[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.
---------------------------------------------------------------------------

    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

[[Page 20482]]

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