Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities, 20370-20484 [08-1102]

Agencies

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

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



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Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 405, 410, 413 et al.



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

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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

[CMS-3818-F]
RIN 0938-AG82


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

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

ACTION: Final rule.

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

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

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

SUPPLEMENTARY INFORMATION:

Table of Contents

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

Acronym List

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

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

I. Background

A. Introduction

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

B. Legislative History

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

C. Existing ESRD Regulation

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

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

D. The Establishment of Central Requirements

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

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

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

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

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

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

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

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

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

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

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

[[Page 20375]]

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

[[Page 20376]]

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

[[Page 20377]]

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

[[Page 20378]]

removed the proposed infection control officer requirement, as 
discussed below.
    Under the ``Oversight'' standard at Sec.  494.30(b)(2) we are 
requiring the clinical staff to ``demonstrate compliance with current 
aseptic technique when dispensing and administering intravenous 
medications from vials and ampules.''
    Comment: Several comments were submitted in response to our 
solicitation as to whether we should incorporate by reference the 
Healthcare Infection Control Practices Advisory Committee's (HICPAC) 
``Hand Hygiene in Healthcare Settings'' guidelines and the ``Guideline 
for Preventing Intravascular Device-Related Infections.'' Comments were 
evenly divided regarding incorporation of the hand hygiene guidelines. 
Two of the commenters stated there is no consensus between HICPAC hand 
hygiene guidelines and guidelines developed by Society for Healthcare 
Epidemiology of America (SHEA) regarding standards of care for 
preventing nosocomial transmission of staph aureus and enterococcus. 
While one commenter did not support incorporation of the intravascular 
device guidelines, there was some support for their inclusion, notably 
from the American Nephrology Nurses Association.
    Response: We would expect that dialysis facilities demonstrate 
adherence to professional standards of practice for infection control, 
which include adherence to hand hygiene guidelines. This expectation is 
included in the stem statement of the infection control condition: 
``The dialysis facility must provide and monitor a sanitary environment 
to minimize the transmission of infectious agents within and between 
the unit and any adjacent hospital or other public areas.'' The 
expectation of acceptable hand hygiene extends to all healthcare 
providers. We will not specifically incorporate by reference the HICPAC 
hand hygiene standards, but we do expect compliance to the hand hygiene 
professional standards of practice.
    We do not agree that the guidelines developed by SHEA regarding 
standards of care for preventing nosocomial transmission of staph 
aureus and enterococcus conflict with the HICPAC hand hygiene 
standards. We note that the SHEA guidelines are not specific to 
dialysis facilities where contact precautions are recommended, but 
address infection control issues in the hospital setting. The SHEA 
guidelines reflect the general lack of adherence by health care workers 
to hand hygiene standards and recommend additional measures, such as 
surveillance cultures, to prevent and monitor cross-contamination. 
Facilities have the flexibility to use appropriate resources to assist 
in the development and implementation of their hand hygiene infection 
control and prevention program.
    Catheter infections continue to be a concern in hemodialysis 
facilities and lead to hospitalizations. HICPAC states in its 
``Guidelines for the Prevention of Intravascular Catheter-Related 
Infections'' RR-10 document (https://www.cdc.gov/mmwr/preview/mmwrhtml/
rr5110a1.htm) (page 11), that the use of catheters for hemodialysis is 
the most common factor contributing to bacteremia in dialysis patients 
and the relative risk for bacteremia in patients with dialysis 
catheters is sevenfold the risk for patients with primary arteriovenous 
fistulas. In Sec.  494.30(a)(2) we are incorporating by reference the 
pertinent hemodialysis catheter use sections (pages 13-14, and 17-18) 
of RR-10, 2002, ``Guidelines for the Prevention of Intravascular 
Catheter-Related Infections.'' These guidelines describe appropriate 
health-care worker education and training, surveillance, hand hygiene 
(I-III, page 16), aseptic technique (IV, page 16), hemodialysis 
catheter exit site care (section III-V, page 21), and catheter-site 
dressing regimens (section VI, C, page 22), and are the nursing 
standard of practice for catheter care. We expect that incorporation of 
these guidelines will increase staff awareness of the protections 
needed for hemodialysis patients with catheters and lead to reduced 
catheter infections.
    Comment: Few commenters responded to our solicitation for comment 
regarding whether we should incorporate by reference the American 
Institute of Architects (AIA) Guidelines for Design and Construction of 
Hospitals an