[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Proposed Rules]
[Pages 6184-6254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1622]



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Part IV





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 400, 405, 410, et al.



Medicare Program; Conditions for Coverage for End Stage Renal Disease 
Facilities; Proposed Rule

  Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

42 CFR Parts 400, 405, 410, 412, 413, 414, 488, and 494

[CMS-3818-P]
RIN 0938-AG82


Medicare Program; Conditions for Coverage for End Stage Renal 
Disease Facilities

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would revise the requirements that end 
stage renal disease (ESRD) dialysis facilities must meet to be 
certified under the Medicare program. The revised requirements focus on 
the patient and the results of the care provided to the patient, 
establish performance expectations for facilities, encourage patients 
to participate in their care plan and treatment, eliminate many 
procedural requirements from the current conditions for coverage, and 
preserve strong process measures when necessary to promote patient well 
being and continuous quality improvement. These changes are necessary 
to reflect the advances in dialysis technology and standard care 
practices since the requirements were last revised in their entirety in 
1976.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on May 5, 2005.

ADDRESSES: In commenting, please refer to file code CMS-3818-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (fax) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments. (Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.)
    2. By mail. You may mail written comments (one original and two 
copies) to the following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3818-P, PO Box 8012, Baltimore, MD 
21244-8012.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    Submission of comments on paperwork requirements. You may submit 
comments on this document's paperwork requirements by mailing your 
comments to the addresses provided at the end of the ``Collection of 
Information Requirements'' section in this document.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Robert Miller (410) 786-6797, Teresa 
Casey (410) 786-7215, and Rachael Weinstein (410) 786-6775 (Conditions 
for Coverage and Quality Standards). Jan Tarantino, (410) 786-0905 
(Survey and Certification).

SUPPLEMENTARY INFORMATION:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this rule to assist us in fully considering issues 
and developing policies. You can assist us by referencing the file code 
CMS-3818-P and the specific ``issue identifier'' that precedes the 
section on which you choose to comment.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. After the close of the 
comment period, CMS posts all electronic comments received before the 
close of the comment period on its public website. Comments received 
timely will be available for public inspection as they are received, 
generally beginning approximately 3 weeks after publication of a 
document, at the headquarters of the Centers for Medicare & Medicaid 
Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday 
through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an 
appointment to view public comments, phone 1-800-743-3951.
    Copies: To order copies of the Federal Register containing this 
document, send your request to: New Orders, Superintendent of 
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date 
of the issue requested and enclose a check or money order payable to 
the Superintendent of Documents, or enclose your Visa or Master Card 
number and expiration date. Credit card orders can also be placed by 
calling the order desk at (202) 512-1800 (or toll-free at 1-888-293-
6498) or by faxing to (202) 512-2250. As an alternative, you can view 
and photocopy the Federal Register document at most libraries 
designated as Federal Depository Libraries and at many other public and 
academic libraries throughout the country that receive the Federal 
Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The Web site address is: http://www.gpoaccess.gov/fr/index.html.

Table of Contents

I. Introduction and the Provision of Reference Materials
II. Background
    A.History
    B. Existing ESRD Regulations
    C. Overview
    D. Establishment of Central Requirements
    E. Development of Outcome-Based Performance Quality Measures
    1. Dialysis Facility Compare
    2. Dialysis Facility Data Reporting Requirements
    3. Facility Specific Reports
    4. The National Kidney Foundation Kidney Disease Outcomes 
Quality Initiative (NKF-K/DOQI) Clinical Practice Guidelines
    5. CMS ESRD Clinical Performance Measures Project
    6. CPM Data Reporting
    7. Updating Existing ESRD Patient-Specific Performance Measures 
and Developing Future ESRD Facility Performance Standards
    F. Summary of the Contents of the Proposed Rule
III. Provisions of Proposed Part 494 Subpart A (General Provisions)
    A. Basis and Scope (Proposed Sec.  494.1)
    B. Definitions (Proposed Sec.  494.10)

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    C. Compliance with Federal, State, and Local Laws and 
Regulations (Proposed Sec.  494.20)
IV. Provisions of Proposed Part 494 Subpart B (Patient Safety)
    A. Infection Control (Proposed Sec.  494.30)
    B. Water Quality (Proposed Sec.  494.40)
    C. Reuse of Hemodialyzers and Bloodlines (Proposed Sec.  494.50)
    D. Physical Environment (Proposed Sec.  494.60)
V. Provisions of Proposed Part 494 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)
    1. Development of the Patient Plan of Care (Proposed Sec.  
494.90(a))
    a. Dose of Dialysis (Proposed Sec.  494.90(a)(1))
    b. Nutritional Status (Proposed Sec.  494.90(a)(2))
    c. Anemia (Proposed Sec.  494.90(a)(3))
    d. Vascular Access (Proposed Sec.  494.90(a)(4))
    e. Transplantation Status (Proposed Sec.  494.90(a)(5))
    f. Rehabilitation Status (Proposed Sec.  494.90(a)(6))
    g. Social Services
    2. Implementation of the Patient Plan of Care (Proposed Sec.  
494.90(b))
    3. Transplantation Referral (Proposed Sec.  494.90(c))
    4. Patient Education and Training (Proposed Sec.  494.90(d))
    D. Care at Home (Proposed Sec.  494.100)
    1. Dialysis of ESRD Patient in the Home Setting
    2. Dialysis of ESRD Patients in Nursing Facilities and Skilled 
Nursing Facilities
    a. Delineation of Responsibility
    b. Applicable ESRD Conditions for Coverage
    c. Nursing Coverage
    d. Training
    e. Monitoring
    E. Quality Assessment and Performance Improvement (Proposed 
Sec.  494.110)
    1. Program Scope (Proposed Sec.  494.110(a))
    2. Monitoring Performance Improvement (Proposed Sec.  
494.110(b))
    3. Prioritizing Improvement Activities (Proposed Sec.  
494.110(c))
    4. Facility Specific Standards of Enforcement
    F. Special Purpose Renal Dialysis Facilities (Proposed Sec.  
494.120)
    G. Laboratory Services (Proposed Sec.  494.130)
VI. Provisions of Proposed Part 494 Subpart D (Administration)
    A. Personnel Qualifications (Proposed Sec.  494.140)
    1. Medical Director (Proposed Sec.  494.140(a))
    2. Nursing Services (Proposed Sec.  494.140(b))
    3. Dietitian (Proposed Sec.  494.140(c))
    4. Social Worker (Proposed Sec.  494.140(d))
    5. Patient Care Dialysis Technicians (Proposed Sec.  494.140(e))
    6. Other Personnel Issues
    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)
    1. Existing Requirements for Governing Bodies
    2. Overview of the Proposed Governance Requirements
    3. Governance Condition (Proposed Sec.  494.180)
    4. Designating a Chief Executive Officer or Administrator 
(Proposed Sec.  494.180(a))
    5. Adequate Number of Qualified and Trained Staff (Sec.  
494.180(b))
    6. Medical Staff Appointments (Proposed Sec.  494.180(c))
    7. Furnishing Services (Proposed Sec.  494.180(d))
    8. Internal Grievance Process (Proposed Sec.  494.180(e))
    9. Discharge and Transfer Policies and Procedures (Proposed 
Sec.  494.180(f))
    10. Emergency Coverage (Proposed Sec.  494.180(g))
    11. Furnishing Data and Information for ESRD Program 
Administration (Proposed Sec.  494.180(h))
    12. Disclosure of Ownership (Proposed Sec.  494.180(i))
VII. Other Proposed Changes
    A. Proposed Cross-Reference Changes
    B. Proposed Additions to Part 488
VIII. Reference Materials
    A. New Provisions in Part 494
    B. ESRD Crosswalk
    C. Bibliography
IX. Collection of Information Requirements and Public Comments
    A. Collection of Information Requirements
    B. Response to Comments
X. Regulatory Impact Analysis
    Regulations Text

Acronyms

AKF American Kidney Fund
AAMI Association for the Advancement of Medical Instrumentation
ANNA American Nephrology Nurses Association
AHRQ Agency for Healthcare Research and Quality
AED Automatic external defibrillator
AIA American Institute of Architects
ANSI American National Standards Institute
BBA Balanced Budget Act of 1997
BONENT Board of Nephrology Nursing Examiners Nursing and Technology
BUN Blood urea nitrogen
CAHPS Consumer Assessment of Health Plans Survey
CBC Center for Beneficiary Choices
CDC Centers for Disease Control and Prevention
CHI Consolidated Health Informatics
CEO Chief executive officer
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare and Medicaid Services
CPG Clinical practice guidelines
CPM Clinical performance measures
CPR Cardiopulmonary resuscitation
CROWN Consolidated Renal Operations in a Web-enabled Network
DHHS Department of Health and Human Services
DME Durable medical equipment
DOQI Disease Outcomes Quality Initiative
DSN Dialysis Surveillance Network
EMS Emergency medical system
ESRD End stage renal disease
FDA Food and Drug Administration
HHA Home health agency
HIPAA Health Insurance Portability and Accountability Act of 1996
ICH In-center hemodialysis
IOM Institute of Medicine
IT Information technology
LSC Life Safety Code
MedPAC Medicare Payment Advisory Commission
MSW Master's degree social worker
NANT National Association of Nephrology Technicians
NF Nursing facility
NFPA National Fire Protection Association
NIH National Institutes of Health
NISTA National Institute of Standards and Technology Act
NKF National Kidney Foundation
NKF-K/DOQI National Kidney Foundation's Kidney Disease Outcomes 
Quality Initiatives
NNCC Nephrology Nursing Certification Commission
NNCO National Nephrology Certification Organization
NQF National Quality Forum
NTTAA National Technology Transfer and Advancement Act of 1995
OBRA 1990 Omnibus Reconciliation Act 1990
OIG Office of the Inspector General
OMB Office of Management and Budget
QAPI Quality assessment and performance improvement
RPA Renal Physicians Association
RRG Rapid response group
SNF Skilled nursing facility
VISION Vital Information System to Improve Outcomes in Nephrology
URR Urea reduction rate
USRDS United States Renal Data System

I. Introduction and the Provision of Reference Materials

A. Introduction

    The Centers for Medicare and Medicaid Services (CMS) is committed 
to modernizing the existing regulations that are based on largely 
procedural standards. One of our key initiatives is to revise many of 
the health and safety conditions to focus on the patient's experience 
with care in the delivery setting, patient outcomes of care, and the 
elimination of unnecessary procedural requirements.
    In concert with the Administration's regulatory reform initiative, 
we believe that new ESRD regulations should--
     Be founded on evidence;
     Be patient-centered;
     Promote outcomes desired for Medicaid and Medicare 
beneficiaries as well as others served by participating ESRD suppliers 
of services;
     Establish a framework for the collection and reporting of 
consensus-driven performance standards;

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     Set clear expectations for dialysis facility 
accountability; and
     Stimulate improvements in processes, outcomes of care, and 
beneficiary satisfaction.
    In addition, the new ESRD conditions for coverage must comport with 
our national performance measurement strategy, which consists of three 
principles: (1) Performance measures should be consumer and purchaser-
driven; (2) performance measures should be in general, commonly-used 
terms, and their associated collection tools should be generally 
available at little or no cost to dialysis facilities; and (3) the 
content and collection of data and performance measures derived from 
that data should be standardized.

B. Provision of Informational and Review Aids

    In our development of the proposed rule, we have included 
references to a number of reports, articles, and other documents in the 
preamble. To indicate the source of this information, we have provided 
a brief parenthetical acknowledgement at the end of referenced 
statement and have provided a full citation for the reference in the 
bibliography (see section of VIII.C. of this preamble). Other 
informational and review aids incorporated in this proposed rule 
include--
     A table of contents;
     A list of acronyms;
     A chart listing the new provisions (see section VIII.A. of 
this preamble); and
     A crosswalk of the existing requirements to the proposed 
requirements (see section VIII.B. of this preamble).

II. Background

A. History

    ESRD is a kidney impairment that is irreversible and permanent and 
requires a regular course of dialysis or kidney transplantation to 
maintain life. Dialysis is the process of cleaning the blood 
artificially with special equipment when the kidneys have failed.
    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 regulations relating to:
     The Medicare conditions for coverage for suppliers of ESRD 
services;
     Certification procedures;
     Establishment of minimal utilization rates;
     Designation of ESRD network areas;
     Establishment of Network Coordination Councils; and
     The provision of a Medical Review Board.
    A comment period lasting 60 days followed and comments were 
carefully considered. 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 reimbursement. In addition, 
section 1881(c) of the Act establishes ESRD network areas and network 
organizations to assure that dialysis patients are provided appropriate 
care.

B. Existing ESRD Regulations

    The requirements from section 1881(b), (c), and (f)(7) are 
implemented in regulations at 42 CFR 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 and renal transplantation centers 
must meet to furnish care to Medicare beneficiaries. The regulations in 
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.
    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 and kidney transplantation facilities. To determine 
if a facility meets these conditions, the State survey agency performs 
on-site surveys 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 
and kidney transplantation is limited to facilities meeting these 
conditions.
    Our decision to propose major changes to the existing conditions is 
based on several considerations. As discussed above, revising the ESRD 
requirements is part of our effort to modernize regulations and move 
toward a patient outcome-based system that focuses on quality 
assessment and performance improvement. We believe that revising the 
conditions for coverage will encourage improvement in outcomes of care 
for beneficiaries. Secondly, the existing ESRD conditions were 
originally adopted in 1976 and although some amendments have been made 
they have not been comprehensively revised since that time. The 
existing requirements for dialysis facilities emphasize the policies 
and procedures that must be in place to support good patient care, and 
they focus on a facility's capacity to furnish quality care, rather 
than on the actual provision of quality care to patients and the 
outcomes of that care. Third, 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 standards of practice 
such as the National Kidney Foundation's Kidney Disease Outcomes 
Quality Initiative (NKF-K/DOQI) clinical practice guidelines (CPGs).
    The existing ESRD conditions do not require the facility to operate 
a patient-centered, outcome-oriented quality assessment and performance 
improvement program. Moreover, changes have taken place in the delivery 
of services to dialysis patients, and these advances are not reflected 
in the existing requirements. Thus, we have concluded that significant 
revisions to the conditions for coverage for ESRD facilities are 
essential. The proposed changes reflect improvements in standard care 
practices, the use of more advanced technology and equipment, and, most 
notably, a framework to incorporate performance measures viewed by the 
scientific and medical community to be related to the quality of care 
provided to dialysis patients.

C. Overview

    Since 1994, we have received comments from the renal community at 
large and we have used the contributions provided by the community in 
developing the revised conditions contained in this proposed rule. 
Several renal organizations have offered recommendations regarding the 
conditions for coverage during the bimonthly public 2001 and 2002 CMS 
meetings on ESRD topics. Notices of

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these were announced on the CMS Web site (http://www.cms.hhs.gov/opendoor/schedule.asp). We believe that many in the community support 
the overall shift in the proposed conditions 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 on the characteristics of ESRD facilities, its 
patient population, 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. Thus, the new conditions would invest a 
major expectation for performance in a requirement that each facility 
participate in its own quality assessment and performance improvement 
program. This allows the facility flexibility to create its own self-
tailored program of continuous quality improvement. Facilities could be 
flexible and creative in their approach to patient care and delivery of 
services as they use their own information to assess and improve 
patient services, outcomes, and satisfaction.
     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 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.

D. The Establishment of Central Requirements

    We are proposing 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 
the proposed rule are grouped into three broad categories: (1) Patient 
safety; (2) patient care (which includes quality assessment and 
performance improvement); and (3) administration. Subpart A contains 
general provisions, for example, statutory authority, definitions, and 
requirements for compliance with Federal, State and local laws and 
regulations. Subparts B (patient safety) and C (patient care) of the 
proposed conditions for coverage would focus the facility's efforts 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.
    In Subpart B (patient safety), we are proposing 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 patient safety 
requirements incorporate current CDC infection control procedures, 
retain and update our incorporation by reference of the AAMI standards 
and guidelines for water quality and dialyzer reuse practices, and 
incorporate by reference applicable current Life Safety Code (LSC) 
provisions.
    Subpart C (patient care) includes: (1) Requirements that emphasize 
a dialysis facility's fundamental responsibility to respect and promote 
the rights of each patient (patient rights); (2) the critical nature of 
a comprehensive assessment in determining appropriate treatments and 
achieving desired health outcomes (patient assessment); (3) the 
interdisciplinary team approach of providing dialysis services to 
patients and the process by which the interdisciplinary team will 
achieve effective patient health outcomes (patient plan of care); (4) 
the quality assessment and performance improvement program which would 
charge each dialysis facility with the responsibility for carrying out 
a performance improvement program of its own design to affect 
continuing improvement in quality outcomes and patient satisfaction; 
and (5) the consolidation of the various aspects of home dialysis care 
into a single condition (care at home).
    Subpart D (administration) covers 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).
    We recognize that there are some who believe that regulations--
particularly those that directly affect the health and safety of 
patients--should be very prescriptive in their detail to ensure that 
providers do not engage in practices that threaten patient health and 
safety. Therefore, we invite public comment on this fundamental shift 
in our regulatory approach, especially in terms of: (1) How we could 
improve on this approach; (2) what additional requirements could be 
removed or added to provide greater flexibility; and (3) which existing 
and new requirements are critical to patient care and safety.

E. Development of Outcome-Based Performance Quality Measures

    Sections 1881(b)(5)(B) through (D) of the Act provide authority for 
us to obtain the data we need from ESRD suppliers. In accordance with 
these goals, we envision an information system that protects patients' 
privacy in compliance with the new privacy protections afforded by the 
Department's health information privacy regulations at 45 CFR Parts 160 
and 164. These regulations were developed under the authority of the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
The data could be accessed by us as well as dialysis patients, the 
public, dialysis facilities, State survey agencies, ESRD networks, 
researchers, policy makers, renal physicians, and other professionals 
providing care to dialysis patients (where permitted by the privacy 
regulations). This system would provide information to meet the needs 
of the entire renal community, particularly the patients, to make 
better choices about care, and to help dialysis providers identify 
opportunities for continuous improvement in patient care processes.
    This proposal is in keeping with our strategic plan to help 
patients and the public become better informed about the health care 
services they need and receive so they can make better health

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care choices and participate more fully in their care. The availability 
of information will permit patients to become more active and effective 
participants in their own care and in their facility's quality 
improvement process.
1. Dialysis Facility Compare
    One of the first steps to make information more available to the 
public is the CMS Dialysis Facility Compare website at: http://www.Medicare.gov/Dialysis/Home.asp. Dialysis Facility Compare contains 
various dialysis facility characteristics and specific quality measures 
including the percentage of in-center hemodialysis patients with a urea 
reduction rate (URR) (a measure of the adequacy of dialysis) equal to 
or greater than 65, the percentage of patients treated with Epogen who 
have hematocrits of 33 percent or greater (reflecting adequately 
managed anemia), and patient data categories on every dialysis facility 
approved to participate in the Medicare program.
2. Dialysis Facility Data Reporting Requirements
    Sections 1881(b)(5)(B) through (D) of the Act require ESRD 
suppliers to furnish all necessary information to CMS, the ESRD 
networks, and State survey agencies. Moreover, existing regulations at 
Sec.  405.2133 require that each ESRD facility furnish data and 
information in a manner and frequency specified by the Secretary. This 
proposed regulation would continue to require facilities to provide 
data and other information, but in electronic format, including 
clinical performance measures (CPM) data, necessary for the 
administration of the ESRD program.
3. Facility Specific Reports
    In 1996, CMS first distributed facility-specific reports to 
Networks and facilities. These reports were compiled by the University 
of Michigan, using data from the CMS forms used for patient eligibility 
and patient death purposes; the CMS claims forms; the certification 
forms; and facility-specific data on infection control practices 
collected by the CDC.
    The initial reports presented comparative data on patient 
characteristics, patient outcomes, and facility practice patterns. A 
common CMS database and common data formulations were used to create 
these reports. Each year since 1996, these reports have been 
distributed to ESRD Networks and ESRD facilities. The reports have 
formed a basis for implementing and understanding quality improvement 
activities. The data that form the basis for these facility-specific 
reports are used to report patient outcomes and to develop additional 
reports.
    CMS has expanded the Facility Specific Reports to include a broader 
array of information, including facility-specific reports for the use 
of State survey agencies, state-specific reports, and region-specific 
reports. The facility-specific reports have been improved by the 
expansion of facility practice pattern information, explanatory text 
with each report, table and graph modifications, and the inclusion of 
additional risk-adjusters in the calculations of the standardized 
mortality ratio.
4. The National Kidney Foundation Kidney Disease Outcomes Quality 
Initiative (NKF-K/DOQI) Clinical Practice Guidelines
    In March 1995, the National Kidney Foundation (NKF) initiated the 
National Kidney Foundation-Dialysis Outcomes Quality Initiative (NKF-
DOQI), the first comprehensive effort in nephrology designed to provide 
evidence-based guidance to clinical care in nephrology. Development of 
the NKF-DOQI clinical practice guidelines involved a 2-year effort in 
which independent interdisciplinary workgroups reviewed the available 
body of scientific literature on hemodialysis and peritoneal dialysis 
adequacy, vascular access, and anemia. Each workgroup was composed of 
renal experts from diverse clinical disciplines and renal patients. The 
workgroups were tasked with developing and promulgating clinical 
practice guidelines for the treatments of patients with ESRD. Four 
principles guided the project's decision-making: (1) Use of a high 
level of scientific and methodological rigor in the guideline 
development process; (2) commitment to an interdisciplinary approach; 
(3) independence of the workgroups; and (4) openness of the guideline 
development process. To that end, the workgroups developed draft 
guidelines with supporting rationales that included the evidentiary 
basis for the recommendations.
    Draft guidelines were subject to an unprecedented three-stage 
review process: (1) An advisory council, comprised of 25 experts, 
provided comments on the initial draft of the guidelines; (2) a variety 
of organizations (that is, ESRD networks, professional and patient 
associations, dialysis providers, government agencies, product 
manufacturers, and managed care groups) were invited by NKF to review 
and comment on a revised draft of the guidelines; and (3) a final draft 
of the guidelines was made available for public review by all 
interested individuals or parties.
    Four sets of DOQI clinical practice guidelines were published by 
the NKF in 1997, including recommended practices for management of 
anemia, adequacy of hemodialysis, adequacy of peritoneal dialysis, and 
vascular access. In 2000, the scope of DOQI expanded to encompass the 
spectrum of chronic kidney disease prior to the need for dialysis 
services. To reflect this expansion, DOQI became K/DOQI. A total of 114 
chronic kidney disease clinical practice guidelines were developed by 
the workgroups and reviewed by numerous professionals and patients. The 
NKF has published Bone Metabolism and Disease in Chronic Kidney Disease 
clinical practice guidelines and Hypertension and Antihypertensive 
Agents in Chronic Kidney Disease as well as Managing Dyslipidemias 
guidelines. The latest set of clinical practice guidelines being 
developed under the K/DOQI umbrella are the CPGs for Cardiovascular 
Disease in Dialysis patients.
5. CMS ESRD Clinical Performance Measures Project
    In 1999, we merged our ongoing ESRD Core Indicators Project, a 
quality improvement project, originally started in 1994, into a new 
ESRD Clinical Performance Measures Project (ESRD CPM Project). The ESRD 
CPM Project is an ongoing effort between us, the ESRD networks, and 
dialysis facilities to collect performance measures on a representative 
sample of dialysis patients in the areas of adequacy of dialysis, 
anemia management, nutrition (that is, serum albumin), and more 
recently, vascular access (DHHS/CMS/CBC, pp. 1-104). The ESRD CPM 
Project was 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 goal of the CPM Project was to identify NKF DOQI guidelines 
that were suitable for the agency's quality improvement initiatives and 
to meet the BBA requirement. The ultimate purpose of the project is to 
assist suppliers of ESRD services in improving the care provided to 
ESRD patients.
    In 1998, we contracted with PRO-West (now named Qualis Health), a 
Seattle-based private nonprofit healthcare quality improvement 
organization, to facilitate the process of developing dialysis clinical

[[Page 6189]]

performance measures (CPMs) based on the NKF's DOQI (now K/DOQI) 
guidelines.
    The process included several components. The first was to develop a 
mechanism to assure appropriate participation from the community in 
order to facilitate the acceptability and utility of the CPMs. The 
second was to prioritize the NKF DOQI guidelines based on the strength 
of the evidence supporting the guidelines, the feasibility of 
developing performance measures, and the significance of the areas 
addressed to the quality of care delivered to dialysis patients. The 
third was to identify a limited set of CPMs that could be used to 
support quality improvement activities as well as assist us in 
assessing nationally the quality of care delivered to Medicare 
beneficiaries. The fourth was to develop sampling and data 
specifications for the CPMs to facilitate measurement. Finally, we 
requested the development of data collection and analysis strategies to 
be used to augment the existing national performance measurement 
system.
    The CPM Project was conducted in collaboration with a broad range 
of stakeholders in the community. In order to facilitate this 
involvement, participation was solicited through contacts with 
professional and voluntary associations, presentations at national 
meetings, and invitations to individuals identified through a variety 
of sources.
    Four expert groups were convened to address each of the topic areas 
covered by the NKF DOQI guidelines: (1) Hemodialysis adequacy; (2) 
peritoneal dialysis adequacy; (3) vascular access; and (4) anemia 
management. The NKF DOQI guidelines were ranked via a survey of renal 
experts for their suitability as candidates for development of CPMs. 
All 114 NKF DOQI guidelines were included on a survey tool developed by 
CMS that was distributed to the rapid response group (RRG) and other 
expert consultants. Suitability of guidelines was based on clinical 
importance, feasibility of measurement, and the respondent's assessment 
of the strength of the evidence supporting the guideline.
    We accepted 36 proposed guidelines for further evaluation and the 4 
expert groups developed specific review criteria, algorithms, and CPMs 
selected through the prioritization process described above. The CPM 
development process was a modification of a methodology described by 
the Agency for Healthcare Research and Quality (AHRQ) (formerly the 
Agency for Health Care Policy and Research (AHCPR)). Candidate 
guidelines that did not have a strong evidence basis were eliminated 
from further consideration. Sixteen CPMs were developed based on 22 of 
36 candidate NKF DOQI clinical practice guidelines.
    Data collection instruments were subsequently developed and 
submitted to us for field testing. Three data collection tools were 
developed and pilot tested. The first instrument was intended to 
collect data for the hemodialysis adequacy, anemia management, and 
vascular access CPMs from hemodialysis patient records. The second 
instrument was designed to collect adequacy and anemia management data 
for peritoneal dialysis patients. The third instrument focused on 
information about facility policies, procedures, and practices related 
to selected hemodialysis adequacy CPMs. In the summer of 1999, after 
field-testing, the CPMs were applied to a sample of 8,853 randomly 
selected adult hemodialysis patients and 1,650 randomly selected adult 
peritoneal dialysis patients.
    In summary, the NKF DOQI process resulted in a broad set of 
guidelines amenable to prioritization based on strength of evidence, 
clinical importance and feasibility. The current NKF K/DOQI guidelines 
are widely accepted among the renal community and increase the 
likelihood that future CPMs 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 
dialysis patients.
    We have been working closely with the ESRD networks and information 
technology contractors to develop the Vital Information System to 
Improve Outcomes in Nephrology (VISION) database. VISION is a patient-
specific, facility-based, outcome-oriented information system that will 
enable dialysis facilities to electronically collect and report both 
demographic and clinical data that can be profiled to assist efforts to 
improve outcomes of care. VISION will capture, among other things, data 
from the CMS ESRD CPM Project. VISION will be designed so that 
Consolidated Health Informatics (CHI) standards will be met.
    The CHI establishes health messaging and vocabulary standards that 
enable data sharing across all Federal systems. Implementation of the 
CHI standards is prospective (that is, applicable to new systems and 
systems undergoing major upgrades). Current plans are to upgrade the 
ESRD Information System within the next 2 to 3 years. Since the CHI 
standards are prospectively applied, the CHI standards will be 
incorporated when we upgrade the ESRD information system.
    Following the upgrade to the ESRD information system, ESRD 
facilities will be required to submit data using the new information 
technology (IT) system. They can accomplish submission of data that is 
consistent with the CHI standards by either modifying their internal 
systems or by using mapping tools that are provided by the National 
Library of Medicine (NLM) at no cost. The CHI standards are posted on 
the egov.gov Web site located at http://www.whitehouse.gov/omb/egov/gtob/health_informatics.htm.
6. CPM Data Reporting
    ESRD CPM Project data have been collected for 1999, 2000, 2001, and 
2002 and published in annual reports. The 2001 ESRD CPM report can be 
found on the Internet at http://www.cms.gov/esrd/l.asp. The data for 
each year include a random sample, stratified by ESRD network, of adult 
in-center hemodialysis patients and a random peritoneal dialysis 
patient sample of 5 percent of adult peritoneal dialysis patients in 
the nation. The sample size of adult in-center hemodialysis patients 
was selected to allow us to be 95 percent confident that Network-
specific estimates for selected clinical measures are accurate within 
plus or minus 5 percent. The sample also included a 30 percent ``over 
sample'' for in-center hemodialysis patients and a 10 percent ``over 
sample'' for peritoneal dialysis patients to compensate for anticipated 
nonresponse rates. In 2002, the in-center hemodialysis sample included 
8,863 patients and the peritoneal dialysis sample included 1,451 
patients. Also, a 5 percent national sample of hemodialysis facilities 
was drawn, consisting over 200 hemodialysis facilities.
    Three data collection tools were used, an in-center hemodialysis 
form (Form CMS-820), a peritoneal dialysis form (Form CMS-821), and a 
hemodialysis facility-specific form.
    We believe that the ESRD CPM Project is an effective tool to 
facilitate ESRD quality improvement, and this project has successfully 
tracked positive improvements in patient outcomes of care in several 
areas. The 2001 Annual Report for the ESRD CPM Project contains 
additional Outcomes Comparison Tools (for hemodialysis and peritoneal 
dialysis). Outcomes Comparison Tools are practical quality improvement 
instruments that can be used by ESRD facilities to benchmark their 
performance outcomes against rates at the ESRD network's level

[[Page 6190]]

(hemodialysis only) and the nation. Therefore, we are proposing in the 
Governance condition for coverage (Sec.  494.180(h)), that all ESRD 
facilities collect and provide us with ESRD CPM Project data 
electronically. This proposal applies only to the current CPMs and is 
discussed in more detail later in this preamble. We will carefully 
evaluate any revisions to the CPMs as well as any future CPMs, 
developed in accordance with the National Technology Transfer and 
Advancement Act of 1995 process (described in the next section of this 
preamble) for possible inclusion as electronic reporting requirements. 
The Secretary will provide notice and an opportunity for comment in the 
Federal Register before the CPMs are updated or new measures are 
adopted.
7. Updating Existing ESRD Patient-Specific Performance Measures and 
Developing Future ESRD Facility Performance Standards
    We would like to propose ESRD performance standards that dialysis 
facilities would be required to meet as well as propose a method to 
recognize updates in existing consensus-based patient-specific 
performance measures. We are proposing to adopt a framework that will 
utilize existing Federal legislation and operational guidelines. The 
National Technology Transfer and Advancement Act of 1995 ((NTTAA) Pub. 
L. 104-113) and OMB Circular A-119 specify circumstances in which 
Federal agencies should use technical standards developed by voluntary 
consensus bodies. The phrase ``technical standards'' is defined in the 
NTTAA at section 12(d)(4) as ``performance-based or design-specific 
technical specifications and related management systems practices.''
    The NTTAA has been implemented by, among other things, the 
provisions of the Office of Management and Budget (OMB) Circular No. A-
119 (63 FR 8546, February 19, 1998). OMB Circular No. A-119 was 
published to: (1) Revise and clarify policies on Federal use and 
development of voluntary consensus standards; (2) set policy for 
conformity assessment activities; and (3) improve the clarity and 
effectiveness of the previously published (October 20, 1993) circular. 
By implementing the policies in this circular, we intend to reduce to a 
minimum our reliance on government-specific standards.
    Definitions of terms and phrases within the circular are designed 
for very broad application, but are meant to be applicable to any 
specific and appropriate subject matter, including health care 
performance measures.
    The circular defines a ``performance standard'' as a standard that 
states requirements in terms of required results with criteria for 
verifying compliance but without stating the methods for achieving 
required results. ``Voluntary consensus standards'' are defined as 
standards developed or adopted by voluntary consensus standards bodies, 
both domestic and international. ``Voluntary consensus standards 
bodies'' are organizations that plan, develop, establish, or coordinate 
voluntary consensus standards using agreed-upon procedures. One example 
of a voluntary consensus standards body is the National Forum for 
Health Care Quality Measurement and Reporting, also known as the 
National Quality Forum (NQF), which is currently engaged in various 
projects such as standardizing measures of hospital quality and 
developing diabetes mellitus treatment performance measures.
    The expected products of a voluntary consensus body would include 
the measures or indicators and standards, as well as explanatory text 
and other supporting documentation, such as guidelines for reporting 
the indicators. A voluntary consensus body would make a draft product 
available for general public review during the development of the 
measures. When the performance standards are complete, we would 
evaluate them and then promulgate the standards following the 
requirements of the Administrative Procedures Act.
    We are not advocating the NQF as the voluntary consensus body that 
is most appropriate to develop ESRD performance standards. We have only 
provided an illustration of the manner in which performance standards 
are being developed. Other organizations, for example, the NKF-K/DOQI, 
also function in a manner consistent with voluntary consensus bodies. 
Once ESRD facility performance measures are developed by a voluntary 
consensus body, the Secretary would evaluate those facility performance 
measures and adopt those that meet our needs for the effective 
administration of the ESRD program after notice and comment rulemaking 
required by the Administrative Procedures Act.
    We will also reference the NTTAA later in this preamble under our 
discussion of the Governance condition for coverage (see Sec.  
494.180(h)).

F. Summary of the Contents of the Proposed Rule

    We are proposing to revise both the content and the organization of 
the existing regulations. The ESRD Network conditions for coverage will 
remain in part 405, subpart U. Through a separate proposed rule 
regarding conditions of participation for transplant hospitals, we are 
proposing to move the renal transplant center conditions to part 482. 
The ESRD conditions for coverage (health and safety provisions for 
dialysis facilities) would be moved from existing 42 CFR part 405, 
subpart U, to a new 42 CFR part 494, where they would 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 to Sec.  488.604 through Sec.  488.610. Since many of the 
existing ESRD conditions would be revised, consolidated with other 
conditions, or deleted, we also propose to completely renumber and 
reorganize the requirements. The format for the dialysis facility 
conditions for coverage represents a dramatic change from the 
organization of the existing regulations, which contain nearly 20 
conditions addressing organizational structure, utilization rate 
requirements, and other process-intensive requirements. The proposed 
regulations are divided into four subparts: general provisions, patient 
safety, patient care, and administration.
    The proposed organization of Part 494 is as follows:

Subpart A--General Provisions

Sec.  494.1 Basis and scope.
Sec.  494.10 Definitions.
Sec.  494.20 Compliance with Federal, State, and local laws and 
regulations.

Subpart B--Patient Safety

Sec.  494.30 Condition: Infection control.
Sec.  494.40 Condition: Water quality.
Sec.  494.50 Condition: Reuse of hemodialyzers and other dialysis 
supplies.
Sec.  494.60 Condition: Physical environment.

Subpart C--Patient Care

Sec.  494.70 Condition: Patient rights.
Sec.  494.80 Condition: Patient assessment.
Sec.  494.90 Condition: Patient plan of care.
Sec.  494.100 Condition: Care at home.
Sec.  494.110 Condition: Quality assessment and performance 
improvement.
Sec.  494.120 Condition: Special purpose renal dialysis facilities.
Sec.  494.130 Condition: Laboratory services.

Subpart D--Administration

Sec.  494.140 Condition: Personnel qualifications.
Sec.  494.150 Condition: Responsibilities of the medical director.
Sec.  494.160 Condition: Relationship with ESRD network.

[[Page 6191]]

Sec.  494.170 Condition: Medical recordkeeping.
Sec.  494.180 Condition: Governance.

    The following provides a detailed discussion of each new 
requirement and a discussion of the existing ESRD requirements that 
have been revised or deleted in this proposed rule.

III. Provisions of Proposed Part 494 Subpart A (General Provisions)

A. Basis and Scope (Proposed Sec.  494.1)

[If you choose to comment on issues in this section please include the 
caption ``Basis'' at the beginning of your comment.]
    Proposed Sec.  494.1, identifies the statutory authority for the 
regulations. Proposed Sec.  494.1 also states that provisions of part 
494 serve as the basis for survey activities for determining whether a 
dialysis facility meets the conditions for coverage under the Medicare 
program. We note that the organizational format of the proposed 
conditions permits the elimination of almost all of the material in 
existing Sec.  405.2100, Scope of subpart, which consists largely of a 
description of the contents of the existing ESRD conditions for 
coverage.

B. Definitions (Proposed Sec.  494.10)

[If you choose to comment on issues in this section please include the 
caption ``Definitions'' at the beginning of your comment.]
    Under proposed Sec.  494.10, we set forth definitions for terms 
used in the ESRD conditions. Existing Sec.  405.2102 provides a list of 
32 definitions. We are proposing to eliminate the definitions of 
several terms for which we believe the meaning is self-evident, as well 
as terms that are not used in the revised conditions. We do not believe 
it is appropriate to have substantive requirements contained in those 
definitions. Thus, we would move definitions that contain qualification 
requirements to the appropriate conditions in the proposed rule. We 
have proposed to retain the definition of ``furnishes on the premises'' 
and add it to proposed Sec.  494.180 (Governance). We are proposing a 
modification of the definition of ``home dialysis'' to recognize the 
assisting role that a family member/caregiver may play. We have 
previously received questions about whether the definition of ``home'' 
includes institutional settings such as nursing facilities (NFs) and 
skilled nursing facilities (SNFs). Please refer to section V.D. of this 
preamble in which we discuss the unique needs of the NF/SNF dialysis 
patient and the overall issue. We are soliciting comment on whether the 
definition of ``home'' for ``home dialysis'' should also include these 
institutional settings.
    We propose to include the following definitions in Sec.  494.10:
     Dialysis facility means an entity that provides (1) 
outpatient maintenance dialysis services; or (2) home dialysis training 
and support services; or (3) both. A dialysis facility may be an 
independent or hospital-based unit (as described in Sec.  413.174(b) 
and (c) of this chapter), or a self-care dialysis unit, which furnishes 
only self-dialysis services.
     Discharge means the termination of patient care services 
by a dialysis facility.
     Furnishes directly means the ESRD facility provides the 
service through its own staff and employees or through individuals who 
are under contract with the facility to furnish these services 
personally for the facility. We note that furnishes directly does not 
apply to companies providing services under contract or arrangement.
     Home dialysis means outpatient dialysis performed at home 
by an ESRD patient (or caregiver) if the individual performing such 
dialysis has completed the course of training required in Sec.  
494.100(a) of this part.
     Interdisciplinary team (as required in Sec.  494.80 
(Patient assessment)) means the group of persons responsible for 
providing patient care to each dialysis patient.
     Self-dialysis means dialysis performed with little or no 
professional assistance by an ESRD patient (or caregiver) if the 
individual performing such dialysis has completed an appropriate course 
of training as required in Sec.  494.100(a) (Care at Home).
     Transfer means a temporary or permanent move of a patient 
from one dialysis facility to another that requires the transmission of 
the patient's medical record information to the facility receiving the 
patient.

C. Compliance With Federal, State, and Local Laws and Regulations 
(Proposed Sec.  494.20)

[If you choose to comment on issues in this section please include the 
caption ``Compliance with Laws and Regulations'' at the beginning of 
your comment.]
    Existing Sec.  405.2135 requires that a dialysis facility be in 
compliance with applicable Federal laws and that a dialysis facility be 
licensed or approved as meeting applicable standards by the agency of 
the State or locality responsible for approval. Section 405.2135 
further requires a facility to comply with all relevant laws (for 
example, laws relating to licensure of staff) and requires conformity 
with other laws (for example, fire safety, equipment maintenance).
    We propose to retain the requirement that dialysis facilities must 
be in compliance with applicable Federal, State, and local laws and 
regulations pertaining to fire safety, equipment, and any other 
relevant health and safety issues. We are also proposing that dialysis 
facilities must be in compliance with the appropriate Federal, State, 
and local laws and regulations regarding drug and medical device usage. 
An example of meeting applicable Federal regulations is that the 
dialysis facility must use FDA-approved/cleared medical devices and 
adhere to the devices' labelling instructions. We have added these 
examples because drugs and medical devices are major components of 
dialysis facilities and compliance with existing laws and regulations 
in this area is important in ensuring patient safety.
    We may find a facility to be in violation of these conditions for 
coverage if the facility is found out of compliance with any Federal, 
State, and local law or regulation pertaining to health and safety 
requirements.

IV. Provisions of Proposed Part 494 Subpart B (Patient Safety)

A. Infection Control (Proposed Sec.  494.30)

[If you choose to comment on issues in this section please include the 
caption ``Infection Control'' at the beginning of your comment.]
    Patients with ESRD have impaired immunological systems and are more 
at risk of developing serious infections than similarly situated non-
ESRD patients. During hemodialysis therapy, there is a potential for 
patients to be exposed to a variety of microbial pathogens (including 
blood-borne pathogens) if proper procedures are not meticulously 
followed. Likewise, peritoneal dialysis patients are at risk of 
contamination leading to peritonitis if proper procedures are not 
followed. This proposed rule stipulates that the dialysis facility must 
provide and monitor conditions to ensure a sanitary environment that 
prevents the transmission of infectious agents.
    The existing standards relating to infection control are contained 
in Sec.  405.2140(b)(1) and (c). Section 405.2140(b)(1) requires 
written procedures for controlling hepatitis and other infections. It 
further specifies that the procedures include surveillance and 
reporting of infections, housekeeping, handling of waste and 
contaminants, and sterilization and disinfection. Section 405.2140(c) 
requires the facility

[[Page 6192]]

to employ appropriate techniques to prevent cross-contamination between 
the unit and adjacent hospital or public areas.
    We believe infection control is vital to the health and safety of 
dialysis patients and others; and therefore, we propose to establish 
infection control as a separate condition for coverage (Sec.  494.30). 
The proposed infection control requirement states that each dialysis 
facility must provide and monitor a sanitary environment that prevents 
and controls the transmission of infectious agents, within and between 
the unit and any adjacent hospital, or other public areas. The proposed 
requirement sets forth the basic guidelines or procedures that 
facilities must follow to prevent and control infections.
    Proposed Sec.  494.30(a)(1) requires that the facility demonstrate 
that it follows standard infection control precautions, including the 
``Recommended Infection Control Practices for Hemodialysis Units At a 
Glance'' with the exception of screening for Hepatitis C as explained 
below. The ``At a Glance'' section is in the publication, 
``Recommendations for Preventing Transmission of Infections Among 
Chronic Hemodialysis Patients'' developed by the Centers for Disease 
Control and Prevention (CDC) (DHHS/CDC, 20-21). We propose to 
incorporate these guidelines to prevent and control cross contamination 
and the spread of infectious agents. These CDC infection control 
recommendations specific to the hemodialysis setting were developed in 
consultation with other Federal agencies and specialists and are based 
on available knowledge regarding transmission of infectious agents.

Recommended Infection Control Practices for Hemodialysis Units at a 
Glance

Infection Control Precautions for All Patients

     Wear disposable gloves when caring for the patient or 
touching the patient's equipment at the dialysis station; remove gloves 
and wash hands between each patient or station.
     Items taken into the dialysis station should either be 
disposed of, dedicated for use only on a single patient, or cleaned and 
disinfected before taken to a common clean area or used on another 
patient.

    --Nondisposable items that cannot be cleaned and disinfected (e.g., 
adhesive tape, cloth covered blood pressure cuffs) should be dedicated 
for use only on a single patient.
    --Unused medications (including multiple dose vials containing 
diluents) or supplies (syringes, alcohol swabs, etc.) taken to the 
patient's station should be used only for that patient and should not 
be returned to a common clean area or used on other patients.

     When multiple dose medication vials are used (including 
vials containing diluents), prepare individual patient doses in a clean 
(centralized) area away from dialysis stations and deliver separately 
to each patient. Do not carry multiple dose medication vials from 
station to station.
     Do not use common medication carts to deliver medications 
to patients. Do not carry medication vials, syringes, alcohol swabs or 
supplies in pockets. If trays are used to deliver medications to 
individual patients, they must be cleaned between patients.
     Clean areas should be clearly designated for the 
preparation, handling and storage of medications and unused supplies 
and equipment. Clean areas should be clearly separated from 
contaminated areas where used supplies and equipment are handled. Do 
not handle and store medications or clean supplies in the same or an 
adjacent area to that where used equipment or blood samples are 
handled.
     Use external venous and arterial pressure transducer 
filters/protectors for each patient treatment to prevent blood 
contamination of the dialysis machines pressure monitors. Change 
filters/protectors between each patient treatment, and do not reuse 
them. Internal transducer filters do not need to be changed routinely 
between patients.
     Clean and disinfect the dialysis station (chairs, beds, 
tables, machines, etc.) between patients.

--Give special attention to cleaning control panels on the dialysis 
machines and other surfaces that are frequently touched and potentially 
contaminated with patients' blood.
--Discard all fluid and clean and disinfect all surfaces and containers 
associated with the prime waste (including buckets attached to the 
machines).

     For dialyzers and blood tubing that will be reprocessed, 
cap dialyzer ports and clamp tubing. Place all used dialyzers and 
tubing in leak-proof containers for transport from station to 
reprocessing or disposal area.

         Schedule for Routine Testing for Hepatitis B Virus (HBV) and Hepatitis C virus (HCV) Infections
----------------------------------------------------------------------------------------------------------------
       Patient status                On admission              Monthly          Semi-annual          Annual
----------------------------------------------------------------------------------------------------------------
All patients                 HBsAg*, Anti-HBc (total)*
                              Anti-HBs*, Anti-HCV,
                              ALT[dagger]
----------------------------
HBV susceptible, including   ...........................  HBsAg
 non-responders to vaccine
----------------------------
Anti-HBs positive(>10 mIU/   ...........................  .................  .................  Anti-HBs
 mL), anti-HBc negative
----------------------------
Anti-HBs and anti-HBc        ...........................  No additional HBV testing needed
 positive
----------------------------
Anti-HCV negative            ...........................  ALT                Anti-HCV
----------------------------------------------------------------------------------------------------------------

Hepatitis B Vaccination

     Vaccinate all susceptible patients against hepatitis B.
     Test for anti-HBs 1-2 months after last dose.

--If anti-HBs is <10 mIU/mL, consider patient susceptible, revaccinate 
with an additional three doses, and retest for anti-HBs.
--If anti-HBs is >10 mIU/mL, consider immune, and retest annually.
--Give booster dose of vaccine if anti-HBs declines to <10 mIU/mL and 
continue to retest annually.

Management of HBsAg-Positive Patients

     Follow infection control practices for hemodialysis units 
for all patients.
     Dialyze HBsAg-positive patients in a separate room using 
separate machines, equipment, instruments, and supplies.

[[Page 6193]]

     Staff members caring for HBsAg-positive patients should 
not care for HBV susceptible patients at the same time (e.g., during 
the same shift or during patient change-over).
    We are proposing an exception to the CDC recommendation for monthly 
and semiannual screening for all hemodialysis patients for hepatitis C. 
Patients with clinical indicators or risk factors for hepatitis C 
should receive diagnostic testing as deemed necessary by the attending 
physician. Medicare covers diagnostic testing for hepatitis C on a 
case-by-case basis, but does not cover blanket hepatitis C screening at 
this time. According to the CDC, transmission of hepatitis C can be 
prevented by strict adherence to infection control precautions 
recommended for all hemodialysis patients.
    The ``At a Glance'' page highlights the crucial CDC recommendations 
that serve as the minimum acceptable infection control practices. This 
document reproduced above is currently available on the CDC Web site at 
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm.
    There is substantial evidence that the CDC guidelines work in 
preventing the transmission of bloodborne infections. Recommendations 
for the control of hepatitis B in hemodialysis centers were first 
published in 1977 and within 3 years there was a sharp reduction in 
incidence of hepatitis B infection among both patients and staff 
members in hemodialysis centers (Alter, pp. 860-865).
    The entire CDC RR05 report contains recommendations for infection 
control precautions in greater detail than the ``At a Glance'' 
highlights. We considered proposing that the entire CDC RR05 document 
be incorporated by reference. However, we want to be less prescriptive 
and burdensome in our requirements while protecting patient safety. 
Dialysis facilities are encouraged to utilize the more comprehensive 
document when developing their infection control programs. For example, 
the CDC infection control precautions for all patients identify 
procedures for cleaning up a blood spill; and detail information on 
glove use, protective gear, and handwashing. The CDC has issued 
additional guidance regarding hand hygiene and environmental infection 
control in the October 25, 2002 and June 6, 2003 issues of the 
Morbidity and Mortality Weekly Report that dialysis facilities may want 
to reference in their infection control policies (DHHS/CDC, pp.1-45 and 
DHHS/CDC, pp. 1-44, respectively).
    Existing Sec.  405.2140(b)(1) requires that written policies and 
procedures must be in effect for preventing and controlling hepatitis 
and other infections. There is no current requirement in the conditions 
for coverage addressing patient isolation. However, many facilities 
have adopted the 1977 CDC guidelines that recommend use of a separate 
dialysis area, preferably a separate isolation room, for dialyzing 
hepatitis B surface antigen positive patients. Newly opened 
hemodialysis units would be required to have isolation rooms for 
hepatitis B positive patients as described in the ``At a Glance'' 
section. For existing units in which a separate room is not possible, 
there would be required to be a separate area removed from the 
mainstream of activity that also allows for dedicated staff and 
dedicated dialysis machines. When the facility determines that a 
patient is infectious (from admission or at least annual testing) the 
guidelines state that the facility would be required to isolate the 
infected patient from susceptible patients to prevent the transmission 
of the disease. We propose to require at Sec.  494.30(a)(2) that a 
facility implement and maintain patient isolation procedures that 
prevent and control the spread of infectious agents and communicable 
diseases.
    We also propose at Sec.  494.30(a)(3) that facilities implement 
appropriate procedures for the handling, storage, and disposal of 
waste, and for disinfection. Appropriate waste storage and disposal 
procedures are important not only for the control of infections within 
the units, but also for the welfare of the unit staff and the 
community. Since local policies vary, we do not believe it is 
appropriate to specify the minimum requirements for waste storage and 
disposal. Rather, facilities should continue to operate in accordance 
with applicable local laws and accepted public health procedures. We 
also propose to require that facilities implement protocols for 
cleaning and disinfection because we believe that adequate disinfection 
of surfaces, medical devices, and equipment is an important part of a 
facility's efforts to control and prevent cross-contamination. We 
propose to add a requirement for the implementation and maintenance of 
procedures regarding cleaning of surfaces and devices potentially 
contaminated with blood to prevent patients from coming into contact 
with a blood-borne pathogen. The CDC RR05 recommendations and dialysis 
equipment manufacturers' instructions provide valuable information on 
procedures a facility may adopt to meet this requirement.
    We considered proposing to include 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. The AIA standards provide guidance to 
facilities regarding unit design and parts of the guidance relate to 
infection control. While we believe it is desirable for new units to 
follow AIA standards, and many States have adopted these as minimum 
standards, we recognize it may be overly burdensome to require existing 
dialysis units to adhere to these standards.
    We also considered including in the proposed rule the Healthcare 
Infection Control Practices Advisory Committee's (HICPAC) guidelines 
entitled ``Hand Hygiene in Healthcare Settings'' and ``Guideline for 
Preventing Intravascular Device-Related Infections.'' We are inviting 
comments on whether we should require new dialysis facilities to adhere 
to AIA design standards or HICPAC guidelines.
    We propose requirements for oversight of facility infection control 
in Sec.  494.30(b). The facility must implement and monitor biohazard 
and infection control policies and activities within the dialysis unit. 
Any infection control policies adopted by the facility are only 
effective when put into action. We propose that facilities must 
designate a registered nurse as the infection control or safety officer 
who maintains current infection control information, and reports to the 
facility's chief executive officer or administrator and quality 
improvement committee. The infection control nurse must maintain 
current infection control information including the most current CDC 
guidelines for the proper techniques in the use of vials and ampules 
containing medication. For example, facilities should not pool vials of 
any medications. An outbreak of serratia liquefacies from contamination 
of erythropoietin at a hemodialysis center serves as a reminder of the 
importance of the proper handling of medications in protecting the 
dialysis patient. (Grohskopf, pp. 1491-1497.)
    The infection control or safety officer is also responsible for 
making recommendations regarding infection control training and 
improvements. The designation of an infection control officer provides 
a structure for infection control, encourages the maintenance of up-to-
date information, and increases accountability for infection control.
    We propose to maintain the essence of the existing requirement for 
surveillance and reporting of the incidence of

[[Page 6194]]

infection (Sec.  405.2140(b)(1)). The facility must analyze and 
document the incidence of infections to identify trends and establish 
baseline information on infection incidence as proposed in Sec.  
494.30(c). By conducting a trend analysis of infections, the facility 
will be able to identify opportunities for improvement to prevent or 
eliminate the spread of infection or communicable disease between 
patients. By tracking the number and types of infections, the facility 
can identify areas that require improvement, indicate areas that have 
improved, define measures to improve outcomes, review implementation of 
improvement measures, and determine the success of the improvement 
measures implemented.
    In August 1999, the CDC initiated the CDC Dialysis Surveillance 
Network (DSN), a voluntary national surveillance system monitoring 
bloodstream and vascular infections by individual hemodialysis centers. 
The purposes of the DSN are to provide a method for individual 
hemodialysis centers to record and track rates of vascular access 
infections, other bacterial infections, and intravenous antimicrobial 
starts, and to provide rates for comparisons among various dialysis 
centers. The infection control or safety officer should look toward the 
CDC surveillance system as a resource. Information on the DSN may be 
found on the following Web site: http://www.cdc.gov/ncidod/hip/Dialysis/dsn.htm.
    The existing standard governing infection control (Sec.  
405.2140(b)(1)) contains a requirement governing reuse of dialyzers 
which states that when dialysis supplies are reused, records are 
maintained that can be used to determine whether established procedures 
covering the rinsing, cleaning, disinfection, preparation, and storage 
of reused items conform to the requirements for reuse. This standard is 
redundant with the reuse requirements included in the AAMI guidelines 
that are incorporated by reference in both the existing and proposed 
regulations. Therefore, we are proposing to delete the requirement in 
Sec.  405.2140(b).
    Existing Sec.  405.2140(c) requires that written patient care 
policies specify the functions of facility personnel and self-dialysis 
patients with respect to contamination prevention. We are proposing to 
delete the ``written policy'' requirement because it is process-
oriented and a paperwork burden.
    As noted above, the existing conditions for coverage require 
policies for surveillance and reporting of infections at Sec.  
405.2140(b)(1). In this proposed rule, reporting requirements for 
communicable diseases are listed at Sec.  494.30(d). The facility must 
maintain a current list of the communicable diseases that must be 
reported according to Federal, State, and local requirements, and have 
a procedure for reporting these communicable diseases, which allows the 
facility to accurately report incidences of communicable diseases. 
These requirements are in concert with the present standard operating 
practices in dialysis facilities.

B. Water Quality (Proposed Sec.  494.40)

[If you choose to comment on issues in this section please include the 
caption ``Water Quality'' at the beginning of your comment.]
    Water quality is of vital importance to a dialysis facility and to 
the patient. Because we believe water quality is an essential health 
and safety issue for ESRD patients, we are proposing a condition for 
coverage for water quality in this proposed rule.
    The hemodialysis patient's blood has the potential to be exposed to 
toxic contaminants present in water. Some chemical contaminants are not 
normally harmful when present in small amounts in usual physiological 
fluids. However, since hemodialysis patients are exposed to the large 
volume of water that is used to make dialysate, chemical contaminants 
can be dangerous to them. If water supplies are biologically or 
chemically contaminated, the patient may experience infection or other 
adverse consequences. Limits on bacterial growth in water and dialysate 
are necessary to prevent high bacterial counts associated with 
pyrogenic reactions (fevers, chills, nausea).
    The patient's exposure to contaminated water can be through water 
mixed with dialysate, water mixed with reprocessing germicides, or 
water used to flush out dialyzers. Contamination of the water system 
with organic and inorganic chemicals, bacteria, and endotoxins can 
result in adverse patient reactions, such as hemolysis, bacteremia, 
pyrogenic reactions, or death. Exposure to some contaminants such as 
aluminum can cause chronic health problems, while exposure to other 
contaminants such as fluoride can be fatal. Therefore, a dialysis 
facility must monitor the quality of the water used in treatments, as 
well as monitor the equipment used in water treatment.
    In the September 18, 1995 Federal Register (60 FR 48039), we 
published a final rule that incorporated by reference the 1992 AAMI 
standard for water quality and the AAMI recommended guidelines for 
monitoring purity of water as published in the ``Hemodialysis 
Systems,'' ANSI/AAMI RD5: 1992, sections 3.2.1, 3.2.2, and Appendix B, 
sections B1-B5 (American National Standards Institute 1992). Each AAMI 
standard or recommended practice reflects the collective expertise of a 
committee of health care professionals and industrial representatives, 
whose work has been reviewed nationally. AAMI standards and guidelines 
undergo a regular 5-year review process that allows updates and 
revisions. These consensus recommendations are intended to help ensure 
patient safety.
    The AAMI guidelines referenced in the existing conditions for 
coverage have been replaced by more recent AAMI guidelines, and 
therefore, we are proposing to incorporate new AAMI references. The 
ANSI/AAMI RD5: 1992 document has been replaced by ``Concentrates for 
Hemodialysis'' ANSI/AAMI RD61: 2000, ``Water Treatment Equipment for 
Hemodialysis Applications'' ANSI/AAMI RD62: 2001, and ``Dialysate for 
Hemodialysis'' ANSI/AAMI RD 52:2004. These publications update the 
information on monitoring of water quality currently incorporated by 
reference in Sec.  405.2140(a)(5) and provide additional recommended 
practices.
    We are proposing to incorporate by reference the following revised 
AAMI water quality standards, published in ``Water Treatment Equipment 
for Hemodialysis Applications,'' 4.2.1 and 5.2.1, Water Bacteriology; 
4.2.2 and 5.2.2, Maximum Level of Chemical Contaminants; and 4.3, Water 
Treatment Equipment requirements (American National Standards 
Institute, 2001). The updated water purity standards, section 4.2.1, 
now include bacteria and endotoxin action levels that identify the 
concentration at which steps (such as system disinfection and 
retesting) should be taken to reduce the levels to an acceptable range. 
Facilities must take corrective action when these action levels are met 
or exceeded.
    The AAMI list of contaminants for which water must be tested has 
been expanded to include antimony, beryllium, and thallium. These 
chemicals were added based on changes in the United States 
Environmental Protection Agency Safe Drinking Water Act 1996 (Pub. L. 
104-182). AAMI's rationale for testing water for these contaminants may 
be found in the appendix of the ANSI/AAMI RD62: 2001 document at 
A.4.2.2 (American National Standards Institute, 2001).
    We have also included the updated AAMI requirements for water 
treatment equipment. This inclusion provides clarity by defining the 
minimum

[[Page 6195]]

standards for water treatment equipment needed to protect patient 
safety. Proper hemodialysis is dependent on the quality of the 
dialysate. A water system consisting of the proper components and 
maintained in accordance with the manufacturers' instructions, can be 
expected to produce dialysate that meets the AAMI standards and 
produces acceptable patient outcomes. The minimum safety requirements 
are specified in the AAMI standards referenced in proposed Sec.  
494.40(a)(1)(iii) for each component of the water treatment system 
(that is, deionization, reverse osmosis, monitors, sediment filters, 
carbon absorption media, automatically regenerated water softeners, 
storage tanks, piping systems; and when used, ultrafilters, ultraviolet 
irradiators, hot water disinfection systems, ozone disinfection 
systems, and tempering valves). A water treatment system consisting of 
the proper equipment components as identified by AAMI (and the Food and 
Drug Administration (FDA)) is standard practice in dialysis facilities.
    We are proposing state of the art water purity monitoring 
guidelines outlined in ANSI/AAMI RD52: 2004 ``Dialysate for 
Hemodialyzers'' section 7.2.1 document. Proposed Sec.  494.40(a)(2) 
incorporates by reference the section that specifies the frequency of 
water purity testing to insure meeting the AAMI limits specified in 
Sec.  494.40(a)(1)(i) and (ii) as follows:
     Bacteria and bacterial endotoxin levels of water must be 
measured--
    ++ In established systems at least monthly;
    ++ In newly-installed systems at least weekly until an established 
pattern of compliance can be demonstrated.
     At least monthly in samples drawn from--
    ++ The first and last outlets of the water distribution loop;
    ++ Where water enters the dialyzer reprocessing equipment;
    ++ Outlet of the water storage tanks, if used;
    ++ Concentrate or from the bicarbonate concentrate mixing tank.
     Bacteria levels must be measured at least monthly from a 
sample of two or more dialysis machines, this sampling must ensure that 
all machines are tested at least once a year.
     Chemical analysis of water purity must be done at least 
once a year and when--
    ++ The system is installed;
    ++ Membranes are replaced if using a reverse osmosis system;
    ++ Seasonal variations in source water suggest worsening water 
quality; and
    ++ Reverse osmosis rejection rates, which are monitored daily using 
continuous-reading monitors that measure product water conductivity, 
fall below 90 percent.
    Ultrapure dialysate has received attention in the clinical 
literature and the working draft AAMI standards ``Dialysate for 
Hemodialysis'' RD52 contains guidelines pertaining to ultrapure 
dialysate. We are not proposing a requirement for ultrapure dialysate 
at this time but we do invite comment on this topic. We also welcome 
comment on the requirements for the frequency of water purity testing.
    In addition, we are proposing further evidence-based requirements 
consistent with AAMI guidelines within the proposed water quality 
condition. The existing conditions for coverage do not address 
requirements for the water treatment equipment, although the 
interpretive guidelines for Sec.  405.2140(a)(5)(ii) do advise that 
water treatment systems must include a carbon tank and either a reverse 
osmosis or deionization system (DHHS/CMS, 1995). We are proposing that 
the water treatment system must include a reverse osmosis or 
deionization component that conforms to the referenced water treatment 
equipment for hemodialysis applications AAMI guidelines 4.3.5 and 
4.3.6. This is in keeping with current standards of practice, which are 
widely adhered to by dialysis facilities. The reverse osmosis process 
serves to remove dissolved salts, bacteria, viruses, pyrogens, and 
organic molecules. Deionization serves to remove ions. A reverse 
osmosis system along with pretreatment is used in the vast majority of 
all dialysis centers and this requirement should not present an 
additional burden to hemodialysis centers.
    A consequence of patient exposure to high levels of chloramine via 
dialysis is hemolytic anemia, which may be life-threatening. The 1992 
AAMI guidelines specified at least once daily testing of purified water 
for chlorine/chloramine levels. It is now widely recognized that 
testing before each shift of hemodialysis sessions, which is the 
current standard in many dialysis units, provides greater patient 
safety. Therefore, we are proposing at Sec.  494.40(c)(2) to require 
chlorine/chloramine testing of water samples that must be taken from 
the exit port of the initial chlorine/chloramine removal component (or 
carbon tank) prior to each patient shift or every 4 hours, whichever is 
shorter, during operation of the water system, unless the facility 
ensures on a daily basis that the source water is chlorine/chloramine 
free by way of testing. In addition, proposed Sec.  494.40(c)(2)(i) 
would require subsequent testing from the backup component (or second 
carbon tank) if the test shows greater than 0.50 parts per million 
(ppm) for free chlorine or 0.10 ppm for chloramine. Due to the dangers 
of chlorine/chloramine exposure, each water purification system must 
provide for the adequate removal of chlorine/chloramine and this is 
standard operating practice in hemodialysis facilities. In conformity 
with the referenced AAMI guidelines at 4.3.9, carbon tanks used for the 
removal of chlorine/chloramine must contain granulated activated carbon 
and provide adequate empty bed contact time to be effective. A backup 
component or second carbon tank must be in place for failure of the 
first line component for chlorine/chloramine removal (or first carbon 
tank), in order to protect patients during a hemodialysis session.
    Dialysis facilities would be required to follow the applicable FDA 
recommendations in ``Guidance for the Content of Premarket 
Notifications for Water Purification Components and Systems for 
Hemodialysis'' that 2 carbon tanks be installed in series with empty 
bed contact time of 10 minutes (DHHS/FDA, 1997). The second carbon tank 
provides the backup safety measure. Some dialysis facilities have three 
or four carbon tanks that provide even more assurance there will not be 
chloramine breakthrough. We invite comment as to whether our proposed 
conditions for coverage that include expanded water equipment 
requirements are still too minimal. In addition, we are requesting 
comments on whether the current AAMI guidance regarding carbon tanks is 
adequate to address all potential health and safety problems associated 
with chlorine, chloramines, and unannounced variations in source water. 
Specifically, we seek comments regarding where there is sufficient 
evidence to require Medicare-participating dialysis facilities to 
maintain at least two carbon tanks (that is, primary and backup) as 
part of their water treatment system, regardless of the current 
composition of its source water.
    We are proposing in Sec.  494.40(e) to require active surveillance 
of hemodialysis patient reactions during and following dialysis, 
particularly when there are adverse reactions that might be associated 
with a problem with the water purification system. The facility must 
take steps to protect patient safety and obtain the appropriate blood 
and dialysate cultures. Evaluation of the water purification system 
must be undertaken as well as any necessary corrective action (Sec.  
494.40(d)).

[[Page 6196]]

    If chlorine/chloramine levels in treated water from the last backup 
component (or carbon tank) are above the AAMI standards as required in 
proposed Sec.  494.40(a)(1)(ii), dialysis treatments must be 
immediately stopped to protect patients from exposure to chlorine/
chloramine as proposed in Sec.  494.40(c)(2)(ii). The medical director, 
who is ultimately responsible for water quality, must be notified 
immediately and corrective action taken. A corrective action plan is 
also required (see Sec.  494.40(d)) whenever any of the water purity 
action levels or standards, including but not limited to, chemical, 
microbial, and endotoxin, are detected.
    We propose to add a requirement, consistent with in the AAMI 
document RD52:2004, that specifies that once mixed, bicarbonate 
concentrate must be used within the time specified by the manufacturer 
of the concentrate and may not be mixed with fresh concentrate. The 
holding of the bicarbonate concentrate presents the risk of bacterial 
growth and should be avoided.
    We considered addressing water quality for home dialysis patients 
in this condition, but we decided instead to include a requirement that 
the facility monitor water used by its home dialysis patients to ensure 
that the water meets the AAMI standards under the proposed ``care at 
home'' condition for coverage (Sec.  494.100). Addressing all home 
dialysis issues under a single condition simplifies the organization of 
the regulations and eliminates the need for readers to refer to 
separate sections for the requirements for home dialysis services.

C. Reuse of Hemodialyzers and Bloodlines (Proposed Sec.  494.50)

    Section 1881(f)(7) of the Act requires the Secretary to establish 
protocols for reuse of hemodialyzers for those facilities that 
voluntarily elect to reuse the filters. The Act further states that 
dialysis facilities that fail to follow the reuse protocol will be 
subject to denial of participation in the Medicare program and denial 
of payment for dialysis treatment not furnished in compliance with the 
reuse protocol.
    In hemodialysis the patient's blood is cleansed of impurities when 
it passes through the filter (hemodialyzer) of a hemodialysis machine. 
There are various techniques that allow some of these filters to be 
reused under certain conditions. Reuse involves cleaning, disinfecting, 
and preparing such hemodialysis devices for subsequent use for the same 
patient. Although the potential exists for adverse patient outcomes 
from reuse, reprocessing and reuse of dialyzers are safe when proper 
techniques are utilized.
    The existing regulation at Sec.  405.2150 requires ESRD facilities 
reusing hemodialyzers to meet the guidelines and standards adopted by 
AAMI and issued in July 1993, as ``Reuse of Hemodialyzers'' (American 
National Standards Institute, 1993). We are proposing to retain this 
requirement in the proposed rule but to incorporate by reference the 
newly revised version and associated amendment (ANSI/AAMI RD47: 2002 
and ANSI/AAMI RD47: 2002/A1: 2003) which replaces the 1993 version. 
This document received final AAMI approval on November 7, 2002.
    Some in the renal community believe that we should not incorporate 
the CDC guideline that prohibits reuse for hepatitis B patients. They 
believe there is no documentation that reuse contributes to the spread 
of hepatitis or that it negatively affects the patient with hepatitis. 
In addition, they indicated that this prohibition is costly to 
facilities because a new dialyzer must be used for each session.
    Hepatitis B is a highly contagious and potentially damaging 
illness, especially for a dialysis patient. Thus, the CDC has for many 
years recommended extreme caution and isolation for those patients who 
are Hepatitis B positive. Many physicians, nurses and other 
professionals involved in the dialysis field have similarly supported 
the position of extreme caution in treating the hepatitis B positive 
patient. The 2001 CDC guidelines advise against the reprocessing of 
dialyzers used for patients who have Hepatitis B because of the risk to 
facility staff. The hepatitis virus is relatively stable in the 
environment and has been shown to remain viable for several days on 
surfaces (via blood spills). While there may be no appreciable evidence 
to demonstrate that reuse would increase the spread of hepatitis B, 
there is not conclusive evidence that reuse in this population is safe. 
At this time we propose to maintain the CDC guidelines prohibiting 
reuse for hepatitis B patients to minimize the incidence of this mode 
of transmission.
    We are also proposing at Sec.  494.50(b)(2) that the hemodialyzer 
manufacturer recommendations be followed, or if an alternate method for 
reprocessing hemodialyzers is used, that the facility have documented 
evidence that the method is safe and effective. According to FDA 
guidance, hemodialyzer labeling should reflect the clinical use of a 
hemodialyzer, and whether it is intended for single or multiple usage 
(DHHS/FDA, 1995). Only hemodialyzers and bloodlines labeled for 
multiple use may be reused. In addition, manufacturers of reusable 
hemodialyzers are required to provide adequate instructions for safe 
and effective reuse in accordance with 21 CFR 801.5. If the facility 
chooses to use an alternate method for reprocessing hemodialyzers there 
must be sufficient scientific evidence that the method is safe and 
effective. This flexibility is provided to allow for the use of newer 
and improved technologies that are proven safe in scientific studies 
which may become available in the future. The FDA approved label 
recommendations for the proper use of the device must be adhered to by 
dialysis facilities.
    Existing Sec.  405.2150(a)(2) states that to prevent any risk of 
dialyzer membrane leaks due to the combined action of different 
chemical germicides, dialyzers are exposed to only one chemical 
germicide during the reprocessing procedure. We have received informal 
suggestions that we alter the current language because many facilities 
use bleach as part of the reuse process to flush and clean blood 
deposits before the actual germicide soaking process is initiated. 
However, for purposes of reuse, we consider bleach to be a cleansing 
agent, not a germicide. The requirement to discard dialyzers treated 
with a different germicide does not apply to bleaching. Nonetheless, 
since the language appears to be confusing to some, we are proposing to 
clarify the provision in proposed Sec.  494.50(b)(3) by inserting the 
phrase ``other than bleach.''
    Some in the renal community and on the AAMI RD47 workgroup stated 
that discarding dialyzers exposed to a second germicide was expensive 
and unnecessary if air pressure leak test results indicated the 
dialyzer was still effective. However, we are proposing to retain the 
requirement in existing Sec.  405.2150 that if a dialyzer is exposed to 
a second germicide it must be discarded because we are concerned that 
exposure to different germicides may cause membrane leaks. While we 
recognize that it may be considered wasteful by some to discard 
dialyzers with test values that indicate they are still effective, we 
believe this is a necessary safety measure. We do not have sufficient 
evidence that clearly supports the safety of using multiple germicides 
on hemodialyzers. We welcome comment on the issue of multiple germicide 
use in reused hemodialyzers.
    Existing Sec.  405.2150(a)(3) requires that facilities take 
appropriate blood cultures at the time a patient has a febrile response 
and discontinue reuse of

[[Page 6197]]

hemodialyzers in the case of pyrogenic reactions, bacteremia, or 
unexplained reactions possibly associated with ineffective 
reprocessing, until the entire reprocessing system is evaluated. We 
have been advised that a single febrile response in one patient can be 
the consequence of many different etiologies not related to reuse, 
including an infected access, a current infection, or contamination of 
the water purification system. Members of the renal community suggested 
that a febrile reaction in a single patient is rarely attributed to 
dialyzer reuse. Facilities do not believe it is necessary to terminate 
reuse or order blood cultures when a febrile reaction occurs in only a 
single patient. It was suggested that a facility need only respond 
through aggressive evaluation of its water purification system, 
dialysis concentrates, and reuse system when the surveillance of 
febrile events reveals a cluster of febrile patients. Based on this 
evaluation, the facility can make an appropriate clinical decision 
concerning termination of reuse. As a result, we are proposing in Sec.  
494.50(c) to revise the regulations to state that a facility need only 
obtain blood and dialysate cultures and evaluate its reprocessing and 
water purification systems in response to an adverse reaction when 
clinically indicated. If the evaluation indicates that the facility 
should discontinue reuse, we expect facilities to have established 
contingency plans, suspend the reuse of hemodialyzers until the problem 
has been corrected, and report the adverse outcomes to the FDA and 
other agencies as required by Federal, State or local laws and 
regulations.
    Existing Sec.  405.2150(c) lists 4 requirements applicable to a 
facility that reuses bloodlines. Facilities must: (1) Limit the reuse 
of bloodlines to the same patient; (2) not reuse bloodlines labeled for 
``single use only''; (3) reuse only bloodlines for which the 
manufacturer's protocol for reuse has been accepted by the FDA in 
accordance with the premarket notification (see section 510(k) of the 
Food, Drug, and Cosmetic Act and 21 CFR 876.5860 of the regulations); 
and (4) follow the FDA-accepted manufacturer's protocol for reuse of 
that bloodline. We propose to maintain the first requirement to limit 
the reuse of bloodlines to the same patient because the risk of 
transmitting blood-borne pathogens is so high, and reusing for the same 
patient limits the risk of cross-contamination. We also propose to 
maintain the third and fourth requirements, that is, a facility may 
reuse only bloodlines for which the manufacturer's protocol for reuse 
has been accepted by the FDA; and that the facility must follow the 
FDA-accepted manufacturer's protocol for reuse of the bloodline. With 
these requirements, the facility must follow any specific instructions 
listed by the FDA, as well as any guidelines by the manufacturer that 
may not be discussed in the FDA regulations. We are proposing to delete 
the second existing requirement that facilities not reuse bloodlines 
labeled for ``single use only'' because it is redundant with the 
existing third and fourth requirements. Since the FDA would not 
recommend reuse on bloodlines labeled ``single use only,'' there is no 
need to maintain the requirement.

D. Physical Environment (Proposed Sec.  494.60)

[If you choose to comment on issues in this section please include the 
caption ``Physical Environment'' at the beginning of your comment.]
    The existing physical environment condition (Sec.  405.2140) 
stipulates that the physical environment in which dialysis services are 
furnished afford a functional, sanitary, safe, and comfortable setting 
for patients, staff, and the public. The existing regulation consists 
of four separate standards concerning building and equipment, favorable 
environment for patients, contamination prevention, and emergency 
preparedness. We propose to refine the physical environment section to 
include only those elements that relate directly to the physical 
surroundings of the dialysis facility and to relocate the remaining 
elements to other sections in the proposed rule that relate more 
closely to those subject areas.
    The existing building and equipment requirements in Sec.  
405.2140(a), include fire safety procedures, equipment maintenance, 
facility maintenance, and water treatment. Based on the experience and 
suggestions of our surveyors, we propose to establish separate 
standards for the building itself in proposed Sec.  494.60(a) and 
equipment in proposed Sec.  494.60(b). We propose to maintain the 
existing requirement (described in Sec.  405.2140(a)) that the building 
in which dialysis services are furnished be constructed and maintained 
to ensure the safety of patients, the staff, and the public. The 
dialysis facility should be free from hazards that may bring harm to 
the patients, the staff, and the public.
    The existing language of Sec.  405.2140(a)(2) stipulates that all 
electrical and other equipment used in the facility be maintained free 
of defects that could present a potential hazard to patients or 
personnel and that there is a planned program of preventive maintenance 
of equipment used in dialysis and related procedures in the facility. 
We propose at Sec.  494.60(b) to maintain the essence of this 
requirement but to clarify that all equipment is maintained in 
accordance with the manufacturer's recommendations. Based on their 
experience with the equipment, we believe manufacturers have the most 
knowledge about routine maintenance and recommended repair.
    Existing Sec.  405.2140(b) requires each facility to maintain a 
favorable environment for patients; and the facility must be maintained 
and equipped to provide a functional, sanitary, and comfortable 
environment with an adequate amount of well-lighted space for the 
services provided. The existing language in this standard combines 
several different concepts, including sanitary environment and 
infection control, and we propose to address each subject in separate 
sections of the regulation. As a result, we are proposing at Sec.  
494.60(c) to include only those standards regarding the safety and 
comfort of each patient.
    Since the proposed conditions are outcome-oriented, we believe that 
we do not need to specify all the process requirements that a facility 
must meet to provide a dialysis environment in which the patient can 
receive quality care. Each facility can develop its own strategies and 
techniques as long as the space for treating each patient is sufficient 
to provide needed care and services, prevent cross-contamination, and 
accommodate medically needed emergency equipment and staff. Existing 
Sec.  405.2140(b) also requires the facility to provide a well-lit 
space. We propose to delete this requirement because it is too 
subjective to be meaningful, and we believe this detail is better left 
to the judgment of the facility staff.
    We expect the dialysis facility to provide patients with a 
comfortable environment. Existing Sec.  405.2140(b)(4) requires that 
heating and ventilation systems be capable of maintaining adequate and 
comfortable temperatures. We recognize that not all patients are 
comfortable at the same temperature; and therefore, proposed Sec.  
494.60(c)(2) specifies that the facility maintain a temperature that is 
comfortable for the majority of patients. The dialysis facility must 
make reasonable accommodations for patients who are not comfortable at 
the temperature setting determined by the majority of patients. The 
facility has the option of allowing patients to bring a blanket to 
dialysis or providing freshly laundered blankets to the patients. 
Infection control procedures must be

[[Page 6198]]

adhered to in either case. Often patients need a warm environment 
because of lowered body temperature during the dialysis process, and 
therefore, facilities should look to patients rather than staff to 
ascertain comfortable building temperatures.
    In the emergency preparedness standard (proposed Sec.  494.60(d)), 
we have proposed requirements that we believe are fundamental for a 
dialysis facility to prepare effectively for emergency situations. 
These requirements include: (1) Procedures for medical and non-medical 
emergencies; (2) staff and patient training; (3) facility emergency 
equipment; and (4) periodic evaluation of emergency plans. Existing 
Sec.  405.2140(d) requires the facility to have written policies and 
procedures that specifically define the handling of emergencies that 
may threaten the health and safety of patients. The existing 
regulations also stipulate that facility staff should be trained for 
any emergency or disaster, as part of their employment orientation.
    We propose to clarify at Sec.  494.60(d) that each dialysis 
facility must implement emergency preparedness procedures to manage 
potential medical and nonmedical emergencies that are likely to 
threaten the health or safety of facility patients, the staff, and 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. The facility will need to identify which hazards are 
most likely to effect their facility, evaluate how to minimize risks, 
and plan how to best protect patients in the event of an emergency, 
using an emergency management approach. We do not expect individual 
facilities to develop emergency plans for natural disasters that 
typically do not affect their geographic location. For example, 
facilities located in the Southeast would not typically need to develop 
emergency procedures for earthquakes. Facilities located in the central 
plains States, on the other hand, would need to be prepared for 
tornadoes. All facilities must plan for fire, care related emergencies, 
equipment and power failures, and interruption of the water supply, 
because these emergencies may occur regardless of a facility's 
geographic location.
    In addition to having emergency procedures, a facility will need to 
plan ahead so that necessary information and tools are available to 
staff and patients. For example, a facility would need to have current 
patient telephone numbers, addresses, and transportation information 
available before an emergency happens rather then scrambling to update 
this kind of information during an emergency. As a resource in their 
movement toward an emergency management approach, dialysis facilities 
may want to use the ESRD facility emergency preparedness guidelines 
available from the ESRD Networks.
    We propose to maintain the existing requirement that a facility 
train each staff member on the actions required for different medical 
and nonmedical emergencies. The existing conditions for coverage 
require that emergency preparedness procedures be reviewed and tested 
at least annually and revised as necessary. Also, all personnel must be 
knowledgeable and trained in their respective roles in emergency 
situations. We are proposing that staff training must be evaluated at 
least annually and that staff must demonstrate knowledge of emergency 
procedures. This requirement is designed to ensure the safety and 
security of both the patients and the staff. We propose also to require 
that the facility provide periodic training to patients and staff. 
Patients routinely treated in dialysis units are at risk for medical 
emergencies. As a result, standard medical practice dictates that the 
facility must have trained personnel, drugs, and emergency equipment 
available to adequately support patients until an Emergency Medical 
System (EMS) unit responds to the facility.
    We are proposing at Sec.  494.60(d)(1)(ii) that staff must maintain 
current cardiopulmonary resuscitation (CPR) certification. This is the 
standard practice in United States dialysis facilities. We have not 
prescribed the type or number of staff who must maintain CPR 
certification but at a minimum, the patient care staff must maintain 
current CPR certification. In this instance, patient care staff are 
staff who routinely provide direct medical care to patients in the 
dialysis unit.
    We would maintain the standard in the existing regulation (Sec.  
405.2140(d)(5)) that the facility provides appropriate training to 
patients, so that they know the facility's emergency procedures, since 
they may need to take steps to protect themselves during an emergency. 
Dialysis patients need to be informed on what to do, where to go, whom 
to contact from home, and how to disconnect themselves from dialysis 
equipment if an emergency occurs.
    The existing text in Sec.  405.2140(d)(3) requires that the 
facility have available at all times on the premises a fully equipped 
emergency tray, including emergency drugs, medical supplies, and 
equipment. We propose to maintain this requirement, but we want to 
eliminate the confusion regarding the meaning of ``fully equipped.'' We 
propose to define the minimum emergency equipment that must be on the 
premises and immediately available as ``oxygen, airways, suction, 
artificial resuscitator ventilation bag, defibrillator, and emergency 
drugs.'' We propose to specifically require defibrillators. Automated 
external defibrillators (AEDs), in particular, have been shown to save 
lives in a variety of settings, most notably aboard airlines and in 
airports. One Seattle study (Arch Intern Med. 2001;161:1509-1512 
available at http://www.ARCHINTERNMED.com) identified dialysis centers 
as having a relatively high incidence of cardiac arrest (>= 0.746 per 
practice annually). In the 9 dialysis facilities studied there were 47 
cardiac arrests over a 7-year period. Approximately 56 percent, or 26 
patients, had ventricular fibrillation and may have benefited from use 
of an AED. The authors of this study presented their findings to the 
nine dialysis centers and all nine agreed to equip their centers with 
AEDs and to train their staff in the use of AEDs.
    The key to saving a life is getting the defibrillator on the 
patient as soon as possible. The AED allows dialysis facility staff to 
defibrillate a patient without requiring the immediate presence of a 
physician. According to the American College of Emergency Physicians 
(www.acep.org/1,2891,0.html), when a person suffers a sudden cardiac 
arrest, the chance of survival decreases by 7 to 10 percent for each 
minute that passes without defibrillation. The very real potential for 
saved lives supports the financial investment in an AED. The cost of an 
AED is approximately $2,000 to $3,000. Some units have already 
voluntarily purchased AEDs. Very small units (for example, units with 
two hemodialysis stations) may find the purchase of an AED to be a 
heavy financial burden. We are soliciting comments on whether small, 
predominantly rural dialysis facilities should receive special 
consideration and possibly an exemption from the defibrillator 
requirement. We propose that the dialysis nursing staff must be trained 
on the proper use of emergency equipment and emergency drugs. Staff 
could be trained on the use of an AED in conjunction with the CPR 
training. Having the right equipment at the time of an emergency is 
only useful when staff is well versed in how to effectively use it. In 
addition, the facility must have

[[Page 6199]]

a plan to obtain EMS assistance when needed.
    We are proposing to require a defibrillator without specifying an 
AED due to the fact that some dialysis units already have access to a 
defibrillator. Hospital-based dialysis units, in particular, may have 
immediate physician availability built into the hospital-wide cardiac 
resuscitation plan. This reduces the financial burden of the proposed 
defibrillator requirement.
    We are proposing to maintain the requirement that facilities 
conduct reviews of their emergency and disaster plans to ensure that 
facilities appropriately respond to the situations and needs that may 
arise from a variety of emergencies, medical and nonmedical. We are 
proposing in Sec.  494.60(d)(3)(ii) that facilities review their 
emergency and disaster plans at least annually. Drill and emergency 
episodes often reveal a weakness or flaw in the design of the emergency 
plan. An annual update will allow such flaws or potential problems to 
be identified and corrected.
    Existing Sec.  405.2140(b)(3) specifies that the facility have a 
nursing/monitoring station from which adequate surveillance of patients 
receiving dialysis services can be made. We propose to delete this 
requirement because we believe this is not a physical environment 
issue. It is important that patients are appropriately monitored during 
the dialysis session. However, monitoring is most effectively done 
through interaction between the patients and the staff in the dialysis 
area and not from a monitoring station.
    We believe that existing Sec.  405.2140(b)(5) is another process-
oriented requirement, and we propose to delete this requirement. This 
requirement states that facilities using central batch processing must 
make arrangements to meet the needs of patients with special dialysis 
solutions. The Patient plan of care condition, proposed Sec.  494.90, 
would require the dialysis facility to implement the care plan and make 
arrangements to meet the individual requirements of each patient 
regardless of whether those needs are related to special dialysis 
solutions or other medically necessary supplies or equipment.
    The existing emergency preparedness standard (Sec.  405.2140(d)) 
enumerates the facility physical emergency management procedures but 
provides minimal standards for the procedures that must be followed 
during a fire. We propose to strengthen the section governing fire 
safety to provide greater detail regarding the appropriate procedures 
that must be followed.
    We are proposing at Sec.  494.60(e) to adopt the 2000 edition of 
the National Fire Protection Association's (NFPA) Life Safety Code 
(LSC). The LSC is a compilation of fire safety requirements for new and 
existing buildings and is updated and published every 3 years by the 
NPFA, a private, non-profit organization dedicated to reducing loss of 
life due to fire.
    The Medicare and Medicaid conditions of participation have 
historically incorporated by reference these requirements along with 
Secretarial waiver authority. The statutory basis for incorporating 
NFPA's LSC for ESRD facilities falls under the Secretary's general 
rulemaking authority.
    The 2000 edition of the LSC is divided into several occupancy 
chapters including a business chapter, educational chapters, ambulatory 
health care occupancy chapters, and health care occupancy chapters. The 
business occupancy chapter pertains to clinics and offices. The 
educational occupancy chapters pertain to schools and day care centers. 
The health care occupancy chapters pertain to inpatient health care 
facilities (for example, hospitals, nursing homes). Finally, the 
ambulatory health care occupancy chapters pertain to facilities that 
provide outpatient medical treatment that may render the patient 
temporarily incapable of self-preservation (for example, critical 
access hospitals, dialysis centers).
    The NFPA LSC Handbook specifically designates Chapter 20 and 
Chapter 21 for outpatient dialysis services. We propose to adopt, as 
recommended by the NFPA LSC, Chapter 20 (that is, new ambulatory health 
care occupancy buildings) and Chapter 21 (that is, existing ambulatory 
health care occupancy buildings) of the 2000 edition of the LSC for all 
outpatient dialysis facilities regardless of size.
    The LSC classifies dialysis facilities as ambulatory health care 
occupancies because the treatment is not a routine medical visit to a 
doctor's office but rather a procedure that may hinder the patient from 
self-preservation in the event of an emergency or fire. Incapability of 
self-preservation might be the result of the use of general anesthesia 
or a treatment such as dialysis. Dialysis patients are not as mobile as 
a person working or visiting an office building or health clinic but 
more mobile than patients being treated in an inpatient health care 
facility, such as a hospital or nursing home. Chapters 20 and 21 give a 
level of safety from fire that is greater than the typical business 
occupancy but less than a health care occupancy such as a hospital or 
nursing home.
    Under our proposal, an outpatient dialysis facility would comply 
with the business occupancy provisions in Chapters 38 (that is, the new 
business occupancies) and 39 (that is, existing business occupancies) 
with the additional provisions contained within Chapters 20 and 21. 
Where there may be a conflict between the business occupancy chapter 
and the ambulatory health care occupancy chapter, the more stringent 
requirements would apply (LSC sections 20.1.1.1.2 and 21.1.1.1.2). The 
requirements of Chapters 20 and 21 are described below.
    Chapter 20.1.2.1 and Chapter 21.1.2.1 require 1-hour fire 
separation between different occupancies or tenants in a multi-tenant 
building. We believe most dialysis facilities currently meet this 
requirement because most State building codes already require this 
provision.
    Chapters 20.2.4 and 21.2.4 require that there be at least two 
emergency exits. Emergency lighting is required by Chapters 20.2.9.1 
and 21.2.9.1 to ensure that the center is lighted and that egress paths 
are illuminated to allow movement during an emergency.
    Chapters 20.2.9.2 and 21.2.9.2 require an essential electrical 
system. This provision does not apply to dialysis facilities because 
dialysis equipment is not life-support equipment under the Life Safety 
Code.
    Chapters 20.3.4.4 and 21.3.4.4 require the fire alarm system to 
provide automatic notification of a fire to emergency forces. This is 
of great importance for the protection of patients. Any delay in the 
notification of fire and rescue personnel could adversely impact the 
health and safety of patients and expose them to a fire, smoke, or 
toxic gases created by the fire.
    Chapters 20.3.7 and 21.3.7 pertain to smoke compartmentation, 
otherwise known as subdivision of building space. Section 3.7 of 
Chapters 20 and 21 apply to any dialysis facility that is larger than 
5,000 square feet (or 10,000 square feet for facilities with 
sprinklers). We believe most dialysis facilities will fall within the 
exceptions outlined in this provision. If a dialysis facility is 
smaller that 5,000 square feet and protected by an approved, supervised 
sprinkler system, then section 3.7 of Chapters 20 and 21 do not apply.
    Section 7 of Chapters 20 and 21 specify procedures to assist 
outpatient dialysis facilities in providing fire safety. Section 7.1 of 
Chapters 20 and 21 propose evacuation plans and fire exit drills and 
require staff to practice the

[[Page 6200]]

procedures outlined in the dialysis facilities written emergency plans. 
Section 7.1 of Chapters 20 and 21 are appropriate for outpatient 
dialysis facilities because there is a possibility a dialysis patient 
could lose blood or suffer unnecessary risks if the patient were 
removed from the dialysis machine during a fire drill. We believe that 
requiring a dialysis facility to stop dialysis treatment and evacuate 
all dialysis patients during a fire drill is an unnecessary procedure 
that could jeopardize the dialysis patient's health and safety. Annex 
A, Explanatory Material to the 2000 NFPA LSC provides guidance for 
conducting fire drills when it is inexpedient and impractical to move 
patients during a fire drill. Many health care occupancies conduct fire 
drills by choosing the location of the simulated emergency in advance; 
practicing the movement of simulated patients or empty wheelchairs to 
adjacent safe areas, and ensuring that staff have the efficiency, 
knowledge, and response capability to implement the facility's fire 
emergency plan. Surveyors may determine whether this standard was met 
by checking a dialysis facility's records and interviewing staff to 
verify that the emergency and fire drills were conducted not less than 
once in each 3-month period and that staff are very familiar with the 
procedures.
    Section 7.1.1 in Chapters 20 and 21 also require that the dialysis 
facility prominently post its emergency plan. We expect the plan to 
include continuity of essential building operations in the event of an 
emergency. Electrical, water, fire protection, ventilation, and 
communications systems are some, but not all, areas a dialysis facility 
should consider in its disaster plan. A good reference, but not a 
requirement for developing an emergency plan for a dialysis facility, 
is the NFPA 99--Standard for Health Care Facilities, Chapter 11, Health 
Care Emergency Preparedness (NFPA, November 2001). Our intent in 
proposing the posting requirement is to ensure patients, staff and the 
public have the proper information to quickly evacuate in the event of 
an emergency.
    The remaining provisions in section 7 of Chapters 20 and 21 include 
requirements for the procedures in case of fire (20.7.2 and 21.7.2); 
maintenance of exits (20.7.3 and 21.7.3); smoking regulations (20.7.4 
and 21.7.4); furnishings, beddings, decorations (20.7.5 and 21.7.5); 
maintenance and testing of life safety-related equipment (20.7.6 and 
21.7.6); portable space heating devices (20.7.7 and 21.7.7); and 
construction, repair and improvement operation (20.7.9 and 21.7.9).
    We recognize that for some dialysis facilities it would be 
extremely burdensome to adhere strictly to all of the LSC requirements. 
For example, older dialysis facilities or facilities leasing space in 
an office building may not be able to add sprinkler systems. We are 
proposing to retain our existing authority to waive specific provisions 
of the LSC on a case-by-case basis, further reducing the exposure to 
additional cost and burden for facilities with unique situations that 
can justify the application of waivers which we determine will not 
endanger the health and safety of patients. We propose that a waiver 
may be granted for a specific LSC requirement if: (1) We determine that 
the waiver would not adversely affect the patient/staff health and 
safety; and (2) we determine that it would impose an unreasonable 
hardship on the facility to meet a specific LSC requirement. A provider 
may request a waiver from its State Agency. The State Agency will 
review the request and make a recommendation to the appropriate CMS 
Regional Office. The CMS Regional Office will review the waiver request 
and the State Agency's recommendation and make a final decision on the 
waiver request. A waiver cannot be granted if patient safety is 
compromised in any way.
    A State may also request that a State fire and safety code, imposed 
by State law, be applicable to all dialysis facilities rather than the 
LSC proposed in this rule. The State must submit the request to its CMS 
Regional Office and the Regional Office will forward the State's 
request to CMS Central office for a final determination.

V. Proposed Part 494 Subpart C (Patient Care)

A. Patients' Rights (Sec.  494.70)

[If you choose to comment on issues in this section please include the 
caption ``Patients' Rights'' at the beginning of your comment.]
    The existing patients' rights condition, Sec.  405.2138, requires 
that the facility's governing body adopt written patients' rights 
policies that are administered by the facility's chief executive 
officer (CEO). Sections 405.2138(a)(1) through (5) state that patients 
must be informed regarding the following: (1) Their rights and 
responsibilities; (2) services available at the facility and charges 
not covered; (3) their medical condition (by a physician); (4) the 
facility's reuse policies; and (5) their suitability for 
transplantation or home dialysis. Sections 405.2138(b)(1) and (2) 
afford patients the right to participate in planning their medical 
treatment; require that a patient may be transferred or discharged for 
only medical reasons or for the patient's or other patient's welfare or 
nonpayment of fees; and require that patients must be given advance 
notice to ensure an orderly transfer or discharge. Section 405.2138(c) 
states that patients must be treated with respect and dignity; Sec.  
405.2138(d) protects patient confidentiality of personal and medical 
records; and Sec.  405.2138(e) states patients must be advised, 
encouraged, and assisted in exercising their rights to bring grievances 
(through a representative, if desired) without fear of discrimination 
or reprisal.
    We are proposing to revise the provisions of this condition to 
include a number of changes, in keeping with our goals to reduce the 
Federal regulatory burden on dialysis facilities, eliminate unnecessary 
procedural requirements, and revise the conditions for coverage to be 
more outcome-oriented while protecting the basic rights of ESRD 
patients.
    First, we are proposing at Sec.  494.70 that the facility must 
inform patients (or their representatives) of their rights and 
responsibilities when they begin their treatment at the facility, and 
must also protect and provide for the exercise of those rights. We 
believe it is important to take steps to ensure that patients are fully 
and promptly informed of their rights. The existing regulatory language 
permits a facility an unspecified period of time to complete this 
activity. However, we believe that all dialysis patients must be 
informed of their rights and responsibilities when they begin their 
treatment, which is the standard practice in dialysis facilities, so 
they may exercise them from the beginning of their relationship with 
the facility.
    Existing Sec.  405.2138 provides a list of numerous persons to whom 
these written patient rights policies must be ``made available.'' The 
list includes patients and guardians, next of kin, sponsoring agencies, 
representative payees, and the public. Essentially, the facility must 
provide the list of patient rights to anyone who asks to see them. 
Rather than specifying a list of people to whom the patients' rights 
policies must be made available, we are proposing at Sec.  494.70 that 
facilities inform the patients (or their representatives), and at Sec.  
494.70(c) that facilities post a copy of the patients' rights in a 
prominent location where it can easily be seen and read. This not only 
meets the objectives of the current list of disclosures, it also allows 
patients

[[Page 6201]]

to review their rights at any time during the course of their care at 
the dialysis facility.
    Section 405.2138 also states that the CEO is responsible for the 
development of, and adherence to, procedures implementing the patients' 
rights policies. In Sec.  494.70, we are proposing to change this 
requirement by holding the facility accountable for the outcome, which 
is to ensure that each patient's rights and the ability to exercise 
them are protected.
    We are proposing to retain the patients' rights enumerated in Sec.  
405.2138(a)(1) through (a)(5) and include them in the proposed Sec.  
494.70(a).
    Proposed Sec.  494.70(a)(1) requires the dialysis facility to 
inform patients of their right to be treated with respect, dignity, and 
recognition of their individuality and personal needs as well as 
sensitivity to the patients' psychosocial needs and ability to cope 
with ESRD.
    Proposed Sec.  494.70(a)(2) requires a dialysis facility to provide 
information to patients in an understandable manner. The existing 
requirement at Sec.  405.2138(c) requires dialysis facilities to 
provide translators ``where a significant number of patients exhibit 
language barriers.'' Presumably, under this existing requirement, if a 
single patient has language difficulty, the facility does not need to 
act to address this patient's needs. We are proposing to modify this 
requirement. Since written information is not required, the dialysis 
facility has the flexibility to decide the best vehicle for providing 
information to patients. We believe this more outcome-oriented 
requirement provides a facility with the latitude to devise its own 
means to ensure the outcome is met.
    Proposed Sec. Sec.  494.70(a)(3) and (4) would require a dialysis 
facility to inform patients regarding privacy and confidentiality, and 
also expands those rights to include specific references to privacy and 
confidentiality in all aspects of the patient's treatment as well as 
the patient's medical records. These requirements include existing 
provisions from Sec.  405.2138(c) and (d). Staff should be instructed 
that any discussions with dialysis patients or relatives regarding 
treatment, the patient care plan, and medical conditions should be held 
in private and kept confidential. There should be reasonable 
precautions to keep both written and verbal patient information 
private. Staff should be aware of the need to speak at a volume and at 
a proximity to patients such that privacy is reasonably protected. 
Facility staff must make efforts to protect patient information and 
physical privacy. While recognizing the patient's right to privacy and 
confidentiality, we are not necessarily advocating physical barriers in 
the dialysis clinical area that provide patient privacy because 
patients should be in view of staff at all times during treatment to 
ensure safety. However, in situations when there is patient body 
exposure during therapy, the staff should be instructed to provide 
temporary screens, curtains, or blankets.
    We are proposing at Sec.  494.70(a)(5) to retain the existing 
requirement under Sec.  405.2138(b)(1) that describes the right of 
patients to participate in the planning of their medical treatment and 
to refuse to participate in experimental research (or any part of their 
care). Section 494.70(a)(5) requires a facility to inform patients 
regarding their right to participate in all aspects of their care. 
Although we recognize that a facility cannot require its patients to 
participate in the care process, we expect the facility to work closely 
with patients and encourage patient participation to ensure that a care 
plan is developed that is suitable to the needs and concerns of both 
the patient and staff. The facility should notify patients in advance, 
if possible, of any changes in the treatment plan recommended by the 
physician and the basis for the changes. The facility should also 
encourage patients to disclose any concerns they may have with the 
proposed changes.
    Proposed Sec.  494.70(a)(5) would also require the facility to 
inform patients of the right to establish an advance directive. Advance 
directives establish in writing an individual's preference with respect 
to the degree of medical care and treatment desired or who should make 
treatment decisions if the individual should become incapacitated and 
lose the ability to make or communicate medical decisions. Advance 
directives include written documents including living wills and durable 
powers of attorney for health care, as recognized by State law.
    Congress passed section 4206 of the Omnibus Budget Reconciliation 
Act of 1990 (OBRA 1990) (Pub. L. 101-508) to ensure that patients 
receive information regarding their right to execute or not to execute 
advance directives. While the OBRA 1990 requires hospitals, skilled 
nursing facilities, HHAs, managed care plans, and hospice programs 
participating in the Medicare program to establish and maintain written 
policies and procedures regarding advance directives, it does not 
specifically mention dialysis facilities.
    In proposing to add advance directives to the patients' rights 
condition for coverage we took several factors into consideration. 
First is the chronic nature of ESRD. Kidney impairment is irreversible 
and permanent, and a regular course of dialysis or transplantation is 
essential to maintain life. In addition, we considered the amount of 
time a patient spends in the dialysis unit, and also the rapidly 
changing demographics of the ESRD patient population. The average age 
of the ESRD patient population is increasing annually. Elderly ESRD 
patients now comprise a large percentage of the total ESRD patient 
population. Data compiled by the United States Renal Data System, from 
1990 to 2001, shows the following rate of new cases of ESRD for 
patients 65 years of age and older:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Year
               Age  (in years)               -----------------------------------------------------------------------------------------------------------
                                                1990     1991     1992     1993     1994     1995     1996     1997     1998     1999     2000     2001
--------------------------------------------------------------------------------------------------------------------------------------------------------
65-69.......................................    7,177    7,982    8,597    8,895    9,852    9,643   10,390   10,829   11,078   11,225   11,415   11,545
70-74.......................................    6,159    7,260    8,093    8,533    9,664    9,678   10,753   11,248   11,648   12,005   12,276   12,367
75-79.......................................    4,587    5,367    5,997    6,293    7,243    7,404    8,481    9,339   10,133   11,170   11,407   11,408
80-84.......................................    2,386    2,754    3,228    3,427    4,051    4,290    4,959    5,725    6,125    6,785    7,349    7,477
85+.........................................      961    1,113    1,277    1,481    1,659    1,833    2,248    2,598    3,110    3,587    3,870    4,146
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The emergence of an older, sicker ESRD patient population has 
motivated the Renal Physicians Association (RPA) and the NKF to develop 
guidelines for implementation of advance directives in dialysis 
facilities, and we are encouraging dialysis facilities to adopt 
voluntary consensus guidelines for advance directives. The guidelines 
can be obtained through the NKF's Web site at: http://www.kidneyva.org/public_ed/orderforms.pdf and through the RPA

[[Page 6202]]

Web site at http://www.renalmd.org/publications/index.cfm.
    After taking these factors into account, we believe it is prudent 
to consider adding advance directives as a requirement in the patients' 
rights condition of this proposed rule.
    Existing Sec.  405.2138(a)(5) requires that patients be informed of 
their suitability for transplantation or home dialysis. We have 
strengthened this requirement at Sec.  494.70(a)(6) by proposing that 
patients be informed about alternative treatment modalities by 
requiring dialysis facilities to address all treatment choices. The 
treatment modality selected may directly affect the quality of life for 
dialysis patients. This choice is a very personal one, with important 
implications for how likely the patient is to be rehabilitated to the 
highest possible level. To assist dialysis patients in achieving the 
optimal quality of life, patients need education about each modality 
and must have access to the widest array of treatment choices possible.
    For example, a successful kidney transplant is the most desirable 
treatment for many ESRD patients and facilities should make every 
effort to both educate and inform patients regarding the 
transplantation option. Also, forms of dialysis that can be performed 
at home have been shown to have a positive influence on the patient's 
quality of life. Home dialysis affords patients' control over 
scheduling and setting, and it can be done in comfortable, familiar 
surroundings. Also, home dialysis is generally perceived to be less 
disruptive to family life and employment. We propose to require that a 
facility inform patients about all available treatment modalities and 
settings, so patients can make an informed decision regarding the most 
appropriate course of treatment that meets their needs.
    Open communication between the facility staff and the patient and 
patient access to treatment information are vital tools for enhancing 
the patient's participation in his or her coordinated care planning. 
Proposed Sec.  494.70(a)(7) requires that patients be informed of the 
facility's patient care policies, including its patient isolation 
policies.
    Proposed Sec. Sec.  494.70(a)(8) through (10) retain existing 
requirements in Sec.  405.2138(a)(2) through (4) that patients be fully 
informed regarding the facility's reuse of dialysis supplies, including 
hemodialyzers; be informed by a physician regarding his or her own 
medical condition unless contraindicated; and be informed of services 
available in the facility and charges not covered by Medicare.
    Proposed Sec.  494.70(a)(11) would require that patients be 
informed of the right to receive the necessary services outlined in the 
patient plan of care in proposed Sec.  494.90. The importance of the 
patient plan of care is discussed in section V.C. of this preamble.
    Proposed Sec.  494.70(a)(12) would retain the existing requirement 
at Sec.  405.2138(a)(1) that patients be informed of the rules and 
expectations of the facility regarding patient conduct and 
responsibilities. The success of the dialysis treatment is as 
contingent upon patients adhering to their responsibilities as it is 
upon other important factors. There is a discussion of the dialysis 
facility's responsibility regarding disruptive and difficult patients 
in section VI.E.9. of this preamble.
    Proposed Sec.  494.70(a)(13) would require facilities to inform 
patients regarding the facility's internal grievance process and their 
right to express grievances against the facility using the internal 
grievance process through a representative chosen by the patient (if so 
desired).
    Proposed Sec.  494.70(a)(14) strengthens the existing requirement 
for facilities to inform patients regarding the various external 
grievance mechanisms available to them, including how to contact the 
ESRD network and the State survey agency, and how to file external 
grievances without reprisal or denial of services, through a 
representative chosen by the patient or anonymously (if so desired). We 
believe that patients must be made aware of every grievance option 
available to them, including, at a minimum, contacting the two entities 
with the statutory responsibility under Federal law for addressing 
patient grievances (that is, the ESRD networks and the State survey 
agencies).
    In proposed Sec. Sec.  494.70(b)(1) and (2), we would require a 
facility to inform patients regarding its transfer and discharge 
policies and provide 30 days notice in advance of reducing or 
terminating patient care services following the discharge and transfer 
procedure outlined in Sec.  494.180(f). The facility would be exempt 
from the 30-day notification requirement in cases when there was an 
immediate threat to the health and safety of others. Proposed 
Sec. Sec.  494.70(b)(1) and (b)(2) and the procedure outlined at Sec.  
494.180(f) have been proposed, in part, in response to the 
``disruptive'' or ``challenging'' patient issue. Increasing numbers of 
staff and patient grievances presented to the ESRD networks and the 
State survey agencies involve allegations of disruptive behavior by 
patients and allegations of inappropriate patient discharges from 
facilities for noncompliance or disruptive behavior. 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. However, it may be necessary to discharge a disruptive patient 
in order to protect the rights and safety of other patients in the 
facility, or to protect the safety of facility staff.
    We believe that a dialysis facility has both the resources and a 
responsibility to make a good faith effort to work with every patient, 
including patients perceived to be disruptive or challenging, to 
provide the necessary assessment, training, knowledge, and motivation 
to facilitate good outcomes of care. This process begins when the 
facility interdisciplinary team performs the comprehensive patient 
assessment described in proposed Sec.  494.80, with periodic 
reassessments as needed; continues through the care planning process 
described in proposed Sec.  494.90; as well as the facility's quality 
assessment and performance improvement (QAPI) program described in 
proposed Sec.  494.110. We believe the disruptive or challenging 
patient problem is multifaceted, and even conscientious assessments, 
care planning, and QAPI programs by a facility will not always be 
successful in mitigating the disruptive behavior of some patients. In 
those instances when good faith efforts by a facility have been 
unsuccessful and the facility has determined that it wants to discharge 
or transfer the patient, facilities must follow the procedure outlined 
in proposed Sec.  494.180(f), and arrange to transfer or discharge the 
patient, as appropriate.
    We also recognize there will be rare instances when a facility must 
act immediately to discharge a patient. Such instances could be, for 
example, when a patient physically harms or threatens other patients 
and staff, a patient who brings weapons or illegal drugs into a 
facility, or a patient who is verbally abusive and disruptive to such 
an extreme degree that the facility is unable to operate effectively. 
In those and comparable circumstances, we would propose to shorten the 
30-day notification requirement. We are soliciting comments on the 
proposed Sec. Sec.  494.70(b)(1) and (b)(2), as well as suggestions for 
addressing the disruptive or challenging patient issue in the proposed 
ESRD conditions.
    If a patient chooses not to use a facility's internal grievance 
process, or when grievances cannot be resolved at the facility level, 
the patient may elect to register a grievance with the

[[Page 6203]]

appropriate ESRD network or make a complaint directly to the State 
survey agency at any time. We believe it is essential that we require 
that patients be informed of every grievance and complaint option 
currently available to them under the law.
    Proposed Sec.  494.70(c) would require dialysis facilities to 
prominently display a copy of the patients' rights as well as the 
telephone numbers for the appropriate ESRD network and State survey 
agency in order to afford patients the opportunity to contact either 
entity, if desired. Dialysis patients have the right to be advised of 
and to use grievance processes developed by the facility, the ESRD 
network and the State survey agency.

B. Patient Assessment (Proposed Sec.  494.80)

    The proposed patient assessment condition at Sec.  494.80 
underscores our belief that systematic patient assessment is essential 
to improving quality of care and patient outcomes. The information 
generated from the patient assessment is a vital tool for developing a 
patient's care plan and subsequent treatment. A comprehensive patient 
assessment allows the dialysis facility to monitor the patient's 
progress toward achieving the desired care outcomes and adjust the plan 
of care and treatment prescription as necessary.
    The existing regulations in part 405 subpart U do not state that a 
patient will receive a comprehensive assessment. However, two sections 
of the existing regulations, Sec. Sec.  405.2136(g)(1) and 
405.2137(b)(1), provide a basis for a patient assessment. For example, 
Sec.  405.2136(g)(1) holds the patient's physician responsible to 
prescribe a planned regimen of care, ``which covers indicated dialysis 
and other ESRD treatments, services, medications, diet, special 
procedures recommended for the health and safety of the patient, and 
plans for continuing care and discharge.'' That section also states 
that such plans are made with the input of the professional personnel 
providing care to the patient. Existing Sec.  405.2137(b)(1) states 
that a patient care plan ``reflects the psychological, social, and 
functional needs of the patient,'' and indicates ESRD and other care 
needed to achieve the long- and short-term treatment goals.
    Therefore, while the existing regulations indicate that a 
specialized care plan must be developed based upon the nature of the 
patient's illness, the treatment prescribed, and an assessment of the 
patient's needs, it does not specify the criteria that a facility must 
include in a patient assessment. Over the past 25 years, research has 
improved our knowledge of the components important to assessing and 
treating the dialysis patient so that improvements in quality of life 
and morbidity and mortality rates have been achieved.
    We believe that a comprehensive patient assessment that includes 
clinical interaction with the patient is a prerequisite for the 
delivery of quality care and is the basis for determining a patient's 
functional status and identifying the services necessary to address the 
patient's needs. Accurate and accessible patient information generated 
from the comprehensive assessment is critical to the development of a 
successful patient care plan and the achievement of desired patient 
outcomes.
    We do not believe that expanding the existing requirements in this 
proposed condition will impose any additional burden on facilities. 
Rather, we believe quality-oriented facilities already routinely 
perform comprehensive patient assessments upon initiating treatment. 
Further, we believe most facilities already have this information in 
different parts of the medical record since an appropriate and 
effective treatment plan cannot be developed without an initial 
assessment.
    We are proposing at Sec.  494.80 to add a patient assessment 
condition for coverage that would make the ESRD facility, through the 
patient's interdisciplinary team, responsible for providing each of its 
patients with an individualized and comprehensive assessment of his or 
her needs. The members of the interdisciplinary team (see proposed 
Sec.  494.10) would include the patient (if he or she chooses), a 
registered nurse, a physician, a social worker, and a registered 
dietitian. With the team concept, the goal is to obtain input from each 
designated health professional as well as from the patient to develop 
an assessment that identifies the patient's needs and allows for 
planning for necessary services. The proposed team members represent 
vital components of the patient's medical treatment and psychosocial 
development. These professionals are also key to a successful 
transition to dialysis as well as to maintaining the patient's quality 
of life. An assessment that involves the patient as a key member of the 
interdisciplinary team is important to the successful delivery of 
service and the patient's adherence to the program.
    In proposed Sec.  494.80(a), we list the assessment criteria. The 
minimum proposed elements of a patient's assessment include the 
following:
     Evaluation of current health status, including comorbid 
conditions and medical condition.
     Evaluation of the appropriateness of the dialysis 
prescription, blood pressure control, and fluid management needs.
     Laboratory profile and medication history.
     Evaluation of factors associated with anemia, such as 
hematocrit, hemoglobin, iron stores, and potential treatment plans for 
anemia, including administration of recombinant erythropoietin.
     Evaluation of factors associated with renal bone disease.
     Evaluation of nutritional status.
     Evaluation of psychosocial needs.
     Evaluation of dialysis access type and maintenance.
     Evaluation of the patient's ability, interests, 
preferences, and goals, including level of participation in the 
dialysis care process; modality and setting (for example, home 
dialysis, including home hemodialysis or peritoneal dialysis); and 
expectations for care outcomes.
     Evaluation of suitability for transplantation referral, 
based on criteria developed by the transplant surgeon at the transplant 
center that would receive such transplantation referral including the 
basis for referral or nonreferral.
     Evaluation of family and other support systems.
     Evaluation of current physical activity level.
     Evaluation of vocational and physical rehabilitation 
status and potential.
    Other information to be included in the initial assessment would be 
determined by the interdisciplinary team based on the specific 
characteristics and needs of the patient.
    We recognize that inclusion of a minimum set of assessment criteria 
may appear to be inconsistent with our goal of eliminating 
unnecessarily prescriptive and process-oriented requirements. However, 
we believe it is appropriate and necessary for every patient assessment 
to focus not only on the patient's medical needs, but also on his or 
her psychosocial and rehabilitation needs. Further, these assessment 
criteria would assure that needed information would be available for 
the patient plan of care and the facility's quality assurance and 
performance improvement program.
    We propose criteria for the frequency of assessment and 
reassessment of new patients in Sec. Sec.  494.80(b)(1) and (2). A 
timely, comprehensive assessment is critical for planning patient care 
and achieving desired patient outcomes. We

[[Page 6204]]

believe this requirement, though process-oriented, is necessary to 
prevent harm to the patient. By permitting facilities 20 calendar days 
to complete assessments, we are providing a reasonable timeframe for 
every member of the team to assess the patient prior to development of 
the treatment plan.
    We also recognize that patients who are new to dialysis need time 
to adjust and adapt to the treatment. Initially, patients may 
experience a great deal of anxiety while learning self-care skills, 
modifying their diet, changing their behavior, and perhaps dealing with 
access issues. The level of compliance with the renal regimen may be 
set by the time the person has been on dialysis for 4 to 6 months 
(Sciarini, pp. 299-305). Because of this period of adjustment, and the 
opportunity to establish the patient's adherence to the renal regimen, 
proposed Sec.  494.80(b)(2) would require a follow-up comprehensive 
reassessment for new patients within 3 months after the completion of 
the initial comprehensive assessment. Three months was chosen so that 
the window of opportunity for establishing adherence to the renal 
regimen by a new patient is not missed. We recognize the additional 
burden this 3-month reassessment will place on the interdisciplinary 
team. However, an updated plan of care and the attention to the 
patient's adjustment to the renal regimen may prevent problems in the 
coming months. The reassessment also ensures the continued accuracy and 
effectiveness of the treatment regimen.
    Existing Sec.  405.2136(g) states that the physician responsible 
for the patient's medical supervision evaluates the patient's needs and 
prescribes a planned regimen of care for dialysis. Sections 
494.80(c)(1) and (2) propose a schedule for the assessment of the 
treatment prescription for hemodialysis and peritoneal dialysis 
patients. Studies indicate that ESRD patient mortality is lower when 
patients receive sufficient dialysis treatments. There has been 
considerable research recently indicating that the dose of dialysis is 
an important determinant of survival and morbidity of patients on 
hemodialysis ((Held, pp.871-875); (Owen, pp.1001-1006); (Parker, 
pp.981-989); and (Parker, pp.670-680)). The delivered dose of dialysis 
(Kt/V or an equivalent measure) indicates how well the dialysis 
treatment is working. Kt/V is the dialyzer clearance of urea (K) times 
the time of treatment (t), divided by the volume of distribution of 
urea (V), which yields a dimensionless value. Adequacy of dialysis 
clinical practice guidelines are available in the National Kidney 
Foundation's Kidney Disease Quality Initiative (NKF-K/DOQI). As 
previously discussed in this preamble, the NKF-K/DOQI has established 
clinical practice guidelines for ESRD patients. This systematic, 
evidence-based approach to developing guidelines used focus workgroups 
to identify target issues and conducted extensive literature searches 
to extract relevant clinical study reports for each target issue. 
Clinical practice guidelines were derived from this information. The 
guidelines are available for public review and comment, and they 
continue to be reviewed. Health care professionals and providers, ESRD 
networks, managed care groups, industry, government, patient 
associations and individuals are invited to provide comments to the 
NKF-K/DOQI workgroups. These comments are reviewed and when 
appropriate, incorporated in future editions.
    An important initiative of this project is the development of 
guidelines for the dose of dialysis, including standard 
methodology(ies) for measuring the dialysis dosage.
    To ensure that ESRD patients receive sufficient dialysis, the 
delivered dose of dialysis needs to be measured. Therefore, in keeping 
with the NKF's K/DOQI clinical practice guidelines, we propose in Sec.  
494.80(c) to specify that the delivered dose of dialysis for the 
patient's hemodialysis treatment prescription must be measured at least 
monthly, and the patient's peritoneal dialysis treatment prescription 
should be assessed at least every 4 months. More frequent monitoring 
may be necessary for new dialysis patients or when the dialysis 
prescription is changed. Less frequent monitoring of the adequacy of 
dialysis may compromise the timeliness with which deficiencies in the 
delivered dose of dialysis are identified and hence may delay 
implementation of corrective action.
    In Sec. Sec.  494.80(d)(1) and (2) we propose patient reassessment 
timeframes for both stable and unstable patients with respect to the 
standards specified in Sec. Sec.  494.80(a)(1) through (a)(13). The 
comprehensive assessment process can be seen as part of a cycle. 
Through the use of the 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. If the patient's 
condition is stable, we propose in Sec.  494.80(d)(1) that the facility 
must perform comprehensive reassessments at least annually, which 
assures that patients are receiving a continuing program of care that 
meets their needs. This proposed timeframe minimizes the facility 
burden because the existing Sec.  405.2137(b)(4) requires care plan 
review every 6 months for stable patients. If the patient is unstable, 
we are proposing in Sec.  494.80(d)(2) to require a monthly 
reassessment, to allow for the update of the plan of care. Existing 
Sec.  405.2137(b)(4) also requires a monthly review of the care plan 
for patients whose medical condition has not become stabilized. In 
proposed Sec. Sec.  494.80 (d)(2)(i) through (d)(2)(iv), we added 
criteria to specify at a minimum, which patients may be considered to 
be unstable patients. These criteria include extended or frequent 
hospitalizations, marked deterioration in health status, a significant 
change in psychosocial needs, or poor nutritional status, with 
unmanaged anemia and inadequate dialysis. Extremely frail patients may 
need monthly reassessments. However, we are not proposing a specific 
requirement for monthly reassessments for frail patients because we 
believe this type of requirement would be too prescriptive and limit 
the flexibility of dialysis facilities to make clinical determinations 
on a case-by-case basis.
    The renal community has been unable to reach a consensus regarding 
the optimum frequency of assessments. Some believe that the proposed 
time periods create a strain on facilities, while others have 
encouraged us to propose more stringent timeframes. Because of the wide 
range of opinion in this matter, we are specifically soliciting public 
comments on whether the proposed 3-month timeframe for reassessment of 
new patients is reasonable and consistent with meeting the patient's 
needs.

C. Patient Plan of Care (Proposed Sec.  494.90)

[If you choose to comment on issues in this section please include the 
caption ``Plan of Care'' at the beginning of your comments.]
    The patient assessment serves as the basis for the patient plan of 
care. Existing Sec.  405.2137 contains a large number of prescriptive 
requirements for the development of patient care plans. These 
requirements specify that there needs to be a patient long-term program 
and a patient care plan.
    The patient long-term program described in existing Sec. Sec.  
405.2137(a)(1) through (a)(4) relates to the selection of a suitable 
treatment modality and treatment setting by the treatment team. It also 
requires active participation by the physician director in the unit 
where the patient is being treated, a formal review of the written 
long-term plan by the team every 12 months, patient involvement in the 
plan's development,

[[Page 6205]]

and a requirement to send the plan to the receiving facility within 1 
day of an interfacility transfer.
    The patient care plan in existing Sec.  405.2137(b) requires a 
written care plan based on the nature of the patient's illness, the 
treatment prescribed, and an assessment of the patient's needs. 
Additional requirements in existing Sec. Sec.  405.2137(b)(1) through 
(b)(7) include a personalized care plan reflecting the patient's needs, 
a care plan developed by a professional team (including the physician 
responsible for the patient's care), the involvement of the patient (or 
the patient's parent or legal guardian), a monthly review for unstable 
patients, a 6 month review for stable patients, sending the plan to the 
receiving facility within one day for interfacility transfers, periodic 
monitoring of home dialysis patients, and monitoring for home dialysis 
patients who use erythropoietin.
    In accordance with our goal of reducing Federal regulatory burden, 
we have simplified the proposed patient care plan condition (Sec.  
494.90) by eliminating the separate requirement for a patient long-term 
program.
    We propose to retain some of the existing requirements of Sec.  
405.2137 in the patient assessment condition (proposed Sec.  494.80). 
We believe that the patient assessment and patient care planning 
processes are inextricably linked. That is, each patient assessment 
must be followed with a review and revision, if necessary, of the 
patient's plan of care.
    The comprehensive plan of care is an individualized program that 
ensures that each dialysis patient receives personalized and 
appropriate patient care within the selected modality and setting of 
treatment. In proposed Sec.  494.90 we would specify that the patient's 
plan of care must include measurable and expected outcomes and 
estimated timetables to meet the patient's medical and psychosocial 
needs as identified in the initial and subsequent comprehensive 
assessments. This section would also specify that the patient's plan of 
care must address all the services that are to be furnished to achieve 
and maintain the expected outcomes of care.
    Existing Sec. Sec.  405.2137(a)(1) and 405.2137(b)(2) specify the 
composition of the professional team responsible for the preparation of 
the long-term and the patient care plans. The facility's professional 
team currently writes a patient long-term program and a short-term care 
plan. However, proposed Sec.  494.90 would require that a single 
patient plan of care be developed and this plan would address all of 
the patient's needs. We are proposing in Sec.  494.90 to retain the 
existing requirement that the patient plan of care to be developed by 
the interdisciplinary team. Although we would retain the existing 
Sec. Sec.  405.2137 (a)(1) and (2), we have chosen to use the term 
``interdisciplinary team.'' The term ``interdisciplinary team'' is 
defined Sec.  494.10 and described in Sec.  494.80. In Sec.  494.80, we 
are proposing that the interdisciplinary team consist of, at a minimum, 
the patient (if he or she desires) or his/her designee, a registered 
nurse, a nephrologist or physician treating the patient for ESRD, a 
social worker, and a dietitian. We are using the term 
``interdisciplinary team'' instead of ``professional team'' because the 
term ``interdisciplinary team'' is commonly used in health care 
settings, including dialysis facilities.
    Although existing Sec.  405.2137(a)(1) specifies a transplant 
surgeon as a member of the professional team, we did not include a 
transplant surgeon as a member of the interdisciplinary team as defined 
in proposed Sec.  494.10 and described in proposed Sec.  494.80. We 
believe all eligible ESRD patients must be referred for 
transplantation. However, it may not be reasonable to have transplant 
surgeons sign every care plan. The existing interpretive guidelines for 
surveyors (Survey Procedures and Interpretive Guidelines for End-Stage 
Renal Disease Facilities, Appendix H, State Operations Manual) allow a 
transplant surgeon's designee, who could be a transplant coordinator or 
the treating nephrologist, to screen patients in the long-term care 
plan process (DHHS/CMS, April 1995). The designee would have to use 
screening criteria developed by the transplant surgeon. Because not 
every patient is medically suited for a transplant, we believe the 
transplant surgeon need not be involved with the team unless a possible 
candidate has been identified. We are proposing that the dialysis 
facility must have inclusion/exclusion criteria, defined by the 
transplant surgeon based at the transplant center that would receive 
the transplantation referral, to use in the evaluation of patients for 
transplant referral. Therefore, we propose to delete the requirement 
that a transplant surgeon directly sign the care plan. We believe 
transplant referral tracking must be part of the comprehensive plan of 
care condition (see Sec.  494.90(c)), and we have also proposed to 
strengthen this requirement in the patient assessment (Sec.  494.80) 
and patient's rights (Sec.  494.70) conditions. We are soliciting 
comment on the appropriate role of the transplant surgeon in developing 
the patient plan of care.
    Existing Sec.  405.2137(a)(1) also requires that the facility 
medical director and a physician from a facility that offers home 
dialysis (if the patient's present facility does not) be included in 
the team that develops the patient's long-term program. While we 
believe the involvement of these physicians would be valuable in most 
cases, we recognize that there are situations when the services of 
these physicians may not be needed. Thus, in keeping with our goal of 
eliminating unnecessary process requirements, proposed Sec.  494.10 
specifies the definition of ``interdisciplinary team'' without 
including the facility medical director and the home dialysis 
physician. Nonetheless, we encourage facilities to expand the 
interdisciplinary team to include as many health professionals as 
necessary to furnish the best care possible to their patients.
    As required in existing Sec.  405.2137 and in proposed Sec.  
494.10, a physician is part of the interdisciplinary team. We propose 
retention of this requirement because we believe the physician must 
play an integral role on the interdisciplinary team. The physician 
responsible for the patient's dialysis treatment works with the other 
team members to ensure the development of an appropriate care plan for 
the patient. We also expect the physician to see the patients and 
monitor their care.
    Existing Sec.  405.2137(b)(3) specifies that the patient may be 
involved in the development of the care plan and consideration is given 
to the patient's preferences. The patient's right to be informed about 
and participate within the interdisciplinary team is encompassed in 
proposed Sec.  494.70(a)(5). The patient or his/her designee, if he or 
she desires, as a member of the interdisciplinary team, must 
collaborate to design a plan of care that enables the patient to reach 
his or her desired level of general health, activity, and quality of 
care. When a patient communicates his or her goals regarding their 
medical treatment, he or she plays a more active role in improving 
their quality of life. We have eliminated the phrase ``due 
consideration is given to [the patient's] preferences'' because we 
believe it implies the patient (or the patient's designee) is not an 
equal member of the team. Each patient must be given the opportunity to 
participate with the interdisciplinary team. However, we would not 
require them to do so in the proposed requirements because we recognize 
that some patients may not wish to participate in the team process. We 
are proposing that the patient or

[[Page 6206]]

designee must sign the plan of care to assure the patient is aware of 
treatment plans and goals regardless of whether the patient has opted 
to participate in the care planning team process.
    The patient plan of care must include measurable and expected 
outcome targets or goals for each patient based on the individual 
patient's assessment. These outcome targets must allow the patient to 
achieve current evidence-based community-accepted standards. Currently, 
the K/DOQI clinical practice guidelines are the community-accepted 
standards for individual patient care and we expect ESRD facilities to 
reflect the current standards of care for dialysis adequacy and anemia 
management in the patient plan of care. As additional evidence-based 
community-accepted standards become evident, they could be targeted in 
the patient plan of care as well.
    We propose that allowing the patient to achieve current evidence-
based community-accepted standards for dialysis adequacy and anemia 
means (at Sec.  494.90(a)(1)), that the patient plan of care should 
specify a minimum delivered threshold for Kt/V of at least 1.2 (single 
pool) for hemodialysis patients (NKF, Guideline 4); 1.7 (weekly) for 
continuous ambulatory peritoneal dialysis (NKF, Guideline 15); 2.1 
(weekly) for continuous cycling peritoneal dialysis patients (NKF, 
Guideline 16); and 2.2 (quarterly) for intermittent peritoneal dialysis 
patients (NKF, Guideline 16). For anemia management (proposed Sec.  
494.90(a)(3)), the minimum specified threshold levels in the patient 
plan of care are: a hemoglobin level of 11 gm/dL or comparable 
hematocrit of at least 33 percent (NKF, Guideline 4).
    There is significant correlation between achieving recommended NKF-
K/DOQI values for the adequacy of dialysis and anemia management 
measures with positive outcomes in mortality, hospitalization, and/or 
quality of life. Thus, the advantages of assigning patient-level 
minimum targets and thresholds is that we would establish a process 
when patients whose values do not meet the criteria are evaluated for 
possible further intervention so that they can achieve values that are 
associated with better outcomes. It is understood that guidelines and 
standards, although evidence-based, are not appropriate for all 
patients in all situations. Thus these minimum thresholds serve as 
indicators for potential quality improvement activity.
    We are proposing that outcomes specified in the patient plan of 
care must allow the patient to achieve current evidence-based 
community-accepted standards.
    However, we are soliciting public comments on this issue, and we 
will be guided by those comments in reaching a final determination on 
whether to require minimum threshold values for the patient plan of 
care as we develop the final rule for new ESRD conditions for coverage.
1. Development of the Patient Plan Of Care (Proposed Sec.  494.90(a))
    In developing this proposed rule, we determined that there is 
sufficient evidence to support the inclusion of minimum set of 
evaluative categories in the patient plan of care that have been shown 
by independent medical research to be important in achieving desirable 
patient outcomes. We are proposing (in Sec.  494.90) that the patient 
plan of care must, at a minimum, address: (1) Dose of dialysis; (2) 
nutritional status; (3) anemia; (4) vascular access; (5) 
transplantation status; and (6) rehabilitation status. Each of these 
elements is discussed below.
a. Dose of Dialysis (Proposed Sec.  494.90(a)(1))
    There is a consensus in the renal community that adequacy of 
dialysis in terms of a Kt/V is an important clinical performance 
measure and the vast majority of dialysis facilities do use minimal 
target levels or goal levels or both to ensure delivery of quality 
care. We are proposing in Sec.  494.90(a)(1) that the patient's 
interdisciplinary team assist and support the hemodialysis and 
peritoneal dialysis patient in achieving and maintaining an adequate 
dose of dialysis that meets evidence-based community-accepted standards 
as specified by the Secretary. We are soliciting comments on the 
possible use and appropriate minimum threshold values for the adequacy 
of dialysis.
b. Nutritional Status (Proposed Sec.  494.90(a)(2))
    Existing Sec.  405.2163(d) states that the dietitian, in 
consultation with the attending physician, is responsible for assessing 
the nutritional and dietetic needs of each patient, recommending 
therapeutic diets, counseling on prescribed diets, and monitoring 
adherence and response to diets.
    Our proposed requirement on nutrition at Sec.  494.90(a)(2) would 
require the interdisciplinary team to provide the necessary care and 
services to achieve and sustain an effective nutritional status. 
Effective nutritional status encompasses acceptable levels of protein, 
calorie, and fluid intake as well as acceptable levels of nutrients in 
the blood. We did specify that one patient plan of care nutritional 
measure, the serum albumin (a marker of visceral protein stores), must 
be monitored on a monthly basis to reflect current standards of 
practice.
    The National Institutes of Health (NIH), in its Consensus 
Conference Report entitled ``Morbidity and Mortality of Dialysis,'' 
identified nutritional status as an important indication of the renal 
patient's health (DHHS/NIH, pp.1-33). We recognize that nutrition plays 
an important role in the management of renal disease. However, we have 
found diverse opinions about using an objective measure as a clinical 
outcome measure for nutritional status. Potential clinical outcome 
measures of nutritional status include anthropometric measures, 
clinical signs of nutrient deficiency, urea kinetic modeling, 
prognostic nutrition indexing, and measurement of biochemical 
parameters. The NKF-K/DOQI clinical practice guidelines for Nutrition 
of Chronic Renal Failure (Guideline 1) state that, ``there is no single 
measure that provides a comprehensive indication of protein-energy 
nutritional status.'' (NKF, pp. S17.) NKF-K/DOQI guideline 3 further 
states that, ``serum albumin is a valid and clinically useful measure 
of protein-energy nutritional status in maintenance dialysis 
patients.'' (NKF, pp. S20.)
    We invite comments on whether any additional specific nutritional 
outcome measures, such as other biochemical parameters of serum protein 
(total protein, transferrin, or prealbumin), or the protein catabolic 
rate or protein equivalent of total nitrogen appearance measure should 
be used as a patient plan of care outcome measure.
c. Anemia (Proposed Sec.  494.90(a)(3))
    Proposed Sec.  494.90(a)(3) uses anemia, as measured by the 
hematocrit (or comparable hemoglobin) level, as a specified patient 
outcome. There is a consensus in the community that the use of 
hemoglobin, hematocrit or both to monitor anemia management are 
important clinical performance measures and the vast majority of 
dialysis facilities do use minimal target levels or goal levels or both 
for these measures to manage anemia in the dialysis patient. In Sec.  
494.90(a)(3) we propose that the patient's interdisciplinary team 
assist and support the hemodialysis and peritoneal dialysis patient in 
achieving and maintaining the expected hemoglobin/hematocrit level. The 
hemoglobin or hematocrit level must be measured at least monthly, as is 
the current standard practice. We are soliciting comments on

[[Page 6207]]

the possible use and appropriate minimum threshold values for anemia 
management.
    Existing Sec.  405.2163(g) address the patient's hematocrit or 
comparable hemoglobin level as a marker for the necessity for 
administering erythropoietin at home. The assessment criteria include: 
(1) Preselection monitoring (lab values and blood pressure); (2) 
hematocrit or comparable hemoglobin level less than 30 percent or 
medical justification for a higher hematocrit or comparable hemoglobin 
level; (3) a target hematocrit or comparable hemoglobin range for a 
patient receiving erythropoietin of 30 to 33 percent; and (4) the 
patient is under the care of a physician responsible for dialysis-
related services. There are also additional process requirements. We 
are eliminating some of these process requirements and proposing that 
each patient be evaluated for anemia as specified in the patient 
assessment condition at Sec.  494.80(a)(4). We are also proposing that 
any patient with a hematocrit of less than 33 percent or a hemoglobin 
of less than 11 gm/dL must be evaluated as a candidate for 
erythropoietin use. For home dialysis patients, we are proposing that 
the facility evaluate whether the patient can be trained to safely, 
aseptically and effectively administer erythropoietin, and store 
erythropoietin under refrigeration. The patient's response to 
erythropoietin, including blood pressure levels and the patient's 
utilization of iron stores, must be monitored on a routine basis.
    Section 1881(b)(1)(C) of the Act specifies that the patient self-
administering erythropoietin must be able to safely and effectively 
administer the drug in accordance with the applicable methods and 
standards established by the Secretary. Section 1861(s)(2)(O) of the 
Act states that Medicare will pay for erythropoietin as ``medical and 
other services'' if the patient self-administers the drug ``subject to 
methods and standards established by the Secretary by regulation for 
the safe and effective use of such drug. * * *'' Section 405.2163(g)(2) 
and (3) of the existing regulations specify the applicable methods as 
established by the Secretary. In keeping with our outcome-oriented 
focus, we are proposing to retain only those specific evaluation 
criteria that are clinically necessary and supported by the NKF-K/DOQI 
Clinical Practice Guidelines for Anemia of Chronic Kidney Disease, 2000 
Update. Also, we are not proposing to retain all of the requirements in 
existing Sec.  405.2137(b)(7) relating to the plan providing for 
monitoring home use of erythropoietin. We believe these requirements 
are unduly prescriptive and may not reflect the most appropriate items 
to monitor for each individual patient. We want to provide flexibility 
to a facility to develop its own criteria to monitor all patients who 
are using erythropoietin.
    In Sec.  494.90(a)(3) we are proposing to provide the facility with 
the flexibility to develop their own assessment and patient plan of 
care criteria for patients for whom the use of erythropoietin would be 
appropriate. In addition, we are proposing in Sec.  494.90(a)(3) that a 
dialysis patient's response, including blood pressure and utilization 
of iron stores, to erythropoietin must be monitored on a routine basis. 
The patient plan of care should ensure that the patient is trained and 
is competent to safely, aseptically, and effectively administer the 
drug; provide for monitoring and safe refrigerated storage for home use 
of erythropoietin; and target appropriate hematocrit or hemoglobin 
levels.
d. Vascular Access (Proposed Sec.  494.90(a)(4))
    Our existing regulations do not contain any specific requirements 
pertaining to hemodialysis vascular access. We note that the 
hemodialysis procedure is dependent on the availability of a patent 
vascular access. According to data from the United States Renal Data 
System access failure is the second most frequent cause of 
hospitalization among ESRD patients. Access failure is also one of the 
significant contributors to hemodialysis patient morbidity. The costs 
of vascular access failure are also significant. In 1999 the total 
Medicare ESRD program expenditure for vascular graft failure was more 
than $97 million. Dialysis facilities may not have complete control 
over the type and placement of the access. However, it has been 
demonstrated that efforts to improve access patency can help to extend 
the life of an access. The NKF-K/DOQI provides vascular access clinical 
practice guidelines that address the importance of access monitoring 
and methods for improving the quality of patient care in this area 
(NKF, pp. S137-S181).
    Therefore, we are proposing in Sec.  494.90(a)(4) to include 
vascular access as a component of the patient plan of care with the 
following requirements for the interdisciplinary team:
     Evaluation of the hemodialysis patient for the appropriate 
vascular access type, taking into consideration co-morbid conditions 
and other risk factors.
     Support and assist the patient in achieving and 
maintaining vascular access patency.
     Routinely monitor the hemodialysis patient's vascular 
access to prevent access failure, including routine monitoring of 
artiovenous grafts and fistulae for stenosis.
e. Transplantation Status (Proposed Sec.  494.90(a)(5))
    Although we are proposing to remove the existing requirements for a 
separate long-term program from the conditions (see Sec.  405.2137), we 
are proposing in Sec.  494.90(a)(5) to retain the concept of transplant 
planning. Within the plan of care, the interdisciplinary team must 
address whether the patient is a transplant candidate and identify the 
plan for obtaining a transplant. The plan and the actions necessary to 
make the transplant a reality must be addressed in the plan of care. 
Necessary actions would include, for example, patient transplant 
referral for evaluation by a transplant center, communication with the 
transplant center, and monthly blood draws for antigen/antibody 
testing. We are soliciting public comment on whether the ``necessary 
actions'' listed above should be a requirement for dialysis facilities.
    When the patient is not suitable for transplantation referral 
evaluation, the reason for nonreferral must be written in the patient's 
assessment and notated in the patient plan of care. The reason(s) for 
nonreferral must be consistent with the criteria developed by the 
prospective transplantation center and surgeon. In cases when the 
patient meets the transplantation criteria but declines referral, there 
must be documentation in the patient plan of care that the patient has 
made an informed decision to decline renal transplantation.
f. Rehabilitation Status (Proposed Sec.  494.90(a)(6))
    Existing Sec.  405.2163 includes rehabilitation-related activities 
under the minimal service requirements for social services. Advances in 
technology and pharmacology have offered the possibility of significant 
improvements in the well-being of dialysis patients. More efficient 
dialysis equipment, the development of the synthetic hormone 
erythropoietin and active vitamin D, for example, represent important 
breakthroughs in quality-of-life areas. However, despite this improved 
potential for restoration, it is generally acknowledged that renal 
rehabilitation has not yet been addressed nationally in

[[Page 6208]]

a consistent, integrated fashion. Therefore, we are proposing to focus 
on rehabilitation outcomes through this requirement.
    For dialysis patients, rehabilitation means restoring the mind and 
body to encourage the individual to maintain as full and active a life 
as possible. The Life Options Rehabilitation Advisory Council has 
defined the ideal process of rehabilitation for a dialysis patient as a 
coordinated program of adequate dialysis, education, counseling, and 
dietary regimens designed to maximize the vocational potential, 
functional status, and quality of life of dialysis patients (The Life 
Options Rehabilitation Advisory Council, p. 20). The ultimate goals of 
renal rehabilitation include employment for those who can work, 
enhanced physical fitness, increased individual control over the 
effects of kidney disease and dialysis, and the ability to maintain as 
active a lifestyle as possible. Many renal professionals equate 
successful renal rehabilitation with employment, in part because 
employment can be readily measured and documented, but factors other 
than employment must be examined in a complete discussion of 
rehabilitation or functional status of dialysis patients.
    Comprehensive rehabilitation efforts can make the difference 
between an acceptable quality of life and mere existence. The improved 
overall health and outlook of successfully rehabilitated patients may 
have positive cost implications as well (Stewart, pp. 907-913). 
Patients who are rehabilitated to the point of employment may be able 
to offset Medicare costs, subject to Part 411, Subpart F, of our rules, 
if they have health insurance through their employment that would cover 
the costs of ESRD treatment in place of Medicare. Patients whose 
physical health improves to the point when they can manage self-care 
activities may allow an adult caregiver to re-enter the workforce. Even 
patients who cannot care for themselves, but whose outlook and quality 
of life are improved, can experience positive health consequences that 
reduce costs; thus keeping patients at home rather than in nursing 
homes decreases the costs of care as well. And costs notwithstanding, 
the achievement of these improvements in the patient's condition is 
inherently invaluable. (The Life Options Rehabilitation Advisory 
Council, p. 20).
    Rehabilitation cannot be ``done to'' the patient. Active patient 
participation in rehabilitation is key to the success of any 
rehabilitation effort. Facility staff must inform and educate patients 
that their participation in rehabilitation programs is critical to 
their well being, ongoing treatment, and attainment of a successful 
adjustment to their condition. The patient's responsibility to 
participate in rehabilitation efforts is no less essential than her or 
his compliance with any aspect of the management of her or his care.
    In this proposed rule, we are separating the rehabilitation 
requirements (proposed Sec.  494.90(a)(6)) into a distinct plan of care 
category, and we are implicitly extending the definition of 
rehabilitation to include education. We have chosen to include 
rehabilitation as a specific category because we want the 
interdisciplinary team to focus on providing patients with the 
opportunity and the education for rehabilitation. In addition, staff 
attitudes about rehabilitation may have a correlation to patients' own 
attitudes about their potential to regain functional status.
    It is not sufficient for facility staff to merely provide 
information about rehabilitation to patients. Rather, the essential 
role of rehabilitation in the treatment and recovery process must be 
continuously conveyed to patients and their families. To that end, the 
proposed requirement for rehabilitation status requires that the 
interdisciplinary team play a critical role in supporting the patient 
and advising the patient on his or her rehabilitative efforts. 
Specifically, the interdisciplinary team must provide the necessary 
care and services for the patient to achieve and maintain an 
appropriate level of productive activity, including vocational, that 
permits the patient to resume, to the extent feasible, activities 
engaged in prior to kidney failure. As part of this requirement, 
rehabilitation should be included in the patient's treatment 
prescription; the patient's involvement in rehabilitation activities 
should be incorporated in patient education materials; and facility 
patient support groups focusing on rehabilitation activities could be 
offered. Under this condition, facility staff should encourage and 
educate patients on the benefits of rehabilitation. The importance of 
rehabilitation as part of the treatment and recovery process must be 
conveyed, so patients come to recognize it as a benefit to themselves. 
The team must reinforce activities that lead to successful 
rehabilitation. The interdisciplinary team must provide care and 
services to younger patients to enhance the possibility of a successful 
transition to adult life and responsibilities. Although rehabilitation 
services may not be needed by pediatric patients, there may be 
educational needs and developmental needs that the interdisciplinary 
team must consider when writing and implementing the patient plan of 
care.
    This proposed condition does not hold facilities accountable for 
rehabilitative outcomes that are beyond their control; instead, this 
proposed standard requires that interdisciplinary team staff use a 
combination of medical treatment, education, counseling, and dietary 
regimens to maximize dialysis patients' rehabilitation activity. 
Patients may be able to lead more active and productive lives if other 
rehabilitation interventions such as physical, occupational, and 
recreational therapy, counseling, and education are made available to 
them on a regular basis. Joint goal-setting by informed patients and 
the facility staff assists this process. We believe the 
interdisciplinary team should refer patients to appropriate agencies 
and health professionals for additional services that the facility 
cannot provide.
    This proposed rule does not incorporate the use of any particular 
measure of rehabilitation status because we do not believe there is 
consensus in the renal community about a specific measurement at this 
time.
g. Social Services
    We would like to specify social service outcomes that must be 
included in the patient plan of care. However, we believe the social 
worker should identify social service outcomes based on the patient 
assessment (described at Sec.  494.80(a)) as part of the plan of care 
goals for each patient.
    Complex emotional and social factors affect the dialysis patient, 
including, but not limited to, changes in self-image, loss of 
independence, changes in financial security, loss of physical 
integrity, problems with sexual functioning, changes in roles, and 
coping with the anxiety and discomfort associated with treatment. We 
believe that the interdisciplinary team could influence many of these 
factors. We are soliciting comment regarding the most effective way to 
address these factors within a patient plan of care requirement that 
supports an effective level of emotional and social well-being for the 
patient.
    Work is being done on a variety of assessment instruments that 
could measure the emotional and social well-being of patients. We 
considered the current experiences with such instruments as the Kidney 
Dialysis Quality of Life instrument, the RAND Short Form-36, and the 
Duke Health Profile ((Hays, pp. 329-338); (Rand Corporation, (1997)); 
and (Parkerson, pp. 1056-1069), respectively). However, at this time we 
do not believe that there

[[Page 6209]]

is a consensus on a single instrument or a level of psychosocial 
achievement for dialysis patients that could be included as a specific 
measure for a patient plan of care requirement.
    As specified in existing Sec.  405.2163(c), the social worker is 
responsible for counseling the patient and the patient's family, 
assisting the patient with the emotional adjustment to ESRD and 
dialysis treatment, performing crisis intervention, coordinating 
referrals and other community services, and arranging other benefits. 
Social workers can, in some instances, provide some of the necessary 
care and services for the patient to achieve and sustain an effective 
level of emotional and social well-being. For example, a necessary care 
and services component of social services is facility staff counseling 
and educating the patient and providing necessary information for the 
patient to have a smooth transition to life on dialysis. The social 
worker has an important role in addressing patient behavior that may be 
challenging or disruptive. The social worker is uniquely qualified to 
provide counseling, anger management, and emotional support services to 
patients with ESRD. In cases in which the social worker is not able to 
provide the necessary services for the patient to adapt to dialysis 
treatment, the social worker should refer patients to appropriate 
agencies and health professionals for additional services. We are 
soliciting comments regarding the potential for an outcome-based 
requirement for social services in the patient plan of care.
2. Implementation of the Patient Plan of Care (Proposed Sec.  
494.90(b))
    The patient plan of care stems from the patient comprehensive 
assessment that identifies patient care needs. Proposed Sec.  
494.90(b)(1) would require that the patient's plan of care be completed 
by the interdisciplinary team, signed by the patient or the patient's 
designee, and implementation must begin within 10 calendar days after 
an assessment is completed. As stated in the patient assessment 
condition, the facility interdisciplinary team has 20 days from the 
initiation of dialysis treatment to complete the comprehensive 
assessment. After the assessment has been completed, the 
interdisciplinary team has 10 days to develop the patient's plan of 
care. This gives the dialysis facility a maximum of 30 days to complete 
the comprehensive assessment and the patient plan of care. We selected 
10 days for completion of the patient care plan because the plan 
directs the patient's treatment, and therefore, the plan of care should 
be initiated as soon as possible. Clearly, we are limiting a facility's 
flexibility when we identify a timeframe for development of the plan of 
care. However, we believe that a timely, accurate, comprehensive plan 
of care is critical for planning patient care and achieving desired 
health care outcomes. We believe that a maximum of 30 days to complete 
the assessment and patient plan of care is ample time, considering the 
seriousness of the condition that necessitates the dialysis. We are 
soliciting comments on both the appropriateness of prescribing a 
timeframe as well as the suitability of the proposed timeframe.
    We propose at Sec.  494.80(d) that patients be reassessed as needed 
but no less frequently than annually. The patient plan of care would 
also be reviewed at least annually since we are proposing that every 
comprehensive assessment must be followed by completion and 
implementation of the plan of care. Existing Sec.  405.2137(b)(4) 
states that care planning is conducted monthly for unstable patients 
and every 6 months for those patients who have become stabilized. While 
we have retained patient plan of care monthly timeframes for unstable 
patients (proposed at Sec.  494.80(d)(2)), we believe that the 6-month 
review requirement for stable patients may be unnecessarily burdensome.
    The individualized patient plan of care is not static and will 
require adjustments as the needs of the patient change, particularly if 
the patient is not stable. We propose at Sec.  494.90(b)(3) that the 
interdisciplinary team must adjust the patient plan of care to achieve 
and sustain the specified patient outcomes goals. New strategies may 
need to be implemented as assessment, response, and patient preference 
information requires. If the targeted plan of care goal is achievable 
but is not being attained, the facility must implement an improvement 
plan to reach the 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 compliance. Further, we recognize that health 
care delivery is dynamic and that all patients may not 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. The 
explanation for not achieving the specific level of care may include 
patient preferences and patient noncompliance.
    Proposed Sec.  494.90(b)(4) would specify that the facility must 
ensure every patient is seen at least monthly by a physician providing 
the ESRD care as evidenced by a monthly progress note that is either 
written in the beneficiary's medical record by the physician or 
communicated from the physician's office and placed in the 
beneficiary's medical record. We are proposing this requirement based 
on a continuing concern of beneficiaries regarding the amount of 
interaction between patients and their physicians. We chose the time 
period of at least once a month because physicians have traditionally 
been paid for their services to renal patients on a monthly basis 
through the monthly capitation payment. Patients who are not stable 
will need to see the physician more frequently than our proposed 
minimal timeframe. According to preliminary information from the 
Dialysis Outcomes and Practice Patterns Study (DOPPS), better patient 
outcomes are associated with high levels of patient contact from the 
physician. Almost 70 percent of the dialysis patients sampled in the 
United States, as part of the DOPPS, see their physician once per week 
or more frequently, as reported by the nurse. However, we are concerned 
about the suggestion that as many as 5 percent of the dialysis patients 
may see their physician less often than once a month. While we are 
proposing a minimum monthly physician visit (without specifying any 
duration for the visit itself), we do not want to discourage more 
frequent visits. On November 7, 2003, we published a final rule (68 FR 
63196, 63216) regarding the revisions to the payment policies under the 
physician fee schedule for calendar year 2004. This rule aligns payment 
incentives with the frequency of the physician's evaluation of the 
dialysis patient. In addition, the rule assigned new G codes that 
associate a higher payment to a physician who provides more visits 
within each month to an ESRD patient. Physicians should see patients 
and monitor their care as often as is medically necessary to ensure 
that they are progressing towards the specified outcomes.
    We believe it is important for physicians to see in-center 
hemodialysis patients periodically while they are undergoing dialysis 
in order to monitor the quality of care they are receiving and to 
address the patient's particular clinical concerns and needs while in 
the treatment environment. We believe

[[Page 6210]]

periodic in-center monitoring by the patient's hemodialysis physician 
is an accepted medical practice and would not impose any additional 
burden on dialysis facilities. We are soliciting comments regarding 
whether physicians should be required to see their in-center patients 
periodically while those patients are being dialyzed in the dialysis 
facility. Such in-center visits would not be in addition to the monthly 
requirement proposed in Sec.  494.90(b)(4).
3. Transplantation Referral Tracking (Proposed Sec.  494.90(c))
    We are proposing at Sec.  494.90(c) that the interdisciplinary team 
track the results of each kidney transplant center referral and monitor 
the status of any facility patients who are on the transplant wait 
list. The routine exchange of information between the dialysis facility 
and the transplant center is important so that both facilities know who 
is active on the transplant wait list, who is temporarily or 
permanently inactive, and who is under evaluation. In addition, there 
may be a need to coordinate histocompatibility testing, which must be 
completed on a monthly basis. We invite comment on the coordination of 
the transplant process and the method and frequency of communication 
with the transplantation center.
4. Patient Education and Training (Proposed Sec.  494.90(d))
    The existing regulations do not specifically address patient 
education and training for in-center patients. However, in Sec.  
494.90(d), we are proposing to stipulate that the patient plan of care 
must include, as applicable, education and training for patients and 
families in all relevant aspects of the dialysis experience, dialysis 
management, quality of life, rehabilitation, and education regarding 
renal transplantation. When kidneys fail, the resulting physical 
changes stimulate a chain of psychological and physiological events 
that alter the lives of the affected individuals and their families. 
The education of patients and their families goes beyond providing the 
necessary information for patients to make an informed choice regarding 
treatment modality. Because the life changes associated with beginning 
dialysis are so profound, patients and their families need to be 
educated and trained about strategies for successful adaptation to 
dialysis, optimizing functional status, employment options, and many 
other issues. Patients and their families must learn about the disease 
and the possibilities of life beyond it and then assume responsibility 
for their own health by complying with the treatment plan and 
participating actively in rehabilitation activities. Educating and 
training patients and their families is key to a successful transition 
to a life with dialysis.
    However, not all elements of the existing Sec.  405.2137 will be 
retained in proposed Sec.  494.90. In accordance with our approach to 
consolidate all similar standards, we propose to move the requirements 
in existing Sec.  405.2137(b)(5) regarding the transfer of the 
patient's medical records to the proposed medical records condition for 
coverage (Sec.  494.170), and move the requirements in existing Sec.  
405.2137(b)(6) regarding the monitoring of home dialysis patients to 
the proposed Care at Home condition for coverage (Sec.  494.100). We 
believe that this reclassification will improve the proposed 
regulation's organization.

D. Condition: Care at Home (Proposed Sec.  494.100)

[If you choose to comment on issues in this section please include the 
caption ``Care at Home'' at the beginning of your comments.]
1. Dialysis of the ESRD Patient in the Home Setting
    Home dialysis has been shown to have a positive effect on a 
patient's quality of life. Home dialysis affords the patient control 
over the scheduling and setting; it can be done in comfortable, 
familiar surroundings; and it is less disruptive to family life and 
employment than in-center dialysis.
    The existing requirements for home dialysis are located in four 
sections: (1) Definitions (Sec.  405.2102); (2) patient care plan 
(Sec.  405.2137(b)); (3) medical records (Sec.  405.2139); and (4) 
minimal service requirements (Sec.  405.2163(e) and (g)).
    Existing Sec.  405.2102 defines home dialysis as dialysis performed 
by an appropriately trained patient at home.
    Existing Sec.  405.2137(b) states that home dialysis patients will 
receive a written care plan with the same criteria that are specified 
for in-center patients. Section 405.2137(b)(6) requires the ESRD 
facility to conduct periodic monitoring of the patient's home 
adaptation, including visits to the home by ``qualified facility 
personnel'' as appropriate. Section 405.2137(b)(7) contains patient 
care plan requirements that apply to home dialysis patients who use 
erythropoietin, including: (1) Monitoring diet and fluid intake; (2) 
medication usage; (3) hematocrit and iron stores; (4) reevaluations of 
the dialysis prescription; (5) a method for physician follow-up on 
blood tests and a mechanism to inform the physician of the results; (6) 
training the patient to identify signs of hypotension and hypertension; 
and (7) decreasing or discontinuing erythropoietin usage if 
hypertension is uncontrolled.
    Existing Sec.  405.2139 requires facility to maintain ``complete 
medical records'' on all patients, including its home patients. Section 
405.2139(d) contains requirements regarding medical records information 
generated by self-dialysis patients and entries of medical records 
information by trained self-dialysis patients, or ``trained 
assistants,'' countersigned by facility staff.
    Existing Sec. Sec.  405.2163(e)(1) through (6) list a facility's 
home dialysis support services including: (1) Surveillance of the 
patient's home, including periodic visits; (2) consultation for the 
patient with a qualified social worker and qualified dietitian; (3) a 
record keeping system that assures continuity of care; (4) installation 
and maintenance of equipment; (5) testing and appropriate treatment of 
the water; and (6) ordering supplies on an ongoing basis.
    Existing Sec.  405.2163(g)(1) through (4) requires the facility or 
physician responsible to make a comprehensive patient assessment that 
includes the following: (1) Preselection monitoring, including the 
patient's hematocrit (or hemoglobin), serum iron, transferrin 
saturation, serum ferritin, and blood pressure; (2) conditions the 
patient must meet, including a hematocrit (or comparable hemoglobin) 
hematocrit level of 30 percent (for patients initiating erythropoietin 
treatment), or a level of 30 to 33 percent (for patients already under 
the care of a dialysis facility or physician); (3) a requirement that 
patients or caregivers must be trained to inject erythropoietin, read 
and understand drug labeling, and observe aseptic techniques; and (4) 
the assessment must find that erythropoietin can be refrigerated in the 
patient's residence and potential risks and hazards related to the drug 
and syringes are understood by the patient.
    In Sec.  494.100, we proposed requirements that are only applicable 
to home dialysis. Since not every facility chooses to provide home 
dialysis, this condition would apply only to a facility that provides 
these services.
    We propose in the opening paragraph of Sec.  494.100 to retain the 
implicit requirement in existing Sec.  405.2163 that services to home 
patients are at least equivalent to those provided to in-center 
patients. Home dialysis patients are patients of the ESRD facility; and 
therefore, they are entitled to the same rights, services, and efforts 
to achieve

[[Page 6211]]

expected patient outcomes as any other patient of the facility.
    We are proposing to address home dialysis training in Sec.  
494.100(a). In our deliberations regarding home dialysis training 
requirements, we took into account the considerable lifestyle changes 
associated with initiating home dialysis and the unique needs of 
patients and caregivers engaged in home dialysis. Patients and their 
caregivers need to be trained and educated about strategies for 
successfully adapting to dialysis at home, ways to optimize functional 
status, proper self-dialysis procedures, and many other issues. 
Therefore, the processes of educating and training patients and their 
caregivers are crucial to a successful transition to a life with 
dialysis and to achieving good patient care outcomes.
    In the opening paragraph of Sec.  494.100(a), we are proposing that 
before the initiation of home dialysis, when the caregiver changes, or 
when the home modality changes, that the facility's interdisciplinary 
team is responsible for providing self-dialysis training to the home 
patient, the patient's designated caregiver, or both. Self-dialysis (as 
defined in existing Sec.  405.2102(b)(2)(ii) and proposed Sec.  494.10) 
means dialysis performed with little or no professional assistance by 
an ESRD patient who has completed an appropriate course of training. 
Home dialysis training may be only be provided by a dialysis facility 
certified to provide home dialysis services. Durable medical equipment 
(DME) companies cannot provide home dialysis training. We are proposing 
in Sec.  494.100(a)(1) to modify the existing requirement at Sec.  
405.2102(d)(3) that self-dialysis training must be conducted by a 
registered nurse with 18 months of clinical experience and at least 3 
months of specialized experience in training dialysis patients in self-
care. We are proposing to modify these requirements to state that self-
care training must be conducted by a registered nurse who meets the 
personnel qualifications specified in Sec.  494.140(b)(2) (that is, 12 
months clinical experience and an additional 3 months of clinical 
experience in the specific modality for which the registered nurse will 
provide training). As previously stated, home dialysis training is 
crucial to achieving desired patient outcomes; and therefore, we 
believe the initial training a patient receives must be provided by an 
experienced health care professional.
    Existing Sec.  405.2102 requires that a facility provide a training 
program for self-dialysis and home dialysis patients, if it chooses to 
provide this service, but it does not specify the content of that 
training program. Therefore, we are proposing the following subject 
areas for home dialysis training programs in Sec. Sec.  
494.100(a)(3)(i) through (a)(3)(x). These types of programs would, at a 
minimum, be required to provide training in the following:
     The nature and management of ESRD.
     The full range of techniques associated with the 
applicable type of home dialysis, including effective use of dialysis 
supplies and equipment in achieving the physician's prescription of Kt/
V or URR, and effective erythropoietin administration (if prescribed) 
to achieve a hematocrit level of at least 33 percent or a hemoglobin 
level of 11 gm/dl.
     Nutritional care planning.
     Achieving and maintaining emotional and social well-being.
     How to detect, report, and manage potential complications.
     Availability of support services and how to access and use 
available support services.
     How to self-monitor health status and record and report 
health status information.
     How to handle medical and non-medical emergencies.
     Infection control precautions.
     Proper waste storage and disposal procedures.
    While we recognize that specifying the topics for a training 
program appears to be inconsistent with our goal of reducing process-
oriented requirements, we believe it is critical and necessary that the 
items listed above be required, so that patients and caregivers are 
fully informed regarding the health and safety procedures that must be 
followed and precautions that must be taken when providing dialysis at 
home.
    Home patients are not seen 3 times a week by facility staff like 
in-center patients; and therefore, the quality and content of home 
training given to patients and their caregivers is an extension of the 
care and monitoring that would normally be provided in the dialysis 
facility. In addition, the facility is responsible for ensuring that 
home dialysis patients are achieving the desired outcomes, and this 
training will inform home care patients or their caregivers or both of 
the plan of care that must be followed (see proposed Sec.  494.90) to 
achieve the expected results.
    We propose in Sec. Sec.  494.100(b)(1) through (3) that the 
dialysis facility: (1) Record who received the training described in 
Sec.  494.100(a)(3) and indicate that the patient or caregiver 
demonstrated adequate comprehension; (2) retrieve and review self-
monitoring data from patients or caregivers at least every 2 months; 
and (3) maintain this information in the patient's medical record. The 
goal of the proposed standards is that facilities effectively 
coordinate the care of all patients, including home dialysis patients, 
to achieve the desired outcomes. As previously stated, we recognize 
that home patients do not see facility staff as frequently as in-
facility patients, so the purpose of this proposed requirement is to 
ensure that the facility's interdisciplinary team periodically monitors 
the care of home dialysis patients' plans of care.
    Existing Sec.  405.2139(d) requires dialysis facilities to collect 
medical information generated by self-dialysis patients, but it does 
not specify the frequency of the data collection. By proposing at Sec.  
494.100(b)(2) that the home patient's facility collect and review 
information at least every 2 months, we ensure the interdisciplinary 
team can determine if the patient is having problems with any aspect of 
the dialysis therapy at regular intervals. We would recommend that the 
facility collect data that will enable it to determine if home patients 
are adhering to the plan of care and achieving expected outcomes. Based 
on the data received, the facility staff can determine if the patient 
or caregiver needs to be retrained or, in some cases, determine that 
the patient is no longer a suitable candidate for self-care dialysis. 
As with in-facility patients, the goal of collecting data on home 
dialysis patients is to ensure that they are achieving the expected 
outcomes.
    We propose to retain many of the existing support services 
requirements at Sec.  405.2163(e) in proposed Sec.  494.100(c). We have 
always taken the view that the law and the regulations require that the 
facility provide all of these support services, regardless of whether 
the dialysis supplies are provided by the dialysis facility or a 
durable medical equipment (DME) company, to the extent that they are 
medically necessary for a beneficiary's care. In addition to meeting 
other requirements, the proposed Care at Home condition is intended to 
assure that home dialysis patients, including those residing in nursing 
facilities (NFs) or skilled nursing facilities (SNFs), are receiving 
care that is comparable to the care provided to in-facility patients. 
Thus, the support services provided to home dialysis patients should 
parallel the treatment provided to patients in a dialysis facility.
    We are proposing in Sec.  494.100(c)(1)(i) to retain the existing 
requirements at

[[Page 6212]]

Sec.  405.2137(b)(6) regarding periodic surveillance of the patient's 
home adaptation, including provisions for visits to the home by 
facility personnel.
    In addition, we are proposing in Sec. Sec.  494.100(c)(1)(ii) 
through (iv) to retain existing requirements in Sec. Sec.  405.2137(b) 
and 405.2163(e) to: (1) Coordinate the home patient's care by a member 
of the facility interdisciplinary team; (2) develop and periodically 
review the patient's plan of care (see Sec.  494.90) to address the 
patient's needs and achieve expected outcomes of care; and (3) consult 
with the members of the interdisciplinary team as needed.
    Existing Sec.  405.2163(e)(2) requires consultation with a 
qualified social worker and dietitian. We are proposing in Sec.  
494.100(c)(1)(iv) to strengthen this requirement by including any 
member of the patient's interdisciplinary team because some home 
dialysis patients may experience problems or have needs that require 
consultation with several members of the interdisciplinary team, and we 
do not want to limit their access to appropriate care. In addition, we 
recognize that patients who are new to dialysis therapy need a period 
to adjust and adapt to their treatment. Initially patients may 
experience anxiety while learning self-care skills, how to perform the 
dialysis treatment, how to modify their diet, and how to change their 
behavior.
    We also believe the interdisciplinary team must be responsible for 
the development and periodic review of the patient's individualized, 
comprehensive care plan based on the comprehensive assessment (see 
Sec.  494.80) that specifies the services necessary to address the 
patient's needs and includes measurable and expected outcomes. We are 
proposing in Sec.  494.100(c)(1)(iii) to expand the existing 
requirements by including a statement that the patient's comprehensive 
plan of care will be developed and reviewed by the interdisciplinary 
team to address the patient's needs and to achieve the expected 
outcomes of care. To that end we are encouraging and recommending that 
dialysis facilities adopt the same clinical performance measures for 
home patients as those that are used for in-center patients. As 
previously stated in the discussion of the patient plan of care 
condition for coverage (Sec.  494.90), the goal is to obtain input from 
each member of the interdisciplinary team as well as from the home 
patient so as to develop a comprehensive plan of care that indicates 
the services necessary to address the home patient's needs. The home 
dialysis patient's plan of care should stipulate the services that are 
to be furnished to achieve and maintain the expected outcomes of care.
    We are proposing in Sec.  494.100(c)(1)(v) to retain and expand the 
existing requirement at Sec.  405.2163(e)(5) to monitor the quality of 
the water used by home hemodialysis patients. We are specifically 
including onsite evaluation of the water system. Since we have 
incorporated by reference the AAMI standards regarding water quality at 
Sec.  494.40(a)(1)(i) and (ii), we are also proposing that a facility 
adhere to the applicable AAMI guidelines in determining whether the 
home dialysis patient's water system meets acceptable standards. If 
water supplies are biologically or chemically contaminated, 
contaminants may be passed to the patient during the dialysis session, 
leading to infection or other adverse consequences. Therefore, a 
dialysis facility must monitor the quality of water used in treatments, 
as well as monitor the equipment used in water treatment. Because water 
is one of the most important aspects of health and safety, we are 
proposing in Sec.  494.100(c)(l)(v) to require that the facility 
conduct onsite evaluation of the patient's water system if the AAMI-
specified analysis of the water quality indicates contamination or if 
the home patient demonstrates clinical symptoms associated with water 
contamination. The dialysis facility must ensure that any problems with 
the water treatment system are corrected. If the problem cannot be 
corrected immediately, the dialysis facility must arrange for backup 
dialysis until the water quality at the patient's home can be 
adequately restored.
    We are proposing in Sec.  494.100(c)(1)(vi) to retain the existing 
requirements of section 1881(b)(9) of the Act and Sec. Sec.  
405.2163(e)(4) and (e)(6) of the regulations that require the facility 
to install and maintain medically necessary home dialysis supplies and 
equipment prescribed by the attending physician. In addition, for those 
home patients not receiving equipment and supplies from a DME company 
the dialysis facility must also purchase and deliver the necessary home 
dialysis supplies and equipment.
    Furthermore, we propose in Sec.  494.100(c)(1)(vii) to require the 
facility to plan for and arrange for emergency backup dialysis 
services. This plan should address how emergency situations will be 
dealt with, and should hemodialysis be required, include a plan for 
obtaining this service.
    We are proposing in Sec.  494.100(c)(2) to retain the requirement 
at Sec.  405.2163(e)(3) that a facility maintain a record keeping 
system that promotes continuity of care. The medical record is used for 
diagnosing, treating, and caring for the patient. We believe this 
requirement is vital to the effective coordination of services provided 
to home dialysis patients because the medical record indicates what 
care has actually been provided and what outcomes have been achieved. 
The medical record documents the services provided by the 
interdisciplinary team members and provides an accurate picture of the 
patient's progress in achieving care goals. Further, it provides the 
data for evaluation and documentation of the quality and 
appropriateness of care delivered. Adequate record keeping is vital to 
ensure continuity of care and to ensure that the home dialysis patient 
is receiving quality care.
    In addition, the patient's supplier is often not part of the 
facility staff; and therefore, it may be difficult to ascertain the 
services they provide the home patient. In some instances, the services 
of home patients are not effectively coordinated. As a result, the 
facility staff is often not able to provide comprehensive care to home 
patients, and the quality of care suffers. In an effort to encourage 
facilities to coordinate services effectively, Sec.  
414.330(a)(2)(ii)(C) would require that the patient's supplier report 
to the facility, every 30 days, all services and items furnished to the 
beneficiary so that the information can be documented in the patient's 
medical record. One of our primary goals is to have the care of home 
patients parallel the care of in-facility patients, and this can only 
be accomplished if all information on patient care is reported to the 
facility. We selected 30 days because monthly reporting and billing is 
commonly used by dialysis facilities and by suppliers and we believe 
that this will not produce additional burden. All patient data are 
necessary to effectively evaluate the patient's dialysis prescription 
and make changes to the patient plan of care. A less frequent reporting 
timeframe would compromise efforts to correct deficiencies in the 
patient's plan of care (for example, adjustments to the dialysis 
prescription) by the patient's physician and other necessary corrective 
actions by the patient's interdisciplinary team. We welcome comments on 
the proposed timeframe for the patient's supplier to report to the 
facility.
2. Dialysis of ESRD Patients in Nursing Facilities and Skilled Nursing 
Facilities
    The existing regulations allow hemodialysis to be provided within 
NFs and SNFs when there is a certified

[[Page 6213]]

hemodialysis facility on-site or adjoining the NF or SNF and when the 
patient is a home dialysis patient who has been appropriately trained. 
In a March 19, 2004 letter to State survey agency directors entitled, 
``Clarification of Certification Requirements and Coordination of Care 
for Residents of Long-term (LTC) Facilities Who Receive End Stage Renal 
Disease (ESRD) Services'' (Reference: S&C-04-24), we clarified 
certification requirements and coordination of care expectations for 
residents of LTCs who receive dialysis. On July 8, 2004, we sent State 
survey agency directors and addendum to the March 19, 2004 letter that 
included as an attachment follow-up questions and answers regarding the 
scope of the guidance and the responsibilities of the providers 
(Reference: S&C-04-37). In this proposed rule, we are soliciting 
comments on a wide range of issues affecting the population of patients 
who are nursing home residents and who desire to be dialyzed in the 
nursing home. We have received inquiries as to whether an 
institutionalized setting such as a long-term care facility may be 
considered to be a beneficiary's ``home'' for self-dialysis purposes. 
In the past we have provided guidance in response to these inquiries. 
Home dialysis is currently only an option for NF or SNF patients when 
certain conditions are satisfied: (1) The NF or SNF must be considered 
to be the patient's home (for short NF or SNF stays, such as 
rehabilitation or brief recovery time admissions, the nursing home 
would not be considered the patient's home since the expectation is 
that the patient would soon be discharged and return to their own 
home); (2) the patient (and his or her family member or caregiver) must 
complete the home dialysis training; (3) all home dialysis patients 
must have their own dialysis machine, equipment, and supplies; and (4) 
home dialysis patients must receive their support services from a 
certified dialysis facility.
    Currently the NF or SNF patient who requires hemodialysis may be 
transported to a certified outpatient hemodialysis facility or may 
receive treatment from a certified hemodialysis facility available 
within or adjoining the NF or SNF. We recognize the hardship placed on 
long-term care patients who must be transported to offsite dialysis 
facilities 3 times per week. Since there is potential growth for home 
dialysis in NFs and SNFs because of changing demographics in both the 
ESRD population and the general population, it may be appropriate for 
us to provide further guidance regarding the regulatory expectations 
for the provision of dialysis in the NF or SNF.
    Dialyzing patients in NFs or SNFs without a certified ESRD facility 
within or adjoining the NF or SNF may present both opportunities and 
risks. Dialysis patients who remain in the NF or SNF are less likely to 
miss medication administration, treatment regimens, meals or planned 
activities during time that would otherwise be spent in waiting and 
transportation to and from a dialysis facility. We know that some 
patients would prefer to stay in their residence and dialyze while 
others would prefer to be transported to a certified dialysis facility 
for care. We believe that both choices should be available for NF or 
SNF residents, and we believe that both choices should provide patient 
protections for health and safety. In addition, we believe that 
patients receiving dialysis in a NF or SNF should not be deprived of 
essential services that they would normally receive in an outpatient 
dialysis facility. Finally, we need to assure that, in providing 
hemodialysis treatments in a NF or SNF, the care of other residents in 
the NF or SNF not requiring dialysis is not negatively impacted. We are 
soliciting comments on whether the current home dialysis regulations 
need to be modified to protect this vulnerable population, and if so, 
in what ways and under what particular set of circumstances.
    In the current ESRD regulations, the home dialysis training 
requirement presents a significant barrier in providing home dialysis 
to NF or SNF residents as the patient may be untrainable and may not 
have a ready caregiver who could be co-trained to assist the resident 
in performing dialysis. The patient's role in home dialysis is defined 
at Sec.  405.2102 under the definitions section of the requirements. 
The regulations require the patient to take part in the training. We 
have received correspondence requesting that the home-dialysis training 
requirement be waived for NF or SNF residents. It has been our long-
standing policy to encourage home dialysis. We are also aware of the 
current limitations relative to severely debilitated patients who are 
ineligible for home dialysis based on the training requirement. Given 
the relative acuity of nursing home patients, there are safety concerns 
associated with allowing patients in nursing homes to be home dialysis 
patients. These patients may be less able to voice symptoms/problems 
then the typical ESRD home patient. In addition, the dialysis care of a 
patient who requires nursing home services may be more complex than the 
dialysis care of an independent home dialysis patient, and given their 
frailty, these patients may be more vulnerable than an independent home 
dialysis patient. Because of this, we have significant safety concerns 
about encouraging home dialysis, provided by multiple caregivers, who 
may not have any dialysis experience, in this setting.
    Home dialysis patients may choose to obtain their dialysis supplies 
and equipment from either the dialysis facility that provides the home 
training and support services (Method I payment) or from a DME company 
(Method II payment). The dialysis facility may have more patient 
contact and be more able to determine that necessary supplies are 
provided at the right time and in the right amounts to meet the needs 
of home patients due to the enhanced patient contact. If hemodialysis 
were provided to NF or SNF residents within the home dialysis model, 
these patients would continue to be able to choose between Method I and 
Method II.
    In order to address the issue of home dialysis in the NF or SNF, we 
believe there needs to be clarity about the various roles and 
responsibilities of the certified ESRD facility providing dialysis care 
and the responsibilities of the NF or SNF when there is no certified 
ESRD facility onsite or adjoining the NF or SNF. While we have 
addressed many of these concerns relative to the existing regulations 
through guidance to the State survey agency directors, the important 
issues that we would have to address through new rulemaking and the 
issues on which we request comment are discussed below.
a. Delineation of Responsibility
    We believe the home hemodialysis services provided in a NF or SNF 
should be provided under the direction of a certified dialysis facility 
that is responsible for the dialysis care provided to the ESRD 
patients, for assuring that the NF or SNF is capable of providing 
appropriate pre- and post-dialysis care, and for assuring that there is 
coordination of care between the two entities, that is, the nursing 
home and the ESRD facility. In order to assure that roles and 
responsibilities are clearly delineated prior to the initiation of 
care, we believe there should be a written agreement (specifying 
responsibilities and the coordination of care) between all parties 
providing the care, including the NF or SNF (and the DME supplier, if 
applicable).

[[Page 6214]]

b. Applicable ESRD Conditions for Coverage
    Consideration must be given as to whether home dialysis care 
provided in a NF or SNF must comply with all of the proposed conditions 
for coverage, except Sec.  494.120, that governs special purpose 
dialysis facilities and the specification at Sec.  494.180(d) that 
services must be provided on or contiguous with the premises.
c. Nursing Coverage
    The existing regulations (Sec.  405.2162(b)) require that a 
licensed health professional (for example, physician, registered nurse, 
or licensed practical nurse) experienced in rendering ESRD care is on 
duty to oversee ESRD patient care whenever patients are being dialyzed. 
This proposed rule would require (proposed Sec.  494.180(b)(2)) that a 
registered nurse be on the premises whenever in-center patients are 
being treated. We believe that there would be a comparable risk to 
patient health and safety if a licensed nurse was not on the premises 
of the NF or SNF and available during multiple simultaneous home NF or 
SNF dialysis treatments. Consideration must be given as to whether this 
registered nurse could be a NF or SNF registered nurse trained by the 
ESRD facility, or a registered nurse provided by the ESRD facility to 
be available during NF or SNF hemodialysis treatments.
    If the NF or SNF were allowed to provide this registered nurse to 
be available during hemodialysis treatments then the implications for 
care (requiring registered nurse attention) provided to other NF or SNF 
residents must be considered. We are considering whether a limitation 
of the NF or SNF registered nurse's duties is necessary, so that the 
nurse is available to meet dialysis needs while another nurse tends to 
the NF or SNF residents (for example, such as the absence of direct NF 
or SNF resident care responsibilities and allowance of only 
administrative duties). When considering whether the NF or SNF 
registered nurse may be the licensed individual responsible for 
overseeing resident care when residents are being dialyzed, the 
provision of training by the ESRD facility for this individual also 
must be addressed.
    While the registered nurse would oversee the dialysis, a trained 
caregiver would administer the dialysis treatment. In a typical home 
dialysis patient situation, the ratio of patient to caregiver is one-
to-one. We solicit comments on whether we should address patient to 
caregiver ratios in a situation when the NF or SNF is considered the 
patient's residence.
d. Training
    We believe that training provided by the certified ESRD facility 
should be specified and the ESRD facility should be responsible for 
providing training to NF or SNF staff and to all caregivers who will be 
working with the ESRD patients. These caregivers could possibly include 
the nursing and support staff of the residential institution, dialysis 
facility nurses and patient care technicians, and the caretaker that 
may be provided by the DME supplier, if available and the patient is a 
Method II home dialysis patient. We note that Medicare does not provide 
additional reimbursement for caregiver services within the current 
payment system. We believe that caregiver-training requirements that 
are similar to the training specifications for home dialysis patients 
may be appropriate.
e. Monitoring
    If we were to propose requirements on this topic, we believe that 
the certified ESRD facility should be responsible for monitoring the 
care of the ESRD patient in the NF or SNF. We also believe that the 
dialysis facility should assure that trained caregivers be present in 
the room with the patient at all times while the hemodialysis is being 
provided. This ensures that a knowledgeable individual is available to 
assist the patient if any problems arise.
    We believe that the ESRD facility should--(1) periodically assess 
the ability of the staff (NF or SNF staff and caregiver) responsible 
for care of the ESRD patient to assure that they are competent in their 
tasks; (2) retrieve and review complete data, including laboratory 
data, clinical data, outcome data, and interdisciplinary team notes to 
assure that adequate care is being provided; (3) monitor the care of 
the patients, using appropriate clinical standards; and (4) work with 
the NF or SNF staff to monitor whether dialysis treatments being 
provided in the nursing home negatively impact the care of other NF or 
SNF residents and correct such impact as appropriate.
    We believe that the dialysis facility should ensure that care being 
provided to patients receiving dialysis in a NF or SNF is comparable to 
the care provided to facility patients. Thus, the support services 
provided to NF or SNF residents should parallel the treatment provided 
to patients in a dialysis facility. Therefore, we believe that the 
dialysis facility providing dialysis in a NF or SNF must also: (1) 
Provide periodic monitoring of the institutional residence to assure 
that appropriate care is being provided; (2) provide monitoring of 
supplies and equipment; (3) maintain medical records in both the NF or 
SNF and at the certified ESRD facility; and (4) assure that patient 
rights are protected as they would be in a dialysis facility, including 
access to a formal grievance process by the patient or the patient's 
guardian or advocate.
    We want to ensure that the health and safety of NF or SNF 
hemodialysis patients is protected and so we are soliciting comment on 
the provision of hemodialysis in the NF or SNF on the issues discussed 
above. Specifically, we solicit comment on what competency requirements 
and experience/qualifications should be proposed for the caregiver (who 
is not a patient's family member) and for the registered nurse, what 
restrictions should be placed on the caregiver or the registered nurse 
or both, and whether caregiver to patient ratio limits should be 
proposed. We are interested in any suggestions regarding this issue to 
provide for the specific needs of this vulnerable population, and on 
how we can make these requirements more flexible to meet the needs of 
the providers, while providing appropriate patient protections.

E. Condition: Quality Assessment and Performance Improvement (Proposed 
Sec.  494.110)

[If you choose to comment on issues in this section please include the 
caption ``QAPI'' at the beginning of your comment.]
    An integral part of our effort to move toward a patient outcome-
based system is the facility level quality assessment and performance 
improvement (QAPI) program. We propose to require that a dialysis 
facility create its own tailored program for quality improvement based 
on the framework provided in this condition. Existing Sec. Sec.  
405.2112(c) and 405.2113(a) address quality standards for patient care 
in the context of the ESRD network organization's role. Although Sec.  
405.2134 requires each dialysis facility to participate in network 
activities and to pursue network goals, there is currently no clear 
Federal requirement for an ongoing facility-specific, patient-centered 
continuous quality improvement program. The focus on outcomes in this 
proposed rule is a result of the fundamental shift in approach to 
performance expectations within the health care industry and efforts 
within the renal community to define and examine outcomes.

[[Page 6215]]

    In 2000, the Office of the Inspector General (OIG) of the 
Department of Health and Human Services (DHHS) conducted an extensive 
review to ascertain the effectiveness of our monitoring of the ESRD 
program. Their subsequent report was entitled ``External Quality Review 
of Dialysis Facilities: A Call for Greater Accountability'' (DHHS/OIG, 
June 2000). The purpose of this review was to ``assess external 
mechanisms HCFA relies upon to monitor the quality of care provided by 
dialysis facilities to Medicare beneficiaries with ESRD.'' This OIG 
report provides a thorough review of the external quality oversight of 
dialysis facilities in the United States and the roles played by CMS, 
the State survey agencies, and the ESRD networks. The OIG recommended 
that dialysis facilities be required to conduct their own quality 
improvement programs. The OIG also recommended that facilities be 
required to establish internal systems for identifying and analyzing 
the causes of medical injuries and medical errors. Another 
recommendation was to require facilities to monitor patient 
satisfaction. The Institute of Medicine's (IOM) 1991 report, ``Report 
on Kidney Failure and the Federal Government'' suggests that relating 
the conditions for coverage to patient outcomes would assist the 
quality assurance efforts of the ESRD program (IOM, 1991).
    The 2001 IOM report, ``Crossing the Quality Chasm: A New Health 
System for the 21st Century'' addresses the need to narrow the quality 
chasm between the potential benefits of medical science and technology 
and the actual level of health care provided in the United States (IOM, 
2001). The report offers a strategy and action plan for building a 
stronger health system over the coming decade. The report presents 
multiple challenges to health care leaders and points out that all 
organizations can improve their performance by incorporating care 
process and outcome measures into their daily work. In addition, many 
renal groups (including the RPA, the American Nephrology Nurses 
Association, the NKF, and the American Association of Kidney Patients) 
have developed similar positions. We believe that the quality 
improvement activities in this proposed rule and the data systems of 
the future will provide an opportunity to focus more closely on patient 
outcomes. We believe that it is critically important that dialysis 
facilities examine the adequacy of their information technology and 
identify opportunities to improve and expand the use of such 
technologies to prevent medical errors and improve the quality of care. 
This Administration is committed to working with other public and 
private stakeholders to develop means for improving and expanding the 
use of information technologies (such as bar coding and computerized 
physician order entry systems) in health care settings.
    Proposed Sec.  494.110 would require that a facility develop, 
implement, maintain, and evaluate an effective, data-driven, quality 
assessment and performance improvement program that reflects the 
complexity of the dialysis facility's patient population and its 
processes of care. The dialysis facility must take actions that result 
in performance improvements in the quality of patient care. We believe 
that dialysis facilities need to have a continuous quality improvement 
system in place to continually assess and improve health care delivery. 
The facility's quality improvement program should monitor the systems 
and processes of care that are used to achieve the targeted patient 
outcomes. This approach calls for facilities to systematically collect 
and analyze clinical data about the components of their care processes. 
The majority of facilities already collect clinical performance 
measures as described in the 2002 OIG report, which describes the 
quality improvement programs of large dialysis corporations (DHHS/OIG, 
January 2002). The 5 largest dialysis corporations (representing 67 
percent of the total number of dialysis facilities) routinely collect 
data on at least 14 clinical performance measures; and therefore, 
requiring collection of those clinical performance data would not 
impose an additional data collection burden on most dialysis 
facilities. These types of data can be used to assess facility care 
processes and to identify opportunities for improvement. Once the 
opportunity has been identified, the facility should develop and 
implement an intervention strategy that focuses on the processes that 
need improvement, and then evaluate whether the improvement strategy 
achieved the desired results. The facility should reexamine goals that 
have been achieved and, if applicable, undertake new interventions to 
further increase the quality of care processes, outcomes, and patient 
satisfaction. The facility must continue to track its performance to 
assure that improvements in patient outcomes and patient satisfaction 
are sustained. This is what is meant by the cycle of continuous quality 
improvement.
    This QAPI approach demands an evaluation of organizational 
performance and a patient-centered focus. The evaluation includes 
measuring actual performance, as well as the impact of the performance 
on patient outcomes and satisfaction. The evaluation answers the 
question: ``Did that process, treatment or procedure produce the 
targeted outcomes?'' The approach gives the facility the ability to 
analyze interdependent processes of care and adjust them to optimize 
the system for providing care.
1. Program Scope (Sec.  494.110(a))
    We are proposing in Sec.  494.110(a) to require that the dialysis 
facility's QAPI program address at least the following areas: (1) 
Adequacy of dialysis; (2) nutritional status; (3) anemia management; 
(4) vascular access; (5) medical injuries and medical errors 
identification; (6) hemodialyzer reuse program (if applicable); and (7) 
patient satisfaction and grievances. We believe that these areas are 
reflective of: (1) the degree to which the facility achieves desirable 
patient outcomes; the extent of patient safety within the facility; and 
(2) the level of satisfaction attained as the patient experiences the 
continuum of care.
    Adequacy of dialysis has become an important clinical performance 
measure for benchmarking the quality of dialysis care. We believe that 
it is appropriate and necessary to consider using consensus performance 
measures in our health and safety standards for facilities. The NKF-K/
DOQI guidelines for hemodialysis adequacy (guideline 4) provide minimal 
adequacy of hemodialysis levels of Kt/V of 1.2 and URR of 65, but do 
not suggest optimal dialysis target levels, based on their conclusion, 
after a literature review, that there is not sufficient data to make 
that determination (NKF, 2000).
    The Hemodialysis Study sponsored by the National Institutes of 
Health began in 1995 and was a comprehensive randomized clinical trial 
of dose and flux interventions to identify improvements in therapy that 
will reduce hemodialysis mortality. The study entitled ``Effect of 
Dialysis Dose and Membrane Flux in Maintenance Hemodialysis,'' 
confirmed that the minimum dosage of thrice weekly hemodialysis as 
stated in the NKF-K/DOQI Guideline 4 (that is, Kt/V of 1.2 and URR of 
65) is adequate and that, in general, a high dosage and special high-
flux filters provide no added benefit in terms of survival, rate of 
hospitalization, and albumin levels to patients (Eknoyan, pp. 2010-
2019). The Hemodialysis Study also found statistically nonsignificant 
data suggesting that higher dialysis dosage

[[Page 6216]]

appeared to reduce mortality and hospitalization for women in those who 
had been receiving hemodialysis longer than 3.5 years when they joined 
the study (DHHS/NIH, 2002).
    A recent retrospective study suggests that the recommended minimal 
urea reduction ratio of 65 percent may be too low to provide for an 
optimal mortality benefit (Szczech, pages 738 through 745). Also, we 
recognize that there are several possible methods for calculating Kt/V. 
In addition, a major concern for accurate measurement of either URR or 
Kt/V is that small differences in the method and timing of the blood 
draw used for the postdialysis blood urea nitrogen (BUN) blood sample 
can make clinically important differences in the resulting hemodialysis 
adequacy estimates.
    We acknowledge the need for consistency in the techniques used for 
blood withdrawal as well as the method or formula used to calculate the 
Kt/V value. We considered proposing requirements that specified pre and 
postdialysis blood draw methods and Kt/V calculation methods that might 
allow for more accurate benchmarking. However, we are not proposing a 
specific methodology at this time, because we believe it would be more 
appropriate to recommend and encourage dialysis facilities to adopt the 
methodology(ies) recommended by a consensus process such as the NKF-K/
DOQI.
    Despite these difficulties, dialysis facilities do use adequacy of 
dialysis as one of their benchmarks when evaluating the quality of 
peritoneal and hemodialysis patient care. The CMS ESRD CPM Project 
calculates the adequacy of dialysis measures for hemodialysis and 
peritoneal dialysis patients (that is, URR and Kt/V) that can be used 
by facilities and ESRD networks for benchmarking and comparison 
purposes. The CMS ``Dialysis Facility Compare'' website provides 
facility-specific adequacy-of-dialysis information in terms of what 
percentage of patients are receiving at least the minimal dose of 
dialysis (defined as a URR >= 65 percent). The use of minimal 
performance levels for adequate dialysis is widely used to allow for 
comparisons. However, facilities are encouraged to evaluate the needs 
of individual patients and to deliver the amount of dialysis that will 
promote optimal health outcomes for that patient.
    In addition, we are proposing in Sec.  494.110(a)(2)(ii) that the 
dialysis facility's QAPI program must also address nutrition. The 
nutritional status of the dialysis patient impacts the patient's 
morbidity, mortality, and overall quality of life. The nutritional 
status of the patient may be affected by medical symptoms, 
physiological responses to ESRD, the dialysis process itself, anemia, 
endocrine disorders, etc. The importance of nutritional status in 
dialysis patients is recognized in the K/DOQI clinical practice 
guidelines for nutrition of chronic renal failure and in the ESRD CPM 
Project's inclusion of serum albumin levels. Under the plan of care 
condition (proposed Sec.  494.90) we are proposing that the serum 
albumin level be monitored on a monthly basis. The facility may track 
the serum albumin levels or any other pertinent markers of nutritional 
status as part of its QAPI program. The goal is to identify care system 
opportunities for improving patient nutritional outcomes and then 
develop and implement interventions that will potentially achieve the 
targeted outcomes.
    We are also proposing in Sec.  494.110(a)(2)(iii) that the QAPI 
program must include anemia management. Existing Sec. Sec.  405.2137(b) 
and 405.2163(g) address the patient's hematocrit level as the indicator 
for the necessity for administering erythropoietin. In 1996, anemia was 
the subject of the first National Cooperative Project conducted by the 
ESRD networks. The reasons for selecting anemia both for the study and 
as an outcome measure included: (1) The prevalence of anemia among the 
Medicare population; (2) a consensus among the renal community that 
anemia is a major quality-of-life problem for dialysis patients and 
that proper drug manipulation can improve this condition; (3) the fact 
that commonly used measures of anemia (hematocrit and hemoglobin 
levels) are routinely collected by us when facilities bill Medicare for 
erythropoietin on the outpatient billing form; and (4) the relatively 
straightforward and easily accomplished process for monitoring 
hematocrit (or hemoglobin) levels.
    The United States Renal Data System (USRDS) Annual Data Report and 
the ESRD CPM Project provides regional and national anemia data that 
allow for facility benchmarking. The NKF-K/DOQI clinical practice 
guidelines for Anemia of Chronic Kidney Disease (Guideline 4) recommend 
an evidence-based target for hemoglobin of 11-12 g/dL (and hematocrit 
of 33 to 36 percent) for erythropoietin therapy. In May 2000, according 
to the 2001 Atlas of ESRD in the United States (USRDS), 12 percent of 
prevalent dialysis patients (that is, patients who have received 
chronic renal replacement therapy for at least 90 days) with 
erythropoietin claims had hematocrits less then 30 percent and the risk 
of hospitalization is increased with hematocrit levels less than 30 
percent. The 2001 ESRD Clinical Performance Measures (CPM) Project 
Annual Report revealed that 74 percent of in-center hemodialysis 
patients who were prescribed erythropoietin during the last 3 months of 
2000 had a mean hemoglobin of equal to or greater than 11gm/dL (which 
is approximately equal to a hematocrit of 33 percent). This same report 
reveals that 63 percent of peritoneal dialysis patients prescribed 
Erythropoietin during the study period had a mean hemoglobin of equal 
to or greater than 11 gm/dL. This proposed rule uses anemia, as 
measured by the hematocrit or hemoglobin level, as an element of 
patient outcomes for both hemodialysis and peritoneal dialysis 
patients.
    Vascular access insertions and complications (for example, 
infection) have received increasing attention over the past few years. 
The current ESRD network quality improvement project, Fistula First, is 
focused on vascular access. Complications associated with vascular 
access account for about 18.3 percent of ESRD patient hospitalizations 
(USRDS data from 2000) and is associated with high financial costs and 
diminished quality of life for the hemodialysis patient. Therefore, we 
are proposing in Sec.  494.110(a)(2)(iv) that vascular access 
management be included in the facility's QAPI program. Facilities 
should look for opportunities to improve patient outcomes related to 
vascular access by reviewing ESRD Fistula First data and ESRD CPM 
Project data in conjunction with the NFK-K/DOQI clinical practice 
guidelines for vascular access. The ESRD CPM Project and the USRDS 
Annual Data Report provide regional and national data pertaining to 
vascular access. The NKF-K/DOQI clinical practice guidelines for 
vascular access provide valuable information useful to a facility QAPI 
program regarding vascular access management.
    We are proposing in Sec.  449.110(a)(2)(v) to require a patient 
safety component specific to medical injuries and medical errors 
identification as part of each facility's QAPI program. The IOM 
published a report entitled ``To Err is Human: Building a Safer Health 
System,'' that focused on the magnitude of medical errors, serious 
adverse events and the risks of medical care in the United States (IOM, 
2000). Medical injuries and medical errors were also identified by the 
OIG as areas in which we should facilitate the development of publicly 
accountable means for identifying serious medical injuries and 
analyzing their causes. The OIG found

[[Page 6217]]

that medical injuries are not systematically monitored in dialysis 
facilities.
    The Renal Physicians Association (RPA), in partnership with the 
Forum of ESRD networks and the Patient Safety Foundation, has formed a 
Patient Safety Committee to address patient safety in dialysis 
facilities. The Committee's report describes the work of 42 stakeholder 
representatives from 34 organizations as they engage in collaborative 
action planning (The Renal Physicians Association, 2001). The group 
identified challenges in improving patient safety, action options, and 
priorities. These participants have expressed their commitment to 
interorganizational collaboration on selected actions in the launch of 
the next phase of this initiative. The Phase I Report supports for the 
incorporation of patient safety activities into the conditions for 
coverage for ESRD, to encourage universal engagement in patient safety 
participation. This initiative provides resource information that may 
be useful to facilities as they develop their QAPI program to reduce 
medical errors and injuries.
    We propose in Sec.  494.110(a)(2)(vi) that if a dialysis facility 
reprocesses hemodialyzers they must include reuse systems in their QAPI 
program. The AAMI Reuse of hemodialyzers RD47 chapter (incorporated by 
reference in both the existing and the proposed conditions) includes 
guidelines for a reuse quality assurance program under section 14. 
Section 14 outlines quality assurance program areas that include: (1) 
Records that serve as the quality assurance foundation; (2) schedule of 
quality assurance activities; (3) patient considerations; (4) 
equipment; (5) physical plant; (6) supplies; (7) dialyzer labeling; and 
(8) reprocessing and preparation for dialysis. Since these activities 
are the same in the proposed conditions for coverage as in the existing 
conditions for coverage, there is no additional regulatory burden. 
Continuous quality management in the reuse area is important to 
ensuring patient safety.
    Assessment of patient satisfaction was identified by the OIG as a 
means of identifying patient concerns often missed by the complaint 
process. The OIG recognized that patients play an increasingly 
important role in their own health care, and that techniques of 
assessing patient satisfaction have become increasingly sophisticated. 
We concurred with the OIG's recommendation. Therefore in Sec.  
494.110(a)(2)(vii), we are proposing that dialysis facilities include 
patient satisfaction in their QAPI programs. The OIG further 
recommended that we exert leadership to facilitate the development of a 
common instrument that facilities and others could use to assess 
patient satisfaction. Many facilities do currently use a patient survey 
as a means to assess patient satisfaction and some have experience in 
utilizing the results for quality improvement efforts.
    We are proposing that facilities monitor patient satisfaction and 
grievances as part of the QAPI program and have the flexibility to use 
the method of their choice to meet this requirement. Tracking patient 
satisfaction and grievances allow the facility to identify any areas in 
which patients have expressed concerns. The facility can analyze this 
information and determine what aspect of facility operations needs 
improvement. CMS has an Intra-agency Agreement with AHRQ to develop a 
standardized patient experience of care instrument and survey protocol. 
In 2003, AHRQ conducted a feasibility study to assess the feasibility 
and applications (that is, quality improvement and public reporting) of 
a survey that measures dialysis patients' experience of care in renal 
dialysis facilities. In the August 25, 2003 Federal Register (68 FR 
51017), AHRQ published a notice that identified and cataloged existing 
surveys and survey results made available to the team and presented the 
exhaustive literature review that was performed. In addition, a 
Technical Expert Panel consisting of ESRD patients and professionals 
was consulted. AHRQ's ESRD Consumer Assessment of Health Plan Survey 
(CAHPS) Feasibility Final Report and the CMS response can be found on 
http://www.cms.hhs.gov/quality (follow the ESRD link to the CAHPS 
link).
    In the Feasibility Report, AHRQ recommended that a standardized 
survey for measuring in-center hemodialysis (ICH) patients' experience 
and ratings of their care be developed that could serve several 
important and distinct purposes. An ICH CAHPS survey would provide 
information for consumer choice, reports that facilities can use for 
internal quality improvement and external benchmarking against other 
facilities, and finally, information that we can use for public 
reporting and monitoring purposes. The survey would be in the public 
domain and consist of a core set of questions that could be used in 
conjunction with existing surveys.
    In a January 30, 2004 Federal Register notice (69 FR 4520) 
published as part of the Paperwork Reduction Act (PRA) process, a draft 
survey and pilot test plan were issued. On July 23, 2004, a second 
Federal Register notice (69 FR 44012) was published and the package 
including the draft survey and pilot test plan was submitted to OMB at 
that time.
    We will take into consideration the practical difficulties and 
potential burden on facilities that may result from requiring the use 
of a common instrument for assessing patients' experience of care. 
However, we invite comment on the value of utilizing one common survey 
that can yield information permitting comparisons of facilities across 
the nation.
    We are also interested in how facilities will assess the 
effectiveness of their internal grievance adjudication process, track 
the outcomes of patient grievances, and identify meaningful criteria 
for evaluation and tracking purposes. We are soliciting comment on how 
evaluating and tracking grievances can be used to improve patient 
outcomes of care.
2. Monitoring Performance Improvement (Proposed 494.110(b))
    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. Therefore, we are proposing in Sec.  494.110(b) that the 
dialysis facility must take actions that result in performance 
improvements and must track performance to assure standards are met and 
that improvements are sustained over time. This action stimulates the 
provider to continuously examine and improve performance. In addition, 
we are retaining the requirement in existing Sec.  405.2134 that 
requires a dialysis facility to participate in ESRD network activities 
and pursue Network goals.
3. Prioritizing Improvement Activities (Proposed 494.110(c))
    The principal focus of the facility's continuous quality 
improvement program should be to establish a strategy to prioritize 
improvements in facility services so that performance improvements lead 
to better outcomes of care and increased satisfaction for patients. To 
this end, the proposed Sec.  494.110(c) requires the dialysis facility 
to set priorities for performance improvement, considering prevalence 
and severity of identified problems and giving priority to improvement 
activities that affect clinical outcomes. The facility must immediately 
correct any identified problems that directly or potentially threaten 
the health and safety of patients. Under the continuous quality 
improvement system, facilities should be analyzing care processes that

[[Page 6218]]

determine how the facility's performance has affected--positively and 
negatively--patients, especially in terms of what the patient actually 
experiences. This proposed requirement emphasizes the need for the 
facility to focus on the areas of performance where problems have been 
specifically identified, especially in areas relating to outcomes of 
patient care. By prioritizing areas of improvement, facilities can: (1) 
Identify areas where outcomes indicate a need for improvement; (2) 
define measures to improve outcomes; (3) review implementation of 
improvement actions; and (4) determine the success of the actions 
implemented to improve the performance measures.
    With an effective QAPI program, the dialysis facility can identify 
and reinforce the activities that it is performing well and seek and 
respond to opportunities for improvement on a continuous basis. We 
intend that as a result of this proposed requirement the facility 
itself will be the catalyst that precipitates continuous improvements. 
The dialysis facility may choose to inform their patients of facility's 
quality improvement activities and may want to engage patients who are 
dialyzing in their facility of these activities. The patient's role in 
achieving quality improvement goals in areas such as adequacy of 
dialysis and vascular access should be acknowledged. Partnering with 
the patients to make improvements may be an important aspect of a 
successful QAPI program.
    The proposed QAPI Condition discussed in this section of the 
preamble encompasses a facility's internal approach to improving the 
quality of dialysis care. We are considering putting into place, within 
these conditions, minimum clinical standards that would serve as 
external stimuli for further improvements in the quality of dialysis 
services. The following is a discussion of how minimum clinical 
standards could be implemented and specific areas for which we are 
soliciting public comment.
4. Facility Specific Standards for Enforcement
    In this proposed rule, we have discussed and taken an approach to 
quality assurance that relies exclusively upon the facility's own 
process for setting, monitoring, and maintaining clinical standards as 
the basis for evaluating its performance. This approach is consistent 
with our overall approach to quality improvement. However, dialysis 
care is provided in as homogeneous a medical context as any service and 
may well be susceptible to measurement against baseline clinical 
expectations.
    The OIG's Report of 2000 on External Quality Review of Dialysis 
Facilities: A Call for Greater Accountability encourages the use of 
standardized performance measures to hold individual facilities 
accountable for quality of care. OIG also recommends an approach that 
reflects a balance between collegial and regulatory modes of oversight. 
Their report addresses the use of standardized performance measures 
both to engage in quality improvement activities and to enforce minimum 
standards.
    Supporters of an approach requiring adherence to clinical standards 
for ESRD facilities argue that: (1) There is specificity and relative 
homogeneity in the services delivered; (2) there are significant risks 
to patient safety if care is not delivered appropriately; (3) the renal 
community has been proactive in defining and using clinical standards; 
(4) there are correlations between having acceptable NKF-K/DOQI-derived 
measures for adequacy of dialysis and anemia and positive outcomes for 
individual patients; and (5) the data systems supporting ESRD program 
operations are comprehensive and unique.
    We are soliciting comments on the feasibility of using commonly 
agreed-upon clinical standards in our requirements and enforcement 
efforts. In setting the minimum clinical standards for performance, we 
would use selected clinical practice guidelines developed by the NKF-K/
DOQI, which were developed with broad community input and consensus, 
and have gained extensive national and international acceptance. We 
would initially establish minimal expectations about adequacy of 
dialysis rates and anemia levels, but we would continuously look to 
science for updated standards.
    The method for applying these standards would be to require that a 
dialysis facility must maintain minimum clinical standards (that is, 
adequacy of dialysis and anemia levels) for all patients. If the 
patient's outcomes did not meet the clinical expectations, the 
interdisciplinary team would be required to make adjustments. If the 
patient is unable to achieve the minimum expected clinical outcomes, a 
member of the interdisciplinary team would need to enter an explanation 
in the patient's medical records. If the minimum expected clinical 
outcome is achievable but is not being achieved, the interdisciplinary 
team would be expected to develop and implement an improvement program 
to achieve and maintain the expected outcome.
    We would periodically establish our requirements and publish them 
in the Federal Register. The standards that we would use if this 
approach were adopted are as follows:
     The minimum delivered threshold for Kt/V is--

--1.2 (single pool) for hemodialysis patients (as specified in the NKF-
K/DOQI Clinical Practice Guidelines For Hemodialysis Adequacy: Update 
2000, Guideline 4);
--1.7 (weekly) for continuous ambulatory peritoneal dialysis patients 
(as specified in the NKF-K/DOQI Clinical Practice Guidelines for 
Peritoneal Dialysis Adequacy: Update 2000, Guideline 15);
--2.1 (weekly) for continuous cycling peritoneal dialysis patients (as 
specified in the Peritoneal Dialysis Adequacy: Update 2000, Guideline 
16); and
--2.2 (weekly) for intermittent peritoneal dialysis patients (as 
specified in the Peritoneal Dialysis Adequacy: Update 2000, Guideline 
16).

     For anemia management, the minimum required levels would 
be--

--A hemoglobin level of 11 gm/dL (as specified in the NKF-K/DOQI 
Clinical Practice Guidelines for Anemia of Chronic Kidney Disease: 
Update 2000, Guideline 4); or
--A comparable hematocrit of at least 33 percent (as specified in the 
NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney 
Disease: Update 2000, Guideline 4).

    To make this approach work, we would need to address and mitigate 
the disadvantages that arise from assigning minimum numerical target 
values. We would be required to go through a rulemaking process each 
time we wanted to update the numerical values to correspond with any 
scientific advances. NKF-K/DOQI clinical practice guidelines for 
adequacy of dialysis and anemia are designed for assessing individual 
patient care based on individual patient characteristics. We would need 
to address the issue of using these as measures for facility-wide 
performance. Can this effectively be done or would a risk adjustor need 
to be developed to avoid disadvantaging facilities that have a 
different case mix? We are also soliciting comments on methods for 
using current NKF-K/DOQI clinical practice guidelines as facility-wide 
measures. For example, comments on the use of the statistically based 
threshold measures of performance would be especially helpful. Under 
such an approach, facilities in which a predetermined portion of 
patients fail to

[[Page 6219]]

meet the selected clinical standards over some period of time, using a 
standard deviation, percentile-based, or some other method, need to 
develop a corrective action plan. We are specifically soliciting 
comments on this issue.
    If we were to codify a clinical standards condition, the text would 
read as follows:

Condition: Clinical Standards

    The dialysis facility must maintain minimum clinical standards for 
all patients. If the patient's care does not meet such standards, the 
interdisciplinary team must make adjustments. If the patient is unable 
to achieve the minimum expected clinical outcomes, a member of the 
interdisciplinary team must provide an explanation in the patient's 
medical records. If the minimum expected clinical outcome is achievable 
but is not being achieved, the interdisciplinary team must develop and 
implement an improvement program to achieve and maintain the patient's 
expected level of general health.

Standard: Performance Expectations

    (a) Dose of dialysis. The interdisciplinary team must assist and 
support facility patients in achieving and maintaining the expected 
dose of dialysis as specified by the Secretary and published in 
accordance with the notification requirements in paragraph (d)(i) of 
this section.
    (b) Anemia. The interdisciplinary team must assist and support 
facility patients in achieving and maintaining the expected hematocrit/
hemoglobin level as specified by the Secretary and published in 
accordance with the notification requirements in paragraph (d)(i) of 
this section. The patient's hematocrit/hemoglobin levels must be 
measured at least monthly.
    (c) Additional clinical standards. Facilities are responsible for 
assuring that their patients achieve at least a minimum performance 
level on additional clinical standards that may be selected by the 
Secretary. The methodology and minimum performance expectations will be 
determined in accordance with the NTTAA guidelines.
    (d) Notification. CMS will publish a Federal Register document that 
proposes or finalizes--
    (i) The current minimum expected outcomes for dose of dialysis and 
anemia referenced in paragraphs (a) and (b) of this section.
    (ii) Other standards upon development and acceptance of the 
standards by the Secretary.

F. Condition: Special Purpose Renal Dialysis Facilities (Proposed Sec.  
494.120)

[If you choose to comment on issues in this section please include the 
caption ``Special Purpose Renal Dialysis Facilities'' at the beginning 
of your comment.]
    Special purpose renal dialysis facilities are dialysis units 
approved on a short-term basis (currently, for no more than 8 months) 
to provide dialysis services to a group of patients otherwise unable to 
obtain treatment in the geographic area served by the facility.
    The existing requirements for special purpose renal dialysis units 
are in Sec.  405.2164. That section states that special purpose units 
must comply with the conditions specified at Sec. Sec.  405.2130 
through 404.2164, with the exception of Sec. Sec.  405.2134 to 405.2137 
(that is, conditions relating to participation in network activities 
and the patient long-term care program). Existing Sec.  405.2164(b) 
requires a special purpose facility to consult with the patient's 
physician to ensure that care provided is consistent with the care plan 
and long-term care plan required in existing Sec.  405.2137. Existing 
Sec.  405.2164(c) requires the ``period of approval'' (that is, 
Medicare certification), not to exceed 8 calendar months.
    In the May 11, 1983 Federal Register (48 FR 21254), we published a 
final rule that provided for time-limited approval of special purpose 
renal dialysis facilities. These facilities were established for two 
purposes: (1) To serve ESRD patients in a vacation area (such as a 
vacation camp) when the area is too remote from existing approved 
facilities to allow convenient access by patients; or when a convenient 
approved facility does not have sufficient available capacity to serve 
a number of vacationing patients; and (2) to serve ESRD patients on an 
emergency basis when approved permanent facilities close due to natural 
disasters, strikes, or bankruptcies, and the backup facilities in the 
area cannot accommodate the patients of the closed facilities. In the 
May 11, 1983 final rule, the last provision was added specifically, 
``to ensure continuous access to care in the event that an approved 
permanent facility is closed because it cannot achieve adequate 
revenues under the prospective reimbursement system.'' The 
certification period of 8 months was determined to be appropriate in 
response to public comments urging that the original temporary 
certification proposal (of 6 months) be extended.
    Following the publication of the May 11, 1983 final rule, we 
developed a certification and approval process and a separate series of 
provider numbers for ESRD facilities approved as special purpose renal 
dialysis facilities.
    In our deliberations regarding any possible revisions to this 
condition, we found that very few vacation camps have requested 
approval for certification as special purpose renal dialysis 
facilities. In March 2001, for example, Medicare records indicated that 
only one vacation camp in the United States was certified as a special 
purpose renal dialysis facility. We now question whether the 
requirements for vacation camp renal facilities to be certified as a 
special purpose renal dialysis facility are too onerous.
    A search on the web lists 36 camps for ESRD patients throughout the 
United States. Some of the camps do not accept hemodialysis patients or 
accept hemodialysis patients for weekend only camps. These camps do not 
have a need for hemodialysis services. Other camps provide 
transportation to a certified hemodialysis facility off the 
campgrounds. Since the number of United States certified hemodialysis 
facilities has doubled in the last decade to approximately 4,000, 
transporting campers to a nearby dialysis facility may be feasible in 
many locations. It is not clear whether there remains a need to 
continue to establish vacation camp special purpose renal dialysis 
facilities in the conditions for coverage.
    However, we are proposing to retain this condition in order to 
address the possible needs of patients who, as a result of the 
emergency conditions listed above, or participation in a remote 
vacation camp, need dialysis services on a short-term basis, and to 
ensure that facilities providing this type of care are properly 
certified for participation in the Medicare program. We are also 
proposing to reduce the burden of the requirements that a vacation camp 
must meet in order to be certified as a special purpose renal facility. 
Vacation camps generally operate during the summer months, when schools 
are closed, and usually offer sessions lasting up to 2 weeks. The task 
of meeting the ESRD conditions for coverage in order to offer a few 
camp sessions each year (with the exception of the conditions relating 
to participation in network activities and the patient long-term care 
program), may deter vacation camps from providing hemodialysis services 
and seeking Medicare certification.
    Therefore, we are proposing in Sec.  494.120 that a special purpose 
renal dialysis facility would be approved to furnish dialysis at 
special locations, that is, vacation camps that serve ESRD patients in 
a temporary residence, or

[[Page 6220]]

facilities established to serve ESRD patients under emergency 
circumstances. A vacation camp must be operated under the direction of 
a certified renal dialysis facility that assumes full responsibility 
for the care provided to patients.
    Proposed Sec.  494.120(a) maintains the 8-month approval period in 
the existing Sec.  405.2164(c). In view of the history of the few 
Medicare-certified special purpose dialysis facilities, we believe a 8-
month approval period is adequate.
    Proposed Sec.  494.120(b) would retain the existing service 
limitation requirement (specified in Sec.  405.2164(d)) that limits the 
special purpose unit to providing services only to those patients who 
would otherwise be unable to obtain treatments in the geographic 
locality served by the facility.
    In addition, we are proposing in Sec.  494.120(c)(1) that a special 
purpose renal dialysis facility would be approved as a vacation camp by 
demonstrating compliance with the following standards and conditions 
for coverage:
     Infection control (Sec.  494.30)).
     Water quality (Sec.  494.40); if the facility uses home 
portable water treatment systems, the facility would instead comply 
with the provision regulating home monitoring of water quality (Sec.  
494.100(c)(1)-(v)).
     Reuse of hemodialyzers and other dialysis supplies if 
reuse is performed (Sec.  494.50).
     Patients' rights (Sec. Sec.  494.70(a) and (c)).
     Laboratory services (Sec.  494.130); a facility would be 
required to have a plan for obtaining laboratory services for cases 
when it is necessary for patient safety.
     Medical director responsibilities for patient care 
policies and procedures (Sec.  494.150(c) and (d)).
     Medical records (Sec.  494.170).
    We are proposing in Sec.  494.120(c)(2) to specify that a special 
purpose renal dialysis facility certified due to emergency 
circumstances may provide services only to those patients who would 
otherwise be unable to obtain treatments in the geographical areas 
served by the facility and is approved by demonstrating compliance with 
Sec.  494.120(c)(1) and the following additional conditions:
     Compliance with Federal, State, and local laws and 
regulations (Sec.  494.20).
     Physical environment (Sec.  494.60).
     Patients' rights (Sec. Sec.  494.70(a) through (c)).
     Personnel qualifications (Sec.  494.140).
     Medical director (Sec.  494.150).
     Governance (Sec.  494.180).
    While the certification of a special purpose unit is time-limited 
and the patient's treatment in the unit will be limited, we believe 
that every effort must be made to ensure that the quality of care 
provided is comparable to that provided to any dialysis patient in a 
Medicare-approved unit. However, we believe requiring compliance with 
any additional requirements would be too burdensome for a special 
purpose unit.
    We are proposing in Sec.  494.120(d) to retain the existing 
requirement that a special purpose unit consult with the patient's 
physician, with an added provision that this consultation must occur 
before the initiation of dialysis in the special purpose unit. This 
provision is added to ensure that the special purpose unit is fully 
aware of the patient's current medical condition and that the special 
purpose unit can provide dialysis services consistent with the 
patient's plan of care described at Sec.  494.90.
    In addition, we are proposing in Sec.  494.120(e) 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 of the last scheduled treatment in the special purpose 
unit.
    We are soliciting comments on whether vacation camps should 
continue to be included under the special purpose renal dialysis 
facility condition for coverage.

G. Laboratory Services (Proposed Sec.  494.130)

[If you choose to comment on issues in this section please include the 
caption ``Laboratory Services'' at the beginning of your comment.]
    In 1994, we revised existing Sec.  405.2163 to stipulate that the 
dialysis facility must make available laboratory services (other than 
tissue pathology and histocompatibility) and that all laboratory 
services must be performed by an appropriately certified laboratory in 
accordance with the Clinical Laboratory Improvement Amendments (CLIA) 
regulations at 42 CFR 493. Existing Sec.  405.2163(b) also requires a 
dialysis facility that furnishes laboratory services to furnish these 
services in accordance with applicable requirements established for 
certification of laboratories under the CLIA. Independent dialysis 
facilities must be certified under CLIA to perform and bill most 
laboratory tests to the Medicare program. This section also allows a 
dialysis facility that does not provide laboratory services to make 
arrangements to obtain these services with a laboratory certified under 
CLIA.
    We are proposing in Sec.  494.130 to retain the existing 
requirements governing laboratory services in Sec.  405.2163(b) without 
change.

VI. Provisions of Proposed Subpart D: Administration

A. Personnel Qualifications (Proposed Sec.  494.140)

[If you choose to comment on issues in this section please include the 
caption ``Personnel Qualifications'' at the beginning of your comment.]
    The existing personnel qualifications of dialysis facility staff 
can be found in Sec.  405.2102. Those requirements list the education 
and experiential requirements for chief executive officers, physician-
directors, nurses responsible for nursing services, dietitians, medical 
records practitioners, transplantation surgeons, and social workers.
    In existing Sec.  405.2102(e), a physician-director must be board 
eligible or board certified in internal medicine or pediatrics with at 
least 12 months of experience or training in the care of patients at 
ESRD facilities.
    Existing Sec.  405.2102(d) defines the nurse ``responsible for 
nursing service'' as a person who is licensed as a registered nurse by 
the State in which practicing, with at least 12 months experience in 
clinical nursing, with at least 6 months experience in nursing care of 
patients with permanent kidney failure or patients undergoing kidney 
transplantation, or 18 months of experience in nursing care of the 
patient on maintenance dialysis. This section also states that if the 
same individual is assigned responsibility for self-care dialysis 
training, that individual must have at least 3 months experience in 
training ESRD patients for self-care.
    Existing Sec.  405.2102(b) defines a dietitian as a person who--
     Is eligible for registration by the American Dietetic 
Association under its requirements in effect on June 3, 1976 and has at 
least 1 year of experience in clinical nutrition; or
     Has a baccalaureate or advanced degree with major studies 
in food and nutrition or dietetics and at least 1 year of experience in 
clinical nutrition.
    Existing Sec.  405.2102(f) defines a social worker as a person who 
is licensed in the State in which practicing, has completed a course of 
study with specialization in clinical practice at, and holds a masters 
degree from, a graduate school accredited by the Council on Social Work 
Education, or has served for at least 2 years as a social worker with 
at least 1 year in a dialysis or

[[Page 6221]]

transplantation program before September 1, 1976 and consults with a 
social worker holding a masters degree.
    ESRD is an extremely complex disease requiring highly technical and 
complex treatment, and patients with this disease have special needs 
that require highly specialized care that can only be provided by 
qualified personnel. As the demographics of the dialysis population 
continue to change, producing a more elderly patient population with 
more co-morbid conditions, direct patient care needs and the skill 
needed to meet those needs will continue to increase. Also, as we move 
away from unnecessary process and procedural requirements in the 
conditions for coverage towards better patient outcomes, it becomes 
even more important to have qualified, experienced, and well-trained 
staff to achieve the targeted clinical outcomes for each patient.
    In the past, industry representatives have supported the retention 
of minimum personnel qualifications in the conditions, and we are 
proposing to retain most of the existing personnel qualifications 
requirements in this proposed rule. We are also proposing changes where 
we believe they are needed, and those changes are discussed in the 
preamble discussion that follows.
    In Sec.  494.140, we are proposing to consolidate all of the 
personnel qualifications requirements into a single condition, entitled 
``Personnel qualifications.'' In addition, proposed Sec.  494.140 would 
require that a dialysis facility's staff (whether employees or 
contractors) meet the personnel qualifications and demonstrated 
competencies necessary to serve the general needs of its patients. We 
also propose that the dialysis facility's staff must have the ability 
to sustain and demonstrate the skills needed to perform the specific 
duties of their positions.
    We recognize that facilities are not always able to directly employ 
individuals to perform all required services; and therefore, facilities 
may continue to furnish services through qualified personnel by 
arrangement. Any position in a facility may be filled by a contracted 
employee, but the contracted employees must meet the personnel 
requirements as well as the demonstrated skills and competencies in 
proposed Sec.  494.140 to ensure that patients receive quality care 
from all personnel.
    The expected outcome is the coordinated, comprehensive 
interdisciplinary delivery of appropriate and effective services 
provided by skilled professionals. These professionals would meet the 
requirements in this proposed rule and would adhere to the facility's 
policies and procedures. The dialysis facility has the flexibility to 
assign specific duties to each staff member (either employee or 
contractor) who provides services in the facility, as long as the 
required outcomes required are being met.
1. Medical Director (Proposed Sec.  494.140(a))
    In proposed Sec.  494.140(a) we would maintain some of the 
qualification requirements for a physician director. However, we 
propose to change the word ``physician'' to ``medical'' to be 
consistent with current standards of practice in the industry. The 
medical director of a facility is responsible for the development of 
patient care policies and the delivery of services. For this reason, we 
chose to require that the medical director be trained in nephrology and 
have experience in the care of dialysis patients to emphasize the need 
for experience in managing dialysis care and associated medical 
conditions. The medical director of a dialysis unit must have a 
thorough knowledge and understanding of the complexity of ESRD and its 
effects on the dialysis patient.
    The existing regulation at Sec.  405.2102 requires that the 
director of the facility be either board certified or board eligible. 
There has been considerable disagreement within the medical community 
as to whether board certification or eligibility is an important 
indicator of professional competence. In view of the diversity of 
opinion in the industry and the absence of any indication that the 
quality of care would decline if this requirement were deleted, we are 
proposing to eliminate the requirement that the medical director be 
either board certified or board eligible. Thus, we propose to require 
only that the 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 are 
retaining the alternate option for situations when a physician who 
meets this criterion is not available that allows another physician to 
direct the facility, subject to the approval of the Secretary. In the 
absence of a compelling reason for maintaining the grandfathering 
provision for the physician director under Sec.  405.2102(e)(2), we 
have not incorporated this provision in our proposed personnel 
qualifications for the medical director at Sec.  494.140(a).
2. Nursing Services (Proposed Sec.  494.140(b))
    In Sec.  494.140(b) we propose a Nursing Services standard that 
would include the necessary qualifications for 4 nurse categories: (1) 
The nurse responsible for nursing services in the facility; (2) the 
nurse responsible for training in self-care; (3) the charge nurse with 
responsibility for each patient shift; and (4) any nurse who provides 
care and treatment in the unit.
    We are proposing in Sec.  494.140(b)(1)(i) to retain the existing 
requirement at Sec.  405.2162(a) that each facility employ at least 1 
full time qualified nurse responsible for nursing service in the unit. 
In proposed Sec.  494.140(b)(1)(ii) and (iii) we would maintain the 
existing requirements that the nurse responsible for nursing services 
in the unit be a registered nurse who meets the practice requirements 
of the State in which he or she is employed, and has at least 12 months 
of experience in clinical nursing with an additional 6 months of 
experience in providing nursing care to patients on maintenance 
dialysis.
    We are proposing in Sec.  494.140(b)(2) to specify the requirements 
for the nurse responsible for training in self-care. For a detailed 
discussion of these nursing requirements see section V.D.1. of this 
preamble.
    We are proposing in Sec.  494.140(b)(3)(i) to retain with minor 
modifications the existing requirement at Sec.  405.2162(b)(1) that the 
individual responsible for each shift be a licensed health professional 
such as a registered nurse (RN) or a licensed practical nurse (LPN) who 
meets the practice requirements of the State in which he or she is 
employed. We recognize that in some instances, a licensed practical 
nurse is able to demonstrate the knowledge, training, and experience to 
serve as the charge nurse in a dialysis unit and this is currently the 
practice in some units. In proposed Sec.  494.140(b)(3)(ii) we would 
specify that the charge nurse must have at least 12 months experience 
in nursing care, including 3 months of specialized experience in 
providing clinical nursing care to patients on maintenance dialysis.
    We are proposing in Sec.  494.140(b)(4) that each nurse who 
provides care and treatment to patients must be either a registered 
nurse or a licensed practical nurse who meets the practice requirements 
of the State in which he or she is employed.
3. Dietitian (Proposed Sec.  494.140(c))
    Renal dietitians are important and necessary members of the 
patient's interdisciplinary care team. Some of the

[[Page 6222]]

responsibilities of the renal dietitian are: (1) Counseling patients on 
management of protein, sodium, potassium, phosphorus, and fluid 
controlled diets, translating the chemistry of these limits into meals 
for patients; (2) monitoring vitamin and mineral supplementation, 
including iron levels and their effect on erythropoietin; (3) managing 
glycemic control of diabetic patients by manipulation of diet; and (4) 
assessing nutritional status by using clinical and biochemical 
measures.
    We believe that these kinds of activities will require a dietitian 
with specialized experience in clinical nutrition. The specialized 
training and experience would ensure that dialysis facilities have a 
dietitian knowledgeable about medical nutrition therapy, physiology, 
and food composition. This specialized knowledge is critical if a 
dietitian is to effectively manage the complex tasks necessary in 
treating a dialysis patient, so the patient is able to manage his or 
her own disease.
    We are proposing in Sec.  494.140(c) to retain requirements 
comparable to the existing requirements laid out under the definition 
of ``qualified personnel'' at Sec.  405.2102(b). We propose that the 
dialysis facility dietitian be a registered dietitian with the 
Commission on Dietetic Registration, the official credentialing agent 
for the American Dietetic Association. We also propose that the 
dietitian meet the practice requirements of the State in which he or 
she is employed and have a minimum of 1 year of professional work 
experience in clinical nutrition as a registered dietitian in order to 
qualify to perform the special responsibilities of renal dietitians 
discussed above.
4. Social Worker (Proposed Sec.  494.140(d))
    We are proposing in Sec.  494.140(d) to retain the existing 
requirements for social workers at Sec.  405.2102(f), except for the 
``grandfather clause'' which exempted individuals hired prior to the 
effective date of the existing regulations (that is, September 1, 1976) 
from the social work master's degree requirement and substituted an 
experience criterion, which is 1 year in a dialysis setting; and a 
criterion requiring including a consultative relationship with a social 
worker with a master's degree. Since this clause only applied to social 
workers without a master's degree, already employed in a dialysis or 
transplantation setting as of 1975, we question whether there is any 
need to retain it.
    We recognize the importance of the professional social worker, and 
we believe there is a need for the requirement that the social worker 
have a master's degree. Since the extension of Medicare coverage to 
individuals with ESRD, the ESRD patient population has become 
increasingly more complex from both medical and psychosocial 
perspectives. In order to meet the many and varied psychosocial needs 
of this patient population, we believe qualified master's degree social 
workers (MSW) trained to function autonomously are essential. Social 
workers must have knowledge of individual behavior, family dynamics, 
and the psychosocial impact of chronic illness and treatment on the 
patient and family. The dialysis patient needs psychosocial 
evaluations, a treatment plan based on the patient's current 
psychosocial needs, and direct social work interventions. Facility 
social worker services include counseling services, long-term 
behavioral and adaptation therapy, and grieving therapy. We believe 
that MSW training provides the necessary education and experience in 
these areas. We have removed the requirement for specialization in 
clinical practice, because this designation is not available in all 
States and may prove to be a barrier to social workers entering 
practice in the dialysis arena.
    While nonprofessional personnel may serve in a supportive capacity, 
we do not believe they can be employed in place of a fully-credentialed 
MSW. We recognize that dialysis patients also need other essential 
services including transportation and information on Medicare benefits, 
eligibility for Medicaid, housing, and medications, but these tasks 
should be handled by other facility staff in order for the MSW to 
participate fully with the patient's interdisciplinary teams so that 
optimal outcomes of care may be achieved.
5. Dialysis Technicians (Proposed Sec.  494.140(e))
    There are no Federal requirements for dialysis technicians in the 
existing ESRD conditions for coverage with the single exception of 
reuse technicians, who are covered by the AAMI guidelines. When the 
existing conditions for coverage were published in 1976, dialysis 
technicians were an emerging occupation. At that time it was common for 
one nurse to provide dialysis care to two dialysis patients at a time. 
Currently, dialysis patient care technicians are the primary caregivers 
in most facilities and it is not unusual for a single technician to 
provide dialysis care to three or four patients at a time.
    The discussion that follows applies primarily to dialysis 
technicians who provide direct patient care. Training and other 
requirements for reuse technicians are described in specific sections 
of the AAMI guidelines, which have been incorporated by reference in 
existing Sec.  405.2150(a)(1) and in this proposed rule (see Sec.  
494.50).
    As we researched this issue, we reviewed past and current efforts 
by the States to regulate dialysis technicians. The States are 
currently using a variety of approaches and methodologies to regulate 
dialysis technicians, including minimum qualification requirements, 
mandatory competency testing, registration, licensure, and 
certification. We also looked at the typical scope of practice for this 
occupation in dialysis facilities, and took into account the public 
policy positions and statements from national associations and 
organizations that advocate uniform Federal guidelines for dialysis 
technicians.
    Arizona, Ohio, and Oregon now require dialysis technician 
certification via a nationally standardized examination. California and 
Texas require specific training and testing, but allow a nationally 
standardized certification examination to be substituted for their 
training and testing requirements. Georgia identifies a standardized 
training program for hemodialysis patient care technicians (PCTs), but 
does not require technicians to pass a national certification test 
unless a facility's training program fails to provide adequate 
training. The three organizations that provide nationally recognized 
standardized certification examinations are listed later in this 
section of the preamble.
    Other States including Connecticut, South Dakota, Kentucky, Utah, 
Virginia, Washington, New Mexico, and the District of Columbia require 
certain training and competencies for dialysis technicians. States with 
past or ongoing efforts to regulate the practice of unlicensed dialysis 
technicians and technical staff include Colorado, Illinois, Louisiana, 
Maryland, New York and Oklahoma.
    Some national associations (for example, the American Nephrology 
Nurses Association (ANNA) and the National Association of Nephrology 
Technicians (NANT)) have advocated uniform training and certification 
requirements for dialysis technicians for several years and continue to 
advocate for these measures at the State and national level. Their 
primary concern is to ensure that care is provided by qualified and 
trained health care workers who are able to demonstrate the necessary 
competencies to perform the assigned duties of their positions.

[[Page 6223]]

    Since 1990, NKF's Public Policy Board has been interested in 
evaluating and defining the proper role of, and training needed by, 
dialysis technicians. In 1992, NKF's Dialysis Technician Task Force 
published an extensive list of tasks that define the ``patient care 
role description'' as well as the appropriate areas of required 
training (NKF, pp. 229-232). The authors of that article advocated, 
among other things, that technicians should have at least a high school 
diploma or equivalency; take training courses in the basic sciences; 
report directly to a registered nurse; and be able to effectively 
perform specific tasks, subject to individual State licensure and scope 
of practice laws and regulations. The article also recommended a basic 
training course curriculum for renal technicians which included, among 
other things: (1) An introduction to dialytic therapies; (2) principles 
of hemodialysis; (3) the effects on the patient of kidney failure; (4) 
dialysis procedures; (5) hemodialysis devices; (6) water treatment; (7) 
reprocessing (if applicable); (8) patient education; (9) infection 
control; and (10) the techniques used in quality assurance and 
continuous quality improvement.
    The adverse outcomes for dialysis patients of improper care from 
inadequately trained dialysis technicians could include blood leaks, 
access damage, incorrect dialysis concentrate, infection, and 
hypotension. Increased numbers of patient hospitalizations, which in 
turn result in higher costs to both public and private payers, could 
also be a direct outcome of poor patient care from dialysis 
technicians.
    In most dialysis facilities, renal technicians now provide a large 
percentage of direct patient care services. In most instances, care is 
provided under the supervision of a registered nurse. However, the 
degree of supervision and the technician-to-patient ratio will often 
vary from facility to facility.
    A wide variety of tasks are performed by dialysis technicians, 
depending on the limitations of State law. These tasks include, but are 
not limited to the following:
     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 fistula needles.
     Intraperitoneal administration of sterile electrolyte 
solutions and heparin for peritoneal dialysis.
     Monitoring patients during dialysis.
     Taking vital signs.
     Documenting tasks and patient observations.
     Equipment maintenance and repair.
     Water systems monitoring and maintenance.
     Quality control measures.
     Inventory.
    One of the options we considered was requiring certification for 
dialysis technicians. Certification is a voluntary process by which 
recognition is granted to an individual who has met certain 
qualifications. Certification is typically awarded upon the successful 
completion of an approved competency examination. The goal would be a 
national, standardized requirement for education, training, and 
competency testing for dialysis technicians. In considering this 
option, we noted that some States have chosen to develop their own 
competency examinations or to recognize competency examinations 
prepared and administered by one of the three national organizations 
that provide competency testing and certification for dialysis 
technicians. Those organizations are the Nephrology Nursing 
Certification Commission (NNCC), the Board of Nephrology Examiners 
Nursing and Technology (BONENT), and the National Nephrology 
Certification Organization (NNCO). The common goal of these 
organizations is to administer an effective test that serves as a basis 
to certify technicians for initial or more advanced competencies in 
knowledge, skill and abilities.
    In our deliberations on whether to propose Federal requirements for 
dialysis technicians engaged in direct patient care, we are reminded 
that Medicare has had a longstanding policy of respecting State control 
and oversight of health professionals. The Congress has left this 
licensure function to the States and Medicare recognizes State-defined 
scope-of-practice laws under which health care professionals are 
licensed in the United States.
    After careful consideration, we do not believe it would be prudent 
to propose a national certification requirement for dialysis 
technicians at this time. We take this position for several reasons. 
First, there is no consensus within the renal community regarding the 
efficacy of technician certification to produce improved patient 
outcomes of care. Second, there is no standardized national 
certification test at this time, and the individuals and organizations, 
including the States, who advocate or have adopted certification are 
not in agreement regarding which certification test is the most 
effective. Some States have designed, or are in the process of 
designing, their own competency examinations, while others have 
recognized one or more of the existing examinations as evidence of 
compliance with their requirements. Finally, a Federal certification 
requirement entailing mandatory competency examinations would 
necessitate additional costs for transportation, lodging, fees, and 
preparatory materials associated with the examination. Those costs 
would have to be borne by either the individuals seeking certification, 
the dialysis facilities, or both. Without clear evidence that 
certification would produce better patient outcomes, we are reluctant 
to propose any new requirements that would drive up costs for 
technicians in current practice, dialysis facilities, or both. 
Therefore, for these reasons, we believe it is more prudent at this 
time, not to propose a national certification requirement for dialysis 
technicians. Instead, we are proposing in Sec.  494.140(e) a set of 
minimum qualifications for dialysis technicians that will include a 
minimum education requirement, minimum requirements for on-the-job 
training and experience, and proposals for the composition of an 
effective technician-training program.
    We are proposing in Sec.  494.140(e)(1) to specify that dialysis 
technicians meet all applicable State requirements (for example, 
credentialing, certification, and licensure) in the State in which they 
are employed. As stated above, we believe technicians in any Medicare-
approved facility should comply with any existing State requirements 
for their profession.
    In proposed Sec.  494.140(e)(2) we would require dialysis 
technicians to have at least a high school diploma or equivalency. We 
are proposing this criterion for two reasons. First, some of the States 
that regulate dialysis technicians (for example, Connecticut and Ohio) 
require dialysis technicians to have a high school education or 
equivalency.
    Second, other States (for example, Texas, California, Oregon, and 
New Mexico) that require (among other options) certification by one of 
the national certification organizations (that is, NNCC, NNCO, BONENT) 
also require a high school diploma or equivalency because that is a 
prerequisite for taking the certification examination. We concur with 
the position taken by States that regulate dialysis technicians and the 
national technician certification organizations because we believe a

[[Page 6224]]

minimal education requirement is appropriate and necessary to enable an 
individual to complete the wide variety of patient care functions.
    We are proposing in Sec.  494.140(e)(3) to require that each 
technician complete at least 3 months experience, following the 
facility's training program (also required by Sec.  494.180(b)(5)). 
This experience must be gained under the direct supervision of a 
registered nurse with a focus on the operation of kidney dialysis 
equipment and machines and providing direct patient care with 
particular sensitivity to the management of difficult patients. We see 
dialysis technician training as a cycle that proceeds from written 
instruction that would provide a basic foundation of knowledge, to a 
necessary period of on-the-job training under the supervision of a 
knowledgeable professional trained in all aspects of patient care, 
including medical emergencies.
    While written instruction is essential, we also believe properly 
supervised on-the-job training must follow to allow the technician to 
take maximum advantage of the information provided in the training 
program before the dialysis technician is allowed to provide direct 
patient care with minimal supervision. We believe 3 months of effective 
on-the-job, supervised training is necessary before a technician is 
permitted to care for patients without close and direct supervision.
    We have made this proposal for several reasons. As discussed in 
section VI.A.2 of this preamble, a registered nurse has the necessary 
professional training and expertise to coordinate care in the unit, 
perform patient assessments, respond to clinical questions from staff 
and patients, and coordinate ongoing care. Dialysis technicians, as the 
primary caregivers in most dialysis units, function as extensions of 
the unit's professional nursing staff. We believe it is essential that 
a unit's registered nurse provide the ``hands-on'' direct supervision 
to impart this training to new dialysis technicians. For example, in 
the patient outcomes environment these regulations are designed to 
encourage, it is essential that technicians understand the significance 
of continuous quality improvement (that is, collecting data, keeping 
logs, the clinical importance and meaning of target patient outcome 
measures, and recognizing and reporting medical errors). We also 
believe a registered nurse can be very effective in instructing new 
dialysis technicians in necessary aspects of patient care, such as 
ensuring patient privacy and confidentiality, and demonstrating good 
interpersonal skills when dealing with patients, including disruptive 
or challenging patients. In addition, a registered nurse is best 
equipped, through training and experience, to ensure that every 
technician can demonstrate the basic skills needed to provide routine 
patient care (for example, initiating, monitoring, and terminating 
dialysis; proper aseptic techniques; recognizing and reporting medical 
errors; and dealing with medical emergencies). For all of these 
reasons, we believe a 3-month period of direct supervision by a 
registered nurse is essential to ensure patient health and safety and 
to ensure that dialysis technicians that provide direct patient care 
can do their part to ensure that the unit meets its patient outcomes 
goals. We invite comments on the 3-month training proposal.
    We are proposing implementation of a training program that is 
specific to technicians who monitor the water treatment system. Water 
purity is important to protecting patient safety and the water must be 
adequately monitored and properly collected for testing as specified at 
proposed Sec.  494.40. The technician who carries out water testing and 
monitoring of the water treatment system must be appropriately trained 
following a program that has been approved by the medical director and 
governing body. Typically, facility patient care technician training 
programs contain a water treatment system training module. This module 
may form the basis of a training program that could be used to train a 
water treatment technician.
6. Other Personnel Issues
    Existing Sec.  405.2136(f)(1)(vi) requires the facility have 
patient care policies that cover pharmaceutical services. There is 
currently no Federal requirement for a pharmacist to play a role on the 
multidisciplinary team within the dialysis facility. The dialysis 
facility generally has some access to the pharmacist who is dispensing 
outpatient medications to the dialysis patient. A hospital-based 
dialysis unit might be able to use the hospital pharmacist as a 
resource. There may also be limited pharmacy resources available to the 
average dialysis facility that is administering intravenous drugs and 
making adjustments to a patient's medication regimen. It has been 
suggested by some in the renal community that there should be a 
requirement within the proposed conditions for coverage for each 
dialysis facility to ensure a routine assessment of patient medications 
by a pharmacist. The reasons for this recommendation are: (1) Most 
dialysis patients take an average of 12 medications, which increases 
the risk of adverse drug events; and (2) the patients' have complex 
pathophysiology, which affects how medications can be used safely 
(Kaplan, pp. 316-319). There are a number of publications that describe 
the contributions of pharmacists to the improved care of various 
patient populations while simultaneously reducing medication-related 
costs.
    Therefore, we have proposed, as part of the new patient assessment 
condition at Sec.  494.80(a)(3), that facilities conduct a laboratory 
profile and medication history on each patient as part of their 
comprehensive patient assessment. However, we have not proposed a 
specific requirement for pharmaceutical services. We invite comments 
regarding what role, if any, the pharmacist should play within the 
dialysis facility as well as the facility's appropriate responsibility 
for pharmaceutical services and the efficient use of medications in the 
new conditions for coverage.

B. Condition: Responsibilities of the Medical Director (Proposed Sec.  
494.150)

[If you choose to comment on issues in this section please include the 
caption ``Responsibilities of the Medical Director'' at the beginning 
of your comment.]
    The requirements for the director of a renal dialysis facility are 
found in existing Sec.  405.2161. Section 405.2161 requires the 
director to be a physician who devotes sufficient time to his or her 
director responsibilities to plan, organize, conduct, and direct the 
professional ESRD services of the facility. Existing Sec.  405.2161 
also states that the physician-director may also serve as the chief 
executive officer (CEO) of the unit.
    Existing Sec.  405.2161(a) states that the director must meet the 
qualifications described in Sec.  405.2102 (that is, be board eligible 
or board certified and have at least 12 months of experience or 
training in the care of patients in ESRD facilities). Existing Sec.  
405.2161(b) requires the physician-director to: (1) Participate in the 
selection of a suitable treatment modality for all patients treated in 
the unit; (2) assure adequate training of nurses and technicians in 
dialysis techniques; (3) assure adequate monitoring of the patient and 
the dialysis process, including periodic monitoring of self-dialysis 
patients; (4) assure the development of a patient care policy and 
procedures manual and its implementation; and (5) assure that patient 
teaching materials are made available for self-dialysis and home 
dialysis patients.

[[Page 6225]]

    The June 2000 OIG Report was an extensive review to ascertain our 
effectiveness in monitoring the ESRD program. The report contained 
several recommendations regarding ways we should revise the ESRD 
conditions for coverage in order to strengthen the accountability of 
dialysis facilities that participate in the Medicare program. One of 
those recommendations was to reinforce the accountability of the 
dialysis facility's medical director for the provision of patient care. 
Specifically, the report stated the following: ``While the governing 
body of the facility is the basic source of accountability, the medical 
director should clearly be empowered as the on-site agent most directly 
responsible for the quality of care being delivered. In this capacity, 
the medical director should clearly have the authority to develop and 
monitor quality improvement efforts, to serve as an educational 
resource for medical and nursing staff, and, when individual staff are 
not performing adequately, to bring that to the attention of the 
facility's designated governing authority.''
    In response to the OIG's recommendations, we are proposing in Sec.  
494.150 to retain medical director as a separate condition for coverage 
and strengthen the medical director's role. Section Sec.  494.150 would 
require each dialysis facility to have a medical director who meets the 
qualifications for that position at Sec.  494.140(a) and who is 
responsible for the delivery of patient care and patient outcomes in 
the facility.
    We are proposing in Sec.  494.150(a) to assign the operational 
responsibility for the facility's quality assessment and performance 
improvement (QAPI) program (Sec.  494.110) to the medical director. 
While the facility's governing body is ultimately responsible for 
allocating the necessary resources (for example, dedicated staff and 
computers) to establish a QAPI program, we believe the medical director 
is best qualified to ensure that the facility's QAPI program is 
effectively developed, implemented, maintained, and periodically 
evaluated. We are also proposing that the medical director ensure that 
all clinical staff in the facility, including attending physicians, 
actively participate in achieving the performance goals and objectives 
specified in the facility's QAPI program. It is essential for an 
effective QAPI program that the attending physician and nonphysician 
staff, who treat patients in the facility, ``buy-in'' to the facility's 
quality improvement initiatives and actively participate in achieving 
the facility's QAPI goals. In order for this to happen, we believe the 
medical director should be given the responsibility to ensure that all 
staff that treat patients actively participate in the facility's QAPI 
program. In that capacity we would expect the medical director to make 
a special effort to educate and encourage facility staff, including 
attending physician and nonphysician staff, who have not actively 
participated in the facility's QAPI program. In those rare instances 
when in-house or attending physician or nonphysician staff will not 
actively participate in the facility's QAPI program, we would expect 
the medical director to refer those individuals to the facility's 
governing body through its CEO or administrator. The governing body 
(see Sec.  494.180) has the final legal responsibility and authority 
for the operation of the facility and the ultimate responsibility for 
the facility's compliance with Federal Medicare regulations.
    In assuming operational responsibility for QAPI, this requirement 
emphasizes the importance of the medical director utilizing the best 
practices within a strong QAPI program. Under this requirement, we 
would expect the facility's medical director to seek and use 
comparative data with other facilities when available and use the 
facility's historical data to demonstrate internal improvements in 
outcomes over time. This standard also underscores the medical 
director's ongoing responsibility to ensure that each patient treated 
in the facility achieves the best possible outcomes of care.
    We propose in Sec.  494.150(b) to retain the existing requirement 
at Sec.  405.2161(b)(2) for the medical director to ensure that staff 
in the unit are adequately trained. We believe that all patient care 
personnel in the facility should receive the necessary education and 
ongoing training to furnish services effectively, efficiently, and 
completely.
    We are proposing in Sec.  494.150(c)(1) to retain the existing 
requirement Sec.  405.2161(b)(4) for the medical director to assure the 
development of a ``patient care policies and procedures manual'' for 
the facility. While our goal throughout this proposed rule has been to 
eliminate unnecessary process requirements, we believe that a 
comprehensive patient care policies and procedures manual within a 
dialysis unit is an essential reference for clinical staff within the 
unit. The manual is also an opportunity for the medical director to 
incorporate improved treatment methodologies and current medical 
practices into day-to-day patient care within the facility in order to 
ensure better outcomes of care.
    We are proposing in Sec.  494.150(c)(1) that the medical director 
participate in the development, periodic review, and approval of the 
patient care policies and procedures manual. We are also proposing in 
Sec.  494.150(c)(2) that the medical director, as the individual with 
direct responsibility for the manner in which patient care is 
administered within the facility, be responsible to ensure that these 
patient care policies and procedures are adhered to by staff who treat 
patients in the dialysis facility, including attending physician and 
nonphysician staff. In those instances when facility staff or attending 
physicians or nonphysicians have not, or will not, follow the 
facility's written patient care policies and procedures, we would 
expect the medical director to educate and encourage those individuals 
to follow facility policies and procedures. In those rare instances 
when the medical director has been unsuccessful in achieving 
compliance, we would expect the medical director to refer the matter to 
the facility's governing body (see Sec.  494.180).
    We are proposing in Sec.  494.150(c)(2)(ii) that the medical 
director ensure that the interdisciplinary team follows the facility's 
patient discharge and transfer policies and procedures described in 
Sec.  494.180(f). In section VI.E9 of this preamble, we proposed that 
all patients be informed of a facility's transfer and discharge 
policies and be given 30 days notice in advance of a facility reducing 
or terminating on-going care. In addition, we are proposing that the 
medical director monitor and review each involuntary patient discharge 
to ensure that the patient's interdisciplinary team has performed the 
tasks required in Sec.  494.180(f).
    In a January 2002 report (Building on the Experiences of Dialysis 
Corporations, OEI-01-99-0052), the OIG recommended that the ESRD 
conditions for coverage specify the responsibilities of the Medical 
Director in situations when there is a quality problem related to an 
ESRD facility physician. The OIG recommendation follows:

    CMS should also address in the Conditions what medical directors 
are expected to do when a quality problem is attributable to an 
attending physician who is not performing adequately. It should make 
clear that: (1) Medical directors have the authority to conduct or 
initiate peer review and to address performance problems through 
directed education, and (2) for more serious situations, the medical 
director's responsibility to report a physician to an authoritative 
body, such as the End-Stage Renal Disease Network and/or the State 
Medical Board.


[[Page 6226]]


    We are soliciting comments on adding language to this regulation 
under the Medical Director condition to more specifically state Medical 
Director responsibilities in regard to ESRD facility attending 
physicians.

C. Relationship With ESRD Network (Sec.  494.160)

[If you choose to comment on issues in this section please include the 
caption ``ESRD Network'' at the beginning of your comment.]
    Existing Sec. Sec.  405.2110 through 405.2113 contain provisions 
that relate to the designation of the ESRD networks, the functions of 
the ESRD networks, and the role of the medical review boards. These 
provisions focus primarily on the role and responsibilities of the ESRD 
networks, rather than establishing conditions for Medicare coverage 
that must be met by dialysis facilities. Therefore, we are not 
incorporating these requirements in the proposed ESRD conditions for 
coverage. These regulations will remain in part 405 and any revisions 
will be addressed in a separate notice of proposed rulemaking.
    While we believe that the role and responsibilities of the networks 
do not need to be included in the proposed conditions for coverage, we 
believe that dialysis facilities must continue to share information 
with the networks. Thus, we propose to require at Sec.  494.160 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, similar to the requirement under existing Sec.  405.2134 
concerning participation in network activities. In addition, we believe 
that this proposed condition pertains directly to the dialysis facility 
rather than the network and is a condition that a dialysis facility 
must meet in order to qualify for Medicare approval.

D. Condition: Medical Records (Sec.  494.170)

[If you choose to comment on issues in this section please include the 
caption ``Medical Records'' at the beginning of your comment.]
    The patient's medical record presents a total picture of the care 
provided by the dialysis facility. The medical record--
     Serves as an organized plan for treatment and is used for 
diagnosing, treating, and caring for the patient;
     Facilitates communication among the various health care 
professionals providing services to the patient;
     Provides a focal point for coordinating the actions of the 
interdisciplinary team;
     Provides an accurate picture of the patient's progress in 
achieving care goals;
     Provides the team interdisciplinary members with data for 
evaluating and documenting the quality and appropriateness of care 
delivered; and
     Provides evidence of the facility's implementation of 
policies and procedures relating to patient care.
    The existing Medical records requirements at Sec.  405.2139 contain 
a large number of prescriptive requirements. These requirements include 
the following:
     Requires that each medical record contain sufficient 
information to identify the patient, justify the diagnosis and 
treatment, and document the results accurately.
     Prescribes the content of the medical record to include, 
for example, patient assessment information, evidence the patient was 
informed of the assessment, identification and social data, consent 
forms, medical and nursing history, diagnostic and therapeutic orders, 
observations and progress notes, laboratory results, and, if necessary, 
a discharge summary.
     Requires written policies and procedures to protect 
medical records information.
     Requires the facility to designate a medical records 
supervisor and includes a list of duties and responsibilities for that 
individual.
     Requires medical records to be completed promptly and 
states that all clinical information pertaining to the patient be 
maintained in a centralized location.
     Requires facilities to maintain medical records in 
compliance with State laws, or for 5 years in the absence of State 
requirements.
     Requires a facility to maintain adequate facilities, 
equipment, and space conveniently located, to provide efficient 
processing, viewing, filing, and prompt retrieval of medical records.
     Requires that a facility provide for the interchange of 
medical and other information ``necessary or useful'' in the care and 
treatment of patients transferred between treating facilities.
    In keeping with our goals to eliminate unnecessary requirements and 
to reduce burden on dialysis facilities, we are retaining only those 
minimum facility requirements that we believe would be necessary in a 
patient outcome-oriented environment.
    In the proposed medical records condition for coverage (Sec.  
494.170), we would state that the facility must maintain complete, 
accurate, and accessible medical records on all patients, including 
home dialysis patients for whom the facility has signed a backup 
agreement with a DME supplier to provide support services to the 
patient or whose care is under their supervision. The proposed rule 
emphasizes that a facility must maintain complete medical records for 
all patients under its supervision, including home patients.
    We propose to no longer prescribe the elements that facilities must 
include in the patient medical record. Instead, we believe that 
facilities should have the flexibility to decide what information must 
be included in the medical record as long as the services provided are 
consistent with the patient's diagnosed condition. We believe 
facilities will document patient outcomes (such as Kt/V and hematocrit 
levels), results of assessments and reassessments (see Sec.  494.80), 
changes in the care plan (see Sec.  494.90), and other pertinent 
information even though the elements are not prescribed, because this 
information is necessary to track patient progress, implement the 
patient care plan, record information needed to comply with the patient 
discharge or transfer procedure (see Sec.  494.150(e)), and effectively 
manage a facility quality assessment and performance improvement 
program (see Sec.  494.110). The patient's plan of care condition (see 
Sec.  494.90(b)) would require the facility to monitor and track 
patient progress toward the desired outcomes, and inherent in these 
requirements is the need to document patient results in some form.
    We are proposing at Sec.  494.170(a)(1) to retain the existing 
Sec.  405.2139(b) that requires a facility to protect its patients' 
medical records against loss, destruction, or unauthorized use because 
the records are crucial to the patient's care.
    However, we propose to eliminate the requirement at Sec.  
405.2139(b) that the facility must have written policies and procedures 
for recordkeeping. We believe this existing requirement is too 
restrictive and inflexible. The facilities must protect medical record 
information and keep all patient records confidential. Therefore, as 
long as there is a system in place to achieve the outcome, we believe 
that it is not necessary to require the facility to have written 
policies. However, facilities may find it necessary to have written 
procedures to ensure that they achieve the expected outcome.
    The existing requirement at Sec.  405.2139(b) mandates 
confidentiality in the handling of patient information

[[Page 6227]]

and requires facilities to safeguard patients' records by making them 
available only to authorized individuals. Under this requirement, a 
patient may refuse release of records to any individual outside the 
facility, except in specific situations such as a patient's transfer to 
another health facility or the release of information required by law.
    We are proposing in Sec.  494.170(a)(2) that the patient's medical 
record be released only under the following circumstances: (1) The 
transfer of the dialysis patient to another facility; (2) certain 
exceptions provided for in law; (3) provisions allowed under a third 
party payment contract; (4) approval by the patient; or (5) inspection 
by authorized agents of the Secretary as required for the 
administration of the Medicare program.
    We are proposing in Sec.  494.170(a)(3) to maintain the existing 
requirement at Sec.  405.2139(b) that the facility obtain written 
authorization of the patient or legal representative for release of 
information not required or authorized to be released by law.
    We are proposing in Sec.  494.170(b)(1) to retain the existing 
requirement at Sec.  405.2139(d) that current medical records and those 
of discharged patients are completed promptly. In a dialysis unit, it 
is essential that each clinical event be documented as soon as possible 
after its occurrence. Documentation must be current so that the medical 
records provide an up-to-date picture of the status of the patient at 
all times. We recognize that stating that medical records should be 
completed promptly is somewhat vague and subject to interpretation. We 
invite comments on the addition of a specific timeframe for the 
completion of patient medical records.
    In proposed Sec.  494.170(b)(2) we would maintain the existing 
requirement at Sec.  405.2139(d) that all clinical information 
pertaining to a patient is centralized. Regardless of how the medical 
record is completed and maintained (on paper or electronically), each 
member of the interdisciplinary team has access to the most recent 
information on the patient's condition and prescribed treatment.
    We are also proposing, in Sec.  494.170(b)(3), that the dialysis 
facility is responsible for completing, maintaining and monitoring 
medical records for its Method II home dialysis patients and its other 
home patients. Under Method II, home dialysis patients elect to receive 
all equipment and supplies from a DME company. The DME supplier must 
have a backup agreement with a dialysis facility that provides support 
services to the patient. We have mentioned Method II specifically in 
this proposed requirement because Method II requires that the patient's 
ESRD facility is fully aware of the equipment and supplies being used 
by the patient in order to accurately update the patient's medical 
record. Our new focus on achieving better patient outcomes is 
contingent upon accurate and current medical records for Method II and 
all other home dialysis patients.
    In proposed Sec.  494.170(c), we would make minor revisions to the 
existing requirement at Sec.  405.2139(e) that medical records be 
retained for a period of time not less than that determined by State 
statute governing records retention or statute of limitations; or in 
the absence of a State statute, 5 years from the date of discharge; or, 
in the case of a minor, 3 years or until the patient becomes of age 
under State law, whichever is longer. The facility's policy for the 
retention and preservation of records must conform to the requirements 
of State law or regulations. In this case, the date of discharge means 
the latest date the patient was discharged from any type of service 
provided by the dialysis facility.
    As previously stated, existing Sec.  405.2139(f) requires the 
dialysis facility to maintain adequate facilities, equipment, and space 
conveniently located, to provide efficient processing of medical 
records (for example, reviewing, filing, and prompt retrieval) and 
statistical medical information (for example, required abstracts, 
reports). The rationale for this requirement was that patient records 
should be easily retrievable and available to all facility staff and 
that medical records of patients undergoing treatment should be located 
close to the treatment area so that no time is lost in obtaining 
records for review and documentation. Although we agree that patient 
medical records should be accessible, we do not believe the 
prescriptive requirements in existing Sec.  405.2139(f) are necessary. 
As a result, we are proposing to eliminate this requirement. We believe 
that facilities already provide easy access to all patient medical 
records to ensure that all staff can promptly retrieve and review 
patient information.
    In Sec.  494.170(d) we are proposing to retain the requirement in 
existing Sec.  405.2139(g) that requires the facility to provide for 
prompt transfer of medical information between treatment facilities. 
The intent of this requirement is to facilitate continuation of care 
whenever a patient has to either temporarily leave the facility (for 
example, for vacation or hospitalization) or transfer permanently to a 
new facility. We believe that it is essential to the continuation of 
care that a patient's medical history and plan of treatment follow the 
patient. In addition, we are proposing to require that the facility 
exchange all medical records within 1 working day. The requirement that 
information be transferred within 1 working day is in existing Sec.  
405.2137(b)(5) (Patient long-term program and patient care plan), which 
states that if the patient is transferred to another facility, the care 
plan is sent with the patient or within 1 working day of the transfer. 
However, we believe the requirement should apply not only to the care 
plan, but to any medical record information, including, but not limited 
to, nutritional information, social work services, and rehabilitation 
status.
    Because dialysis patients must receive frequent treatments at 
prescribed intervals, this proposed requirement would minimize 
disruption in care. Without the medical information, the patient might 
receive inappropriate treatment. Requiring that the facility transfer 
information within 1 working day would minimize the possibility of a 
breakdown in communication between facilities. It would also ensure 
that the patient continues to receive care in accordance with his or 
her designed plan of treatment.
    Finally, we are proposing to eliminate the requirement at existing 
Sec.  405.2139(c) that the facility designate a staff member to serve 
as the medical records supervisor to facilitate the recordkeeping 
process. The current functions of the medical record supervisor 
include, but are not limited to: (1) Ensuring that the medical records 
are documented, completed, and maintained in accordance with accepted 
professional standards and practices; (2) safeguarding the 
confidentiality of the records in accordance with established policy 
and legal requirements; (3) ensuring that the records contain pertinent 
medical information and are filed for easy retrieval; and (4) obtaining 
the services of a qualified medical records practitioner when 
necessary. In keeping with our goal of eliminating process requirements 
that are not predictive of good outcomes for patients or necessary to 
prevent harmful outcomes for patients, we are proposing to eliminate 
the requirement that a facility designate a medical records supervisor.

E. Condition: Governance (Proposed Sec.  494.180)

[If you choose to comment on issues in this section please include the 
caption

[[Page 6228]]

``Governance'' at the beginning of your comment.]
1. Existing Requirements for Governing Bodies
    The existing requirements for the dialysis facility's governing 
body are found at Sec.  405.2136. Section 405.2136 states that the 
facility governing body or designated person(s) so functioning has the 
full legal authority and responsibility for the governance and 
operation of the facility. The governing body adopts and enforces rules 
relative to its own governance and to the health and safety of 
patients, acts upon recommendations from the Networks, and appoints a 
CEO who is responsible for the overall management of the facility.
    Existing Sec.  405.2136(a) covers the full disclosure of ownership 
for facilities that are independently owned, controlled by a 
partnership, or wholly or partially owned by corporate entities.
    Existing Sec.  405.2136(b) requires the governing body to develop, 
delineate, and review annually written operational objectives for the 
facility. These objectives apply to, among other things, services 
provided and admission criteria.
    Existing Sec.  405.2136(c) requires the appointment of a full-time 
or part-time CEO who acts as the facility's administrator. The CEO's 
responsibilities for the operation of the facility include the 
following:
     Implementing facility policies.
     Coordinating administrative functions.
     Authorizing expenditures.
     Familiarizing staff with facility policies, rules and 
regulations and applicable Federal, State and local laws and 
regulations.
     Maintaining and submitting required records and reports.
     Developing, negotiating and implementing contracts.
     Developing and implementing accounting and reporting 
systems, an annual budget, tracking expenses and revenues, submitting 
reports;
     Ensuring the facility employs the necessary number of 
qualified personnel, that those personnel are assigned appropriate 
duties, and have opportunities for continuing education and related 
developmental activities.
    Existing Sec.  405.2136(d) requires the governing body, through the 
CEO, to develop and implement personnel policies and procedures, 
covering, for example, assigned duties, health and safety hazards, 
supervising trainees, maintaining personnel records for staff, 
maintaining written personnel policies, orientation and in-service 
education, and maintaining written personnel manuals.
    Existing Sec.  405.2136(e) requires the facility to develop 
detailed, written arrangements for the use of outside resources, as 
needed, through its CEO who will serve as a consultant with the 
responsibility to continually assess performance and use documentation 
(that is, dated, signed reports).
    Existing Sec.  405.2136(f) specifies that the ESRD facility must 
have written patient care policies, and that policies are--
     Developed by the physician responsible for supervising or 
directing the provision of ESRD services or the facility's organized 
medical staff (if there is one) with the advice of (and with provision 
for review of such policies from time to time, but at least annually, 
by) a group of professional personnel associated with the facility, 
including but not limited to, one or more physicians and one or more 
registered nurses experienced in rendering ESRD care; and
     Approved by the governing body. The governing body is also 
responsible for periodic review of the implementation of policies to 
ensure that the intent of the policies is carried out.
    Under this section patient care policies must include the 
following: (1) Scope of services; (2) admission and discharge policies; 
(3) medical supervision and physician services; (4) patient long-term 
programs and care plans; (5) medical and other emergencies; (6) 
pharmaceutical services; (7) medical records; (8) administrative 
records; (9) maintenance of the physical plant; (10) consultant 
qualifications and activities; and (11) home dialysis support services. 
This standard also requires the medical director to execute these 
patient care policies, schedule hours of operation (when feasible) that 
are convenient to patients, and evaluate patients' progress toward 
goals in their long-term programs and care plans.
    Existing Sec.  405.2136(g) requires the governing body to ensure 
that every patient is under the continuing care of a physician and that 
a physician is available in emergency situations. This standard 
requires the physician responsible for the patient's care to evaluate 
the patient's immediate and long-term needs and prescribe a planned 
regimen of care. The standard also requires the governing body to 
ensure that there is always medical care available for emergencies with 
a list of physicians to contact posted at the nursing/monitoring 
station.
    Existing Sec.  405.2136(h) requires the governing body to designate 
a qualified physician as director of the ESRD facility and establish 
written policies regarding how medical appointments should be 
developed, maintained, and if necessary, terminated.
2. Overview of the Proposed Governance Requirements
    Consistent with the shift from process-oriented requirements to a 
more patient-centered, outcome-oriented approach, we are proposing 
significant revisions to the governance condition. In developing these 
proposed revisions for the Governance condition we sought to identify 
requirements that are covered in other parts of this proposed rule, as 
well as any other redundant, unnecessary or overly burdensome 
requirements that are unrelated to better patient outcomes. At the same 
time, we want to retain those structural requirements that might be 
indicative of better patient outcomes or offer necessary protections to 
patient health and safety. We also want to be responsive to a 
recommendation from the OIG (in its June 2000 report) to ``strengthen 
the accountability of the dialysis facility governing body'' (DHHS/OIG, 
June 2000). In that report, the OIG made the following recommendation: 
``The governing body should be held clearly accountable for the overall 
quality outcomes provided by the facility. Moreover, since most 
dialysis facilities are now part of national or multi-national 
corporations, the governing bodies should ensure that authoritative 
representatives are readily available to respond to queries and/or 
visits by State survey agencies or Networks.'' (DHHS/OIG, June 2000.)
    We believe that the performance of certain basic organizational 
functions is a minimum condition for an environment in which 
appropriate patient-centered care can occur. Therefore, the proposed 
Governance condition, Sec.  494.180, requires the necessary minimum 
administrative features to allow the governing body to safely and 
effectively run a facility in an outcomes environment while being 
responsive to the patients and to the OIG's recommendation to 
strengthen the accountability of the governing body.
3. Governance Condition (Proposed Sec.  494.180)
    In proposed Sec.  494.180 we state the dialysis facility must be 
under the control of an identifiable governing body, or designated 
person(s) so functioning, with full legal authority and responsibility 
for the governance and operation of the facility. The

[[Page 6229]]

Medicare program requires that each dialysis facility be independently 
certified, and therefore, each facility must independently achieve 
compliance with the conditions for coverage. It is essential that 
surveyors and networks be able to identify the group or individual with 
legal responsibility and accountability for managing patient health 
care, safety, and protection of patient rights and for the operation of 
each dialysis facility.
4. Designating of a Chief Executive Officer or Administrator (Proposed 
Sec.  494.180(a))
    Proposed Sec.  494.180(a) retains the existing requirement for the 
governing body or responsible party(ies) to appoint an individual who 
will serve as the facility's CEO or administrator. We are proposing to 
use these terms interchangably (that is, CEO and administrator) because 
the duties would be the same regardless of the title assigned. We have 
previously proposed that the facility's medical director (see Sec.  
494.150) assume certain clinical responsibilities for the care provided 
within the unit. We recognize that in smaller units it would be 
possible for the same individual to perform the duties of both medical 
director and CEO/administrator and these regulations do not preclude 
that. However, in a typical unit we believe the volume, scope, and 
complexity of administrative, financial, and operational 
responsibilities requires the day-to-day attention of a separate CEO/
administrator position. Therefore, we are proposing to retain this 
position and the performance of certain duties and responsibilities by 
the occupant of this position in these proposed conditions.
    We are proposing in Sec.  494.180(a) that the CEO/administrator 
exercise overall management responsibility for the facility and oversee 
staff appointments, fiscal operations, the relationship with the ESRD 
network, and the allocation of necessary staff and other resources for 
the facility's QAPI program (see Sec.  494.110).
5. Adequate Number of Qualified and Trained Staff (Sec.  494.180(b))
    Proposed Sec.  494.180(b) would retain and consolidate some of the 
existing requirements at Sec. Sec.  405.2136(c)(3)(viii) and 
405.2162(b)(2).
    We propose at Sec.  494.180(b)(1) to retain the existing 
requirement at Sec.  405.2162(b)(2) that a dialysis facility ensure an 
adequate number of qualified personnel are present whenever patients 
are undergoing dialysis. Under the existing requirement, every approved 
dialysis facility must maintain staff-to-patient ratios that are 
appropriate to the level of dialysis care being given in order to meet 
the needs of its patients. The determination and allocation of 
appropriate staff-to-patient ratios is left to each dialysis facility. 
State agency surveyors would assess facility compliance with this 
requirement by evaluating whether routine care is being delivered, 
assessments are conducted as the patient's condition changes, routine 
monitoring adheres to facility policy, and patients care provided by 
staff during surveys (for example, equipment alarms are responded to 
promptly). In our deliberations regarding ``adequate staff'', we noted 
that there is no national consensus within the dialysis industry 
regarding the appropriate staff-to-patient ratios. We also noted the 
wide variety of State staff-to-patient ratio requirements. For example, 
some States have staff-to-patient ratio requirements for registered 
nurses. Connecticut requires that 50 percent of a dialysis unit's 
patient care staff be registered nurses. New Jersey requires a 
registered nurse for the first nine patients in the unit. Georgia and 
South Carolina mandate a registered nurse for every 10 patients, while 
Texas requires a registered nurse for every 12 patients. Washington 
requires two registered nurses per shift. Oregon requires that a 
written staff plan for registered nurses be on file with the State.
    Some States have staff-to-patient ratios for patient care 
technicians. Maryland, Massachusetts, New Jersey, Washington, Puerto 
Rico, and the Virgin Islands require a three-to-one patient-to-staff 
care technician ratio. Georgia, South Carolina, and Texas require a 
four-to-one patient-to-patient care technician ratio. Nevada has a 100 
to 1 patient-to-staff ratio for social workers and renal dietitians. 
Further complicating the wide variation in State regulations are 
decisions involving scope of practice and the various nurse practice 
acts administered by the State boards of nursing. For the reasons cited 
above, we are not proposing any Federal staff-to-patient ratios.
    However, we are interested in strengthening the existing 
requirement while at the same time preserving the facility's 
flexibility in determining the appropriate staff-to-patient ratio.
    One alternative to mandated staff-to-patient ratios is an acuity-
based staffing system developed by each dialysis facility. This type of 
system would take into account the number of patients treated on each 
shift, individual patient characteristics, patient needs, the expertise 
and experience levels of facility staff, the physical layout of the 
facility, available technology, and the availability of support 
services. An acuity-based staffing plan, including some or all of the 
criteria listed above, could be developed by the nurse responsible for 
nursing services in the facility and approved by the medical director. 
It could also be incorporated into the facility's QAPI program (see 
Sec.  494.110) as a means of achieving desired outcomes of care 
specified in the facility's individual patient plans of care (see Sec.  
494.90). We are soliciting public comment on whether we should include 
a requirement for an acuity-based staffing plan in Sec.  494.180(b)(1) 
to ensure that every dialysis facility has ``adequate staffing'' and 
appropriate staff-to-patient ratios to meet the needs of its patients.
    We are proposing in Sec.  494.180(b)(2) that a registered nurse 
must be present in the facility at all times that patients are being 
treated. We have made this proposal for several reasons. As previously 
discussed in this preamble, the rapidly changing demographics of the 
dialysis patient population has resulted in an older, sicker patient 
population. An older patient population with more serious co-morbid 
conditions elevates the potential for medical emergencies (for example, 
heart attack, stroke, severe reactions to chemicals). A registered 
nurse has the professional training and expertise to properly react to 
these types of emergencies. Properly trained dialysis technicians and 
licensed practical nurses may be effective in providing day-to-day 
patient care, but may lack the training and expertise to react to 
critical medical emergencies. Therefore, we believe that having a 
registered nurse on the premises when treatment is being provided is a 
necessary health and safety measure for dialysis patients. Registered 
nurses, by training and professional expertise, are also needed to 
provide other important patient care functions that occur routinely 
while patients are being dialyzed. Those functions include: (1) 
Assessing patient needs; (2) developing treatment plans; (3) 
coordinating ongoing care in the unit; (4) continually evaluating the 
ability of the other nursing and technical staff to use the most 
current skills and techniques; (5) answering clinical questions from 
patients and staff; (6) and providing direct supervision for dialysis 
technicians during their 3-month training period (see proposed Sec.  
494.140(e)(3)).
    At Sec.  494.180(b)(3), we are proposing to retain the existing 
requirement that all employees have appropriate orientation to the 
facility and their work responsibilities upon employment. In addition, 
at Sec.  494.180(b)(4), we are

[[Page 6230]]

proposing to retain the existing requirement that all employees have an 
opportunity for continuing education and related development 
activities.
    At Sec.  494.180(b)(5), we are proposing a new requirement for a 
written approved training program, designed by the facilities, that is 
specific to dialysis technicians. As discussed earlier in this 
preamble, dialysis technicians are now the primary caregivers in many 
dialysis units, and we have proposed minimum Federal requirements for 
this occupation because we believe properly trained dialysis 
technicians are essential in achieving good patient outcomes of care 
(see Sec.  494.140(e)). Many States that regulate dialysis technicians 
require training programs that include: (1) The initiation of dialysis; 
(2) monitoring and termination of dialysis; (3) possible complications 
of dialysis; (4) water treatment; and (5) infection control procedures.
    We are proposing that every dialysis patient care technician-
training program contain criteria that would provide at least a minimal 
set of skills. When State requirements meet or exceed these proposed 
patient care technician-training requirements, the State requirements 
would have to be met. The criteria we are proposing include the 
following competencies: (1) Principles of dialysis; (2) care of the 
patient with kidney failure, including interpersonal skills; (3) 
dialysis procedures and documentation, including initiation, 
monitoring, and termination of dialysis; (4) possible complications of 
dialysis; (5) water treatment; (6) infection control; (7) safety; and 
(8) dialyzer reprocessing, if applicable. We invite public comment on 
the basic criteria proposed for Sec.  494.180(b)(5)(i) through (viii).
6. Medical Staff Appointments (Proposed Sec.  494.180(c))
    In Sec.  494.180(c) we propose to retain some of the existing 
requirements at Sec.  405.2136(h) that the governing body be 
responsible to oversee appointments to medical staff. We propose to 
expand this requirement to include all medical staff appointments, 
including appointments and credentialing for attending physicians, 
physician assistants, and nurse practitioners. However, consistent with 
our goal to reduce unnecessary process-oriented requirements and 
regulatory burden, we are not proposing to retain the existing 
requirement in Sec.  405.2136(h) for the governing body to establish 
written policies regarding the development, negotiation, consummation, 
evaluation, and termination of appointments to the medical staff (if 
the facility has a medical staff). Consistent with the new patient 
outcomes in this regulation, we are proposing to add a new requirement 
at Sec.  494.180(c)(2) that the governing body be responsible for 
ensuring that all attending physicians, physicians assistants, and 
nurse practitioners who provide care in the facility are informed 
regarding all patient care policies and procedures as well as the QAPI 
program. We believe adding this new requirement will assist the 
facility medical director in achieving better patient outcomes through 
direct care and through the QAPI program without adding any unnecessary 
burden to a dialysis facility. We are soliciting comments on our 
proposal to delete process requirements for medical staff appointments 
and add a new governing body requirement to inform the facility's 
medical staff regarding the facility's patient care policies and the 
facility's quality assurance and performance improvement program.
7. Furnishing Services (Proposed Sec.  494.180(d))
    Proposed Sec.  494.180(d) would retain the existing requirement 
Sec.  405.2102 for the governing body to ensure that (except for home 
care services provided pursuant to Sec.  494.100) services are 
furnished directly (see Sec.  494.10) on its main premises or on other 
premises that are contiguous with the main premises under the direction 
of the same professional staff and governing body as the main premises. 
We believe this requirement is essential to ensure that dialysis 
services are not provided in uncertified locations.
8. Internal Grievance Process (Proposed Sec.  494.180(e))
    In Sec.  494.180(e), we are proposing to require that facilities 
have an internal grievance process. We believe a good internal 
grievance process is an invaluable tool in resolving patient grievances 
in a positive and expeditious manner for both the patient and the 
facility. 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. The grievance process must be implemented so that the 
patient may file a grievance with the facility without reprisal or 
denial of services.
9. Discharge and Transfer Policies and Procedures (Proposed Sec.  
494.180(f))
    We are also proposing that the facility's discharge and transfer 
policy be designed to ensure that no patient, including disruptive or 
noncompliant patients, is discharged or transferred from the facility 
unless one of the following situations applies:
     The patient or payor will no longer reimburse the facility 
for covered services;
     The facility ceases to operate;
     The transfer is necessary for the patient's welfare 
because the facility can no longer meet the patient's documented 
medical needs;
     The facility has determined the patient's behavior is so 
disruptive or abusive that the facility is unable to deliver care to 
the patient or to operate effectively.
    We are proposing that the governing body assign the medical 
director the responsibility to monitor and review every patient 
discharge of an abusive or disruptive patient to ensure that the 
patient's interdisciplinary team has reassessed the patient and 
documented the ongoing problem(s) and efforts to resolve the 
problem(s); obtained a written physician's order which must be signed 
by the medical director and (if applicable) the patient's attending 
physician; and that a documented attempt has been made to place the 
patient in another facility. The State survey agency and the ESRD 
network must be notified of the involuntary discharge of any patient. 
We believe, as the individual in charge of patient care in the 
facility, the medical director (see proposed Sec.  494.150(c)(2)(ii)) 
is the appropriate individual to ensure that a patient's 
interdisciplinary team has followed the procedure described in Sec.  
494.180(f) before any transfers or discharges from the facility. We 
also believe it is important to allow facilities the flexibility to 
make these determinations on a case-by-case basis without the 
imposition of prescriptive criteria that would define disruptive or 
abusive behavior. However, the facility's interventions and reasons for 
involuntary discharge of a disruptive or abusive patient must be 
clearly documented in the patient's medical record. We invite comments 
on our proposal to hold the dialysis facility accountable for their 
staff adherence to facility's patient discharge or transfer policies 
and procedures.
10. Emergency Coverage (Proposed Sec.  494.180(g)
    Proposed Sec.  494.180(g) would require the governing body to be 
responsible for emergency coverage. Emergency coverage is not the same 
thing as emergency preparedness (see Sec.  494.60(d) in the proposed 
physical environment condition). As previously

[[Page 6231]]

discussed, emergency preparedness applies to medical and nonmedical 
emergencies related to fire, equipment or power failures, care-related 
emergencies, water supply interruptions, and natural disasters. The 
emphasis in emergency preparedness is on the facility staff's ability 
to manage and respond appropriately to these facility-wide problems. 
Emergency coverage, as proposed in Sec.  494.180(g), relates only to 
patient medical emergencies. Specifically, proposed Sec.  494.180(g)(1) 
would require the governing body to ensure that patients and staff have 
written instructions for obtaining emergency medical care. We believe 
giving patients and staff written instructions is both prudent and 
necessary to ensure that every patient has the necessary information if 
and when a medical emergency should arise.
    Proposed Sec.  494.180(g)(2) would retain the existing provision at 
Sec.  405.2136(g)(2) that requires the dialysis facility to post, at 
the nursing/monitoring station, a roster of physician names to be 
called for emergencies, when they can be reached, and how they can be 
reached.
    Proposed Sec.  494.180(g)(3) retains and combines existing 
provision at Sec.  405.2136(g)(2) which requires the governing body to 
ensure emergency care is always available, and existing Sec.  405.2160 
which requires the facility to have an agreement with a hospital to 
provide inpatient care and other services to patients at all times. 
However, our proposed agreement requirement at Sec.  494.180(g)(3) is 
much less prescriptive than the existing requirement at Sec.  405.2160, 
which is a condition-level requirement. For example, Sec.  405.2160 
requires a dialysis facility to have an agreement with a renal dialysis 
center, which is defined in existing Sec.  405.2102 as a hospital that 
is qualified to provide the full spectrum of diagnostic, therapeutic, 
and rehabilitative services required for the care of ESRD dialysis 
patients. Existing Sec.  405.2160 also contains explicit requirements 
for the affiliation agreement, that is, the agreement must (1) include 
the basis for working relationships between staff of both facilities to 
ensure that services are available promptly; (2) specify transfers for 
only medically appropriate circumstances as determined by the medical 
director or attending physician; (3) prescribe an interchange (within 1 
working day) between facilities of the patient's long-term plan and 
patient care plans; and (4) specify security and accountability for 
patients' personal effects. Our proposal, at Sec.  494.180(g)(3) states 
simply that the dialysis facility must have an arrangement with a 
hospital that can provide inpatient care, other hospital services, and 
emergency services which are available 24 hours a day, 7 days a week; 
services will be made available promptly; and there are reasonable 
assurances in the agreement that patients from the dialysis facility 
will be accepted and treated in emergencies. This is consistent with 
our goal of transitioning from unnecessary procedural and process 
requirements to a patient-outcomes environment in which a dialysis 
facility will have more flexibility in determining how necessary 
services, including emergency services, are provided to its patients.
11. Furnishing Data and Information for ESRD Program Administration 
(Proposed Sec.  494.180(h)
    We propose in Sec.  494.180(h) that dialysis facilities furnish 
data and information electronically and in intervals that conform to 
specifications established by the Secretary. While reporting data and 
information is an existing requirement in Sec.  405.2133, the proposal 
to require the ESRD CPM data and to require electronic data reporting 
are new requirements. The CPM project, a quality improvement initiative 
between CMS, the ESRD networks, and ESRD facilities was discussed in 
section II.E.4.1 of this proposed rule. Currently, dialysis facilities 
participate in this project voluntarily. We are proposing full 
participation in reporting the existing CPMs by all dialysis 
facilities. We have received recommendations from the OIG ``External 
Quality Review of Dialysis Facilities/A Call For Greater 
Accountability,'' the IOM ``Crossing the Quality Chasm, 2001'', and 
Medicare Payment Advisory Commission (MedPAC) ``Improving Quality 
Assurance for Institutional Providers'' to require facilities 
participating in Medicare to report on performance measures to 
stimulate improvements in the quality of care and to achieve a degree 
of accountability for performance ((DHHS/OIG, 1999), (IOM, 2001), and 
(MedPAC, 2000) respectively). The requirement for full CPM reporting is 
an important step in moving in that direction.
    Section 4558(b) of Pub. L. 105-33 requires us to develop a method 
to measure and report the quality of dialysis services provided in the 
Medicare program. To comply with this requirement, we developed the 
CPMs from the NKF-DOQI (now NKF-K/DOQI) clinical practice guidelines. 
The CPM project assists providers in the assessment of care provided to 
ESRD patients and stimulates improvement in that care. The processes 
used to develop the CPMs and the DOQI guidelines were also discussed in 
section II.E.3 and 4 of this preamble.
    Dialysis facilities and ESRD networks have used the ESRD CPM 
project annual reports for benchmarking purposes and as a means of 
identifying opportunities to improve care. The approach of this 
proposed rule is to decrease process requirements and instead look to 
outcomes of patient care so that quality may be assessed and reported. 
The CPMs will be a part of the vehicle by which we measure and report 
on the quality of dialysis services provided in the Medicare program.
    The CPM data collection tools were briefly described in section 
II.E.5 of this preamble. Data elements included on these forms are 
intermediate outcome measures and process markers for adequacy of 
hemodialysis and peritoneal dialysis, anemia management, nutrition 
(albumin), and vascular access management.
    The CMS VISION software will provide the electronic means for 
collection of the ESRD administrative forms (that is, CMS-2728, CMS-
2746, and CMS-2744) as well as the CPM data (CMS-820 and CMS-821). In 
the future, CMS VISION software may also collect other information such 
as patient experience of care survey data. The VISION program will 
utilize an encryption technology that assures privacy, confidentiality, 
and security for electronic communications. The requirement for full 
CPM reporting on all patients by all facilities will be implemented 
only when the VISION software is fully operational. Vision software 
will be provided to independent dialysis facilities and small to medium 
size corporate dialysis facilities at no cost. Specifications are being 
provided for developing an interface between the major corporate 
dialysis facilities' databases and the CMS database to enable ESRD 
administrative data and CPM data to be transmitted electronically with 
minimal effort from dialysis facility staff. There are initial costs 
for major corporate dialysis facilities as they develop the software 
interface and for initial training. For a more detailed discussion of 
these costs see section IX. of this preamble.
    The Secretary will determine the frequency of CPM data collection. 
Facilities currently report (via billing submissions) monthly URR 
values for all hemodialysis patients and monthly hematocrit levels for 
all patients receiving erythropoietin.
    The CPM data collection would provide a means for the reporting of 
facility-specific performance measures capturing information related to 
the

[[Page 6232]]

quality of care delivered. This kind of information is especially 
important if a fully-bundled payment system for the ESRD program 
expands the composite rate structure to include all outpatient routine 
dialysis payments. We are concerned that this change in the payment 
structure could provide financial incentives to reduce services 
provided to ESRD beneficiaries; thereby compromising quality of care. 
Any shift in payment policy necessitates a strong external monitoring 
process to ensure that an acceptable level of care continues. The 
reporting of facility-specific performance measures and the development 
of standards would provide us with the means externally to evaluate and 
monitor dialysis facilities to ensure that the necessary services have 
been provided and to assist patients to reach optimal outcomes.
    We are looking at the feasibility of developing minimum performance 
standards. There are widely accepted (K/DOQI) clinical practice 
guidelines and clinical performance measures (CPMs) in existence. 
However, there is no consensus for minimum performance standards. 
Dialysis facility performance is generally compared to performance of 
other facilities in the network or to national performance data. 
Facilities whose performance measures fall well below the comparison 
group are generally identified as needing improvement. However, we do 
not have defined thresholds that tell us, for example, that if a 
dialysis facility provided a KT/V of 1.2 or higher to at least 85 
percent of its hemodialysis patients, that facility is providing an 
acceptable level of care.
    An additional problem in using minimum standards for accountability 
purposes is the possibility of ``cherry picking'' and decreased access 
to dialysis for some patients. Dialysis facilities may have a 
disincentive to accept patients likely to be more difficult to manage 
as well as patients that are more resource-intensive and who are less 
likely to achieve acceptable levels on the performance measures. This 
raises the issue of the necessity of risk adjusters to be used in 
developing the bundled payment rate, as well as developing performance 
standards for accountability. We are looking at these difficult issues 
and considering the implications of any changes in payment and 
performance accountability. We are soliciting comments on how the 
incentives to ``cherry pick'' could be minimized. Any performance 
standards that we may use for dialysis facilities would be developed in 
conjunction with the NTTAA process discussed in section II.E.6 of this 
preamble.
    This proposal, which requires CPM reporting, is specific to the 
CPMs as they currently exist. The process for updating, revising, and 
expanding the CPMs will be done in conjunction with the NTTAA process. 
A voluntary consensus standards body, which as yet has not been 
identified, would likely plan, develop, establish, or coordinate 
voluntary consensus standards using agreed upon procedures in 
conjunction with the NTTAA.
    In the February 19, 1998 Federal Register (63 FR 8546), the Office 
of Management and Budget published a notice regarding the Federal 
participation in the development and use of voluntary consensus 
standards. We will use the policies established in this publication and 
the Administrative Procedure Act (APA) when adopting voluntary 
consensus standards. If we adopt voluntary consensus standards that are 
not legally binding, we would publish them as a notice in the Federal 
Register.
    The ESRD CPM project data, which would provide the use patterns of 
100 percent of dialysis patients, would provide an array of 
possibilities for facilities to compare performance and practice 
patterns at facility, State, network, and national levels in order to 
identify opportunities for improvement in the care of dialysis 
patients.
    This information would provide independent dialysis facilities with 
the same type of information that some dialysis chain corporations have 
been able to collect on their own dialysis facilities across the 
nation. These CPM data would expand the breadth of data that have been 
previously available even to the large dialysis corporations.
    The ESRD networks would use the CPM data elements and calculated 
measures in order to assist dialysis facilities with quality 
improvement activities and as a benchmark to look at their own 
performance.
    The State survey agencies would receive facility profiles as well 
as data for dialysis adequacy, vascular access, anemia management, and 
nutrition for use in their survey activities.
    At a minimum, we would use the following facility-specific 
information for public reporting on our Dialysis Facility Compare Web 
site:
     Number of patients included in each calculation.
     Percent of patients treated in the facility with a Kt/V >= 
1.2.
     Percent of patients treated in the facility with a 
hemoglobin >= 11 gms/dL.
    Public reporting of performance measures provides an important 
resource to dialysis patients and their families. The Dialysis Facility 
Compare website provides detailed information about Medicare-certified 
dialysis facilities and allows for comparison of facility 
characteristics and quality measures. We are evaluating the information 
reported on the Dialysis Facility Compare website for usability and to 
ensure that the publicly reported information meets the needs of the 
beneficiary. The availability of information will permit patients to 
become more active participants in their facilities' quality 
improvement process. Informed patients make better health care choices 
and are more active participants in their medical care.
12. Disclosure of Ownership (Proposed Sec.  494.180(i))
    In Sec.  494.180(i) we are proposing to retain the existing Sec.  
405.2136(a) that the dialysis facility must provide complete 
information to the State survey agency regarding persons who have any 
direct or indirect ownership of the facility in whole or in part in 
compliance with the requirements of Sec. Sec.  420.200 through 420.406. 
This requirement, reporting ownership interests of 5 percent or more, 
is a conforming change to comport with the existing requirements in 
Sec.  420.201, which have been in effect since 1992.

VII. Other Proposed Changes and Issues

A. Proposed Cross-Reference Changes

[If you choose to comment on issues in this section please include the 
caption ``Cross-Reference Changes'' at the beginning of your comment.]
    We are proposing to make technical changes in the following 
sections of the regulations to correct cross-references to the sections 
in part 405, subpart U that are proposed to be relocated or deleted: 
Sec. Sec.  410.5, 410.50, 410.52, 410.152, 410.170, 413.170, 413.172, 
413.198, and 414.330.

B. Proposed Additions to Part 488

[If you choose to comment on issues in this section please include the 
caption ``Part 488'' at the beginning of your comment.]
    We are proposing 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. Sec.  405.2180, 
405.2181, 405.2182, and 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

[[Page 6233]]

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 propose to redesignate these provisions (with technical and 
cross-reference changes) as Sec. Sec.  488.604, 488.606, 488.608, and 
488.610 respectively.

VIII. Reference Materials

A. New Provisions of Part 494

    This proposed 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).  Sec.   494.30(a)--Infection control
                                     procedures (including the
                                     Recommended Infection Control
                                     Practices for Hemodialysis Units At
                                     a Glance CDC guidelines).
                                    Sec.   494.30(a)(2)--Patient
                                     isolation procedures.
Water quality (Sec.   494.40).....  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.          Sec.   494.60(e)--Fire safety.
 494.60).
Patient rights (Sec.   494.70)....  Sec.   494.70(a)(5)--Advance
                                     directives.
                                    Sec.   494.70(a)(14)--Complaint
                                     systems.
                                    Sec.   494.70(b)--Discharge and
                                     transfer policies.
                                    Sec.   494.70(d)--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.
                                    Sec.   494.80(a)(10)--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.
Patient plan of care (Sec.          Sec.   494.90(a)(1)--Dose of
 494.90).                            dialysis.
                                    Sec.   494.90(a)(2)--Nutritional
                                     status.
                                    Sec.   494.90(a)(3)--Anemia.
                                    Sec.   494.90(a)(4)--Vascular
                                     access.
                                    Sec.   494.90(a)(5)--Transplantation
                                     status.
                                    Sec.   494.90(a)(7)--Rehabilitation
                                     status.
                                    Sec.   494.90(b)--Implementation of
                                     patient plan of care.
                                    Sec.   494.90(b)(3)--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)--Anemia
                                     management.
                                    Sec.   494.110(a)(2)(iv)--Vascular
                                     access.
                                    Sec.   494.110(a)(2)(v)--Medical
                                     injuries and medical error
                                     identification.
                                    Sec.   494.110(a)(2)(vi)--
                                     Hemodialyzer reuse.
                                    Sec.   494.110(a)(vii)--Patient
                                     satisfaction.
                                    Sec.   494.110(b)--Monitoring
                                     performance improvement.
                                    Sec.   494.110(c)--Prioritizing
                                     improvement activities.
Special purpose renal dialysis      (Sec.   494.120)--Definition.
 facilities (Sec.   494.120).
Personnel qualifications (Sec.      Sec.   494.140(b)--Nursing services.
 494.140).                          Sec.   494.140(e)--Dialysis
                                     technicians.
Responsibilities of the medical     Sec.   494.150(a)--Quality
 director (Sec.   494.150).          assessment and performance
                                     improvement program.
                                    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)--Discharge and
                                     transfer policies and procedures.
                                    Sec.   494.180(g)--Emergency
                                     coverage.
                                    Sec.   494.180(h)--Furnishing data
                                     and information for ESRD program
                                     administration.
------------------------------------------------------------------------

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

[[Page 6234]]



----------------------------------------------------------------------------------------------------------------
    Existing conditions (part 405,                                Proposed conditions
              subpart U)                  Existing citation            (part 494)           Proposed citation
----------------------------------------------------------------------------------------------------------------
Scope of subpart.....................  405.2100(a)............  Basis and scope........  494.1
                                       405.2100(b)............  Deleted................
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)  .......................  .......................  .......................
        (a) Renal transplantation      .......................  Retained in 405,         494.10
         center.                                                 Subpart U.
        (b) Renal dialysis center....  .......................   Deleted...............  .......................
        (c) Renal dialysis facility..  .......................  Definitions............  494.10
        (d) Self-dialysis unit.......  .......................  Deleted................  .......................
        (e) Special purpose renal      .......................  Special purpose renal    494.120
         dialysis facility.                                      dialysis facilities.
    ESRD service (introductory text).  .......................  Retained in 405,         .......................
                                                                 Subpart U.
        (a) Transplantation service..  .......................  Deleted................  .......................
        (b) Dialysis service.........  .......................  Deleted................  .......................
            (1) Inpatient dialysis...  .......................  Deleted................  .......................
            (2) Outpatient dialysis..  .......................   Deleted...............  .......................
                (i) Staff-assisted     .......................  Definitions............  .......................
                 dialysis.
                (ii) Self-dialysis...  .......................  Deleted................  494.10
            (3) Home dialysis........  .......................  Care at home...........  .......................
        (c) Self-dialysis and home     .......................  Deleted................  494.100
         dialysis.
    Furnishes directly...............  .......................  Governance.............  .......................
    Furnishes on the premises........  .......................  Retained in 405,         494.180(d)
                                                                 Subpart U.
    Histocompatibility testing.......  .......................  Deleted................  .......................
    Medical care criteria............  .......................  Deleted................  .......................
    Medical care norms...............  .......................  Deleted................  .......................
    Medical care standards...........  .......................  Deleted................  .......................
    Medical care evaluation study....  .......................  Deleted................  .......................
    Network ESRD.....................  .......................  Retained in 405,         .......................
                                                                 Subpart U.
    Network organization.............  .......................  Retained in 405,         .......................
                                                                 Subpart U.
    Organ procurement (introductory    .......................  Deleted................  .......................
     text).                                                     Governance.............
        (a) Chief executive officer..  .......................  Personnel                494.190(a)
                                                                 qualifications.
        (b) Dietitian................  .......................  Deleted................  494.150(c)
        (c) Medical record             .......................  Personnel                .......................
         practitioner.                                           qualifications.
        (d) Nurse responsible for      .......................  Personnel                494.150(b)
         nursing services.                                       qualifications.
        (e) Physician-director.......  .......................  Personnel                494.150(a)
                                                                 qualifications.
        (f) Social worker............  .......................  Retained in 405,         494.150(d)
                                                                 Subpart U.
        (g) Transplantation surgeon..  .......................  .......................  .......................
Designation of ESRD networks.........  405.2110...............  Retained in 405,         .......................
                                                                 Subpart U.
[Reserved]...........................  405.2111...............  Deleted................  .......................
ESRD network organizations...........  405.2112...............  Retained in 405,         .......................
                                                                 Subpart U.
Medical review board.................  405.2113...............  Retained in 405,         .......................
                                                                 Subpart U.
[Reserved]...........................  405.2114...............  Deleted................  .......................
Minimum utilization rates: General...  405.2120...............  Retained in Subpart U..  .......................
Basis for determining minimum          405.2121...............  Retained in Subpart U..  .......................
 utilization rates.
Types and duration of classification   405.2122...............  Retained in Subpart U..  .......................
 according to utilization rates.
Reporting of utilization rates for     405.2123...............  Retained in Subpart U..  .......................
 classification.
Calculation of utilization rates for   405.2124...............  Retained in Subpart U..  .......................
 comparison with minimum utilization
 rate(s) and notification of status.
Minimum utilization rates............  405.2130...............  Retained in Subpart U..  .......................
Provider status: renal                 405.2131...............  Retained in 405,         .......................
 transplantation center or renal                                 Subpart U.
 dialysis center.
[Reserved]...........................  405.2132...............  Deleted................  .......................
Furnishing data and information for    405.2133...............  Governance.............  494.190(f)
 ESRD program administration.
Participation in network activities..  405.2134...............  Relationship with ESRD   494.170
                                                                 network.
Compliance with Federal, State, and    405.2135...............  Compliance with          494.20
 local laws and regulations.                                     Federal, State, and
                                                                 local laws and
                                                                 regulations.
Governing body and management........  405.2136...............  Governance.............  494.180 (introductory
                                                                                          text)
    (a) Disclosure of ownership......  405.2136(a)............  Governance.............  494.180(g)
    (b) Operational objectives.......  405.2136(b)............  Deleted................  .......................
    (c) Chief executive officer......  405.2136(c)............  Governance.............  494.180(a)
    (d) Personnel policies and         405.2136(d)(1,3-5,7)...  Deleted................  .......................
     procedures.
    (d)(2) Infection control/Incident  405.2136(d)(2).........  Infection control and     494.30(a) &
     reports.                                                    Quality assessment and   494.110(a)(5)
                                                                 performance
                                                                 improvement.

[[Page 6235]]

 
    (d)(6) Facility personnel          405.2136(d)(6).........  Personnel                494.140(e)
     educational programs.                                       qualifications.
    (e) Use of outside resources.....  .......................  Medical Director.......  494.150(c)
    (f) Patient care policies........  405.2136(e)............  Deleted................  .......................
    (g) Medical supervision and        405.2136(f)............  Medical Director.......  494.150(d)
     emergency coverage.               405.2136(g)(1).........  Patient plan of care...  494.90 (introductory
                                                                                          text)
    (h) Medical staff................  .......................  Care at home and         494.100(c) & 494.180(b)
                                                                 Governance.
                                       494.2136(g)(2).........  Governance.............  494.180(e)
                                       405.2136(h)............  Governance.............  494.180(c)
Patient long-term program and patient  405.2137 (introductory   Patient care plan......  494.90 (introductory
 care plan.                             text).                                            text)
    (a) Patient long-term program....  405.2137(a)............  Deleted................  .......................
    (b) Patient care plan............  405.2137(b)............  Patient care plan......  494.90 (introductory
                                                                                          text)
    (b)(1) Personalized care plan....  405.2137(b)(1).........  Patient care plan......  494.90 (introductory
                                                                                          text)
    (b)(2) Developed by a              405.2137(b)(2).........  Patient care plan......  494.90 (introductory
     professional team.                                                                   text)
    (b)(3) The patient is involved...  405.2137(b)(3).........  Patient rights.........  494.70(a)(5)
    (b)(4) Frequency of care plan      405.2137(b)(4).........  Patient plan of care...  494.90(b), (1)
     review.
    (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).........  Care at home...........  494.100 (introductory
     dialysis patient.                                                                    text)
    (b)(7) Erythropoietin for the      405.2137(b)(7).........  Patient plan of care...  494.90(a)(3)
     home dialysis patient.
Patient's rights and responsibilities  405.2138(a)-(d)........  Patient rights and       494.70(a) and
                                                                 medical records.         494.170(a)
                                       405.2138(e)............  Patient rights.........  494.70(c) (13 and 14)
Medical records......................  405.2139...............  Recordkeeping..........  494.170 (introductory
                                                                                          text)
    (a) Medical record contents......  405.2139(a)............  Deleted................  .......................
    (b) Protection of medical record   405.2139(b)............  Recordkeeping..........  494.170(a)
     information.
    (c) Medical record supervisor....  405.2139(c)............  Deleted................  .......................
    (d) Completion and centralization  405.2139(d)............  Recordkeeping..........  494.170(b)
    (e) Retention and preservation...  405.2139(e)............  Recordkeeping..........  494.170(c)
    (f) Location and facilities......  405.2139(f)............  Deleted................  .......................
    (g) Transfer of medical            405.2139(g)............  Recordkeeping..........  494.170(d)
     information.
Physical environment.................  405.2140(a)              Physical environment...  494.60 (introductory
                                        (introductory text).                              text)
    (a) Building and equipment.......  405.2140(a)(1).........  .......................  .......................
    (a)(1) Fire......................  405.2140(a)(2), (3)....  Physical environment...  494.60(e)
    (a)(2), (3) Equipment and areas    .......................  Physical environment...  494.60(a), (b)
     are hazard free.
    (a)(5) Water quality requirements  405.2140(a)(5).........  .......................  .......................
    (b) Favorable environment for      405.2140(b)              Water quality..........  494.40
     patients.                          (introductory text).
    (b)(1) Infection prevention......  .......................  Physical environment...  494.60(c)
    (b)(2)(4) Adequate treatment       405.2140(b)(1).........  Infection control......  494.60(c)
     areas/Heating and ventilation     405.2140(b)(2)(4)......  Physical environment...  494.60(c)
     systems.
    (b)(3) Nursing station...........  .......................  .......................  .......................
    (b)(5) Special dialysis solutions  405.2140(b)(3).........  Deleted................  .......................
    (c) Contamination prevention.....  405.2140(b)(5).........  Deleted................  .......................
                                       405.2140(c)............  Infection control and    494.30(a) and 494.40
                                                                 Reuse of.
    (d) Emergency preparedness.......  405.2140(d)............  Hemodialyzers..........  (introductory text),
                                                                                          (a)
                                                                Physical environment...  494.60(d)
Reuse of hemodialyzers and other       405.2150 (introductory   Reuse of hemodialyzers   494.50 (introduction)
 dialysis supplies.                     text).                   and Bloodlines.
    (a) Hemodialyzers................  405.2150(a)(1-3).......  Reuse of hemodialyzers   494.50 (introduction),
                                                                 and Bloodlines.          (a), (b)
    (b) Transducer filters...........  405.2150(b)............  Infection Control......  494.30(a)(1)
    (c) Bloodlines...................  405.2150(c)............  Resuse of hemodialyzers  494.50(c)
                                                                 and Bloodlines.
Affiliation agreement or arrangement.  405.2160 (a), (b)(1),    Governance.............  494.180(e)(3)
                                        (b)(3).
                                       405.2160(b)(2).........  Medical records........  494.170(d)
Director of a renal dialysis facility  405.2161...............  Personnel                494.140(a)
 or renal dialysis center.                                       qualifications.
                                                                Medical Director.......  494.150
Staff of a renal dialysis facility or  405.2162 (stem           Governance.............  494.180(b)
 renal dialysis center.                 statement).
Adequate numbers of personnel are      405.2162(a)............  Governance.............  494.180(b)
 present to meet patient needs.
    (a) Registered nurse.............  405.2162(b)............  Personnel                494.140(b) & (e)
                                                                 qualifications.
    (b) On-duty personnel............  405.2162(b)............  Governance.............  494.180(b)
    (c) Self-care dialysis training    405.2162(c)............  Care at home...........  494.100(a)
     personnel.
Minimal service requirements for a     405.2163...............  Patient plan of care...  494.90 (introductory
 renal dialysis facility or renal                                                         text)
 dialysis center.
    (a) Outpatient dialysis services.  405.2163(a)............  Patient plan of care...  494.90
                                                                Care at home...........  494.100
    (b) Laboratory services..........  405.2163(b)............  Laboratory services....  494.130
    (c) Social services..............  405.2163(c)............  Patient Assessment.....  494.80(a)

[[Page 6236]]

 
                                                                Patient plan of care...  494.90(a)
                                                                Care at home...........  494.100(a)
    (d) Dietetic services............  405.2163(d)............  Patient Assessment.....  494.80(a)
                                                                Patient plan of care...  494.90
    (e) Self-dialysis support          405.2163(e)............  Care at home...........  494.100(c)
     services.
    (f) Participation in recipient     405.2163(f)............  Patient plan of care...  494.90(c)
     registry.
    (g) Use of erythropoietin at home  405.2163(g)............  Patient Assessment.....  494.80(a)(4)
                                                                Patient plan of care...  494.90(a)(3)
                                                                Care at home...........  494.100(a)(2)
    (h) Responsibilities of the        405.2163(h)............  Care at home...........  494.100(b)(2)
     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.
Director of a renal transplantation    405.2170...............  Retained in 405,         .......................
 center.                                                         Subpart U.
Minimal service requirements for a     405.2171 (introductory   Retained in 405,
 transplantation center.                text).                   Subpart U.
                                       405.2171(a)-(e)........  .......................  .......................
Termination of Medicare coverage.....  405.2180...............  Termination of Medicare  488.604
                                                                 coverage.
Alternative sanctions................  405.2181...............  Alternative sanctions..  488.606
Notice of sanction and appear rights:  405.2182...............  Notice of appeal         488.608
 Termination of coverage.                                        rights: Termination of
                                                                 coverage.
Notice of appeal rights: Alternative   405.2184...............  Notice of appeal         488.610
 sanctions.                                                      rights: Alternative
                                                                 sanctions.
----------------------------------------------------------------------------------------------------------------

C. Bibliography

Alter, M.J., et al. ``Dialysis & Transplantation.'' Annals of 
Internal Medicine 12 (1983): 860-865.
American National Standards Institute. Association for the 
Advancement of Medical Instrumentation. Hemodialysis Systems. (RD5) 
1992. Sections 3.2.1, 3.2.2 and Appendix B, Sections B1-B5.
--Reuse of Hemodialyzers. 1993.
--Reuse of Hemodialyzers. (RD47) 2002.
--Reuse of Hemodialyzers (Corrected Copy). (RD47) 2003.
--Concentrates for Hemodialysis. (RD61) 2000.
--Water Treatment Equipment for Hemodialysis Applications. (RD62) 
2001.
--Dialysate for Hemodialysis. (RD52) 2004.
Becker, Linda, M.A. et al. ``Cardiac Arrest in Medical and
Department of Health and Human Services. Centers for Disease Control 
and Prevention. ``Recommendations for Preventing Transmission of 
Infections Among Chronic Hemodialysis Patients.'' Morbidity and 
Mortality Weekly Report 50 (RR05) (April 27, 2001): 20-21. 
(Available at www.cdc.govmmwr/preview/mmwrhtml/rr5005al.htm.)
--``Recommended Infection Control Practices for Hemodialysis Units 
At a Glance.'' 50 (RR05) (April 27, 2001): 20-21. (Available at 
www.cdc.govmmwr/preview/mmwrhtml/rr5005al.htm.)
--``Guidelines for Hand Hygiene in Health-Care Settings: 
Recommendations of the Healthcare Infection Control Practice 
Advisory Committee and the HCIPAC/SHEA/APIC/IDSA Hand Hygiene Task 
Force.'' Morbidity and Mortality Weekly Report 51 (RR16) (October 
25, 2002): 1-45. (Available at www.cdc.govmmwr/preview/mmwrhtml/
rr5116al.htm.)
--``Guidelines for Environmental Infection Control in Health-Care 
Facilities: Recommendations of CDC and the Healthcare Infection 
Control Practices Advisory Committee (HICPAC).'' Morbidity and 
Mortality Weekly Report 52 (RR10) June 6, 2003: 1-44. (Available at 
www.cdc.govmmwr/preview/mmwrhtml/rr5210al.htm.)
--Centers for Medicare & Medicaid Services. ``Appendix H: Survey 
Procedures and Interpretive Guidelines for Surveyors of End-Stage 
Renal Disease Facilities.'' State Operations Manual. April 1995: Tag 
V-188.
--Center for Beneficiary Choices. ``2002 Annual Report ESRD Clinical 
Performance Measures Project: Opportunities to Improve Care for 
Adult In-Center Hemodialysis, Adult Peritoneal Dialysis, and 
Pediatric In-Center Hemodialysis Patients.'' December 2002: 1-104. 
(Available at www.cms.hhs.gov/esrd/1.asp)
--Food and Drug Administration. ``Guidance for Hemodialyzer Reuse 
Labeling.'' 1995.
--``Guidance for the Content of Premarket Notification for Water 
Purification Components and Systems for Hemodialysis.'' 1997.
--National Institutes of Health. ``Morbidity and Mortality of 
Dialysis.'' Consensus Conference Report, 11.2 (1993): 1-33.
--``Study Confirms Recommended Dialysis Dose''. National Institute 
of Diabetes and Digestive and Kidney Diseases (April 23, 2002). 
(Available at www.nih.gov/news/pr/apr2002/niddk-23.htm)
--Office of the Inspector General. ``External Quality Review of 
Dialysis Facilities: A Call for Greater Accountability.'' Report, 
1999. (p. 131, 189)
--``Clinical Performance Measures for Dialysis Corporations, 
Practices of Major Dialysis Corporations.'' Report, OEI-01-99-00053, 
January 2002.
--``Clinical Performance Measures for Dialysis Facilities: Building 
on the Experiences of the Corporations.'' Report, 2002.
Ekoyan, Garabed, M.D., Beck, Gerald J., Ph.D., Cheung, Alfred K., 
M.D. et al. ``Effect of Dialysis Dose and Membrane Flux in 
Maintenance Hemodialysis,'' New England Journal of Medicine 347.25 
(December 19, 2002): 2010-2019. (Available at www.nejm.org)
Grohskopf, Lisa A., M.D. et al. ``Serratia Liquefaciens Bloodstream 
Infections From Contamination of Erythropoietin Alfa At A 
Hemodialysis Center.'' New England Journal of Medicine 344.20 (May 
17, 2001): 1491-1497. (Available at www.nejm.org)
Hays, R.D., Kallich, J.D., Mapes, D.L., Coons, S.J., Carter, W.B. 
``Development of the Kidney Disease Quality of Life (KDQOL) 
Instrument.'' Quality of Life Research 3.5 (October 1994): 329-338.
Held, P.J., Levin, N.W., Bovbjerg, R.R., et al. ``Mortality and 
Duration of Hemodialysis Treatment.'' Journal of the American 
Medical Association 265 (1991): 871-875.
Institute of Medicine. ``Report on Kidney Failure and the Federal 
Government.'' Report, 1991.
--``To Err is Human: Building a Safer Health System.'' Report, 2000.
--``Crossing the Quality Chasm: A New Health System for the 21st 
Century.'' Report, 2001. (Available at www.books.nap.edu/books/0309072808/html/indes.html.)
Kaplan, B., et al. ``Chronic Hemodialysis Patients. Part I: 
Characterization and Drug-Related Problems.'' The Annals of 
Pharmacotherapy. 28 (1994): 316-319.
The Life Options Rehabilitation Advisory Council. Renal 
Rehabilitation, Bridging the Barriers. 1994. Madison, Wisconsin: 
Medical Education Institute, Incorporated. (Available at 
www.lifeoptions.org.)
Medicare Payment Advisory Commision. ``Chapter 4: Improving Quality 
Assurance for Institutional Providers,'' Report to Congress: 
Selected Medicare Issues. June 2000. 81-103.

[[Page 6237]]

National Fire Protection Association. NFPA 101, Life Safety Code 
Handbook. Chapters 20 and 21. January 12, 2000.
--Standard for Health Care Facilities. Chapter 11: Health Care 
Emergency Preparedness. November 2001.
National Kidney Foundation. ``Kidney/Disease Outcomes Quality 
Initiative Clinical Practice Guidelines for Nutrition in Chronic 
Renal Failure.'' American Journal of Kidney Diseases. 35 (2000): S1-
S140.
--Hemodialysis Adequacy Guidelines. 1997 (updated June 2000). 
Guideline 4.
--Peritoneal Dialysis Adequacy Guidelines. 1997 (updated June 2000). 
Guidelines 15 and 16.
--Guidelines for Advance Directives. 2000. (Available at 
www.kidneyva.org/public ed/orderforms.pdf.)
--``Kidney/Disease Outcomes Quality Initiative Clinical Practice 
Guidelines for Vascular Access.'' American Journal of Kidney 
Diseases 37 (supplement 1) (2001): S137-S181.
--``Disease Outcome Quality Initiative Clinical Practice Guidelines 
for Hemodialysis Adequacy, Peritoneal Dialysis Adequacy, Vascular 
Access, and Anemia for Chronic Kidney Disease.'' American Journal of 
Kidney Diseases 37 (supplement 1) (January 2001): S182-S238.
``National Kidney Foundation Dialysis Technician Task Force.'' 
American Journal of Kidney Diseases. 21 (1993): 2.
Owen, W.F., Jr., Lew, N.L., Lui, Y., et al. ``The Urea Reduction 
Ratio and Serum Albumin Concentration as Predictors of Mortality in 
Patients Undergoing Hemodialysis.'' New England Journal of Medicine 
329 (1993): 1001-1006.
Parker, T.F., III. ``Role of Dialysis Dose on Morbidity and 
Mortality in Maintenance Hemodialysis Patients.'' American Journal 
of Kidney Diseases 24 (1994): 981-989.
Parker, T.F., III, Husni, L., Haugn, W., et al. ``Survival of 
Hemodialysis Patients in the United States is Improved with a 
Greater Quantity of Dialysis.'' American Journal of Kidney Diseases 
23 (1994): 670-680.
Parkerson, G.R. et al. ``The Duke Health Profile: A 17-Item Measure 
of Health and Dysfunction.'' Medical Care 28.11 (1990): 1056-1069.
RAND Corporation. ``Kidney Dialysis Quality of Life Short Form, 
Version 1.3: A Manual for Scoring.'' 1997.
The Renal Physicians Association. The Collaborative Leadership for 
ESRD Patient Safety, Phase I Report of the National Patient Safety 
Consensus for the Community of Stakeholders in End Stage Renal 
Disease. Patient Safety Committee Report. 2001.
Sciarini, P. and Dungan, J.M. ``A Holistic Protocol for Management 
of Fluid Volume Excess in Hemodialysis Patients'' Nephrology Nursing 
Journal 23.3 (1996): 299-305.
Stewart, A.L. et al. ``Functional Status and Well-Being of Patients 
with Chronic Conditions.'' Journal of the American Medical 
Association 262.7 (1989): 907-913.
Szczech, L.A. ``Changing Hemodialysis Thresholds for Optimal 
Survival.'' Kidney International 59 (2001): 738-745.

VIII. Collection of Information Requirements and Response to Comments

A. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-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:
    Section 414.330 Payment for home dialysis equipment, supplies and 
support services. Suppliers must report to the ESRD facility providing 
support services, every 30 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.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, exempts the 
burden associated with this requirement from the PRA as stipulated 
under 5 CFR 1320.3(b)(2).
    Section 488.60 Special procedures for approving end stage renal 
disease facilities. 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, must submit the documents and data as 
outlined in Sec.  488.60(a)(1) through (a)(4).
    We estimate that it will take 250 facilities on an annual basis 40 
hours each to gather and submit the necessary documentation for 
consideration of approval.
    Section 494.30 Condition: Infection control. The dialysis facility 
must maintain current infection control information including the most 
current CDC guidelines for the proper techniques in the use of vials 
and ampules containing medication. In addition, facilities must report 
infection control issues to the dialysis facility's chief executive 
officer or administrator (see Sec.  494.180(a)) and the quality 
improvement committee.
    While these requirements are subject to the PRA, the fact that they 
are usual and customary business practices, exempts the burden 
associated with these requirements from the PRA as stipulated under 5 
CFR 1320.3(b)(2).
    The facility must document the incidence of infection to identify 
trends and establish baseline information on infection incidence, 
develop recommendations to prevent infection transmission and take 
corrective actions to reduce future incidents, and report incidences of 
communicable diseases as required by Federal, State and local laws.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice and may be 
required under State or local law, exempts the burden associated with 
this requirement from the PRA as stipulated under 5 CFR 1320.3(b)(2) or 
(b)(3) or both.
    Section 494.40 Condition: Water quality. If the test results from 
the last component or carbon tank are greater than the parameters for 
chlorine or chloramine described at Sec.  494.30(c)(2)(i) the facility 
must immediately notify the medical director.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, exempts the 
burden associated with this requirement from the PRA as stipulated 
under 5 CFR 1320.3(b)(2).
    Section 494.50 Condition: Reuse of hemodialyzers and bloodlines. 
The dialysis facility must monitor patient reactions, undertake 
evaluation of its dialyzer reprocessing and water purification system, 
and report any adverse outcomes to FDA and other Federal, State, or 
local governments agencies as required by law.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice and is required 
under other Federal, State, and local laws, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    Section 494.70 Condition: Patients' rights. The dialysis facility 
must inform patients (or their representatives) of their rights and 
responsibilities when they begin their treatment. The facility must 
also inform patients of the facility's policies for transfer, 
discharge, and discontinuation of services to patients.

[[Page 6238]]

    We estimate that 4,317 facilities will need 8 hours each on an 
annual basis to disclose the necessary information. This is based on 
the belief that the materials will be standardized and incorporated 
into the facility's entrance materials.
    In addition, the dialysis facility must prominently display a copy 
of the patients' rights in the facility. These rights must include the 
current State agency and ESRD network telephone compliant numbers and 
it must be posted in a place where it can be easily seen and read by 
patients.
    We estimate that 4,317 facilities will need 1 hour each on an 
annual basis to comply with this requirement.
    Section 494.90 Condition: Patient plan of care. The 
interdisciplinary team must develop and implement a written, 
individualized comprehensive plan of care that meets the requirements 
of Sec.  494.90.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    Section 494.100 Condition: Care at home. The dialysis facility must 
document in the patient's medical record, that the patient, the 
caregiver, or both received and comprehended required training. In 
addition, the facility must document, in the patient's medical record, 
that the self-monitoring data and other information from self-care were 
reviewed, at least every 2 months.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    Section 494.110 Condition: Quality assessment and performance 
improvement. The dialysis facility must develop, implement, maintain, 
and evaluate an effective, data-driven interdisciplinary quality 
assessment and performance improvement program that reflects the 
complexity of the dialysis facility's organization and services.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    Section 494.120 Condition: Special purpose renal dialysis 
facilities. Facilities must contact the patient's physician 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 (specified in Sec.  494.90).
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    Facilities must document all care provided in the special purpose 
facility and forward the documentation to the patient's dialysis 
facility within 30 days of the last scheduled treatment in the special 
purpose renal dialysis facility.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    Section 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.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    The dialysis facility must obtain written authorization from the 
patient or legal representative before releasing information that is 
not compelled by law.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, exempts the 
burden associated with this requirement from the PRA as stipulated 
under 5 CFR 1320.3(b)(2).
    Patient records must be retained for a period of time not less than 
that required by State law, or in the absence of State law, 5 years 
from the date of discharge, including death for adults and 3 years for 
minors or until the patient reaches legal age under State law, 
whichever is longer.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    When a dialysis patient is transferred, the transferring facility 
must provide the receiving facility with all medical records and other 
information necessary or useful in the patient's care or treatment.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    Section 494.180 Condition: Governance. 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.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    The dialysis facility must have a written agreement, that meets the 
requirements in Sec.  494.180, with a hospital that can provide 
inpatient care, other hospital services, and emergency medical care 
that is available 24 hours a day, 7 days a week.
    While this requirement is subject to the PRA, the fact that this 
requirement is a usual and customary business practice, or is required 
under other Federal, State, and local laws, or both, exempts the burden 
associated with this requirement from the PRA as stipulated under 5 CFR 
1320.3(b)(2) or (b)(3) or both.
    The facility must provide each patient with written notice 30 days 
in advance of the facility reducing or terminating ongoing care after 
following the procedure specified in Sec.  494.180(f).
    We estimate that 500 facilities will need 1 hour on an annual basis 
to provide the required disclosure. This is

[[Page 6239]]

based on the assumption that the disclosure will be standardized and 
will not be required by the majority of facilities.
    The dialysis facility must furnish data information electronically 
to CMS at intervals specified by the Secretary, which meet the 
requirements referenced in this section.
    While these requirements are subject to the PRA, they are currently 
approved under the following OMB approval numbers: 0938-0046, 0938-
0360, 0938-0386, 0938-0657, and 0938-0658.
    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.
    While these requirements are subject to the PRA, it is currently 
approved under OMB approval number 0938-0086.
    We have submitted a copy of this proposed rule to OMB for its 
review of the information collection requirements in Sec. Sec.  
414.330, 488.60, 494.40, 494.50, 494.70, 494.80, 494.90, 494.100, 
494.110, 494.120, 494.170, and 494.180. These requirements are not 
effective until they have been approved by OMB.
    If you comment on these information collection and recordkeeping 
requirements, please mail copies directly to the following:

Centers for Medicare & Medicaid Services, Office of Strategic 
Operations and Regulatory Affairs, Regulations Development and 
Issuances Group, Attn: Dawn Willinghan, Room C4-26-05, 7500 Security 
Boulevard, Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Christopher J. Martin, CMS Desk Officer, [email protected]. Fax: (202) 395-6974.

B. Response to Comments

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

X. Regulatory Impact Analysis

[If you choose to comment on issues in this section please include the 
caption ``Impact Analysis'' at the beginning of your comment.]

A. Overall Impact

    We have examined the impact of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 19, 1980, Public Law 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.
    Executive Order 12866 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 proposed revision of the Medicare conditions for coverage for end-
stage renal disease (ESRD) 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 proposed rule would incorporate new scientific advances 
and current medical practices in treating ESRD while removing numerous 
burdensome process and procedural requirements contained in the 
existing conditions for coverage. While it is not possible at this 
point to determine definitively the additional costs to the Medicare 
program resulting from this rule, we believe that the impact will be 
below the $100 million threshold; and therefore, believe that this 
proposed 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 government agencies. 
Individuals and States are not included in the definition of small 
entity. According to the latest numbers from the Small Business 
Administration's North American Industrial Classification System, 37 
percent (1,751) of dialysis facilities have revenues of $29 million or 
less annually; and therefore, are considered to be small entities. 
Thirty of these facilities have annual revenue less than $100,000. It 
is possible that this proposed regulation could cost some of these 
small facilities an additional $6,545 (about 6.5 percent of $100,000). 
However, this is an essential upgrading necessary to bring these 
facilities into conformity with what is becoming standard practice in 
the renal field and to provide essential quality in health care, 
potentially saving lives. For these reasons, we are not preparing 
analyses for either the RFA or section 1102(b) of the Act because we 
have determined, and we certify, that this 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 facilities.
    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. Since 
this rule applies only to dialysis facilities, it has no impact on 
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 that may result in expenditures in any one year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $110 million. This rule has no impact on the 
expenditures of State, local or tribal governments, and the impact on 
the private sector is estimated to be less than $110 million.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. This rule will not have any effect on State and local 
governments. The costs associated with treating ESRD are currently a 
Medicare-covered benefit for individuals with ESRD. This rule will not 
increase the costs of the Medicare program.

B. Impact of the Proposed Policy Changes

1. Retained Requirements
    We note that we have retained a number of requirements from the 
existing regulations in this proposed rule. Therefore, these 
requirements do not add any new financial burden for dialysis 
facilities. These requirements include the following:
     Special procedures for approving end stage renal disease 
facilities.
     Infection control.
     Water quality.
     Reuse of hemodialyzers.
     Patient plan of care.

[[Page 6240]]

2. Physical Environment and Emergency Preparedness
    The existing 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. Facilities are now expending resources to 
develop procedures and train staff for natural disasters that had never 
been known to occur in their region. The proposed rule requires only 
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 would still be required, the proposed rule does not 
require the involvement of the CEO in this activity. We estimate a 
typical facility will expend 4 hours less of staff time for this 
activity at $50 per hour, with a net savings of $200 per year for an 
overall savings of $947,000.
    The proposed 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 because of State and local 
building codes as well as facilities' own liability purposes. However, 
there may be some burden for existing facilities in regard to the 
installation and maintenance of the fire department alarm connection. 
We estimate that approximately 1,136 facilities will need to be 
upgraded to meet this requirement. The one-time cost to install a fire 
department or central monitoring station connection is estimated to be 
$1,000 per facility. The monthly fee for the monitoring station and 
telephone cost is estimated to be about $80. Thus, we estimate the 
additional overall cost of compliance for facilities in the first year 
will be $2,226,500, with the annual cost thereafter being $1,090,560 
($80 month X 12 months X 1,136 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. If the health and safety of patients and staff are not 
adversely affected, the proposed 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.
    The proposed rule requires that every dialysis facility have access 
to a defibrillator. As discussed earlier in this preamble, USRDS data 
on causes of death among hemodialysis patients between 1997 and 1999 
indicates that nearly half (49 percent) of the deaths were attributable 
to cardiovascular conditions, with cardiac arrest ranking first among 
the specified causes.
    One study found that the typical dialysis facility faces one 
cardiac arrest each year (Becker, pp. 1509-1512). The study estimated 
the cost of AEDs at $3,000, with a useful life of 10 years, that is, 
$300 annually for each life potentially saved. Currently, AEDs can be 
purchased for $2,000 with a useful life of 10 years (that is, an AED 
can be use at a cost of $200 each year for 10 years).
    Since 19 percent of dialysis facilities are hospital-based, it is 
presumed that these facilities have already met the requirement, since 
they have access to an in-hospital defibrillator. However, we assume 
that all of the remaining 81 percent of facilities would have to 
acquire this piece of equipment. The only ongoing annual costs for 
maintaining the equipment are those for testing and replacing 
batteries, and these costs are negligible. The cost of AEDs in 81 
percent of dialysis facilities is estimated to be $7,670,700. We have 
requested public comment regarding the AED proposal as well as comments 
regarding the appropriateness of waivers or a phase-in period or both 
for small rural dialysis facilities.
3. Patients' Rights
    The existing regulations require dialysis facilities to have 
written patients' rights policies and procedures and a list of numerous 
persons to whom the patient rights policies must be made available. The 
proposed rule details basic information that must be provided to 
patients (for example, advance directives and how to contact entities 
in regard to complaints) but only requires that patient rights be 
prominently displayed. Proposing minimum contents in the patients' 
rights condition, and proposing 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 time at $15 per hour, that is, 
$30 annually, for an overall savings of $142,050.
    The existing regulations require translators when a significant 
number of patients exhibit language barriers. The proposed rule would 
delete this requirement and specify information be given to patients in 
a manner that assures their understanding. However, translators could 
still be used and facilities would have more flexibility in overcoming 
language barriers in lieu of hiring translators. This results in a net 
reduction in facility costs.
    The existing regulations require that advance notice be given to 
patients who are being terminated from a dialysis facility. The 
proposed rule is more specific and requires that written notice be 
given 30 days in advance. However, since involuntary terminations are a 
relatively infrequent occurrence, we consider the financial impact on 
dialysis facilities to be negligible.
    We estimate that 569 facilities will need 1 hour at $15 an hour on 
an annual basis to provide the required disclosure for a total annual 
cost of $8,535 (569 x 1 x 15). This is based on the assumption that the 
disclosure will be standardized and will not be required by the 
majority of facilities.
4. Quality Assessment and Performance Improvement
    Existing regulations are not comparable to the proposed rule's 
requirement that the facility develop, implement, maintain, and 
evaluate a data-driven QAPI program. However, quality improvement 
efforts are considered part of the professional staff's job and the 
renal community has developed considerable consensus in recent years in 
regard to clinical performance data. The top 5 dialysis chains, 
representing two-thirds of all dialysis facilities are already 
collecting and reporting standardized data on 14 data elements, some of 
which are reported to the USRDS.
    This proposed rule simply requires the facilities to use this data 
internally, in a formal QAPI program that each facility has the 
flexibility to develop to suit its own purposes. The two-thirds of 
dialysis facilities in the top five chains are already complying with 
this requirement and many others also consider use of this data as part 
of their standard practice. We estimate that the QAPI requirements 
would impose a burden on no more than 10 percent of the dialysis 
facilities (that is, 473 facilities).
    Assuming that a facility were initiating a QAPI program only as a 
result of this proposed rule, this may entail a 1-hour meeting of 4 
staff persons quarterly, with each staff person having an additional 
hour of work each month beyond the meeting (that is, 16 staff hours of 
meeting time + 48 staff hours beyond meetings = 64 hours annually). 
Assuming that the average staff cost is $25, the total additional cost 
to the facility would be $1,600 annually. The total cost for 473 
facilities would be $756,800.

[[Page 6241]]

5. Medical Records
    In the proposed rule, essential requirements in regard to 
retention, preservation, and transfer of medical records would be 
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. The proposed rule would delete 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 $15 per hour, 
that is, $600 annually for an overall savings of $2,841,000.
6. Governance
    The existing regulations specify the minimum requirements for CEO 
education and experience, whereas the proposed rule would delete these 
requirements.
    However, the proposed rule would add new requirements, for a 
training program for water treatment system technicians and a written 
training program for dialysis patient care technicians, in regard to 
the operation of kidney dialysis equipment and machines and the 
provision of patient care. This training program would be developed or 
adopted by the facility and must be approved by the medical director 
and the governing body of the facility. The water system training 
program may be written, audiovisual, or computer based. Since the major 
dialysis chains 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, so dialysis facilities in these States, if they are 
unaffiliated with a major chain, may simply declare that meeting the 
State credentialing requirement is equivalent to completion of their 
training program. Even facilities that are not affiliated with a major 
dialysis chain 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 that includes a water treatment system module, 
which has been developed by organizations in the renal field and is 
available to any dialysis facility without cost.
7. Clinical Performance Measures
    The proposed rule would add a requirement that all dialysis 
facilities electronically collect and report ESRD CPM Project data on 
all patients. The data include several measures of dialysis adequacy, 
vascular access, anemia management and nutrition.
    Any potential burden added by this requirement is mitigated by the 
following:
     More than half the dialysis facilities already collect 
data on at least 14 clinical performance measures, including measures 
that evaluate adequacy of dialysis treatment, anemia, nutritional 
level, vascular access, bone disease, and hypertension. Many units 
affiliated with the major dialysis chains have integrated their 
electronic data systems for quality management with their data systems 
for patient management, to minimize the data reporting burden. These 
facilities understand that it is important to collect and to use the 
data to allow an accurate comparison of the facility's performance 
relative to that of its peers, since these comparisons can serve to 
identify significant opportunities for improvement.
     CPM data is already reported to CMS on a voluntary basis 
for a 5 percent national sample of patients, so many facilities are 
already familiar with the data reporting and collection process.
     The CPM data set will become a part of the Consolidated 
Renal Operations in a Web-enabled Network (CROWN) data system, and CMS 
will supply VISION software free to dialysis facilities to permit them 
to enter CPM data electronically directly into the system. VISION is 
available for general use and is currently being used by 138 
independent dialysis facilities. Any dialysis facility that chooses to 
voluntarily participate in the CPM Project will be allowed to do so 
before the publication of a final rule. This could substantially reduce 
the number of facilities that need to be brought on line before the 
effective date of the final rule.
     Training for purposes of implementing the CPM requirement 
will be provided by CMS and its ESRD Networks without cost to the 
dialysis industry, and some of the training will be done using an 
Internet Web tool.
    However, we do estimate that there will be some additional costs 
involved in: (1) Travel costs to training sites for some dialysis 
facility or chain representatives; (2) computer hardware and Internet 
Service Provider (ISP) connections for some facilities; and (3) 
collecting and transmitting data on the residual patients who are not 
served by the major dialysis chains and who are not part of the 5 
percent sample of patients in the current CPM project. The detail in 
these estimates is as follows:
     Estimated costs for travel to training sites will be 
approximately $200 for each facility/chain representative and we 
estimate that 2,000 persons will be sent for training, most 
representing chains of dialysis facilities. The total cost of travel to 
training would, then, be $400,000, and this would be only for the 
initial year of implementation;
     Very few dialysis facilities would have to purchase 
computer hardware to implement this requirement, possibly no more than 
142 (3 percent of total facilities). We estimate the cost of this 
purchase to be $1,000. Thus, the total cost for purchasing hardware 
would be $142,000, and this would be only in the initial year of 
implementation. We estimate ISP costs to be $150 annually ($150 x 142 
facilities = $21,300);
     The estimated 5 percent annual growth rate in the ESRD 
population would mean that in 2005 there will be approximately 337,839 
ESRD beneficiaries. We believe that the larger chains are already 
collecting CPM data on approximately 65 percent of these patients. 
Since the CPM project requires submission of this data on a 5 percent 
sample, we assume that the burden is only in regard to 95 percent of 
the remaining 35 percent of patients. Thus, we estimate that additional 
CPM data collection and reporting will be required for 112,331 patients 
annually (337,839 x .35 x .95). Based on current CPM project norms, we 
assume: One-half hour to abstract the data from the medical record by 
staff who are typically paid $25 per hour, for a cost of $1,404,142 
(112,331 x .5 x $25) annually; and key-entry at the rate of 12 patients 
per hour by staff who are typically paid $12 per hour, for a cost of 
$112,331 annually.
    Thus, in the first year of implementation, the total financial 
impact on the dialysis facilities of implementing the CPM requirement 
is estimated to be $2,079,774; thereafter, the cost would be 
approximately $1,537,774 ($1,404,142 + $112,331 + $21,300) annually for 
collecting and

[[Page 6242]]

transmitting the data and paying the ISP.

              Cost Estimate for the Collection of CPM Data
------------------------------------------------------------------------
 
------------------------------------------------------------------------
$400,000                     for travel to training (first year).
$142,000                     for computer hardware (first year).
$1,537,474                   for abstracting & key-entry of CPM data and
                              ISP annually.
----------------------------
$2,079,774                   Total
------------------------------------------------------------------------

    The following chart provides an overall estimate of the impact of 
the proposed rule:

           Overall Impact of the Proposed Rule on the Economy
------------------------------------------------------------------------
 
-------------------------------------------------------
4,735 facilities disaster planning burden @ $200.   =          -$947,000
1,136 facilities (24%) LSC upgrades @ $1,960.....   =         +2,226,560
3,835 facilities (81%) purchasing AEDs @ $3,000..   =         +7,670,700
4,735 facilities (patient rights distribution) @    =           -142,050
 $30.............................................
473 facilities (QAPI) @ $1,600...................   =           +756,800
4,735 facilities (medical records burden) @ $600.   =         -2,841,000
569 facilities (30-day discharge notice) @ $15...   =             +8,535
CPM reporting requirement (detailed above).......   =          2,079,774
                                                       -----------------
    Total impact on the economy..................   =         +8,812,319
------------------------------------------------------------------------

C. Anticipated Effects of the Revised ESRD Conditions on Suppliers of 
ESRD Services

    The Medicare conditions for coverage for ESRD facilities have not 
been revised in their entirety since their original publication in 
1976. The revisions in this proposed rule reflect, for the most part, 
advances in dialysis technology and standard care practices. Transplant 
centers will not be affected because they are not included in this 
rule. One of the major purposes of this revision is to be responsive to 
regulatory reform initiatives, eliminating unnecessary procedural 
requirements and focusing on better patient outcomes of care.

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 proposing 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 propose compliance with all of the CDC 
guidelines in the RR05 report rather than just the crucial 
``Recommended Infection Control Practices for Hemodialysis Units At a 
Glance'' (At a Glance) requirements. However, although we encourage 
compliance with the entire report, we decided against proposing 
compliance with the entire report. Our rationale was compliance with 
guidelines in the entire report would reduce flexibility and add 
unnecessary burden for dialysis facilities since some of the guidelines 
exceed the scope of these health and safety requirements.
    A third alternative was to propose 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 propose to incorporate AIA 
guidelines as federal requirements.
3. Water Quality
    One alternative was to propose to continue to require compliance 
with portions of the current AAMI guidelines,--ANSI/AAMI RD5: 1992 
Appendix B5. However, we decided to propose compliance with portions of 
the newer AAMI document--RD62: 2001 and additional requirements that 
are compatible with ANSI/AAMI RD52: 2004 because RD62 and RD52, are the 
state-of-the-art water quality guidelines. We have asked for comments 
on this proposal.
4. Reuse of Hemodialyzers and Bloodlines
    One potential cost-saving alternative was to remove the proposal 
that dialyzers exposed to more than one germicide were acceptable for 
reuse. We decided against this proposal because exposure to different 
germicides may cause membrane leaks and we have no scientific evidence 
to support the safety of using dialyzers exposed to more than one 
germicide.
5. Physical Environment and Emergency Preparedness
    One alternative was to remove the proposal that every dialysis 
facility have a defibrillator. We retained this proposal because a 
Seattle study (Becker, pp. 1509-1512) identified dialysis centers as 
having a relatively high incidence of cardiac arrests over a 7-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 propose a waiver or phase-in period for 
defibrillators in small rural satellite

[[Page 6243]]

dialysis facilities with very low utilization. We are considering this 
alternative and have requested public comments on the defibrillator 
proposal.
6. Patients' Rights
    One alternative was to remove the proposal for advance directives. 
We retained this proposal because of the nature of ESRD and the aging 
dialysis population.
    Another alternative considered was not proposing 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 
proposal 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 proposal for a 3-month 
timeframe to reassess new patients. We are aware that the dialysis 
industry has not reached consensus regarding the appropriate frequency 
for reassessments, and therefore, we have requested comments on the 
current proposal to reassess new patients 3 months after starting 
dialysis.
8. Patient Plan of Care
    One alternative was to retain the existing requirement for an 
individualized care plan with a 6-month review and a long-term program 
with an annual review. We did not adopt this approach because it was 
less burdensome to propose a single individualized plan of care 
(without a long-term program) to be reviewed annually.
    Another alternative was to propose to adopt specific evidence-based 
NKF-K/DOQI clinical practice guidelines as numerical minimum target 
values within the patient plan of care condition (that is, adequacy of 
dialysis and anemia management). This issue is discussed in detail in 
the preamble and we are requesting public comments on the issue.
9. Quality Assessment and Performance Improvement
    One alternative was to propose a QAPI program without specific 
threshold criteria. We determined, based on the work of the NFK-K/DOQI 
committees (adequacy, nutrition, anemia, and vascular access), AAMI 
guidelines (reuse), and specific recommendations from the OIG (medical 
error identification and patient satisfaction) that there was 
sufficient basis to include 7 basic criteria. We have requested public 
comment on QAPI.
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 inhibit 
access to care during natural disasters.
    Another alternative was to retain the current 8-month certification 
period and 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 proposing to reduce the number of certification 
requirements addresses this issue. The existing 8-month certification 
period is also excessive (that is, vacation camps are typically not 
open for 8 months and natural emergencies are of shorter duration). The 
current proposal represents a significant reduction in administrative 
burden for special purpose units.
11. Personnel Qualifications
    One alternative was to retain the existing requirement that at 
least a licensed practical nurse must be on the premises during 
dialysis. We decided to propose that a registered nurse be on the 
premises during dialysis to protect patient health and safety and 
because this did not represent an increase in burden for dialysis 
units.
    Other options were to propose no Federal requirements for dialysis 
technicians, or, to propose minimal Federal requirements for dialysis 
technicians and include proposals for competency testing and 
certification. A detailed discussion of this issue is in section VI.A.5 
of this preamble. We determined that minimal Federal requirements are 
needed at this time because dialysis technicians are the primary 
caregivers in most dialysis facilities. However, we did not propose 
competency testing or certification and have requested public comment.
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 proposed to retain 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. We have requested public 
comments on these proposals.
13. Governance
    One alternative considered was to remove the proposal for a 30-day 
advanced notice before involuntary patient discharge or transfer and 
retain the existing 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 chains 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 added a proposal to waive the 30-
day notice under unusual circumstances.
    This proposed rule contains a requirement for every dialysis 
facility to report ESRD CPM Project data to CMS. One option considered 
was to propose that less than 100 percent of facilities be required to 
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 5 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 2005. A gradual voluntary 
phase-in will be undertaken for facilities that want to participate 
before full implementation. We believe that 100 percent CPM data 
collection is necessary to comply with the intent of the statute. The 
large chain dialysis 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 have a difficult 
time coming into compliance, and therefore,

[[Page 6244]]

we are considering a phase-in period for these facilities.
    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, 
and Reporting and recordkeeping requirements.

42 CFR Part 494

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

    For the reasons stated in the preamble of this proposed rule, the 
Centers for Medicare & Medicaid Services proposes to amend 42 CFR 
chapter IV as follows:

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

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

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

    Authority: Secs. 1102, 1138, 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.
    2. The title of the subpart is revised to read as follows:

Subpart U--Conditions for Coverage for Suppliers of Renal 
Transplantation Services and Requirements for ESRD Networks


Sec. Sec.  405.2100, 405.2101, 405.2135 through 405.2164, and 405.2180 
through 405.2184  [Removed and Reserved]

    3. Sections 405.2100, 405.2101, 405.2135 through 405.2164, and 
405.2180 through 405.2184 are removed and reserved.
    4. Section 405.2102 is revised to read as follows:


Sec.  405.2102  Definitions.

    As used in this subpart, the following definitions apply:
    ESRD Network organization. The administrative governing body to the 
network and liaison to the Federal government.
    Histocompatibility testing. Laboratory test procedures which 
determine compatibility between an organ donor and a potential organ 
transplant recipient.
    Network, ESRD. All Medicare-approved ESRD facilities in a 
designated geographic area specified by CMS.
    Organ procurement. The process of acquiring donor organs. (See 
definition of Organ procurement organization in Sec.  486.302 of this 
chapter.)
    Renal transplantation center. A hospital unit which is approved to 
furnish directly transplantation and other medical and surgical 
specialty services required for the care of the ESRD transplant 
patients, including inpatient dialysis furnished directly or under 
arrangement. A Renal Transplantation Center may also be a Renal 
Dialysis Center.
    Transplantation service. A process by which (1) a kidney is excised 
from a live or cadaveric donor, (2) that kidney is implanted in an ESRD 
patient, and (3) supportive care is furnished to the living donor and 
to the recipient following implantation.
    Transplantation surgeon. A person who--
    (1) Is board eligible or board certified in general surgery or 
urology by a professional board; and
    (2) Has at least 12 months training or experience in the 
performance of renal transplantation and the care of patients with 
renal transplants.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

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

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


Sec.  410.5  [Amended]

    2. In Sec.  410.5(a), the reference ``Part 405, subpart U'' is 
revised to read ``Part 494''.


Sec.  410.50  [Amended]

    3. 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]

    4. Section 410.52 is amended as follows:
    a. In paragraph (a)(4), the reference to ``Sec.  405.2163'' is 
revised to read ``Sec.  494.90(a)(3)''.
    b. 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]

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


Sec.  410.170  [Amended]

    6. 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; OPTIONAL PROSPECTIVELY DETERMINED 
PAYMENT RATES FOR SKILLED NURSING FACILITIES

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

    Authority: Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), 
(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).

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


Sec.  413.170  Scope.

    This subpart implements sections 1881(b)(2) and (b)(7) of the Act 
by--
    (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. Sec.  413.172 
through 413.198, ``outpatient maintenance dialysis'' means outpatient 
dialysis provided by a dialysis facility, home dialysis or self-
dialysis as defined in

[[Page 6245]]

Sec.  494.10 of this chapter and includes all items and services 
specified in Sec. Sec.  410.50 and 410.52 of this chapter.
* * * * *
    3. In Sec.  413.172, paragraph (b) is revised to read as follows:


Sec.  4l3.172  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 (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]

    4. 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

    1. Part 414 is amended as follows:
    1a. 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]

    2. In Sec.  414.330(a)(2)(iii)(B), the reference ``subpart U of 
part 405'' is revised to read ``part 494''; and in Sec.  
414.330(a)(2)(iii)(B)(l), the reference to ``subpart U'' is changed to 
read ``part 494''.
    3. In Sec.  414.330(a)(2)(iii)(B)(1) the references ``subpart U'' 
are revised to read ``part 494'.
    4. In Sec.  414.330(a)(2)(iii)(B)(7) the references ``subpart U'' 
are revised to read ``part 494'.
    5. Section 414.330(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, every 30 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.
* * * * *

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

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

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1895hh).
    2. In Sec.  488.60 paragraph (a) is revised to read as follows:


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 subchapter, 
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.
* * * * *
    3. A new subpart H, consisting of Sec. Sec.  488.604, 488.606, 
488.608, and 488.610, 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 subchapter 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.  494.160 of this subchapter, 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 subchapter, 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

[[Page 6246]]

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 subchapter.


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.
    1. 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 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: Medical director.
494.160 Condition: Relationship with the ESRD network.
494.170 Condition: Medical records.
494.180 Condition: Governance.

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

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 1138(a)(1)(B) of the Act, which requires hospitals to 
be members and abide by the rules and requirements of the Organ 
Procurement and Transplantation Network.
    (3) 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.
    (4) 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.
    (5) Section 1862(a) of the Act, which specifies exclusions from 
coverage.
    (6) 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 recombinant epoetin 
alpha (EPO).
    (7) Section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (Pub. L. 104-113), which requires Federal 
agencies to achieve greater reliance on voluntary standards and 
emphasize, where possible, the use of standards developed by private, 
consensus organizations.
    (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 (1) outpatient 
maintenance dialysis services; or (2) home dialysis training and 
support services; or (3) both. A dialysis facility may be an 
independent or hospital-based unit (as described in Sec.  413.174(b) 
and (c) of this chapter), or a self-care dialysis unit that furnishes 
only self-dialysis services.
    Discharge means the termination of patient care services by a 
dialysis 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.
    Interdisciplinary team means the group of persons, specified Sec.  
494.80 of this part, responsible for providing patient care to each 
dialysis patient.
    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, staff licensure and other 
personnel staff qualifications, fire safety, equipment, building codes, 
drugs, medical device usage, 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

[[Page 6247]]

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) The ``Recommended Infection Control Practices for Hemodialysis 
Units at a Glance,'' with the exception of screening for Hepatitis C, 
found in ``Recommendations for Preventing Transmission of Infections 
Among Chronic Hemodialysis Patients' Morbidity and Mortality Weekly 
Report, volume 50 number RR05, April 27, 2001, pages 20 and 21, 
developed by the Centers for Disease Control and Prevention, which are 
incorporated by reference, to prevent and control cross-contamination 
and the spread of infectious agents. Incorporation by reference of the 
CDC ``Recommended Infection Control Practices for Hemodialysis Units at 
a Glance,'' was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.\1\
---------------------------------------------------------------------------

    \1\ This publication is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Central 
Building, Baltimore, MD and at the National Archives and Records 
Administration (NARA). For availability of this material at NARA, 
call 202-741-6030, or got to http://www.archives.gov./ federal--
register/code lowbar;of--federal--regulations/ ibr--locations.html.
---------------------------------------------------------------------------

    (2) Patient isolation procedures to minimize the spread of 
infectious agents and communicable diseases; and
    (3) 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; and
    (2) Designate a registered nurse as the infection control or safety 
officer, responsible for--
    (i) Maintaining current infection control information including the 
most current Centers for Disease Control and Prevention guidelines for 
the proper techniques in the use of vials and ampules containing 
medication;
    (ii) Reporting infection control issues to the dialysis facility's 
chief executive officer or administrator (see Sec.  494.180(a) of this 
part) and the quality improvement committee; and
    (iii) Making recommendations regarding infection control training 
and improvements.
    (c) Standard: Monitoring. The facility must--
    (1) Analyze and document the incidence of infection to identify 
trends and establish baseline information on infection incidence; and
    (2) Develop recommendations to minimize infection transmission and 
take actions to reduce future incidents.
    (d) Standard: Reporting. The facility must report incidences of 
communicable diseases as required by Federal, State, and local 
regulations.


Sec.  494.40  Condition: Water quality.

    The facility must be able to demonstrate the following:
    (a) Standard: Water purity. Water used for dialysis meets the 
following water quality standards and equipment requirements of the 
Association for the Advancement of Medical Instrumentation (AAMI) 
published in ``Water Treatment Equipment for Hemodialysis 
Applications,'' ANSI/AAMI RD62: 2001, which are incorporated by 
reference. Incorporation by reference of the AAMI Water Treatment 
Equipment for Hemodialysis Applications, was approved by the Director 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51.\2\
---------------------------------------------------------------------------

    \2\ This publication is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Central 
Building, Baltimore, MD and at the National Archives and Records 
Administration (NARA). For availability of this material at NARA, 
call 202-741-6030, or go to http://www.archives.gov./federal--
register/ code--of--federal--regulations/ ibr--locations.html. 
Copies may be purchased from the Association for the Advancement of 
Medical Instrumentation, 3300 Washington Boulevard, Suite 400, 
Arlington, VA 22201-4598.
---------------------------------------------------------------------------

    (1) Incorporated water quality requirements are those listed in 
sections--
    (i) 4.2.1 and 5.2.1, Water Bacteriology;
    (ii) 4.2.2 and 5.2.2 Maximum Level of Chemical Contaminants; and
    (iii) 4.3, Water Treatment Equipment requirements.
    (2) The requirements for frequency of water purity testing to 
insure meeting the AAMI limits specified in paragraphs (a)(1)(i) and 
(ii) of this section are as follows:
    (i) Bacteria and bacterial endotoxin levels of water/dialysate must 
be monitored--
    (A) In established systems at least monthly;
    (B) In newly-installed systems at least weekly until an established 
pattern of compliance can be demonstrated;
    (C) In accordance with the requirements of AAMI published in 
``Dialysate for Hemodialysis,'' ANSI/AAMI RD52:2004 section 7.2.1, 
which are incorporated by reference. Incorporation by reference of the 
AAMI Dialysate for Hemodialysis was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51.\3\
---------------------------------------------------------------------------

    \3\ This publication is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Central 
Building, Baltimore, MD and at the National Archives and Records 
Administration (NARA). For availability of this material at NARA, 
call 202-741-6030, or got to http://www.archives.gov./federal--
register/ code--of--federal--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.
---------------------------------------------------------------------------

    (ii) Chemical analysis of water purity must be done at least once a 
year and when--
    (A) The system is installed;
    (B) Membranes are replaced, if using a reverse osmosis system;
    (C) Seasonal variations in source water suggest worsening water 
quality;
    (D) Reverse osmosis rejection rates, which are monitored daily 
using continuous-reading monitors that measure product water 
conductivity, fall below 90 percent.
    (b) Standard: Reverse osmosis or deionization. Each water treatment 
system must include reverse osmosis membranes or a deionization 
component with resistivity monitors.
    (c) Standard: Chlorine/chloramines. The facility must ensure, on a 
daily basis, that the source water does not contain chlorine/
chloramines or the facility must ensure that--
    (1) The water treatment system includes a component or carbon tank 
which removes chlorine/chloramine along with a backup component or 
second carbon tank for chlorine/chloramine removal; and
    (2) The water from the exit port of the first component or carbon 
tank which removes chlorine/chloramine is tested for chlorine/
chloramine levels, at a minimum, before each patient shift or every 4 
hours, whichever is shorter, during operation of the water treatment 
system.
    (i) If the test results are greater than 0.50 mg/L for free 
chlorine or 0.10 mg/L for chloramines from the port of the initial 
component or carbon tank then the second component or carbon tank which 
removes chlorine/chloramine must be tested; and
    (ii) If the test results from the last component or carbon tank are 
greater than the parameters for chlorine or chloramine specified in 
paragraph (c)(2)(i) of this section the facility must--
    (A) Immediately terminate dialysis treatment to protect patients 
from exposure to chlorine/chloramine;

[[Page 6248]]

    (B) Immediately notify the medical director; and
    (C) Take corrective action.
    (d) 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.
    (e) 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;
    (2) Undertake evaluation of the water purification system; and
    (3) Take corrective action.
    (f) Standard: Unused bicarbonate. Once mixed, bicarbonate 
concentrate must be used within the timeframe specified by the 
manufacturer of the concentrate.


Sec.  494.50  Condition: Reuse of hemodialyzers and bloodlines.

    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.
    (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 501(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/A1:2003, which is 
incorporated by reference. Incorporation by reference of the ``Reuse of 
Hemodialyzers, third edition, RD47:2002/A1:2003'' was approved by the 
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51.\4\
---------------------------------------------------------------------------

    \4\ This publication is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Central 
Building, Baltimore, MD and at the National Archives and Records 
Administration (NARA). For availability of this material at NARA, 
call 202-741-6030, or got to: http://www.archives.gov./federal--
register/code--of--federal--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, 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
    (ii) Undertake evaluation of its dialyzer reprocessing and water 
purification system. When this 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 temperature within the facility that is comfortable 
for the majority of its patients; and
    (ii) Make reasonable accommodations for the patients who are not 
comfortable at the temperature that is comfortable for the majority.
    (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;
    (C) Whom to contact if an emergency occurs while the patient is not 
in the dialysis facility; 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 and plans. Emergency equipment, including, 
but not limited to, oxygen, airways, suction, defibrillator, artificial 
resuscitator, and emergency drugs, must be on the premises at all times 
and immediately available. The facility must--

[[Page 6249]]

    (i) Have a plan to obtain emergency medical system assistance when 
needed; and
    (ii) Evaluate at least annually the effectiveness of emergency and 
disaster plans and update them as necessary.
    (e) Standard: Fire safety. (1) The dialysis facility must meet 
applicable provisions of the 2000 edition of the Life Safety Code of 
the National Fire Protection Association (which is incorporated by 
reference in Sec.  403.744(a)(1)(i) of this chapter).
    (2) Chapter 5 of the 2000 edition of the Life Safety Code does not 
apply to a dialysis facility.
    (3) If CMS finds that a State has a fire and safety code imposed by 
State law that 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 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, including advance directives, and be informed of 
the right to refuse treatment and to refuse to participate in 
experimental research;
    (6) 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;
    (7) Be informed of facility policies regarding patient care, 
including, but not limited to, isolation of patients;
    (8) Be informed of facility policies regarding the reuse of 
dialysis supplies, including hemodialyzers;
    (9) Be informed by a physician of his or her own medical status as 
documented in the patient's medical record unless the medical record 
contains a documented contraindication to do so;
    (10) Be informed of services available in the facility and charges 
for services not covered under Medicare;
    (11) Receive the necessary services outlined in the patient plan of 
care described in Sec.  494.90 of this part;
    (12) Be informed of the rules and expectations of the facility 
regarding patient conduct and responsibilities;
    (13) Be informed of the facility's internal grievance process;
    (14) Be informed of external grievance mechanisms and processes, 
including how to contact the ESRD Network and the State survey agency;
    (15) Be informed of his or her right to file internal grievances or 
external grievances or both without reprisal or denial of services; and
    (16) 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, discharge, 
and discontinuation of services to patients; and
    (2) Receive written notice 30 days in advance of the facility 
reducing or terminating ongoing care after following the procedure 
described in Sec.  494.180(f) of this part. In the case of immediate 
threats to the health and safety of others, a shortened 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 telephone complaint 
numbers, where it can be easily seen and read by patients.


Sec.  494.80  Condition: Patient assessment.

    The facility's interdisciplinary team, consisting of, at a minimum, 
the patient (if the patient chooses) or the patient's designee, a 
registered nurse, a nephrologist or the physician treating the patient 
for ESRD, a social worker, and a dietitian, 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 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 erythropoietin.
    (5) Evaluation of factors associated with renal bone disease.
    (6) Evaluation of nutritional status.
    (7) Evaluation of psychosocial needs.
    (8) Evaluation of dialysis access type and maintenance (for 
example, arteriovenous fistulas, arteriovenous grafts, and peritoneal 
catheters).
    (9) Evaluation of the patient's ability, interests, preferences, 
and goals, including level of participation in the dialysis care 
process; modality and setting, for example, home dialysis, including 
hemodialysis or peritoneal dialysis; and 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 of vocational and physical rehabilitation status 
and potential.
    (b) Standard: Frequency of assessment for new patients.
    (1) An initial comprehensive assessment must be conducted within 20 
calendar days after the first dialysis treatment.
    (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 of this part.
    (c) Standard: Assessment of treatment prescription.

[[Page 6250]]

    The adequacy of the patient's dialysis prescription, as described 
in Sec.  494.90(a)(1) of this part, 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--
    (i) Extended or frequent hospitalizations;
    (ii) Marked deterioration in health status;
    (iii) Significant change in psychosocial needs; or
    (iv) Poor nutritional status, with unmanaged anemia and inadequate 
dialysis.


Sec.  494.90  Condition: Patient plan of care.

    The interdisciplinary team 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 allow the patient to achieve current evidence-based 
community-accepted 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 achieve and sustain the prescribed dose 
of dialysis.
    (2) Nutritional status. The interdisciplinary team must provide the 
necessary care and services to achieve and sustain an effective 
nutritional status. A patient's albumin level must be measured at least 
monthly.
    (3) Anemia. The interdisciplinary team must provide the necessary 
care and services to achieve and sustain the expected hemoglobin/
hematocrit level. The patient's hemoglobin/hematocrit must be measured 
at least monthly. If a patient has hemoglobin less than 11 gm/dL or 
hematocrit of less than 33 percent, the dialysis facility must conduct 
an evaluation to determine whether the patient is an erythropoietin 
candidate. For a home dialysis patient, the facility must evaluate 
whether the patient can safely, aseptically, and effectively administer 
erythropoietin and store erythropoietin under refrigeration. The 
patient's response to erythropoietin, including blood pressure levels 
and utilization of iron stores, must be monitored on a routine basis.
    (4) Vascular access. The interdisciplinary team must provide the 
necessary care and services to achieve and sustain vascular access. The 
hemodialysis patient must be evaluated for the appropriate vascular 
access type, taking into consideration co-morbid conditions and other 
risk factors. The patient's vascular access must be monitored to 
prevent access failure, including monitoring of ateriovenous grafts and 
fistulae for stenosis.
    (5) Transplantation status. When the patient is a transplantation 
referral candidate, the interdisciplinary team must develop plans for 
pursuing transplantation. The patient's plan of care must include 
documentation of the--
    (i) Plan for transplantation, if the patient accepts to 
transplantation referral;
    (ii) Patient's decision, if the patient is a transplantation 
referral candidate but declines the transplantation referral; or
    (iii) Reason(s) for the patient's nonreferral as a transplantation 
candidate as documented in accordance with Sec.  494.80(a)(10) of this 
part.
    (6) Rehabilitation status. 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).
    (b) Standard: Implementation of the patient plan of care.
    (1) The patient's plan of care--
    (i) Must be completed by the interdisciplinary team;
    (ii) Must be signed by the patient or the patient's designee.
    (2) Implementation of the plan of care must begin within 10 
calendar days after completion the patient assessment as specified in 
Sec.  494.80 of this part.
    (3) If the expected outcome is not achieved, the interdisciplinary 
team, must adjust the patient's plan of care to achieve the specified 
goals.
    (4) The dialysis facility must ensure that all dialysis patients 
are seen by a physician providing the 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 track the results of each kidney transplant 
center referral and must monitor the status of any facility patients 
who are on the transplant wait list. The team must communicate with the 
transplant center regarding patient transplant status at least 
quarterly or more frequently if necessary.
    (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, quality of life, rehabilitation, and 
transplantation.


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.
    (a) Standard: Training. The interdisciplinary team must provide 
training to 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 of this part) and when the home 
dialysis caregiver or home dialysis modality changes. The training--
    (1) Must be provided by a dialysis facility that is approved to 
provide home dialysis services;
    (2) For self-care, must be conducted by a registered nurse who 
meets the requirements of Sec.  494.140(b)(2) of this part; and
    (3) Must be conducted for each home 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 treatment 
modality selected, including effective use of dialysis supplies and 
equipment in achieving and delivering the physician's prescription of 
Kt/V or URR, and effective erythropoietin administration (if 
prescribed) to achieve and maintain a hematocrit level of at least 33 
percent or a hemoglobin level of 11 gm/dL;
    (iii) Implementation of a nutritional care plan;

[[Page 6251]]

    (iv) How to achieve and maintain emotional and social well-being;
    (v) How to detect, report, and manage potential dialysis 
complications;
    (vi) Availability of support resources and how to access and use 
resources;
    (vii) How to self-monitor health status and record and report 
health status information;
    (viii) How to handle medical and non-medical emergencies;
    (ix) Infection control precautions; and
    (x) 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 dialysis facility must furnish directly home dialysis support 
services regardless of whether dialysis supplies are provided by the 
dialysis facility or a durable medical equipment company, that 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 meet 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 used by home hemodialysis 
patients in accordance with the requirements specified in Sec.  
494.40(a)(1)(i) and (ii) of this part and conducting an onsite 
evaluation of the water system. The dialysis facility must correct the 
water quality of the home hemodialysis patient, and if necessary, 
arrange for backup dialysis until the problem is corrected if--
    (A) Analysis of the water quality indicates contamination; or
    (B) The home hemodialysis patient demonstrates clinical symptoms 
associated with water contamination.
    (vi) Purchasing, 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, interdisciplinary quality 
assessment and performance improvement program. 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) Anemia management.
    (iv) Vascular access.
    (v) Medical injuries and medical errors identification.
    (vi) Hemodialyzer reuse program, if the facility reuses 
hemodialyzers.
    (vii) Patient satisfaction and grievances.
    (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. Each facility must 
participate in ESRD network activities and pursue network goals.
    (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 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 of this part;
    (ii) Water quality at Sec.  494.40 of this part (except as provided 
in paragraph (c)(1)(viii) of this section;
    (iii) Reuse of hemodialyzers at Sec.  494.50 of this part (if reuse 
is performed);
    (iv) Patients' rights and posting of patients' rights) Sec. Sec.  
494.70(a) and (c) of this part;
    (v) Laboratory services at Sec.  494.130 of this part;

[[Page 6252]]

    (vi) Medical director responsibilities for staff education and 
patient care policies and procedures at Sec.  494.150(c) and (d) of 
this part;
    (vii) Medical records at Sec.  494.170 of this part; 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) of this part, in 
place of Sec.  494.40 (water quality) of this part.
    (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 additionally comply with the following conditions:
    (i) Sec.  494.20 (compliance with Federal, State, and local laws 
and regulations).
    (ii) Sec.  494.60 (physical environment).
    (iii) Sec.  494.70(a) through (c) (patient rights).
    (iv) Sec.  494.140 (personnel qualifications).
    (v) Sec.  494.150 (medical director).
    (vi) Sec.  494.180 (governance).
    (d) Standard: Physician contact. The facility must contact the 
patient's physician, 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 of this part).
    (e) Standard: Documentation. All patient care provided in the 
special purpose facility is documented and forwarded to the patient's 
dialysis facility 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.

    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 
physician 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 who meets the practice requirements of 
the State in which he or she is employed; 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 training nurse. The nurse responsible for self-care 
training must--
    (i) Be a registered nurse who meets the practice requirements of 
the State in which he or she is employed; 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 or a practical nurse who meets the 
practice requirements in the State in which he or she is employed; and
    (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.
    (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;
    (2) Meet the practice requirements in the State in which he or she 
is employed; and
    (3) Have a minimum of one year's 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 from a school of social 
work accredited by the Council on Social Work Education; and
    (2) Meets the practice requirements for social work practice in the 
State in which he or she is employed.
    (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;
    (3) Have completed at least 3 months experience, following a 
training program that is approved by the medical director and governing 
body. This experience must be under the direct supervision of a 
registered nurse, and be 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.
    (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) of this part to be responsible for 
the delivery of patient care and outcomes in the facility. 
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 care and safety 
are adhered to by all individuals who treat patients in the facility, 
including attending physicians and nonphysician providers; and

[[Page 6253]]

    (ii) The interdisciplinary team adheres to the discharge and 
transfer policies and procedures specified in Sec.  494.180(f) of this 
part.


Sec.  494.160  Condition: Relationship with 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.


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.
    (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) Obtain 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. 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. Patient records 
must be retained for a period of time not less than that required by 
State law or, in the absence of State law--
    (1) Adults. 5 years from the date of the patient's discharge, 
transfer or death; or
    (2) Minors. 3 years or until the patient reaches legal age under 
State law, whichever is longer, 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 the patient's medical record and other information 
necessary in the patient's care or treatment 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. The governing body receives and 
acts upon recommendations from the ESRD Network.
    (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 
described in Sec.  494.110 of this part.
    (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;
    (2) A registered nurse is present in the facility at all times that 
patients are being treated;
    (3) All employees have appropriate orientation to the facility and 
their work responsibilities upon employment;
    (4) All employees have an opportunity for continuing education and 
related development activities; and
    (5) There is an approved written training program specific to 
dialysis technicians that includes--
    (i) Principles of dialysis;
    (ii) Care of patients with kidney failure, including interpersonal 
skills;
    (iii) Dialysis procedures and documentation, including the 
initiation, monitoring, and termination of dialysis;
    (iv) Possible complications of dialysis;
    (v) Water treatment;
    (vi) Infection control; and
    (vii) Safety; and
    (viii) Dialyzer reprocessing, if applicable.
    (6) When State requirements meet or exceed Sec.  494.180(b)(5) the 
State requirements must be met.
    (c) Standard: Medical staff appointments. The governing body--
    (1) Is responsible for all medical staff appointments and 
credentialing, including attending physicians, physician assistants, 
and nurse practitioners; 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 of this part.
    (d) Standard: Furnishing services. The governing body is 
responsible for ensuring that the dialysis facility furnishes directly 
(see Sec.  494.10 of this part) services 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 of this 
part).
    (e) Standard: Internal grievance process. The facility's internal 
grievance process must be implemented so that the patient may file a 
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: 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;

[[Page 6254]]

    (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) 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;
    (iii) Attempts to place the patient in another facility and 
documents that effort; and
    (iv) Notifies the State survey agency and the ESRD Network that 
services the area (where the facility is located) of the involuntary 
transfer or discharge.
    (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, 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. 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 the 
National Technology Transfer and Advancement Act process adopted by the 
Secretary.
    (i) Standard: 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.

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

    Approved: July 19, 2004.
Tommy G. Thompson,
Secretary.

    Note: This document was received at the Office of the Federal 
Register on January 25, 2005.

[FR Doc. 05-1622 Filed 1-28-05; 8:45 am]
BILLING CODE 4120-01-P