement. We have retained this requirement as
proposed.
Comment: We received a few comments regarding the qualifications of
the self-care training nurse.
Response: Please refer to the earlier discussion of self-care
training nurse qualifications found under the discussion of Sec.
494.100 in this preamble.
Comment: A commenter suggested that we change the position title
``self-care training nurse'' to ``self-care or home training nurse'' in
order to specify that self-care nurses can train patients for in-home
or in-facility dialysis.
Response: We agree, and have modified the position title at Sec.
494.140(b)(2) to clarify that ``self-care'' includes home dialysis. The
new position title is ``self-care and home dialysis training nurse.''
Comment: A commenter suggested that staff nurse requirements be the
same as those proposed for PCTs, which are at least 3 months
experience, following a training program that is approved by the
governing body.
Response: We agree that the requirements should be similar. We have
eliminated the experience requirements for both staff nurses (Sec.
494.140(b)(4)) and PCTs (Sec. 494.140(e)). Each professional, however,
will be required to meet the training requirements appropriate to their
specialty.
Comment: One commenter suggested that a statement be added to the
final rule that would mandate that there could be no contract nurse(s)
filling the roles of the nurse manager, self-care training nurse, or
the charge nurse.
Response: We agree, and are adopting the proposed requirement at
Sec. 494.140(b)(1)(i) that the nurse manager be a full-time employee
of the facility, which means this position cannot be filled by a
contracted nurse. The self-care and home dialysis training nurse and
the charge nurse positions do not have this restriction and may be
either employees or contractors. Employees are subject to the following
directions of an employer relative to what needs to be done and how it
should be done. Contractors, on the other hand, are generally not held
to how a job is done and the methods that are used. A nurse manager
fills a critical role and it is important that his or her actions meet
the needs of the facility's governing body. If a nurse under contract
fills these roles, he or she must have the proper qualifications and
complete the orientation for the position as required in this final
rule at Sec. 494.180(b)(3).
Comment: A commenter suggested we specify that RNs have training in
the care of patients with chronic disease and physical, emotional, and
psychosocial issues.
Response: We would expect that RNs have received training in each
of these areas as part of their nursing curriculum. We do not agree
there is a need to specify this training in regulation.
Comment: One commenter suggested that advance practice nurses
should serve as ``case managers'' and be reimbursed for this role.
Response: This rule does not preclude the use of advance practice
nurses in dialysis facilities, but we do not feel we should be this
prescriptive because of the degree of regulatory burden imposed upon
facilities. In addition, this final rule does not address reimbursement
issues.
Comment: We received more than 15 comments on dietitian
qualifications at Sec. 494.140(c). The majority of commenters agreed
and supported our proposal to require a ``minimum of one year's
professional work experience in clinical nutrition as a registered
dietitian''. One commenter suggested that the American Dietetic
Association (ADA) registration is not enough and minimum experience
criteria are needed.
The ADA agreed with the proposed qualifications for dietitians. The
ADA noted that registered dietitians (RDs) also possess clinical
knowledge and

[[Page 20422]]

skills to manage anemia and bone disease and to conduct urea kinetic
analysis. The ADA stated that according to the Commission on Dietetic
Registration, there are more than 72,000 RDs nationwide, and the supply
of RDs is well established.
One commenter stated that 1 year of registered dietitian
professional work experience in clinical nutrition is acceptable, but 2
years would be ideal. Newly hired RDs without renal experience should
have a training period of at least 2 weeks with an experienced renal
dietitian. This commenter also noted that the role of the dietitian has
expanded and recommended that the responsibilities of dietitians
include monitoring adherence and response to diet, and recommending
interventions for improving nutritional status. The commenter provided
examples of the expanded role of the dietitian, which included anemia
manager, and bone and urea kinetic modeling manager, to improve
clinical outcomes.
One commenter agreed with the proposed 1-year experience
requirement since quality care depends on renal training and
specialization, but said facility managers point to the difficulty of
finding sufficient numbers of experienced dietitians. This commenter
suggested that the one year of experience be preferred but not
required.
Three commenters disagreed with the proposed 1-year professional
experience requirement. One commenter stated the 1 year of professional
work experience is unnecessary; only registration with the Commission
on Dietetic Registration is needed. This commenter stated that instead,
mentoring and direction from an experienced renal dietitian is needed.
The commenter stated that the experience requirement would diminish the
pool of qualified dietitians. Another commenter also stated that adding
a year of experience as a requirement for RDs would create even more of
a RD shortage and is not necessary given their extensive education.
Another commenter suggested that we delete ``as a registered
dietitian'' from regulations text, so that experience obtained prior to
becoming a registered dietitian could be counted, and professional work
experience gained during an internship would apply. This commenter
further suggested that all dialysis dietitians be required to
participate in training from experienced dietitians.
Three commenters recommended that the dietitian qualifications
match the medical nutrition therapy (MNT) regulation requirements,
which call for a bachelor of arts degree or higher, an academic program
in nutrition or dietetics, 900 hours of supervised dietetics practice,
and being licensed or certified as a dietitian or nutritional
professional by the State in which the professional is practicing. One
of these commenters agreed with requiring a minimum of 1 year's
professional work experience as a registered dietitian.
Response: The dietitian qualifications in subpart U at Sec.
405.2102(b) specify at least 1-year experience in clinical nutrition.
In this final rule, we redesignated proposed Sec. 494.140(c)(3) as
Sec. 494.140(c)(2), which requires 1 year of professional work
experience in clinical nutrition as a registered dietitian. Renal
nutrition is a specialized area within the practice of dietetics. The
dialysis facility dietitian must be able to perform independently
complex nutritional assessments, evaluate laboratory results, and
assist the interdisciplinary team in managing anemia, renal bone
disease, and performing kinetic modeling. A typical therapeutic diet
for a hemodialysis patient has multiple restrictions and is limited in
sodium, phosphorus, potassium, fluid, and includes specified amounts of
protein. Many patients must follow additional dietary restrictions such
as low cholesterol or diabetic limitations. We believe that a
registered dietitian would need at least one year of experience to
perform this specialized work. The majority of commenters recognized
the specialized work of a RD in the dialysis setting.
The MNT dietitian qualifications at 42 CFR 410.134 require the MNT
provider to be a registered dietitian with the Commission on Dietetic
Registration or to have a bachelor's degree or higher in nutrition or
dietetics, 900 hours of supervised experience and state licensure, if
applicable. The MNT dietitian qualifications allow a nutritionist who
is not a registered dietitian to provide medical nutrition therapy. By
contrast, dialysis dietitians must be registered dietitians under both
the previous ESRD regulations and the proposed rule. We have not
removed the registered dietitian qualification requirement, as we find
no reason to do so.
We do not have evidence that there is a shortage of registered
dietitians that necessitates deletion of the clinical experience
requirement. While mentoring programs are desirable, we did not propose
them and have not added this requirement to the final rule. Registered
dietitians must be oriented to the facility and their work
responsibilities (Sec. 494.180(b)(3)) and have an opportunity for
continuing education and related development activities (Sec.
494.180(b)(4)).
Comment: Two commenters suggested including the word ``clinical''
in the ``professional work experience'' phrase so that foodservice
experience does not apply.
Response: The proposed rule at Sec. 494.140(c)(3), (now Sec.
494.140(c)(2)), requires dietitians ``have a minimum of one year's
professional work experience in clinical nutrition as a registered
dietitian.'' This wording would preclude a dietitian who only has
foodservice professional experience from qualifying for a position as a
dialysis dietitian. We do not agree that a change in wording is needed
here because clearly, the experience must be in ``clinical nutrition.''
Comment: One commenter recommended that dietitian-to-patient
caseloads be limited to 90-100 patients per dietitian.
Response: We address adequate staffing under the ``Governance''
condition for coverage at Sec. 494.180(b). Some States have
implemented staff-to-dialysis patient ratios, and we defer to State
provisions on this issue. Dialysis dietitian caseloads must not prevent
RDs from providing care consistent with national standards of practice
for dietitians. National standards have been published by the ADA
entitled ``Standards of Practice in Nutrition Care and Updated
Standards of Professional Performance'' in April 2005 (Kieselhorst,
K.J., Journal of the American Dietetic Association, Vol. 105, No. 4,
April 2005).
Comment: One commenter suggested that dietetic technicians be
included in the final rule. The commenter stated that she strongly
supported the use of dietetic technicians, registered (DTRs) under RD
supervision and that DTRs are nationally certified and have education
requirements similar to the RDs.
Response: We do not agree that RDs and DTRs have similar education
requirements. According to the ADA, DTRs must complete at least a 2-
year associate's degree while an RD must complete a minimum of a
bachelor's degree at a U.S. regionally accredited college or
university. A DTR must complete a dietetic technician program
accredited and approved by the Commission on Accreditation for
Dietetics Education (CADE), including 450 hours of supervised practice
experience. An RD must complete a CADE accredited supervised practice
program that typically runs 6 to 12 months in length. RDs and DTRs also
have different continuing education requirements.

[[Page 20423]]

This final rule requires an RD to be a member of the dialysis
facility interdisciplinary team, perform patient assessments, and
participate in patient care planning and the QAPI program. The RD may
use a DTR to provide assistance under RD supervision, but it is the RD
who must meet these conditions for coverage. Therefore, we have not
added DTRs to the ``Personnel qualifications'' condition.
Comment: We received more than 70 comments regarding social worker
qualifications. The vast majority of commenters supported the proposed
social worker qualifications, which require a master's degree in social
work from a school of social work accredited by the Council on Social
Work Education.
Commenters stated that dialysis patients have highly complex needs
and require care from an MSW who has a ``specialization in clinical
practice'' education. Commenters made the following statements in
support of an MSW with a specialization in clinical practice. They
stated that the nephrology social workers must be skilled in assessing
for psychosocial influences and their interrelatedness in predicting
treatment outcomes, and must be able to design interventions with the
patient, the family, the medical team, and community systems at large
to maximize the effectiveness of ESRD treatment. The additional
training received by MSWs enables them to perform these complex
professional tasks and ensure effective outcomes that have a direct
relationship to morbidity and mortality. Masters-prepared social
workers are trained to use validated tools, such as the SF36 (the
Medical Outcomes Study 36-item short-form health survey) and the KDQOL
(Kidney Disease Quality of Life), to improve care and to monitor the
outcomes of directed interventions. Most nephrology social workers
provide psychosocial services autonomously as primary providers without
social work supervision or consultation, using highly developed social
work intervention skills obtained in a master's level curriculum. The
masters in social work degree provides an additional 900 hours of
specialized training beyond a baccalaureate degree in social work. An
MSW curriculum is the only curriculum that offers additional
specialization in the Bio-Psycho-Social-Cultural, Person-in-Environment
model of understanding human behavior. Undergraduate degrees or other
mental health credentials do not offer this specialized and
comprehensive training. The National Association of Social Workers
Standards of Classification considers the baccalaureate degree as a
basic level of practice, while the masters degree is considered a
specialized level of professional practice and requires a demonstration
of skill or competency in performance. These commenters provided
references and citations along with these comments.
A few commenters suggested that the master's degree qualification
be eliminated because it is difficult to recruit MSWs in some rural
areas. A commenter stated that in California a licensed clinical social
worker requires 2 years of supervision and two examinations, which
makes it difficult to get a licensed clinical social worker license.
Another commenter suggested that we keep the MSW requirement but
include an ``exceptions process'' for units that cannot hire an MSW.
Some commenters stated that bachelor's prepared social workers are
competent as long as they are supervised by an MSW.
Response: We appreciate the large degree of support for the MSW
qualification for social workers. We have revised the MSW requirement
in Sec. 494.140(d)(1) by adding ``specialization in clinical
practice,'' as specified in part 405, subpart U, as the majority of
comments supported this. The consensus among the commenters is that
this level of knowledge and skill is needed to deal with an
increasingly older, sicker, more complex dialysis patient population.
Comment: One commenter recommended that we delete Sec. 494.140(d)
in its entirety or delete any preamble references to MSWs performing
counseling, long-term behavioral and adaptation therapy, and grieving
therapy. The commenter stated that such counseling exceeds the
expertise of MSWs, and that patients should be referred outside the
units for this service. The commenter also claimed that an
``expansion'' of counseling requirements represents a potential $18
million burden to his large dialysis organization.
Response: The ``Personnel qualifications'' condition for coverage
at Sec. 494.140 does not specify tasks or responsibilities for
dialysis facility social workers, but only their education and
qualifications. The proposed rule preamble discussion provided examples
of social worker services that facilities might offer, including
counseling services, long-term behavioral and adaptation therapy, and
grieving therapy (70 FR 6222) that would require the education and
training of an MSW. The proposed rule's preamble discussion is
consistent with part 405, subpart U social worker requirements at Sec.
405.2163(c), which state that ``Social services are provided to
patients and their families and are directed at supporting and
maximizing the social functioning and adjustment of the patient.''
Social services needed for each patient should be determined during the
assessment and identified in the plan of care.
Only one commenter suggested Sec. 494.140(d) be deleted in its
entirety, while a very large number of comments supported this
requirement, and the consensus was to retain MSWs in dialysis units.
MSWs are trained and competent to counsel patients. The social worker
professional standards of practice (http://www.socialworkers.org/practice/standards/NASWHealthCareStandards.pdf) do include patient and
family counseling within the scope of services provided by a social
worker. MSW services, which include counseling, is incorporated into
the Medicare composite payment rate and should not be outsourced or
separately billed.
Comment: We received a large number of comments regarding our
proposed deletion of the master's degree ``grandfather clause'' for
social workers. Many commenters agreed with eliminating the
``grandfather clause'' because ``30 years was more than enough time for
dialysis social workers to obtain masters degree.'' Commenters stated
that MSW and BSW tasks could be broken out into separate job
descriptions so that BSWs may assist MSWs. Commenters said that there
was no MSW shortage.
A larger number of commenters suggested that we retain the
``grandfather clause'' for non-MSWs so that currently employed non-MSWs
working as dialysis social workers do not lose their jobs. Some
commenters suggested that experienced non-MSW social workers were
competent and had much to offer dialysis patients. A few commenters
recommended that we continue the grandfather clause until the year 2015
to allow current non-MSWs who met the subpart U requirements to finish
out their careers.
Response: According to the definition of ``Qualified personnel'' at
Sec. 405.2102, a non-masters degree social worker may serve as an ESRD
social worker (under Sec. 405.2102(f)(2), qualified personnel) when he
or she ``has served for at least 2 years as a social worker, 1 year of
which was in a dialysis unit or transplantation program prior to
September 1, 1976, and has established a consultative relationship with
a social worker who qualifies under paragraph (f)(1) of this
definition'' (that is, has completed a course of study with

[[Page 20424]]

specialization in clinical practice at, and holds a masters degree from
a graduate school of social work). This subpart U grandfather clause
only applies to non-MSWs who have been practicing social work since
1974, and any ESRD social workers who do not have 2 years of experience
prior 1976 must have a masters degree.
While we believe the number of non-masters-degree social workers
still practicing over the past 32 years is small, we do not intend that
these long-time employees should become unqualified for their jobs
because of deletion of the ``grandfather clause.'' In response to
comments we will adopt the proposed ``grandfather clause'' and add the
existing provision from subpart U to the final rule at Sec.
494.140(d)(2) to read as follows: ``Has served at least 2 years as a
social worker, 1 year of which was in a dialysis unit or
transplantation program prior to September 1, 1976, and has established
a consultative relationship with a social worker who qualifies under
Sec. 494.140(d)(1) of this part.'' The grandfather clause may not be
applied to social workers who do not meet the 1976 experience
criterion. Bachelors-prepared social workers may function as assistants
to the MSW. The MSW is the staff member who must satisfy these
conditions for coverage.
Comment: A few commenters suggested that we eliminate the proposed
Sec. 494.140(d)(2) requirement, ``Meets the practice requirements for
social services in the State in which he or she is employed.''
Response: Adherence to State scope-of-practice requirements is an
appropriate minimum requirement for a federal health and safety
regulation. This final rule supports compliance with State regulations.
The final rule provision for meeting applicable scope-of-practice board
and licensure requirements for dialysis facility personnel has been
moved to the beginning of Sec. 494.140 to avoid redundancy within the
standards for each of the dialysis facility staff members.
Comment: Several commenters suggested that we add a social worker
licensure requirement to Sec. 494.140(d)(2).
Response: The proposed rule at Sec. 494.20 required licensure for
all staff. To prevent confusion regarding whether licensure is required
under personnel qualifications, we have moved the requirement to the
beginning of Sec. 494.140, to read: ``All dialysis facility staff must
meet the applicable scope of practice board and licensure requirements
in effect in the State in which they are employed.''
Comment: Many social workers as well as some commenters who are not
social workers suggested that a new social worker aide personnel
standard be added to the final rule. The rationale given was that this
new staff member could perform many of the clerical tasks (admissions,
billing, transportation, transient patient paperwork, determining
insurance coverage) often assigned to social workers, so that the
social worker would be freed up to perform clinical social services,
such as counseling, that would result in improved patient care and
better outcomes. Many commenters stated this position should be
required for dialysis facilities with more than 75 patients.
Response: This final rule requires each facility to have adequate
staff to meet patient needs. Paragraph Sec. 494.180(b)(1) applies to
all dialysis staff, including social workers. The use of ancillary
staff is not precluded by this regulation. Some dialysis facilities do
employ staff to assist the social worker with clerical tasks, while
other facilities may employ more than one social worker. Each facility
should assess their staffing needs and determine appropriate staffing
levels. While we agree that using an MSW to perform clerical tasks and
manage patient financial information may not be the most effective or
efficient use of trained and licensed professional clinical staff, we
are not requiring that dialysis facilities employ social worker aides.
We encourage dialysis facilities to use staff resources in the most
effective and efficient manner to provide quality care to dialysis
patients.
Comment: Many commenters suggested that the final rule state that
MSWs could not be assigned non-MSW tasks. These commenters object to
the number of clerical tasks that are assigned to social workers.
Response: Dialysis facilities have the flexibility to assess
facility-staffing needs and use staff as necessary. This final rule
requires social workers to provide appropriate clinical services to
dialysis patients under the ``Patient assessment'' and ``Patient plan
of care'' conditions for coverage (Sec. 494.80 and Sec. 494.90
respectively). The social worker must also participate in the facility
QAPI program (Sec. 494.110). The facility must have a sufficient
social services staff to meet dialysis patient needs as required at
Sec. 494.180(b)(1), which applies to all dialysis staff, including
social workers. We would expect that any tasks assigned to the social
worker would not compromise the social worker's ability to meet his or
her obligations to patients and these conditions for coverage. We have
not added restrictions regarding staff assignments to this final rule.
Comment: Many commenters recommended that we specify a maximum MSW
caseload or an MSW-to-patient ratio.
Response: As discussed above, adequate staffing is addressed under
the ``Governance'' condition for coverage at Sec. 494.180(b). Some
states have implemented staff-to-dialysis patient ratios, and we defer
to State provisions on this issue.
Nephrology social workers should adhere to the professional
standards of practice for social workers. The National Association of
Social Workers published ``NASW Standards for Social Work Practice in
Health Care Settings'' in 2005. These professional practice standards
may be found at http://www.socialworkers.org/practice/standards/NASWHealthCareStandards.pdf. The National Association of Social Workers
and Council of Nephrology Social Workers jointly published ``NASW/NKF
Clinical Indicators for Social Work and Psychosocial Service in
Nephrology Settings'' in October 1994, which may be found at http://www.socialworkers.org/practice/standards/nephrologysettings.asp. In
addition, the NKF has published the 2003 Council of Nephrology Social
Workers ``Standards of Practice for Nephrology Social Work.'' These
standards of practice include guidelines for clinical practice, a
description of the nephrology social work role, as well as staffing
information.
Comment: A commenter suggested that the final rule state that
different facilities can share the same renal dietitian or social
worker.
Response: Neither part 405, subpart U nor the proposed rule
precludes facility sharing of renal dietitians and social workers, as
long as each facility has adequate staff and staff hours to meet
patient needs and provide care consistent with professional practice
standards. Please refer to Sec. 494.180(b)(1), which applies to all
dialysis staff.
Comment: We received a very large number of comments on Sec.
494.140(e), addressing patient care dialysis technician qualifications.
Commenters generally supported the addition of technician
qualifications and training requirements to the conditions for
coverage.
More than 20 commenters, including the National Kidney Foundation,
American Association of Kidney Patients, American Kidney Fund, CNSW,
some of the ESRD Networks, the National Association of Nephrology

[[Page 20425]]

Technicians/Technologists, the Renal Support Network, and various ESRD
suppliers and professionals, recommended that we require PCTs to be
certified. Commenters stated that PCTs are now the predominant
caregivers in ESRD facilities. Certification is necessary to protect
patient health and safety in view of the ongoing nursing shortage.
Commenters stated that certification is the first step towards minimal
competency, and is the national trend; California, Arizona, Oregon, and
Ohio now require PCT certification. Commenters state that a
standardized curriculum and examination is desirable to improve quality
of care.
Kidney Care Partners (KCP), which represents a coalition of renal
stakeholders, including the large dialysis organizations; renal
physician, nurse, and administrator organizations; and pharmaceutical
companies, stated that it supported more consistent training and
certification for patient care dialysis technicians. In the 109th
Congress, they noted that S. 635 and H.R. 1298 introduced by Sens. Rick
Santorum (R-PA) and Kent Conrad (D-ND) in the Senate and Reps. Dave
Camp (R-MI) and William Jefferson (D-LA) in the House, would have
required that patient care dialysis technicians receive uniform
training and become certified, indicating at least a minimum level of
competency to provide dialysis-related services. These technicians
would have been required to repeat training or become recertified if 24
consecutive months had passed during which they had not performed
dialysis-related services. Service providers and renal dialysis
facilities would have been required to provide performance reviews and
in-service education to assure ongoing competency. Although KCP
recognized the importance of deferring to the States to regulate health
care workers, they noted that the Medicare program had already
established similar training requirements for unlicensed personnel in
skilled nursing facilities. They urged us to incorporate these
substantive requirements from the legislation (which expired without
action at the end of the 109th Congress) into our final rule.
A commenter suggested that on-the-job training was only equal to an
orientation and recommended national certification for PCTs. Another
commenter advocating certification stated that dialysis patients have
been asking for assurances of technician competency and certification
would help assure such minimal competency.
One state surveyor opposed any language permitting the use of
unlicensed personnel for the practice of nursing or medicine, and
stated that our requirement should not conflict with State nursing and
medicine practice acts. The commenter also argued that the use of
unlicensed staff was dangerous.
One commenter opposed PCT certification, stating that it would not
be prudent to add this requirement, pointing to the ``pro and con''
certification discussion in the proposed rule (70 FR 6223).
Response: PCTs perform a variety of clinical tasks (subject to the
limitations of State law), that include preparing dialysis apparatus,
performing equipment safety checks, initiating dialysis (including
cannulation and venipucture with large gauge needles), intravenous
administration of heparin and sodium chloride solutions, subcutaneous
or topical administration of local anesthetics in conjunction with
placement of dialysis needles, monitoring patients during dialysis,
taking vital signs, documenting tasks and patient observations, and
more. The proposed rule preamble discussed PCT certification, but
recognized some barriers to national certification (70 FR 6223). The
large majority of commenters did not agree that these potential
barriers (state control, lack of renal community consensus at that
time, burden and costs) outweighed the patient safety benefits of PCT
certification.
Therefore, we have revised Sec. 494.140(e) ``Patient care dialysis
technicians'' by adding paragraph (e)(4), which requires that PCTs,
``Be certified under a State certification program or a national
commercially available certification program as follows: (i) For newly
employed patient care technicians, within 18 months of being hired as a
dialysis patient care technician, or (ii) For patient care technicians
employed on October 14, 2008, within 18 months after such date. We are
allowing an 18-month time period for certification to ensure that a
sufficient time period is available for PCTs to schedule a date to sit
for the certification exam. Because we are allowing a lengthy time
period to become certified, we are retaining the proposed rule's
training program topics to ensure that non-certified PCTs have
appropriate training before they begin to provide patient care as a PCT
trainee.
National commercially available certification programs include
those of the Nephrology Nursing Certification Commission (NNCC), the
Board of Nephrology Examiners Nursing and Technology (BONENT), and the
National Nephrology Certification Organization (NNCO). Dialysis
facilities or dialysis corporations may conduct their own in-house
certification programs and testing but it must be in addition to a
certification program made available by an external body. The NNCC
offers the Certified Clinical Hemodialysis Technician (CCHT)
examination, which is offered as a valid measure of basic competency
for hemodialysis PCTs. Technicians are eligible to take the CCHT
examination with a suggested minimum of six months experience in
nephrology technology. The CCHT examination measures performance in
four dialysis practice areas: clinical (50 percent), technical (23
percent), environmental (15 percent), and role (12 percent).
Information on the CCHT examination, a schedule of test sites and
dates, and applications is available at http://www.nncc-exam.org. If
the State has a certification and competency-testing program in place
that is specific to dialysis PCTs, then State certification also
satisfies this requirement.
We will be reviewing any new national commercially available
certification programs that emerge in the future to determine whether a
program meets the intent of these conditions for coverage. Based on
these reviews, we will determine whether further rulemaking is
necessary to ensure the competency of PCTs and to protect patient
safety.
Comment: A small number of commenters did not agree that PCTs
should have 3 months of experience following a training program under
the ``direct'' supervision of an RN. While commenters agreed there
should be PCT training, they did not agree that 3 months of experience
should be under the ``direct'' supervision of an RN. Some of the
commenters stated that the 3 months was too long a time period, and
others said this would demand too much RN time. A few commenters stated
the training program and 3 months of experience should be allowed to
occur simultaneously. Some commenters sought clarification of the term
``direct supervision'', since RNs could supervise without constant one-
on-one contact. Some commenters stated this was not good use of RN time
and that other staff, for example, PCTs and LPNs, could mentor new
PCTs. Two commenters agreed with the 3-month experience provision. One
commenter stated that some State nurse practice acts delineate
delegation of training by RNs.
Response: Since we are requiring that new PCTs complete an initial
training

[[Page 20426]]

program and become certified within 18 months of beginning PCT
employment, we are not finalizing the requirement that the PCT have at
least 3 months of experience that was proposed at Sec. 494.140(e)(3).
In addition, this training program includes on-the-job training and
experience that must be under the general supervision of a registered
nurse. We agree with some commenters that PCT trainees may gain patient
care experience during the up to 18-month period under the supervision
of an RN with mentoring by LPNs, licensed vocational nurses (LVNs), and
certified PCTs. Therefore, we have revised Sec. 494.140(e)(3) to
provide this clarification. This new wording allows new PCTs to be
mentored by LPNs, LVNs, and certified PCTs under the guidance of an RN.
Also, once certified, PCTs work ``under the direction of a registered
nurse,'' instead of ``under the direct supervision of a registered
nurse.''
We have moved the description of the PCT training program from
proposed Sec. 494.180(b)(5) to Sec. 494.140(e)(3) in this final rule
so that the PCT training requirements may be located in one section of
the final rule.
Comment: One commenter suggested that we strengthen the training
requirement so that training must be provided under the direct
supervision of an ``RN with at least 6 months of experience of
providing care in dialysis.''
Response: We do not agree with this comment. As stated in the
previous response, PCT trainees may gain patient care experience during
the up to 18-month period under the supervision of an RN with mentoring
by LPNs, LVNs, and certified PCTs. We have revised Sec. 494.140(e)(3)
to provide this clarification. This new wording allows new PCTs to be
mentored by LPNs, LVNs, and certified PCTs under the guidance of an RN.
Once certified, PCTs work under a nurse's direction.
In addition, for nurse manager and charge nurse experience in this
final rule we require all registered nurses to have 12 months
experience in providing nursing care, including 3 months of experience
in providing nursing care to patients on maintenance dialysis. We
believe that this level of experience is sufficient for a nurse manager
or charge nurse to be able to provide or oversee training to a PCT.
Comment: A commenter suggested that we revise proposed Sec.
494.140(e)(3) and replace ``patient sensitivity training and care of
difficult patients'' with ``conflict management and patient centered
care.''
Response: We do not agree that the suggested more general wording
adds clarification. Therefore, we have retained the proposed language.
Comment: Several commenters supported inclusion of Sec. 494.140(f)
``Water treatment system technicians,'' as proposed. A few commenters
suggested that we revise or expand Sec. 494.140(f) to make the
educational requirements the same as those proposed for PCTs. Another
commenter recommended that water treatment training be required for all
staff who work on the water treatment system.
Response: We have incorporated the AAMI RD52 2004 ``Dialysate for
hemodialysis'' guidelines into this final rule at Sec. 494.40(a).
Section 9 of the guidelines entitled ``Personnel'' includes
requirements for water treatment staff as follows:
Policies and procedures that are understandable and accessible are
mandatory, along with a training program that includes quality testing,
the risks and hazards of improperly prepared concentrate, and bacterial
issues. Operators should be trained in the use of the equipment by the
manufacturer or should be trained using materials provided by the
manufacturer. The training should be specific to the functions
performed (that is, mixing, disinfection, maintenance, and repairs).
Periodic audits of the operators' compliance with procedures should be
performed. The user should establish an ongoing training program
designed to maintain the operator's knowledge and skills.
Any staff who operate the water treatment system must complete a
training program that has been approved by the medical director and the
governing body as required at Sec. 494.140(f).
Comment: A few commenters suggested that advanced practice nurses
and physician assistants be recognized in the final rule as ``physician
extenders'' (that is, NPs, CNs, PAs (Nurse Practitioners, Clinical
Nurse Specialists, and Physician Assistants)). Some commenters were
concerned that excluding these professionals from the final rule might
affect reimbursement.
Response: We recognize the contributions of physician extenders in
dialysis facilities in providing quality dialysis care and note that
the Medicare payment system recognizes the role of physician extenders.
While we will not require dialysis facilities to have NPs, CNs, or PAs,
they are subject to our requirement at Sec. 494.140, which requires
that ``all dialysis facility staff meet the applicable scope of
practice board and licensure requirements in effect in the State in
which they are employed.'' The provisions of this section will not
affect reimbursement of physician extenders.
Comment: We received a very large number of comments regarding the
proposed rule preamble discussion (70 FR 6224) regarding what role, if
any, the pharmacist should play within a dialysis facility and what a
dialysis facility's appropriate responsibility is for pharmaceutical
services and the efficient use of medication.
More than 40 pharmacists recommended that we include a pharmacist
on the facility interdisciplinary team, and submitted comments
containing references and journal articles. According to the
commenters, the DOPPS data showed that ESRD patients take 9-12
medications on average, per patient, and that there are complex
interactions between many of these medications. Pharmacists receive
specialized training for renal patient care; and pharmacists with such
training should prepare facility protocols and policies to manage
medications. Pharmacists believe they will be able to coordinate
medication administered within facilities with medications administered
outside the facility and over-the-counter drugs. The commenters stated
that dialysis patients need comprehensive medication reviews at
appropriate intervals, similar to the CMS-required monthly medication
reviews in SNFs and ICFs. The pharmacists believed they could train
other staff regarding various medications' relationships, which would
improve quality of care and treatment plans. Pharmacist-consultants
could work with patients and caregivers to coordinate medication use
and dietary supplements. They observed that the Department of Veterans
Affairs has assigned pharmacists to its dialysis clinics. They argued
that comprehensive medication plans and reviews would increase patient
safety and reduce overall program (Medicare) costs by preventing
adverse ``medication events'' and reducing medication costs. They noted
that expert knowledge of the new Part D formulary will be an important
part of treating dialysis patients.
One commenter suggested dialysis patients should be recipients of
dialysis-provided Medication Therapy Management Services for third-
party payers that participate in Part D. In addition, the commenter
indicated that Dialysis pharmacists would like to be able to bill for
ESRD patient consultation using these codes.
Several commenters did not support including pharmacists on the
dialysis facility interdisciplinary team. These

[[Page 20427]]

commenters suggested that pharmacist consultation should remain an
option, not a requirement. One commenter stated there was no need for
pharmacist participation. Other commenters stated that routine
assessment of medications should not be required unless it was Medicare
reimbursable. A commenter stated that this would be an unnecessary,
burdensome requirement without benefit, since nephrologists have the
necessary dosing and medication interaction knowledge; the average
pharmacist salary is $73,000 annually, which was cost-prohibitive for
his organization's 1,200 dialysis facilities. Another commenter said
that RNs were the appropriate professionals to monitor patients'
medications and to do patient teaching, and believes it could be
confusing to the patient to further fragment care by introducing
another discipline into the patient care scenario. This commenter did
not believe there was a need for clinical pharmaceutical services
beyond continuing staff education on new products for dialysis
patients; the commenter stated that technology would improve medication
management and safety. One commenter said that dialysis facilities
lacked the expertise to manage a pharmacist properly. Another commenter
suggested that since Medicare did not cover the cost of providing
treatments and pharmaceuticals to patients, this suggestion was
fiscally unrealistic.
Several commenters stated that pharmacist participation was
desirable but not practical absent funding. A commenter stated that a
routine pharmacist assessment for patient medications would be
desirable and Medicare payment should be revised to allow direct
reimbursement outside the composite rate. A few commenters suggested
that we add a requirement for routine consultations with pharmacists to
review policies on medication acquisitions, storage, administration,
and medical record reviews.
Response: Pharmacists fully support a role for the pharmacist on
the interdisciplinary team, while other commenters support an optional
role for pharmacists in dialysis facilities.
The Medicare Part D reimbursement for pharmacists suggested by one
commenter is limited, as pharmacist charges are paid on a case-by-case
basis if an individual pharmacy plan has agreed to reimburse Medicare
for this service under Part D.
Due to a lack of consensus among commenters, we are not requiring
dialysis facilities to include pharmacists as members of the dialysis
interdisciplinary team. We do, however, encourage dialysis facilities
to use pharmacist expertise as appropriate. The facility policies and
procedures referred to at Sec. 494.150(c)(1) must include medication
policies and procedures that adequately protect patient safety.
b. Responsibilities of the Medical Director (Proposed Sec. 494.150)
We proposed to retain the condition addressing the facility's
medical director (Sec. 405.2161) as a separate condition and
strengthen the role of the medical director, at Sec. 494.150. The
medical director would be required to meet the qualifications for the
position at proposed Sec. 494.140(a) and would be responsible for the
delivery of patient care and patient outcomes in the facility. The
medical director would be responsible for operational responsibility
for the facility's QAPI program. We proposed to retain the existing
requirement at Sec. 405.2161 for the medical director to ensure that
staff in the facility are adequately trained. The existing requirement
at Sec. 405.2161 was modified in the proposed rule to require that the
medical director participate in the development, periodic review, and
approval of the patient care policies and procedures manual. We also
proposed that the medical director be responsible to ensure these
patient care policies and procedures are adhered to by staff who treat
patients in the dialysis facility, including attending physicians and
non-physician staff. The proposed rule also would require that the
medical director be responsible for ensuring that the interdisciplinary
team follows the facility's discharge and transfer policies and
procedures.
Comment: Many commenters supported the proposed condition for the
medical director, including the responsibilities laid out in the new
condition. Commenters remarked that this condition assigned more
accountability to the medical director for the overall care of
patients.
Several other commenters suggested additional language in or
revisions to the final rule. One commenter remarked that there should
be a direct line of responsibility from the medical director to the
care provided. One commenter suggested clearly delineating
responsibilities by deleting the phrase ``but are not limited to'' in
the last phrase of the proposed condition stem statement.
Another commenter recommended that we clarify that facilities
should have only one medical director. The commenter went on to state
that some facilities have multiple medical directors. Another commenter
however, suggested it may be advantageous for the same individual to
hold the medical director position for a defined number of facilities.
Response: We appreciate the comments regarding the proposed medical
director condition for coverage. In response to comments, we have added
language at Sec. 494.150 to state explicitly that ``The medical
director is accountable to the governing body for the quality of
medical care provided to patients.'' In addition, the medical director
has the responsibility of ensuring that all policies and procedures
relative to patient care and safety are followed by all who treat the
patient, as required at Sec. 494.150(c)(2). This modification clearly
holds the medical director responsible for the care that is furnished.
Each facility must have a single medical director to carry out the
responsibilities of this position.
We have retained the language in the final rule making the medical
director responsible for matters that are related to health and safety
standards for patient care. Individual dialysis centers may have
individual needs that surpass these minimum requirements. Therefore, we
are allowing facilities to have flexibility in their dealings with
their medical directors. Regarding the number of facilities for which a
physician may act as the medical director, this regulation requires
that the medical director meet all conditions and responsibilities,
regardless of whether he or she directs one facility or multiple
facilities. However, each facility must have exactly one specific
individual to be fully responsible for all matters under Sec. 494.150.
Comment: Several commenters supported assigning responsibility for
QAPI program to the medical director.
Response: We appreciate the supportive comments to retain the
proposed language regarding responsibility for QAPI. Language at Sec.
494.150(a) has been adopted in the final rule.
Comment: One commenter remarked that the wording at Sec. 494.150
needs to be clarified. The commenter stated that ``the medical director
is acting in an administrative leadership capacity'' and thus the final
rule needs to take into account that responsibilities of the medical
director should be performed in that context. One commenter suggested
that the medical director undergo management training, as staff needs
``leadership from the top'' to effect necessary changes needed in
quality control situations.
Response: The medical director is responsible for care provided by
the facility. The governing body has the

[[Page 20428]]

flexibility to use the medical director in an administrative capacity
as long as this does not prevent the medical director from performing
the responsibilities required by this final rule. The final rule at
Sec. 494.180(b)(3) requires that the governing body ensure that all
staff have appropriate orientation regarding their employment
responsibilities, including medical directors employed by the facility.
This requirement does not preclude the governing body from requiring
that the medical director receive additional training deemed necessary
to perform the duties of his or her position. The proposed language has
been retained in the final rule.
Comment: One commenter suggested we add record-keeping to the list
of responsibilities for which the medical director is ultimately held
responsible.
Response: Record-keeping is a responsibility that falls under
policies and procedures relative to patient care, and thus is covered
under the purview of the medical director at Sec. 494.150(c)(2)(i). In
addition, there is a condition for Medical records, found at Sec.
494.170, which stipulates what is required of the dialysis facility
with respect to record-keeping. Therefore, we are not making the
suggested additions to the final rule.
Comment: Another commenter suggested we add language to require the
medical director to be present in the facility at least once a month.
Response: Dialysis facilities have the flexibility to address this
issue in their agreement with their medical director. The medical
director's presence must be frequent enough to perform his or her
responsibilities as required by these conditions.
Comment: One commenter suggested that we add language stating that
the medical director has the responsibility for assuring that pediatric
patients have regular access to care from a nephrologist, dietitian,
and a social worker with pediatric expertise.
Response: Dialysis facilities are required by this final rule to
provide quality care and services that meet the needs of the patient,
as identified during the comprehensive assessment and addressed in the
plan of care. The patient assessment and patient plan of care required
at Sec. 494.80 and Sec. 494.90 respectively, should accurately
reflect the needs of all patients, including pediatric patients, and
the proper resources should be obtained and used as necessary.
Comment: Some commenters remarked that the medical director should
bear primary responsibility for infection control oversight in the
dialysis unit, as opposed to a nurse.
Response: We determined that it would be practical to hold the
medical director accountable for oversight of infection control as the
leader of the quality improvement committee. We also proposed that the
medical director be responsible for assessment and performance policies
and procedures relative to patient care and safety at Sec.
494.150(c)(2)(i). Upon consideration of comments, we have added
infection control to the list of policies and procedures for which the
medical director exercises oversight at Sec. 494.150(c)(2)(i). In
addition to this new requirement at Sec. 494.150(c)(2)(i), we have
also added ``patient admissions'' to the list of policies for which the
medical director is responsible. This modification is in response to
comments received on the ``Governance'' condition. Please see the
``Governance'' preamble discussion below for more information.
Comment: Some commenters expressed concern regarding oversight of
the medical director's performance of his or her duties under Sec.
494.150. The commenters remarked that the only mechanism to deal with a
poorly performing medical director would be to dismiss him/her.
Commenters went on to explain that it could be difficult to fill a
vacant medical director position, which would be required to be done
quickly in order to continue to be reimbursed by Medicare. It was
recommended that CMS consider mechanisms by which medical directors who
failed to fulfill their responsibilities as outlined in the conditions
for coverage, could be disciplined by the facility. Commenters
suggested perhaps there was a role for Network Medical Advisory Boards,
State Licensing Boards or State Professional Boards to assist
facilities in evaluating medical director performance and determining
disciplinary action.
Response: The medical director is accountable to the governing
body. The governing body is responsible for communicating expectations
to the medical staff regarding their participation in improving the
quality of medical care provided to facility patients, as required at
Sec. 494.180(c)(3). The governing body could develop a process to
improve the medical director's performance. A facility's governing body
could also contact the appropriate authorities, such as the Network
Medical Advisory Boards, State Licensing Boards, State Professional
Boards, and any other suitable agencies or organizations. We feel that
this matter is best left to the governing body's discretion. We are
making no changes based on this comment.
Comment: One commenter concurred with the language regarding the
medical director's responsibility for managing problem nephrologists,
but suggested that there be some reasonable basis for protecting the
medical director from lawsuits related to this management activity.
Another commenter asked for clarification regarding the legal
liabilities for medical directors employed by large dialysis
organizations (LDOs). The commenter questioned what recourse a medical
director would have when he or she disagreed with the LDO.
Response: We do not have authority through this vehicle to provide
legal protection for the medical director, moreover, these issues are
generally matters of state law. Medical directors employed under a
contract may negotiate the terms of that contract with business owners/
center management within the state practice limitations, including
issues such as legal liability, but such matters are not under the
purview of this regulation.
Comment: Some commenters recommended that the medical director
should have responsibility for ensuring that the ESRD facility supports
the goals of the ESRD Network.
Response: The Medicare statute specifies that facilities must meet
Network goals (section 1881 of the Act) in order to participate in
Medicare. We do not agree it is necessary to add language to the
medical director condition regarding responsibility for Network
relationships. As stipulated at Sec. 494.180(i), dialysis facilities
must cooperate with the ESRD Network in fulfilling the terms of the
Network's current statement of work. Section 494.180(a)(3) mandates
that the chief executive officer or the administrator be responsible
for the relationship with the ESRD Networks.
Comment: One commenter believed that the proposed new
responsibilities for the medical director were overly burdensome with
respect to very small dialysis units, where the medical director might
be the only attending physician with an internal medicine practice.
Another commenter disagreed with the proposed language, remarking that
it was too restrictive and confusing for multi-facility organizations
to have the medical director responsibilities assigned at the unit
level. This commenter remarked further that policies were made at the
corporate level and recommended that this requirement be removed
entirely.

[[Page 20429]]

Response: As stated earlier, the majority of commenters supported
the ``Medical director'' condition for coverage. No evidence was
submitted to support removing the condition for coverage from the final
rule. Several responsibilities addressed in the proposed condition are
included in existing regulation at Sec. 405.2161(b), and thus medical
directors have previously been expected to ensure that the needs of the
patient are properly addressed. We do not believe that the duties of
the medical director are too burdensome, therefore, the proposed
language will be retained in the final rule.
Comment: A commenter recommended that we add language in the final
rule that would allow the medical director to have a major role in the
appointment and selection process for hiring individuals who would have
admitting privileges in the facility (specifically physicians,
physician's assistants, and nurse practitioners).
Response: The medical staff appointments standard at Sec.
494.180(c) places responsibility for medical staff appointments with
the governing body. The governing body would address the question of
whether medical directors would be included in medical staff
appointment decisions. Regulatory language does not preclude the
medical director from participating in the selection process; however,
we are not going to require that medical directors participate in these
decisions.
Comment: One commenter suggested changing the language of the final
rule to reflect that most medical directors would normally not
participate in developing policies and procedures for an ESRD facility.
A commenter noted that policies and procedures are most often developed
by the large dialysis organizations; however, medical directors may
assist or be asked to assist in revisions. The commenter suggested we
add ``participate in the development or refinement (of policies and
procedures) * * *.'' in the final rule language. Another commenter
suggested we change the language at Sec. 494.150(c)(2) to indicate
that the medical director would ``participate with the facility staff
to ensure'' that the conditions of that paragraph were met. Another
commenter remarked that the medical director could oversee and support
the facility but could not ``ensure'' policies and procedures were
adhered to by facility staff, as often the owner/chain refused to
support their own policies and procedures.
Response: Regardless of whether policies and procedures are
developed within the facility or via a corporate process, the medical
director is responsible for ensuring that appropriate patient care
polices are developed and implemented. The majority of commenters
supported the proposed requirement without modification. The medical
director is responsible for the clinical care provided in an ESRD
facility and thus should be held accountable for that care. We expect
the medical director would work with the governing body to ensure that
appropriate patient care policies are developed and implemented within
the facility.
Comment: We received many comments regarding the medical director's
scope of authority within a facility. Some commenters recommended that
the final rule mandate that medical directors be given the ability and
the authority to monitor and improve the care provided by attending
physicians, as well as the entire patient care team, including nurses,
physician's assistants, dietitians, social workers and other staff;
these commenters thought there ought to be more accountability for poor
performers in the facility. Another commenter remarked that if
attending physicians were uncooperative, then the medical director
should assume responsibility for patient care. The commenter further
remarked that the final rule language needs to be ``grounded in a
realistic approach'' by which medical directors could influence
attending physicians with competing goals. Some commenters suggested
that Sec. 494.150(c)(2)(i) be expanded to allow medical directors the
ability and authority to monitor and improve care in the facility,
including the care provided by attending nephrologists. Other
commenters supported the idea that the unit's attending physicians be
subject to peer review, under the direction of the medical director,
and potentially subject to discipline (within the framework of due
process procedures). One commenter remarked that governing bodies
should be required, as part of their policies and procedures, to
specify the extent of the medical director's authority to manage
inadequately performing staff and attending physicians.
Response: The medical director is responsible for the delivery of
patient care and outcomes in the facility, which includes
responsibility for the QAPI program, staff education, training and
performance as well as policies and procedures of the ESRD facility. To
strengthen the ``Responsibilities of the medical director'' condition
for coverage, we have added language to the first paragraph of Sec.
494.150, reading ``The medical director is accountable to the governing
body for the quality of medical care provided to patients.'' The role
of the medical director is also strengthened in the final rule at Sec.
494.150(c)(2)(i), to include patient admissions and infection control.
Section 494.150(c)(2)(i) now requires the medical director to ensure
that all policies and procedures relative to patient admissions,
patient care, infection control, and safety are adhered to by all
individuals who treat patients in the facility, including attending
physicians and non-physician providers. We believe that the facility
governing bodies will provide medical directors with adequate
institutional authority to permit the medical directors to perform
these duties effectively.
If the medical director is unsuccessful in achieving staff
compliance or managing disciplinary issues involving attending
physicians and has exhausted all options, we expect that the matter
would be referred to the governing body, the ESRD Network or other
appropriate authorities, such as the state agency and state licensing
boards.
Comment: One commenter suggested the addition of a new Sec.
494.150(c)(2)(iii) to require the medical director to ensure that
``staffing is sufficient to meet the acuity of patients treated in the
facility.''
Response: We have not added the suggested language to the
``Responsibilities of the medical director'' condition. Staffing
concerns are addressed under Sec. 494.180(b), which pertains to
adequate and trained staff in an ESRD facility. We also note that the
medical director may not have the organizational authority to determine
staffing levels within the facility.
Comment: One commenter suggested we add language in the final rule
to read, ``the medical director will have direct communication with the
patient's other physicians when new or existing co-morbid conditions
arise during the course of dialysis treatment.''
Response: We have not added the suggested language in the final
rule. We encourage communication and coordination of care among all
parties involved in the patient's care and we expect this would be an
effort of the attending physician in order to decrease fragmentation of
patient care and to ensure proper care for each patient.
Comment: One commenter recommended increased cooperation between
nephrologists and dialysis facilities, via the medical director, to
assist patients with transplant eligibility.
Response: We have added language throughout the final rule, such as
in Sec. 494.70, Sec. 494.80, and Sec. 494.90, to

[[Page 20430]]

ensure that patients are aware of their modality choices, including
transplant options. Additionally, the medical director is responsible
to ensure that all policies and procedures affecting patient care are
adhered to by all individuals who treat patients in the facility,
including attending physicians and non-physician providers, as required
at Sec. 494.150(c)(2)(i).
c. Relationship With the ESRD Network (Proposed Sec. 494.160)
Requirements found in existing Sec. 405.2110 through Sec.
405.2113, related to the designation of ESRD Networks, the functions of
ESRD Networks, and the role of the medical review boards will remain
unchanged in subpart U. These provisions focus primarily on the role
and responsibilities of the Networks rather than dialysis facilities.
We proposed to require that each facility cooperate with the ESRD
Network serving its designated area in fulfilling the terms of the
Network's scope of work contract with CMS, consistent with the
requirement at Sec. 405.2134.
Comment: Several commenters suggested we replace ``statement of
work'' with ``goals and objectives.'' Another commenter suggested we
expand the requirements beyond the contract scope of work to include
explicit references to local projects. A couple commenters recommended
we retain language from subpart U at Sec. 405.2134 that states that
facilities must ``participate in network activities.''
Response: We appreciate the positive comments. The final rule at
Sec. 494.180(i) requires that each facility cooperate with the ESRD
Network serving its designated area in fulfilling the terms of the
Network scope of work contract with CMS, which is similar to the
requirement under existing Sec. 405.2134 concerning participation in
network activities. The ESRD Network scope of work includes goals,
objectives, and local projects. Therefore, it is unnecessary to modify
the requirements as suggested by the commenter. Facilities must
continue to share information with the Networks as necessary to support
Network goals and objectives.
Comment: One commenter recommended that we require random audits by
the ESRD Networks to validate the accuracy of self-reported dialysis
facility data.
Response: Random audits by ESRD Networks are outside the scope of
this regulation. We are not revising our ESRD network regulations at
this time.
Comment: One commenter agreed with the proposed language, remarking
that roles and responsibilities of the Network should not be part of
the conditions for coverage. Two commenters supported the requirement
that mandates each ESRD facility to cooperate with its own Network to
fulfill the terms of the Network contract scope of work. A commenter
remarked that the scope of work should emphasize the coordination of
Network activities across all Networks as well as a limited number of
local and national initiatives. Another commenter recommended we
require Networks to share more information with the State agency,
especially during a state survey of ESRD facilities.
Response: As noted above, the ESRD Network Scope of Work (SOW) is
outside the scope of this regulation.
Comment: One commenter recommended we expand the language in this
regulation to include transplant centers, as well as dialysis centers,
using the rationale that ESRD Networks provide oversight to both.
Response: A separate transplant center health and safety regulation
was published on March 30, 2007 (72 FR 15198), which requires
transplant centers to participate in Network activities. This
requirement can be found at Sec. 482.104(c). Therefore we are not
modifying language at proposed Sec. 494.160 to include the suggested
language in the final rule. We note, that for reasons described in that
section, we have moved the substance of proposed Sec. 494.160 to Sec.
494.180, and removed and reserved Sec. 494.160.
d. Medical Records (Proposed Sec. 494.170)
In keeping with our goals to eliminate unnecessary requirements and
to reduce burden on dialysis facilities, we proposed a modified version
of existing Sec. 405.2139. The proposed rule emphasized that a
facility must maintain complete medical records for all patients under
its supervision, including home patients. We proposed not to prescribe
the elements facilities would have to include in the patient medical
record, as was required in subpart U. We proposed to retain with
modifications a previous requirement at Sec. 405.2139 that requires a
facility to protect its patients' medical records against loss,
destruction, or unauthorized use, and proposed to eliminate the
requirement that the facility must have written policies and procedures
for recordkeeping. We proposed an expansion of the existing
requirements regarding medical record release. Medical records could be
released when the patient transferred to another facility; under
certain exceptions provided for in law; under a third party payment
contract; subject to approval by the patient, or in the course of an
inspection by authorized agents of the Secretary, and as required by
the Medicare program. We proposed to retain with modifications the
previous requirement at Sec. 405.2139(d) that current medical records
and those of discharged patients be completed promptly and that all
clinical information pertaining to a patient be centralized. We
proposed that the dialysis facility be responsible for completing,
maintaining and monitoring medical records for its Method II home
dialysis patients and its other home patients. Minor revisions were
proposed to Sec. 405.2139(e) regarding medical record retention. We
proposed that medical records be retained for a period of time not less
than that determined by the applicable State statutes governing records
retention or the State's statute of limitations. In the absence of
State statutes, records would be required to be retained for 5 years
from the date of discharge for an adult; or for a minor, 3 years from
date of discharge or until the patient becomes of age under State law,
whichever was longer. We proposed the elimination of the prescriptive
requirements in existing Sec. 405.2139(f) regarding medical record
accessibility. We proposed to retain the existing requirement at Sec.
405.2139(g) to require the facility to provide prompt transfer of
medical information between treatment facilities. We also proposed a
modification of Sec. 405.2137(b)(4) to require that the facility
exchange all medical record information within one working day.
Finally, we proposed the elimination of the existing requirement for
the designation of a medical records supervisor.
Comment: One commenter fully supported the less prescriptive
approach in the proposed condition, while another commenter remarked
that the proposed reduction of regulatory requirements in this
condition for coverage was too broad. Some commenters concurred with
the deletion of the medical records supervisor, while others disagreed
with the elimination of this position, citing that a designated staff
member for this task is essential to ensure an adequate recordkeeping
process.
Response: We appreciate the positive comments regarding the
elimination of the medical records supervisor requirement in Sec.
494.170. Eliminating process-type requirements is in keeping with our
overall goals. Additionally, we believe that the deletion of the
medical records supervisor requirement would result in a cost savings
for facilities. There is no evidence that removing this requirement
would result in poor

[[Page 20431]]

outcomes. Therefore, the medical records supervisor requirement has not
been included in the final rule.
Comment: Several commenters disagreed with the proposed elimination
of the requirement that facilities have written policies and procedures
regarding record-keeping. One commenter argued that a facility must
have written policies and procedures for record-keeping in order for
required outcomes to be achieved. This commenter argued that allowing
facilities the flexibility to decide what information to include in the
medical record would not assure that outcomes were achieved.
Response: We have decided not to carry over the language from part
405, subpart U, in order to decrease prescriptive, non-outcome oriented
requirements and to increase dialysis facility flexibility. As long as
there is a system in place to achieve that outcome, we do not believe
it is necessary to dictate prescriptive requirements. Facilities are
still required to protect medical record information and keep all
patient records confidential and demonstrate that all of these
conditions for coverage have been met. We do not, however, preclude a
facility from having record-keeping policies and procedures as they see
fit.
Comment: Two commenters suggested that a reference be added to the
final rule to state that a medical record could always be released to a
patient, guardian or other legally appointed patient representative.
Response: Patients have the right to look at their own medical
record. We proposed at Sec. 494.170(a)(2) that all patient medical
record information be kept confidential, except when released to an
authorized person approved by the patient. Furthermore, patients have
the right to be informed of their medical status as documented in the
medical record unless the medical record contains a documented
contraindication to do so, as required at Sec. 494.70(a)(10). The
proposed language will be retained in the final rule, as it protects
the patient's medical record information, while allowing for the
release of confidential information to the patient or the patient's
representative. We also note that many of our protections correspond to
more general protections under HIPAA, found at 45 CFR parts 160 and
164.
Comment: One commenter suggested proposed language at Sec.
494.170(a)(2) and Sec. 494.170(a)(3) was unnecessary because of HIPAA
protections already in place. The commenter suggested we retain
existing language at Sec. 405.2139(b).
Response: The proposed language was carried through from part 405,
subpart U, and we believe the language at Sec. 494.170(a)(2) and Sec.
494.170(a)(3) adds clarification regarding the circumstances under
which a patient's medical record may be released and any appropriate
authorizations that are needed for that release. As noted above, the
proposed language was consistent with the HIPAA privacy regulations at
45 CFR parts 160 and 164 and remains in the final rule.
Comment: A commenter suggested adding language at Sec. 494.170(b)
to require that when records are stored electronically, the facility
must have procedures to protect in-center and home dialysis patient
information, and must back up data daily.
Response: The concern of this commenter is addressed at Sec.
494.170(a)(1), which mandates patient records be safeguarded against
loss, destruction or unauthorized use. This requirement must be
followed regardless of whether a facility uses written or electronic
medical records. Additionally, Sec. 494.170(b)(3) charges dialysis
facilities with responsibility for completing, maintaining and
monitoring medical records for its home patients.
Comment: Many commenters made remarks regarding what information
should be required in the patient's medical record. One commenter was
concerned that the proposed condition was reduced too much, stating
that medical records of ESRD patients were even now often incomplete,
inaccurate and not in accordance with identified medical records
standards. Two commenters suggested that the day-to-day events should
be documented by the end of each shift in which they occurred, and
another commenter suggested we retain existing language from Sec.
405.2139, which specified the information that must be kept in the
active patients' chart and readily available. Other commenters
suggested a requirement specifying inclusion of treatment information,
the treatment settings, safety checks, medical events, pre/post-patient
assessments, medications, etc. Another commenter recommended that the
final rule include a requirement for documentation of medical injuries
and accidents, medication changes, as well as patient phone numbers and
emergency contact numbers, which should be entered immediately in the
patient's record and be updated if they changed. One commenter
suggested a requirement that unusual events during treatment be
documented.
Response: The existing part 405, subpart U language was removed
from the proposed rule because we believe facilities should have the
flexibility to decide what information would be included in the medical
record, as long as the patient's medical needs were being addressed and
these conditions for coverage were met. Medical professionals are
expected to accurately record complete and pertinent information in
their patients' medical records, including many of the issues
identified by the commenters. Many of the topics identified by the
commenters would have to be included in the patient's record in order
to comply with the ``Patient assessment'' and ``Patient plan of care''
conditions at Sec. 494.80 and Sec. 494.90. All clinical information
pertaining to a patient must be centralized in the medical record
(Sec. 494.170(b)(2)). If a facility kept incomplete, inaccurate
medical records, as suggested by the first commenter, this ``Medical
records'' condition for coverage would not be met and would be cited
during a facility survey.
Comment: One commenter suggested we add language to allow use of
electronic medical records and recognize them as a satisfactory and
secure system for keeping and protecting patient medical records.
Response: The proposed language at Sec. 494.170(b) does not
specify that medical records must be in ``hard-copy'' form only, and
thus we see no need to make this suggested change in the final rule. We
allow electronic health records, and in fact encourage them. In 2004,
the President issued an executive order calling for the widespread
adoption of interoperable health records within ten years, and the
Department of Health and Human Services has been leading the nation's
efforts in advancing the nationwide health IT agenda.
Comment: We received several comments regarding the timeframe for
completion of medical records. One commenter supported a requirement
that records be up-to-date and accurate. Some commenters suggested we
specify a 30-day timeframe for completion of the medical record, while
another remarked that the medical record should be updated within 2-4
days after any event so that the information would be available by the
next dialysis treatment. One commenter remarked that the proposed
language regarding prompt completion of medical records was sufficient.
Another commenter suggested that we require all assessments to be
placed in the front of the chart to improve availability.
Response: To ensure a comprehensive and accurate medical record, we
feel that it is vital that charting be completed promptly. The language
at proposed

[[Page 20432]]

Sec. 494.170(b) was retained from existing language in subpart U at
Sec. 405.2139(d), and we are codifying it in the final rule. Each
member of the interdisciplinary team must have access to the most
recent information on the patient's condition and prescribed treatment.
It is a ``best practice'' to complete charting without delay to ensure
patient health and safety during each treatment. Facilities may choose
to establish policies regarding the method in which patient medical
records are organized, but we will not mandate such a requirement in
this regulation.
Comment: Some commenters pointed out that according to HIPAA
regulation at 45 CFR Sec. 164.530(j), documentation must be retained
for 6 years.
Response: According to the HIPAA Privacy Rule at 45 CFR Sec.
164.530(j)(2), certain written communications, policies and procedures
must be retained for 6 years. Therefore, we agree with the commenters
and we have modified standard (c) to stipulate that medical record
documentation must be retained for 6 years for both adults and
children. Standard (c) now reads as follows: ``In accordance with 45
CFR 164.530(j)(2), all patient records must be retained for 6 years
from the date of the patient's discharge, transfer, or death.'' Note,
proposed Sec. 494.170(c)(1) has been redesignated to standard (c) and
Sec. 494.170(c)(2) has been removed.
Comment: Several commenters argued that transferring all medical
records within one day was unreasonable, burdensome, and unnecessary,
while other commenters supported the requirement. Another commenter
remarked that discharged patient records, including mortality reviews,
should be completed within 30 days. This commenter also stated 30 days
was plenty of time to collect necessary data and was within the
timeframe of one cycle of required monthly patient blood work from
which thresholds were evaluated. One commenter remarked that the
transfer of medical records information should be defined clearly to
include at least the care plan, the three most recent dialysis flow
sheets, the patient's medication list, lab reports, the comprehensive
assessment, and any physician order(s). Still another commenter
suggested the addition of language in the final rule to require
information such as nutritional status, psychosocial status, and
rehabilitation status be transferred within one working day. Another
commenter suggested that it would be helpful to have standard criteria
and a form for patients to use when traveling to another unit, in order
to ensure that appropriate and consistent information is transferred.
Response: The proposed language at Sec. 494.170(d) required the
transfer of all medical record and other necessary information within
one working day. We maintain that the requirement should apply not only
to the care plan, but also to all medical record information. However,
we recognize the commenters' concerns that there may be a substantial
amount of documentation that may require more time for transfer. We
have therefore revised the language at Sec. 494.170(d), which now
reads, ``When a dialysis patient is transferred, the dialysis facility
releasing the patient must send all requested medical record
information to the receiving facility within 1 working day of the
transfer.'' Our goal is to minimize the potential for communication
breakdown between facilities and ensure that patients continue to
receive the necessary care and services. We are therefore requiring
only that the minimum amount of medical information be forwarded as
appropriate. Some information, such as recent lab results, may not be
readily available within 1 day. This minimum information would likely
include the physician orders, the patient assessment, and the patient
plan of care, insurance information, the last three recent dialysis run
sheets, and other pertinent information as necessary. Facilities may
wish to create a standard medical record information transfer form as
part of their policies and procedures regarding the transfer of
patients, but we are not mandating it.
Comment: One commenter suggested we add the following language:
``Patients must have physician orders for all treatment parameters and
these orders must be followed.''
Response: We expect that the facility is following physician orders
for all of its patients, as required by State Practice Acts and in
accordance with Federal, State and local laws and regulations, as
required at Sec. 494.20. Therefore, there is no need to add the
suggested language in the medical records condition for coverage of
this final rule.
Comment: Two commenters remarked that facilities need a centralized
medication administration record in order to identify and track
medication errors. Another commenter recommended that facilities be
required to work towards a system to improve documentation of
medication administration and decrease the incidence of potential
medication errors. The commenter further suggested that the success or
failure of these systems be followed by a quality assessment and
performance improvement program within the facility.
Response: Under the final QAPI condition at Sec.
494.110(a)(2)(vi), facilities must measure, analyze, and track medical
injuries and medical errors. We believe this requirement addresses the
commenters' concerns. Some facilities may choose to put into practice a
specialized centralized medication administration record or some
alternative process to assist in easier detection of medical errors.
e. Governance (Proposed Sec. 494.180)
We proposed an updated version of Sec. 405.2136 to modernize the
requirements and delete unnecessary processes where possible.
Consistent with Sec. 405.2136, we proposed that the ESRD facility be
under the control of an identifiable governing body, or designated
person, with full legal authority and responsibility for the governance
and operation of the facility. The proposed rule retained the
requirement that a CEO or administrator be identified. Proposed
administrator responsibilities would include management of staff
appointments, fiscal operations, ESRD Network relationships, and
allocation of staff and resources for the QAPI program. We proposed a
standard similar to Sec. 405.2162(b)(2) that would require that the
governing body or designated person ensure that there was an adequate
number of qualified and trained staff to provide a level of dialysis
care to meet the needs of patients. The proposed licensed person on
duty when patients were undergoing dialysis would be an RN who would be
available in the event of a patient emergency. We proposed, consistent
with part 405, subpart U, that dialysis facility employees have an
opportunity for continuing education and related development
activities. A new proposed provision specified a governing-body-
approved, written patient care technician-training program that
included eight mandatory topics. We proposed that the governing body be
responsible for medical staff appointments and credentialing, and
ensuring that all medical staff providing care in the facility were
informed of facility policies and procedures and the QAPI program.
We proposed that the governing body ensure that the dialysis
facility furnished directly services on its main premises or on other
premises that were at least contiguous with the main premises. A new
standard was proposed that would require the dialysis facility to
implement an internal grievance process that included a procedure for
the submission of grievances, facility timeframes for grievance review,
and a description of how the patient (or

[[Page 20433]]

representative) would be informed of steps taken to resolve the
grievance. The proposed rule also addressed a procedure that would have
to be followed before a patient could be discharged involuntarily. We
proposed to retain the Sec. 405.2138(b)(2) provisions that allowed
patient transfer or discharge because of non-payment, or because of
facility inability to meet the patient's medical needs. We also
proposed that a patient could be discharged or transferred because of
disruptive patient behavior that seriously impaired the facility's
ability to operate effectively. We proposed a process for involuntarily
discharging or transferring a patient. These steps included reassessing
the patient, documenting the problem and ongoing efforts to resolve the
problem, obtaining a written discharge or transfer order signed by the
attending physician and the medical director, documenting efforts to
place the patient in another facility, and notifying the State survey
agency and the ESRD Network.
The proposed rule included emergency coverage provisions at Sec.
494.180(g) that were similar to those at Sec. 405.2136(g)(2) and Sec.
405.2160(a). This proposed standard would task the governing body with
ensuring that patients and staff received written instructions for
obtaining emergency medical care, that there was a roster with the
names of physicians to be called for emergencies and their contact
information, and that there was an agreement with a hospital capable of
providing emergency medical care to dialysis patients at any time.
We specified in the February 4, 2005 proposed rule at Sec.
494.180(h) that dialysis facilities would continue to be required to
provide to CMS data and information for ESRD program administration,
however, this data would be required to be sent electronically in a
format and at a frequency specified by the Secretary. We added to the
proposed requirements, a proposal that facilities submit data necessary
for existing ESRD clinical performance measures, currently only
collected on a sample of dialysis patients, and any future clinical
performance standards developed in accordance with the National
Technology Transfer and Advancement Act of 1995 process adopted by the
Secretary. The final subsection of proposed Sec. 494.180 would update
Sec. 405.2136(a)(1) to require the governing body to report ownership
interests of 5 percent or more to the State survey agency, consistent
with Sec. 420.200 through Sec. 420.206. We received more than 100
comments on Sec. 494.180 ``Governance'' condition. Some commenters
concurred with the condition as proposed, and many commenters suggested
modifications.
Comment: Two commenters suggested that the final rule (at Sec.
494.180(a)) limit the number of facilities a single CEO may serve, as
it is not unusual for one CEO to cover 4 or more units.
Response: A facility CEO or administrator must have available
sufficient time to carry out his or her responsibilities and
requirements to allow the facility to fully comply with Sec. 494.180.
Although the CEO of a large facility may not have adequate availability
to serve multiple dialysis facilities, it is possible that a CEO could
adequately serve more than one small facility. We have not added a
restriction to limit the number of dialysis facilities a CEO may serve,
but require the CEO to satisfactorily fulfill the CEO responsibilities
listed at Sec. 494.180(a).
Comment: One commenter suggested that we not use the terms ``CEO''
and ``administrator'' interchangeably in the final rule. A second
commenter recommended that we delete the term ``CEO'' from the final
rule and use the term ``administrator.'' The rationale given by one
commenter is that the terms imply different things; for example, an
administrator manages a unit and a CEO has ultimate authority in the
organization.
Response: The proposed rule specified that the CEO or administrator
would exercise responsibility for the management of a specific facility
and the provision of all dialysis services including, but not limited
to, staff appointments, fiscal operations, the ESRD Network
relationship, and allocation of resources. The term specifically does
not refer to the CEO of a parent company or entity that owns or
controls several facilities. We do not expect that there will be
confusion about the use of the terms ``CEO'' or ``administrator,'' as
the responsibilities are clearly specified in the final rule.
Comment: One commenter suggested that the CEO or administrator be
responsible for addressing those financial collections issues with
patients that affect the functioning of the facility or jeopardize the
continuance of provision of dialysis services to the patient.
Response: As stated in the response above, the CEO or administrator
is responsible for the fiscal operations of the facility. We are not
detailing the tasks associated with this function in this regulation
because financial issues are normally a component of the facility's
business practices and are therefore not within the scope of this rule.
Discharges of facility patients for non-payment are allowed as stated
in Sec. 494.180(f)(1), and we believe that facilities generally make
every effort to collect payment for dialysis services.
Comment: We received more than 70 comments regarding our proposed
requirement at Sec. 494.180(b)(1), that the governing body ensures
that there is an ``adequate number of trained and qualified staff.'' A
few commenters concurred with standard (b) as proposed. One commenter
stated that the term ``adequate staff'' is ``too open to
interpretation'' and should be clearer.
More than 60 commenters recommended placing staffing ratios for
various patient care staff in the final rule. Many commenters stated
that huge case loads are affecting the quality of care, and that
Medicare should designate at least an enforceable upper limit on the
number of patients for each staff member. A commenter stated that
``California does not have any (staffing ratios) for dialysis
facilities'' and she has ``seen as much as 1 RN for 21 patients in
facilities by one corporate provider.'' This commenter stated that
adequate staffing provisions are difficult to enforce and she has found
facility staffing policies that allowed unsafe staffing levels. The
commenter argued that to ensure the safety of the patients, minimum
staffing ratios are necessary, and should be included in the CMS
regulations. Commenters suggested staff-to-patient ratios for various
dialysis staff; one commenter stated the RN-to-patient ratio should not
exceed 1:10, and other commenters suggested PCT-to-patient ratios of
1:4.
Many commenters suggested a 1:75 MSW-to-patient ratio, and stated
that it was impossible for MSWs to do case review and counseling with
high patient ratios. Commenters stated that MSWs were assigned large
caseloads of between 125 and 300 patients each, and cited a 2005 study
(Bogatz, Colasanto, and Sweeney) in support of this contention. Some
commenters recommended that we require use of a standardized acuity-
based formula for adequate staff, such as the NKF Council of Nephrology
Social Workers' ``Professional Advocacy for the Nephrology Social
Worker, First Edition 2002'' (pages 9-11). One social worker stated she
had 150 patients in 3 units and could therefore only triage and ``put
out fires.''
The American Dietetic Association voiced concern that inadequate
staffing would affect the quality of care and was aware of many
situations where RD-to-patient staffing ratios was 1:200. The ADA
further stated that if CMS did not at least reference an optimum RD

[[Page 20434]]

national staffing ratio, facilities ``will demonstrate a lack of
restraint for large case loads'' and the positive expectations for the
new conditions for coverage will not be seen and may even negatively
impact patient-focused quality care. Some commenters suggested a RD-to-
patient ratio of 1:100 to 125. Some commenters stated that K/DOQI
recommends a RD-to-patient ratio of 1:100 and no more than 1:150. A
commenter stated that Texas has implemented a RD to patient ratio of
1:125, and that RDs are increasingly directed to do non-RD work that
reduces the time available for care of patients who are older and
sicker. Some commenters pointed out that dietitians and social workers
are often shared between multiple facilities.
Several commenters recommended adding a new requirement for use of
an acuity-based staffing model. A commenter stated that software was
available to help establish staff to patient ratios based on patient
acuity. One commenter stated that acuity-based staffing would reduce
facilities ``cherry picking'' patients that would likely occur if
minimum facility-level standards were implemented. Some commenters
would like to see staffing ratios included in acuity-based staffing
plans. One commenter suggested convening an acuity-based staffing plan
technical expert panel, and another, an acuity-based staffing plan
demonstration. One commenter suggested that we require policies and
procedures for staffing that identify numbers of patients, acuity
levels, and patient-to-staff ratios.
Several commenters were opposed to both ratios and acuity-based
staffing models, stating the current proposal provided necessary
flexibility, and that facilities could assign adequate staff based on
patient acuity. One commenter stated that CMS should not lock dialysis
facilities into a ratio system in regulation, because regulations could
take too long (as much as 20 years) to change. Another commenter stated
there were no data to support mandated staff-to-patient ratios, and a
case mix adjustment formula was needed to avoid facilities ``cherry
picking'' patients. One commenter stated that acuity-based staffing
ratios would foster confusion, ``up-coding,'' and additional paperwork
burdens. The commenter further stated that if acuity-based ratios were
adopted, then payment should be adjusted to allow providers to
accommodate acuity-based staffing needs. A commenter stated that
acuity-based staffing plans have been unsatisfactory and that the
nursing shortage exacerbated problems. Another commenter stated that a
federal acuity-based system was a bad idea, as there were too many
variations from facility to facility, there would be conflicts with
many State requirements, and this approach was very subjective.
Response: We solicited public comment in the proposed rule
regarding whether we should include a requirement for an acuity-based
staffing plan. The public comments were split on the acuity-based
staffing plan issue. Clearly staffing is of concern to many commenters.
While commenters agreed with the intent of the proposed adequate staff
provision at Sec. 494.180(b)(1), there was discontent related to how
this provision would be interpreted and enforced. First, we would like
to clarify that the adequate staff standard applies to all clinical
patient care staff, including nurses, technicians, social workers, and
dietitians who provide services to the dialysis patients. Appropriate
staffing ratios are affected by a number of factors. These factors
include patient acuity, level of staff expertise and skill mix,
presence or absence of support staff/unlicensed personnel, available
technology, distances between groups of patients served, efficiency of
systems in place, scope of staff duties, degree of team work, State
requirements, practice board-imposed limitations, number of meetings in
which staff participation is required, paperwork demands, etc. We do
not have a method available to identify and account for all of these
types of characteristics in determining staff ratios that balance staff
time to provide quality care and meet patient needs with the economic
factors associated with dialysis facility labor costs. We are also
concerned that any mandated minimum staffing ratios would be
interpreted as the ``maximum ceiling'' that must be complied with which
could lead to a decline in the number of patient care staff available.
``Adequate staff'' means staffing must be sufficient so that
quality care is provided to dialysis patients that is consistent with
the patient plan of care and professional practice standards. We are
requiring under the ``Patient assessment'' and ``Patient plan of care''
conditions (Sec. 494.80 and Sec. 494.90 respectively) that members of
the interdisciplinary team complete a comprehensive assessment,
followed by a plan of care that identifies goals for patient care and
the services that will be provided in order to meet those goals. This
includes psychosocial and nutrition services to be provided by the
social worker and the dietitian. The assessment and plan of care
requirements necessitate that the RN, social worker, and dietitian
provide appropriate professional care to each patient. We are also
requiring at Sec. 494.110 that the interdisciplinary team, which
includes the RN, social worker, and dietitian, play an active role in
the QAPI program. This final rule requires that the interdisciplinary
team provide appropriate care to dialysis patients and improve patient
care on an ongoing basis. The dialysis facility may need to evaluate
staffing levels as part of their action plan for the QAPI program. In
order to clarify that the adequate staffing standard applies to all
clinical staff, we have added language to the requirement at Sec.
494.180(b)(1), requiring that the RN, social worker and the dietitian
be available to meet patient clinical needs.
Comment: Two commenters suggested that we hold the medical director
accountable for adequate staffing.
Response: We proposed that the governing body or designated person
responsible must ensure adequate staffing. The medical director would
generally not be responsible for hiring and firing, and replacing
vacant positions, or developing the work schedules for dialysis
facility. The final rule will continue to hold the governing body or
designated person responsible for ensuring an adequate number of
trained and qualified staff.
Comment: More than 15 commenters supported the proposal that an RN
be present in the facility during dialysis (Sec. 494.180(b)(2)). Two
commenters requested that this provision be limited to hemodialysis
because 24-hour RN coverage for peritoneal dialysis patients would be
too burdensome. A few commenters recommended that the final rule
prescribe more than one RN in large units. One commenter suggested that
the final rule state that the RN must not be merely ``available'' but
``a directed patient care giver that provides direct supervision of
care.''
A few providers opposed the proposal that requires the presence of
an RN, stating that an LPN would be sufficient. They suggested that the
nursing shortage would make this provision difficult to meet,
especially in rural locations, and the LPN was capable of fulfilling
this role. They further stated that this provision could force dialysis
facilities to close.
Response: We do not agree with these commenters that the RN
shortages would create an access to care problem. Therefore, we are
retaining the requirement that an RN be present in the facility at all
times that patients were being treated so that a nurse would be
available who had the experience and training to react to patient care
emergencies that could occur in this

[[Page 20435]]

increasingly older and medically-complex patient population. We believe
that the RN has a key role in patient assessment and supervising LPNs,
LVNs, and PCTs, and is the appropriate staff member to be responsible
for the nursing care provided. An RN may also be needed to answer
clinical questions from patients and caregivers. The rapidly changing
demographics of the dialysis patient population has resulted in an
older, sicker patient population with more serious co-morbid conditions
and elevated potential for medical emergencies. An RN has the
professional training and expertise to properly react to emergencies.
Therefore, we believe that having an RN on the premises when treatment
is being provided is a necessary health and safety measure for all
patients.
We agree with commenters that large dialysis facilities caring for
large numbers of dialysis patients simultaneously could require the
presence of more than one RN; however, we are not mandating more than
one RN. The presence of one RN is a minimum requirement and large
dialysis facilities have the flexibility to schedule more than one RN
if patient acuity and the number of patients dialyzing at one time
necessitates it.
The provision at Sec. 494.180(b)(2) regarding RN presence during
dialysis is applicable to in-center dialysis and does not apply to
times when peritoneal dialysis patients are self-dialyzing at home.
While an RN may not be available at the dialysis center at all times
that a patient is performing home dialysis, there must be an emergency
plan for when home patients have an urgent situation, as required at
Sec. 494.180(g). We have clarified the RN presence requirement by
modifying Sec. 494.180(b)(2)(i), to require a registered nurse must be
present in the facility at all times that ``in-center dialysis
patients'' are being treated. We have also added the phrase
``responsible for the nursing care provided'' to further clarify the
role of the RN on duty.
Comment: One commenter asked whether an ESRD facility within a
larger facility needs to have an RN present during dialysis if other
RNs are in the larger facility.
Response: This provision requires the RN to be present in the
dialysis unit regardless of where the facility is located.
Comment: A few commenters suggested that we require medical
director training so that the medical director is fully informed of the
expectations associated with her/his role. One commenter suggested
adding a requirement to properly orient, train, and inform the medical
director.
Response: We agree that the proposed orientation requirement at
Sec. 494.180(b)(3) should apply not only to employees, but also to the
medical director and all dialysis facility staff, regardless of
employee or contractual status. In this final rule, we have modified
this provision to read as follows: ``All staff, including the medical
director, have appropriate orientation to the facility and their work
responsibilities.'' This requirement now applies to all dialysis
facility staff.
Comment: We received several comments regarding the proposed
requirement at Sec. 494.180(b)(4), that ``All employees have an
opportunity for continuing education and related development
activities.''
One commenter suggested deletion of this requirement because
facilities should not be ``obligated'' to provide developmental
activities without funding.
Response: This continuing education provision was previously found
at part 405, subpart U (Sec. 405.2136(c)(3)(viii)), and we are
retaining it in the final rule. This requirement does not represent a
new cost to dialysis facilities, since a normal cost of doing business
is training and developing employees.
Comment: A commenter suggested that Sec. 494.180(b)(4) be revised
to read, ``all employees are provided continuing education and related
developmental activities.'' Another commenter recommended the wording
be modified to state that all employees ``must'' have opportunities for
continuing education. A commenter suggested that we require mandatory
training on quality improvement, quality standards, and the ESRD
Network role. One commenter stated that Sec. 494.180(b)(4) is vague
and should include a requirement for mandatory continuing education for
PCTs.
Response: We do not agree that inserting the word ``must'' after
the word ``employees'' adds clarity. This provision requires the
governing body or designated person responsible to ensure that
employees have the opportunity for continuing education and development
activities, which include education that is provided by the facility as
well as education that is available outside the facility. We have not
modified the wording to more narrowly define the continuing education
opportunities as only those ``provided'' by the facility, nor have we
added prescriptive language to define the areas in which the continuing
education and development activities must occur. The facility has the
flexibility to identify areas on which to focus educational efforts.
Some areas might be identified via the QAPI program. Licensed,
registered, or certified dialysis facility staff must meet certain
ongoing educational requirements to maintain their licensures,
registrations, and/or certifications, which are required under the
``Personnel qualifications'' condition.
Comment: Two commenters suggested that we require mandatory staff
education on the patients' right to be free of verbal abuse by staff,
as there have been ``numerous allegations'' of staff verbally abusing
patients in the absence of such a requirement, and there was a need to
maintain ``professionalism'' in facilities. The commenters stated that
the line of professionalism was often crossed by staff in dialysis
facilities.
Response: We are alarmed about allegations of dialysis patient
abuse by facility staff. Any allegations of abuse should be immediately
reported to the State survey agency and appropriate local authorities.
We agree with the commenter regarding the need for staff to be
knowledgeable about patient rights. A dialysis facility must inform
patients of their rights and the facility must protect and provide for
the exercise of those rights as required under the ``Patients' rights''
condition for coverage at Sec. 494.70. These rights include the right
to respect and dignity (Sec. 494.70(a)(1)). Dialysis facilities must
ensure that patient rights are recognized and protected by all staff
and would therefore need to educate staff regarding patient rights in
order to achieve compliance with the conditions for coverage. Patient
rights must be posted prominently in the facility. In addition, the
medical director at Sec. 494.150(c)(2)(i) must ensure all patient care
staff adhere to all patient care policies. These policies would include
protection of patient rights. We require, at Sec. 494.180(b)(3), that
all staff receive appropriate orientation to the facility and work
responsibilities, which would include patients' rights training.
However, we are not going to mandate that the facility provide training
to staff on this matter because we do not want to prescribe or limit
the orientation topics. Facilities must provide adequate staff training
to ensure that they meet these conditions for coverage.
Comment: Several commenters concurred with the written PCT training
program proposal at Sec. 494.180(b)(5). One commenter was concerned
that dialysis facilities would be allowed to ``police'' their own PCT
training

[[Page 20436]]

programs, which could lead to a lack of consistency and validity.
Response: We appreciate the support for the PCT training
requirements. We discussed PCT qualifications earlier in this preamble
under ``Personnel qualifications.'' We have relocated the PCT training
requirements from Sec. 494.180(b)(5) and Sec. 494.180(b)(6), to Sec.
494.140(e)(3) and Sec. 494.140(e)(4) so that all of the PCT
qualifications may be found in one section of these conditions. We are
requiring national PCT certification in this final rule. The
certification exam would serve as a measure of PCT competency, and
facilities would not be in the position of instituting their own
certification programs.
Comment: We received many comments suggesting revisions to the
content of the PCT training program. A large number of commenters
recommended that we add a PCT training topic regarding patient
psychosocial needs related to ESRD and its treatment regimens, and that
this training be provided by the MSW. A commenter suggested adding
``communication and interpersonal skills, including patient sensitivity
training and care of difficult patients.'' Another commenter suggested
adding training on ethics and professionalism, and dealing with
conflicts and challenging situations. A few commenters suggested PCT
training on patient nutrition and psychosocial needs. One commenter
recommended PCT training regarding possible symptoms and complications
of dialysis, the potential for patients to live long and active lives
on dialysis, and patient expectations.
Response: We do not agree that there is a need to expand the PCT
training subject matter list. The proposed PCT training program
(proposed at Sec. 494.180(b)(5)) included the ``care of patients with
kidney failure, including interpersonal skills'' and ``possible
complications of dialysis.'' ``Care of patients with kidney failure''
(proposed Sec. 494.180(b)(5)(ii)) would include psychosocial and
nutritional aspects of care. The ``interpersonal skills'' training
would include professional conduct and interactions during challenging
situations. The ``complications of dialysis'' (proposed Sec.
494.180(b)(5)(iv)) was already addressed in the proposed training
topics list.
As discussed in the ``Personnel qualifications'' section of this
preamble, we have moved the training list to Sec. 494.140(e)(3). The
training program must be approved by the medical director and the
governing body. We are requiring certification of PCTs to ensure
competency.
Comment: A commenter suggested that we retain all or part of
existing Sec. 405.2136(d) and Sec. 405.2136(g).
Response: Standard 405.2136(d) required written personnel policies
and procedures; and standard (g) addressed medical supervision and
emergency coverage. Section 405.2136, standard (d) required that
facility policies and procedures ensure the following: That all staff
members are qualified to perform their duties; that a safe and sanitary
environment exists for patients and staff; that trainees are directly
supervised; that complete personnel records are maintained; that
personnel policies including grievance policies are written and
available; that all facility personnel are oriented and have continuing
in-service training that is documented, and; that personnel manuals are
maintained, updated, and available.
This final rule addresses staff qualifications at Sec. 494.140,
and a safe and sanitary facility environment is addressed throughout
part 494, subpart B. Facility staff training and educational
requirements are set out at Sec. 494.180(b). In keeping with our goal
of removing process requirements, we are not including personnel policy
provisions in the final rule. Personnel policies and procedures are
maintained as a usual business practice and do not need to be required
by this regulation.
As for former Sec. 405.2136(g), issues of emergency preparedness
and emergency coverage are addressed in this final rule at Sec.
494.60(d) and Sec. 494.180(g), respectively. The substantive elements
of medical supervision are encompassed within the ``Patient
assessment'' (Sec. 494.80), ``Patient plan of care'' (Sec. 494.90),
and ``Medical director'' (Sec. 494.150) conditions.
Comment: One commenter suggested adding a requirement for
facilities to notify the State agency when there are changes in the
governing body make-up, facility location, or medical staff.
Response: We do not believe that these specific procedural
requirements should be included in the final rule. Communications of
this type will be addressed via program instructions or interpretative
guidelines as needed.
Comment: A commenter suggested that we require facilities to report
all unusual incidents to the State agency.
Response: The condition at Sec. 494.20 requires compliance with
relevant Federal, State and local laws, some of which may include
reporting requirements. We did not propose that facilities report
unusual incidents to the state agency, although we are requiring that
the State and ESRD Network complaint phone numbers be prominently
posted (Sec. 494.70(c)). Dialysis facilities must report certain
diseases to the state health department and must report certain
incidents related to equipment failure to the FDA. We have not added
any further reporting requirements to the ``Governance'' condition.
Comment: One commenter suggested that patients be able to nominate
an individual to serve on the facility governing body.
Response: The governing body is an entity with full legal
responsibility and accountability to operate the facility. Dialysis
facilities have the option of having patient representation on their
governing bodies if they choose. We support patient participation and
encourage facilities to include patients in quality assessment and
performance improvement efforts, and as representatives on facility
committees and boards whenever appropriate.
Comment: Several commenters suggested that we add other staff
(physician assistants, nurse practitioners, and clinical nurse
specialists) to the Sec. 494.180(c) list of medical staff that the
dialysis facility would appoint and credential. One commenter stated
that we should only refer to physician credentialing unless State law
allows other professionals to be credentialed.
Response: The proposed rule addressed credentialing for physicians,
physician assistants, and nurse practitioners. We have modified the
language at Sec. 494.180(c)(1) to include clinical nurse specialists
since some dialysis facilities use these professionals. We agree with
the commenter regarding congruency with State law. We have also added
the phrase ``in accordance with State law'' at Sec. 494.180(c)(1) to
indicate that these credentialing requirements do not supersede State
law regarding such ``physician extenders.''
Comment: A few commenters agreed that the governing body should
support medical staff appointments. Two commenters stated the governing
body should authorize and require the medical director to monitor and
improve performance of attending nephrologists.
Response: The proposed language at Sec. 494.180(c)(2) would
require the governing body to ensure that all medical staff who
provided care in the facility were informed of all facility policies
and procedures, including the facility's quality assessment and
performance improvement program. The medical director is accountable to
the

[[Page 20437]]

governing body for the quality of care provided. As discussed earlier
in this preamble we have modified the language at Sec. 494.150 to
include, ``The medical director is accountable to the governing body
for the quality of medical care provided to patients.'' In recognition
of the role of medical staff in providing quality care we have also
added language at Sec. 494.180(c)(3) to require the governing body to
communicate expectations to the medical staff regarding staff
participation in improving the quality of medical care provided to
facility patients. The governing body must ensure that adequate
resources are available to provide quality care. The medical director
is responsible for patient outcomes and must ensure adequate
cooperation from anyone who treats patients in the facility (Sec.
494.150(c)(2)). If the medical director is unable to secure cooperation
from individuals providing treatment, including attending physicians,
the problem should be referred to the governing body. If the governing
body is unable to remedy the problem, the medical director should
notify the state medical board and/or the ESRD Network.
Comment: One commenter suggested that more physician accountability
could be achieved through periodic re-credentialing. Another commenter
stated that facilities had little control over physicians, and
suggested use of hospital credentialing as required by the Medicare
hospital conditions of participation, as a model. The commenter also
stated that if physicians did not participate in QAPI, they should lose
their credentialing.
Response: The hospital conditions of participation at Sec. 482.22
require that the medical staff operate under bylaws approved by the
governing body, be responsible for the quality of medical care provided
to patients, be composed of doctors of medicine or osteopathy and in
accordance with State law, may be composed of other practitioners
appointed by the governing body, conduct periodic appraisals of its
members, examine credentials of candidates and make recommendations to
the governing body based on qualifications established in the medical
staff bylaws, be well organized and accountable to the governing body
for the quality of care.
We believe that the proposed rule has been strengthened via
language in the final rule at Sec. 494.150, ``Responsibilities of the
medical director'' that states, ``The medical director is accountable
to the governing body for the quality of the medical care provided to
patients.'' This is consistent with the hospital conditions of
participation. We have also added language to Sec. 494.180(c) that
states not only is medical staff informed of facility policies and
procedures and the QAPI program, but that the governing body must
communicate to all medical staff the expectations for the role of the
medical staff and required participation in improving the quality of
medical patient care. The governing body has the flexibility to perform
annual credentialing or to choose another credentialing frequency.
During initial credentialing, the governing body should review previous
medical staff positions and whether a physician or physician extender
has had privileges revoked in any other facilities.
Comment: We received two comments regarding Sec. 494.180(d)
``Furnishing services.'' One commenter suggested that we define the
phrase ``(the facility's) main premises'' so as to include home
dialysis, while another commenter would like a loosening of the ``on-
the-premises'' provision to allow ``across the street'' units.
Response: The provision at Sec. 494.180(d) that the governing body
ensure that services are furnished directly on its ``main premises'' or
on other premises that are ``contiguous'' with (that is, not physically
separate from) the main premises, facilitates dialysis facility
accountability for the patient care provided. Therefore, an ``across
the street'' dialysis facility is not considered to be part of another
dialysis facility but an independent facility. As such, it must meet
all these conditions for coverage and be certified to receive Medicare
payment.
Home dialysis services must be provided in the certified dialysis
facility or at the patient's home, unless the patient requests an
alternate location. Home dialysis by definition includes the patient's
home as an acceptable location for the performance of dialysis, and
therefore is an acceptable site for the provision of support services.
Comment: One commenter suggested the final rule state (at Sec.
494.180(e)) that the facility must accept a grievance in any form (oral
or written) presented.
Response: We agree that facilities should not limit acceptance of
grievances to written grievances, and therefore, we have added the
words ``oral or written'' at Sec. 494.180(e) to allow patients more
flexibility in how they communicate a grievance. The sentence now
reads, ``The facility's internal grievance process must be implemented
so that the patient may file an oral or written grievance with the
facility without reprisal or denial of services.''
Comment: Two commenters suggested we require the internal grievance
process to be posted. Another commenter recommended patient involvement
in the design and administration of internal grievance process.
Response: We are not prescribing the manner in which a facility
must make its grievance process known. The facility has the flexibility
to inform patients of the grievance process as required under the
``Patients' rights'' condition at Sec. 494.70(a)(14), using the
methods of its choice.
Comment: One commenter recommended that we require routine
reporting to the ESRD Network on the number and topics of complaints. A
second commenter supported the concept of an internal grievance
process, but suggested the addition of an expectation of timely
investigation, documentation, and resolution, along with a quality
assurance requirement to prevent any recurrences.
Response: Grievances resolved at the facility level might not need
to be escalated to the ESRD Network level. Grievances are to be
addressed in a reasonable fashion in a reasonable period of time. The
grievance process must include a clearly explained procedure for the
submission of grievances, timeframes for reviewing the grievance, and a
description of how the patient or the patient's designated
representative will be informed of steps taken to resolve the
grievance. Dialysis facilities must track grievances and patient
satisfaction as part of the QAPI program in which trending and quality
improvement efforts are expected (Sec. 494.110(a)(2)(viii)).
Comment: We received many comments supporting proposed Sec.
494.180(f), ``Discharge and transfer policies and procedures.'' Several
commenters endorsed the preamble language regarding the
inappropriateness of patient discharges for non-compliance and
recommended that we add language to the final rule stating that a
patient cannot be discharged for non-compliance. A commenter stated
that non-compliance could be due to lack of education on the effects of
non-compliance. A few commenters suggested that recommendations from
``Decreasing Dialysis Patient-Provider Conflict National Task Force
Position Statement on Involuntary Discharge'' developed by a national
consensus conference held in October of 2003, be included. The report
stated that patient non-adherence to the medical regimen was not an
appropriate reason to discharge a patient, primarily because this type
of behavior mainly

[[Page 20438]]

harmed the patient himself and not others, and because the patient
could exercise his right to non-adhere to instructions. One commenter
recommended that we include in the final rule the key elements from
this report, which include the facility's right to refuse to treat
violent, physically abusive patients; a physician right to terminate
care only after taking ethical steps; and the recognition that both the
unit and physician have legal obligations.
Some commenters stated that when an attending physician discharges
a patient from care and another physician is not found to take over the
patient's medical care, the dialysis facility has no choice but to
discharge the patient. One commenter stated discharge should be allowed
for patients whose behavior interferes with the plan of care, including
non-compliance.
Response: The background section of the ``Decreasing Dialysis
Patient-Provider Conflict National Task Force Position Statement on
Involuntary Discharge'' (http://www.esrdnetwork8.org/assets/pdf/DPCPositionStatement06.pdf), adopted by the task force in January 2005,
provides data on involuntary discharges. The number of involuntary
discharges in 70 percent of dialysis facilities in 2002 was 458 (0.2
percent of 285,982 patients). ``Treatment non-adherence was the leading
reason for discharge nationally at 25.5 percent (117 patients),
followed by verbal threat at 8.5 percent (39 patients). Other reasons
for discharge were lack of payment at 5.2 percent (35 patients),
combinations of verbal abuse, verbal threat and physical threats at 5.2
percent (24 patients) and verbal abuse at 5 percent (23 patients).''
The report also stated that discharged patients were at high risk for
morbidity and mortality and an unknown number of deaths have occurred
due to lack of access to dialysis.
Patients may be involuntarily discharged for non-compliance by
their physician because physicians have a right to end an established
care relationship with a patient after providing the patient adequate
notice (30 days) of the termination of the medical care and reasonable
assistance in obtaining care elsewhere. If a physician discharges a
patient from his or her personal care, the dialysis facility should
locate another attending physician in the facility to provide ESRD
care, or discharge the patient from the facility following the process
required at Sec. 494.180(f)(4).
The proposed rule preamble (70 FR 6202) stated, ``We would not
expect a patient to be involuntarily discharged from a dialysis
facility for failure to follow the instructions of a facility staff
member.'' Facilities are expected to make ``good faith'' efforts to
mitigate problems and prevent an involuntary discharge. The proposed
circumstances under which involuntary discharge would be permissible,
laid out at Sec. 494.180(f)(1) through Sec. 494.180(f)(4) were: Lack
of payment; facility closes; the transfer is necessary for the
patient's welfare because the facility can no longer meet the patient's
documented medical needs; or the facility has reassessed the patient
and determined that the patient's behavior is disruptive and abusive to
the extent that the delivery of care to the patient or the ability of
the facility to operate effectively has been seriously impaired.
The previous conditions for coverage at Sec. 405.2138(b)(2),
stated that patients could be transferred or discharged only for
medical reasons or for the patient's welfare or that of other patients,
or for nonpayment of fees (except as prohibited by title XVIII of the
Act) and that facilities would have to provide the patients with
advance notice to ensure orderly transfer or discharge. Neither the
proposed rule nor subpart U encouraged the involuntary discharge of
patients because of patient non-compliance. Aside from a minor
grammatical change we have not modified the proposed language regarding
the permissible conditions for an involuntary patient discharge in this
final rule. This final rule requires that if there is a problem with
non-compliance, the problem must be addressed in the plan of care and
facility staff must take appropriate actions. Patient education and
social work interventions may be appropriate. The facility must weigh
the ethical issues regarding the discharge of a patient from a life-
saving therapy against the gravity and consequences of any non-
adherence problem.
Immediate discharge is addressed under ``Patients' rights'' in this
final rule at Sec. 494.70(b)(2) and at Sec. 494.180(f)(4) and Sec.
494.180(f)(5). Under Sec. 494.70(b)(2) the patient has the right to
receive written notice 30 days in advance of the facility terminating
care after following the procedure described in Sec. 494.180(f).
Moreover, in the case of immediate threats to the health and safety of
others, an abbreviated discharge procedure may be allowed. There may be
situations where a patient's behavior is so egregious that a facility
must discharge a patient with less than 30 days notice or even
immediately. The facility must weigh the safety and care of other
patients and staff against the consequences of continuing to provide
dialysis care or conducting an expedited discharge of the patient from
a lifesaving therapy. We proposed a process, which is retained in this
final rule, that must be adhered to before a patient with disruptive or
abusive behavior may be discharged.
We encourage facilities to use the materials and tool kit developed
by the ``Decreasing Dialysis Patient-Provider Conflict National Task
Force'' to proactively prevent conflicts and disruptive situations and
to undertake appropriate actions when involuntary discharge is being
considered. This kit is available from the ESRD Networks.
Comment: One commenter suggested revising proposed Sec.
494.180(f)(3) to permit transfer under that paragraph when the transfer
is necessary for the patient's welfare because the facility can no
longer meet the patient's medical needs and goals as documented in the
patient's plan of care as specified in Sec. 494.90.
Response: The suggested additional phrase defines the medical needs
as those specified in the plan of care and would therefore permit a
facility to involuntarily discharge a patient if he/she did not meet
care plan goals. We believe that the term ``medical needs'' is commonly
understood and do not believe that failure to meet the plan of care
goals should result in discharge of a patient. We are making no changes
to this provision based on this comment.
Comment: A commenter recommended revising Sec. 494.180(f)(4)(iii)
to read, ``The governing body of facilities approached to accept the
patient must ensure that the patient is not summarily declined a
transfer without following the individual facility's policies and
procedures for patient admission (including patient interview and
medical records review, if applicable).''
Another commenter recommended the addition of a requirement for a
facility admission policy that discourages discrimination. The
commenter asked that our regulations address admission restrictions and
discharges of patients who require a higher level of skilled care
(ventilator, bed-bound, morbidly obese) since some current practices
have caused access-to-care problems.
Response: Dialysis facilities should not deny admission to their
facilities because they ``heard'' the patient was a ``problem'' without
assessing the patient. Patient privacy rules must be observed and the
admission review should include medical record information and not
``hearsay.''

[[Page 20439]]

Facilities should assess the medical needs of patients and the
facility's ability to meet these medical needs. Facilities must comply
with federal civil rights and anti-discrimination laws as required in
Sec. 494.20. Under our previous regulation, the facility was required
to have admission criteria that insured equitable access to services,
and to make such criteria readily available to the public (Sec.
405.2136(b)(3)). While we did not carry forward this provision in the
proposed rule, in the final rule, we are holding the medical director
responsible for the development, review, approval, and staff adherence
to facility policies and procedures (Sec. 494.150(c)). Because
facility admission policies would fall under the responsibilities of
the medical director, we have added ``patient admissions'' to the list
of policies and procedure categories for which the medical director is
responsible (Sec. 494.150(c)(2)(i)). Dialysis facilities should offer
equitable patient access to their facility and should have well defined
ethical and legal admission policies. Facilities will be expected to
adhere to their written admission policies.
Comment: One commenter agreed that both the governing body and the
medical director should be responsible for ensuring that the facility
complies with the involuntary patient discharge process. Another
commenter suggested that only the governing body should be responsible.
Response: We believe that both the medical director and the
governing body have an obligation to ensure that the facility
appropriately conducts involuntary patient discharges.
Comment: Two commenters suggested adding ``patient choice'' to
reasons for discharge so that when a dialysis patient voluntarily
leaves, the facility does not have to implement the involuntary
discharge procedure.
Response: We have renamed Sec. 494.180(f) to include the word
``involuntary.'' The new title is ``Involuntary discharge and transfer
policies and procedures.'' This clarifies that these provisions
specifically apply to involuntary discharges, not all dialysis facility
discharges.
Comment: A few commenters supported our proposal at Sec.
494.180(f)(4)(ii), which would require both the attending physician and
the medical director to sign an involuntary discharge order. One of the
commenters stated that some patients have been involuntarily discharged
from a dialysis facility without the attending physician's knowledge. A
few other commenters suggested that one, not two physicians (attending
physician and medical director), provide the discharge signature.
Another commenter suggested that we only require the medical director's
signature for involuntary discharges only.
Response: An involuntary discharge of a patient from dialysis, a
life-saving therapy, is a last-resort action that can have grave
consequences. We believe the responsibility for, and obligations to,
the patient, are shared between the attending physician and the
dialysis facility. In this situation, the medical director represents
the dialysis facility. The medical director and the attending physician
should concur that the last resort approach is needed before
discharging the patient; otherwise, the involuntary discharge should
not occur.
We agree that the medical director's discharge signature is only
necessary when the discharge is involuntary. We have renamed standard
(f) ``Involuntary discharge and transfer policies and procedures.''
This clarifies that these provisions apply to involuntary discharges,
and not all dialysis facility discharges. The signature requirement has
been redesignated in the final rule as Sec. 494.180(f)(4)(ii).
Comment: Commenters offered varying interpretations of how
facilities may satisfy the requirement at Sec. 494.180(f)(4)(iii)
regarding attempts to place the patient in another facility and
documentation of that effort. One commenter stated that a ``good faith
effort'' in finding a new facility should be enough, and the facility
should not be held accountable for a patient's bad choices. Another
commenter agreed, saying that facilities should document their attempt
to place the patient in a new facility, and in some cases, difficult
patients should make his or her own arrangements. Two commenters
requested clarification of what would be required, and stated their
belief that the responsibility for finding an alternate facility rested
with the patient. Some commenters stated the facility should be
required to provide a list of other nearby dialysis facilities and
assistance with the transfer.
A few commenters suggested that the facility demonstrate its
attempt to find an alternate placement ``by direct contact with the
other facility.'' This suggestion is consistent with the ``Decreasing
Dialysis Patient-Provider Conflict National Task Force''
recommendations. Another commenter recommended inclusion of a
requirement for the discharging facility to make arrangements and pay
for treatment at a hospital for the services they are refusing to
provide, until a hearing is held.
Response: In response to comments, we have revised the provision to
require that the facility must contact an alternate dialysis facility
to attempt to place the patient who is involuntarily discharged and
must document that effort.
Comment: We received several comments regarding the requirement at
proposed Sec. 494.180(f)(4)(iv) that the facility notify the State
survey agency and the ESRD Network of an involuntary discharge. Several
commenters suggested that we require ESRD Network involvement or a
mandatory ESRD Network referral before an involuntary discharge. Two
commenters said there should be Network notification 48 hours prior to
an involuntary discharge. A commenter stated that notifying the State
agency and the Network after the fact was too late; community human
services agencies should be notified earlier in the process, in order
to provide resource support to help prevent an involuntary discharge.
Response: We agree that the ESRD Network could be of more
assistance in acting as a resource and resolving problems leading up to
an involuntary discharge if notification were provided prior to the
discharge. The proposed rule required notification of the State survey
agency and the ESRD Network of the involuntary transfer or discharge
without specifying when notice would be given. We have modified
standard (f) to include a new requirement, now at Sec.
494.180(f)(4)(ii) in this final rule, so that the facility must now
notify its ESRD Network within the same time frame in which the patient
is given written notice of the involuntary discharge (that is, 30
days). The proposed provisions at Sec. 494.180(f)(4)(ii) through Sec.
494.180(f)(4)(iv) have been renumbered in this final rule to reflect
the insertion of the new paragraph (ii).
Comment: A few commenters suggested that the ESRD Network be
involved in performing audits, patient placement, arbitration, and in
finding alternate solutions related to dialysis facility grievances
related to involuntary discharges.
Response: The extent of the role of the ESRD Network in involuntary
discharges is defined by the ESRD Network scope of work. It would be
inappropriate in these conditions for coverage to address Network
authority or responsibilities.
Comment: One commenter stated the ESRD Network should be allowed to
notify the State survey agency so the facility does not have to call
both entities. Another commenter stated that notification of both State
and Network

[[Page 20440]]

is too burdensome, and one (the ESRD Network) should be enough.
Response: We believe the burden of notifying both the ESRD Network
and the State survey agency represents an acceptable level of burden.
We have retained ESRD Network and State agency notification of an
involuntary patient discharge in the final rule.
Comment: A commenter suggested facilities be encouraged to develop
and share discharge criteria with patients to ensure they are fully
informed of expectations, policies, and procedures.
Response: We refer the commenter to the ``Patients' rights''
condition. Patients have the right to be informed regarding the
facility's discharge and transfer policies as required at Sec.
494.70(b). Facilities must also inform patients of the rules and
expectations of the facility regarding patient conduct and
responsibilities (Sec. 494.70(a)(13)).
Comment: A few commenters recommended the addition of a final rule
provision that would allow immediate patient discharge when an
immediate serious physical threat to staff or patients exists. Two
commenters noted that in these cases, there must be thorough
documentation and a police report is normally filed.
Response: The proposed rule preamble (70 FR 6202) discussion
recognized that there may be occasions when an immediate or an
abbreviated patient discharge process may be appropriate in order to
protect other patients and staff. We agree that it is reasonable to add
language under the discharge standard in Sec. 494.180. We also note
that there may be instances when local law enforcement officials must
be notified of questionable behavior. Therefore, in response to
comments we have modified Sec. 494.180(f) by adding, at (5) ``In the
case of immediate severe threats to the health and safety of others,
the facility may utilize an abbreviated involuntary discharge
procedure.'' This abbreviated procedure allows less than a 30-day time
period for the discharge notice. The facility must still provide
patient assessment, interventions, and an effort for resolution to the
extent possible based on the unique situation. Documentation in the
medical record of the events leading up to the involuntary discharge is
required in every case.
Comment: Two commenters suggested the addition of language to Sec.
494.180(f)(4)(i) that would require counseling and support from the
team to resolve patient behavioral issues and also require that the
team inform patients of behaviors that could lead staff to notify
police or referral for evaluation of risk to self or others. Some
commenters stated there should be social worker involvement before a
patient is involuntarily discharged. Another commenter suggested that
we add a condition that no patient be involuntarily discharged except
in an emergency situation without documentation that a program was
implemented to resolve inappropriate behavior.
Response: The involuntary patient discharge requirements at Sec.
494.180(f)(4)(i) address reassessments, ongoing problems, efforts made
to resolve the problem, and documentation in the patient's medical
record. These ``efforts made to resolve the problem'' may include
counseling and support from the team to resolve behavioral issues. We
are not narrowly defining or specifying what the ``efforts made to
resolve the problem'' must encompass, as patient needs vary. The team
must assess the patient and use appropriate interventions that address
the patient's individual issues.
As stated above, patients have the right to be informed regarding
the facility's discharge and transfer policies as required at Sec.
494.70(b), which include policies regarding notification and referrals.
Comment: We received a few comments regarding Sec. 494.180(g)(3),
``Emergency coverage.'' Some commenters supported our proposed
requirement that each ESRD facility have an agreement with a hospital.
One commenter suggested including a provision requiring that the
agreement address psychiatric emergencies. Two commenters recommended
requiring the facility to make an agreement only with hospitals that
had the ability to provide inpatient dialysis, which the commenter
argued was especially important in rural areas. One commenter stated
that patients needed to know about the nature of the relationship
between the dialysis unit and the hospital under agreement to provide
emergency services.
A commenter stated that this provision should require the dialysis
facility and hospital to agree to provide mutual aid in the event of a
large disaster and suggested that each unit have one or more ``mutual
aid agreements'' with other facilities both near and far. The commenter
stated that the issues facing ESRD patients in the event of a disaster
are not often considered by emergency planners.
Another commenter questioned the need for an agreement with a
hospital, stating that hospitals were reluctant to enter into such
agreements and that such agreements were not required of hospitals in
their conditions of participation.
Response: The proposed provision regarding the hospital agreement
is less prescriptive than part 405, subpart U requirement formerly
found at Sec. 405.2160. Instead of including process-oriented
requirements, we proposed a requirement that was aligned with our
intent to ensure access to suitable inpatient care for dialysis
patients. We agree with the commenter that dialysis care should be
available in any hospital with which an agreement is made. We have
revised the final rule to require that dialysis facilities must have an
agreement with a hospital that can provide routine and emergency
dialysis services, and to specify this in the agreement. The provision
at Sec. 494.180(g)(3) now reads, ``The dialysis facility must have an
agreement with a hospital that can provide inpatient care, routine and
emergency dialysis and other hospital services, and emergency medical
care which is available 24 hours a day, 7 days a week * * *.''
One commenter (a state survey agency) noted that hospitals were
often reluctant to enter into agreements with dialysis facilities, but
no dialysis facilities related any difficulties in this regard in their
comments. Therefore, we do not believe that this is a barrier to
dialysis facility compliance with this provision.
Our final rule at Sec. 494.60(d)(4)(iii) requires a dialysis
facility to contact its local disaster management agency to make the
agency aware of dialysis facility needs in the event of an emergency.
This provision will ensure at least annual communication between the
dialysis facility and the local disaster management program. We believe
this addresses the commenter's concern about lack of contact with
emergency planners.
Facilities also have the flexibility to include any of the
additional commenter suggestions when writing their agreements and to
communicate emergency services arrangements with patients as
appropriate. We are not mandating these processes in this final rule.
Comment: We received many comments regarding proposed Sec.
494.180(h), ``Furnishing data and information for ESRD program
administration,'' which would require a dialysis facility participating
in Medicare to furnish data and information electronically and in
intervals specified by the Secretary. These data would include cost
reports, administrative forms, patient survival data, ESRD clinical
performance measures and any future standards developed in accordance
with the

[[Page 20441]]

NTTAA process adopted by the Secretary.
Many commenters expressed support for the proposed electronic data
collection. Some commenters recommended expansion of the ``Dialysis
Facility Compare'' Web site at http://www.cms.hhs.gov/dialysisfacilitycompare/ to include all data collected, home dialysis
data, measurements of patient satisfaction, other relevant lab data,
and facility aggregate functioning and/or well-being data.
Several commenters had concerns regarding the burden associated
with electronic data collection. Two commenters stated that VISION
(Vital Information System to Improve Outcomes in Nephrology) is not
ready for full implementation and may not be universally applicable,
and therefore a data collection requirement should be delayed.
One commenter stated that electronic reporting would duplicate the
information collected by large dialysis organization information
technology systems. A few commenters recommended that only one of
electronic or paper data collection should be required, as both would
be too burdensome. One commenter suggested that a timeline was needed
to implement electronic reporting.
One commenter stated that providers should have the opportunity to
provide input when CMS defines data collection efforts.
Response: The proposed rule would require the electronic submission
of data necessary for CMS administration of the Medicare ESRD program.
These electronic data specifically include administrative data
(including, but not limited to the CMS-2728, Medical Evidence/Medicare
entitlement form data and CMS-2746, ESRD death notification data, and
the United States Renal Data System data) and the existing ESRD
Clinical Performance Measures (CPM) data (CMS-820 and CMS-821), and any
data necessary for future performance measures developed in accordance
with a voluntary consensus standards process identified by the
Secretary.
This final regulation requires facilities to provide data and other
information that are necessary to support administration of the ESRD
program. In order to increase efficiencies and improve the usefulness
of these data, we are requiring electronic submission of necessary
administrative data as well as specified data for calculation of ESRD
CPMs.
This electronic data collection is consistent with the IOM's
recommendation that ``* * * the Department of Health and Human Services
should move forward expeditiously with the establishment of monitoring
and tracking processes for use in evaluating the progress of the health
system in pursuit of the above-cited aims'' (IOM 2001). It is also
consistent with White House Executive Order 13410, Promoting Quality
and Efficient Health Care in Federal Government Administered or
Sponsored Health Care Programs, issued on August 22, 2006, which
states:

``Each agency shall implement programs measuring the quality of
services supplied by health care providers to the beneficiaries or
enrollees of a Federal health care program. Such programs shall be
based upon standards established by multi-stakeholder entities
identified by the Secretary or by another agency subject to this
order. Each agency shall develop its quality measurements in
collaboration with similar initiatives in the private and non-
Federal public sectors.''

(http://www.whitehouse.gov/news/releases/2006/08/print/20060822-2.html)
(71 FR 51089.)
Finally, it is consistent with recommendations from various
governmental bodies that provide oversight of the Medicare program. For
example, in a recent report (OEI-05-05-00300) titled ``Availability of
Quality of Care Data in the Medicare End-Stage Renal Disease Program,''
the Department of Health and Human Services' Office of the Inspector
General (OIG) recommended that CMS ``increase its efforts towards
regularly collecting data from all patients and all facilities on all
clinical performance measures identified by CMS to address quality of
care issues in the ESRD program'' (HHS/OIG 2006). We have received
recommendations to require facilities participating in Medicare to
report on performance measures to stimulate improvements in the quality
of care and to achieve a greater degree of accountability for
performance. These recommendations come from the OIG in its reports
``External Quality Review of Dialysis Facilities/A Call For Greater
Accountability'' and ``Availability of Quality of Care Data in the
Medicare End-Stage Renal Disease Program'' (DHHS/OIG, 1999, 2006); from
the IOM in its report ``Crossing the Quality Chasm, 2001'' (IOM, 2001);
from the Medicare Payment Advisory Commission (MedPAC) in its report
``Improving Quality Assurance for Institutional Providers'' (MedPAC,
2000); and from the Government Accountability Office (GAO) in its
report ``Dialysis Facilities: Problems Remain in Ensuring Compliance
with Medicare Quality Standards'' (GAO, 2004). The requirement to
submit data necessary to calculate specified CPMs is an important step
in moving in this direction.
The electronic data provided to CMS will be used to monitor the
performance of the public health system and dialysis facilities
certified to care for Medicare beneficiaries with ESRD. The data will
also be used to provide information to individuals who have or may
develop ESRD and their caregivers to assist them in making health care
decisions; to allow the identification of opportunities for quality
improvement at a national, regional, or dialysis-facility level; and to
help align our payment system with high-quality care through
improvements in case-mix adjustment and the potential future use of
payment for performance.
CMS, the ESRD Networks, dialysis facilities, and other interested
stakeholders have used the ESRD CPMs to assess the care of a
representative sample of individuals with ESRD in the areas of adequacy
of dialysis, anemia management, nutrition (serum albumin), and more
recently, vascular access (Centers for Medicare & Medicaid Services.
2005 Annual Report, End-Stage Renal Disease Clinical Performance
Measures Project. Am J Kidney Dis 48:S1-106, 2006 (supp. 2)). CMS
developed the ESRD CPMs to implement section 4558(b) of the Balanced
Budget Act of 1997 (Pub. L. 105-33), which required the Secretary to
develop and implement a method to measure and report on the quality of
renal dialysis services provided under Medicare no later than January
1, 2000. These measures were developed based on widely accepted,
evidence-based clinical practice guidelines and were subsequently used
to guide national, regional, and facility based quality improvement
efforts.
Beginning in the mid-1990s, the National Kidney Foundation's
(NKF's) Dialysis Outcomes Quality Initiative (DOQI) development process
released guidelines to help shape the development of clinical measures
based on strength of evidence, clinical importance and feasibility. The
NKF has since expanded and updated their early efforts and their Kidney
Disease Outcomes Quality Initiative (K/DOQI) guidelines are widely
accepted among the renal community. These may be a source of potential
future CPMs that can be developed and supported by a broad cross-
section of stakeholders, including clinical practitioners, industry
representatives, professional associations, and others interested in
assessment and improvement of the care provided to individuals with
ESRD.

[[Page 20442]]

We proposed using the VISION application for the provision of
electronic data but based on technological advances and public
comments, we are implementing a new Web-based system, Consolidated
Renal Operations in a Web-enabled Network (CROWNWeb), for this purpose.
VISION was a patient-specific, stand-alone, facility-based information
system with software that resides on facility computers, which presents
challenges for updating the software. We agree with commenters that
VISION did not represent the best technology for widespread collection
of data from dialysis facilities and large dialysis organizations.
Use of the CROWNWeb system will increase the efficiency of data
collection both for CMS and for facilities, improve data quality, and
provide a more stable and accessible platform for continual
improvements in functionality. It will also complement the advanced
information infrastructure used by many dialysis facilities.\1\ We
believe that CROWNWeb will not duplicate information technology systems
in large dialysis organizations, but will facilitate data reporting and
provide efficiencies.
---------------------------------------------------------------------------

\1\ This advanced information capability is detailed in the 2002
OIG series, ``Clinical Performance Measures for Dialysis
Facilities,'' OEI-01-99-00052.
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We believe that the collection and reporting of ESRD CPMs has been
an effective tool to facilitate ESRD quality improvement, and has
allowed us to track positive improvements in several intermediate
outcomes for individuals with ESRD. Therefore, we are requiring under
the ``Governance'' condition for coverage (Sec. 494.180(h)), that the
ESRD CPMs in effect on the date of the Final Rule's publication be
included as the initial set of CPMs that all ESRD facilities are
required to collect for all individuals with ESRD and submit to us
electronically. We will carefully evaluate any revisions to current
CPMs as well as any future CPMs developed in accordance with a
voluntary consensus standards process for possible inclusion in these
electronic reporting requirements. The Secretary will provide notice
and an opportunity for comment in the Federal Register before any
changes to the electronic reporting requirements based on the CPMs are
enacted.
We recognize that electronic data reporting may result in some
additional facility burden. However, the availability of batch data
reporting will reduce the level of burden. We believe that there is a
return on this investment for all primary stakeholders, including
patients, dialysis facilities, and the public. CROWNWeb will allow for
the more timely, accurate, and efficient use of data to support
administration of the ESRD program by replacing the current
predominately paper process with an electronic process that considers
the capabilities of providers, which has tangible benefits for dialysis
facilities, individuals who have or may develop ESRD, and other
stakeholders. CROWNWeb provides facilities with the ability to submit
the required data directly from their electronic health records, thus
reducing burden and freeing facility personnel to concentrate on
patient care. Another expectation is that claims payment will be
improved due to improved quality and timeliness of patient eligibility
and enrollment information. Finally, we expect that the new system will
provide reports that will allow facilities to compare themselves with
their peers.
CROWNWeb will also increase the transparency of the health care
system for patients and thus, help empower patients to find better
health care value and better health care quality as well as help assure
appropriate patient access to care. For ESRD Networks, CROWNWeb will
provide more timely, accurate, and complete information to inform
quality improvement, and it would reduce Network resource use for data
collection activities. For example, CROWNWeb will be able to recreate
the data included on the current CMS 2744 Annual Facility Survey more
timely as opposed to on the last day of the year and it would free up
Network resources that currently perform a four-month manual
reconciliation process. In addition, for all primary stakeholders, we
expect that the new system will provide more timely report capabilities
that will allow them to compare individual facilities and facility
groups with various peer groups, national, and local benchmarks.
In February 2007, CMS' Quality Infrastructure Support (QIS)
contractor held its first CROWNWeb CPM technical expert panel, which
represented initial CROWNWeb users, including large and small dialysis
organizations, dialysis professional societies, ESRD Networks, CMS, and
associated Federal contractors, to survey primary stakeholders about
desired/expected performance attributes of CROWNWeb relative to the
CPMs, including feedback reporting. Based on the input received from
members of the panel as well as ongoing input from the community at
large through either publicized monthly calls and/or e-mail
([email protected]), CMS' QIS contractor developed draft business
requirements, which CMS evaluated, approved, and forwarded to its IT
contractor for incorporation into CROWNWeb.
CROWNWeb will also facilitate greater transparency for patients
through more timely, accurate, and complete reporting. In September
2002, CMS contracted with the Research Triangle Institute to conduct an
evaluation of the content of DFC. The Final Report of the Evaluation of
the Content Dialysis Facility Compare as submitted to CMS in March of
2004 (http://www.cms.hhs.gov/DialysisFacilityCompare/03_Evaluation%20of%20DFC.asp.) A revised version of the Web site, based on
findings from the evaluation and integrating more user-friendly ``next
generation compare'' software, was posted in June 2004 and CROWNWeb
will provide the infrastructure so that DFC can provide additional
value for persons who have or may develop ESRD and the caregivers who
assist them in making health care decisions.
The electronic collection and reporting of CPM data via CROWNWeb
for all individuals with ESRD will add significant value for facilities
and individuals who have or may develop ESRD in three ways:
1. Validation and comparative reports can be viewed more timely
once the data submission is complete since the CPM data are
electronically available.
2. There is no claims time lag because the CPM measures are
computed using clinical as opposed to administrative and claims
information.
3. Facilities can see facility-specific information that compares
themselves to various peer groups because the CPM data cover all
Medicare-certified dialysis facilities and will include all patients.
While submission of data and information is an existing requirement
in Sec. 405.2133 and electronic submission of cost report data and
information is an existing requirement in Sec. 413.24, the requirement
to provide CPM data is new. Additionally, the requirement to provide
necessary administrative data in electronic format is a change from the
paper-based process that has historically been used to support the ESRD
program.
Initially, the data will consist of information necessary to
calculate the ESRD CPMs and administrative data elements from existing
data collections in effect as of publication of this final rule. In
response to community input requesting time to get their information
systems aligned with this new requirement as well as train necessary
resources, we will delay the requirement for reporting the data

[[Page 20443]]

necessary to calculate the specified CPMs and other administrative data
using the CROWNWeb system until February 1, 2009. Thereafter, all
facilities must collect and report on an ongoing basis the necessary
administrative data, and the CPM data at least annually for all
eligible ESRD patients via CROWNWeb as specified by CMS. In the
interim, dialysis facilities will use existing processes to collect and
report necessary administrative data and data necessary to calculate
ESRD CPMs for individuals with ESRD that are included in the national
ESRD CPM sample. Thus, 2008 will be the last year we will collect data
to calculate the existing ESRD CPMs on a 5 percent representative
sample to fulfill section 4558(b) of the Balanced Budget Act of 1997
(Pub. L. 105-33). In 2009, we will be requiring facilities to collect
and report CPM data on all ESRD patients in their facilities.
In order to provide support for facility-based quality assurance
and performance improvement as specified in Sec. 494.110, facilities
may voluntarily submit specified CPM data via CROWNWeb more frequently
than annually. In order to support national quality improvement efforts
(for example, the Fistula First Breakthrough Initiative) as specified
in the Relationship with the ESRD Network condition at Sec.
494.180(i), facilities may be required to submit data for a subset of
specified CPMs more frequently than on an annual basis. Thus,
facilities may provide a more frequent subset of data either
voluntarily or as required as part of a national quality initiative,
but we will only require the submission of the complete set of data
necessary to calculate specified CPMs on an annual basis in this final
rule.
In response to the comment regarding including providers' input as
we define data collection efforts, CMS and the ESRD Networks have a
history of collaboratively working with the ESRD community on improving
data quality. Between 2003 and 2005, CMS and the ESRD Networks
partnered with the ESRD community to develop the Core Data Set, which
created a common ``kidney data dictionary'' complete with standardized
data elements, data definitions, and integrity constraints necessary
for ESRD Networks to conduct quality improvement oversight activities
and for CMS to conduct ESRD Program oversight activities.
In 2006, CMS funded a Quality Infrastructure Support (QIS)
contractor to solidify the early work of the Core Data Set by
soliciting ongoing input from the ESRD Networks and other stakeholders
and summarizing it in recommended business requirements to CMS for the
new information system. The process the QIS contractor used for
incorporation of community input is referred to as CRAFT (CROWN
Responsiveness and Feedback Tree) and includes public presentations
(available at http://www.esrdnetworks.org/2007CMSForumAMpresentations.htm), monthly calls, technical expert
panels, an e-mail suggestion box, focus groups, and site visits.
CROWNWeb supports the following existing systems, all of which will
be integrated by CROWN, thus reducing the federal cost of administering
the ESRD program.
The ESRD Standard Information Management System (SIMS).
SIMS supports the business processes of the ESRD Network Organizations
and allows data exchange among the Networks, the facilities and CMS via
a secure, web-enabled environment called the ``QualityNet Exchange.''
The Renal Management Information System (REMIS). REMIS
determines the Medicare coverage periods for ESRD patients and serves
as the primary mechanism to store and access information in the ESRD
program Management and Medical Information System Database. REMIS
includes an operational interface to the SIMS Central Repository.
(REMIS replaces REBUS, the mainframe Renal Beneficiary and Utilization
System.)
CROWNWeb uses an encryption technology that assures privacy,
confidentiality, and security for electronic communications and is
consistent with applicable HIPAA and Privacy Act statutes and related
regulations and would be available free-of-charge to all dialysis
facilities with Internet access. CROWNWeb also meets applicable
security criteria included in the CMS Information Security Acceptable
Risk Safeguards (ARS) policy (http://www.cms.hhs.gov/InformationSecurity/14standards.asp#TopOfPage) which contains a broad
set of CMS security controls based upon National Institute of Standards
and Technology (NIST) requirements. We have further improved CROWNWeb's
efficiency, functionality, and timeliness by working with dialysis
organizations to develop a mechanism for accepting batch data
submittals.
Comment: Two commenters stated that large dialysis organizations
should not have to subsidize the small independent dialysis facility
electronic data collections.
Response: We assume the commenters are referring to the proposed
rule preamble discussion (70 FR 6231 and 70 FR 6241). The VISION
software was intended to be available to all dialysis facilities. If an
LDO opted not to use VISION, then file specifications would be
developed and this approach might result in costs to those dialysis
facilities. We are no longer planning to use the VISION software and
our approach does not call for LDOs to ``subsidize'' small independent
facilities.
Comment: We received several comments regarding the content of the
clinical performance measures. One commenter stated support for using
the same CPMs for home patients and in-center patients. Another
commenter suggested that special consideration be given to small rural
units and that we consider case-mix when developing new measures.
Some commenters suggested the addition of one of the following
indicators for use as CPMs: Depression scale scores, infection control
measures, K/DOQI Bone metabolism and renal bone disease, patient
functioning and well being, and ESRD Network 9/10 technical expert
panel recommended transplant referral measures.
Response: The development of new CPMs is not carried out via the
conditions for coverage. Historically, we have funded the development
of measures by contracting with an organization that possesses the
technical knowledge and skills and who convenes a TEP to assist them in
the development of the measures or in the review of the science or
guidelines to determine when existing measures need to be updated.
Facility-level measures that would be enforced under the conditions for
coverage would be developed in compliance with the National Technology
Transfer and Advancement Act of 1995 (NTTAA) by a voluntary consensus
standards body (Sec. 494.180(h)(3)(iv)). This process allows
transparency as the facility-level measures and thresholds are
developed. The implementation of new facility-level measures adopted by
the Secretary will be done via a future rulemaking process, which will
allow for public comment.
Comment: One commenter stated that an outcomes approach requires
measures and standards. Several commenters supported the proposal to
develop federal standards using a voluntary consensus standards body as
described by the NTTAA. Another commenter suggested that any changes in
the CPMs should be done in partnership with nephrologists and key
stakeholders in the renal community. One commenter stated voluntary
consensus standards and quality thresholds should be defined by actual

[[Page 20444]]

data distributions of outcomes of each parameter, denoting thresholds
at one and two standard deviations. The commenter stated clinicians
would support this approach.
Response: We agree that an outcomes approach requires measures and
standards. The proposed process of using a voluntary consensus
standards body to arrive at facility-level standards has been retained
in the final rule. Nephrology experts and stakeholders should
participate in the voluntary consensus standards process in which the
development of facility-level thresholds would occur. Public comment
will also be invited during the rulemaking process that implements the
facility-level measures that are adopted by the Secretary.
Comment: One commenter suggested that ownership information be
available to any member of the public upon request.
Response: The proposed requirement at Sec. 494.180(i) has been
moved to now Sec. 494.180(j), regarding disclosure of ownership, which
is consistent with Sec. 420.200 through Sec. 420.206. Information
subject to public disclosure is addressed at Sec. 420.206(a). The
public may request current dialysis facility ownership information from
the State survey agency. We also refer the commenter to 42 CFR
431.115(e)(4) and Sec. 455.104 which describe Medicaid and State
Children's Health Insurance Program ownership disclosure provisions,
respectively.
As stated previously in this section, we will delay the requirement
for reporting the data necessary to calculate the specified CPMs and
other administrative data using the CROWNWeb system until February 1,
2009. The delay affects the specific standard found at Sec.
494.180(h). We are delaying this requirement in response to dialysis
facility community input requesting time to align their information
systems with this new requirement, as well as train necessary staff.

D. Other Proposed Changes and Issues

1. Proposed Cross-Reference Changes
We proposed to make technical changes in the following sections of
the regulations to correct cross-references to the sections in part
405, subpart U that have been relocated or deleted: Sec. 410.5, Sec.
410.50, Sec. 410.52, Sec. 410.152, Sec. 410.170, Sec. 413.170,
Sec. 413.172, Sec. 413.198, and Sec. 414.330.
2. Proposed Additions to Part 488
We proposed to add a new subpart H to part 488. Proposed subpart H
would consist of the existing sanction provisions in part 405 subpart
U. The existing sanction provisions are in Sec. 405.2180, Sec.
405.2181, Sec. 405.2182, and Sec. 405.2184 and are summarized as
follows:
Section 405.2180 specifies the basic sanction, which is
termination of Medicare coverage, and the basis for reinstatement of
coverage after termination.
Section 405.2181 specifies the alternative sanctions
denial of payment of any patients accepted for care after the effective
date of the sanction, and gradual reduction of payments for all
patients) and the circumstances under which they might be imposed.
Section 405.2182 specifies the notice procedures that we
will follow and the appeal rights of sanctioned suppliers.
Section 405.2184 specifies (in greater detail) the rights
of suppliers that appeal proposed imposition of an alternative
sanction.
We proposed to redesignate these provisions (with technical and
cross-reference changes) as Sec. 488.604, Sec. 488.606, Sec.
488.608, and Sec. 488.610 respectively.
We did not receive any comments on these proposed changes.
Therefore, we are finalizing these proposals without change.

E. Survey & Certification Comments

Comment: There were several comments, including comments from many
national organizations, which recommended that CMS convene a panel of
experts, with a broad representation of dialysis providers including
nephrology health care professionals and patients, to contribute to the
development of the Interpretive Guidelines for the ESRD conditions for
coverage. Commenters remarked that there is a wealth of expertise
available in the renal community, which would be of great value to CMS.
Commenters also strongly recommended that CMS ensure ``consistency in
enforcement through the state survey process,'' stating that there is a
need for clear, specific interpretations so that national consistency
can be achieved.
Response: We have used and will continue to solicit input from
experts from the renal community as well as the general public in
developing the Interpretive Guidelines.
Comment: Two commenters stated that ESRD surveys are not completed
frequently enough to ensure ongoing compliance with the ESRD Conditions
for Coverage. One national organization expressed concern about having
effective surveillance and enforcement of the conditions for coverage.
Two State health departments suggested CMS mandate ESRD facilities be
surveyed at least every 3 years with follow-up surveys for 2 years when
a facility has been noncompliant with one or more conditions.
Commenters also recommended funding be increased for this activity.
Response: We issue a Mission and Priority Document (MPD) each year,
which prioritizes the survey goals for the upcoming fiscal year. Budget
restrictions, statutorily mandated surveys, and CMS initiatives
influence the survey priorities of the MPD. In Fiscal Year 2006, ESRD
surveys were moved up in priority because safety and health can be
positively influenced by compliance with the conditions for coverage.
Changes in funding for surveys and/or survey mandates would likely
require Congressional action.
Comment: Two commenters remarked on the redundancies in the format
of the CMS survey report, Statement of Deficiencies. It was pointed out
that the report is difficult to read and one commenter urged that state
surveyors be instructed to list deficiencies only once in the Statement
of Deficiencies report for corrective action.
Response: We are working on limiting the repetitive citing of a
deficient practice to egregious cases where serious problems must be
cited under several survey tags. We are aware that the format of the
survey report, Statement of Deficiencies, could be improved and are
considering the best ways to improve it.
Comment: One commenter asked if State laws could only be cited
during a Federal survey after the law has been cited by the appropriate
State authority.
Response: In the CMS Federal survey process, citations for a lack
of compliance with State laws occur after the State authority has made
a final determination regarding compliance with State law.

F. Impact Analysis Comments

Comment: Many commenters stated that the new conditions for
coverage need to be consistent with payment rules.
Response: Specific commenter concerns about proposed rule
requirements that were perceived to be inconsistent with Medicare
payment policy were addressed in earlier sections of this preamble as
each provision was discussed. We have modified requirements to more
accurately reflect the dialysis facility's role in cases where the
proposed requirement arguably exceeded the scope of services that
dialysis facilities

[[Page 20445]]

provide. For example, in response to comments, we revised the patient
rehabilitation services requirement (Sec. 494.90(a)(8)) so that
dialysis facilities would provide rehabilitation assistance and
referral as appropriate, but would not be required to provide the
actual rehabilitation services. Payment concerns regarding
erythropoietin were addressed under the Patient plan of care preamble
discussion (proposed Sec. 494.90(a)(3)). Physician visit payment
comments were addressed under the proposed Sec. 494.90(b)(4) preamble
discussion, and the monthly physician visit provision was deleted. We
provided clarification of vascular access ``monitoring'' in our earlier
preamble discussion (proposed Sec. 494.90(a)(4)) so that our
requirement is clearly aligned with payment policy. Concerns regarding
the costs of LSC compliance were addressed under the ``Physical
environment'' condition at (Sec. 494.60) and the small number of
existing dialysis facilities that would have been required to retrofit
sprinkler systems are now exempted from this provision if such
retrofitting is not required by the facility's State law and CMS finds
that State law adequately protects facility patients.
Comment: Some commenters recommended that Medicare payment be
adjusted to provide reimbursement for dialysis facility costs resulting
from implementation of the final rule.
Response: The Medicare reimbursement rates for dialysis facilities
are divided into distinct categories. The first category is the
composite rate that covers the provision of dialysis and associated
services that are enumerated in the Medicare renal dialysis facility
payment manual. The composite rate is set by the Congress, and may be
influenced by the recommendations of MedPAC, which performs cost
analysis and provides annual reports to the Congress. The MedPAC
analysis includes a review of the dialysis facility cost report data,
which will encompass any new costs facilities bear due to compliance
with the new conditions for coverage, including some categories of
overhead costs. We expect that the MedPAC analysis and recommendations
will reflect any new across-the-board dialysis facility costs that are
associated with this final rule. The second reimbursement category
focuses on separately billable drugs and biologicals. The Medicare
Modernization Act of 2003 (amending sections 1842(o) and 1847A of the
Act) included provisions regarding medication and biologicals
reimbursement rates. The new provisions call for the calculation of the
drug average sales price plus an add-on payment that is adjusted on a
quarterly basis. Dialysis payment adjustments for 2007 implemented by
Medicare were published on December 1, 2006 in the Physician Fee
Schedule rule (71 FR 69623) and established calendar year 2007
reimbursement rates. We are not making any changes to our payment
methodologies based on the issuance of these conditions for coverage.
Comment: One commenter requested a reimbursement change to allow
advanced practice nurses to be identified and Medicare reimbursed in
the final rule.
Response: Services that would be provided by advanced practice
nurses would be included either in the physician monthly charges or
under the dialysis facility composite payment rate, depending on the
role of the individual. Insofar as the commenter is advocating a pass-
through for APNs, this is not being considered in this rule; however,
we will take the commenter's suggestion under advisement.
Comment: A few commenters suggested that Medicare provide funding
for the purchase of automated external defibrillators (AEDs) if they
are required in the final rule.
Response: AEDs would be included under ``capital costs'' in the
dialysis facility cost report. MedPAC reviews all costs and makes
recommendations to the Congress regarding the appropriate dialysis
facility payment update. Medicare does not pay separately for specific
dialysis facility capital expenditures.
Comment: Several commenters included general remarks regarding the
overall Medicare payment system. Commenters stated that Medicare does
not appropriately fund the ESRD program and that dialysis facilities
must ``subsidize'' the cost of care provided to Medicare beneficiaries.
They also referred to the ESRD composite rate as the only Medicare
prospective payment system without an annual update mechanism to adjust
for changes in input prices and inflation. Commenters discouraged CMS
from implementing new conditions for coverage that would add
significant costs to providing care without directly providing benefits
to patients, unless an annual update mechanism is established for the
ESRD composite rate.
Response: Although an annual composite rate update mechanism has
not been established by Congress, we note that the Tax Relief and
Health Care Act of 2006 (Pub. L. 109-432, Division B, Title I, section
103(a)) provided an update of 1.6 percent to the composite rate
component of the basic case-mix adjusted prospective payment system for
dialysis services effective April 1, 2007. However, the issue of
payment updates to dialysis facilities is determined by Congress and is
outside the scope of these conditions for coverage. We have addressed
specific concerns of commenters earlier in this preamble and have
modified proposed requirements in several instances so that the
provisions of this final rule do not exceed the scope of services that
we could expect from Medicare-certified dialysis facilities.

III. Provisions of the Final Rule

In this final rule we are adopting the proposed provisions as set
forth in the February 4, 2005, proposed rule, subject to the following
revisions:
Amend Sec. 405.2102 ``Definitions'' by removing the
definitions for ``Histocompatibility testing,'' ``Organ procurement,''
``Renal transplantation center,'' ``Transplantation service,'' and
``Transplantation surgeon,'' leaving ``Network requirements'' the only
remaining substantive component of the subpart.
Amend Sec. 405.2180 through Sec. 405.2184 ``Termination
of Medicare coverage'' and ``Alternative sanctions'' by recodifying
these sections at Sec. 488.604 through Sec. 488.610 under Subpart H--
Termination of Medicare Coverage and Alternative Sanctions for End-
Stage Renal Disease (ESRD) Facilities.
Amend Sec. 414.330 ``Payment for home dialysis equipment,
suppliers, and support services'' by revising paragraph (a)(2)(iii)(C)
to change the reporting timeframe from every 30 days to at least every
45 days.
Amend Sec. 494.1 ``Basis and scope'' by--
+ Removing paragraph (a)(2).
+ Redesignating paragraphs (a)(3) through (a)(7) as (a)(2) through
(a)(6), respectively.
+ Replacing the phrase ``recombinant epoetin alpha (EPO)'' with
``erythropoiesis-stimulating agent(s)'', in paragraph (a)(5).
+ Revising paragraph (a)(6) to read ``Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113),
which requires Federal agencies to use technical standards that are
developed or adopted by voluntary consensus standards bodies, unless
their use would be inconsistent with applicable law or otherwise
impractical.''
Amend Sec. 494.10 ``Definitions'' by--
+ Revising the definition for ``discharge'' to read ``means the
termination of patient care services by a

[[Page 20446]]

dialysis facility or the patient voluntarily terminating dialysis when
he or she no longer wants to be dialyzed by that facility.''
+ Removing the definition for the term ``interdisciplinary team.''
Amend Sec. 494.20 ``Compliance with Federal, State, and
local laws and regulations'' by removing the phrase ``staff licensure
and other personnel staff qualifications, fire safety, equipment,
building codes, drugs and medical device usage.''
Amend Sec. 494.30 ``Infection Control'' by--
+ Expanding our incorporation by reference section (pages 20-21) of
the CDC ``Recommended Infection Control Practices for Hemodialysis
Units at a Glance,'' to include the corresponding narrative section
(pages 18-28) with the exception of the hepatitis C screening found in
``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients,'' Morbidity and Mortality Weekly Report,
volume 50, number RR05, April 27, 2001. The recommendation found on
pages 27 and 28 under the ``HBV-Infected Patient'' header section of
RR05 requires a separate isolation room. Therefore, we are allowing
dialysis facilities 300 days after the publication of the final rule in
the Federal Register to comply with the requirements of this provision
at (a)(1)(i). Specifically, this provision must be complied with by
February 9, 2009.
+ Adding a dialysis isolation room waiver provision at (a)(1)(ii),
which allows a new dialysis facility to request a waiver of the
isolation room requirement, subject to the Secretary's approval, when
dialysis isolation rooms are available locally that sufficiently serve
the needs of patients in the geographic area.
+ Redesignating proposed paragraph (a)(2) as paragraph (a)(3).
+ Redesignating proposed paragraph (a)(3) as paragraph (a)(4).
+ Adding a new paragraph (a)(2) incorporation by reference for the
``Guidelines for the Prevention of Intravascular Catheter-Related
Infections'' sections entitled ``Recommendations for Placement of
Intravascular Catheters in Adults and Children'' parts I-IV; and
``Central Venous Catheters, Including PICCs, Hemodialysis, and
Pulmonary Artery Catheters, in Adult and Pediatric Patients''
(Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages
16 through 18, August 9, 2002, developed by the HICPAC).
+ Removing the requirement in paragraph (b)(2) that an infection
control officer that is a registered nurse be designated as the
infection control or safety officer, and adding infection control as a
component of the quality assessment and performance improvement program
required at Sec. 494.110(a)(2)(ix).
+ Revising the proposed requirement at paragraph (b)(2) to clarify
that clinical staff in a dialysis facility must demonstrate compliance
with current aseptic techniques when dispensing and administering
intravenous medications from vials and ampules.
+ Redesignating paragraph (b)(2)(ii) as paragraph (b)(3) and
revising to read as follows: ``Require all clinical staff to report
infection control issues to the dialysis facility's medical director
(see Sec. 494.150 of this part) and the quality improvement
committee.''
+ Removing and moving the monitoring standard paragraph (c) to the
QAPI condition for coverage at Sec. 494.110(a)(2)(ix).
+ Redesignating paragraph (d) as paragraph (c).
Amend Sec. 494.40 ``Water quality'' by--
+ Revising the title to read ``Water and dialysate quality.''
+ Revising paragraph (a) to read, Water and equipment used for
dialysis meets the water and dialysate quality standards and equipment
requirements found in the Association for the Advancement of Medical
Instrumentation (AAMI) publication, ``Dialysate for hemodialysis,''
ANSI/AAMI RD52:2004, which are incorporated by reference. Incorporation
by reference of the AAMI ``Dialysate for hemodialysis'' has been
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.''
+ Removing from paragraph (a)(2) the requirements for frequency of
water purity testing.
+ Removing the proposed requirement at paragraph (b).
+ Redesignating paragraphs (c) through (e) as paragraphs (b)
through (d), respectively.
+ Removing the stem statement from proposed paragraph (c), now
paragraph (b), chlorine/chloramines.
+ Removing language from proposed paragraph (a)(2)(i)(B).
+ Removing redundant language at proposed paragraphs (a)(2)(ii)(C)
and (a)(2)(ii)(D).
+ Clarifying the carbon tank requirement at proposed paragraph
(c)(1), now paragraph (b)(1), so that the water treatment system must
include a component or carbon tank which removes chlorine/chloramine,
and that the backup component or second carbon tank must be ``in
series'' with the first component.
+ Adding at redesignated paragraph (b)(2)(i) (proposed paragraph
(c)(2)(i)) an alternative to permit the facility to test total chlorine
for acceptable levels of less than 0.1mg/L as an alternative to testing
free chlorine and chloramines levels, and adding a reference to the
frequency of water testing specified in our incorporation by reference
of ANSI/AAM RD52:2004.
+ Revising redesignated paragraph (b)(2)(ii)(A) (proposed paragraph
(c)(2)(ii)(A)) to allow an alternate action to terminating dialysis
treatments when chlorine/chloramines testing reveals high levels. We
have added, ``Immediately take corrective action to bring chlorine or
chloramine levels into compliance with paragraph (b)(2)(i) of this
section and confirm through testing that the corrective action has been
effective * * *.''
+ Redesignating proposed paragraph (c)(2)(ii)(B) as paragraph
(b)(2)(ii)(C).
+ Revising redesignated paragraph (b)(2)(ii) (proposed paragraph
(c)(2)(ii)) with new language. The provision reads ``Only allow use of
purified water in a holding tank, if appropriate, and if testing shows
water chlorine or chloramine levels that are in compliance with
paragraph (b)(2)(i) of this section above * * *.''
+ Clarifying at redesignated paragraph (b)(2)(ii)(D) that
corrective action taken must ensure ongoing compliance with acceptable
chlorine and chloramines levels.
+ Adding ``endotoxin levels'' to the testing that must be done
(when clinically indicated) at redesignated paragraph (d)(1), (proposed
paragraph (e)(1)).
+ Adding a new standard at paragraph (e) that addresses in-center
use of preconfigured hemodialysis systems. The standard requires that
when facilities use a preconfigured, FDA-approved hemodialysis system
designed, tested and validated to yield AAMI quality (which includes
standards for chemical and chlorine/chloramine testing) water and
dialysate, the system's FDA-approved labeling must be adhered to for
machine use and monitoring of the water and dialysate quality. The
facility must meet all AAMI RD52:2004 requirements for water and
dialysate. Moreover, the facility must perform bacteriological and
endotoxin testing on a quarterly, or more frequent basis, as needed, to
ensure that the water and dialysate are within AAMI limits.
+ Removing proposed standard at paragraph (f) regarding unused
mixed bicarbonate; use of mixed bicarbonate is

[[Page 20447]]

addressed in the ANSI/AAM RD52:2004 document, which is incorporated by
reference.
Amend Sec. 494.50 ``Condition: Reuse of hemodialyzers and
bloodlines'' by--
+ Removing the undesignated paragraph that states, ``The dialysis
facility that reuses hemodialyzers or bloodlines must meet the
requirements of this section. Failure to meet any of these requirements
constitutes grounds for denial of payment for the dialysis treatment
affected and termination from participation in the Medicare program.''
+ Incorporating by reference the AAMI reuse guidelines, ``Reuse of
hemodialyzers,'' ANSI/AAMI RD47:2002/AL:2003 at paragraph (b)(1).
+ Clarifying at paragraph (b)(3) that bleach used on hemodialyzers
is considered to be a ``cleaner'' in this application.
+ Adding endotoxin levels to the blood and dialysate culture
testing that must be done when clinically indicated at
paragraph(c)(2)(i).
Amend Sec. 494.60 ``Physical environment'' by--
+ Modifying the room temperature requirement at paragraph (c)(2) by
removing the phrase ``that is comfortable for the majority of its
patients'', so that the facility must ``Maintain a comfortable
temperature within the facility and make reasonable accommodations for
the patients who are not comfortable at this temperature.''
+ Adding a privacy provision at paragraph (c)(3), which reads,
``The dialysis facility must make accommodations to provide for patient
privacy when patients are examined or treated and body exposure is
required.''
+ Adding a new monitoring requirement at paragraph (c)(4) that
states, ``Patients must be in view of staff during hemodialysis
treatment to ensure patient safety (video surveillance will not meet
this requirement).''
+ Revising paragraph (d)(1)(i)(B) to read, ``Where to go, including
instructions for occasions when the geographic area of the dialysis
facility must be evacuated.''
+ Revising the requirement at paragraph (d)(1)(i)(C) that the
dialysis facility contact information must include an alternate
emergency phone number for instances when the dialysis facility is
unable to receive phone calls due to emergency, unless the facility has
the ability to forward calls to a working phone number under such
emergency conditions.
+ Revising paragraph (d)(3) by adding an automated external
defibrillator as an alternative to the defibrillator.
+ Redesignating proposed paragraphs (d)(3)(i) and (d)(3)(ii) as
paragraphs (d)(4)(i) and (d)(4)(ii).
+ Adding a new requirement at paragraph (d)(4)(iii) that the
facility must, ``Contact its local disaster management agency at least
annually to ensure that such agency is aware of dialysis facility needs
in the event of an emergency.''
+ Revising paragraph (e)(1) to indicate that it is effective
February 9, 2009.
+ Removing proposed paragraph (e)(2).
+ Adding a new paragraph (e)(2), to state that sprinkler systems
are not required for dialysis providers using facilities built before
2008 on the rule's effective date, if their State law so permits.
+ Adding a clarifying phrase ``for individual dialysis facilities''
at paragraph (e)(4).
Amend Sec. 494.70 ``Patients' rights'' by--
+ Revising proposed paragraph (a)(5) to add the patients ``right to
discontinue treatment'' as an option.
+ Revising proposed paragraph (a)(5) by redesignating the ``advance
directive'' policy as paragraph (a)(6), and adding the phrase ``and the
facility's policy regarding advance directives.''
+ Redesignating proposed paragraphs (a)(6) through (a)(16) as
paragraphs (a)(7) through (a)(17), respectively.
+ Revising newly redesignated paragraph (a)(7), (formerly paragraph
(a)(6)) to specify that patients have the right to receive resource
information about dialysis modalities and options not offered by the
facility, including alternative scheduling options for working
patients.
+ Revising newly redesignated (a)(10) (formerly (a)(9)) to clarify
that the patient has the right to be informed of his or her medical
status by not only the physician, but the ``nurse practitioner,
clinical nurse specialist or physician's assistant treating the patient
for ESRD.''
+ Adding at paragraph (b)(1) a phrase, ``routine or involuntary''
to clarify that patients must be informed of both routine and
involuntary discharge policies.
+ Removing the words ``reducing or'' and ``ongoing'' at paragraph
(b)(2), and changing the word ``shortened'' to ``abbreviated.''
+ Adding ESRD Network ``mailing addresses'' to the list of
information that must be posted in the dialysis facility at subsection
(c).
Amend Sec. 494.80 ``Patient Assessment'' by--
+ Clarifying in the introductory paragraph that the patient may
choose whether he or she wants to identify a designee to participate in
the interdisciplinary team.
+ Clarifying the introductory paragraph to include ``a physician
treating the patient for ESRD'' and removing our reference to the
nephrologists.
+ Adding immunization history to the assessment criteria at
paragraph (a)(3).
+ Modifying our reference to erythropoietin at paragraph (a)(4), by
using the term ``erythropoiesis-stimulating agent(s).''
+ Clarifying at paragraph (a)(6) that the evaluation of patient
nutritional status must be performed by a dietitian.
+ Clarifying at paragraph (a)(7) that the evaluation of patient
psychosocial needs must be performed by a social worker.
+ Modifying the requirement in paragraph (a)(13) for evaluation of
vocational and physical rehabilitation status and potential, so that
the interdisciplinary team need only evaluate the patient for referral
to vocational and rehabilitation services.
+ Modifying the title of paragraph (b), to clarify the meaning of
``new patient.'' It now reads ``Frequency of assessment for patients
admitted to the dialysis facility.''
+ Modifying the time allowed to complete the initial patient
assessment at paragraph (b)(1) from 20 days to 30 days, which
corresponds to the implementation time for the plan of care. An
alternate method of determining when the assessment must be completed
(and plan of care implemented) was added; 13 outpatient hemodialysis
sessions beginning with the first outpatient dialysis session to allow
for occasions (such as hospitalizations) when the patient may be away
from the unit. The assessment now must be completed within the latter
of 30 days or 13 dialysis sessions.
+ Adding at paragraph (d)(2)(iv) the word ``concurrent'' and
deleting ``with''.
Amend Sec. 494.90 ``Patient plan of care'' by--
+ Adding to the introductory text, ``The interdisciplinary team as
defined at Sec. 494.80 must develop and implement * * *.''
+ Removing the term ``community accepted'', from the introductory
statement, and substituting ``professionally-accepted clinical
practice,'' so that the ``outcomes'' specified in the patient plan of
care may be ``consistent with current evidence-based professionally-
accepted clinical practice standards.''
+ Adding ``manage the patient's volume status'' at paragraph
(a)(1). We

[[Page 20448]]

are also adding the current NKF-KDOQI clinical practice guideline
targets for dialysis adequacy (Kt/V of 1.2 for hemodialysis, and a
weekly Kt/V of 1.7 for peritoneal dialysis), as well as an alternative
equivalent of professionally-accepted clinical practice standards for
adequacy of dialysis.
+ Revising paragraph (a)(2) to read, ``The interdisciplinary team
must provide the necessary care and counseling services to achieve and
sustain an effective nutritional status. A patient's albumin level and
body weight must be measured at least monthly. Additional evidence-
based professionally-accepted clinical nutrition indicators may be
monitored, as appropriate.''
+ Adding new paragraph (a)(3), requiring the interdisciplinary team
to provide the necessary care to manage mineral metabolism and prevent
or treat renal bone disease. The remaining plan of care components are
renumbered to reflect the addition of a new paragraph (a)(3).
+ Revising proposed paragraph (a)(3) (now paragraph (a)(4)), to
read in part, ``The interdisciplinary team must provide the necessary
care and services to achieve and sustain the clinically appropriate
hemoglobin/hematocrit level. The patient's hemoglobin/hematocrit must
be measured at least monthly. The dialysis facility must conduct an
evaluation of the patient's anemia management needs.''
+ Modifying the vascular access plan of care component at proposed
paragraph (a)(4), now paragraph (a)(5), so that instead of providing
the necessary care and services to achieve and sustain the vascular
access, the interdisciplinary team must provide vascular access
monitoring and appropriate, timely referrals to achieve and sustain
vascular access. The interdisciplinary team must also evaluate whether
the patient is a potential candidate for arteriovenous fistula
placement.
+ Adding a new psychosocial status requirement at paragraph (a)(6),
requiring the interdisciplinary team to provide the necessary
monitoring and social work interventions, including counseling and
referrals for social services, to assist the patient in achieving and
sustaining an appropriate psychosocial status as measured by a
standardized mental and physical assessment tool chosen by the social
worker, at regular intervals, or more frequently on an as-needed basis.
+ Revising and redesignating proposed paragraph (a)(5) (now located
at paragraph (a)(7)(i)), to require the interdisciplinary team to plan
for home dialysis or explain why the patient is not a candidate for
home dialysis.
+ Modifying the rehabilitation plan of care requirement, now at
paragraph (a)(8), to require that the interdisciplinary team assist the
patient in achieving and sustaining an appropriate level of productive
activity, and make rehabilitation and vocational rehabilitation
referrals as appropriate.
+ Clarifying at paragraph (b)(i) that the patient is to be included
(if he or she desires) when the interdisciplinary team is completing
the plan of care.
+ Clarifying the patient plan of care signature requirement
(paragraph (b)(1)(ii)) to indicate that team members must sign the plan
of care and, if applicable, the facility must document a patient's
refusal to sign the plan of care, along with the reason the signature
was not provided.
+ Modifying the plan of care implementation requirements (paragraph
(b)(2)) so that the implementation of the initial plan of care must
begin within the latter of 30 calendar days after admission to the
dialysis facility or 13 outpatient hemodialysis sessions beginning with
the first outpatient dialysis session. Implementation of monthly or
annual updates of the plan of care must be performed within 15 days of
the completion of the additional patient assessments specified in Sec.
494.80 of this part.
+ Adding language to paragraph (b)(3) that requires the plan of
care to be adjusted when the plan of care outcome targets are not met
to reflect the patient's condition along with an explanation, and that
the team must identify opportunities for improvement.
+ Adding ``nurse practitioner, clinical nurse specialist, or
physician's assistant'' as the types of professionals who can meet the
monthly visit requirement at paragraph (b)(4).
+ Modifying the transplantation referral-tracking standard at
paragraph (c)(3), by requiring that the interdisciplinary team
communicate with the transplant center regarding patient transplant
status ``at least annually, and when there is a change in transplant
candidate status.''
+ Revising the standard at subsection (d), ``Patient education and
training,'' to require that the care plan include training in infection
prevention and personal care, home dialysis and self-care, and benefits
and risks of various vascular access types.
Amend Sec. 494.100 ``Care at home'' by--
+ Clarifying in the introductory text that care at home services
must meet all applicable conditions of this part.
+ Replacing the word ``provide'' with ``oversee'' at paragraph (a).
+ Replacing ``hematocrit level of at least 33 percent or a
hemoglobin of at least 11 gm/dL'' at paragraph (a)(3)(ii) with the
phrase ``target level hemoglobin or hematocrit as written in the
patient's plan of care.'' We are also replacing ``erythropoietin
administration'' with ``administration of erythropoiesis-stimulating
agent(s).''
+ Deleting ``implementation of a nutritional care plan'' at
proposed paragraph (a)(3)(iii). We are also deleting ``how to achieve
and maintain emotional and social well being'' from paragraph
(a)(3)(iv). The remaining paragraphs have been renumbered to reflect
these revisions.
+ Adding that potential dialysis complication training includes
addressing ``water treatment problems'' (new paragraph (a)(3)(iii)).
+ Clarifying at paragraph (c)(1) that a home dialysis training
facility must furnish home dialysis support services either directly,
under agreement, or by arrangement with another ESRD facility.
+ Modifying paragraph (c)(1)(v) to specify that the facility must
monitor the quality of water and dialysate used by home hemodialysis
patients and conduct onsite evaluations and testing of the water and
dialysate system in accordance with (A) the recommendations specified
in the manufacturer's instructions; and (B) the system's FDA-approved
labeling for preconfigured systems designed, tested, and validated to
meet AAMI quality (which includes standards for chemical and chlorine/
chloramine testing) water and dialysate. The facility must meet testing
and other requirements of AAMI RD52:2004. In addition, bacteriological
and endotoxin testing must be performed on a quarterly, or more
frequent basis as needed, to ensure that the water and dialysate are
within the AAMI limits.
+ Revising paragraph (c)(1)(v) (revised as paragraph (c)(1)(v)(C))
to change ``the water quality'' to ``any water and dialysate quality
problem.''
+ Adding ``and dialysate'' at paragraphs (c)(1) and (c)(2).
+ Clarifying at paragraph (c)(2)(vi) that the dialysis facility may
not only purchase, but may also lease or rent medically necessary home
dialysis supplies and equipment.
Amend Sec. 494.110 ``Quality assessment and performance
improvement'' by--
+ Clarifying in the introductory paragraph, that the QAPI program
requires participation by the professional members of the

[[Page 20449]]

interdisciplinary team to meet these conditions for coverage.
+ Adding mineral metabolism and renal bone disease to the list of
QAPI program components at paragraph (a)(2)(iii). The subsequent QAPI
program components have been renumbered accordingly.
+ Adding infection control to the list of QAPI program components
at paragraph (a)(2)(ix).
Amend Sec. 494.120 ``Special purpose renal dialysis
facilities'' by--
+ Revising standard (d), to require the special purpose facility to
contact the patient's physician ``if possible'' prior to initiating
dialysis.
+ Revising standard (e), to require the special purpose facility
patient documentation to be forwarded to the patient's usual dialysis
facility, if possible within 30 days of the last scheduled treatment.
Amend Sec. 494.140 ``Personnel qualifications'' by--
+ Adding a requirement to the introductory text to read, ``All
dialysis facility staff must meet the applicable scope of practice
board and licensure requirements in effect in the State in which they
are employed.'' References to State licensure and board of practice
compliance for dialysis facility staff have been removed, where
appropriate, in the later sections of Sec. 494.140.
+ Revising paragraph (a)(1), to require the medical director be a
board-certified physician in internal medicine or pediatrics by a
professional board.
+ Revising the title of paragraph (b)(2) to read, ``Self-care and
home dialysis training nurse.''
+ Adding a new provision at paragraph (b)(3)(iii) so that a charge
nurse who is a licensed practical nurse or licensed vocational nurse,
must work under the supervision of a registered nurse in accordance
with State nursing practice act provisions.
+ Deleting proposed paragraph (c)(2).
+ Redesignating proposed Sec. 494.140(c)(3) as Sec.
494.140(c)(2).
+ Adding a ``specialization in clinical practice'' requirement to
the social worker's master's degree provisions at paragraph (d)(1).
+ Adding the grandfather provision from part 405, subpart U for
non-master's prepared social workers to paragraph (d)(2), to allow a
dialysis social worker to qualify for this position if he or she has
``served at least 2 years as a social worker, 1 year of which was in a
dialysis unit or transplantation program prior to September 1, 1976,
and has established a consultative relationship with a social worker
who qualifies under Sec. 494.140(d)(2) of this part.''
+ Revising the patient care technician (PCT) qualifications at
paragraph (e)(3), to remove the proposed requirement that the PCT have
at least 3 months experience, and to require that the training program
be only ``under the direction'' of a registered nurse, rather than
``under the direct supervision of a registered nurse.''
+ Revising paragraph (e)(3), to include the training program
requirements from proposed Sec. 494.180((b)(5).
+ Adding ``proper cannulation techniques'' to the training program
subjects redesignated at paragraph (e)(3)(iii).
+ Adding ``and dialysate preparation'' to redesignated paragraph
(e)(3)(v).
+ Adding a new requirement at paragraph (e)(4) that patient care
dialysis technicians be certified under a State certification program
or a national commercially available certification program. At
paragraphs (e)(4)(i) and (e)(4)(ii), we are adding that newly employed
patient care dialysis technicians must be certified within 18 months of
being hired as a dialysis patient care technician and for dialysis
patient care technician employed on the effective date of this rule
within 18 months of such date.
Amend Sec. 494.150 ``Responsibilities of the medical
director'' by--
+ Adding to the introductory paragraph, ``The medical director is
accountable to the governing body for the quality of medical care
provided to patients.''
+ Revising the requirement at paragraph (c)(2)(i) to read, ``All
policies and procedures relative to patient admissions, patient care,
infection control, and safety are adhered to by all individuals who
treat patients in the facility, including attending physicians and
nonphysician providers.''
Amend Sec. 494.160 ``Condition: Relationship with the
ESRD Network'' by--
+ Redesignating the ``Relationship with the ERSD Network''
condition (at Sec. 494.160) as Sec. 494.180(i). The language for the
ESRD Network requirements has been retained from the proposed rule.
+ Reserving section 494.160 without requirements.
Amend Sec. 494.170 ``Medical records'' by--
+ Adding at paragraph (b)(2) that the patient's record must
indicate ``whether the patient has executed an advance directive.''
+ Revising language in standard (c) to read, ``In accordance with
45 CFR 164.530(j)(2), all patient records must be retained for 6 years
from the date of the patient's discharge, transfer, or death.''
+ Revising language at paragraph (d), to require the dialysis
transferring a patient to send to the receiving facility only ``all
requested medical record information.''
Amend Sec. 494.180 ``Governance'' by--
+ Removing the sentence, ``The governing body receives and acts
upon recommendations from the ESRD Network'' from the introductory
paragraph.
+ Adding language at paragraph (b)(1), to require that the RN,
social worker and dietitian members of the interdisciplinary team must
be available to meet patient clinical needs.
+ Revising paragraph (b)(2) to read, ``A registered nurse, who is
responsible for the nursing care provided, is present in the facility
at all times that in-center dialysis patients are being treated.''
+ Revising paragraph (b)(3) to read, ``All staff, including the
medical director, have appropriate orientation to the facility and work
responsibilities.''
+ Removing the written training program requirements specific to
dialysis patient care technicians from paragraphs (b)(5) and (b)(6) and
adding them to paragraphs (e)(3) and (e)(4).
+ Revising paragraph (c), to indicate that the governing body is
responsible for all medical staff appointments and credentialing in
accordance with State law, including clinical nurse specialists.
+ Adding a new paragraph (c)(3), which requires the governing body
to communicate ``expectations to the medical staff regarding staff
participation in improving the quality of medical care provided to
facility patients.''
+ Clarifying the standard at subsection (e) that patients may file
``an oral or written'' grievance with the facility.
+ Revising the title of standard (f), to read ``Involuntary
discharge and transfer policies and procedures.''
+ Modifying paragraph (f)(4), to clarify the sequence of procedures
when a patient is involuntarily discharged, and to require ESRD Network
notification at the time the patient is provided 30 days advance notice
of the discharge, instead of at the time of discharge or later. New
paragraph (f)(4)(ii) now requires that the interdisciplinary team
provides the patient with a 30 day notice of the planned discharge, and
also notifies the ESRD Network of the planned discharge. The proposed
provisions at proposed paragraphs (f)(4)(ii) through (f)(4)(iv) are
renumbered to reflect insertion of a new paragraph (ii).

[[Page 20450]]

+ Revising new paragraph (f)(4)(iv), to require a facility
contemplating an involuntary discharge to contact and attempt to place
the patient in another facility, and to document that effort.
+ Adding a new provision at paragraph (f)(5), which reads, ``In the
case of immediate severe threats to the health and safety of others,
the facility may utilize an abbreviated involuntary discharge
procedure.''
+ Adding ``routine and emergency dialysis'' to the services a
hospital agrees to provide in an agreement with a dialysis facility at
paragraph (g)(3).
+ Revising the proposed paragraph (h) introductory text to reflect
an effective date of February 1, 2009 in the Federal Register.
+ Redesignating proposed paragraph (i) as paragraph (j).
+ Relocating the proposed ESRD Network-related requirements
(proposed Sec. 494.160) for dialysis facilities at new paragraph (i).

IV. Effective Dates for the Final Rule

The Administrative Procedure Act (APA) does not require that a
final rule become effective within a certain maximum timeframe after
publication in the Federal Register. However, under the APA, the
effective date of a substantive rule must be no less than 30 days after
its publication date, unless there is good cause for an earlier
effective date (5 U.S.C. 553(b)). This final rule will be effective 180
days after its publication in the Federal Register. We are allowing
dialysis facilities additional time beyond 180 days to come into
compliance with three specific provisions of this final rule.
This final rule modernizes the existing ESRD dialysis facility
conditions for coverage originally promulgated in 1976, which have not
been revised in their entirety in 31 years. The ESRD conditions for
coverage proposed rule (published on February 5, 2005 (70 FR 6184))
emphasized a patient-centered approach to care, thereby decreasing
dialysis facility structure and process requirements while moving to an
outcome-based orientation. This final rule will implement those
proposed changes, while reflecting current professional standards of
practice. In addition, they will update patient safety standards,
provide a structure for internal facility quality improvement, and add
a framework for external oversight. Because we are changing from a
process-oriented to patient-centered approach, we believe that ESRD
facility providers will need additional time to come into full
compliance with the requirements of this final rule.
Under section 494.30(a)(1)(i), ``Infection control,'' certain
facilities could be required to build isolation rooms as set out in
``HBV-Infected Patients'' found on pages 27 and 28 of RR05
(``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients,'') which has been incorporated by
reference into our regulations. Some facilities would need additional
time to implement this requirement, since construction of isolation
rooms would require time for project development, construction
approvals, architectural design, contractor bids and obtaining building
permits. Therefore, we are allowing dialysis facilities 300 days after
publication of this final rule to comply with the requirements found at
Sec. 494.30(a)(1)(i).
Under section 494.60(e)(1), ``Physical environment,'' facilities
will be required to be in compliance with the 2000 edition of the Life
Safety Code. If changes are required in the building structure,
facilities will need time to make the appropriate changes. Therefore,
we are allowing dialysis facilities 300 days after publication of this
final rule time to comply with the requirements found at Sec.
494.60(e)(1).
Under section 494.180(h), ``Governance,'' we are requiring
facilities to submit certain data to CMS in an electronic format.
Facilities may have to develop programs or obtain software that can be
used to provide the data to CMS. This requirement may have a financial
impact on some facilities and may also require them to make changes to
their data systems to capture the data that they will be required to
submit. We are allowing dialysis facilities until February 1, 2009 to
comply with the requirements at Sec. 494.180(h).

V. Reference Materials

A. Provisions of Part 494

This final rule contains a number of requirements that are not
included in the existing regulations. For information and ease of
reference, outlined below is a list of the new provisions, grouped by
condition:

----------------------------------------------------------------------------------------------------------------
Condition New provisions
----------------------------------------------------------------------------------------------------------------
Infection control (Sec. 494.30)............ Infection control procedures (including the Recommended Infection
Control Practices for Hemodialysis Units At A Glance CDC
guidelines).
Sec. 494.30(a)(1)(i)--Patient isolation procedures.
Water quality (Sec. 494.40)................ Incorporates by reference the updated 2001 American National
Standard/Association for the Advancement of Medical
Instrumentation guidelines for water purity.
Physical environment (Sec. 494.60)......... Sec. 494.60(e)--Fire safety.
Patient rights (Sec. 494.70)............... Sec. 494.70(a)(6)--Advance directives.
Sec. 494.70(a)(14)--Complaint systems.
Sec. 494.70(a)(15)--Complaint systems.
Sec. 494.70(b)--Discharge and transfer policies.
Sec. 494.70(c)--Posting of rights.
Patient assessment (Sec. 494.80)........... Sec. 494.80(a)(2)--Appropriateness of dialysis prescription.
Sec. 494.80(a)(5)--Renal bone disease.
Sec. 494.80(a)(8)--Dialysis access type and maintenance.
--Suitability for transplantation referral, including basis for
referral or nonreferral.
Sec. 494.80(b)--Frequency of assessment.
Sec. 494.80(c)--Assessment of treatment prescription.
Sec. 494.80(d)--Patient reassessment.

[[Page 20451]]

Patient plan of care (Sec. 494.90)......... Sec. 494.90(a)(1)--Dose of dialysis.
Sec. 494.90(a)(2)--Nutritional status.
Sec. 494.90(a)(4)--Anemia.
Sec. 494.90(a)(5)--Vascular access.
Sec. 494.90(a)(7)--Home dialysis and transplantation status.
Sec. 494.90(a)(8)--Rehabilitation status.
Sec. 494.90(b)--Implementation of patient plan of care.
Sec. 494.90(b)(4)--Direct physician/patient interaction.
Sec. 494.90(c)--Transplantation referral tracking.
Care at home (Sec. 494.100)................ Sec. 494.100(a)--Training.
Sec. 494.100(b)--Home dialysis monitoring.
Sec. 494.100(c)--Support services.
Quality assessment and performance Sec. 494.110(a)--Program scope.
improvement (Sec. 494.110). Sec. 494.110(a)(2)(i)--Adequacy of dialysis.
Sec. 494.110(a)(2)(ii)--Nutritional status.
Sec. 494.110(a)(2)(iii)--Mineral metabolism and renal bone
disease.
Sec. 494.110(a)(2)(iv)--Anemia management.
Sec. 494.110(a)(2)(v)--Vascular access.
Sec. 494.110(a)(2)(vi)--Medical injuries and medical error
identification.
Sec. 494.110(a)(2)(vii)--Hemodialyzer reuse.
Sec. 494.110(a)(viii)--Patient satisfaction.
Sec. 494.110(a)(ix)--Infection control.
Sec. 494.110(b)--Monitoring performance improvement.
Sec. 494.110(c)--Prioritizing improvement activities.
Special purpose renal dialysis facilities Sec. 494.120--Definition.
(Sec. 494.120).
Personnel qualifications (Sec. 494.140).... Sec. 494.140(b)--Nursing services.
Sec. 494.140(e)--Dialysis technicians.
Responsibilities of the medical director Quality assessment and performance improvement program.
(Sec. 494.150). Sec. 494.150(b)--Staff education, training, and performance.
Sec. 494.150(c)--Patient care policies and procedures.
Governance (Sec. 494.180).................. Sec. 494.180(c)--Medical staff appointments.
Sec. 494.180(d)--Furnishing services.
Sec. 494.180(e)--Internal grievance process.
Sec. 494.180(f)--Involuntary discharge and transfer policies
and procedures.
Emergency coverage.
Furnishing data and information for ESRD program administration.
Relationship with the ESRD Network.
----------------------------------------------------------------------------------------------------------------

B. ESRD Crosswalk (Cross Refers Existing Requirements to Final
Requirements)

--------------------------------------------------------------------------------------------------------------------------------------------------------
Existing conditions (Part 405, Subpart
U) Existing citation Final conditions (Part 494) Final citation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Scope of subpart...................... 405.2100(a).............................. Statutory basis............ 494.1(a).
405.2100(b).............................. Scope...................... 494.1(b).
Objectives of ESRD program............ 405.2101................................. Deleted. ........................................
Definitions........................... 405.2102................................. Definitions................ 494.10.
Agreement......................... ......................................... Deleted. ........................................
Arrangement....................... ......................................... Deleted. ........................................
Dialysis.......................... ......................................... Deleted. ........................................
End-stage renal disease........... ......................................... Deleted. 406.13(b).
ESRD facility (introductory text). ......................................... Deleted. ........................................
(a) Renal dialysis center..... ......................................... Deleted. ........................................
(b) Renal dialysis facility... ......................................... Definitions................ 494.10.
(c) Self-dialysis unit........ ......................................... Deleted. ........................................
(d) Special purpose renal ......................................... Special purpose renal 494.120.
dialysis facility. dialysis facilities.
ESRD service (introductory text).. ......................................... Deleted. ........................................
(a) Dialysis service.......... ......................................... Deleted. ........................................
(1) Inpatient dialysis........ ......................................... Deleted. ........................................
(2) Outpatient dialysis....... ......................................... Deleted. ........................................
(i) Staff-assisted dialysis... ......................................... Deleted. ........................................
(ii) Self-dialysis............ ......................................... Definitions................ 494.10.
(3) Home dialysis............. ......................................... Definitions................ 494.10.
(b) Self-dialysis and home ......................................... Deleted. ........................................
dialysis.
Furnishes directly.................... ......................................... Definitions................ 494.10.
Furnishes on the premises............. ......................................... Deleted. 494.180(d).
Medical care criteria................. ......................................... Deleted. ........................................
Medical care norms.................... ......................................... Deleted. ........................................
Medical care standards................ ......................................... Deleted. ........................................
Medical care evaluation study......... ......................................... Deleted. ........................................

[[Page 20452]]

Network, ESRD......................... ......................................... Retained in 405, Subpart U. 405.2102.
Network, organization................. ......................................... ESRD Network organization.. 405.2102.
(a) Chief executive officer....... ......................................... Deleted. ........................................
(b) Dietitian..................... ......................................... Personnel qualifications... 494.140(c).
(c) Medical record practitioner... ......................................... Deleted. ........................................
(d) Nurse responsible for nursing ......................................... Personnel qualifications... 494.140(b).
services.
(e) Physician-director............ ......................................... Personnel qualifications... 494.140(a).
(f) Social worker................. ......................................... Personnel qualifications... 494.140(d).
Designation of ESRD networks.......... 405.2110................................. Retained in 405, Subpart U. ........................................
[Reserved]............................ 405.2111................................. Reserved in Part 405 ........................................
Subpart U.
ESRD network organizations............ 405.2112................................. Retained in 405, Subpart U. ........................................
Medical review board.................. 405.2113................................. Retained in 405, Subpart U. ........................................
[Reserved]............................ 405.2114................................. Reserved in Part 405 ........................................
Subpart U.
Provider status: renal transplantation 405.2131................................. Deleted. ........................................
center or renal dialysis center.
[Reserved]............................ 405.2132................................. Deleted. ........................................
Furnishing data and information for 405.2133................................. Furnishing data and 494.180(h).
ESRD program administration. information for ESRD
program administration.
Participation in network activities... 405.2134................................. Relationship with ESRD 494.180(i).
network.
Compliance with Federal, State, and 405.2135................................. Compliance with Federal, 494.20.
local laws and regulations. State, and local laws and
regulations.
Governing body and management 405.2136................................. Governance (introductory 494.180 (introductory text).
(introductory text). text).
(a) Disclosure of ownership....... 405.2136(a).............................. Governance................. 494.180(j).
(b) Operational objectives........ 405.2136(b).............................. Deleted. ........................................
(c) Chief executive officer....... 405.2136(c).............................. Designating a chief 494.180(a).
executive office or
administrator.
(d) Personnel policies and 405.2136(d)(1)........................... Governance................. 494.180(b)(3) and (b)(4).
procedures.
405.2136(d)(3-5, 7)...................... Deleted. ........................................
(d)(2) Infection control/Incident 405.2136(d)(2)........................... Infection control and 494.30(a) and 494.110(a)(ix).
reports. Quality assessment and
performance improvement.
(d)(6) Facility personnel 405.2136(d)(6)........................... Personnel qualifications... 494.140(e).
educational programs. Governance................. 494.180(b)(3) and (b)(4).
Infection Control.......... 494.30(a).
(e) Use of outside resources...... 405.2136(e).............................. Deleted. ........................................
(f) Patient care policies......... 405.2136(f).............................. Policies and procedures.... 494.150(c).
(g) Medical supervision and 405.2136(g).............................. Furnishing services........ 494.180(d).
emergency coverage.
405.2136(g)(1)........................... Patient plan of care....... 494.90 (introductory text).
405.2136(g)(2)........................... Emergency Coverage......... 494.180(g).
(h) Medical staff................. 405.2136(h).............................. Medical staff appointments. 494.180(c).
Patient long-term program and patient 405.2137 (introductory text)............. Patient plan of care....... 494.90 (introductory text).
care plan.
(a) Patient long-term program..... 405.2137(a).............................. Deleted. ........................................
(b) Patient care plan............. 405.2137(b).............................. Patient plan of care....... 494.90 (introductory text).
(b)(1) Personalized care plan..... 405.2137(b)(1)........................... Patient plan of care....... 494.90 (introductory text).
(b)(2) Developed by a professional 405.2137(b)(2)........................... Patient plan of care....... 494.90 (introductory text).
team.
(b)(3) The patient is involved.... 405.2137(b)(3)........................... Patient plan of care....... 494.90(b)(1).
Patient's rights........... 494.70(a)(5).
(b)(4) Frequency of care plan 405.2137(b)(4)........................... Patient plan of care....... 494.90(b)(2).
review. Patient reassessment....... 494.80(d).
(b)(5) Transfer of care plan...... 405.2137(b)(5)........................... Medical records............ 494.170(d).
(b)(6) Care plan for the home 405.2137(b)(6)........................... Development of patient plan 494.90(a)(4).
dialysis patient. of care. 494.100(c)(1).
Care at home...............
(b)(7) Erythropoietin for the home 405.2137(b)(7)........................... Patient plan of care....... 494.90(a)(4).
dialysis patient.
Patients' rights and responsibilities. 405.2138(a)-(d).......................... Patients' rights........... 494.70(a).
Medical records............ 494.170(a).
Posting of rights.......... 494.70(c).
405.2138(e).............................. Internal grievance process. 494.180(e).
Patients' rights........... 494.70(a)(14) and (a)(15).
Posting of rights.......... 494.70(c).
Medical records....................... 405.2139................................. Medical records............ 494.170 (introductory text).
(a) Medical record contents....... 405.2139(a).............................. Medical records............ 494.170(b).
(b) Protection of medical record 405.2139(b).............................. Protection of patient's 494.170(a).
information. record.
(c) Medical record supervisor..... 405.2139(c).............................. Deleted. ........................................
(d) Completion and centralization. 405.2139(d).............................. Completion of patient 494.170(b).
records and centralization
of clinical information.

[[Page 20453]]

(e) Retention and preservation.... 405.2139(e).............................. Record retention and 494.170(c).
preservation.
(f) Location and facilities....... 405.2139(f).............................. Deleted. ........................................
(g) Transfer of medical 405.2139(g).............................. Transfer of patient record 494.170(d).
information. information.
Physical environment.................. 405.2140(a) (introductory text).......... Physical environment....... 494.60 (introductory text).
(a) Building and equipment........ 405.2140(a)(1)........................... Building................... 494.60(a) and (b).
(a)(1) Fire....................... 405.2140(a)(2), (3)...................... Fire Safety................ 494.60(e).
(a)(2), (3) Equipment and areas 405.2140(a)(2), (3)...................... Equipment maintenance...... 494.60(b).
are hazard free.
(a)(5) Water quality requirements. 405.2140(a)(5)........................... Water and dialysate quality 494.40(a).
(b) Favorable environment for 405.2140(b) (introductory text).......... Patient care environment... 494.60(c).
patients.
(b)(1) Infection prevention....... 405.2140(b)(1)........................... Procedures for infection 494.30.
control.
(b)(2) and (b)(4) Adequate 405.2140(b)(2) and (b)(4)................ Physical environment....... 494.60 (introductory text) and (c).
treatment areas/Heating and
ventilation systems.
(b)(3) Nursing station............ 405.2140(b)(3)........................... Governance................. 494.180(g)(2).
(b)(5) Special dialysis solutions. 405.2140(b)(5)........................... Deleted. ........................................
(c) Contamination prevention...... 405.2140(c).............................. Infection control.......... 494.30(a).
Reuse of hemodialyzers..... 494.50.
(d) Emergency preparedness........ 405.2140(d).............................. Emergency preparedness..... 494.60(d).
Reuse of hemodialyzers and other 405.2150 (introductory text)............. Reuse of hemodialyzers and 494.50 (introduction).
dialysis supplies. bloodlines.
(a) Hemodialyzers................. 405.2150(a)(1) and (a)(2)................ Reprocessing requirements 494.50(b).
for the reuse of
hemodialyzers and
bloodlines.
405.2150(a)(3)........................... Monitoring, evaluation, and 494.50(c).
reporting requirements for
the reuse of hemodialyzers
and bloodlines.
(b) Transducer filters............... 405.2150(b).............................. Deleted. ........................................
(c) Bloodlines.................... 405.2150(c).............................. General requirements for 494.50(a).
the reuse of hemodialyzers
and bloodlines.
Reprocessing requirements 494.50(b).
for the reuse of
hemodialyzers and
bloodlines.
Affiliation agreement or arrangement.. 405.2160(a), (b)(1), (b)(3).............. Governance................. 494.180(g)(3).
405.2160(b)(2)........................... Transfer of patient record 494.170(d).
information.
Director of a renal dialysis facility 405.2161................................. Personnel qualifications... 494.140 (introductory text).
or renal dialysis center. Medical director........... 494.140(a).
Responsibilities of the 494.150.
medical director.
Staff of a renal dialysis facility or 405.2162 (introductory text)............. Governance................. 494.180(b).
renal dialysis center.
(a) Registered nurse.............. 405.2162(a).............................. Governance................. 494.180(b)(2).
Personnel qualifications... 494.140(b)(1).
(b) On-duty personnel............. 405.2162(b).............................. Governance................. 494.180(b)(1).
(c) Self-care dialysis training 405.2162(c).............................. Care at Home............... 494.100(a)(2).
personnel. Personnel qualifications... 494.140(b)(2).
Minimal service requirements for a 405.2163................................. Patient plan of care....... 494.90 (introductory text).
renal dialysis facility or renal
dialysis center.
(a) Outpatient dialysis services.. 405.2163(a)(1)........................... Patient plan of care....... 494.90 (introductory text).
405.2163(a)(2)........................... Patient plan of care....... 494.90 (introductory text).
Care at home............... 494.100 (introductory text).
(b) Laboratory services........... 405.2163(b).............................. Laboratory services........ 494.130.
(c) Social services............... 405.2163(c).............................. Assessment criteria........ 494.80(a)(7).
Support services........... 494.100(c).
Psychosocial services...... 494.90(a)(6).
(d) Dietetic services............. 405.2163(d).............................. Assessment criteria........ 494.80(a)(5) and (a)(6).
Patient plan of care....... 494.90(a)(2) and (a)(3).
(e) Self-dialysis support services 405.2163(e).............................. Support services........... 494.100(c).
(f) Participation in recipient 405.2163(f).............................. Deleted. ........................................
registry.
(g) Use of erythropoietin at home. 405.2163(g).............................. Patient assessment......... 494.80(a)(2), (4).
Patient plan of care....... 494.90(a)(4).
Care at home............... 494.100(a).
(h) Responsibilities of the 405.2163(h).............................. Care at home............... 494.100(b) and (c).
physician/facility for use of
erythropoietin at home.
Conditions for coverage of special 405.2164................................. Special purpose renal 494.120.
purpose renal dialysis facilities. dialysis facilities.
(a) Special purpose renal renal 405.2164(a).............................. Special purpose dialysis 494.120.
dialysis facilities. facilities.

[[Page 20454]]

(b) Consult patient's physician... 405.2164(b).............................. Physician contact.......... 494.120(d).
(c) Approval period............... 405.2164(c).............................. Approval period............ 494.120(a).
(d) Service limitation............ 405.2164(d).............................. Service limitation......... 494.120(b).
Termination of Medicare coverage...... 405.2180................................. Termination of Medicare 488.604.
coverage and alternative
sanctions for ESRD
facilities.
Alternative sanctions................. 405.2181................................. Alternative sanctions...... 488.606.
Notice of sanction and appeal rights: 405.2182................................. Notice of appeal rights: 488.608.
Termination of coverage. Termination of coverage.
Notice of appeal rights: Alternative 405.2184................................. Notice of appeal rights: 488.610.
sanctions. Alternative sanctions.
--------------------------------------------------------------------------------------------------------------------------------------------------------

VI. Collection of Information Requirement

Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements:

A. ICRs Regarding Payment for Home Dialysis Equipment, Supplies and
Support Services (Sec. 414.330)

Section 414.330 states that suppliers must report to the ESRD
facility providing support services, at least every 45 days, all data
for each patient regarding services and items furnished to the patient
in accordance with Sec. 494.100(c)(2) of this chapter.
The burden to ESRD facilities associated with this requirement is
the time and effort necessary to collect all data for each patient
receiving home dialysis care with respect to services and items
furnished. We estimate that there are approximately 24,657 patients
receiving home dialysis care (approximately 5 percent of all dialysis
patients), and that it would take a dialysis facility 1.5 hours
annually to collect data for each patient. Therefore, we estimate a
total annual burden of 36,986 hours.

B. ICRs Regarding Special Procedures for Approving End-Stage Renal
Disease Facilities (Sec. 488.60)

Section 488.60 states that an ESRD facility wishing to be approved,
or wishing to be approved for an expansion of dialysis services, for
Medicare coverage, in accordance with part 494 of this chapter, must
submit the documents and data as outlined in Sec. 488.60(a)(1) through
(a)(4).
As of the spring of 2007, there were 4,746 Medicare approved
dialysis facilities (http://www.medicare.gov/Download/DownloadDB.asp).
From 1998 to 2004, the average yearly growth (using USRDS data) in
dialysis facilities seeking approval was 4.4 percent. We anticipate a
similar rate of growth in dialysis facilities over the next few years.
Thus, we believe that 218 new and renovated dialysis facilities will
request Medicare approval in 2009 and that over the five-year period
from 2009 to 2013 a total of 1,191 new and renovated dialysis
facilities will request Medicare approval. We estimate the average
number of new facilities per year requesting approval would be 238
facilities per year, over 5 five years. Since we are requiring
compliance with the provisions of this rule 180-300 days after
publication of this final rule, we are using 2009 estimates of the
numbers for new and renovated dialysis facilities for one-time burdens.
We estimate that it will take 40 hours for each of the 238 new and
renovated facilities to gather and submit the necessary documentation
for consideration by the Secretary. The estimated annual burden is 9520
annual hours.

C. ICRs Regarding Infection Control (Sec. 494.30)

Section 494.30 discusses the conditions for infection control
programs. Specifically, Sec. 494.30(a)(1)(ii) states that when
dialysis isolation rooms as required by Sec. 494.30(a)(1)(i) are
available locally that sufficiently serve the needs of patients in the
geographic area, a new facility may request a waiver of the isolation
requirement. The burden associated with this requirement is the time
and effort necessary to draft and submit a waiver request to the
Secretary. We estimate that 90 percent (about 214 per year) of new
dialysis facilities would request a waiver. We estimate that it will
take each facility approximately 1 hour to comply with this information
collection request. The total estimated annual burden is 214 hours.
Section 494.30(b) outlines the standards for infection control
program oversight. Section 494.30(b)(1) states that a facility must
monitor and implement biohazard and infection control policies and
activities within the dialysis unit. The burden associated with this
requirement is the time and effort necessary to develop, draft,
implement, and monitor the biohazard and infection control policies.
This requirement is subject to the PRA; the burden is currently
approved under OMB 0938-0386, with an expiration date of March
31, 2010.
Section 494.30(b)(3) states that a facility must require all
clinical staff to report infection control issues to the dialysis
facility's medical director and the quality improvement committee. We
estimate that it would take staff 5 minutes per incident to notify the
medical director and the quality improvement committee. Such infection
control issues are rare, and so we estimate that only 1 percent of
facilities would experience an incident annually. Therefore, for 54
facilities, we estimate a total annual burden of 4.5 hours.
Section 494.30(c) contains a reporting requirement. The facility
must report incidences of communicable diseases as required by Federal,
State, and local regulations. The burden associated with this
requirement is the time and effort necessary to report incidences of
communicable diseases to the appropriate Federal, State, or local
agency. While this requirement is subject to the PRA, we believe the

[[Page 20455]]

burden is exempt as stated in 5 CFR 1320.3(b)(3). Facilities must
report as required by Federal, State, and local regulations. The burden
associated with this reporting requirement would exist in the absence
of the Federal requirement contained in this regulation. Consequently,
the burden is exempt from the PRA.

D. ICRs Regarding Water and Dialysate Quality (Sec. 494.40)

Section 494.40(b)(1) states that a facility's water treatment
system must include a component or carbon tank which removes chlorine/
chloramines along with a backup component or second carbon tank in
series for chlorine/chloramines removal. Section 494.40(b)(1)(ii)
further specifies the required course of action if the test results
from the last component or carbon tank are greater than the parameters
for chlorine or chloramine specified in paragraph (b)(2)(i) of this
section. As stated in Sec. 494.40(b)(1)(ii)(c), the facility must
immediately notify the medical director. We estimate that it would take
staff 5 minutes per incident to notify the medical director. Such
incidents are rare, and so we estimate that only 1 percent of
facilities would experience an incident annually. Therefore, for 54
facilities, we estimate a total annual burden of 4.5 hours.
Additionally, Sec. 494.40(c) requires a facility to create a
corrective action plan that ensures patient safety. Specifically, when
water testing results, including but not limited to chemical,
microbial, and endotoxin levels which meet AAMI levels or deviate from
the AAMI standards, the dialysis facility must develop a corrective
action plan. The burden associated with this requirement is the time
and effort necessary to develop and implement a corrective action plan.
We estimate that it would take 54 facilities 30 minutes each to develop
and implement a corrective action plan that ensures patient safety.
Therefore, we estimate a total annual burden of 27 hours.
Section 494.40(d) states that a dialysis facility must maintain
active surveillance of patient reactions during and following dialysis.
When clinically indicated, the facility must perform the tasks listed
in Sec. 494.40(d)(1)-(3). The burden associated with these
requirements is the time and effort required to maintain active
surveillance of patient reactions during and following dialysis. In
addition, there is burden associated with the tasks listed in Sec.
494.40(d)(1)-(3). While all of the requirements in Sec. 494.40(d) are
subject to the PRA, they are exempt as stated under 5 CFR 1320.3(h)(5);
facts or opinions obtained initially or in follow-on requests, from
individuals under treatment or clinical examination in connection with
research on or prophylaxis to prevent a clinical disorder, direct
treatment of that disorder, or the interpretation of biological
analyses of body fluids, tissues, or other specimens, or the
identification or classification of such specimens are not subject to
the PRA.

E. ICRs Regarding the Reuse of Hemodialyzers and Bloodlines (Sec.
494.50)

Section 494.50(c)(1) states that a dialysis facility must monitor
patient reactions during and following dialysis. As stated in Sec.
494.50(c)(2), a facility must obtain blood and dialysate cultures and
endotoxin levels, and undertake evaluation of its dialyzer reprocessing
and water purification system. The burden associated with these
requirements is the time and effort necessary to monitor and record
patient reactions and to perform the tasks listed in Sec.
494.50(c)(2)(i)-(ii). While these requirements are subject to the PRA,
they are exempt as stated under 5 CFR 1320.3(h)(5); facts or opinions
obtained initially or in follow-on requests, from individuals under
treatment or clinical examination in connection with research on or
prophylaxis to prevent a clinical disorder, direct treatment of that
disorder, or the interpretation of biological analyses of body fluids,
tissues, or other specimens, or the identification or classification of
such specimens are not subject to the PRA.
Section 494.50(c)(2)(iii) requires a facility to report any adverse
outcomes to FDA and other Federal, State, or local government agencies
as required by law. The burden associated with this requirement is the
time and effort necessary to report the adverse outcomes to the FDA and
other Federal, State, or local government agencies as required by law.
While this requirement is subject to the PRA, the burden is exempt as
stated in 5 CFR 1320.3(b)(3). Facilities must report as required by law
to Federal, State, and local government agencies. The burden associated
with this reporting requirement would exist in the absence of the
Federal requirement contained in this regulation. Consequently, the
burden is exempt from the PRA.

F. ICRs Regarding Physical Environment (Sec. 494.60)

As required by Sec. 494.60(b), a dialysis facility must implement
and maintain a program to ensure that all equipment (including
emergency equipment, dialysis machines and equipment, and the water
treatment system) are maintained and operated in accordance with the
manufacturer's recommendations. The burden associated with this
requirement is the time and effort necessary to develop, implement, and
maintain a program to ensure that all equipment (including emergency
equipment, dialysis machines and equipment, and the water treatment
system) are maintained and operated in accordance with the
manufacturer's recommendations. This requirement is subject to the PRA;
the burden is currently approved under OMB 0938-0386, with an
expiration date of March 31, 2010.
Section 494.60(d) contains the standard for emergency preparedness.
Specifically, Sec. 494.60(d)(1) states that a facility must provide
appropriate training and orientation in emergency preparedness to the
staff as specified in this section. Staff training must be provided and
evaluated at least annually. Section Sec. 494.60(d)(2) states that a
facility must provide appropriate training and orientation in emergency
preparedness to patients as specified in this section. The burden
associated with this requirement is the time and effort necessary to
provide emergency preparedness training and orientation to the staff
and patients. This requirement is subject to the PRA; the burden is
currently approved under OMB 0938-0386, with an expiration
date of March 31, 2010.
Section 494.60(d)(4)(i)-(iii) lists the facility requirements for
emergency plans. Section 494.60(d)(4)(i) states that a facility must
have a plan to obtain emergency medical system assistance when needed.
Section 494.60(d)(4)(ii) requires a facility to, at least annually,
evaluate the effectiveness of emergency and disaster plans and update
them as necessary. Section 494.60(d)(4)(iii) states that a facility
must contact its local disaster management agency at least annually to
ensure that such agency is aware of the dialysis facility's needs in
the event of an emergency. The burden associated with the requirements
in Sec. 494.60(d) is the time and effort necessary to develop,
maintain, and annually evaluate emergency and disaster plans. In
addition, there is also burden associated with contacting its local
disaster management agency on an annual basis. We estimate that it will
take each of the 238 new facilities 5 hours to comply with the
requirements in this section. We estimate that it will take 1 hour each
for 5,415 existing facilities (estimated number of existing facilities
per year, over five years, assuming 4.4 percent growth) to annually
comply with the

[[Page 20456]]

requirements in this section. The total estimated annual burden for new
and existing facilities is 6,605 hours.

G. ICRs Regarding Patients' Rights (Sec. 494.70)

Section 494.70 states that a dialysis facility must inform patients
(or their representatives) of their rights and responsibilities when
they begin their treatment. In addition, the dialysis facility must
prominently display a copy of the patients' rights in the facility,
including the current State agency and ESRD Network mailing addresses
and telephone complaint numbers, where it can be easily seen and read
by patients.
We estimate that it will take 5,415 facilities (estimated number of
existing facilities per year, over five years, assuming 4.4 percent
growth) 1.5 hours each on an annual basis to update their patient
rights materials to comply with this requirement. While this
requirement is subject to the PRA, the burden is currently is approved
under OMB control number 0938-0386 with an expiration date of March 31,
2010.

H. ICRs Regarding Patient Assessment (Sec. 494.80)

Section 494.80 states that a facility's interdisciplinary team is
responsible for providing each patient with an individualized and
comprehensive patient assessment of his or her needs. Sections
494.80(a) through 494.80(d) discuss the standards for the components of
the patient assessment. In addition to meeting the aforementioned
standards, the comprehensive patient assessment must be documented and
maintained in the patient's medical record.
The burden associated with the requirements in Sec. 494.80 is the
time and effort necessary for the interdisciplinary team to develop and
implement an individual assessment for each patient and maintaining the
assessment in the patient's medical record. This requirement is subject
to the PRA; the burden is currently approved under OMB 0938-
0386, with an expiration date of March 31, 2010.

I. ICRs Regarding Patient Plan of Care (Sec. 494.90)

Section 494.90(a) states that a facility's interdisciplinary team
must develop and implement a written, individualized comprehensive plan
of care that meets the all of the requirements of Sec. 494.90. The
burden associated with this requirement is approved under OMB
0938-0386, with an expiration date of March 31, 2010.

J. ICRs Regarding Care at Home (Sec. 494.100)

Section 494.100 details the conditions for care at home.
Specifically, a facility's interdisciplinary team must provide training
to the home dialysis patient, the designated caregiver, or the self-
dialysis patient before the initiation of home dialysis or self-
dialysis (as defined in Sec. 494.10 of this part) and when the home
dialysis caregiver or home dialysis mortality changes. Section
494.100(a) outlines the standards for training. As a requirement of the
standards for home dialysis monitoring discussed in Sec. 494.100(b),
the dialysis facility must document in the medical record that the
patient, the caregiver, or both received and demonstrated adequate
comprehension of the training. In addition, the facility must retrieve
and review complete self monitoring data and other information from
self-care patients or their designated caregiver(s) at least every 2
months and maintain this information in the patient's medical record.
While these requirements are subject to the PRA, they are exempt as
stated under 5 CFR 1320.3(h)(5); facts or opinions obtained initially
or in follow-on requests, from individuals under treatment or clinical
examination in connection with research on or prophylaxis to prevent a
clinical disorder, direct treatment of that disorder, or the
interpretation of biological analyses of body fluids, tissues, or other
specimens, or the identification or classification of such specimens
are not subject to the PRA. In addition, facilities are required to
meet these requirements as stated under Federal, State, and local laws
and thereby exempt under 5 CFR 1320.3(b)(3).
Section 494.100(c) contains the standards for support services. As
required by Sec. 494.100(c)(1)(i), a facility must periodically
monitor the patient's home adaptation. Section 494.100(c)(1)(ii)
requires a member of the facilities interdisciplinary team to
coordinate the home patient's care. Section 494.100(c)(1)(iii) requires
a facility to develop and periodically review each patient's plan of
care. Section 494.100(c)(1)(v) requires that the facility must monitor
the quality of water and dialysate used by home hemodialysis patients.
The monitoring must include onsite evaluations and tests of the water
and dialysate system. We estimate that facilities would have to meet
these requirements for 24,657 care at home patients, and that it would
take them approximately 6 hours per patient, per year. We estimate a
total annual burden of 147,942 hours.
Section 494.100(c)(2) states that the dialysis facility must
maintain a recordkeeping system that ensures continuity of care and
patient privacy. The burden associated with this requirement is the
time and effort necessary to develop a recordkeeping system and to
maintain the records to ensure continuity of care and patient privacy.
This requirement is subject to the PRA; the burden is currently
approved under OMB 0938-0386, with an expiration date of March
31, 2010.

K. ICRs Regarding Quality Assessment and Performance Improvement (Sec.
494.110)

Section 494.110 discusses the conditions for quality assessment and
performance improvement. The dialysis facility must develop, implement,
maintain, and evaluate an effective, data-driven quality assessment and
performance improvement program that reflects the complexity of the
dialysis facility's organization and services. The dialysis facility
must maintain and demonstrate evidence of its quality improvement and
performance improvement program for review by CMS.
Specifically, as part of the program scope in Sec. 494.110(a)(2),
a dialysis facility must measure, analyze, and track quality indicators
or other aspects of performance that the facility adopts or develops
that reflect processes of care and facility operations. The standard
for monitoring performance improvement, Sec. 494.110(b), states that a
facility must continuously monitor its performance, take actions that
result in performance improvement, and track performance to ensure
improvements are sustained over time.
The burden associated with all of the requirements of this section
is the time and effort necessary to develop, implement, maintain,
evaluate, and demonstrate evidence of a quality assessment and
performance improvement program. We believe that an overwhelming
majority of dialysis facilities already have established and sustained
QAPI programs. We estimate that only 10 percent of dialysis facilities
need to develop and implement QAPI programs. It would take 517
facilities (10 percent of the estimated number of existing facilities
in 2009 of 5,173, assuming 4.4 percent annual growth) each
approximately 48 hours to meet these requirements. The one-time burden
associated with this requirement is estimated to be 20,016 hours.
Additionally, all facilities would be subject to an annual burden
to maintain, evaluate, and demonstrate evidence of a quality assessment
and performance

[[Page 20457]]

improvement program. The facility must analyze and document the
incidence of infection and identify trends and establish baseline
information on infection incidence; and develop recommendations and an
action plan to minimize infection transmission, promote immunization,
and take actions to reduce future incidents. The burden associated with
this requirement is the time and effort it would take for a facility to
document the incidence of infection and develop recommendations and an
action plan to reduce future incidents. We estimate it would take 5,415
facilities 12 hours annually each to meet this requirement, for a total
annual burden of 64,980 hours.

L. ICRs Regarding Special Purpose Renal Dialysis Facilities (Sec.
494.120)

As required by Sec. 494.120(d), a facility must contact the
patient's physician, if possible, prior to initiating dialysis in the
special purpose renal dialysis facility, to discuss the patient's
current condition to assure care provided in the special purpose renal
dialysis facility is consistent with the plan of care (described in
Sec. 494.90 of this part). The burden associated with this requirement
is the time and effort necessary to contact the patient's physician to
discuss the patient's current condition and to ensure that the care
provided by the special purpose renal dialysis facility is consistent
with the patient plan of care. This requirement is subject to the PRA;
the burden is currently approved under OMB 0938-0386, with an
expiration date of March 31, 2010.
Section 494.120(e) requires that a facility document all patient
care provided in the special purpose facility and forward the
documentation to the patient's dialysis facility, if possible, within
30 days of the last scheduled treatment in the special purpose renal
dialysis facility. The burden associated with this requirement is the
time and effort necessary to document the patient care and to forward
the documentation to the patient's dialysis facility. The burden
associated with this requirement is approved under OMB 0938-
0386, with an expiration date of March 31, 2010.

M. ICRs Regarding Responsibilities of the Medical Director (Sec.
494.150)

In the proposed rule that published February 4, 2005 (70 FR 6184)
we discussed the responsibilities of the medical director. However, we
erroneously reported that the requirements were previously approved
under OMB control number 0938-0086. This section does not impose any
burden associated with information collection requirements.

N. ICRs Regarding Medical Records (Sec. 494.170)

Section 494.170 requires that a dialysis facility maintain
complete, accurate, and accessible records on all patients, including
home patients who elect to receive dialysis supplies and equipment from
a supplier that is not a provider of ESRD services, and on all other
home dialysis patients whose care is under the supervision of the
facility. The burden associated with this requirement is the time and
effort necessary to maintain the required documentation in the medical
record. This requirement is subject to the PRA; the burden is currently
approved under OMB 0938-0386, with an expiration date of March
31, 2010.
Section 494.170(a)(3) requires that a dialysis facility obtain
written authorization from the patient or legal representative before
releasing information that is not authorized by law. The burden
associated with this requirement is the time and effort necessary to
draft the authorization form and to obtain the signature of the patient
or the patient's legal representative. This requirement is subject to
the PRA; the burden is currently approved under OMB 0938-0386,
with an expiration date of March 31, 2010.
Section 494.170(c) contains a recordkeeping requirement. Facilities
must maintain all patient records on file for 6 years from the date of
the patient's discharge, transfer, or death. The burden associated with
this requirement is the time and effort necessary to maintain the
patient records for 6 years. While the burden associated with this
requirement is approved under OMB 0938-0386, this information
must be maintained in accordance with other Federal, State, and local
laws. We believe this requirement is exempt under 5 CFR 1320.3(b)(3);
the burden would exist in the absence of the Federal requirement
contained in this regulation.
Section 494.170(d) states that when a dialysis patient is
transferred, the dialysis facility releasing the patient must send all
requested medical record information to the receiving facility within 1
working day of the transfer. The burden associated with this
requirement is the time and effort necessary to disclose all requested
medical record information to the receiving facility. This requirement
is subject to the PRA; the burden is currently approved under OMB
0938-0386, with an expiration date of March 31, 2010.

O. ICRs Regarding Governance (Sec. 494.180)

Section 494.180(e) discusses the standard for a facility's internal
grievance process. This section requires that the facility's internal
grievance process be implemented so that the patient may file an oral
or written grievance with the facility without reprisal or denial of
services. In addition, Sec. 494.180(e)(1)-(3) details the required
contents of the process. The burden associated with this requirement is
the time and effort necessary to develop and implement the internal
grievance process. There is also burden associated with making patients
aware of the process. We believe that all existing facilities already
have internal grievance processes, as they are already required in
conjunction with participation in ESRD Network activities. We
acknowledge that there may be a very small number of facilities that do
not have grievance processes in place, so we estimate that it would
take 2 facilities 1.5 hours each to develop grievance processes and
inform patients about them. Therefore, we estimate a total one time
burden of 3 hours.
As required by Sec. 494.180(f)(4), the interdisciplinary team must
document the patient reassessments, ongoing problem(s), and efforts
made to resolve the problem(s) and enter the information into the
patient's medical record. In addition, the facility must notify the
patient with a 30-day written notice of planned involuntary discharge,
and also notify the ESRD Network that services the area and the State
agency of the discharge.
The burden associated with this requirement is the time and effort
necessary to document the reassessments in the medical records and the
time and effort necessary to notify the patient and ESRD Network 30
days prior to the involuntary discharge and the State agency at the
time of involuntary discharge. We estimate it would take 10 minutes per
incident to record the documentation and provide such notification.
While this requirement is subject to the PRA, we have no way to
accurately quantify the number of affected individuals. Our best
estimate is that each facility would have less than one patient
involuntarily discharged on a yearly basis. We estimate that the total
annual burden for 5,415 facilities would be 903 hours.
The interdisciplinary team must obtain a written physician's order
that must be signed by both the medical director and the patient's
attending physician concurring with the patient's

[[Page 20458]]

discharge or transfer from the facility. They must also document any
attempts to place the patient in another facility and notify the State
survey agency of the involuntary transfer or discharge.
The burden associated with this requirement is approved under OMB
0938-0386, with an expiration date of March 31, 2010. However,
the requirement for the second signature from the medical director is
new. We estimate that it would take 5 minutes for the medical director
to sign the discharge order. While this requirement is subject to the
PRA, we have no way to accurately quantify the burden. Our best
estimate is that each facility would have less than one patient
involuntarily discharged on a yearly basis. We estimate that the total
annual additional burden for 5,415 facilities would be 451 hours.
Section 494.180(g) discusses the standard for emergency coverage.
As required by Sec. 494.180(g)(2), the dialysis facility must have
available at the nursing/monitoring station, a roster with the names of
physicians to be called for emergencies, when they can be called, and
how they can be reached. We estimate that it would take 5,415
facilities 10 minutes each to develop such a roster. We estimate that
the total one-time burden would be 903 hours.
Section 494.180(g)(3) contains the requirement that a dialysis
facility must have an agreement with a hospital that can provide
inpatient care, routine and emergency dialysis, and other hospital
services, and emergency medical care that is available 24 hours a day,
7 days a week. The burden associated with this requirement is the time
and effort necessary for the dialysis facility to draft the agreement
and to finalize the agreement with hospital. This requirement is
subject to the PRA; the burden is currently approved under OMB
0938-0386, with an expiration date of March 31, 2010.
Section 494.180(h) states that a dialysis facility must furnish
data and information electronically to CMS at intervals specified by
the Secretary, which meet the requirements referenced in this section.
The information collection activities discussed in this section are
approved under the following OMB control numbers:

----------------------------------------------------------------------------------------------------------------
Expiration
OMB control No. Collection title date
----------------------------------------------------------------------------------------------------------------
0938-0046................................ End-Stage Renal Disease Medical Evidence Report 09/30/2010
Medicare Entitlement and/or Patient Registration.
0938-0386................................ Conditions for Coverage of Suppliers of End-Stage 03/31/2010
Renal Disease (ESRD) Services & Suppt Regs. at 42
CFR 405.2100-.2171.
0938-0657................................ End State Renal Disease Network Semi-annual Cost 12/31/2009
Report Forms.
0938-0658................................ ESRD Network Business Proposal Forms................. 02/28/2010
----------------------------------------------------------------------------------------------------------------

These requirements are subject to the PRA, and are currently
approved under the following OMB approval numbers: 0938-0046, 0938-
0360, 0938-0386, 0938-0657, and 0938-0658.
Section 494.180(j) contains the standard for disclosure of
ownership. In accordance with Sec. Sec. 420.200 through 420.206 of
this chapter, the governing body must report ownership interests of 5
percent or more to its State survey agency. The burden associated with
this requirement is the time and effort necessary to disclose ownership
interests to CMS. This requirement is subject to the PRA; the burden is
currently approved under OMB control number 0938-0086 with an
expiration date of December 31, 2008.

Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Burden per
Regulation section(s) OMB control Respondents Responses response Total annual
number (hours) burden (hours)
----------------------------------------------------------------------------------------------------------------
Sec. 414.330.................. 0938-New 24,657 24,657 1.5 36,986
Sec. 488.60(a)(1-4)........... 0938-New 238 238 40 9520
Sec. 494.30(a)(1)(ii)......... 0938-New 214 214 1 214
Sec. 494.30(b)(1)............. 0938-0386 .............. .............. .............. ..............
Sec. 494.30(b)(1(ii)(c)....... 0938-New 54 54 .05 4.5
Sec. 494.40(c)................ 0938-New 54 54 .50 27
Sec. 494.60(b)................ 0938-0386 .............. .............. .............. ..............
Sec. 494.60(d)(2)............. 0938-0386 .............. .............. .............. ..............
Sec. 494.60(d)(4)(i)-(iii).... 0938-New 238/5,415 238/5,415 5/1 6,605
Sec. 494.70................... 0938-0386 .............. .............. .............. ..............
Sec. 494.80................... 0938-0386 .............. .............. .............. ..............
Sec. 494.90................... 0938-0386 .............. .............. .............. ..............
Sec. 0938-New 24,657 24,657 6 147,942
494.100(c)(1)(i)(ii)(iii)(v)...
Sec. 494.100(c)(2)............ 0938-0386 .............. .............. .............. ..............
Sec. 494.110.................. 0938-New 5,415 5,415 12 64,980
Sec. 494.120.................. 0938-0386 .............. .............. .............. ..............
Sec. 494.120(e)............... 0938-0386 .............. .............. .............. ..............
Sec. 494.170.................. 0938-0386 .............. .............. .............. ..............
Sec. 494.170(a)(3)............ 0938-0386 .............. .............. .............. ..............
Sec. 494.170(c)............... 0938-0386 .............. .............. .............. ..............
Sec. 494.170(d)............... 0938-0386 .............. .............. .............. ..............
Sec. 494.180(e)(1)-(3)........ 0938-New 2 2 1.5 3
Sec. 494.180(f)(4)............ 0938-New 5,415 5,415 .10 903
Sec. 494.180(f)(4)(iii)....... 0938-New 5,415 5,415 .10 451
Sec. 494.180(g)(3)............ 0938-0386 .............. .............. .............. ..............
Sec. 494.180(h)............... 0938-0046 100,000 100,000 .75 75,000
0938-0657 18 36 3 108
0938-0658 18 36 30 1080

[[Page 20459]]

Sec. 494.180(j)............... 0938-0086 125,000 125,000 .5 62,500
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 336,803
----------------------------------------------------------------------------------------------------------------
** There are multiple regulation sections approved under this OMB control number. There is uniform burden per
response.

We have submitted a copy of this final rule to OMB for its review
of the information collection requirements. These requirements are not
effective until they have been approved by OMB. In addition, any burden
requirements previously approved under an OMB control number will be
re-examined and updated during the next OMB PRA review cycle.

VII. Regulatory Impact Analysis

A. Overall Impact

We have examined the impacts of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 on
Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) directs 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 is a revision of the Medicare conditions for coverage for
end-stage renal disease (ESRD) dialysis facilities. The conditions for
coverage are the basic health and safety requirements that an ESRD
supplier of services must meet in order to receive payment from the
Medicare program. This final rule incorporates new scientific advances
and current medical practices utilized in treating ESRD while removing
numerous burdensome process and procedural requirements contained in
the 42 CFR part 405, subpart U conditions for coverage. While it is not
possible at this point to determine definitively the additional costs
and cost savings to the Medicare program resulting from this rule, we
do not believe that the impact will be above the $100 million
economically significant threshold; and therefore, believe that this
final rule is not 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
$6.5 million to $31.5 million in any 1 year. Kidney dialysis centers
with revenues at or below $31.5 million are small entities http://sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf, see Sector 62). According to 2004 revenue data, nearly
163 dialysis facilities (5.2 percent of all establishments) could be
considered to be small entities. This rule will not have a significant
economic impact on small entities. This regulation could cost these
small facilities an average of $2,392 (about 2.4 percent of $100,000)
for upgrades and improvements, and save small facilities up to $5,043
in the first year, resulting in an average net first-year cost savings
of up to $2,651. The Secretary certifies that this final rule will not
have a significant economic impact on a substantial number of small
entities.
In addition, section 1102(b) of 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 604 of the RFA.
Since this final rule applies only to dialysis facilities, it has no
impact on small rural hospitals. The Secretary certifies that this
final rule will 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. That threshold
level is currently approximately $130 million. This rule has no impact
on the expenditures of State, local or tribal governments, and the
impact on private sector expenditures is estimated to be less than $130
million.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on State and local governments,
preempts State law, or otherwise has Federalism implications. This rule
will not have a substantial effect on State and local governments.

B. Anticipated Effects

1. Subpart A--General Provisions
Subpart A ``General Provisions,'' addresses the basis and scope
(Sec. 494.1) of this regulation, definitions used in the new
conditions for coverage (Sec. 494.10), as well as compliance with
Federal, State, and local laws and regulations (Sec. 494.20). These
provisions do not result in any new economic impact as the definitions
do not include any new requirements and facility compliance with laws
and regulations is consistent with the existing requirements at Sec.
405.2135. We have removed the requirements found in 42 CFR part 405,
subpart U, which specify qualifications that the dialysis facility CEO
must have. This change may relieve a degree of burden for small
businesses, as a greater number of candidates would qualify for this
position, thereby affording facilities greater hiring flexibility. We
have also removed the 42 CFR part 405, subpart U, medical record
practitioner requirement (Sec. 405.2102, definition of ``Qualified
Personnel'' at (c)). This may provide some burden relief specifically
for small businesses. The medical record practitioner cost savings is
computed in this impact analysis under the medical record condition for
coverage.
2. Subpart B--Patient Safety
a. Sec. 494.30 Infection Control
This final rule requires (at Sec. 494.30(a)) compliance with the
CDC ``Recommendations for Preventing

[[Page 20460]]

Transmission of Infections Among Chronic Hemodialysis Patients.'' Many
of these infection control precautions are standard care practices and
do not present any additional burden for dialysis facilities. We did
receive a comment regarding the infection control precaution that calls
for the use of disposables or dedication to single patient use those
items that cannot be cleaned and disinfected. This commenter stated
that use of disposable blood pressure cuffs is impractical, as is
dedication of blood pressure cuffs for single patient use, and that
disposable blood pressure cuff covers are not currently available.
However, according to information available on the Internet,
disposable blood pressure cuffs are available (at a cost of
approximately $6 each), as are disposable blood pressure cuff covers. A
blood pressure cuff sleeve is available for 12 cents. In addition,
easy-to-clean, one-piece, nylon latex-free blood pressure cuffs that
are universally compatible with all blood pressure monitors, are
available for about $7.00. The estimated burden for complying with the
CDC infection precautions would be $7.00 per dialysis station with the
cost varying depending on the size of the facility. Smaller dialysis
facilities would have a smaller burden than large dialysis facilities.
Since the CDC ``Recommendations for Preventing Transmission of
Infections Among Chronic Hemodialysis Patients'' were published in
2001, some dialysis facilities have already updated their practices and
are adhering to the CDC guidelines regarding dedicated use of non-
cleanable items or use of disposables. We estimate that 75 percent of
dialysis facilities still need to change their blood pressure cuff use
practices to comply with the 2001 CDC infection control precautions. We
estimate that in 2008 there will be 70,892 dialysis stations (based on
an annual growth rate of 4.4 percent and USRDS data showing 79,567
dialysis stations in 2004) that need to be upgraded with a cleanable
reusable blood pressure cuff. The associated first year cost is
estimated to be $496,244 ($7.00 x 70,892 stations). The annual cost
thereafter is estimated to be $49,624, to account for up to 10 percent
of the blood pressure cuffs that may need to be replaced annually due
to extreme contamination or damage.
One commenter stated that the CDC precautions regarding separate
staff to care for HBV positive and HBV negative/susceptible patients
will produce unintended adverse implications for smaller facilities
and/or smaller dialysis shifts. This commenter further stated that this
requirement may make it cost prohibitive for small facilities (< 9
stations) to admit HBV positive patients. The CDC ``Recommendations for
Preventing Transmission of Infections Among Chronic Hemodialysis
Patients,'' incorporated by reference in this final rule, state that
staff members caring for HBsAG-positive patients should not care for
HBV susceptible patients at the same time. This means a staff member
could care for HBV protected dialysis patients who have been vaccinated
and have developed sufficient antibodies to HBV while caring for an
HBsAG-positive patient. The prevalence of HBsAG positivity and
incidence of HBV infection in hemodialysis patients was 1.0 and 0.12
percent, respectively, in 2002 and had not changed substantially during
the previous 10 years (Finelli, et al., ``National Surveillance of
Dialysis-Associated Diseases in the United States, 2002, Seminars in
Dialysis--Vol. 18, No. 1 (January-February) 2005, pp. 52-61). We note
that the hepatitis B vaccination is now administered universally in the
U.S. as part of standard childhood immunizations. Dialysis facilities
also offer the HBV vaccination and the number of patients immunized
approaches 32 percent in hemodialysis patients age 65 and older (2004
USRDS data). Therefore, the number of dialysis patient acute hepatitis
B cases is not expected to be great and the number of HBV immunized
patients is expected to grow. We believe that when there is appropriate
patient scheduling, the separate staff requirement will present minimal
burden to dialysis facilities.
This final rule calls for adherence to the pertinent sections of
the Healthcare Infection Control Practices Advisory Committee (HICPAC)
guidelines for catheter-related infection prevention at Sec.
494.30(a)(2). We heard from nephrology nurses in their comments that
their organization ``has recognized the `Guideline for Preventing
Intravascular Device-Related Infections' as the appropriate standard of
care. We encourage CMS to do likewise in the Final Rule.'' We believe
that these HICPAC catheter infection prevention guidelines are the
professional nursing standard of practice and no additional burden is
imposed by this requirement.
We are requiring at Sec. 494.30(a) that new dialysis facilities
have an isolation room unless a waiver is requested and approved by the
Secretary. Section 494.30(a)(1)(ii) states that when dialysis isolation
rooms are available locally that sufficiently serve the needs of
patients in the geographic area, a new dialysis facility may request a
waiver of the isolation room requirement, subject to the approval of
the Secretary. According to CDC data, the 2004 reported U.S. rate of
viral hepatitis B cases was 2.1 per 100,000 population, and has
decreased almost every year since a high of 11.5 per 100,000 in 1985
(http://www.cdc.gov/hepatitis). The prevalence of HBsAG positivity and
incidence of HBV infection in hemodialysis patients was 1.0 and 0.12
percent respectively in 2002 and had not changed substantially during
the previous 10 years (Finelli, et al., ``National Surveillance of
Dialysis-Associated Diseases in the United States, 2002, Seminars in
Dialysis--Vol. 18, No. 1 (January-February) 2005, pp. 52-61). As stated
earlier, the hepatitis B vaccination is now administered universally as
part of standard childhood immunizations in the U.S. Therefore, the
number of dialysis patient acute hepatitis B cases is expected to be
small, and we believe that a large number of new dialysis facilities
will request an isolation room waiver. We also believe that this
process allows for variation in geographic isolation room needs that
may present as the local population changes. We expect that the
development and submission of this waiver will require the involvement
of the facility administrator. This individual will need to determine
the number of dialysis isolation rooms available in the facility's
geographic area that could sufficiently serve its patients, prepare the
waiver request, and submit the request to us. We believe that these
tasks will require about 1 hour and should cost about $54.81 (http://www.swz.salary.com).
As of the spring of 2007, there were 4,746 Medicare approved
dialysis facilities (DFC data: http://www.medicare.gov/Download/DownloadDB.asp). From 1998 to 2004, the average yearly growth (using
USRDS data) in dialysis facilities was 4.4 percent. We anticipate a
similar rate of growth in dialysis facilities over the next few years.
Thus, we believe that 218 new dialysis facilities will request Medicare
approval in 2009 and that over the five-year period from 2009 to 2013 a
total of 1,191 new dialysis facilities will request Medicare approval.
Since we are requiring compliance with this isolation room requirement
300 days after publication of this final rule, we are using 2009
estimates of the numbers for new and renovated dialysis facilities.

[[Page 20461]]

Cost of Isolation Room Waiver Requests
----------------------------------------------------------------------------------------------------------------
Estimated total
New dialysis Ninety percent cost for waiver
facilities of new requests ($54.81
Year (4.4% annual dialysis x waiver requests
increase) facilities from 90% of new
facilities)
----------------------------------------------------------------------------------------------------------------
2009......................................................... 218 196 $10,743
2010......................................................... 228 205 11,236
2011......................................................... 238 214 11,729
2012......................................................... 248 223 12,223
2013......................................................... 259 233 12,771
--------------------------------------------------
Total.................................................... 1,191 1,071 \1\ 58,702
----------------------------------------------------------------------------------------------------------------
\1\ 5-year cost.

We believe that approximately 90 percent of the new dialysis
facilities will request a waiver of the isolation room requirement.
Thus, the estimated first year cost of complying with this waiver
requirement is $10,743, and the estimated total five-year
implementation cost for this requirement is $58,702.
Isolation room waivers may be granted at the discretion of, and
subject to, additional qualifications as may be deemed necessary by the
Secretary. We do not have data that shows the current percentage of
dialysis providers that open new dialysis facilities with isolation
rooms under the 42 CFR part 405, subpart U, requirements, nor do we
currently have data that show whether there is a shortage of isolation
rooms in some areas. The CMS regional offices will monitor and evaluate
local dialysis isolation room needs. Since existing facilities may use
a separate area, rather than an isolation room, it is likely that some
HBsAg-positive patients dialyze in units without isolation rooms.
Commenters shared concerns about the costs involved in converting
existing dialysis facilities to include an isolation room. Some
commenters questioned the need for an expense of an isolation room in
all new dialysis units as specified in the CDC infection control
precautions incorporated by reference. We have responded to isolation
room comments by requiring existing facilities only to have a separate
demarcated area, consistent with CDC recommendations, and allowing new
dialysis facilities to request an isolation room waiver.
We believe the infection control provisions at Sec. 494.30(a)(3)
and (4) are consistent with the requirements at Sec. 405.2140(c) and
do not produce additional burden. In addition, we have moved some of
the infection control requirements to the QAPI provisions at Sec.
494.110(a)(ix). We have also removed the requirement at proposed Sec.
494.30(b)(2) regarding the designation of an RN to act as an infection
control officer. Several commenters stated that this proposed
requirement would be unnecessarily burdensome. One commenter stated a
burden of $67,000 in compensation for an additional full-time RN. We
have modified the oversight requirements and removed the RN infection
control officer provision; therefore, no additional burden is imposed.
Infection control issues must be reported to the facility medical
director and the quality improvement committee. We believe that it is
standard practice to track incidents and identify problems related to
infection control and that this requirement will not produce any
additional burden. Dialysis facilities must also report incidences of
communicable diseases as required by Federal, State, and local
regulations. We expect that facilities are already compliant with
communicable disease reporting requirements and that this provision
does not represent any additional burden.
b. Sec. 494.40 Water Quality
The water quality condition for coverage requires compliance with
the ANSI/AAMI RD:52:2004 ``Dialysate for hemodialysis.'' These
guidelines developed for dialysis facilities are the professional
standard of practice and have been available for about 3 years. A
facility's water treatment equipment, equipment maintenance and
monitoring processes, and water testing procedures need to be
consistent with the RD52 guidelines to provide sufficiently pure
dialysate. We believe dialysis facilities strive to deliver dialysate
for use in hemodialysis and in the reuse process that meets the AAMI
water purity guidelines. The American Nephrology Nurses Association
stated that they believe most facilities in the U.S. have already
implemented a two carbon tank water treatment system with a minimum of
10 minutes empty bed contact time to prevent the exposure of patents to
chloramines. We received several comments regarding the burden
associated with the proposed frequency of chlorine/chloramine testing.
We have modified the proposed water quality requirements and the
frequency of chlorine/chloramines testing and require compliance with
the AAMI RD:52 guidelines in this final rule. Since we believe that the
vast majority of dialysis facilities adhere to the AAMI RD52
guidelines, this requirement would result in little additional burden.
c. Sec. 494.50 Reuse of Hemodialyzers and Bloodlines
The Reuse of hemodialyzers condition for coverage requires
compliance with the AAMI guidelines published in ``Reuse of
Hemodialyzers'', third edition, ANSI/AAMI RD47:2002/A1:2003, which is
incorporated by reference. These 2003 guidelines update RD47, second
edition, published in 1993, which is incorporated by reference in 42
CFR part 405, subpart U. The majority of dialysis facilities choosing
to perform hemodialyzer reuse likely have already updated their
procedures and practices to conform to the current professional
standard of practice in the area of reuse.
At Sec. 494.50(c)(2) we require that blood and dialysate cultures
and endotoxin levels be obtained when clinically indicated, while the
former requirement at Sec. 405.2150(a)(3) requires ``appropriate blood
cultures'' and system evaluation. The dialysate cultures and endotoxin
levels to be obtained when an adverse patient reaction to reuse is
suspected may present a small additional burden to facilities. A colony
count (culture) costs approximately $6, while the LAL endotoxin test
costs about $10 to $35 per test, depending on the method utilized. We
expect that since dialysis facilities must adhere to the new AAMI RD47
guidelines, adverse reactions related to hemodialyzer reuse occur
infrequently and the cost burden is small. The remaining provisions of

[[Page 20462]]

Sec. 494.50 primarily provide clarifications that do not add burden.
We did not receive any comments related to burden imposed by this
condition for coverage.
d. Sec. 494.60 Physical Environment
The ``Building'' and ``Equipment maintenance'' standards at Sec.
494.60(a) and (b) contain requirements similar to some of the
provisions at Sec. 405.2140(a), and we believe do not impose any
additional burden. Standard (c) ``Patient care environment'' is
consistent with requirements at Sec. 405.2140(b)(2). The provision
regarding a comfortable room temperature closely resembles Sec.
405.2140(b)(2). However, the requirement to ``make reasonable
accommodations for the patients who are not comfortable at this
temperature'' is new. Facilities could meet this requirement by
providing blankets to patients as many other healthcare providers do,
which could entail added burden, or the facility could simply allow
patients to bring a clean blanket or cover to the dialysis facility.
Although a facility would be required to adhere to infection control
precautions if a patient's blanket became soiled during the dialysis
session, we do not believe this second option would add any significant
burden for the dialysis facility.
We are requiring, similar to Sec. 405.2140(b)(2), that the
dialysis facility make accommodations to provide for patient privacy
when patients are examined or treated and body exposure is required. We
believe that the vast majority of dialysis facilities are equipped with
the movable privacy screens, partitions, or curtains that would be
needed in order to meet this requirement.
Emergency preparedness requirements are found at Sec. 494.60(d) in
this final rule and correspond with the provisions at Sec.
405.2140(d). The existing 42 CFR part 405, subpart U regulations
require dialysis facilities to have written policies and procedures for
handling emergencies with annual reviews, testing, and revisions, and
staff training to handle any emergency or disaster. This final rule
requires that the staff be able to demonstrate the ability to manage
emergencies that are likely to occur in the facility's geographic area.
Although an annual review will be required, the final rule does not
require the involvement of the CEO in this activity. We estimate that a
typical facility will expend 4 hours less of administrator's time for
this activity at $51.93 per hour (http://www.swz.salary.com), with a
net savings of $207.72 per year per facility for an overall savings for
4955 facilities of $1,029,253.
We added a clarification to the 42 CFR part 405, subpart U
requirement that the staff inform patients of where to go during an
emergency. Thus, this final rule requires that these instructions
include direction for when the geographic area of the dialysis facility
is evacuated. Some dialysis facilities may already include this level
of detail in their emergency preparedness instructional materials;
however, we expect that many facilities do not include this
information. Adding these instructions to the patient educational
materials may present a small burden for some dialysis facilities. A
staff member would need to develop the instructions and materials. We
estimate that it would take 2 to 3 hours to develop the instructions
and material needed. Assuming that 90 percent of the dialysis
facilities need to add this patient training to their program, we
estimate a first year cost (using $39.14 per hour compensation (http://www.swz.salary.com) for a RN staff nurse) of $523,634 (4955 x 0.90 x
$117.42).
The final rule also adds a requirement to the 42 CFR part 405,
subpart U provision that the dialysis staff must instruct the patients
about who to contact during an emergency, so that when the dialysis
facility is not operational, there is an alternate emergency telephone
number (unless the facility has the ability to forward calls to another
working phone number). Some facilities already may have a second
emergency phone number or call forwarding for their patients to use in
an emergency. Many phone service packages include call forwarding as a
feature. In addition, some facilities may have obtained call forwarding
or a second telephone line following the 2005 hurricane season in the
south. Nevertheless, we believe many facilities may need to establish a
communication system that would meet the intent of this rule, by for
example, obtaining call forwarding service or an alternate number.
Utilizing business phone services pricing figures available on the
Internet, we estimate a monthly fee of $6.00 for remote access call
forwarding services added onto a business phone service package.
Alternately, we estimate the cost of an additional separate business
phone number at less than $50 per month. If 25 percent of all dialysis
facilities need to set up new remote call forwarding and another 25
percent initiate a new separate emergency phone number, we estimate the
cost of this requirement to be approximately $69,384 (1239 x $6, plus
1239 x $50).
This final rule requires at Sec. 494.60(d)(1)(ii) that dialysis
facility patient care staff maintain current cardiopulmonary
resuscitation (CPR) certification. We believe that CPR training is
provided for direct patient care staff in dialysis facilities in the
U.S. and some units also offer CPR training and certification to staff
that do not care directly for patients. One commenter stated that while
many providers may certify patient care staff in CPR annually or every
2 years, there are also many who conduct CPR training without the
expense of actual certification. The commenter further stated that CPR
certification is too onerous and costly ($67,600 per dialysis facility
to cover the cost of one full-time RN) as it may require a CPR
instructor on staff. The commenter also stated that there is an
American Heart Association (AHA) fee of $25 per person for
certification. A search on the Internet reveals that AHA-certified CPR
classes for healthcare professionals cost an average of $25 per person
with group discounts available. The cost for the class members to
become certified CPR instructors averages about $200 with a
certification period of up to 2 years. We did not find a $25 AHA CPR
certification fee that is separate from the class fees that are
charged. Thus, if a dialysis facility chose to have a staff RN
certified as an instructor, it would likely require only two to four
half-day group CPR classes per year. We believe that CPR training
provided to dialysis facility direct care staff should meet AHA
standards and that CPR training with certification is the standard of
practice among health care providers. We do not have data on any
dialysis facilities that offer CPR training without AHA CPR
certification, nor did the commenter provide data. No other commenters
stated concerns about CPR certification costs for patient care staff.
We believe the vast majority of dialysis facilities provide AHA
certified CPR training to protect patient safety and to mitigate
liability risk, and we believe that the costs associated with this
training and certification are part of the usual and customary costs
assumed by healthcare providers.
We are requiring that facilities have available a defibrillator or
an automated external defibrillator (AED). Several commenters stated
that an AED was more desirable and less burdensome than a traditional
non-automated defibrillator, because the staff training and
certification costs are much lower when an AED is used. Some commenters
stated that use of non-automated defibrillators require staff to

[[Page 20463]]

be certified in Advanced Cardiac Life Support (ACLS) and that ACLS
courses are not readily available to dialysis facilities, and are time
consuming and costly. Commenters pointed out that AED training can be
accomplished along with the usual CPR staff training. We have responded
to commenters who were concerned about the burdensome costs of ACLS
certification and training costs associated with the use of non-
automated defibrillators by including AEDs as an acceptable alternative
device in this final rule.
We are also requiring that certain emergency equipment be
immediately available in the facility including oxygen, airways,
suction, defibrillator or AED. The comparable 42 CFR part 405, subpart
U requirement (Sec. 405.2140(d)(3)) is less specific and calls for an
on-the-premises emergency tray, including emergency drugs, medical
supplies, and equipment. We received comment that all 190 of the
dialysis facilities owned by Dialysis Clinic, Inc. (DCI), a non-profit
dialysis organization, are equipped with AEDs. Comments from Gambro
noted that more than a third of their facilities are equipped with
AEDs. According to USRDS data, in 2004 there were 585 Gambro dialysis
facilities (34 percent equals 198 facilities equipped with AEDs). If we
use 34 percent as our AED equipped estimate for the remaining dialysis
facilities (1118 Fresenius, 626 DaVita, 417 Renal Care Group, 27
National Nephrology Associates, 934 independent--using 2004 USRDS data)
the total number of dialysis facilities equipped with AEDs would be
1061. We presume that the 837 hospital based dialysis facilities (2004
USRDS data) already may have met the requirement, since they likely
have immediate access to an in-hospital defibrillator. Based on the
above figures we would expect that 2,286 dialysis facilities already
are equipped with AEDs or defibrillators (DCI--190, Gambro--198,
hospital-based--837, and 34 percent of all others--1061). We estimate
that the remaining 2,669 dialysis facilities would need to purchase an
AED or traditional defibrillator to comply with this final rule.
Commenters suggest that the cost of an AED is approximately $2,500.
Our research shows that the sales price of an AED ranges from $900 to
$2,600. Using a $2,000 price, we estimate that it will cost $5,338,000
for 2,669 dialysis facilities to purchase AEDs. One commenter stated
that we should recognize the costs of maintaining an AED. The American
Heart Association Web site suggests that, in general, AEDs require
fairly low upkeep, but regular maintenance will ensure their readiness
in the event of an emergency. AED maintenance includes preventive
maintenance checks according to the manufacturer's recommendations and
verifying battery installation and expiration, checking the status/
service indicator light, inspecting exterior components and sockets for
cracks or other damage, and checking AED related supplies (http://www.americanheart.org/downloadable/heart/110262192170770-2272%20ImplementGuide.pdf). We believe these visual checks will take
about 5 minutes and can be done by a biomedical or patient care
technician. Using an hourly compensation rate of $20.45 (http://www.swz.salary.com), this 5 minute task will cost $1.70 each month,
times 12 months to equal $20.45 annually. If we multiply $20.45 times
the 2,669 facilities that will need to purchase AEDs, the cost will be
$54,581 per year.
Two commenters stated that suction machines are costly to maintain
and are seldom used. However, suction machines are necessary emergency
medical devices that are used to clear the airway of secretions or
vomit. To comply with 42 CFR part 405, subpart U, the huge majority of
dialysis facilities are equipped with suction machines and have the
tubing and suction catheter available in the packaging available for
use.
This final rule requires the facility to have a plan to obtain
emergency medical system assistance when needed and to evaluate at
least annually the effectiveness of emergency and disaster plans and
update them as necessary, consistent with Sec. 405.2140(d)
requirements. A new provision calls for the facility to contact the
local disaster management official at least annually to ensure that the
agency is aware of dialysis facility needs in the event of an
emergency. We believe this task will require one hour of time from
either the administrator or the nurse manager. If we estimate the total
compensation (wages plus benefits) for each as $54.81 and $51.93
respectively (http://www.swz.salary.com), and average them, we arrive
at a cost of $53.37 per hour. Since there would be 4,955 dialysis
facilities that need to comply, we estimate the burden associated with
this requirement to be $264,448 during the first year.
This final rule requires that the facility meet the 2000 edition of
Life Safety Code (LSC) requirements of the National Fire Protection
Association. Most dialysis facilities currently meet most of the
provisions required in Chapter 21 of the LSC, ``Existing Ambulatory
Health Care Occupancies,'' because of state and local building codes as
well as facilities' interest in liability mitigation. Commenters were
most concerned about the cost of retrofitting sprinkler systems in
existing dialysis facilities and the implications for facilities housed
in a multi-tenant building. Commenters were also concerned with the
effort and expense incurred in submitting a request for a LSC sprinkler
waiver to the Secretary. In response to comments, we are defining
compliance with the 2000 LSC to include ``grandfathering'' existing
facilities without sprinkler systems that would have needed to comply
with the LSC sprinkler provision or request a waiver. New dialysis
facilities or facilities undergoing extensive renovation would need to
install a sprinkler system, depending on the type of construction
materials and facility location within the building. An example of a
dialysis facility that would likely require a sprinkler system would be
one housed in a wooden construction three-story building, or in a high
rise building. High rise buildings are generally built with sprinkler
systems to satisfy State and local regulations. We estimate that few
newly constructed dialysis facilities would be burdened by the 2000 LSC
sprinkler requirements in this final rule because current local and
state fire safety building requirements must be met. However, there may
be some burden for existing facilities with regard to the installation
and maintenance of the fire department alarm connection. Based on
information we received from the dialysis industry, we estimate that
approximately 10 percent of dialysis facilities (496) will need to be
upgraded to meet this requirement. In the proposed rule we estimated
that the one-time cost to install a fire department or central
monitoring station connection was $1,000 per facility and that the
monthly fee for the monitoring station and telephone cost was about
$80. We received a comment that the installation cost of an automated
notification system in the Orlando, Florida area would exceed $3,000
and the monthly monitoring costs would be approximately $186 per month.
The commenter stated that the CMS calculation was too low because it
did not include the required back-up phone line, which would itself
cost about $106 per month. Another commenter stated that the monthly
monitoring cost would be about $180. Another provider informed us that
the monthly monitoring cost was about $30 and the cost of installing a
monitoring and

[[Page 20464]]

automatic notification system ranges from $10,000 to $25,000 depending
on the building characteristics. We will use $136 as our estimated
monthly cost of automatic notification system monitoring ($106 phone
line fee plus $30 monitoring fee), and $5,000 as our estimated
installation cost. Thus, we estimate the additional overall cost of
compliance for 496 facilities that would need to perform upgrades in
the first year will be $3,289,472 ($2,480,000 installation cost plus
$809,472 monitoring costs), with the annual cost thereafter being
$809,472 ($136 per month x 12 months x 496 facilities).
This estimate does not take into account any specific waivers or
acceptance of a State code in lieu of the LSC that may decrease the
burden. Some commenters were concerned about the cost of installing
smoke barriers in buildings that are over 5000 square feet, which could
be a significant cost because air ducts for heating and air
conditioning would have to be updated with smoke partitions. If the
health and safety of patients and staff are not adversely affected,
this final rule would permit us to waive specific provisions of the
LSC, which, if rigidly applied, would result in an unreasonable
hardship on the facility. In addition, the proposed rule specifies that
the Secretary may accept a State code in lieu of the LSC, if it
adequately protects patients. We cannot estimate how many dialysis
facilities will request a LSC waiver as many facilities already meet
the 2000 LSC due to State and local regulations and liability
mitigation efforts. Additionally, facilities would only consider
applying for a waiver after a LSC inspection found that LSC provisions
were not adequately implemented.
e. Sec. 494.70 Patients' Rights
The 42 CFR part 405, subpart U regulations require dialysis
facilities to have written patients' rights policies and procedures and
sets out a list of persons to whom such patient rights policies must be
made available. This final rule details basic information that must be
provided to patients (to include for example, information regarding
advance directives, how to contact entities in regard to complaints,
and dialysis modalities not offered by the facility including
scheduling options for working patients) and requires that patients'
rights be prominently displayed. Some commenters stated that their
facilities have already developed advance directive procedures that
would help the facilities comply to the provision as stated in the
proposed rule. One commenter recognized that many facilities are
already informing patients of their right to have advance directives.
Requiring minimum contents in the patients' rights condition, and
requiring only that these rights be posted, will limit the
administrative burden. We estimate that this will save the typical
facility about 2 hours of staff (social worker) time at $34.52 per hour
(http://www.swz.salary.com), that is, $69.04 annually, for an overall
savings of $342,093 (4,955 facilities times $69.04).
The 42 CFR part 405, subpart U regulations required the facility to
use translators when a significant number of patients exhibit language
barriers. This final rule modifies this requirement and specifies that
information be given to patients in a manner that assures their
understanding. However, translators could still be used and facilities
will have more flexibility in overcoming language barriers in lieu of
hiring translators. This may result in a net reduction in facility
costs.
The previous regulations required that advance notice be given to
patients who are being terminated from a dialysis facility. This final
rule is more specific and requires that written notice be given 30 days
in advance. However, since involuntary terminations are a relatively
infrequent occurrence and we are only adding a requirement regarding
when the advance notice of involuntary discharge must be given, we
consider the financial impact on dialysis facilities to be negligible.
We expect that each facility must update their patient rights
materials to meet the requirements of this final rule. If this task
required 1 hour of social worker time at $34.52 per hour compensation,
this provision would cost $171,047 (4,955 facilities times $34.52).
f. Sec. 494.80 Patient Assessment
The ``Patient assessment'' condition for coverage includes
assessment criteria that must be included in each comprehensive patient
assessment. The frequency of assessment is identified as initial, 3
months after the initial assessment, and annually for stable patients
and monthly for patients who are not stable. The adequacy of the
patient's dialysis prescription must be assessed at least monthly for
dialysis patients and every four months for peritoneal patients.
Commenters agreed that quality oriented dialysis facilities meet these
new requirements already and that the patient assessment condition for
coverage should not present any new burden to most dialysis facilities.
g. Sec. 494.90 Patient Plan of Care
The ``Patient plan of care'' condition for coverage requires that
the facility write and implement a plan of care after performing the
comprehensive assessment. The facility must address eight clinical
areas in the plan of care, utilizing standards that are consistent with
accepted professional standards of practice. In this final rule, we
have included a ``psychosocial status'' care plan component that
requires that professional social work services be provided and that a
standardized mental and physical assessment tool be utilized. The 42
CFR part 405, subpart U requirements were similar and included a
provision requiring that the qualified social worker be responsible for
conducting psychosocial evaluation, and that the social services
provided maximize the social functioning and adjustment of the patient
(Sec. 405.2163(c)). We do not believe that this final rule requirement
adds new burden.
Title 42 CFR part 405, subpart U provisions call for an initial
short term care plan, an initial long term care plan, an updated short
term plan of care every 6 months for stable patients or monthly for
unstable patients, and an annual review of the long-term care plan. The
short term patient care plan is developed by a professional team
consisting of at least the ESRD physician, an RN, the social worker,
and the dietitian. The annual long-term program must be developed by a
team which includes the dialysis facility physician-director, a
physician-director of a self-care center, a transplant surgeon, an RN,
a social worker, and a dietitian. This final rule removes the
requirement for a separate long-term care program and reduces the
frequency of formal care planning (after the first six months that a
patient is on dialysis) from biannually to annually and reduced the
burden of facility staff. We estimate that the burden associated with
formal full interdisciplinary team care planning will be lessened by
more than 50 percent starting in the seventh month that a stable
patient is on dialysis. Assuming the team meets formally to review and
update the plan of care and spends at least 15 minutes on each care
plan we estimate an annual cost savings of about $57.11 per patient per
year for stable patients after the first year of dialysis.

[[Page 20465]]

Interdisciplinary Team Short Term Care Planning Costs Under Previous Regulation
----------------------------------------------------------------------------------------------------------------
Hourly
compensation
(swz.salary.com)
----------------------------------------------------------------------------------------------------------------
Staff Registered Nurse......................... $39.14 ...........................................
Dietitian...................................... 36.74 ...........................................
Social Worker.................................. 34.52 ...........................................
Attending Physician............................ 118.05 ...........................................
----------------------------------------------------------------
Total per hour............................. 228.45 Cost of 15 minutes
per hour of team time for 1 care plan for 1 patient
= $57.11.
----------------------------------------------------------------------------------------------------------------

According to the USRDS, in 2004 there were 335,963 dialysis
patients. If we add a 3 percent annual growth rate, our 2008 estimate
of patients would be 378,129. We will assume that about 90 percent of
dialysis patients are stable (378,129 x 0.90 = 340,316 stable
patients). If we multiply the cost savings of $57.11 times the
estimated number of stable point prevalent dialysis patients we find an
annual costs savings estimate of $19,435,447. If we divide this total
savings by the number of dialysis facilities (4,955) we see an average
cost savings of $3,922 for each dialysis facility annually. There are
further savings not shown here associated with the new patient plan of
care requirements because the self-care dialysis physician-director,
medical director, and the transplant surgeon do not need to participate
in routine long-term care planning, as was previously required. One
commenter stated that this change ``will be beneficial to transform the
current paper shuffling process into a practical course of action.''
Another commenter stated that deletion of care plan review by the
transplant surgeon is a positive change and allows more efficiency.
This reduction in burden may be particularly helpful for small
businesses, as process is reduced as well as the amount of staff time
required for care planning, allowing more time for direct patient care.
This final rule includes transplantation referral tracking, at
least annual communication with the transplant center, and patient
education and training. In response to comments regarding the burden of
quarterly communications, we are requiring at least annual
communication with the transplant center, rather than quarterly contact
as in the proposed rule. We believe that many dialysis facilities do
track the status of their transplant referred patients and also provide
patient education on a regular basis. We believe these requirements
fall within the scope of reasonable services that a dialysis facility
should provide and do not represent new burden. We received comment
that the new patient assessment and patient plan of care provisions
would increase burden because dialysis facilities would need to
redesign their standards and procedures, modify their electronic
medical record systems, develop processes for implementing these
requirements across all facilities, and retrain all employees. We
expect that quality oriented dialysis facilities already meet the
majority of requirements contained in this final rule. Dialysis
facilities must update systems, processes, and staff training on a
regular basis as part of their usual business practices, in order to
stay current and respond to new technology and new medical information
that becomes available. Our goal is to provide a burden analysis of
costs that are newly required by this final rule. Facilities may choose
to make additional changes to systems, processes, and staff's training
that go beyond what is specifically required by this final rule. These
additional costs cannot be predicted, and we have not included usual or
optional facility activities and their associated costs in this burden
analysis.
h. 494.100 Care at Home
Many of the requirements in the ``Care at home'' condition for
coverage are consistent with 42 CFR part 405, subpart U requirements
and statutory provisions and do not represent new burdens. New
requirements in this final rule include the retrieval and review of
self-monitoring patient data at least every 2 months and inclusion of
services furnished by a durable medical equipment supplier in the
record-keeping system. We believe that this task would present a
minimal burden to home dialysis facilities.
We received comments that the economic impact of this condition for
coverage would be moderate to significant because it requires that
self-care training be conducted by a RN, and according to the
commenter, facilities would likely have to hire additional personnel.
We do not agree with this comment that additional burden is imposed by
this final rule. The 42 CFR part 405, subpart U regulations required at
Sec. 405.2162(c) that ``if the facility offers self-care training, a
qualified nurse is in charge of such training (see Sec. 405.2102).''
Section 405.2102 requires that an RN who is in charge of self-care
dialysis training must have at least 3 months of the total required (18
months) ESRD experience in training patients in self-care. This final
rule requires at Sec. 494.140(b)(2) that the self-care training nurse
be an RN with at least 12 months experience in providing nursing care
and an additional 3 months of experience in the specific modality for
which the nurse will provide self-care training (15 months experience
in total). The requirement at Sec. 494.100 provides that self-care
training must be conducted by a registered nurse who meets the
requirements of Sec. 494.140(b)(2). In both the previous regulations
and this final rule, self-care dialysis training must be ``conducted,''
that is, led, guided, and managed by an RN with the specified dialysis
experience.
i. Sec. 494.110 Quality Assessment and Performance Improvement
This final rule requires dialysis facilities to develop, implement,
maintain, and evaluate an effective, data-driven, quality assessment
and performance improvement program. Facilities will use quality data
internally, in a formal Quality Assessment and Performance Improvement
(QAPI) program that each facility has the flexibility to develop in
accordance with its own priorities. The two-thirds of dialysis
facilities that are part of large dialysis organizations are likely
already complying with this requirement and many other facilities also
use quality data as part of their standard practices. We estimate that
the

[[Page 20466]]

QAPI requirements would impose a new burden on no more than 10 percent
of the dialysis facilities.
Assuming that a facility was initiating a QAPI program only as a
result of this final rule, this may entail a one-hour meeting of four
staff persons monthly, that is, 48 staff hours of meeting time.
Assuming a staff cost of $234.83 per hour (combined costs using hourly
compensation figures as follows; nurse manager--$41.58, social worker--
$34.52, dietitian--$36.74 and medical director--$121.99 per hour), the
total additional cost to the facility would be $2,817.96 annually. The
total cost for 496 facilities would be $1,397,708.
j. Sec. 494.120 Special Purpose Renal Dialysis Facilities
We do not believe that this condition for coverage imposes any new
burdens.
k. Sec. 494.130 Laboratory Services
We do not believe that this condition for coverage imposes any new
burdens.
l. Sec. 494.140 Personnel Qualifications
This condition for coverage delineates the qualifications personnel
must have to provide care in a Medicare certified dialysis facility. We
do not believe any additional burden is imposed by the qualification
provisions for medical directors, nurses, dietitians, or social
workers. The final rule patient care technician qualifications include
new requirements including a high school diploma or equivalency,
completion of a training program, and state certification within 18
months of being hired or within 18 months of the effective date of this
final rule.
This final rule adds new technician qualification requirements,
including completion of a training program for water treatment system
technicians and a written training program for dialysis patient care
technicians that addresses operation of kidney dialysis equipment and
machines and the provision of patient care. The training programs would
be developed or adopted by the facility and must be approved by the
medical director and the governing body of the facility. The training
program may include written, audiovisual, and computer based
instruction. Since the major dialysis organizations all have training
programs for their dialysis patient care technicians and water
treatment technicians, and the majority of dialysis facilities are
affiliated with these chains, a large portion of facilities already
meet this requirement. In addition, at least 11 States already have
some form of credentialing (training; competency exam; certification)
requirements for dialysis patient care technicians. Even facilities
that are not affiliated with major dialysis organizations and are in a
State where there are no credentialing requirements for dialysis
technicians are not likely to be burdened with the requirement to
develop a dialysis training program, since they can request medical
director and governing body approval to use a packaged curriculum,
which has been developed by organizations in the renal field and is
currently available to any dialysis facility without cost.
During the comment period, many commenters voiced concerns related
to the proposed rule provision that required 3 months of dialysis
patient care technician experience following a training program must be
under the ``direct supervision of a registered nurse.'' Commenters
asserted that this requirement presented a large burden, as RNs do not
have time to constantly directly oversee technicians in training and
recommended that LPNs and experienced technicians be allowed to assist
with directing patient care technician trainees. In response to
comments, we revised this requirement in this final rule, so that the
patient care technician training program must be under the direction of
an RN and constant one-on-one RN supervision is not required (unless
mandated by state provisions). This would allow other staff to act as
preceptors under the supervision of an RN. State board of practice
provisions must be adhered to so that technicians in training as well
as experienced technicians function under the auspices of licensed
nurses.
Patient care technician certification under a state certification
program or a nationally recognized certification program is required in
this final rule, in response to commenter concerns of patient safety
and increased risks associated with the prevalent and increasing use of
uncertified personnel providing clinical patient care. Hemodialysis
technicians, who may be uncertified and unlicensed, commonly perform
clinical duties, which include dialysis machine setup, clinical
observations and assessments of patients, cannulation, and
administering local anesthetics, drugs including heparin, and saline
solutions (subject to state nursing board of practice provisions).
Several states already require certification of dialysis patient care
technicians including California, Connecticut, Kentucky, New Mexico,
Ohio, Oregon, Virginia, and West Virginia. According to the Nephrology
Nursing Certification Commission (NNCC) ``2005-2006 Annual Report
Certification: Your Commitment to Quality'' (www.nncc-exam.org/about/annualReport2007.pdf) as of December 2005, there were 1,425 Certified
Clinical Hemodialysis Technicians (CCHT), while the Board of Nephrology
Examiners Nursing and Technology (BONENT) states in a private
communication there are 2,445 BONENT certified hemodialysis
technicians. We do not have data on the number of National Nephrology
Certification Organization (NNCO) certified nephrology technicians.
Although there are three different certification exams available
nationally, only one, the Certified Clinical Hemodialysis Technician
(CCHT) examination, is specifically geared towards entry level dialysis
technicians. Eligibility to take the CCHT exam includes a recommended
six months (1,000 hours) of experience in nephrology technology, while
the other two exams (given by BONENT and NNCO) require 12 months of
experience prior to the exam. We would expect that the majority of
dialysis patient care technicians seeking certification to meet our
requirement would take the CCHT examination offered by the NNCC.
Hemodialysis technicians applying to take the CCHT examination must
be high school graduates or have GEDs, successfully complete a training
program for hemodialysis patient care technicians that includes both
classroom instruction and supervised clinical experience, and meet
state experience requirements. Currently, the examination application
fee is $125 and the certification maintenance fee is $50 every 2 years.
The exam is offered at hosting ANNA chapters and dialysis facilities
around the country, as well as in unison with dialysis conferences. A
dialysis facility may host an examination when there are at least five
participants, and, if there are at least 10 participants, the NNCC exam
manager fee of $150 is refunded. We believe that the flexibility of
CCHT examination scheduling will alleviate the need for dialysis
technicians to travel or incur overnight costs in order to become
certified. We are allowing an 18-month time period so that patient care
technicians have sufficient time to successfully complete the
certification examination. The cost of taking the certification
examination and maintaining certification would likely be borne by the
technician, just as nurses, dietitians, and social workers frequently
bear the costs of professional examination, registration, and licensing
fees. Dialysis patient care technicians will need to complete a
training program before taking the exam and would likely be employed by
a dialysis

[[Page 20467]]

center at the time when taking the examination and so would have an
income from which to pay the necessary fee. Dialysis facilities have
the option of whether to provide a certification fee benefit.
We have retained the proposed requirement that water treatment
system technicians complete a training program that has been approved
by the medical director and the governing body. This requirement is in
keeping with 42 CFR part 405, subpart U requirements (Sec. Sec.
405.2136(c)(3)(viii), 405.2136(d)(6), 405.2161(b)(2), and 405.2162),
which specify governing body and medical director responsibilities
related to proper orientation and training of staff, and we do not
believe that this training requirement will result in new burdens.
m. Sec. 494.150 Responsibilities of the medical director
We have revised and clarified the responsibilities (found at
Sec. Sec. 405.2161, 405.2136(f), and 405.2137(a)(1)) and
accountability of the medical director in this final rule. We do not
believe that these requirements add new burdens.
n. Sec. 494.170 Medical Records
In this final rule, essential requirements in regard to retention,
preservation, and transfer of medical records are retained. However,
the existing regulations are highly prescriptive in not only requiring
the designation of a medical records supervisor, but in detailing that
person's duties, specifying categories of information to be included in
the medical record, requiring written policies and procedures to
protect medical records information, and even addressing spatial issues
in regard to the maintenance and processing of medical records. This
final rule deletes many of these requirements, giving the facility
flexibility in deciding how the medical records are to be maintained
and what is to be in them, as long as they facilitate positive patient
outcomes. This reduces burden on the dialysis facilities. We estimate
that this will save the typical facility about 40 hours of a medical
records professional's time, at $21.09 per hour (http://www.swz.salary.com), that is, $844 annually, for an overall savings of
$4,180,038.
o. Sec. 494.180 Governance
This condition for coverage updates Sec. 405.2136, entitled
``Governing body and management'' and deletes several of the process
requirements (for example, those under standard (b), ``operational
objectives,'' and (d) ``personnel policies and procedures''). We
believe the updated standards related to the CEO or administrator,
adequate number of qualified and trained staff, medical staff
appointments, furnishing services, emergency coverage, and disclosure
of ownership do not produce any additional burdens over previous 42 CFR
part 405, subpart U requirements. We do note that 42 CFR part 405,
subpart U requires the presence of a licensed physician, RN, or LPN
when patients are being dialyzed, and our final rule specifies an RN
presence. We believe that the majority of dialysis facilities strive to
maintain a RN presence in the facility whenever patients are being
dialyzed and expect that this modification would produce little
additional burden.
Standard (e) of the Governance condition for coverage requires a
facility to implement an internal grievance process. The previous
requirement at Sec. 405.2138(e) stated that all patients would be
encouraged and assisted to understand and exercise their rights, and
that grievances and recommended changes in policies and services could
be addressed to facility staff, administration, the network
organization, etc. We believe that many dialysis facilities have
implemented an in-house grievance process; however, it is likely that
approximately 15 percent of dialysis facilities may not have processes
that would meet our new requirements. We estimate that it would take
eight hours for a nurse manager (at $41.58 per hour) to develop and
implement an appropriate grievance process at a cost of $333 per
facility. The estimated total cost for 15 percent (743) of facilities
to meet this requirement is $247,152.
This final rule implements a discharge process that must be used if
facilities must discharge patients against their will. We expect that
this process would be needed infrequently (less than once per year) and
only be used as a last resort.
Furnishing Data and Information for the ESRD Program
This final rule requires that all dialysis facilities furnish data
and information electronically and in intervals specified by the
Secretary, including cost reports, administrative forms, patient
survival data, ESRD Clinical Performance Measures (CPMs) data, and any
future standards developed in accordance with a voluntary consensus
standards process identified by the Secretary. While submission of data
and information is an existing requirement in Sec. 405.2133 and
electronic submission of cost report data and information is an
existing requirement in Sec. 413.24, the requirement to provide CPM
data above the national statistical sample is new. Additionally, the
requirement to provide necessary administrative and CPM data in
electronic format is a change from the paper-based process that has
historically been used to support the ESRD program.
We previously proposed using the VISION application as the
electronic medium for the data collection required by the new
conditions for coverage (70 FR 6231). VISION was a patient-specific,
stand-alone, facility-based information system with software that would
reside on facility computers, which presented challenges for updating
the software. We agree with commenters that VISION did not represent
the best technology for wide-spread collection of data from dialysis
organizations. As discussed earlier in this preamble (under section
Sec. 494.180(h)), we are now implementing a new web-based application,
CROWNWeb, for this purpose. This new approach is superior to the VISION
application in that it will increase the efficiency of data collection,
improve data quality, provide a more stable and accessible platform for
continual improvements in functionality, and complement existing
information infrastructures used by many dialysis facilities. We have
recalculated the burden and cost savings related to electronic data
reporting using CROWNWeb.
The collection and reporting of ESRD CPMs has, to date, been an
effort among CMS, the ESRD Networks, dialysis facilities, and other
interested stakeholders to assess the care of a representative
statistical sample of individuals receiving dialysis, and all
pediatric, and Veteran's Administration dialysis patients, in the areas
of adequacy of dialysis, anemia management, nutrition (serum albumin),
and more recently, vascular access (Centers for Medicare & Medicaid
Services. 2006 Annual Report, ESRD Clinical Performance Measures
Project, http://www.cms.hhs.gov/CPMProject). The ESRD CPMs were
developed to implement section 4558(b) of the Balanced Budget Act (BBA)
of 1997 (Pub. L. 105-33). This provision required the Secretary to
develop and implement a method to measure and report on the quality of
renal dialysis services provided under Medicare no later than January
1, 2000.
The collection and reporting of ESRD CPMs has been an effective
tool to facilitate ESRD quality improvement, and has allowed us to
track overall positive improvements in several intermediate outcomes
for individuals

[[Page 20468]]

receiving dialysis. We believe an expansion of the CPMs from the
statistical sample of about five percent to all individuals with ESRD
and receiving dialysis will create minimal additional burden. During
the last 3 years, over 70 percent of dialysis facilities have
demonstrated an ability to successfully submit data to CMS that could
be used to compute all 13 of the existing CPMs for all their
patients.\2\ Two of the primary reasons provided by the large dialysis
organizations for their participating in this activity included:
---------------------------------------------------------------------------

\2\ These organizations collect data on all 13 CPMs and their
advanced information capability is detailed in the 2002 OIG series,
``Clinical Performance Measures for Dialysis Facilities,'' OEI-01-
99-00052.
---------------------------------------------------------------------------

1. They believed it was less of a burden to electronically submit
data for all of their patients than for facility staff to spend 30
minutes to fill out each entire CPM form for the sample of about five
percent.
2. They believed more transparency in the ESRD Program would allow
favorable quality of care comparisons to other dialysis organizations.
We received a comment that this electronic data submission
requirement would produce a burden to dialysis facilities due to the
need to perform information technology enhancements for increased data
transmission. Two commenters stated that the software necessary to
report data and information electronically in the specified format
should be made available to all dialysis providers free of charge.
Commenters further stated that CMS should also provide funding for
travel related to training and financial relief for the abstracting and
key-entry of CPM data and internet service provider (ISP) costs. Some
commenters recommended that software implementation should not require
duplicate data entry into multiple systems. Commenters did not provide
data or dollar figures that would assist us in determining the cost of
our electronic data reporting requirement.
We believe that because of the streamlining of data submissions
with the CROWNWeb application, these new requirements for additional
electronic data will actually result in less overall facility burden
compared to existing data submissions. We also believe this activity
will lead to a substantial long-term return on investment for all
stakeholders-patients, facilities, and the public. We have invested the
necessary time and resources to develop a stable and accessible
platform, CROWNWeb, for the submission of electronic data. CROWNWeb
includes two methods for electronically submitting data, a single-user
interface (SUI) and electronic data interchange (EDI). With the SUI,
users can log-on to CROWNWeb and enter required data through the
interface while with EDI, technologically advanced users can submit
required data in batches from their own clinical information systems
and thus greatly reduce any facility burden necessary to meet these new
requirements.
CROWNWeb enables the protection of the privacy, confidentiality,
and security of information transmitted electronically. It uses Web-
based technology and is available free-of-charge to all facilities with
Internet access and has little to no impact on facility computer
systems. CROWNWeb meets all applicable security criteria included in
the CMS Information Security Acceptable Risk Safeguards (ARS) policy
(http://www.cms.hhs.gov/InformationSecurity/14_standards.asp), which
contains a broad set of CMS security controls based upon National
Institute of Standards and Technology (NIST) requirements.
Additionally, CROWNWeb does not leave persistent files on a facility's
computer because temporary files stored locally during a CROWNWeb
session are purged when the user exits CROWNWeb. The only persistent
files that will be left on the facility's computer are related to the
installation of Adobe Acrobat Reader, which is a free, universal tool
that is necessary to view some reports generated by CROWNWeb. Also,
CROWNWeb currently requires a Windows XP service pack 2 or greater, and
Internet Explorer 6 or greater.
Any potential facility burden related to electronic data reporting
falls into three main categories: (1) Technology hardware and
enhancements, (2) personnel time and travel for training, and (3)
personnel time for submitting the additional data. We believe very few
dialysis facilities would have to purchase computer hardware to
implement this requirement, possibly no more than 155 (3 percent of
total number of facilities projected in 2009; when electronic data
submission will be required). Our estimate on the number of facilities
required to purchase computer hardware is derived from data revealing
that a majority of dialysis facilities currently submit some kind of
electronic data to CMS and thus, have the necessary computer hardware
to support CROWNWeb. We estimate the cost, with installation to be
$1,000. Thus, the total cost for purchasing hardware would be $155,000,
and this cost would only apply in the initial year of implementation.
We estimate new ISP costs for a minimal broadband connection to be $360
annually ($360 x 155 facilities = $55,800), and this would be an on-
going annual cost. Facilities without access to a broadband connection
might have an interruption of other services while using CROWNWeb, and
they may choose instead to contract with a third party to submit data
on their behalf.
Based on feedback we have received from facilities involved in
CROWNWeb testing, we do not believe dialysis facilities will need more
than the basic training that CMS will provide free-of-charge over the
internet in order to use CROWNWeb. CMS will provide geographically
representative in-person training sessions that will be available for
those facilities who would like to receive their training in-person,
but we do not believe this type of training is required in order to use
CROWNWeb. Additionally, we expect that ESRD Networks will play a
valuable role in educating facilities and that the ESRD Networks as
well as our IT contractor will provide technical assistance to
facilities. For personnel time, we estimate that each of the 5,173
facilities (the number of facilities projected in 2009, using 4.4
percent annual growth rate) will have at least one person at the level
of nurse manager ($41.58) or higher that will take the Web-based
training in order for the facility to meet the new requirement. Thus,
we estimate the cost of training in the initial year to be at least
$430,187 (5,173 usersx2 hoursx$41.58). Many facilities will also want
to train the unit secretary; therefore, we are also adding the training
costs of $227,612 for secretaries who are compensated at approximately
$22.00 per hour (5,173 facilitiesx2 hoursx$22.00). Therefore, our total
training cost estimate is $657,799.
Table 1 shows the estimated 2009 costs of the data submissions from
dialysis facilities, utilizing 2006 methods. In 2006 data were
submitted to CMS and the ESRD Networks under the following categories:
laboratory data, Fistula First vascular access data, CPMs, quarterly
patient rosters, network patient activity report (NPAR), the medical
evidence form (CMS-2728), and the death notification form (CMS-2746).
For each category, the table shows the associated factors for all the
2006 methods of submitting data, which include paper submissions, EDI
submissions, and a hybrid combination submission method that includes
both EDI and paper. Column A shows the number of dialysis facilities
estimated to participate in 2009 data submissions, while column B shows
the number of forms submitted for each year. Column C reveals the
annual frequency of data submission. Column D shows the estimated
number of labor minutes that

[[Page 20469]]

would be required for the submission of a single form. The number of
forms; times the annual frequency; times the number of labor minutes,
is totaled and converted to hours in column E. Other additional
facility data reporting costs, such as mailing costs, are shown in
column F. The total dollar figures shown in column G reflect the sum of
the hours shown in column E times $22.00 in labor costs; plus the costs
shown in column F. The $3,966,601 total at the bottom of table 1
reflects the estimated dialysis facility costs of submitting data to
CMS and the ESRD Networks in 2008, using the data submission methods
available prior to implementation of this final rule.

Table 1.--Estimated 2009 Annual Facility Data Burden Under Existing Data Submission Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
D. Time to
A. Number collect/ E. Total F. Other G. Total
Project (level of data) Method of B. Number C. Data frequency enter data labor time facility facility
facilities of forms (minus)/ (approximate costs costs
each hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lab Data (patient)............... paper............. 542 41192 annual............ 25 17163 * $1,512 $379,098
EDI............... 3622 275272 annual............ 0 0 0 0
Fistula First (summary).......... paper............. 1551 1551 monthly........... 10 3102 0 68,244
EDI............... 3622 3622 monthly........... 0 0 0 0
CPM <5 percent (patient) [Dagger] paper............. 1551 3655 annual............ 30 1828 ** 5,099 45,315
hybrid............ 3622 8531 annual............ 15 2133 ** 5,927 52,853
NPAR (patient) [Dagger][Dagger].. paper............. 5173 5173 monthly........... 30 31038 0 682,836
EDI............... 0 0 monthly........... 0 0 0 0
Quarterly Roster (pt) paper............. 5173 5173 quarterly......... 120 41384 0 910,448
[Dagger][Dagger]. EDI............... 0 0 quarterly......... 0 0 0 0
2728 (patient)................... paper............. 5173 111705 once.............. 15 27926 ** 623,314 1,237,686
EDI............... 0 0 once.............. 0 0 0 0
2746 (patient)................... paper............. 5173 91396 once.............. 10 15233 ** 254,995 590,121
EDI............... 0 0 once.............. 0 0 0 0
------------
Total........................ .................. ........... ........... .................. ........... ............ ........... 3,966,601
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: For ease of interpretation and since the number of users is very small, this table does not include any consideration of facility-use of
CROWNWeb's predecessor software, VISION.
EDI: Electronic Data Interchange.
B: For patient-level data, assumes the average facility size of 76 patients.
E: Total Time (hours) = B * C * D / 60.
F: Includes mailing costs but not long-distance fax charges or paper/printing costs. Note: certified mailing is in the process of being required for all
communications involving personal health information.
G: Total Costs ($) = E * ($22 dollars per hour wage for medical secretary) + F.
* Assumes first class certified mailing of $2.79 for every facility.
** Assumes first class certified mailing of $2.79 for each patient and for the 2728, a second mailing to the Social Security Administration (SSA).
[Dagger] CPM sample has been stable at about 12,000 each year.
[Dagger][Dagger] With the Network Patient Activity Report (NPAR), facilities notify networks of incremental changes whereas with the Quarterly roster,
facilities verify all patients.

We recreated Table 1 to estimate the burden of data submission
under this final rule using the CROWNWeb process (shown in Table 2).
Using the new process, the personnel time necessary to submit data to
meet the new requirements (columns D and E) is markedly decreased.

Table 2.--Annual Facility Data Burden Under Final Rule Sec. 494.180(h)
--------------------------------------------------------------------------------------------------------------------------------------------------------
D. Time to
A. Number collect/ E. total F. Other G. Total
Project (level of data) Method of B. Number C. Data frequency enter data time facility facility
facilities of forms (minus)/ (approximate costs costs
each hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ClinicalPART (patient) [Dagger].. paper............. 0 0 annual............ 30 0 $0 $0
SUI............... 1035 78660 annual............ 25 32775 0 721,050
EDI............... 4138 314488 annual*........... 0 0 0 0
AdminPART (patient) paper............. 0 0 monthly........... 70 0 0 0
[Dagger][Dagger]. SUI............... 1035 1035 monthly........... 70 14490 0 318,780
EDI............... 4138 4138 monthly........... 0 0 0 0
2728 (patient)................... paper............. 0 0 annual............ 15 0 0 0
hybrid............ 5173 111705 annual............ 15 27926 *306,900 921,272
EDI............... **NA 0 annual............ 0 0 0 0
2746 (patient)................... paper............. 0 0 annual............ 10 0 0 0
hybrid............ 5173 91396 annual............ 5 7616 0 167,552
EDI............... **NA 0 annual............ 0 0 0 0
----------------------------------------------------------------------------------------------------------------------
Total........................ .................. ........... ........... .................. ........... ............ ........... 2,128,654
--------------------------------------------------------------------------------------------------------------------------------------------------------
EDI: Electronic Data Interchange.
SUI: Single-user web interface.
B: For patient-level data, assumes the average facility size of 76 patients.
E: Total Time (hours) = B * C * D / 60.

[[Page 20470]]

F: Includes mailing costs but not long-distance fax charges or paper/printing costs. Note: certified mailing is in the process of being required for all
communications involving personal health information.
G: Total Costs ($) = E * ($22 dollars per hour wage for medical secretary) + F.
* Assumes first class certified mailing to SSA of $2.79 for each patient.
** Based on prioritization due to volume, facility preferences, and need to include SSA in EDI, all of the data necessary for the complete submission of
the 2728 and 2746 are not included in the EDI functionality for initial CROWNWeb releases.
*** The Fistula First data included in ClinicalPART will also be required monthly.
[dagger] The required Clinical Patient Attributes and Related Treatment (ClinicalPART) dataset replaces the previous lab data, Fistula First, and CPM
data submissions.
[Dagger][Dagger] The required Administrative Patient Attributes and Related Treatment (AdminPART) dataset replaces both the Network Patient Activity
Report (NPAR) and the Quarterly roster.

By creating efficiencies via integrating various datasets and
complementing the advanced information systems used by most dialysis
facilities, we will be able to expand the CPM data collection from
about a five percent statistical sample to 100 percent of dialysis
patients, while also reducing facility data collection and data entry
burden by about $1.8 million (the sum of Table 2 subtracted from the
sum of Table 1 equals $1,837,947). Table 3 computes the estimated costs
discussed above for computer hardware, Internet access, training costs
for two facility staff members, and the labor cost savings for data
entry and data submission. Our total of about minus $0.97 million
reflects an overall first year cost savings that accompanies
implementation of electronic data submission required by this final
rule. The estimated $1.8 million annual labor cost savings is expected
every subsequent year (not counting inflation) on an ongoing basis.

Table 3.--Cost Estimate for Sec. 494.180(h)
------------------------------------------------------------------------

------------------------------------------------------------------------
$155,000................. Computer hardware (first year).
55,800................... Broadband internet access (first year and
ongoing).
657,799.................. Training (first year).
2,128,654................ Labor (first year and ongoing) (Represents a
savings of $1,837,947 which is the
difference between total costs in Table 1
and total costs in Table 2).
--------------------------
$2,997,253............... Total Cost (first year).
$969,348................. Total Cost savings (first year) (Represents
the difference between total costs in Table
1 and the first year costs of $2,997,253).
------------------------------------------------------------------------

In addition to the short-term return on investment to facilities,
we believe that there is also an ongoing return on this investment for
all other primary stakeholders--including patients, dialysis
practitioners, and the public. CROWNWeb will allow for the more timely,
accurate, and efficient use of data to support administration of the
ESRD program by replacing the predominately paper process that
currently exists with an electronic process that respects the
capabilities of providers and has tangible benefits for dialysis
facilities, individuals who have or may develop ESRD, and other
stakeholders. CROWNWeb will allow facility submission of required data
directly from their electronic health records rather than redundant
data entry, freeing facility personnel to concentrate more on patient
care. Another expectation is that claims payment will be improved due
to improved quality and timeliness of patient eligibility and
enrollment information. In the future, we expect that the system could
include claims data, and serve to inform a facility of, for example,
patient hospitalization. A major benefit of the new system for
facilities will be reports that will allow facilities to compare their
patient outcomes with those of their peers. CPM electronic data
collection for all dialysis patients allows facility level comparisons
and tracking. Information about patient outcomes will be available in a
much more timely fashion than currently exists, and performance
improvement activities may be implemented and evaluated in quicker
succession to optimize patient outcomes. For individuals with ESRD,
CROWNWeb will increase the transparency of the health care system and
empower patients to find better health care value and quality, while
assuring access to care, especially in times of disaster/emergency. For
ESRD Networks, CROWNWeb will not only provide timelier, more accurate,
and more complete information to inform quality improvement, it will
make unnecessary certain activities that require a significant amount
of Network resources. For example, CROWNWeb will be able to recreate
the data included on the CMS 2744 Annual Facility Survey in a more
timely fashion then is currently possible, and will free up Network
resources that currently perform a four month manual reconciliation
process. And for all primary stakeholders, we expect that the new
system will either facilitate or provide timelier reports that will
allow them to compare individual facilities and facility groups with
various peer groups and national and local benchmarks.

Impact Summary

The following chart provides an overall estimate of the impact of
the final rule on dialysis facilities:

------------------------------------------------------------------------
First year Second year
Requirement costs costs
------------------------------------------------------------------------
BP Cuffs (cleanable or disposable)...... $496,244 * $49,624
Isolation Room Waiver Process........... 0 * 10,743
Evacuation Instructions................. 523,634 0
Emergency Phone Number.................. 69,384 * 69,384
Automated External Defibrillator (AED).. 5,338,000 0
AED Maintenance......................... 54,581 * 54,581
Contacting Local Disaster Official...... 264,448 * 264,448

[[Page 20471]]

LSC Automatic Notification System....... 3,289,472 * 809,472
Update of Patient Rights................ 171,046 0
QAPI Program Implementation............. 1,397,708 * 1,397,708
Develop New Grievance Process........... 247,151 0
ESRD CPM Electronic Reporting:
Hardware............................ .............. 155,000
Internet access..................... .............. * 55,800
Training............................ .............. 657,799
-------------------------------
Total Cost...................... 11,851,668 3,524,559
------------------------------------------------------------------------
Cost savings First year Second year
savings savings
------------------------------------------------------------------------
CEO Emergency Preparedness Time......... $1,029,253 * $1,029,253
Patient Rights decreased administrative 342,093 * 342,093
burden.................................
Patient Plan of Care, annually not 19,435,447 * 19,435,447
biennially.............................
Medical Records Personnel no longer 4,180,038 * 4,180,038
required...............................
Data Submission Labor................... .............. * 1,837,947
-------------------------------
Total Cost Savings.................. 24,986,831 26,824,778
-------------------------------
Net Savings......................... 13,135,163 23,300,219
------------------------------------------------------------------------
* Ongoing annual costs/cost savings.

Effects on the Medicare and Medicaid Programs

This final rule contains provisions that will protect patient
health and safety and lead to improvements in patient care. Several of
the expected improvements in patient care may also result in more
efficient, cost effective care. For example, improved infection control
practices may lead to fewer hospitalizations and better patient quality
of life. An increased focus on the transplantation modality may lead to
a greater number of patients on the transplant list, and perhaps more
living-donor transplantations.
This final rule contains several provisions that directly and
indirectly promote the use of the most optimal dialysis access for each
patient. These provisions include Sec. 494.80(a)(8), Sec.
494.90(a)(5), Sec. 494.90(d), Sec. 494.110 (a)(2), Sec. 494.140
(e)(3)&(4), Sec. 494.180 (c)(3), and Sec. 494.180 (h)(3)(iv). We
expect that these new requirements are improvements that will result in
lower rates of access failure and an increase in the number of working
arteriovenous fistulas (AVF). AVFs offer the most benefits to patients
of the three possible hemodialysis access types. Examples of these
benefits include longer average patency of all access types, very low
rate of infection, need for only a minor surgery, and healing and
sealing post-cannulation (http://www.fistulafirst.org/tools.htm#Education). According to the 2006 USRDS Atlas, the per
patient per year (pppy) Medicare costs using 2004 data for dialysis
patients with an AVF was $55,112; the pppy cost with a graft was
$65,556; and the pppy costs with a catheter $75,345. Although this is
raw data, we can see that there is a significant Medicare savings
associated with AVF. According to 2005 ESRD CPM project, 31 percent of
hemodialysis patients were dialyzing using an AVF in 2004 (http://www.cms.hhs.gov/CPMProject). More current Fistula First October 2006
data (http://www.simsproject.com/downloads.php?p=ff) shows an AVF rate
of 44.4 percent for patients. If the AVF rate further improves by 5
percent in all hemodialysis patients (309,269 in 2004 according to
USRDS data) 15,464 more patients would have AVFs (with an average pppy
savings of $15,000). If this were to occur the potential Medicare
savings could be approximately $230 million per year. For purposes of
this Impact Analysis, we have used the savings ($230 million) that
could result from 5 percent additional AVF patients. We believe savings
are possible assuming the medical costs associated with creating AVFs
for these 5 percent additional patients are in line with current costs,
and that the cost differential between patients with AVFs and those
with catheters remain comparable.
This final rule also promotes patient independence and the use of
home dialysis whenever appropriate. The provisions that encourage home
dialysis include Sec. 494.70(a)(7), Sec. 494.80(a)(9), Sec.
494.90(a)(7), and Sec. 494.90(d). We expect that the requirements of
this rule will increase the percentage of patients on home dialysis.
According to USRDS data the 2004 hemodialysis pppy Medicare costs equal
$67,733, while the peritoneal pppy costs equal $48,796. We do not have
USRDS home hemodialysis pppy Medicare costs although home hemodialysis
is less costly than in-center hemodialysis and home peritoneal dialysis
is less costly than home hemodialysis. Approximately 92 percent of U.S.
dialysis patients receive in-center hemodialysis. Based on the
difference between 2004 hemodialysis and peritoneal pppy costs, savings
of as much as $18,937 pppy could be obtained with patients opting for
peritoneal dialysis. If 5 percent additional patients were to opt for
home peritoneal dialysis, which provides added health and quality of
life benefits, that could account for 15,464 patients. The potential
annual savings for these 5 percent additional patients (15,464 x
$18,937) could be as much as $295 million. Combining potential savings
from 5 percent additional patients who opt for AVFs and 5 percent
additional patients who opt for home dialysis, the total Medicare
allowed charges could be reduced by up to $525 million annually.
However, these examples are only illustrative in nature and are based
on limited analytics. Therefore, they are not incorporated in the
quantitative cost analysis of the RIA, but are presented to illustrate
the possibility for Medicare savings.

C. Accounting Statement

As required by OMB Circular A-4 (available at http://www.whitehouse.gov/OMB/circulars/A004/A-4.PDF) in the table below, we
have prepared an accounting statement

[[Page 20472]]

showing the classification of the expenditures and savings associated
with the provisions of this final regulation. This table provides our
best estimate of the total annualized monetized costs and savings.

Primary Estimate for 2008
------------------------------------------------------------------------

------------------------------------------------------------------------
Annualized monetized facility costs..................... $11,851,668
Annualized monetized facility cost savings.............. 24,986,831
Annualized monetized facility net cost savings.......... 13,135,163
Effects on State, local, and tribal governments......... 0
Benefit effects on small businesses..................... 2,651
------------------------------------------------------------------------

D. Alternatives Considered

1. Maintenance of Existing Regulations
One alternative would be to keep the existing regulations. However,
the current regulations inhibit our ability to ensure better outcomes
of patient care, collect electronic data for quality assurance and
quality improvement, incorporate new CDC and AAMI guidelines and fire
safety standards and reduce current facility burden by eliminating
numerous process and procedural requirements.
2. Infection Control
One alternative was not including an exception to the CDC
recommendation for monthly and semiannual screening for hepatitis C. We
retained the exception because blanket screening for hepatitis C is not
a Medicare-covered service.
Another alternative was to include only the ``Recommended Infection
Control Practices for Hemodialysis Units At a Glance'' (At a Glance)
precautions found in the CDC RR05 report and not including the
narrative section explaining the infection control precautions. Our
proposed inclusion of only the ``At a Glance'' two-pager synopsis of
the CDC hemodialysis infection control precautions caused confusion as
evidenced by the comments we received requesting clarification of
various precautions. A third alternative was to require compliance with
AIA Guidelines for Design and Construction of Hospitals and Health Care
Facilities. The AIA guidelines provide instructions regarding dialysis
unit design as it relates to infection control. While some states have
adopted specific AIA guidelines as minimal standards, we believe it
would be too burdensome on dialysis facilities to incorporate AIA
guidelines as federal requirements. Commenters did not support
inclusion of the AIA guidelines in these conditions for coverage.
3. Water Quality
One alternative was to require compliance with portions of the
previous AAMI guidelines--ANSI/AAMI RD5: 1992 Appendix B5. However,
this document has been rescinded by ANSI/AAMI and has been replaced by
updated documents. Although we proposed compliance with portions of the
AAMI document-- RD62: 2001, which is directed to manufacturers, we are
including in this final rule an incorporation by reference of ANSI/AAMI
RD52:2004. This RD52 document reflects the state-of-the-art water
quality guidelines for end users of water purification systems.
Commenters urged us to include the RD52:2004 incorporation by reference
as the most appropriate set of recommendations for dialysis facilities.
4. Reuse of Hemodialyzers
One potential cost-saving alternative was to remove the requirement
that dialyzers exposed to more than one germicide were acceptable for
reuse. We decided against this because exposure to different germicides
may cause membrane leaks and we have no scientific evidence to support
the safety of using hemodialyzers exposed to more than one germicide.
Commenters agreed with this approach.
5. Physical Environment and Emergency Preparedness
One alternative was to remove the requirement that every dialysis
facility have a defibrillator. We retained this proposed provision
because a Seattle study (Becker, pp. 1509-1512) identified dialysis
centers as having a relatively high incidence of cardiac arrests over a
seven year period. Also, automated external defibrillators are now
required on airliners and in other public places because the technology
is simple to use, staff can be trained on the use of such equipment,
and the technology has been proven to save lives.
A second alternative was to allow a waiver or phase-in period for
defibrillators in small rural dialysis facilities. Many commenters
agreed that dialysis facilities should be equipped with a
defibrillator, preferably an AED. Commenters urged that a waiver not be
available to rural facilities and stated that these dialysis facilities
may have the greatest need for AEDs since emergency medical technical
support may be located a long distance from the dialysis facility.
6. Patients' Rights
One alternative was to remove the patients' right to be informed of
the availability of advance directives. We retained this proposal
nonetheless because of the nature of ESRD and the aging dialysis
population.
Another alternative considered was not including that dialysis
facilities have an internal grievance procedure. We did not adopt this
alternative because we believe an internal grievance process is
essential to allow patients to express their concerns directly to the
facility in which they receive dialysis.
7. Patient Assessment
One alternative was to include ``extremely frail patients'' in the
provision to reassess unstable patients monthly. This proposal was not
adopted in order to ensure that dialysis facilities retain the
flexibility to make clinical determinations on a case-by-case basis.
Another alternative was to remove the proposed 3-month timeframe to
reassess new patients. However, we believe that initial patient
adjustment to dialysis is crucial in setting the stage for successful
treatment of ESRD and the reassessment done at 3 months will facilitate
better patient outcomes.
8. Patient Plan of Care
One alternative was to retain the existing requirement for an
individualized care plan with a six month review and a long-term
program with an annual review. We did not adopt this approach because
it was less burdensome to include a single individualized plan of care
(without a long-term program) to be reviewed annually for stable
patients.
9. Quality Assessment and Performance Improvement
One alternative was to require a QAPI program without specific
criteria. We determined, based on the work of the NFK-K/DOQI committees
(adequacy, nutrition, anemia, and vascular access), AAMI guidelines
(reuse), specific recommendations from the OIG (medical error
identification and patient satisfaction), and public comments on our
proposed rule, that there was a sufficient basis to include basic
criteria.
10. Special Purpose Renal Dialysis Facilities
One alternative was to remove this condition entirely based on
historically low levels of participation. We determined that
eliminating this condition would be detrimental to the small number of
vacation camps that choose to participate and it would also

[[Page 20473]]

inhibit access to care during natural disasters.
Another alternative was to retain the current certification
requirements. We believe that the current certification requirements
are onerous; we believe that this is demonstrated by the lack of
participation in Medicare by vacation camps. We believe reducing the
number of certification requirements addresses this issue. The final
rule requirements represent a reduction in administrative burden for
special purpose units.
11. Personnel Qualifications
One alternative was to retain the existing requirement that a
licensed practical nurse, RN, or physician must be on the premises
during dialysis. We are requiring that a registered nurse be on the
premises during dialysis to protect patient health and safety and
believe that this does not represent a significant increase in burden
for dialysis facilities. In response to comments, we included a
provision for the temporary use of an experienced LPN for infrequent
occasions when the lack of an RN would force the facility to close for
the day.
Other options were to propose no or merely minimal Federal
requirements for dialysis technicians. We determined that Federal
requirements are needed at this time because dialysis technicians are
the primary caregivers in most dialysis facilities. Commenters support
the inclusion of qualification criteria for patient care technicians.
12. Medical Director
One alternative was to propose to eliminate the medical director
condition and propose that other health care professionals run dialysis
facilities. However, a June 2000 OIG report strongly recommended that
we strengthen the role of the facility's medical director. In response
to that recommendation, we have retained the condition with a
clarification of the medical director's responsibilities to include
overseeing both the QAPI program and all involuntary patient transfers
or discharges. We do not believe that this approach would impose an
additional cost burden on dialysis facilities.
13. Governance
One alternative considered was to remove the proposal for a 30-day
advance notice before involuntary patient discharge or transfer and
retain the previous requirement (see Sec. 405.2138(b)(2)) for patients
to be ``given advance notice to ensure orderly transfer or discharge.''
We did not adopt this alternative because: (1) A 30-day advance notice
for discharge and transfer has been consistent with the existing
requirements in NFs, SNFs, and hospital swing-beds for over 12 years;
(2) the dialysis patient population is increasingly older and many are
nursing home residents with co-morbid conditions; and (3) large
dialysis organizations have emerged that can offer more flexibility and
options for a patient involuntarily discharged from a facility by
providing numerous units nearby or within commuting distance of that
patient's place of residence. We have retained the proposed provision
to waive the 30-day notice under extraordinary circumstances.
This final rule contains a requirement for every dialysis facility
to report ESRD CPM Project data to CMS. One option considered was to
require that less than 100 percent of facilities participate. However,
section 4558(b) of Pub. L. 105-33 requires CMS to monitor the quality
of care delivered to dialysis patients. To date, CMS has been
collecting a five percent CPM patient sample on a voluntary basis. CPM
electronic data collection has been pilot-tested and is expected to be
ready for general use in 2008. The large dialysis organization
facilities and many other dialysis facilities already collect this data
for benchmarking and quality improvement purposes, and therefore, this
will not create a significant new burden for the industry. However,
small rural facilities may need time to come into compliance, and
therefore, we are including a phase-in period.

E. Conclusion

For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act because we have determined, and the
Secretary certifies, that this final rule will not have a significant
economic impact on a substantial number of small entities or a
significant impact on the operations of a substantial number of small
rural hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 405

Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural
areas, X-rays.

42 CFR Part 413

Health facilities, Kidney diseases, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 414

Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, Reporting and recordkeeping
requirements.

42 CFR Part 488

Administrative practice and procedure, Health facilities, Medicare,
Reporting and recordkeeping requirements.

42 CFR Part 494

Health facilities, Incorporation by reference, Kidney diseases,
Medicare, Reporting and recordkeeping requirements.

0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR Chapter IV as follows:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

Subpart U--Conditions for Coverage of Suppliers of End-Stage Renal
Disease (ESRD) Services

0
1. The authority citation for part 405, subpart U is revised to read as
follows:

Authority: Secs. 1102, 1861, 1862(a), 1871, 1874, and 1881 of
the Social Security Act (42 U.S.C. 1302, 1320b-8, 1395x, 1395y(a),
1395hh, 1395kk, and 1395rr), unless otherwise noted.

Sec. 405.2100 and Sec. 405.2101 [Removed and Reserved]

0
2. Section 405.2100 and Sec. 405.2101 are removed and reserved.

0
3. Section 405.2102 is amended by adding the definition of ``ESRD
Network organization'' in alphabetical order to read as follows:

Sec. 405.2102 Definitions.

* * * * *
ESRD Network organization. The administrative governing body to the
network and liaison to the Federal government.
* * * * *

Sec. 405.2131 and Sec. 405.2133 through Sec. 405.2140 [Removed and
Reserved]

0
4. Section 405.2131 and Sec. 405.2133 through Sec. 405.2140 are
removed and reserved.

[[Page 20474]]

Sec. 405.2150 [Removed and Reserved]

0
5. Section Sec. 405.2150 is removed and reserved.

Sec. 405.2160 through Sec. 405.2164 [Removed and Reserved]

0
6. Sections 405.2160 through Sec. 405.2164 are removed and reserved.

Sec. 405.2180 through Sec. 405.2182 [Removed and Reserved]

0
7. Sections 405.2180 through Sec. 405.2182 are removed and reserved.

Sec. 405.2184 [Removed and Reserved]

0
8. Section 405.2184 is removed and reserved.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
9. The authority citation for part 410 continues to read as follows:

Authority: Secs. 1102, 1834, 1871, and 1893 of the Social
Security Act (42 U.S.C. 1302, 1395(m), 1395hh, and 1395ddd).

Sec. 410.5 [Amended]

0
10. In Sec. 410.5(a), the reference ``Part 405, subpart U: End-Stage
Renal Disease Services,'' is revised to read ``Part 494: End-Stage
Renal Disease Facilities.''

Sec. 410.50 [Amended]

0
11. In Sec. 410.50(b), the reference ``Sec. 405.2163(b)'' is revised
to read ``Sec. 494.130''; and the reference ``subpart M of part 405''
is revised to read ``part 494.''

Sec. 410.52 [Amended]

0
12. Section Sec. 410.52 is amended as follows:
0
A. In paragraph (a)(4), the reference to ``Sec. 405.2163'' is revised
to read ``Sec. 494.90(a)(4).''
0
B. In paragraph (a)(4), the word ``epoetin (EPO)'' is revised to read
``erythropoeisis-stimulating agents.''
0
C. In paragraph (b), the parenthetical statement ``(Section 405.2137 of
this chapter contains specific details.)'' is revised to read
``(Section 494.90 of this chapter contains details on patient plans of
care).''

Sec. 410.152 [Amended]

0
13. In Sec. 410.152(e)(1), ``subpart U of part 405'' is revised to
read ``part 494.''

Sec. 410.170 [Amended]

0
14. In Sec. 410.170(c), the reference to ``Sec. 405.2137(b)(3)'' is
revised to read ``Sec. 494.90.''

PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT
RATES FOR SKILLED NURSING FACILITIES

0
15. The authority citation for part 413 continues to read as follows:

Authority: Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), and
(n), 1861(v), 1871, 1881, 1883, and 1886 of the Social Security Act
(42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n),
1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww); and sec. 124 of
Public Law 106-133 (113 Stat. 1501A-332).

0
16. In Sec. 413.170, paragraph (a) is revised to read as follows:

Sec. 413.170 Scope.

* * * * *
(a) Setting forth the principles and authorities under which CMS is
authorized to establish a prospective payment system for outpatient
maintenance dialysis furnished in or under the supervision of a
dialysis facility under part 494 of this chapter (referred to as
``facility''). For purposes of this section and Sec. 413.172 through
Sec. 413.198, ``outpatient maintenance dialysis'' means outpatient
dialysis provided by a dialysis facility, home dialysis or self-
dialysis as defined in Sec. 494.10 of this chapter and includes all
items and services specified in Sec. 410.50 and Sec. 410.52 of this
chapter.
* * * * *

0
17. In Sec. 413.172, paragraph (b) is revised to read as follows:

Sec. 413.172 Principles of prospective payment.

* * * * *
(b) All approved ESRD facilities must accept the prospective
payment rates established by CMS as payment in full for covered
outpatient maintenance dialysis. Approved ESRD facility means--
(1) Any independent or hospital-based facility (as defined in
accordance with Sec. 413.174(b) and Sec. 413.174(c) of this part)
that has been approved by CMS to participate in Medicare as an ESRD
supplier; or
(2) Any approved independent facility with a written agreement with
the Secretary. Under the agreement, the independent ESRD facility
agrees--
(i) To maintain compliance with the conditions for coverage set
forth in part 494 of this chapter and to report promptly to CMS any
failure to do so; and
(ii) Not to charge the beneficiary or any other person for items
and services for which the beneficiary is entitled to have payment made
under the provisions of this part.
* * * * *

Sec. 413.198 [Amended]

0
18. In Sec. 413.198(a), the phrase ``approved under subpart U of part
405,'' is revised to read ``under part 494.''

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
19. The authority citation for part 414 continues to read as follows:

Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).

Sec. 414.330 [Amended]

0
20. Section 414.330 is amended as follows:
0
A. In paragraph (a)(2)(iii)(B), the reference ``subpart U of part 405''
is revised to read ``part 494.''
0
B. In paragraph (a)(2)(iii)(B)(1), the references ``subpart U
(Conditions for Coverage of Suppliers of ESRD Services)'' are revised
to read ``part 494 (Conditions for Coverage for End-Stage Renal Disease
Facilities).''
0
C. In paragraph (a)(2)(iii)(B)(7), the references ``subpart U
(Conditions for Coverage of Suppliers of ESRD Services)'' are revised
to read ``part 494 (Conditions for Coverage for End-Stage Renal Disease
Facilities).''
0
D. Paragraph (a)(2)(iii)(C) is added to read as follows:

Sec. 414.330 Payment for home dialysis equipment, supplies, and
support services.

(a) * * *
(2) * * *
(iii) * * *
(C) Agrees to report to the ESRD facility providing support
services, at least every 45 days, all data (meaning information showing
what supplies and services were provided to the patient and when each
was provided) for each patient regarding services and items furnished
to the patient in accordance with Sec. 494.100(c)(2) of this chapter.
* * * * *

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
21. The authority citation for part 488 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act,
unless otherwise noted (42 U.S.C. 1302 and 1895hh); Continuing
Resolution Pub. L. 110-149 H.J. Res 72.

0
22. Section 488.60(a) is revised to read as follows:

[[Page 20475]]

Sec. 488.60 Special procedures for approving end-stage renal disease
facilities.

(a) Consideration for approval. An ESRD facility that wishes to be
approved or that wishes an expansion of dialysis services to be
approved for coverage, in accordance with part 494 of this chapter,
must secure a determination by the Secretary. To secure a
determination, the facility must submit the following documents and
data for consideration by the Secretary:
(1) Certification by the State agency referred to in Sec. 488.12
of this part.
(2) Data furnished by ESRD network organizations and
recommendations of the Public Health Service concerning the facility's
contribution to the ESRD services of the network.
(3) Data concerning the facility's compliance with professional
norms and standards.
(4) Data pertaining to the facility's qualifications for approval
or for any expansion of services.
* * * * *

Subpart G [Added and Reserved]

0
23. A new subpart G is added and reserved.

0
24. A new subpart H is added to read as follows:

Subpart H--Termination of Medicare Coverage and Alternative
Sanctions for End-Stage Renal Disease (ESRD) Facilities

Sec.
488.604 Termination of Medicare coverage.
488.606 Alternative sanctions.
488.608 Notice of alternative sanction and appeal rights:
Termination of coverage.
488.610 Notice of appeal rights: Alternative sanctions.

Subpart H--Termination of Medicare Coverage and Alternative
Sanctions for End-Stage Renal Disease (ESRD) Facilities

Sec. 488.604 Termination of Medicare coverage.

(a) Except as otherwise provided in this subpart, failure of a
supplier of ESRD services to meet one or more of the conditions for
coverage set forth in part 494 of this chapter will result in
termination of Medicare coverage of the services furnished by the
supplier.
(b) If termination of coverage is based solely on a supplier's
failure to participate in network activities and pursue network goals,
as required at Sec. 494.180(i) of this chapter, coverage may be
reinstated when CMS determines that the supplier is making reasonable
and appropriate efforts to meet that condition.
(c) If termination of coverage is based on failure to meet any of
the other conditions specified in part 494 of this chapter, coverage
will not be reinstated until CMS finds that the reason for termination
has been removed and there is reasonable assurance that it will not
recur.

Sec. 488.606 Alternative sanctions.

(a) Basis for application of alternative sanctions. CMS may, as an
alternative to termination of Medicare coverage, impose one of the
sanctions specified in paragraph (b) of this section if CMS finds
that--
(1) The supplier fails to participate in the activities and pursue
the goals of the ESRD network that is designated to encompass the
supplier's geographic area; and
(2) This failure does not jeopardize patient health and safety.
(b) Alternative sanctions. The alternative sanctions that CMS may
apply in the circumstances specified in paragraph (a) of this section
include the following:
(1) Denial of payment for services furnished to patients first
accepted for care after the effective date of the sanction as specified
in the sanction notice.
(2) Reduction of payments, for all ESRD services furnished by the
supplier, by 20 percent for each 30-day period after the effective date
of the sanction.
(3) Withholding of all payments, without interest, for all ESRD
services furnished by the supplier to Medicare beneficiaries.
(c) Duration of alternative sanction. An alternative sanction
remains in effect until CMS finds that the supplier is in substantial
compliance with the requirement to cooperate in the network plans and
goals, or terminates coverage of the supplier's services for lack of
compliance.

Sec. 488.608 Notice of alternative sanction and appeal rights:
Termination of coverage.

(a) Notice of alternative sanction. CMS gives the supplier and the
general public notice of the alternative sanction and of the effective
date of the sanction. The effective date of the alternative sanction is
at least 30 days after the date of the notice.
(b) Appeal rights. Termination of Medicare coverage of a supplier's
ESRD services because the supplier no longer meets the conditions for
coverage of its services is an initial determination appealable under
part 498 of this chapter.

Sec. 488.610 Notice of appeal rights: Alternative sanctions.

If CMS proposes to apply an alternative sanction specified in Sec.
488.606(b), the following rules apply:
(a) CMS gives the facility notice of the proposed alternative
sanction and 15 days in which to request a hearing.
(b) If the facility requests a hearing, CMS provides an informal
hearing by a CMS official who was not involved in making the appealed
decision.
(c) During the informal hearing, the facility--
(1) May be represented by counsel;
(2) Has access to the information on which the allegation was
based; and
(3) May present, orally or in writing, evidence and documentation
to refute the finding of failure to participate in network activities
and pursue network goals.
(d) If the written decision of the informal hearing supports
application of the alternative sanction, CMS provides the facility and
the public, at least 30 days before the effective date of the
alternative sanction, a written notice that specifies the effective
date and the reasons for the alternative sanction.
0
25. A new part 494 is added to read as follows:

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

Subpart A--General Provisions
Sec.
494.1 Basis and scope.
494.10 Definitions.
494.20 Condition: Compliance with Federal, State, and local laws and
regulations.
Subpart B--Patient Safety
494.30 Condition: Infection control.
494.40 Condition: Water and dialysate quality.
494.50 Condition: Reuse of hemodialyzers and bloodlines.
494.60 Condition: Physical environment.
Subpart C--Patient Care
494.70 Condition: Patient rights.
494.80 Condition: Patient assessment.
494.90 Condition: Patient plan of care.
494.100 Condition: Care at home.
494.110 Condition: Quality assessment and performance improvement.
494.120 Condition: Special purpose renal dialysis facilities.
494.130 Condition: Laboratory services.
Subpart D--Administration
494.140 Condition: Personnel qualifications.
494.150 Condition: Responsibilities of the Medical director.
494.160 [Reserved]
494.170 Condition: Medical records.
494.180 Condition: Governance.

[[Page 20476]]

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. l302 and l395hh).

Subpart A--General Provisions

Sec. 494.1 Basis and scope.

(a) Statutory basis. This part is based on the following
provisions:
(1) Section 299I of the Social Security Amendments of 1972 (Pub. L.
92-603), which extended Medicare coverage to insured individuals, their
spouses, and their dependent children with ESRD who require dialysis or
transplantation.
(2) Section 1861(e)(9) of the Act, which requires hospitals to meet
such other requirements as the Secretary finds necessary in the
interest of health and safety of individuals who are furnished services
in the institution.
(3) Section 1861(s)(2)(F) of the Act, which describes ``medical and
other health services'' covered under Medicare to include home dialysis
supplies and equipment, self-care home dialysis support services, and
institutional dialysis services and supplies.
(4) Section 1862(a) of the Act, which specifies exclusions from
coverage.
(5) Section 1881 of the Act, which authorizes Medicare coverage and
payment for the treatment of ESRD in approved facilities, including
institutional dialysis services, transplantation services, self-care
home dialysis services, and the administration of erythropoiesis-
stimulating agent(s).
(6) Section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (Pub. L. 104-113), which requires Federal
agencies to use technical standards that are developed or adopted by
voluntary consensus standards bodies, unless their use would be
inconsistent with applicable law or otherwise impractical.
(b) Scope. The provisions of this part establish the conditions for
coverage of services under Medicare and are the basis for survey
activities for the purpose of determining whether an ESRD facility's
services may be covered.

Sec. 494.10 Definitions.

As used in this part--
Dialysis facility means an entity that provides outpatient
maintenance dialysis services, or home dialysis training and support
services, or both. A dialysis facility may be an independent or
hospital-based unit (as described in Sec. 413.174(b) and (c) of this
chapter) that includes a self-care dialysis unit that furnishes only
self-dialysis services.
Discharge means the termination of patient care services by a
dialysis facility or the patient voluntarily terminating dialysis when
he or she no longer wants to be dialyzed by that facility.
Furnishes directly means the ESRD facility provides the service
through its own staff and employees or through individuals who are
under direct contract to furnish these services personally for the
facility.
Home dialysis means dialysis performed at home by an ESRD patient
or caregiver who has completed an appropriate course of training as
described in Sec. 494.100(a) of this part.
Self-dialysis means dialysis performed with little or no
professional assistance by an ESRD patient or caregiver who has
completed an appropriate course of training as specified in Sec.
494.100(a) of this part.
Transfer means a temporary or permanent move of a patient from one
dialysis facility to another that requires a transmission of the
patient's medical record to the facility receiving the patient.

Sec. 494.20 Condition: Compliance with Federal, State, and local laws
and regulations.

The facility and its staff must operate and furnish services in
compliance with applicable Federal, State, and local laws and
regulations pertaining to licensure and any other relevant health and
safety requirements.

Subpart B--Patient Safety

Sec. 494.30 Condition: Infection control.

The dialysis facility must provide and monitor a sanitary
environment to minimize the transmission of infectious agents within
and between the unit and any adjacent hospital or other public areas.
(a) Standard: Procedures for infection control. The facility must
demonstrate that it follows standard infection control precautions by
implementing--
(1)(i) The recommendations (with the exception of screening for
hepatitis C), found in ``Recommendations for Preventing Transmission of
Infections Among Chronic Hemodialysis Patients,'' developed by the
Centers for Disease Control and Prevention, Morbidity and Mortality
Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28.
The Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This
publication is available for inspection at the CMS Information Resource
Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at
the National Archives and Records Administration (NARA). Copies may be
obtained at the CMS Information Resource Center. 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_regulations/ibr_locations.html. The recommendation found under section header ``HBV-
Infected Patients'', found on pages 27 and 28 of RR05
(``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients''), concerning isolation rooms, must be
complied with by February 9, 2009.
(ii) When dialysis isolation rooms as required by (a)(1)(i) are
available locally that sufficiently serve the needs of patients in the
geographic area, a new dialysis facility may request a waiver of such
requirement. Isolation room waivers may be granted at the discretion
of, and subject to, additional qualifications as may be deemed
necessary by the Secretary.
(2) The ``Guidelines for the Prevention of Intravascular Catheter-
Related Infections'' entitled ``Recommendations for Placement of
Intravascular Catheters in Adults and Children'' parts I-IV; and
``Central Venous Catheters, Including PICCs, Hemodialysis, and
Pulmonary Artery Catheters, in Adult and Pediatric Patients,''
Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16
through 18, August 9, 2002. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR Part 51. This publication is available for inspection
at the CMS Information Resource Center, 7500 Security Boulevard,
Central Building, Baltimore, MD or at the National Archives and Records
Administration (NARA). Copies may be obtained at the CMS Information
Resource Center. 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_regulations/ibr_locations.html.
(3) Patient isolation procedures to minimize the spread of
infectious agents and communicable diseases; and
(4) Maintaining procedures, in accordance with applicable State and
local laws and accepted public health procedures, for the--
(i) Handling, storage, and disposal of potentially infectious
waste; and
(ii) Cleaning and disinfection of contaminated surfaces, medical
devices, and equipment.
(b) Standard: Oversight. The facility must--
(1) Monitor and implement biohazard and infection control policies
and activities within the dialysis unit;
(2) Ensure that clinical staff demonstrate compliance with current

[[Page 20477]]

aseptic techniques when dispensing and administering intravenous
medications from vials and ampules; and
(3) Require all clinical staff to report infection control issues
to the dialysis facility's medical director (see Sec. 494.150 of this
part) and the quality improvement committee.
(c) Standard: Reporting. The facility must report incidences of
communicable diseases as required by Federal, State, and local
regulations.

Sec. 494.40 Condition: Water and dialysate quality.

The facility must be able to demonstrate the following:
(a) Standard: Water purity. Water and equipment used for dialysis
meets the water and dialysate quality standards and equipment
requirements found in the Association for the Advancement of Medical
Instrumentation (AAMI) publication, ``Dialysate for hemodialysis,''
ANSI/AAMI RD52: 2004. The Director of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and
1 CFR Part 51. This publication is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Central Building,
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_regulations/ibr_locations.html. Copies may be purchased from
the Association for the Advancement of Medical Instrumentation, 3300
Washington Boulevard, Suite 400, Arlington, VA 22201-4598.
(b) Standard: Chlorine/chloramines.
(1) The water treatment system must include a component or carbon
tank which removes chlorine/chloramine along with a backup component or
second carbon tank in series for chlorine/chloramine removal;
(2) (i) If the test results from the port of the initial component
or carbon tank referred to in section 6.2.5 of AAMI RD52:2004 are
greater than 0.5 mg/L for free chlorine or 0.1 mg/L for chloramines, or
equal to or greater than 0.1 mg/L of total chlorine, then the second
component or carbon tank which removes chlorine/chloramine must be
tested;
(ii) If the test results from the last component or carbon tank are
greater than the parameters for chlorine or chloramine specified in
paragraph (b)(2)(i) of this section the facility must--
(A) Immediately take corrective action to bring chlorine or
chloramine levels into compliance with paragraph (b)(2)(i) of this
section and confirm through testing that the corrective action has been
effective, or terminate dialysis treatment to protect patients from
exposure to chlorine/chloramine;
(B) Only allow use of purified water in a holding tank, if
appropriate, and if testing shows water chlorine or chloramine levels
that are in compliance with paragraph (b)(2)(i) of this section; and
(C) Immediately notify the medical director; and
(D) Take corrective action to ensure ongoing compliance with
acceptable chlorine and chloramine levels as described in paragraph
(b)(2)(i) of this section.
(c) Standard: Corrective action plan. Water testing results
including, but not limited to, chemical, microbial, and endotoxin
levels which meet AAMI action levels or deviate from the AAMI standards
must be addressed with a corrective action plan that ensures patient
safety.
(d) Standard: Adverse events. A dialysis facility must maintain
active surveillance of patient reactions during and following dialysis.
When clinically indicated (for example, after adverse patient
reactions) the facility must--
(1) Obtain blood and dialysate cultures and endotoxin levels;
(2) Evaluate the water purification system; and
(3) Take corrective action.
(e) Standard: In-center use of preconfigured hemodialysis systems.
When using a preconfigured, FDA-approved hemodialysis system designed,
tested and validated to yield AAMI quality (which includes standards
for chemical and chlorine/chloramine testing) water and dialysate, the
system's FDA-approved labeling must be adhered to for machine use and
monitoring of the water and dialysate quality. The facility must meet
all AAMI RD52:2004 requirements for water and dialysate. Moreover, the
facility must perform bacteriological and endotoxin testing on a
quarterly, or more frequent basis, as needed, to ensure that the water
and dialysate are within AAMI limits.

Sec. 494.50 Condition: Reuse of hemodialyzers and bloodlines.

(a) Standard: General requirements for the reuse of hemodialyzers
and bloodlines. Certain hemodialyzers and bloodlines--
(1) May be reused for certain patients with the exception of
Hepatitis B positive patients;
(2) Must be reused only for the same patient; and
(3) Must be labeled for multiple reuse in accordance with the
premarket notification provisions of section 510(k) of the Food, Drug,
and Cosmetics Act and 21 CFR 876.5860.
(b) Standard: Reprocessing requirements for the reuse of
hemodialyzers and bloodlines. A dialysis facility that reuses
hemodialyzers and bloodlines must adhere to the following reprocessing
guidelines:
(1) Meet the requirements of AAMI published in ``Reuse of
Hemodialyzers,'' third edition, ANSI/AAMI RD47:2002 and RD47:2002/
A1:2003. The Director of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
Part 51. This publication is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Central Building,
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_regulations/ibr_locations.html. Copies may be purchased from
the Association for the Advancement of Medical Instrumentation, 3300
Washington Boulevard, Suite 400, Arlington, VA 22201-4598.
(2) Reprocess hemodialyzers and bloodlines--
(i) By following the manufacturer's recommendations; or
(ii) Using an alternate method and maintaining documented evidence
that the method is safe and effective.
(3) Not expose hemodialyzers to more than one chemical germicide,
other than bleach (used as a cleaner in this application), during the
life of the dialyzer. All hemodialyzers must be discarded before a
different chemical germicide is used in the facility.
(c) Standard: Monitoring, evaluation, and reporting requirements
for the reuse of hemodialyzers and bloodlines. In addition to the
requirements for hemodialyzer and bloodline reuse specified in
paragraphs (a) and (b) of this section, the dialysis facility must
adhere to the following:
(1) Monitor patient reactions during and following dialysis.
(2) When clinically indicated (for example, after adverse patient
reactions), the facility must--
(i) Obtain blood and dialysate cultures and endotoxin levels; and
(ii) Undertake evaluation of its dialyzer reprocessing and water
purification system. When this

[[Page 20478]]

evaluation suggests a cluster of adverse patient reactions is
associated with hemodialyzer reuse, the facility must suspend reuse of
hemodialyzers until it is satisfied the problem has been corrected.
(iii) Report the adverse outcomes to the FDA and other Federal,
State or local government agencies as required by law.

Sec. 494.60 Condition: Physical environment.

The dialysis facility must be designed, constructed, equipped, and
maintained to provide dialysis patients, staff, and the public a safe,
functional, and comfortable treatment environment.
(a) Standard: Building. The building in which dialysis services are
furnished must be constructed and maintained to ensure the safety of
the patients, the staff, and the public.
(b) Standard: Equipment maintenance. The dialysis facility must
implement and maintain a program to ensure that all equipment
(including emergency equipment, dialysis machines and equipment, and
the water treatment system) are maintained and operated in accordance
with the manufacturer's recommendations.
(c) Standard: Patient care environment.
(1) The space for treating each patient must be sufficient to
provide needed care and services, prevent cross-contamination, and to
accommodate medical emergency equipment and staff.
(2) The dialysis facility must:
(i) Maintain a comfortable temperature within the facility; and
(ii) Make reasonable accommodations for the patients who are not
comfortable at this temperature.
(3) The dialysis facility must make accommodations to provide for
patient privacy when patients are examined or treated and body exposure
is required.
(4) Patients must be in view of staff during hemodialysis treatment
to ensure patient safety (video surveillance will not meet this
requirement).
(d) Standard: Emergency preparedness. The dialysis facility must
implement processes and procedures to manage medical and nonmedical
emergencies that are likely to threaten the health or safety of the
patients, the staff, or the public. These emergencies include, but are
not limited to, fire, equipment or power failures, care-related
emergencies, water supply interruption, and natural disasters likely to
occur in the facility's geographic area.
(1) Emergency preparedness of staff. The dialysis facility must
provide appropriate training and orientation in emergency preparedness
to the staff. Staff training must be provided and evaluated at least
annually and include the following:
(i) Ensuring that staff can demonstrate a knowledge of emergency
procedures, including informing patients of--
(A) What to do;
(B) Where to go, including instructions for occasions when the
geographic area of the dialysis facility must be evacuated;
(C) Whom to contact if an emergency occurs while the patient is not
in the dialysis facility. This contact information must include an
alternate emergency phone number for the facility for instances when
the dialysis facility is unable to receive phone calls due to an
emergency situation (unless the facility has the ability to forward
calls to a working phone number under such emergency conditions); and
(D) How to disconnect themselves from the dialysis machine if an
emergency occurs.
(ii) Ensuring that, at a minimum, patient care staff maintain
current CPR certification; and
(iii) Ensuring that nursing staff are properly trained in the use
of emergency equipment and emergency drugs.
(2) Emergency preparedness patient training. The facility must
provide appropriate orientation and training to patients, including the
areas specified in paragraph (d)(1)(i) of this section.
(3) Emergency equipment. Emergency equipment, including, but not
limited to, oxygen, airways, suction, defibrillator or automated
external defibrillator, artificial resuscitator, and emergency drugs,
must be on the premises at all times and immediately available.
(4) Emergency plans. The facility must--
(i) Have a plan to obtain emergency medical system assistance when
needed;
(ii) Evaluate at least annually the effectiveness of emergency and
disaster plans and update them as necessary; and
(iii) Contact its local disaster management agency at least
annually to ensure that such agency is aware of dialysis facility needs
in the event of an emergency.
(e) Standard: Fire safety.
(1) Except as provided in paragraph (e)(2) of this section, by
February 9, 2009. The dialysis facility must comply with applicable
provisions of the 2000 edition of the Life Safety Code of the National
Fire Protection Association (which is incorporated by reference at
Sec. 403.744(a)(1)(i) of this chapter).
(2) Notwithstanding paragraph (e)(1) of this section, dialysis
facilities participating in Medicare as of October 14, 2008. Utilizing
non-sprinklered buildings on such date may continue to use such
facilities if such buildings were constructed before January 1, 2008
and State law so permits.
(3) If CMS finds that a fire and safety code imposed by the
facility's State law adequately protects a dialysis facility's
patients, CMS may allow the State survey agency to apply the State's
fire and safety code instead of the Life Safety Code.
(4) After consideration of State survey agency recommendations, CMS
may waive, for individual dialysis facilities and for appropriate
periods, specific provisions of the Life Safety Code, if the following
requirements are met:
(i) The waiver would not adversely affect the health and safety of
the dialysis facility's patients; and
(ii) Rigid application of specific provisions of the Life Safety
Code would result in an unreasonable hardship for the dialysis
facility.

Subpart C--Patient Care

Sec. 494.70 Condition: Patients' rights.

The dialysis facility must inform patients (or their
representatives) of their rights (including their privacy rights) and
responsibilities when they begin their treatment and must protect and
provide for the exercise of those rights.
(a) Standard: Patients' rights. The patient has the right to--
(1) Respect, dignity, and recognition of his or her individuality
and personal needs, and sensitivity to his or her psychological needs
and ability to cope with ESRD;
(2) Receive all information in a way that he or she can understand;
(3) Privacy and confidentiality in all aspects of treatment;
(4) Privacy and confidentiality in personal medical records;
(5) Be informed about and participate, if desired, in all aspects
of his or her care, and be informed of the right to refuse treatment,
to discontinue treatment, and to refuse to participate in experimental
research;
(6) Be informed about his or her right to execute advance
directives, and the facility's policy regarding advance directives;
(7) Be informed about all treatment modalities and settings,
including but not limited to, transplantation, home dialysis modalities
(home hemodialysis, intermittent peritoneal dialysis, continuous
ambulatory peritoneal dialysis, continuous cycling peritoneal
dialysis),and in-facility hemodialysis. The patient has the right to
receive resource information for dialysis

[[Page 20479]]

modalities not offered by the facility, including information about
alternative scheduling options for working patients;
(8) Be informed of facility policies regarding patient care,
including, but not limited to, isolation of patients;
(9) Be informed of facility policies regarding the reuse of
dialysis supplies, including hemodialyzers;
(10) Be informed by the physician, nurse practitioner, clinical
nurse specialist, or physician's assistant treating the patient for
ESRD of his or her own medical status as documented in the patient's
medical record, unless the medical record contains a documented
contraindication;
(11) Be informed of services available in the facility and charges
for services not covered under Medicare;
(12) Receive the necessary services outlined in the patient plan of
care described in Sec. 494.90;
(13) Be informed of the rules and expectations of the facility
regarding patient conduct and responsibilities;
(14) Be informed of the facility's internal grievance process;
(15) Be informed of external grievance mechanisms and processes,
including how to contact the ESRD Network and the State survey agency;
(16) Be informed of his or her right to file internal grievances or
external grievances or both without reprisal or denial of services; and
(17) Be informed that he or she may file internal or external
grievances, personally, anonymously or through a representative of the
patient's choosing.
(b) Standard: Right to be informed regarding the facility's
discharge and transfer policies. The patient has the right to--
(1) Be informed of the facility's policies for transfer, routine or
involuntary discharge, and discontinuation of services to patients; and
(2) Receive written notice 30 days in advance of an involuntary
discharge, after the facility follows the involuntary discharge
procedures described in Sec. 494.180(f)(4). In the case of immediate
threats to the health and safety of others, an abbreviated discharge
procedure may be allowed.
(c) Standard: Posting of rights. The dialysis facility must
prominently display a copy of the patient's rights in the facility,
including the current State agency and ESRD network mailing addresses
and telephone complaint numbers, where it can be easily seen and read
by patients.

Sec. 494.80 Condition: Patient assessment.

The facility's interdisciplinary team consists of, at a minimum,
the patient or the patient's designee (if the patient chooses), a
registered nurse, a physician treating the patient for ESRD, a social
worker, and a dietitian. The interdisciplinary team is responsible for
providing each patient with an individualized and comprehensive
assessment of his or her needs. The comprehensive assessment must be
used to develop the patient's treatment plan and expectations for care.
(a) Standard: Assessment criteria. The patient's comprehensive
assessment must include, but is not limited to, the following:
(1) Evaluation of current health status and medical condition,
including co-morbid conditions.
(2) Evaluation of the appropriateness of the dialysis prescription,
blood pressure, and fluid management needs.
(3) Laboratory profile, immunization history, and medication
history.
(4) Evaluation of factors associated with anemia, such as
hematocrit, hemoglobin, iron stores, and potential treatment plans for
anemia, including administration of erythropoiesis-stimulating
agent(s).
(5) Evaluation of factors associated with renal bone disease.
(6) Evaluation of nutritional status by a dietitian.
(7) Evaluation of psychosocial needs by a social worker.
(8) Evaluation of dialysis access type and maintenance (for
example, arteriovenous fistulas, arteriovenous grafts, and peritoneal
catheters).
(9) Evaluation of the patient's abilities, interests, preferences,
and goals, including the desired level of participation in the dialysis
care process; the preferred modality (hemodialysis or peritoneal
dialysis), and setting, (for example, home dialysis), and the patient's
expectations for care outcomes.
(10) Evaluation of suitability for a transplantation referral,
based on criteria developed by the prospective transplantation center
and its surgeon(s). If the patient is not suitable for transplantation
referral, the basis for nonreferral must be documented in the patient's
medical record.
(11) Evaluation of family and other support systems.
(12) Evaluation of current patient physical activity level.
(13) Evaluation for referral to vocational and physical
rehabilitation services.
(b) Standard: Frequency of assessment for patients admitted to the
dialysis facility. (1) An initial comprehensive assessment must be
conducted on all new patients (that is, all admissions to a dialysis
facility), within the latter of 30 calendar days or 13 outpatient
hemodialysis sessions beginning with the first outpatient dialysis
session.
(2) A follow up comprehensive reassessment must occur within 3
months after the completion of the initial assessment to provide
information to adjust the patient's plan of care specified in Sec.
494.90.
(c) Standard: Assessment of treatment prescription. The adequacy of
the patient's dialysis prescription, as described in Sec.
494.90(a)(1), must be assessed on an ongoing basis as follows:
(1) Hemodialysis patients. At least monthly by calculating
delivered Kt/V or an equivalent measure.
(2) Peritoneal dialysis patients. At least every 4 months by
calculating delivered weekly Kt/V or an equivalent measure.
(d) Standard: Patient reassessment. In accordance with the
standards specified in paragraphs (a)(1) through (a)(13) of this
section, a comprehensive reassessment of each patient and a revision of
the plan of care must be conducted--
(1) At least annually for stable patients; and
(2) At least monthly for unstable patients including, but not
limited to, patients with the following:
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Concurrent poor nutritional status, unmanaged anemia, and
inadequate dialysis.

Sec. 494.90 Condition: Patient plan of care.

The interdisciplinary team as defined at Sec. 494.80 must develop
and implement a written, individualized comprehensive plan of care that
specifies the services necessary to address the patient's needs, as
identified by the comprehensive assessment and changes in the patient's
condition, and must include measurable and expected outcomes and
estimated timetables to achieve these outcomes. The outcomes specified
in the patient plan of care must be consistent with current evidence-
based professionally-accepted clinical practice standards.
(a) Standard: Development of patient plan of care. The
interdisciplinary team must develop a plan of care for each patient.
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the
necessary care and services to manage the patient's volume status; and
achieve

[[Page 20480]]

and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V
of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7
or meet an alternative equivalent professionally-accepted clinical
practice standard for adequacy of dialysis.
(2) Nutritional status. The interdisciplinary team must provide the
necessary care and counseling services to achieve and sustain an
effective nutritional status. A patient's albumin level and body weight
must be measured at least monthly. Additional evidence-based
professionally-accepted clinical nutrition indicators may be monitored,
as appropriate.
(3) Mineral metabolism. Provide the necessary care to manage
mineral metabolism and prevent or treat renal bone disease.
(4) Anemia. The interdisciplinary team must provide the necessary
care and services to achieve and sustain the clinically appropriate
hemoglobin/hematocrit level. The patient's hemoglobin/hematocrit must
be measured at least monthly. The dialysis facility must conduct an
evaluation of the patient's anemia management needs. For a home
dialysis patient, the facility must evaluate whether the patient can
safely, aseptically, and effectively administer erythropoiesis-
stimulating agents and store this medication under refrigeration if
necessary. The patient's response to erythropoiesis-stimulating
agent(s), including blood pressure levels and utilization of iron
stores, must be monitored on a routine basis.
(5) Vascular access. The interdisciplinary team must provide
vascular access monitoring and appropriate, timely referrals to achieve
and sustain vascular access. The hemodialysis patient must be evaluated
for the appropriate vascular access type, taking into consideration co-
morbid conditions, other risk factors, and whether the patient is a
potential candidate for arteriovenous fistula placement. The patient's
vascular access must be monitored to prevent access failure, including
monitoring of arteriovenous grafts and fistulae for symptoms of
stenosis.
(6) Psychosocial status. The interdisciplinary team must provide
the necessary monitoring and social work interventions. These include
counseling services and referrals for other social services, to assist
the patient in achieving and sustaining an appropriate psychosocial
status as measured by a standardized mental and physical assessment
tool chosen by the social worker, at regular intervals, or more
frequently on an as-needed basis.
(7) Modality. (i) Home dialysis. The interdisciplinary team must
identify a plan for the patient's home dialysis or explain why the
patient is not a candidate for home dialysis.
(ii) Transplantation status. When the patient is a transplant
referral candidate, the interdisciplinary team must develop plans for
pursuing transplantation. The patient's plan of care must include
documentation of the--
(A) Plan for transplantation, if the patient accepts the
transplantation referral;
(B) Patient's decision, if the patient is a transplantation
referral candidate but declines the transplantation referral; or
(C) Reason(s) for the patient's nonreferral as a transplantation
candidate as documented in accordance with Sec. 494.80(a)(10).
(8) Rehabilitation status. The interdisciplinary team must assist
the patient in achieving and sustaining an appropriate level of
productive activity, as desired by the patient, including the
educational needs of pediatric patients (patients under the age of 18
years), and make rehabilitation and vocational rehabilitation referrals
as appropriate.
(b) Standard: Implementation of the patient plan of care.
(1) The patient's plan of care must--
(i) Be completed by the interdisciplinary team, including the
patient if the patient desires; and
(ii) Be signed by team members, including the patient or the
patient's designee; or, if the patient chooses not to sign the plan of
care, this choice must be documented on the plan of care, along with
the reason the signature was not provided.
(2) Implementation of the initial plan of care must begin within
the latter of 30 calendar days after admission to the dialysis facility
or 13 outpatient hemodialysis sessions beginning with the first
outpatient dialysis session. Implementation of monthly or annual
updates of the plan of care must be performed within 15 days of the
completion of the additional patient assessments specified in Sec.
494.80(d).
(3) If the expected outcome is not achieved, the interdisciplinary
team must adjust the patient's plan of care to achieve the specified
goals. When a patient is unable to achieve the desired outcomes, the
team must--
(i) Adjust the plan of care to reflect the patient's current
condition;
(ii) Document in the record the reasons why the patient was unable
to achieve the goals; and
(iii) Implement plan of care changes to address the issues
identified in paragraph (b)(3)(ii) of this section.
(4) The dialysis facility must ensure that all dialysis patients
are seen by a physician, nurse practitioner, clinical nurse specialist,
or physician's assistant providing ESRD care at least monthly, as
evidenced by a monthly progress note placed in the medical record, and
periodically while the hemodialysis patient is receiving in-facility
dialysis.
(c) Standard: Transplantation referral tracking. The
interdisciplinary team must--
(1) Track the results of each kidney transplant center referral;
(2) Monitor the status of any facility patients who are on the
transplant wait list; and
(3) Communicate with the transplant center regarding patient
transplant status at least annually, and when there is a change in
transplant candidate status.
(d) Standard: Patient education and training. The patient care plan
must include, as applicable, education and training for patients and
family members or caregivers or both, in aspects of the dialysis
experience, dialysis management, infection prevention and personal
care, home dialysis and self-care, quality of life, rehabilitation,
transplantation, and the benefits and risks of various vascular access
types.

Sec. 494.100 Condition: Care at home.

A dialysis facility that is certified to provide services to home
patients must ensure through its interdisciplinary team, that home
dialysis services are at least equivalent to those provided to in-
facility patients and meet all applicable conditions of this part.
(a) Standard: Training. The interdisciplinary team must oversee
training of the home dialysis patient, the designated caregiver, or
self-dialysis patient before the initiation of home dialysis or self-
dialysis (as defined in Sec. 494.10) and when the home dialysis
caregiver or home dialysis modality changes. The training must--
(1) Be provided by a dialysis facility that is approved to provide
home dialysis services;
(2) Be conducted by a registered nurse who meets the requirements
of Sec. 494.140(b)(2); and
(3) Be conducted for each home dialysis patient and address the
specific needs of the patient, in the following areas:
(i) The nature and management of ESRD.
(ii) The full range of techniques associated with the treatment
modality selected, including effective use of dialysis supplies and
equipment in achieving and delivering the physician's

[[Page 20481]]

prescription of Kt/V or URR, and effective administration of
erythropoiesis-stimulating agent(s) (if prescribed) to achieve and
maintain a target level hemoglobin or hematocrit as written in
patient's plan of care.
(iii) How to detect, report, and manage potential dialysis
complications, including water treatment problems.
(iv) Availability of support resources and how to access and use
resources.
(v) How to self-monitor health status and record and report health
status information.
(vi) How to handle medical and non-medical emergencies.
(vii) Infection control precautions.
(viii) Proper waste storage and disposal procedures.
(b) Standard: Home dialysis monitoring. The dialysis facility
must--
(1) Document in the medical record that the patient, the caregiver,
or both received and demonstrated adequate comprehension of the
training;
(2) Retrieve and review complete self-monitoring data and other
information from self-care patients or their designated caregiver(s) at
least every 2 months; and
(3) Maintain this information in the patient's medical record.
(c) Standard: Support services.
(1) A home dialysis facility must furnish (either directly, under
agreement, or by arrangement with another ESRD facility) home dialysis
support services regardless of whether dialysis supplies are provided
by the dialysis facility or a durable medical equipment company.
Services include, but are not limited to, the following:
(i) Periodic monitoring of the patient's home adaptation, including
visits to the patient's home by facility personnel in accordance with
the patient's plan of care.
(ii) Coordination of the home patient's care by a member of the
dialysis facility's interdisciplinary team.
(iii) Development and periodic review of the patient's
individualized comprehensive plan of care that specifies the services
necessary to address the patient's needs and meets the measurable and
expected outcomes as specified in Sec. 494.90 of this part.
(iv) Patient consultation with members of the interdisciplinary
team, as needed.
(v) Monitoring of the quality of water and dialysate used by home
hemodialysis patients including conducting an onsite evaluation and
testing of the water and dialysate system in accordance with--
(A) The recommendations specified in the manufacturers'
instructions; and
(B) The system's FDA-approved labeling for preconfigured systems
designed, tested, and validated to meet AAMI quality (which includes
standards for chemical and chlorine/chloramine testing) water and
dialysate. The facility must meet testing and other requirements of
AAMI RD52:2004. In addition, bacteriological and endotoxin testing must
be performed on a quarterly, or more frequent basis as needed, to
ensure that the water and dialysate are within the AAMI limits.
(C) The dialysis facility must correct any water and dialysate
quality problem for the home hemodialysis patient, and if necessary,
arrange for backup dialysis until the problem is corrected if--
(1) Analysis of the water and dialysate quality indicates
contamination; or
(2) The home hemodialysis patient demonstrates clinical symptoms
associated with water and dialysate contamination.
(vi) Purchasing, leasing, renting, delivering, installing,
repairing and maintaining medically necessary home dialysis supplies
and equipment (including supportive equipment) prescribed by the
attending physician.
(vii) Identifying a plan and arranging for emergency back-up
dialysis services when needed.
(2) The dialysis facility must maintain a recordkeeping system that
ensures continuity of care and patient privacy. This includes items and
services furnished by durable medical equipment (DME) suppliers
referred to in Sec. 414.330(a)(2) of this chapter.

Sec. 494.110 Condition: Quality assessment and performance
improvement.

The dialysis facility must develop, implement, maintain, and
evaluate an effective, data-driven, quality assessment and performance
improvement program with participation by the professional members of
the interdisciplinary team. The program must reflect the complexity of
the dialysis facility's organization and services (including those
services provided under arrangement), and must focus on indicators
related to improved health outcomes and the prevention and reduction of
medical errors. The dialysis facility must maintain and demonstrate
evidence of its quality improvement and performance improvement program
for review by CMS.
(a) Standard: Program scope.
(1) The program must include, but not be limited to, an ongoing
program that achieves measurable improvement in health outcomes and
reduction of medical errors by using indicators or performance measures
associated with improved health outcomes and with the identification
and reduction of medical errors.
(2) The dialysis facility must measure, analyze, and track quality
indicators or other aspects of performance that the facility adopts or
develops that reflect processes of care and facility operations. These
performance components must influence or relate to the desired outcomes
or be the outcomes themselves. The program must include, but not be
limited to, the following:
(i) Adequacy of dialysis.
(ii) Nutritional status.
(iii) Mineral metabolism and renal bone disease.
(iv) Anemia management.
(v) Vascular access.
(vi) Medical injuries and medical errors identification.
(vii) Hemodialyzer reuse program, if the facility reuses
hemodialyzers.
(viii) Patient satisfaction and grievances.
(ix) Infection control; with respect to this component the facility
must--
(A) Analyze and document the incidence of infection to identify
trends and establish baseline information on infection incidence;
(B) Develop recommendations and action plans to minimize infection
transmission, promote immunization; and
(C) Take actions to reduce future incidents.
(b) Standard: Monitoring performance improvement. The dialysis
facility must continuously monitor its performance, take actions that
result in performance improvements, and track performance to ensure
that improvements are sustained over time.
(c) Standard: Prioritizing improvement activities. The dialysis
facility must set priorities for performance improvement, considering
prevalence and severity of identified problems and giving priority to
improvement activities that affect clinical outcomes or patient safety.
The facility must immediately correct any identified problems that
threaten the health and safety of patients.

Sec. 494.120 Condition: Special purpose renal dialysis facilities.

A special purpose renal dialysis facility is approved to furnish
dialysis on a short-term basis at special locations. Special purpose
dialysis facilities are divided into two categories: vacation camps
(locations that serve ESRD patients while the patients are in a
temporary residence) and facilities established to serve ESRD patients
under emergency circumstances.
(a) Standard: Approval period. The period of approval for a special
purpose

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renal dialysis facility may not exceed 8 months in any 12-month period.
(b) Standard: Service limitation. Special purpose renal dialysis
facilities are limited to areas in which there are limited dialysis
resources or access-to-care problems due to an emergency circumstance.
A special purpose renal dialysis facility may provide services only to
those patients who would otherwise be unable to obtain treatments in
the geographic locality served by the facility.
(c) Standard: Scope of requirements.
(1) Scope of requirements for a vacation camp. A vacation camp that
provides dialysis services must be operated under the direction of a
certified renal dialysis facility that assumes full responsibility for
the care provided to patients. A special purpose renal dialysis
facility established as a vacation camp must comply with the following
conditions for coverage--
(i) Infection control at Sec. 494.30;
(ii) Water and dialysate quality at Sec. 494.40 (except as
provided in paragraph (c)(1)(viii) of this section);
(iii) Reuse of hemodialyzers at Sec. 494.50 (if reuse is
performed);
(iv) Patients' rights and posting of patients' rights at Sec.
494.70(a) and Sec. 494.70(c);
(v) Laboratory services at Sec. 494.130;
(vi) Medical director responsibilities for staff education and
patient care policies and procedures at Sec. 494.150(c) and Sec.
494.150(d);
(vii) Medical records at Sec. 494.170; and
(viii) When portable home water treatment systems are used in place
of a central water treatment system, the facility may adhere to Sec.
494.100(c)(1)(v) (home monitoring of water quality), in place of Sec.
494.40 (water quality).
(2) Scope of requirements for an emergency circumstance facility. A
special purpose renal dialysis facility set up due to emergency
circumstances may provide services only to those patients who would
otherwise be unable to obtain treatments in the geographic areas served
by the facility. These types of special purpose dialysis facilities
must comply with paragraph (c)(1) of this section and addition to
complying with the following conditions:
(i) Section 494.20 (compliance with Federal, State, and local laws
and regulations).
(ii) Section 494.60 (physical environment).
(iii) Section 494.70(a) through section 494.70(c) (patient rights).
(iv) Section 494.140 (personnel qualifications).
(v) Section 494.150 (medical director).
(vi) Section 494.180 (governance).
(d) Standard: Physician contact. The facility must contact the
patient's physician, if possible, prior to initiating dialysis in the
special purpose renal dialysis facility, to discuss the patient's
current condition to assure care provided in the special purpose renal
dialysis facility is consistent with the patient plan of care
(described in Sec. 494.90).
(e) Standard: Documentation. All patient care provided in the
special purpose facility is documented and forwarded to the patient's
usual dialysis facility, if possible, within 30 days of the last
scheduled treatment in the special purpose renal dialysis facility.

Sec. 494.130 Condition: Laboratory services.

The dialysis facility must provide, or make available, laboratory
services (other than tissue pathology and histocompatibility) to meet
the needs of the ESRD patient. Any laboratory services, including
tissue pathology and histocompatibility must be furnished by or
obtained from, a facility that meets the requirements for laboratory
services specified in part 493 of this chapter.

Subpart D--Administration

Sec. 494.140 Condition: Personnel qualifications.

All dialysis facility staff must meet the applicable scope of
practice board and licensure requirements in effect in the State in
which they are employed. The dialysis facility's staff (employee or
contractor) must meet the personnel qualifications and demonstrated
competencies necessary to serve collectively the comprehensive needs of
the patients. The dialysis facility's staff must have the ability to
demonstrate and sustain the skills needed to perform the specific
duties of their positions.
(a) Standard: Medical director.
(l) The medical director must be a board-certified physician in
internal medicine or pediatrics by a professional board who has
completed a board-approved training program in nephrology and has at
least 12-months of experience providing care to patients receiving
dialysis.
(2) If a physician, as specified in paragraph (a)(1) of this
section, is not available to direct a certified dialysis facility
another physician may direct the facility, subject to the approval of
the Secretary.
(b) Standard: Nursing services.
(1) Nurse manager. The facility must have a nurse manager
responsible for nursing services in the facility who must--
(i) Be a full time employee of the facility;
(ii) Be a registered nurse; and
(iii) Have at least 12 months of experience in clinical nursing,
and an additional 6 months of experience in providing nursing care to
patients on maintenance dialysis.
(2) Self-care and home dialysis training nurse. The nurse
responsible for self-care and/or home care training must--
(i) Be a registered nurse; and
(ii) Have at least 12 months experience in providing nursing care
and an additional 3 months of experience in the specific modality for
which the nurse will provide self-care training.
(3) Charge nurse. The charge nurse responsible for each shift
must--
(i) Be a registered nurse, a licensed practical nurse, or
vocational nurse who meets the practice requirements in the State in
which he or she is employed;
(ii) Have at least 12 months experience in providing nursing care,
including 3 months of experience in providing nursing care to patients
on maintenance dialysis; and
(iii) If such nurse is a licensed practical nurse or licensed
vocational nurse, work under the supervision of a registered nurse in
accordance with state nursing practice act provisions.
(4) Staff nurse. Each nurse who provides care and treatment to
patients must be either a registered nurse or a practical nurse who
meets the practice requirements in the State in which he or she is
employed.
(c) Standard: Dietitian. The facility must have a dietitian who
must--
(1) Be a registered dietitian with the Commission on Dietetic
Registration; and
(2) Have a minimum of 1 year professional work experience in
clinical nutrition as a registered dietitian.
(d) Standard: Social worker. The facility must have a social worker
who--
(1) Holds a master's degree in social work with a specialization in
clinical practice from a school of social work accredited by the
Council on Social Work Education; or
(2) Has served at least 2 years as a social worker, 1 year of which
was in a dialysis unit or transplantation program prior to September 1,
1976, and has established a consultative relationship with a social
worker who qualifies under Sec. 494.140(d)(1).
(e) Standard: Patient care dialysis technicians. Patient care
dialysis technicians must--
(1) Meet all applicable State requirements for education, training,
credentialing, competency, standards of practice, certification, and
licensure in the State in which he or she is employed as a dialysis
technician; and
(2) Have a high school diploma or equivalency;

[[Page 20483]]

(3) Have completed a training program that is approved by the
medical director and governing body, under the direction of a
registered nurse, focused on the operation of kidney dialysis equipment
and machines, providing direct patient care, and communication and
interpersonal skills, including patient sensitivity training and care
of difficult patients. The training program must include the following
subjects:
(i) Principles of dialysis.
(ii) Care of patients with kidney failure, including interpersonal
skills.
(iii) Dialysis procedures and documentation, including initiation,
proper cannulation techniques, monitoring, and termination of dialysis.
(iv) Possible complications of dialysis.
(v) Water treatment and dialysate preparation.
(vi) Infection control.
(vii) Safety.
(viii) Dialyzer reprocessing, if applicable.
(4) Be certified under a State certification program or a national
commercially available certification program, as follows--
(i) For newly employed patient care technicians, within 18 months
of being hired as a dialysis patient care technician; or
(ii) For patient care technicians employed on October 14, 2008,
within 18 months after such date.
(f) Standard: Water treatment system technicians. Technicians who
perform monitoring and testing of the water treatment system must
complete a training program that has been approved by the medical
director and the governing body.

Sec. 494.150 Condition: Responsibilities of the medical director.

The dialysis facility must have a medical director who meets the
qualifications of Sec. 494.140(a) to be responsible for the delivery
of patient care and outcomes in the facility. The medical director is
accountable to the governing body for the quality of medical care
provided to patients. Medical director responsibilities include, but
are not limited to, the following:
(a) Quality assessment and performance improvement program.
(b) Staff education, training, and performance.
(c) Policies and procedures. The medical director must--
(1) Participate in the development, periodic review and approval of
a ``patient care policies and procedures manual'' for the facility; and
(2) Ensure that--
(i) All policies and procedures relative to patient admissions,
patient care, infection control, and safety are adhered to by all
individuals who treat patients in the facility, including attending
physicians and nonphysician providers; and
(ii) The interdisciplinary team adheres to the discharge and
transfer policies and procedures specified in Sec. 494.180(f).

Sec. 494.160 [Reserved]

Sec. 494.170 Condition: Medical records.

The dialysis facility must maintain complete, accurate, and
accessible records on all patients, including home patients who elect
to receive dialysis supplies and equipment from a supplier that is not
a provider of ESRD services and all other home dialysis patients whose
care is under the supervision of the facility.
(a) Standard: Protection of the patient's record. The dialysis
facility must--
(1) Safeguard patient records against loss, destruction, or
unauthorized use; and
(2) Keep confidential all information contained in the patient's
record, except when release is authorized pursuant to one of the
following:
(i) The transfer of the patient to another facility.
(ii) Certain exceptions provided for in the law.
(iii) Provisions allowed under third party payment contracts.
(iv) Approval by the patient.
(v) Inspection by authorized agents of the Secretary, as required
for the administration of the dialysis program.
(3) Obtaining written authorization from the patient or legal
representative before releasing information that is not authorized by
law.
(b) Standard: Completion of patient records and centralization of
clinical information.
(1) Current medical records and those of discharged patients must
be completed promptly.
(2) All clinical information pertaining to a patient must be
centralized in the patient's record, including whether the patient has
executed an advance directive. These records must be maintained in a
manner such that each member of the interdisciplinary team has access
to current information regarding the patient's condition and prescribed
treatment.
(3) The dialysis facility must complete, maintain, and monitor home
care patients' records, including the records of patients who receive
supplies and equipment from a durable medical equipment supplier.
(c) Standard: Record retention and preservation. In accordance with
45 CFR Sec. 164.530(j)(2), all patient records must be retained for 6
years from the date of the patient's discharge, transfer, or death.
(d) Standard: Transfer of patient record information. When a
dialysis patient is transferred, the dialysis facility releasing the
patient must send all requested medical record information to the
receiving facility within 1 working day of the transfer.

Sec. 494.180 Condition: Governance.

The ESRD facility is under the control of an identifiable governing
body, or designated person(s) with full legal authority and
responsibility for the governance and operation of the facility. The
governing body adopts and enforces rules and regulations relative to
its own governance and to the health care and safety of patients, to
the protection of the patients' personal and property rights, and to
the general operation of the facility.
(a) Standard: Designating a chief executive officer or
administrator. The governing body or designated person responsible must
appoint an individual who serves as the dialysis facility's chief
executive officer or administrator who exercises responsibility for the
management of the facility and the provision of all dialysis services,
including, but not limited to--
(1) Staff appointments;
(2) Fiscal operations;
(3) The relationship with the ESRD networks; and
(4) Allocation of necessary staff and other resources for the
facility's quality assessment and performance improvement program as
described in Sec. 494.110.
(b) Standard: Adequate number of qualified and trained staff. The
governing body or designated person responsible must ensure that--
(1) An adequate number of qualified personnel are present whenever
patients are undergoing dialysis so that the patient/staff ratio is
appropriate to the level of dialysis care given and meets the needs of
patients; and the registered nurse, social worker and dietitian members
of the interdisciplinary team are available to meet patient clinical
needs;
(2) A registered nurse, who is responsible for the nursing care
provided, is present in the facility at all times that in-center
dialysis patients are being treated;
(3) All staff, including the medical director, have appropriate
orientation to the facility and their work responsibilities; and

[[Page 20484]]

(4) All employees have an opportunity for continuing education and
related development activities.
(c) Standard: Medical staff appointments. The governing body--
(1) Is responsible for all medical staff appointments and
credentialing in accordance with State law, including attending
physicians, physician assistants, nurse practitioners, and clinical
nurse specialists; and
(2) Ensures that all medical staff who provide care in the facility
are informed of all facility policies and procedures, including the
facility's quality assessment and performance improvement program
specified in Sec. 494.110.
(3) Communicates expectations to the medical staff regarding staff
participation in improving the quality of medical care provided to
facility patients.
(d) Standard: Furnishing services. The governing body is
responsible for ensuring that the dialysis facility furnishes services
directly on its main premises or on other premises that are contiguous
with the main premises and are under the direction of the same
professional staff and governing body as the main premises (except for
services provided under Sec. 494.100).
(e) Standard: Internal grievance process. The facility's internal
grievance process must be implemented so that the patient may file an
oral or written grievance with the facility without reprisal or denial
of services. The grievance process must include:
(1) A clearly explained procedure for the submission of grievances.
(2) Timeframes for reviewing the grievance.
(3) A description of how the patient or the patient's designated
representative will be informed of steps taken to resolve the
grievance.
(f) Standard: Involuntary discharge and transfer policies and
procedures. The governing body must ensure that all staff follow the
facility's patient discharge and transfer policies and procedures. The
medical director ensures that no patient is discharged or transferred
from the facility unless--
(1) The patient or payer no longer reimburses the facility for the
ordered services;
(2) The facility ceases to operate;
(3) The transfer is necessary for the patient's welfare because the
facility can no longer meet the patient's documented medical needs; or
(4) The facility has reassessed the patient and determined that the
patient's behavior is disruptive and abusive to the extent that the
delivery of care to the patient or the ability of the facility to
operate effectively is seriously impaired, in which case the medical
director ensures that the patient's interdisciplinary team--
(i) Documents the reassessments, ongoing problem(s), and efforts
made to resolve the problem(s), and enters this documentation into the
patient's medical record;
(ii) Provides the patient and the local ESRD Network with a 30-day
notice of the planned discharge;
(iii) Obtains a written physician's order that must be signed by
both the medical director and the patient's attending physician
concurring with the patient's discharge or transfer from the facility;
(iv) Contacts another facility, attempts to place the patient
there, and documents that effort; and
(v) Notifies the State survey agency of the involuntary transfer or
discharge.
(5) In the case of immediate severe threats to the health and
safety of others, the facility may utilize an abbreviated involuntary
discharge procedure.
(g) Standard: Emergency coverage.
(1) The governing body is responsible for ensuring that the
dialysis facility provides patients and staff with written instructions
for obtaining emergency medical care.
(2) The dialysis facility must have available at the nursing/
monitoring station, a roster with the names of physicians to be called
for emergencies, when they can be called, and how they can be reached.
(3) The dialysis facility must have an agreement with a hospital
that can provide inpatient care, routine and emergency dialysis and
other hospital services, and emergency medical care which is available
24 hours a day, 7 days a week. The agreement must:
(i) Ensure that hospital services are available promptly to the
dialysis facility's patients when needed.
(ii) Include reasonable assurances that patients from the dialysis
facility are accepted and treated in emergencies.
(h) Standard: Furnishing data and information for ESRD program
administration. Effective February 1, 2009, the dialysis facility must
furnish data and information to CMS and at intervals as specified by
the Secretary. This information is used in a national ESRD information
system and in compilations relevant to program administration,
including claims processing and reimbursement, quality improvement, and
performance assessment. The data and information must--
(1) Be submitted at the intervals specified by the Secretary;
(2) Be submitted electronically in the format specified by the
Secretary;
(3) Include, but not be limited to--
(i) Cost reports;
(ii) ESRD administrative forms;
(iii) Patient survival information; and
(iv) Existing ESRD clinical performance measures, and any future
clinical performance standards developed in accordance with a voluntary
consensus standards process identified by the Secretary.
(i) Standard: Relationship with the ESRD network. The governing
body receives and acts upon recommendations from the ESRD network. The
dialysis facility must cooperate with the ESRD network designated for
its geographic area, in fulfilling the terms of the Network's current
statement of work. Each facility must participate in ESRD network
activities and pursue network goals.
(j) Standard: Disclosure of ownership. In accordance with Sec.
420.200 through Sec. 420.206 of this chapter, the governing body must
report ownership interests of 5 percent or more to its State survey
agency.

(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

Approved: July 12, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: December 10, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 08-1102 Filed 4-3-08; 8:45 am]
BILLING CODE 4120-01-P