Medicare Program; Conditions for Coverage for End Stage Renal Disease Facilities, 6184-6254 [05-1622]

Agencies

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

[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Proposed Rules]
[Pages 6184-6254]
From the Federal Register Online via the Government Printing 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 https://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: https://
www.gpoaccess.gov/fr/.

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 (https://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: https://
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 https://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 https://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-H