[Federal Register: February 4, 2005 (Volume 70, Number 23)]
[Proposed Rules]
[Page 6183-6254]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe05-28]
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
42 CFR Parts 400, 405, 410, 412, 413, 414, 488, and 494
[CMS-3818-P]
RIN 0938-AG82
Medicare Program; Conditions for Coverage for End Stage Renal
Disease Facilities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would revise the requirements that end
stage renal disease (ESRD) dialysis facilities must meet to be
certified under the Medicare program. The revised requirements focus on
the patient and the results of the care provided to the patient,
establish performance expectations for facilities, encourage patients
to participate in their care plan and treatment, eliminate many
procedural requirements from the current conditions for coverage, and
preserve strong process measures when necessary to promote patient well
being and continuous quality improvement. These changes are necessary
to reflect the advances in dialysis technology and standard care
practices since the requirements were last revised in their entirety in
1976.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on May 5, 2005.
ADDRESSES: In commenting, please refer to file code CMS-3818-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (fax) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments.
(Attachments should be in Microsoft Word, WordPerfect, or
Excel; however, we prefer Microsoft Word.)
2. By mail. You may mail written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-3818-P, PO Box 8012, Baltimore, MD
21244-8012.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-9994 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Robert Miller (410) 786-6797, Teresa
Casey (410) 786-7215, and Rachael Weinstein (410) 786-6775 (Conditions
for Coverage and Quality Standards). Jan Tarantino, (410) 786-0905
(Survey and Certification).
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-3818-P and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. After the close of the
comment period, CMS posts all electronic comments received before the
close of the comment period on its public website. Comments received
timely will be available for public inspection as they are received,
generally beginning approximately 3 weeks after publication of a
document, at the headquarters of the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an
appointment to view public comments, phone 1-800-743-3951.
Copies: To order copies of the Federal Register containing this
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and photocopy the Federal Register document at most libraries
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This Federal Register document is also available from the Federal
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Government Printing Office. The Web site address is: http://www.gpoaccess.gov/fr/index.html
.
Table of Contents
I. Introduction and the Provision of Reference Materials
II. Background
A.History
B. Existing ESRD Regulations
C. Overview
D. Establishment of Central Requirements
E. Development of Outcome-Based Performance Quality Measures
1. Dialysis Facility Compare
2. Dialysis Facility Data Reporting Requirements
3. Facility Specific Reports
4. The National Kidney Foundation Kidney Disease Outcomes
Quality Initiative (NKF-K/DOQI) Clinical Practice Guidelines
5. CMS ESRD Clinical Performance Measures Project
6. CPM Data Reporting
7. Updating Existing ESRD Patient-Specific Performance Measures
and Developing Future ESRD Facility Performance Standards
F. Summary of the Contents of the Proposed Rule
III. Provisions of Proposed Part 494 Subpart A (General Provisions)
A. Basis and Scope (Proposed Sec. 494.1)
B. Definitions (Proposed Sec. 494.10)
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C. Compliance with Federal, State, and Local Laws and
Regulations (Proposed Sec. 494.20)
IV. Provisions of Proposed Part 494 Subpart B (Patient Safety)
A. Infection Control (Proposed Sec. 494.30)
B. Water Quality (Proposed Sec. 494.40)
C. Reuse of Hemodialyzers and Bloodlines (Proposed Sec. 494.50)
D. Physical Environment (Proposed Sec. 494.60)
V. Provisions of Proposed Part 494 Subpart C (Patient Care)
A. Patients' Rights (Proposed Sec. 494.70)
B. Patient Assessment (Proposed Sec. 494.80)
C. Patient Plan of Care (Proposed Sec. 494.90)
1. Development of the Patient Plan of Care (Proposed Sec.
494.90(a))
a. Dose of Dialysis (Proposed Sec. 494.90(a)(1))
b. Nutritional Status (Proposed Sec. 494.90(a)(2))
c. Anemia (Proposed Sec. 494.90(a)(3))
d. Vascular Access (Proposed Sec. 494.90(a)(4))
e. Transplantation Status (Proposed Sec. 494.90(a)(5))
f. Rehabilitation Status (Proposed Sec. 494.90(a)(6))
g. Social Services
2. Implementation of the Patient Plan of Care (Proposed Sec.
494.90(b))
3. Transplantation Referral (Proposed Sec. 494.90(c))
4. Patient Education and Training (Proposed Sec. 494.90(d))
D. Care at Home (Proposed Sec. 494.100)
1. Dialysis of ESRD Patient in the Home Setting
2. Dialysis of ESRD Patients in Nursing Facilities and Skilled
Nursing Facilities
a. Delineation of Responsibility
b. Applicable ESRD Conditions for Coverage
c. Nursing Coverage
d. Training
e. Monitoring
E. Quality Assessment and Performance Improvement (Proposed
Sec. 494.110)
1. Program Scope (Proposed Sec. 494.110(a))
2. Monitoring Performance Improvement (Proposed Sec.
494.110(b))
3. Prioritizing Improvement Activities (Proposed Sec.
494.110(c))
4. Facility Specific Standards of Enforcement
F. Special Purpose Renal Dialysis Facilities (Proposed Sec.
494.120)
G. Laboratory Services (Proposed Sec. 494.130)
VI. Provisions of Proposed Part 494 Subpart D (Administration)
A. Personnel Qualifications (Proposed Sec. 494.140)
1. Medical Director (Proposed Sec. 494.140(a))
2. Nursing Services (Proposed Sec. 494.140(b))
3. Dietitian (Proposed Sec. 494.140(c))
4. Social Worker (Proposed Sec. 494.140(d))
5. Patient Care Dialysis Technicians (Proposed Sec. 494.140(e))
6. Other Personnel Issues
B. Responsibilities of the Medical Director (Proposed Sec.
494.150)
C. Relationship with the ESRD Network (Proposed Sec. 494.160)
D. Medical Records (Proposed Sec. 494.170)
E. Governance (Proposed Sec. 494.180)
1. Existing Requirements for Governing Bodies
2. Overview of the Proposed Governance Requirements
3. Governance Condition (Proposed Sec. 494.180)
4. Designating a Chief Executive Officer or Administrator
(Proposed Sec. 494.180(a))
5. Adequate Number of Qualified and Trained Staff (Sec.
494.180(b))
6. Medical Staff Appointments (Proposed Sec. 494.180(c))
7. Furnishing Services (Proposed Sec. 494.180(d))
8. Internal Grievance Process (Proposed Sec. 494.180(e))
9. Discharge and Transfer Policies and Procedures (Proposed
Sec. 494.180(f))
10. Emergency Coverage (Proposed Sec. 494.180(g))
11. Furnishing Data and Information for ESRD Program
Administration (Proposed Sec. 494.180(h))
12. Disclosure of Ownership (Proposed Sec. 494.180(i))
VII. Other Proposed Changes
A. Proposed Cross-Reference Changes
B. Proposed Additions to Part 488
VIII. Reference Materials
A. New Provisions in Part 494
B. ESRD Crosswalk
C. Bibliography
IX. Collection of Information Requirements and Public Comments
A. Collection of Information Requirements
B. Response to Comments
X. Regulatory Impact Analysis
Regulations Text
Acronyms
AKF American Kidney Fund
AAMI Association for the Advancement of Medical Instrumentation
ANNA American Nephrology Nurses Association
AHRQ Agency for Healthcare Research and Quality
AED Automatic external defibrillator
AIA American Institute of Architects
ANSI American National Standards Institute
BBA Balanced Budget Act of 1997
BONENT Board of Nephrology Nursing Examiners Nursing and Technology
BUN Blood urea nitrogen
CAHPS Consumer Assessment of Health Plans Survey
CBC Center for Beneficiary Choices
CDC Centers for Disease Control and Prevention
CHI Consolidated Health Informatics
CEO Chief executive officer
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare and Medicaid Services
CPG Clinical practice guidelines
CPM Clinical performance measures
CPR Cardiopulmonary resuscitation
CROWN Consolidated Renal Operations in a Web-enabled Network
DHHS Department of Health and Human Services
DME Durable medical equipment
DOQI Disease Outcomes Quality Initiative
DSN Dialysis Surveillance Network
EMS Emergency medical system
ESRD End stage renal disease
FDA Food and Drug Administration
HHA Home health agency
HIPAA Health Insurance Portability and Accountability Act of 1996
ICH In-center hemodialysis
IOM Institute of Medicine
IT Information technology
LSC Life Safety Code
MedPAC Medicare Payment Advisory Commission
MSW Master's degree social worker
NANT National Association of Nephrology Technicians
NF Nursing facility
NFPA National Fire Protection Association
NIH National Institutes of Health
NISTA National Institute of Standards and Technology Act
NKF National Kidney Foundation
NKF-K/DOQI National Kidney Foundation's Kidney Disease Outcomes
Quality Initiatives
NNCC Nephrology Nursing Certification Commission
NNCO National Nephrology Certification Organization
NQF National Quality Forum
NTTAA National Technology Transfer and Advancement Act of 1995
OBRA 1990 Omnibus Reconciliation Act 1990
OIG Office of the Inspector General
OMB Office of Management and Budget
QAPI Quality assessment and performance improvement
RPA Renal Physicians Association
RRG Rapid response group
SNF Skilled nursing facility
VISION Vital Information System to Improve Outcomes in Nephrology
URR Urea reduction rate
USRDS United States Renal Data System
I. Introduction and the Provision of Reference Materials
A. Introduction
The Centers for Medicare and Medicaid Services (CMS) is committed
to modernizing the existing regulations that are based on largely
procedural standards. One of our key initiatives is to revise many of
the health and safety conditions to focus on the patient's experience
with care in the delivery setting, patient outcomes of care, and the
elimination of unnecessary procedural requirements.
In concert with the Administration's regulatory reform initiative,
we believe that new ESRD regulations should--
Be founded on evidence;
Be patient-centered;
Promote outcomes desired for Medicaid and Medicare
beneficiaries as well as others served by participating ESRD suppliers
of services;
Establish a framework for the collection and reporting of
consensus-driven performance standards;
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Set clear expectations for dialysis facility
accountability; and
Stimulate improvements in processes, outcomes of care, and
beneficiary satisfaction.
In addition, the new ESRD conditions for coverage must comport with
our national performance measurement strategy, which consists of three
principles: (1) Performance measures should be consumer and purchaser-
driven; (2) performance measures should be in general, commonly-used
terms, and their associated collection tools should be generally
available at little or no cost to dialysis facilities; and (3) the
content and collection of data and performance measures derived from
that data should be standardized.
B. Provision of Informational and Review Aids
In our development of the proposed rule, we have included
references to a number of reports, articles, and other documents in the
preamble. To indicate the source of this information, we have provided
a brief parenthetical acknowledgement at the end of referenced
statement and have provided a full citation for the reference in the
bibliography (see section of VIII.C. of this preamble). Other
informational and review aids incorporated in this proposed rule
include--
A table of contents;
A list of acronyms;
A chart listing the new provisions (see section VIII.A. of
this preamble); and
A crosswalk of the existing requirements to the proposed
requirements (see section VIII.B. of this preamble).
II. Background
A. History
ESRD is a kidney impairment that is irreversible and permanent and
requires a regular course of dialysis or kidney transplantation to
maintain life. Dialysis is the process of cleaning the blood
artificially with special equipment when the kidneys have failed.
Section 299I of the Social Security Amendments of 1972 (Pub. L. 92-
603) originally extended Medicare coverage to insured individuals,
their spouses, and their dependent children with ESRD who require
dialysis or transplantation. The ESRD program became effective July 1,
1973, and initially operated under interim regulations published in the
Federal Register on June 29, 1973 (38 FR 17210). In the July 1, 1975
Federal Register (40 FR 27782), we published a proposed rule that
revised sections of the regulations relating to:
The Medicare conditions for coverage for suppliers of ESRD
services;
Certification procedures;
Establishment of minimal utilization rates;
Designation of ESRD network areas;
Establishment of Network Coordination Councils; and
The provision of a Medical Review Board.
A comment period lasting 60 days followed and comments were
carefully considered. On June 3, 1976 the final rule was published in
the Federal Register (41 FR 22501). Subsequently, the ESRD Amendments
of 1978 (Pub. L. 95-292), amended title XVIII of the Social Security
Act (the Act) by adding section 1881. Sections 1881(b)(1) and
1881(f)(7) of the Act further authorize the Secretary to prescribe
health and safety requirements (known as conditions for coverage) that
a facility providing dialysis and transplantation services to dialysis
patients must meet to qualify for Medicare reimbursement. In addition,
section 1881(c) of the Act establishes ESRD network areas and network
organizations to assure that dialysis patients are provided appropriate
care.
B. Existing ESRD Regulations
The requirements from section 1881(b), (c), and (f)(7) are
implemented in regulations at 42 CFR 405, subpart U, Conditions for
Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
The existing regulations describe the health and safety
requirements that dialysis facilities and renal transplantation centers
must meet to furnish care to Medicare beneficiaries. The regulations in
subpart U also include the provision that dialysis facilities be
organized into Network areas and describe the role that Networks play
in the ESRD program.
The purpose of the existing conditions for coverage (also known as
conditions) is to protect dialysis patients' health and safety and to
ensure that quality care is furnished to all patients in Medicare-
approved dialysis and kidney transplantation facilities. To determine
if a facility meets these conditions, the State survey agency performs
on-site surveys of the facility. If a survey indicates that a facility
is in compliance with the conditions, and all other Federal
requirements are met, we then certify the facility as qualifying for
Medicare payment. Medicare payment for outpatient maintenance dialysis
and kidney transplantation is limited to facilities meeting these
conditions.
Our decision to propose major changes to the existing conditions is
based on several considerations. As discussed above, revising the ESRD
requirements is part of our effort to modernize regulations and move
toward a patient outcome-based system that focuses on quality
assessment and performance improvement. We believe that revising the
conditions for coverage will encourage improvement in outcomes of care
for beneficiaries. Secondly, the existing ESRD conditions were
originally adopted in 1976 and although some amendments have been made
they have not been comprehensively revised since that time. The
existing requirements for dialysis facilities emphasize the policies
and procedures that must be in place to support good patient care, and
they focus on a facility's capacity to furnish quality care, rather
than on the actual provision of quality care to patients and the
outcomes of that care. Third, we wish to incorporate the most recent
medical and scientific guidelines and recommendations for dialysis
facilities from the Centers for Disease Control and Prevention (CDC),
the Association for the Advancement of Medical Instrumentation (AAMI),
and recognize current practice guidelines and standards of practice
such as the National Kidney Foundation's Kidney Disease Outcomes
Quality Initiative (NKF-K/DOQI) clinical practice guidelines (CPGs).
The existing ESRD conditions do not require the facility to operate
a patient-centered, outcome-oriented quality assessment and performance
improvement program. Moreover, changes have taken place in the delivery
of services to dialysis patients, and these advances are not reflected
in the existing requirements. Thus, we have concluded that significant
revisions to the conditions for coverage for ESRD facilities are
essential. The proposed changes reflect improvements in standard care
practices, the use of more advanced technology and equipment, and, most
notably, a framework to incorporate performance measures viewed by the
scientific and medical community to be related to the quality of care
provided to dialysis patients.
C. Overview
Since 1994, we have received comments from the renal community at
large and we have used the contributions provided by the community in
developing the revised conditions contained in this proposed rule.
Several renal organizations have offered recommendations regarding the
conditions for coverage during the bimonthly public 2001 and 2002 CMS
meetings on ESRD topics. Notices of
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these were announced on the CMS Web site (http://www.cms.hhs.gov/opendoor/schedule.asp
). We believe that many in the community support
the overall shift in the proposed conditions from an emphasis on
process-oriented requirements to a more patient-centered, outcome-
oriented approach. Further, we believe that virtually all members of
the community support a quality assessment and performance improvement
requirement and the development of a comprehensive data set that will
contain information on the characteristics of ESRD facilities, its
patient population, as well as outcome measures of patient care.
The fundamental principles that guided us during this collaborative
effort to develop new conditions were as follows:
Ensure that patients' rights and physical safety are
protected.
Stress continuous quality assessment and performance
improvement, incorporating, to the greatest extent possible, outcome-
oriented, data-driven measures. Thus, the new conditions would invest a
major expectation for performance in a requirement that each facility
participate in its own quality assessment and performance improvement
program. This allows the facility flexibility to create its own self-
tailored program of continuous quality improvement. Facilities could be
flexible and creative in their approach to patient care and delivery of
services as they use their own information to assess and improve
patient services, outcomes, and satisfaction.
Facilitate flexibility in how dialysis facilities meet our
performance requirements;
Eliminate unnecessary administrative policies. Process-
oriented standards are only included where we believe they are
essential to protect patient health and safety;
Focus on the continuous, interdisciplinary, integrated
care system that a dialysis patient experiences, centered around
patient assessment, care planning, service delivery, and quality
assessment and performance improvement; and
Stress patient satisfaction and ongoing patient
involvement in the development of the care plan and treatment.
Finally, in order for the ESRD facility conditions to move
from a process and structure orientation toward a more patient-
centered, outcome-oriented approach, individual patient and facility
specific outcome measures must be identified and evaluated or in the
absence of existing measures, they must be developed and validated with
community input to ensure they are clinically meaningful and reflect
current scientific knowledge.
D. The Establishment of Central Requirements
We are proposing new conditions for coverage for ESRD facilities
that revise or eliminate many of the existing requirements and
establish critical central requirements. The central requirements of
the proposed rule are grouped into three broad categories: (1) Patient
safety; (2) patient care (which includes quality assessment and
performance improvement); and (3) administration. Subpart A contains
general provisions, for example, statutory authority, definitions, and
requirements for compliance with Federal, State and local laws and
regulations. Subparts B (patient safety) and C (patient care) of the
proposed conditions for coverage would focus the facility's efforts on
the actual care delivered to the patients, the performance of the
dialysis facility, and the impact of the treatment furnished by the
dialysis facility on the health status of its patients.
In Subpart B (patient safety), we are proposing to retain and
strengthen some process-oriented patient safety provisions that we
believe remain highly predictive of ensuring desired outcomes and
preventing harmful outcomes. Accordingly, the patient safety
requirements incorporate current CDC infection control procedures,
retain and update our incorporation by reference of the AAMI standards
and guidelines for water quality and dialyzer reuse practices, and
incorporate by reference applicable current Life Safety Code (LSC)
provisions.
Subpart C (patient care) includes: (1) Requirements that emphasize
a dialysis facility's fundamental responsibility to respect and promote
the rights of each patient (patient rights); (2) the critical nature of
a comprehensive assessment in determining appropriate treatments and
achieving desired health outcomes (patient assessment); (3) the
interdisciplinary team approach of providing dialysis services to
patients and the process by which the interdisciplinary team will
achieve effective patient health outcomes (patient plan of care); (4)
the quality assessment and performance improvement program which would
charge each dialysis facility with the responsibility for carrying out
a performance improvement program of its own design to affect
continuing improvement in quality outcomes and patient satisfaction;
and (5) the consolidation of the various aspects of home dialysis care
into a single condition (care at home).
Subpart D (administration) covers the operation of the dialysis
facility in a patient outcome-oriented environment, including: (1)
Minimum personnel qualifications; (2) the role of the medical director;
(3) the facility's relationship with its servicing ESRD network; (4)
medical recordkeeping; and (5) minimum operating responsibilities of
the facility, including data collection and reporting requirements
(governance).
We recognize that there are some who believe that regulations--
particularly those that directly affect the health and safety of
patients--should be very prescriptive in their detail to ensure that
providers do not engage in practices that threaten patient health and
safety. Therefore, we invite public comment on this fundamental shift
in our regulatory approach, especially in terms of: (1) How we could
improve on this approach; (2) what additional requirements could be
removed or added to provide greater flexibility; and (3) which existing
and new requirements are critical to patient care and safety.
E. Development of Outcome-Based Performance Quality Measures
Sections 1881(b)(5)(B) through (D) of the Act provide authority for
us to obtain the data we need from ESRD suppliers. In accordance with
these goals, we envision an information system that protects patients'
privacy in compliance with the new privacy protections afforded by the
Department's health information privacy regulations at 45 CFR Parts 160
and 164. These regulations were developed under the authority of the
Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The data could be accessed by us as well as dialysis patients, the
public, dialysis facilities, State survey agencies, ESRD networks,
researchers, policy makers, renal physicians, and other professionals
providing care to dialysis patients (where permitted by the privacy
regulations). This system would provide information to meet the needs
of the entire renal community, particularly the patients, to make
better choices about care, and to help dialysis providers identify
opportunities for continuous improvement in patient care processes.
This proposal is in keeping with our strategic plan to help
patients and the public become better informed about the health care
services they need and receive so they can make better health
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care choices and participate more fully in their care. The availability
of information will permit patients to become more active and effective
participants in their own care and in their facility's quality
improvement process.
1. Dialysis Facility Compare
One of the first steps to make information more available to the
public is the CMS Dialysis Facility Compare website at: http://www.Medicare.gov/Dialysis/Home.asp.
Dialysis Facility Compare contains
various dialysis facility characteristics and specific quality measures
including the percentage of in-center hemodialysis patients with a urea
reduction rate (URR) (a measure of the adequacy of dialysis) equal to
or greater than 65, the percentage of patients treated with Epogen who
have hematocrits of 33 percent or greater (reflecting adequately
managed anemia), and patient data categories on every dialysis facility
approved to participate in the Medicare program.
2. Dialysis Facility Data Reporting Requirements
Sections 1881(b)(5)(B) through (D) of the Act require ESRD
suppliers to furnish all necessary information to CMS, the ESRD
networks, and State survey agencies. Moreover, existing regulations at
Sec. 405.2133 require that each ESRD facility furnish data and
information in a manner and frequency specified by the Secretary. This
proposed regulation would continue to require facilities to provide
data and other information, but in electronic format, including
clinical performance measures (CPM) data, necessary for the
administration of the ESRD program.
3. Facility Specific Reports
In 1996, CMS first distributed facility-specific reports to
Networks and facilities. These reports were compiled by the University
of Michigan, using data from the CMS forms used for patient eligibility
and patient death purposes; the CMS claims forms; the certification
forms; and facility-specific data on infection control practices
collected by the CDC.
The initial reports presented comparative data on patient
characteristics, patient outcomes, and facility practice patterns. A
common CMS database and common data formulations were used to create
these reports. Each year since 1996, these reports have been
distributed to ESRD Networks and ESRD facilities. The reports have
formed a basis for implementing and understanding quality improvement
activities. The data that form the basis for these facility-specific
reports are used to report patient outcomes and to develop additional
reports.
CMS has expanded the Facility Specific Reports to include a broader
array of information, including facility-specific reports for the use
of State survey agencies, state-specific reports, and region-specific
reports. The facility-specific reports have been improved by the
expansion of facility practice pattern information, explanatory text
with each report, table and graph modifications, and the inclusion of
additional risk-adjusters in the calculations of the standardized
mortality ratio.
4. The National Kidney Foundation Kidney Disease Outcomes Quality
Initiative (NKF-K/DOQI) Clinical Practice Guidelines
In March 1995, the National Kidney Foundation (NKF) initiated the
National Kidney Foundation-Dialysis Outcomes Quality Initiative (NKF-
DOQI), the first comprehensive effort in nephrology designed to provide
evidence-based guidance to clinical care in nephrology. Development of
the NKF-DOQI clinical practice guidelines involved a 2-year effort in
which independent interdisciplinary workgroups reviewed the available
body of scientific literature on hemodialysis and peritoneal dialysis
adequacy, vascular access, and anemia. Each workgroup was composed of
renal experts from diverse clinical disciplines and renal patients. The
workgroups were tasked with developing and promulgating clinical
practice guidelines for the treatments of patients with ESRD. Four
principles guided the project's decision-making: (1) Use of a high
level of scientific and methodological rigor in the guideline
development process; (2) commitment to an interdisciplinary approach;
(3) independence of the workgroups; and (4) openness of the guideline
development process. To that end, the workgroups developed draft
guidelines with supporting rationales that included the evidentiary
basis for the recommendations.
Draft guidelines were subject to an unprecedented three-stage
review process: (1) An advisory council, comprised of 25 experts,
provided comments on the initial draft of the guidelines; (2) a variety
of organizations (that is, ESRD networks, professional and patient
associations, dialysis providers, government agencies, product
manufacturers, and managed care groups) were invited by NKF to review
and comment on a revised draft of the guidelines; and (3) a final draft
of the guidelines was made available for public review by all
interested individuals or parties.
Four sets of DOQI clinical practice guidelines were published by
the NKF in 1997, including recommended practices for management of
anemia, adequacy of hemodialysis, adequacy of peritoneal dialysis, and
vascular access. In 2000, the scope of DOQI expanded to encompass the
spectrum of chronic kidney disease prior to the need for dialysis
services. To reflect this expansion, DOQI became K/DOQI. A total of 114
chronic kidney disease clinical practice guidelines were developed by
the workgroups and reviewed by numerous professionals and patients. The
NKF has published Bone Metabolism and Disease in Chronic Kidney Disease
clinical practice guidelines and Hypertension and Antihypertensive
Agents in Chronic Kidney Disease as well as Managing Dyslipidemias
guidelines. The latest set of clinical practice guidelines being
developed under the K/DOQI umbrella are the CPGs for Cardiovascular
Disease in Dialysis patients.
5. CMS ESRD Clinical Performance Measures Project
In 1999, we merged our ongoing ESRD Core Indicators Project, a
quality improvement project, originally started in 1994, into a new
ESRD Clinical Performance Measures Project (ESRD CPM Project). The ESRD
CPM Project is an ongoing effort between us, the ESRD networks, and
dialysis facilities to collect performance measures on a representative
sample of dialysis patients in the areas of adequacy of dialysis,
anemia management, nutrition (that is, serum albumin), and more
recently, vascular access (DHHS/CMS/CBC, pp. 1-104). The ESRD CPM
Project was developed to implement section 4558(b) of the Balanced
Budget Act (BBA) of 1997 (Pub. L. 105-33). This provision required the
Secretary to develop and implement a method to measure and report on
the quality of renal dialysis services provided under Medicare no later
than January 1, 2000.
The goal of the CPM Project was to identify NKF DOQI guidelines
that were suitable for the agency's quality improvement initiatives and
to meet the BBA requirement. The ultimate purpose of the project is to
assist suppliers of ESRD services in improving the care provided to
ESRD patients.
In 1998, we contracted with PRO-West (now named Qualis Health), a
Seattle-based private nonprofit healthcare quality improvement
organization, to facilitate the process of developing dialysis clinical
[[Page 6189]]
performance measures (CPMs) based on the NKF's DOQI (now K/DOQI)
guidelines.
The process included several components. The first was to develop a
mechanism to assure appropriate participation from the community in
order to facilitate the acceptability and utility of the CPMs. The
second was to prioritize the NKF DOQI guidelines based on the strength
of the evidence supporting the guidelines, the feasibility of
developing performance measures, and the significance of the areas
addressed to the quality of care delivered to dialysis patients. The
third was to identify a limited set of CPMs that could be used to
support quality improvement activities as well as assist us in
assessing nationally the quality of care delivered to Medicare
beneficiaries. The fourth was to develop sampling and data
specifications for the CPMs to facilitate measurement. Finally, we
requested the development of data collection and analysis strategies to
be used to augment the existing national performance measurement
system.
The CPM Project was conducted in collaboration with a broad range
of stakeholders in the community. In order to facilitate this
involvement, participation was solicited through contacts with
professional and voluntary associations, presentations at national
meetings, and invitations to individuals identified through a variety
of sources.
Four expert groups were convened to address each of the topic areas
covered by the NKF DOQI guidelines: (1) Hemodialysis adequacy; (2)
peritoneal dialysis adequacy; (3) vascular access; and (4) anemia
management. The NKF DOQI guidelines were ranked via a survey of renal
experts for their suitability as candidates for development of CPMs.
All 114 NKF DOQI guidelines were included on a survey tool developed by
CMS that was distributed to the rapid response group (RRG) and other
expert consultants. Suitability of guidelines was based on clinical
importance, feasibility of measurement, and the respondent's assessment
of the strength of the evidence supporting the guideline.
We accepted 36 proposed guidelines for further evaluation and the 4
expert groups developed specific review criteria, algorithms, and CPMs
selected through the prioritization process described above. The CPM
development process was a modification of a methodology described by
the Agency for Healthcare Research and Quality (AHRQ) (formerly the
Agency for Health Care Policy and Research (AHCPR)). Candidate
guidelines that did not have a strong evidence basis were eliminated
from further consideration. Sixteen CPMs were developed based on 22 of
36 candidate NKF DOQI clinical practice guidelines.
Data collection instruments were subsequently developed and
submitted to us for field testing. Three data collection tools were
developed and pilot tested. The first instrument was intended to
collect data for the hemodialysis adequacy, anemia management, and
vascular access CPMs from hemodialysis patient records. The second
instrument was designed to collect adequacy and anemia management data
for peritoneal dialysis patients. The third instrument focused on
information about facility policies, procedures, and practices related
to selected hemodialysis adequacy CPMs. In the summer of 1999, after
field-testing, the CPMs were applied to a sample of 8,853 randomly
selected adult hemodialysis patients and 1,650 randomly selected adult
peritoneal dialysis patients.
In summary, the NKF DOQI process resulted in a broad set of
guidelines amenable to prioritization based on strength of evidence,
clinical importance and feasibility. The current NKF K/DOQI guidelines
are widely accepted among the renal community and increase the
likelihood that future CPMs can be developed and supported by a broad
cross-section of stakeholders, including clinical practitioners,
industry representatives, professional associations, and others
interested in assessment and improvement of the care provided to
dialysis patients.
We have been working closely with the ESRD networks and information
technology contractors to develop the Vital Information System to
Improve Outcomes in Nephrology (VISION) database. VISION is a patient-
specific, facility-based, outcome-oriented information system that will
enable dialysis facilities to electronically collect and report both
demographic and clinical data that can be profiled to assist efforts to
improve outcomes of care. VISION will capture, among other things, data
from the CMS ESRD CPM Project. VISION will be designed so that
Consolidated Health Informatics (CHI) standards will be met.
The CHI establishes health messaging and vocabulary standards that
enable data sharing across all Federal systems. Implementation of the
CHI standards is prospective (that is, applicable to new systems and
systems undergoing major upgrades). Current plans are to upgrade the
ESRD Information System within the next 2 to 3 years. Since the CHI
standards are prospectively applied, the CHI standards will be
incorporated when we upgrade the ESRD information system.
Following the upgrade to the ESRD information system, ESRD
facilities will be required to submit data using the new information
technology (IT) system. They can accomplish submission of data that is
consistent with the CHI standards by either modifying their internal
systems or by using mapping tools that are provided by the National
Library of Medicine (NLM) at no cost. The CHI standards are posted on
the egov.gov Web site located at http://www.whitehouse.gov/omb/egov/gtob/health_informatics.htm
.
6. CPM Data Reporting
ESRD CPM Project data have been collected for 1999, 2000, 2001, and
2002 and published in annual reports. The 2001 ESRD CPM report can be
found on the Internet at http://www.cms.gov/esrd/l.asp. The data for
each year include a random sample, stratified by ESRD network, of adult
in-center hemodialysis patients and a random peritoneal dialysis
patient sample of 5 percent of adult peritoneal dialysis patients in
the nation. The sample size of adult in-center hemodialysis patients
was selected to allow us to be 95 percent confident that Network-
specific estimates for selected clinical measures are accurate within
plus or minus 5 percent. The sample also included a 30 percent ``over
sample'' for in-center hemodialysis patients and a 10 percent ``over
sample'' for peritoneal dialysis patients to compensate for anticipated
nonresponse rates. In 2002, the in-center hemodialysis sample included
8,863 patients and the peritoneal dialysis sample included 1,451
patients. Also, a 5 percent national sample of hemodialysis facilities
was drawn, consisting over 200 hemodialysis facilities.
Three data collection tools were used, an in-center hemodialysis
form (Form CMS-820), a peritoneal dialysis form (Form CMS-821), and a
hemodialysis facility-specific form.
We believe that the ESRD CPM Project is an effective tool to
facilitate ESRD quality improvement, and this project has successfully
tracked positive improvements in patient outcomes of care in several
areas. The 2001 Annual Report for the ESRD CPM Project contains
additional Outcomes Comparison Tools (for hemodialysis and peritoneal
dialysis). Outcomes Comparison Tools are practical quality improvement
instruments that can be used by ESRD facilities to benchmark their
performance outcomes against rates at the ESRD network's level
[[Page 6190]]
(hemodialysis only) and the nation. Therefore, we are proposing in the
Governance condition for coverage (Sec. 494.180(h)), that all ESRD
facilities collect and provide us with ESRD CPM Project data
electronically. This proposal applies only to the current CPMs and is
discussed in more detail later in this preamble. We will carefully
evaluate any revisions to the CPMs as well as any future CPMs,
developed in accordance with the National Technology Transfer and
Advancement Act of 1995 process (described in the next section of this
preamble) for possible inclusion as electronic reporting requirements.
The Secretary will provide notice and an opportunity for comment in the
Federal Register before the CPMs are updated or new measures are
adopted.
7. Updating Existing ESRD Patient-Specific Performance Measures and
Developing Future ESRD Facility Performance Standards
We would like to propose ESRD performance standards that dialysis
facilities would be required to meet as well as propose a method to
recognize updates in existing consensus-based patient-specific
performance measures. We are proposing to adopt a framework that will
utilize existing Federal legislation and operational guidelines. The
National Technology Transfer and Advancement Act of 1995 ((NTTAA) Pub.
L. 104-113) and OMB Circular A-119 specify circumstances in which
Federal agencies should use technical standards developed by voluntary
consensus bodies. The phrase ``technical standards'' is defined in the
NTTAA at section 12(d)(4) as ``performance-based or design-specific
technical specifications and related management systems practices.''
The NTTAA has been implemented by, among other things, the
provisions of the Office of Management and Budget (OMB) Circular No. A-
119 (63 FR 8546, February 19, 1998). OMB Circular No. A-119 was
published to: (1) Revise and clarify policies on Federal use and
development of voluntary consensus standards; (2) set policy for
conformity assessment activities; and (3) improve the clarity and
effectiveness of the previously published (October 20, 1993) circular.
By implementing the policies in this circular, we intend to reduce to a
minimum our reliance on government-specific standards.
Definitions of terms and phrases within the circular are designed
for very broad application, but are meant to be applicable to any
specific and appropriate subject matter, including health care
performance measures.
The circular defines a ``performance standard'' as a standard that
states requirements in terms of required results with criteria for
verifying compliance but without stating the methods for achieving
required results. ``Voluntary consensus standards'' are defined as
standards developed or adopted by voluntary consensus standards bodies,
both domestic and international. ``Voluntary consensus standards
bodies'' are organizations that plan, develop, establish, or coordinate
voluntary consensus standards using agreed-upon procedures. One example
of a voluntary consensus standards body is the National Forum for
Health Care Quality Measurement and Reporting, also known as the
National Quality Forum (NQF), which is currently engaged in various
projects such as standardizing measures of hospital quality and
developing diabetes mellitus treatment performance measures.
The expected products of a voluntary consensus body would include
the measures or indicators and standards, as well as explanatory text
and other supporting documentation, such as guidelines for reporting
the indicators. A voluntary consensus body would make a draft product
available for general public review during the development of the
measures. When the performance standards are complete, we would
evaluate them and then promulgate the standards following the
requirements of the Administrative Procedures Act.
We are not advocating the NQF as the voluntary consensus body that
is most appropriate to develop ESRD performance standards. We have only
provided an illustration of the manner in which performance standards
are being developed. Other organizations, for example, the NKF-K/DOQI,
also function in a manner consistent with voluntary consensus bodies.
Once ESRD facility performance measures are developed by a voluntary
consensus body, the Secretary would evaluate those facility performance
measures and adopt those that meet our needs for the effective
administration of the ESRD program after notice and comment rulemaking
required by the Administrative Procedures Act.
We will also reference the NTTAA later in this preamble under our
discussion of the Governance condition for coverage (see Sec.
494.180(h)).
F. Summary of the Contents of the Proposed Rule
We are proposing to revise both the content and the organization of
the existing regulations. The ESRD Network conditions for coverage will
remain in part 405, subpart U. Through a separate proposed rule
regarding conditions of participation for transplant hospitals, we are
proposing to move the renal transplant center conditions to part 482.
The ESRD conditions for coverage (health and safety provisions for
dialysis facilities) would be moved from existing 42 CFR part 405,
subpart U, to a new 42 CFR part 494, where they would follow
regulations establishing standards for other Medicare providers, such
as the conditions of participation for hospitals (42 CFR part 482),
long-term care facilities (42 CFR part 483), and home health agencies
(42 CFR part 484). The termination of Medicare coverage and alternative
sanctions conditions at Sec. 405.2180 through Sec. 405.2184 will be
recodified to Sec. 488.604 through Sec. 488.610. Since many of the
existing ESRD conditions would be revised, consolidated with other
conditions, or deleted, we also propose to completely renumber and
reorganize the requirements. The format for the dialysis facility
conditions for coverage represents a dramatic change from the
organization of the existing regulations, which contain nearly 20
conditions addressing organizational structure, utilization rate
requirements, and other process-intensive requirements. The proposed
regulations are divided into four subparts: general provisions, patient
safety, patient care, and administration.
The proposed organization of Part 494 is as follows:
Subpart A--General Provisions
Sec. 494.1 Basis and scope.
Sec. 494.10 Definitions.
Sec. 494.20 Compliance with Federal, State, and local laws and
regulations.
Subpart B--Patient Safety
Sec. 494.30 Condition: Infection control.
Sec. 494.40 Condition: Water quality.
Sec. 494.50 Condition: Reuse of hemodialyzers and other dialysis
supplies.
Sec. 494.60 Condition: Physical environment.
Subpart C--Patient Care
Sec. 494.70 Condition: Patient rights.
Sec. 494.80 Condition: Patient assessment.
Sec. 494.90 Condition: Patient plan of care.
Sec. 494.100 Condition: Care at home.
Sec. 494.110 Condition: Quality assessment and performance
improvement.
Sec. 494.120 Condition: Special purpose renal dialysis facilities.
Sec. 494.130 Condition: Laboratory services.
Subpart D--Administration
Sec. 494.140 Condition: Personnel qualifications.
Sec. 494.150 Condition: Responsibilities of the medical director.
Sec. 494.160 Condition: Relationship with ESRD network.
[[Page 6191]]
Sec. 494.170 Condition: Medical recordkeeping.
Sec. 494.180 Condition: Governance.
The following provides a detailed discussion of each new
requirement and a discussion of the existing ESRD requirements that
have been revised or deleted in this proposed rule.
III. Provisions of Proposed Part 494 Subpart A (General Provisions)
A. Basis and Scope (Proposed Sec. 494.1)
[If you choose to comment on issues in this section please include the
caption ``Basis'' at the beginning of your comment.]
Proposed Sec. 494.1, identifies the statutory authority for the
regulations. Proposed Sec. 494.1 also states that provisions of part
494 serve as the basis for survey activities for determining whether a
dialysis facility meets the conditions for coverage under the Medicare
program. We note that the organizational format of the proposed
conditions permits the elimination of almost all of the material in
existing Sec. 405.2100, Scope of subpart, which consists largely of a
description of the contents of the existing ESRD conditions for
coverage.
B. Definitions (Proposed Sec. 494.10)
[If you choose to comment on issues in this section please include the
caption ``Definitions'' at the beginning of your comment.]
Under proposed Sec. 494.10, we set forth definitions for terms
used in the ESRD conditions. Existing Sec. 405.2102 provides a list of
32 definitions. We are proposing to eliminate the definitions of
several terms for which we believe the meaning is self-evident, as well
as terms that are not used in the revised conditions. We do not believe
it is appropriate to have substantive requirements contained in those
definitions. Thus, we would move definitions that contain qualification
requirements to the appropriate conditions in the proposed rule. We
have proposed to retain the definition of ``furnishes on the premises''
and add it to proposed Sec. 494.180 (Governance). We are proposing a
modification of the definition of ``home dialysis'' to recognize the
assisting role that a family member/caregiver may play. We have
previously received questions about whether the definition of ``home''
includes institutional settings such as nursing facilities (NFs) and
skilled nursing facilities (SNFs). Please refer to section V.D. of this
preamble in which we discuss the unique needs of the NF/SNF dialysis
patient and the overall issue. We are soliciting comment on whether the
definition of ``home'' for ``home dialysis'' should also include these
institutional settings.
We propose to include the following definitions in Sec. 494.10:
Dialysis facility means an entity that provides (1)
outpatient maintenance dialysis services; or (2) home dialysis training
and support services; or (3) both. A dialysis facility may be an
independent or hospital-based unit (as described in Sec. 413.174(b)
and (c) of this chapter), or a self-care dialysis unit, which furnishes
only self-dialysis services.
Discharge means the termination of patient care services
by a dialysis facility.
Furnishes directly means the ESRD facility provides the
service through its own staff and employees or through individuals who
are under contract with the facility to furnish these services
personally for the facility. We note that furnishes directly does not
apply to companies providing services under contract or arrangement.
Home dialysis means outpatient dialysis performed at home
by an ESRD patient (or caregiver) if the individual performing such
dialysis has completed the course of training required in Sec.
494.100(a) of this part.
Interdisciplinary team (as required in Sec. 494.80
(Patient assessment)) means the group of persons responsible for
providing patient care to each dialysis patient.
Self-dialysis means dialysis performed with little or no
professional assistance by an ESRD patient (or caregiver) if the
individual performing such dialysis has completed an appropriate course
of training as required in Sec. 494.100(a) (Care at Home).
Transfer means a temporary or permanent move of a patient
from one dialysis facility to another that requires the transmission of
the patient's medical record information to the facility receiving the
patient.
C. Compliance With Federal, State, and Local Laws and Regulations
(Proposed Sec. 494.20)
[If you choose to comment on issues in this section please include the
caption ``Compliance with Laws and Regulations'' at the beginning of
your comment.]
Existing Sec. 405.2135 requires that a dialysis facility be in
compliance with applicable Federal laws and that a dialysis facility be
licensed or approved as meeting applicable standards by the agency of
the State or locality responsible for approval. Section 405.2135
further requires a facility to comply with all relevant laws (for
example, laws relating to licensure of staff) and requires conformity
with other laws (for example, fire safety, equipment maintenance).
We propose to retain the requirement that dialysis facilities must
be in compliance with applicable Federal, State, and local laws and
regulations pertaining to fire safety, equipment, and any other
relevant health and safety issues. We are also proposing that dialysis
facilities must be in compliance with the appropriate Federal, State,
and local laws and regulations regarding drug and medical device usage.
An example of meeting applicable Federal regulations is that the
dialysis facility must use FDA-approved/cleared medical devices and
adhere to the devices' labelling instructions. We have added these
examples because drugs and medical devices are major components of
dialysis facilities and compliance with existing laws and regulations
in this area is important in ensuring patient safety.
We may find a facility to be in violation of these conditions for
coverage if the facility is found out of compliance with any Federal,
State, and local law or regulation pertaining to health and safety
requirements.
IV. Provisions of Proposed Part 494 Subpart B (Patient Safety)
A. Infection Control (Proposed Sec. 494.30)
[If you choose to comment on issues in this section please include the
caption ``Infection Control'' at the beginning of your comment.]
Patients with ESRD have impaired immunological systems and are more
at risk of developing serious infections than similarly situated non-
ESRD patients. During hemodialysis therapy, there is a potential for
patients to be exposed to a variety of microbial pathogens (including
blood-borne pathogens) if proper procedures are not meticulously
followed. Likewise, peritoneal dialysis patients are at risk of
contamination leading to peritonitis if proper procedures are not
followed. This proposed rule stipulates that the dialysis facility must
provide and monitor conditions to ensure a sanitary environment that
prevents the transmission of infectious agents.
The existing standards relating to infection control are contained
in Sec. 405.2140(b)(1) and (c). Section 405.2140(b)(1) requires
written procedures for controlling hepatitis and other infections. It
further specifies that the procedures include surveillance and
reporting of infections, housekeeping, handling of waste and
contaminants, and sterilization and disinfection. Section 405.2140(c)
requires the facility
[[Page 6192]]
to employ appropriate techniques to prevent cross-contamination between
the unit and adjacent hospital or public areas.
We believe infection control is vital to the health and safety of
dialysis patients and others; and therefore, we propose to establish
infection control as a separate condition for coverage (Sec. 494.30).
The proposed infection control requirement states that each dialysis
facility must provide and monitor a sanitary environment that prevents
and controls the transmission of infectious agents, within and between
the unit and any adjacent hospital, or other public areas. The proposed
requirement sets forth the basic guidelines or procedures that
facilities must follow to prevent and control infections.
Proposed Sec. 494.30(a)(1) requires that the facility demonstrate
that it follows standard infection control precautions, including the
``Recommended Infection Control Practices for Hemodialysis Units At a
Glance'' with the exception of screening for Hepatitis C as explained
below. The ``At a Glance'' section is in the publication,
``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients'' developed by the Centers for Disease
Control and Prevention (CDC) (DHHS/CDC, 20-21). We propose to
incorporate these guidelines to prevent and control cross contamination
and the spread of infectious agents. These CDC infection control
recommendations specific to the hemodialysis setting were developed in
consultation with other Federal agencies and specialists and are based
on available knowledge regarding transmission of infectious agents.
Recommended Infection Control Practices for Hemodialysis Units at a
Glance
Infection Control Precautions for All Patients
Wear disposable gloves when caring for the patient or
touching the patient's equipment at the dialysis station; remove gloves
and wash hands between each patient or station.
Items taken into the dialysis station should either be
disposed of, dedicated for use only on a single patient, or cleaned and
disinfected before taken to a common clean area or used on another
patient.
--Nondisposable items that cannot be cleaned and disinfected (e.g.,
adhesive tape, cloth covered blood pressure cuffs) should be dedicated
for use only on a single patient.
--Unused medications (including multiple dose vials containing
diluents) or supplies (syringes, alcohol swabs, etc.) taken to the
patient's station should be used only for that patient and should not
be returned to a common clean area or used on other patients.
When multiple dose medication vials are used (including
vials containing diluents), prepare individual patient doses in a clean
(centralized) area away from dialysis stations and deliver separately
to each patient. Do not carry multiple dose medication vials from
station to station.
Do not use common medication carts to deliver medications
to patients. Do not carry medication vials, syringes, alcohol swabs or
supplies in pockets. If trays are used to deliver medications to
individual patients, they must be cleaned between patients.
Clean areas should be clearly designated for the
preparation, handling and storage of medications and unused supplies
and equipment. Clean areas should be clearly separated from
contaminated areas where used supplies and equipment are handled. Do
not handle and store medications or clean supplies in the same or an
adjacent area to that where used equipment or blood samples are
handled.
Use external venous and arterial pressure transducer
filters/protectors for each patient treatment to prevent blood
contamination of the dialysis machines pressure monitors. Change
filters/protectors between each patient treatment, and do not reuse
them. Internal transducer filters do not need to be changed routinely
between patients.
Clean and disinfect the dialysis station (chairs, beds,
tables, machines, etc.) between patients.
--Give special attention to cleaning control panels on the dialysis
machines and other surfaces that are frequently touched and potentially
contaminated with patients' blood.
--Discard all fluid and clean and disinfect all surfaces and containers
associated with the prime waste (including buckets attached to the
machines).
For dialyzers and blood tubing that will be reprocessed,
cap dialyzer ports and clamp tubing. Place all used dialyzers and
tubing in leak-proof containers for transport from station to
reprocessing or disposal area.
Schedule for Routine Testing for Hepatitis B Virus (HBV) and Hepatitis C virus (HCV) Infections
----------------------------------------------------------------------------------------------------------------
Patient status On admission Monthly Semi-annual Annual
----------------------------------------------------------------------------------------------------------------
All patients HBsAg*, Anti-HBc (total)*
Anti-HBs*, Anti-HCV,
ALT[dagger]
----------------------------
HBV susceptible, including ........................... HBsAg
non-responders to vaccine
----------------------------
Anti-HBs positive(>10 mIU/ ........................... ................. ................. Anti-HBs
mL), anti-HBc negative
----------------------------
Anti-HBs and anti-HBc ........................... No additional HBV testing needed
positive
----------------------------
Anti-HCV negative ........................... ALT Anti-HCV
----------------------------------------------------------------------------------------------------------------
Hepatitis B Vaccination
Vaccinate all susceptible patients against hepatitis B.
Test for anti-HBs 1-2 months after last dose.
--If anti-HBs is < 10 mIU/mL, consider patient susceptible, revaccinate
with an additional three doses, and retest for anti-HBs.
--If anti-HBs is >10 mIU/mL, consider immune, and retest annually.
--Give booster dose of vaccine if anti-HBs declines to < 10 mIU/mL and
continue to retest annually.
Management of HBsAg-Positive Patients
Follow infection control practices for hemodialysis units
for all patients.
Dialyze HBsAg-positive patients in a separate room using
separate machines, equipment, instruments, and supplies.
[[Page 6193]]
Staff members caring for HBsAg-positive patients should
not care for HBV susceptible patients at the same time (e.g., during
the same shift or during patient change-over).
We are proposing an exception to the CDC recommendation for monthly
and semiannual screening for all hemodialysis patients for hepatitis C.
Patients with clinical indicators or risk factors for hepatitis C
should receive diagnostic testing as deemed necessary by the attending
physician. Medicare covers diagnostic testing for hepatitis C on a
case-by-case basis, but does not cover blanket hepatitis C screening at
this time. According to the CDC, transmission of hepatitis C can be
prevented by strict adherence to infection control precautions
recommended for all hemodialysis patients.
The ``At a Glance'' page highlights the crucial CDC recommendations
that serve as the minimum acceptable infection control practices. This
document reproduced above is currently available on the CDC Web site at
http: //http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm.
There is substantial evidence that the CDC guidelines work in
preventing the transmission of bloodborne infections. Recommendations
for the control of hepatitis B in hemodialysis centers were first
published in 1977 and within 3 years there was a sharp reduction in
incidence of hepatitis B infection among both patients and staff
members in hemodialysis centers (Alter, pp. 860-865).
The entire CDC RR05 report contains recommendations for infection
control precautions in greater detail than the ``At a Glance''
highlights. We considered proposing that the entire CDC RR05 document
be incorporated by reference. However, we want to be less prescriptive
and burdensome in our requirements while protecting patient safety.
Dialysis facilities are encouraged to utilize the more comprehensive
document when developing their infection control programs. For example,
the CDC infection control precautions for all patients identify
procedures for cleaning up a blood spill; and detail information on
glove use, protective gear, and handwashing. The CDC has issued
additional guidance regarding hand hygiene and environmental infection
control in the October 25, 2002 and June 6, 2003 issues of the
Morbidity and Mortality Weekly Report that dialysis facilities may want
to reference in their infection control policies (DHHS/CDC, pp.1-45 and
DHHS/CDC, pp. 1-44, respectively).
Existing Sec. 405.2140(b)(1) requires that written policies and
procedures must be in effect for preventing and controlling hepatitis
and other infections. There is no current requirement in the conditions
for coverage addressing patient isolation. However, many facilities
have adopted the 1977 CDC guidelines that recommend use of a separate
dialysis area, preferably a separate isolation room, for dialyzing
hepatitis B surface antigen positive patients. Newly opened
hemodialysis units would be required to have isolation rooms for
hepatitis B positive patients as described in the ``At a Glance''
section. For existing units in which a separate room is not possible,
there would be required to be a separate area removed from the
mainstream of activity that also allows for dedicated staff and
dedicated dialysis machines. When the facility determines that a
patient is infectious (from admission or at least annual testing) the
guidelines state that the facility would be required to isolate the
infected patient from susceptible patients to prevent the transmission
of the disease. We propose to require at Sec. 494.30(a)(2) that a
facility implement and maintain patient isolation procedures that
prevent and control the spread of infectious agents and communicable
diseases.
We also propose at Sec. 494.30(a)(3) that facilities implement
appropriate procedures for the handling, storage, and disposal of
waste, and for disinfection. Appropriate waste storage and disposal
procedures are important not only for the control of infections within
the units, but also for the welfare of the unit staff and the
community. Since local policies vary, we do not believe it is
appropriate to specify the minimum requirements for waste storage and
disposal. Rather, facilities should continue to operate in accordance
with applicable local laws and accepted public health procedures. We
also propose to require that facilities implement protocols for
cleaning and disinfection because we believe that adequate disinfection
of surfaces, medical devices, and equipment is an important part of a
facility's efforts to control and prevent cross-contamination. We
propose to add a requirement for the implementation and maintenance of
procedures regarding cleaning of surfaces and devices potentially
contaminated with blood to prevent patients from coming into contact
with a blood-borne pathogen. The CDC RR05 recommendations and dialysis
equipment manufacturers' instructions provide valuable information on
procedures a facility may adopt to meet this requirement.
We considered proposing to include the American Institute of
Architects (AIA) Guidelines for Design and Construction of Hospitals
and Health Care Facilities, which outline building requirements
pertinent to dialysis facilities. The AIA standards provide guidance to
facilities regarding unit design and parts of the guidance relate to
infection control. While we believe it is desirable for new units to
follow AIA standards, and many States have adopted these as minimum
standards, we recognize it may be overly burdensome to require existing
dialysis units to adhere to these standards.
We also considered including in the proposed rule the Healthcare
Infection Control Practices Advisory Committee's (HICPAC) guidelines
entitled ``Hand Hygiene in Healthcare Settings'' and ``Guideline for
Preventing Intravascular Device-Related Infections.'' We are inviting
comments on whether we should require new dialysis facilities to adhere
to AIA design standards or HICPAC guidelines.
We propose requirements for oversight of facility infection control
in Sec. 494.30(b). The facility must implement and monitor biohazard
and infection control policies and activities within the dialysis unit.
Any infection control policies adopted by the facility are only
effective when put into action. We propose that facilities must
designate a registered nurse as the infection control or safety officer
who maintains current infection control information, and reports to the
facility's chief executive officer or administrator and quality
improvement committee. The infection control nurse must maintain
current infection control information including the most current CDC
guidelines for the proper techniques in the use of vials and ampules
containing medication. For example, facilities should not pool vials of
any medications. An outbreak of serratia liquefacies from contamination
of erythropoietin at a hemodialysis center serves as a reminder of the
importance of the proper handling of medications in protecting the
dialysis patient. (Grohskopf, pp. 1491-1497.)
The infection control or safety officer is also responsible for
making recommendations regarding infection control training and
improvements. The designation of an infection control officer provides
a structure for infection control, encourages the maintenance of up-to-
date information, and increases accountability for infection control.
We propose to maintain the essence of the existing requirement for
surveillance and reporting of the incidence of
[[Page 6194]]
infection (Sec. 405.2140(b)(1)). The facility must analyze and
document the incidence of infections to identify trends and establish
baseline information on infection incidence as proposed in Sec.
494.30(c). By conducting a trend analysis of infections, the facility
will be able to identify opportunities for improvement to prevent or
eliminate the spread of infection or communicable disease between
patients. By tracking the number and types of infections, the facility
can identify areas that require improvement, indicate areas that have
improved, define measures to improve outcomes, review implementation of
improvement measures, and determine the success of the improvement
measures implemented.
In August 1999, the CDC initiated the CDC Dialysis Surveillance
Network (DSN), a voluntary national surveillance system monitoring
bloodstream and vascular infections by individual hemodialysis centers.
The purposes of the DSN are to provide a method for individual
hemodialysis centers to record and track rates of vascular access
infections, other bacterial infections, and intravenous antimicrobial
starts, and to provide rates for comparisons among various dialysis
centers. The infection control or safety officer should look toward the
CDC surveillance system as a resource. Information on the DSN may be
found on the following Web site: http://www.cdc.gov/ncidod/hip/Dialysis/dsn.htm
.
The existing standard governing infection control (Sec.
405.2140(b)(1)) contains a requirement governing reuse of dialyzers
which states that when dialysis supplies are reused, records are
maintained that can be used to determine whether established procedures
covering the rinsing, cleaning, disinfection, preparation, and storage
of reused items conform to the requirements for reuse. This standard is
redundant with the reuse requirements included in the AAMI guidelines
that are incorporated by reference in both the existing and proposed
regulations. Therefore, we are proposing to delete the requirement in
Sec. 405.2140(b).
Existing Sec. 405.2140(c) requires that written patient care
policies specify the functions of facility personnel and self-dialysis
patients with respect to contamination prevention. We are proposing to
delete the ``written policy'' requirement because it is process-
oriented and a paperwork burden.
As noted above, the existing conditions for coverage require
policies for surveillance and reporting of infections at Sec.
405.2140(b)(1). In this proposed rule, reporting requirements for
communicable diseases are listed at Sec. 494.30(d). The facility must
maintain a current list of the communicable diseases that must be
reported according to Federal, State, and local requirements, and have
a procedure for reporting these communicable diseases, which allows the
facility to accurately report incidences of communicable diseases.
These requirements are in concert with the present standard operating
practices in dialysis facilities.
B. Water Quality (Proposed Sec. 494.40)
[If you choose to comment on issues in this section please include the
caption ``Water Quality'' at the beginning of your comment.]
Water quality is of vital importance to a dialysis facility and to
the patient. Because we believe water quality is an essential health
and safety issue for ESRD patients, we are proposing a condition for
coverage for water quality in this proposed rule.
The hemodialysis patient's blood has the potential to be exposed to
toxic contaminants present in water. Some chemical contaminants are not
normally harmful when present in small amounts in usual physiological
fluids. However, since hemodialysis patients are exposed to the large
volume of water that is used to make dialysate, chemical contaminants
can be dangerous to them. If water supplies are biologically or
chemically contaminated, the patient may experience infection or other
adverse consequences. Limits on bacterial growth in water and dialysate
are necessary to prevent high bacterial counts associated with
pyrogenic reactions (fevers, chills, nausea).
The patient's exposure to contaminated water can be through water
mixed with dialysate, water mixed with reprocessing germicides, or
water used to flush out dialyzers. Contamination of the water system
with organic and inorganic chemicals, bacteria, and endotoxins can
result in adverse patient reactions, such as hemolysis, bacteremia,
pyrogenic reactions, or death. Exposure to some contaminants such as
aluminum can cause chronic health problems, while exposure to other
contaminants such as fluoride can be fatal. Therefore, a dialysis
facility must monitor the quality of the water used in treatments, as
well as monitor the equipment used in water treatment.
In the September 18, 1995 Federal Register (60 FR 48039), we
published a final rule that incorporated by reference the 1992 AAMI
standard for water quality and the AAMI recommended guidelines for
monitoring purity of water as published in the ``Hemodialysis
Systems,'' ANSI/AAMI RD5: 1992, sections 3.2.1, 3.2.2, and Appendix B,
sections B1-B5 (American National Standards Institute 1992). Each AAMI
standard or recommended practice reflects the collective expertise of a
committee of health care professionals and industrial representatives,
whose work has been reviewed nationally. AAMI standards and guidelines
undergo a regular 5-year review process that allows updates and
revisions. These consensus recommendations are intended to help ensure
patient safety.
The AAMI guidelines referenced in the existing conditions for
coverage have been replaced by more recent AAMI guidelines, and
therefore, we are proposing to incorporate new AAMI references. The
ANSI/AAMI RD5: 1992 document has been replaced by ``Concentrates for
Hemodialysis'' ANSI/AAMI RD61: 2000, ``Water Treatment Equipment for
Hemodialysis Applications'' ANSI/AAMI RD62: 2001, and ``Dialysate for
Hemodialysis'' ANSI/AAMI RD 52:2004. These publications update the
information on monitoring of water quality currently incorporated by
reference in Sec. 405.2140(a)(5) and provide additional recommended
practices.
We are proposing to incorporate by reference the following revised
AAMI water quality standards, published in ``Water Treatment Equipment
for Hemodialysis Applications,'' 4.2.1 and 5.2.1, Water Bacteriology;
4.2.2 and 5.2.2, Maximum Level of Chemical Contaminants; and 4.3, Water
Treatment Equipment requirements (American National Standards
Institute, 2001). The updated water purity standards, section 4.2.1,
now include bacteria and endotoxin action levels that identify the
concentration at which steps (such as system disinfection and
retesting) should be taken to reduce the levels to an acceptable range.
Facilities must take corrective action when these action levels are met
or exceeded.
The AAMI list of contaminants for which water must be tested has
been expanded to include antimony, beryllium, and thallium. These
chemicals were added based on changes in the United States
Environmental Protection Agency Safe Drinking Water Act 1996 (Pub. L.
104-182). AAMI's rationale for testing water for these contaminants may
be found in the appendix of the ANSI/AAMI RD62: 2001 document at
A.4.2.2 (American National Standards Institute, 2001).
We have also included the updated AAMI requirements for water
treatment equipment. This inclusion provides clarity by defining the
minimum
[[Page 6195]]
standards for water treatment equipment needed to protect patient
safety. Proper hemodialysis is dependent on the quality of the
dialysate. A water system consisting of the proper components and
maintained in accordance with the manufacturers' instructions, can be
expected to produce dialysate that meets the AAMI standards and
produces acceptable patient outcomes. The minimum safety requirements
are specified in the AAMI standards referenced in proposed Sec.
494.40(a)(1)(iii) for each component of the water treatment system
(that is, deionization, reverse osmosis, monitors, sediment filters,
carbon absorption media, automatically regenerated water softeners,
storage tanks, piping systems; and when used, ultrafilters, ultraviolet
irradiators, hot water disinfection systems, ozone disinfection
systems, and tempering valves). A water treatment system consisting of
the proper equipment components as identified by AAMI (and the Food and
Drug Administration (FDA)) is standard practice in dialysis facilities.
We are proposing state of the art water purity monitoring
guidelines outlined in ANSI/AAMI RD52: 2004 ``Dialysate for
Hemodialyzers'' section 7.2.1 document. Proposed Sec. 494.40(a)(2)
incorporates by reference the section that specifies the frequency of
water purity testing to insure meeting the AAMI limits specified in
Sec. 494.40(a)(1)(i) and (ii) as follows:
Bacteria and bacterial endotoxin levels of water must be
measured--
++ In established systems at least monthly;
++ In newly-installed systems at least weekly until an established
pattern of compliance can be demonstrated.
At least monthly in samples drawn from--
++ The first and last outlets of the water distribution loop;
++ Where water enters the dialyzer reprocessing equipment;
++ Outlet of the water storage tanks, if used;
++ Concentrate or from the bicarbonate concentrate mixing tank.
Bacteria levels must be measured at least monthly from a
sample of two or more dialysis machines, this sampling must ensure that
all machines are tested at least once a year.
Chemical analysis of water purity must be done at least
once a year and when--
++ The system is installed;
++ Membranes are replaced if using a reverse osmosis system;
++ Seasonal variations in source water suggest worsening water
quality; and
++ Reverse osmosis rejection rates, which are monitored daily using
continuous-reading monitors that measure product water conductivity,
fall below 90 percent.
Ultrapure dialysate has received attention in the clinical
literature and the working draft AAMI standards ``Dialysate for
Hemodialysis'' RD52 contains guidelines pertaining to ultrapure
dialysate. We are not proposing a requirement for ultrapure dialysate
at this time but we do invite comment on this topic. We also welcome
comment on the requirements for the frequency of water purity testing.
In addition, we are proposing further evidence-based requirements
consistent with AAMI guidelines within the proposed water quality
condition. The existing conditions for coverage do not address
requirements for the water treatment equipment, although the
interpretive guidelines for Sec. 405.2140(a)(5)(ii) do advise that
water treatment systems must include a carbon tank and either a reverse
osmosis or deionization system (DHHS/CMS, 1995). We are proposing that
the water treatment system must include a reverse osmosis or
deionization component that conforms to the referenced water treatment
equipment for hemodialysis applications AAMI guidelines 4.3.5 and
4.3.6. This is in keeping with current standards of practice, which are
widely adhered to by dialysis facilities. The reverse osmosis process
serves to remove dissolved salts, bacteria, viruses, pyrogens, and
organic molecules. Deionization serves to remove ions. A reverse
osmosis system along with pretreatment is used in the vast majority of
all dialysis centers and this requirement should not present an
additional burden to hemodialysis centers.
A consequence of patient exposure to high levels of chloramine via
dialysis is hemolytic anemia, which may be life-threatening. The 1992
AAMI guidelines specified at least once daily testing of purified water
for chlorine/chloramine levels. It is now widely recognized that
testing before each shift of hemodialysis sessions, which is the
current standard in many dialysis units, provides greater patient
safety. Therefore, we are proposing at Sec. 494.40(c)(2) to require
chlorine/chloramine testing of water samples that must be taken from
the exit port of the initial chlorine/chloramine removal component (or
carbon tank) prior to each patient shift or every 4 hours, whichever is
shorter, during operation of the water system, unless the facility
ensures on a daily basis that the source water is chlorine/chloramine
free by way of testing. In addition, proposed Sec. 494.40(c)(2)(i)
would require subsequent testing from the backup component (or second
carbon tank) if the test shows greater than 0.50 parts per million
(ppm) for free chlorine or 0.10 ppm for chloramine. Due to the dangers
of chlorine/chloramine exposure, each water purification system must
provide for the adequate removal of chlorine/chloramine and this is
standard operating practice in hemodialysis facilities. In conformity
with the referenced AAMI guidelines at 4.3.9, carbon tanks used for the
removal of chlorine/chloramine must contain granulated activated carbon
and provide adequate empty bed contact time to be effective. A backup
component or second carbon tank must be in place for failure of the
first line component for chlorine/chloramine removal (or first carbon
tank), in order to protect patients during a hemodialysis session.
Dialysis facilities would be required to follow the applicable FDA
recommendations in ``Guidance for the Content of Premarket
Notifications for Water Purification Components and Systems for
Hemodialysis'' that 2 carbon tanks be installed in series with empty
bed contact time of 10 minutes (DHHS/FDA, 1997). The second carbon tank
provides the backup safety measure. Some dialysis facilities have three
or four carbon tanks that provide even more assurance there will not be
chloramine breakthrough. We invite comment as to whether our proposed
conditions for coverage that include expanded water equipment
requirements are still too minimal. In addition, we are requesting
comments on whether the current AAMI guidance regarding carbon tanks is
adequate to address all potential health and safety problems associated
with chlorine, chloramines, and unannounced variations in source water.
Specifically, we seek comments regarding where there is sufficient
evidence to require Medicare-participating dialysis facilities to
maintain at least two carbon tanks (that is, primary and backup) as
part of their water treatment system, regardless of the current
composition of its source water.
We are proposing in Sec. 494.40(e) to require active surveillance
of hemodialysis patient reactions during and following dialysis,
particularly when there are adverse reactions that might be associated
with a problem with the water purification system. The facility must
take steps to protect patient safety and obtain the appropriate blood
and dialysate cultures. Evaluation of the water purification system
must be undertaken as well as any necessary corrective action (Sec.
494.40(d)).
[[Page 6196]]
If chlorine/chloramine levels in treated water from the last backup
component (or carbon tank) are above the AAMI standards as required in
proposed Sec. 494.40(a)(1)(ii), dialysis treatments must be
immediately stopped to protect patients from exposure to chlorine/
chloramine as proposed in Sec. 494.40(c)(2)(ii). The medical director,
who is ultimately responsible for water quality, must be notified
immediately and corrective action taken. A corrective action plan is
also required (see Sec. 494.40(d)) whenever any of the water purity
action levels or standards, including but not limited to, chemical,
microbial, and endotoxin, are detected.
We propose to add a requirement, consistent with in the AAMI
document RD52:2004, that specifies that once mixed, bicarbonate
concentrate must be used within the time specified by the manufacturer
of the concentrate and may not be mixed with fresh concentrate. The
holding of the bicarbonate concentrate presents the risk of bacterial
growth and should be avoided.
We considered addressing water quality for home dialysis patients
in this condition, but we decided instead to include a requirement that
the facility monitor water used by its home dialysis patients to ensure
that the water meets the AAMI standards under the proposed ``care at
home'' condition for coverage (Sec. 494.100). Addressing all home
dialysis issues under a single condition simplifies the organization of
the regulations and eliminates the need for readers to refer to
separate sections for the requirements for home dialysis services.
C. Reuse of Hemodialyzers and Bloodlines (Proposed Sec. 494.50)
Section 1881(f)(7) of the Act requires the Secretary to establish
protocols for reuse of hemodialyzers for those facilities that
voluntarily elect to reuse the filters. The Act further states that
dialysis facilities that fail to follow the reuse protocol will be
subject to denial of participation in the Medicare program and denial
of payment for dialysis treatment not furnished in compliance with the
reuse protocol.
In hemodialysis the patient's blood is cleansed of impurities when
it passes through the filter (hemodialyzer) of a hemodialysis machine.
There are various techniques that allow some of these filters to be
reused under certain conditions. Reuse involves cleaning, disinfecting,
and preparing such hemodialysis devices for subsequent use for the same
patient. Although the potential exists for adverse patient outcomes
from reuse, reprocessing and reuse of dialyzers are safe when proper
techniques are utilized.
The existing regulation at Sec. 405.2150 requires ESRD facilities
reusing hemodialyzers to meet the guidelines and standards adopted by
AAMI and issued in July 1993, as ``Reuse of Hemodialyzers'' (American
National Standards Institute, 1993). We are proposing to retain this
requirement in the proposed rule but to incorporate by reference the
newly revised version and associated amendment (ANSI/AAMI RD47: 2002
and ANSI/AAMI RD47: 2002/A1: 2003) which replaces the 1993 version.
This document received final AAMI approval on November 7, 2002.
Some in the renal community believe that we should not incorporate
the CDC guideline that prohibits reuse for hepatitis B patients. They
believe there is no documentation that reuse contributes to the spread
of hepatitis or that it negatively affects the patient with hepatitis.
In addition, they indicated that this prohibition is costly to
facilities because a new dialyzer must be used for each session.
Hepatitis B is a highly contagious and potentially damaging
illness, especially for a dialysis patient. Thus, the CDC has for many
years recommended extreme caution and isolation for those patients who
are Hepatitis B positive. Many physicians, nurses and other
professionals involved in the dialysis field have similarly supported
the position of extreme caution in treating the hepatitis B positive
patient. The 2001 CDC guidelines advise against the reprocessing of
dialyzers used for patients who have Hepatitis B because of the risk to
facility staff. The hepatitis virus is relatively stable in the
environment and has been shown to remain viable for several days on
surfaces (via blood spills). While there may be no appreciable evidence
to demonstrate that reuse would increase the spread of hepatitis B,
there is not conclusive evidence that reuse in this population is safe.
At this time we propose to maintain the CDC guidelines prohibiting
reuse for hepatitis B patients to minimize the incidence of this mode
of transmission.
We are also proposing at Sec. 494.50(b)(2) that the hemodialyzer
manufacturer recommendations be followed, or if an alternate method for
reprocessing hemodialyzers is used, that the facility have documented
evidence that the method is safe and effective. According to FDA
guidance, hemodialyzer labeling should reflect the clinical use of a
hemodialyzer, and whether it is intended for single or multiple usage
(DHHS/FDA, 1995). Only hemodialyzers and bloodlines labeled for
multiple use may be reused. In addition, manufacturers of reusable
hemodialyzers are required to provide adequate instructions for safe
and effective reuse in accordance with 21 CFR 801.5. If the facility
chooses to use an alternate method for reprocessing hemodialyzers there
must be sufficient scientific evidence that the method is safe and
effective. This flexibility is provided to allow for the use of newer
and improved technologies that are proven safe in scientific studies
which may become available in the future. The FDA approved label
recommendations for the proper use of the device must be adhered to by
dialysis facilities.
Existing Sec. 405.2150(a)(2) states that to prevent any risk of
dialyzer membrane leaks due to the combined action of different
chemical germicides, dialyzers are exposed to only one chemical
germicide during the reprocessing procedure. We have received informal
suggestions that we alter the current language because many facilities
use bleach as part of the reuse process to flush and clean blood
deposits before the actual germicide soaking process is initiated.
However, for purposes of reuse, we consider bleach to be a cleansing
agent, not a germicide. The requirement to discard dialyzers treated
with a different germicide does not apply to bleaching. Nonetheless,
since the language appears to be confusing to some, we are proposing to
clarify the provision in proposed Sec. 494.50(b)(3) by inserting the
phrase ``other than bleach.''
Some in the renal community and on the AAMI RD47 workgroup stated
that discarding dialyzers exposed to a second germicide was expensive
and unnecessary if air pressure leak test results indicated the
dialyzer was still effective. However, we are proposing to retain the
requirement in existing Sec. 405.2150 that if a dialyzer is exposed to
a second germicide it must be discarded because we are concerned that
exposure to different germicides may cause membrane leaks. While we
recognize that it may be considered wasteful by some to discard
dialyzers with test values that indicate they are still effective, we
believe this is a necessary safety measure. We do not have sufficient
evidence that clearly supports the safety of using multiple germicides
on hemodialyzers. We welcome comment on the issue of multiple germicide
use in reused hemodialyzers.
Existing Sec. 405.2150(a)(3) requires that facilities take
appropriate blood cultures at the time a patient has a febrile response
and discontinue reuse of
[[Page 6197]]
hemodialyzers in the case of pyrogenic reactions, bacteremia, or
unexplained reactions possibly associated with ineffective
reprocessing, until the entire reprocessing system is evaluated. We
have been advised that a single febrile response in one patient can be
the consequence of many different etiologies not related to reuse,
including an infected access, a current infection, or contamination of
the water purification system. Members of the renal community suggested
that a febrile reaction in a single patient is rarely attributed to
dialyzer reuse. Facilities do not believe it is necessary to terminate
reuse or order blood cultures when a febrile reaction occurs in only a
single patient. It was suggested that a facility need only respond
through aggressive evaluation of its water purification system,
dialysis concentrates, and reuse system when the surveillance of
febrile events reveals a cluster of febrile patients. Based on this
evaluation, the facility can make an appropriate clinical decision
concerning termination of reuse. As a result, we are proposing in Sec.
494.50(c) to revise the regulations to state that a facility need only
obtain blood and dialysate cultures and evaluate its reprocessing and
water purification systems in response to an adverse reaction when
clinically indicated. If the evaluation indicates that the facility
should discontinue reuse, we expect facilities to have established
contingency plans, suspend the reuse of hemodialyzers until the problem
has been corrected, and report the adverse outcomes to the FDA and
other agencies as required by Federal, State or local laws and
regulations.
Existing Sec. 405.2150(c) lists 4 requirements applicable to a
facility that reuses bloodlines. Facilities must: (1) Limit the reuse
of bloodlines to the same patient; (2) not reuse bloodlines labeled for
``single use only''; (3) reuse only bloodlines for which the
manufacturer's protocol for reuse has been accepted by the FDA in
accordance with the premarket notification (see section 510(k) of the
Food, Drug, and Cosmetic Act and 21 CFR 876.5860 of the regulations);
and (4) follow the FDA-accepted manufacturer's protocol for reuse of
that bloodline. We propose to maintain the first requirement to limit
the reuse of bloodlines to the same patient because the risk of
transmitting blood-borne pathogens is so high, and reusing for the same
patient limits the risk of cross-contamination. We also propose to
maintain the third and fourth requirements, that is, a facility may
reuse only bloodlines for which the manufacturer's protocol for reuse
has been accepted by the FDA; and that the facility must follow the
FDA-accepted manufacturer's protocol for reuse of the bloodline. With
these requirements, the facility must follow any specific instructions
listed by the FDA, as well as any guidelines by the manufacturer that
may not be discussed in the FDA regulations. We are proposing to delete
the second existing requirement that facilities not reuse bloodlines
labeled for ``single use only'' because it is redundant with the
existing third and fourth requirements. Since the FDA would not
recommend reuse on bloodlines labeled ``single use only,'' there is no
need to maintain the requirement.
D. Physical Environment (Proposed Sec. 494.60)
[If you choose to comment on issues in this section please include the
caption ``Physical Environment'' at the beginning of your comment.]
The existing physical environment condition (Sec. 405.2140)
stipulates that the physical environment in which dialysis services are
furnished afford a functional, sanitary, safe, and comfortable setting
for patients, staff, and the public. The existing regulation consists
of four separate standards concerning building and equipment, favorable
environment for patients, contamination prevention, and emergency
preparedness. We propose to refine the physical environment section to
include only those elements that relate directly to the physical
surroundings of the dialysis facility and to relocate the remaining
elements to other sections in the proposed rule that relate more
closely to those subject areas.
The existing building and equipment requirements in Sec.
405.2140(a), include fire safety procedures, equipment maintenance,
facility maintenance, and water treatment. Based on the experience and
suggestions of our surveyors, we propose to establish separate
standards for the building itself in proposed Sec. 494.60(a) and
equipment in proposed Sec. 494.60(b). We propose to maintain the
existing requirement (described in Sec. 405.2140(a)) that the building
in which dialysis services are furnished be constructed and maintained
to ensure the safety of patients, the staff, and the public. The
dialysis facility should be free from hazards that may bring harm to
the patients, the staff, and the public.
The existing language of Sec. 405.2140(a)(2) stipulates that all
electrical and other equipment used in the facility be maintained free
of defects that could present a potential hazard to patients or
personnel and that there is a planned program of preventive maintenance
of equipment used in dialysis and related procedures in the facility.
We propose at Sec. 494.60(b) to maintain the essence of this
requirement but to clarify that all equipment is maintained in
accordance with the manufacturer's recommendations. Based on their
experience with the equipment, we believe manufacturers have the most
knowledge about routine maintenance and recommended repair.
Existing Sec. 405.2140(b) requires each facility to maintain a
favorable environment for patients; and the facility must be maintained
and equipped to provide a functional, sanitary, and comfortable
environment with an adequate amount of well-lighted space for the
services provided. The existing language in this standard combines
several different concepts, including sanitary environment and
infection control, and we propose to address each subject in separate
sections of the regulation. As a result, we are proposing at Sec.
494.60(c) to include only those standards regarding the safety and
comfort of each patient.
Since the proposed conditions are outcome-oriented, we believe that
we do not need to specify all the process requirements that a facility
must meet to provide a dialysis environment in which the patient can
receive quality care. Each facility can develop its own strategies and
techniques as long as the space for treating each patient is sufficient
to provide needed care and services, prevent cross-contamination, and
accommodate medically needed emergency equipment and staff. Existing
Sec. 405.2140(b) also requires the facility to provide a well-lit
space. We propose to delete this requirement because it is too
subjective to be meaningful, and we believe this detail is better left
to the judgment of the facility staff.
We expect the dialysis facility to provide patients with a
comfortable environment. Existing Sec. 405.2140(b)(4) requires that
heating and ventilation systems be capable of maintaining adequate and
comfortable temperatures. We recognize that not all patients are
comfortable at the same temperature; and therefore, proposed Sec.
494.60(c)(2) specifies that the facility maintain a temperature that is
comfortable for the majority of patients. The dialysis facility must
make reasonable accommodations for patients who are not comfortable at
the temperature setting determined by the majority of patients. The
facility has the option of allowing patients to bring a blanket to
dialysis or providing freshly laundered blankets to the patients.
Infection control procedures must be
[[Page 6198]]
adhered to in either case. Often patients need a warm environment
because of lowered body temperature during the dialysis process, and
therefore, facilities should look to patients rather than staff to
ascertain comfortable building temperatures.
In the emergency preparedness standard (proposed Sec. 494.60(d)),
we have proposed requirements that we believe are fundamental for a
dialysis facility to prepare effectively for emergency situations.
These requirements include: (1) Procedures for medical and non-medical
emergencies; (2) staff and patient training; (3) facility emergency
equipment; and (4) periodic evaluation of emergency plans. Existing
Sec. 405.2140(d) requires the facility to have written policies and
procedures that specifically define the handling of emergencies that
may threaten the health and safety of patients. The existing
regulations also stipulate that facility staff should be trained for
any emergency or disaster, as part of their employment orientation.
We propose to clarify at Sec. 494.60(d) that each dialysis
facility must implement emergency preparedness procedures to manage
potential medical and nonmedical emergencies that are likely to
threaten the health or safety of facility patients, the staff, and the
public. These emergencies include, but are not limited to, fire,
equipment or power failures, care-related emergencies, water supply
interruption, and natural disasters likely to occur in the facility's
geographic area. The facility will need to identify which hazards are
most likely to effect their facility, evaluate how to minimize risks,
and plan how to best protect patients in the event of an emergency,
using an emergency management approach. We do not expect individual
facilities to develop emergency plans for natural disasters that
typically do not affect their geographic location. For example,
facilities located in the Southeast would not typically need to develop
emergency procedures for earthquakes. Facilities located in the central
plains States, on the other hand, would need to be prepared for
tornadoes. All facilities must plan for fire, care related emergencies,
equipment and power failures, and interruption of the water supply,
because these emergencies may occur regardless of a facility's
geographic location.
In addition to having emergency procedures, a facility will need to
plan ahead so that necessary information and tools are available to
staff and patients. For example, a facility would need to have current
patient telephone numbers, addresses, and transportation information
available before an emergency happens rather then scrambling to update
this kind of information during an emergency. As a resource in their
movement toward an emergency management approach, dialysis facilities
may want to use the ESRD facility emergency preparedness guidelines
available from the ESRD Networks.
We propose to maintain the existing requirement that a facility
train each staff member on the actions required for different medical
and nonmedical emergencies. The existing conditions for coverage
require that emergency preparedness procedures be reviewed and tested
at least annually and revised as necessary. Also, all personnel must be
knowledgeable and trained in their respective roles in emergency
situations. We are proposing that staff training must be evaluated at
least annually and that staff must demonstrate knowledge of emergency
procedures. This requirement is designed to ensure the safety and
security of both the patients and the staff. We propose also to require
that the facility provide periodic training to patients and staff.
Patients routinely treated in dialysis units are at risk for medical
emergencies. As a result, standard medical practice dictates that the
facility must have trained personnel, drugs, and emergency equipment
available to adequately support patients until an Emergency Medical
System (EMS) unit responds to the facility.
We are proposing at Sec. 494.60(d)(1)(ii) that staff must maintain
current cardiopulmonary resuscitation (CPR) certification. This is the
standard practice in United States dialysis facilities. We have not
prescribed the type or number of staff who must maintain CPR
certification but at a minimum, the patient care staff must maintain
current CPR certification. In this instance, patient care staff are
staff who routinely provide direct medical care to patients in the
dialysis unit.
We would maintain the standard in the existing regulation (Sec.
405.2140(d)(5)) that the facility provides appropriate training to
patients, so that they know the facility's emergency procedures, since
they may need to take steps to protect themselves during an emergency.
Dialysis patients need to be informed on what to do, where to go, whom
to contact from home, and how to disconnect themselves from dialysis
equipment if an emergency occurs.
The existing text in Sec. 405.2140(d)(3) requires that the
facility have available at all times on the premises a fully equipped
emergency tray, including emergency drugs, medical supplies, and
equipment. We propose to maintain this requirement, but we want to
eliminate the confusion regarding the meaning of ``fully equipped.'' We
propose to define the minimum emergency equipment that must be on the
premises and immediately available as ``oxygen, airways, suction,
artificial resuscitator ventilation bag, defibrillator, and emergency
drugs.'' We propose to specifically require defibrillators. Automated
external defibrillators (AEDs), in particular, have been shown to save
lives in a variety of settings, most notably aboard airlines and in
airports. One Seattle study (Arch Intern Med. 2001;161:1509-1512
available at http://www.ARCHINTERNMED.com) identified dialysis centers
as having a relatively high incidence of cardiac arrest (>= 0.746 per
practice annually). In the 9 dialysis facilities studied there were 47
cardiac arrests over a 7-year period. Approximately 56 percent, or 26
patients, had ventricular fibrillation and may have benefited from use
of an AED. The authors of this study presented their findings to the
nine dialysis centers and all nine agreed to equip their centers with
AEDs and to train their staff in the use of AEDs.
The key to saving a life is getting the defibrillator on the
patient as soon as possible. The AED allows dialysis facility staff to
defibrillate a patient without requiring the immediate presence of a
physician. According to the American College of Emergency Physicians
(http://www.acep.org/1,2891,0.html), when a person suffers a sudden cardiac
arrest, the chance of survival decreases by 7 to 10 percent for each
minute that passes without defibrillation. The very real potential for
saved lives supports the financial investment in an AED. The cost of an
AED is approximately $2,000 to $3,000. Some units have already
voluntarily purchased AEDs. Very small units (for example, units with
two hemodialysis stations) may find the purchase of an AED to be a
heavy financial burden. We are soliciting comments on whether small,
predominantly rural dialysis facilities should receive special
consideration and possibly an exemption from the defibrillator
requirement. We propose that the dialysis nursing staff must be trained
on the proper use of emergency equipment and emergency drugs. Staff
could be trained on the use of an AED in conjunction with the CPR
training. Having the right equipment at the time of an emergency is
only useful when staff is well versed in how to effectively use it. In
addition, the facility must have
[[Page 6199]]
a plan to obtain EMS assistance when needed.
We are proposing to require a defibrillator without specifying an
AED due to the fact that some dialysis units already have access to a
defibrillator. Hospital-based dialysis units, in particular, may have
immediate physician availability built into the hospital-wide cardiac
resuscitation plan. This reduces the financial burden of the proposed
defibrillator requirement.
We are proposing to maintain the requirement that facilities
conduct reviews of their emergency and disaster plans to ensure that
facilities appropriately respond to the situations and needs that may
arise from a variety of emergencies, medical and nonmedical. We are
proposing in Sec. 494.60(d)(3)(ii) that facilities review their
emergency and disaster plans at least annually. Drill and emergency
episodes often reveal a weakness or flaw in the design of the emergency
plan. An annual update will allow such flaws or potential problems to
be identified and corrected.
Existing Sec. 405.2140(b)(3) specifies that the facility have a
nursing/monitoring station from which adequate surveillance of patients
receiving dialysis services can be made. We propose to delete this
requirement because we believe this is not a physical environment
issue. It is important that patients are appropriately monitored during
the dialysis session. However, monitoring is most effectively done
through interaction between the patients and the staff in the dialysis
area and not from a monitoring station.
We believe that existing Sec. 405.2140(b)(5) is another process-
oriented requirement, and we propose to delete this requirement. This
requirement states that facilities using central batch processing must
make arrangements to meet the needs of patients with special dialysis
solutions. The Patient plan of care condition, proposed Sec. 494.90,
would require the dialysis facility to implement the care plan and make
arrangements to meet the individual requirements of each patient
regardless of whether those needs are related to special dialysis
solutions or other medically necessary supplies or equipment.
The existing emergency preparedness standard (Sec. 405.2140(d))
enumerates the facility physical emergency management procedures but
provides minimal standards for the procedures that must be followed
during a fire. We propose to strengthen the section governing fire
safety to provide greater detail regarding the appropriate procedures
that must be followed.
We are proposing at Sec. 494.60(e) to adopt the 2000 edition of
the National Fire Protection Association's (NFPA) Life Safety Code
(LSC). The LSC is a compilation of fire safety requirements for new and
existing buildings and is updated and published every 3 years by the
NPFA, a private, non-profit organization dedicated to reducing loss of
life due to fire.
The Medicare and Medicaid conditions of participation have
historically incorporated by reference these requirements along with
Secretarial waiver authority. The statutory basis for incorporating
NFPA's LSC for ESRD facilities falls under the Secretary's general
rulemaking authority.
The 2000 edition of the LSC is divided into several occupancy
chapters including a business chapter, educational chapters, ambulatory
health care occupancy chapters, and health care occupancy chapters. The
business occupancy chapter pertains to clinics and offices. The
educational occupancy chapters pertain to schools and day care centers.
The health care occupancy chapters pertain to inpatient health care
facilities (for example, hospitals, nursing homes). Finally, the
ambulatory health care occupancy chapters pertain to facilities that
provide outpatient medical treatment that may render the patient
temporarily incapable of self-preservation (for example, critical
access hospitals, dialysis centers).
The NFPA LSC Handbook specifically designates Chapter 20 and
Chapter 21 for outpatient dialysis services. We propose to adopt, as
recommended by the NFPA LSC, Chapter 20 (that is, new ambulatory health
care occupancy buildings) and Chapter 21 (that is, existing ambulatory
health care occupancy buildings) of the 2000 edition of the LSC for all
outpatient dialysis facilities regardless of size.
The LSC classifies dialysis facilities as ambulatory health care
occupancies because the treatment is not a routine medical visit to a
doctor's office but rather a procedure that may hinder the patient from
self-preservation in the event of an emergency or fire. Incapability of
self-preservation might be the result of the use of general anesthesia
or a treatment such as dialysis. Dialysis patients are not as mobile as
a person working or visiting an office building or health clinic but
more mobile than patients being treated in an inpatient health care
facility, such as a hospital or nursing home. Chapters 20 and 21 give a
level of safety from fire that is greater than the typical business
occupancy but less than a health care occupancy such as a hospital or
nursing home.
Under our proposal, an outpatient dialysis facility would comply
with the business occupancy provisions in Chapters 38 (that is, the new
business occupancies) and 39 (that is, existing business occupancies)
with the additional provisions contained within Chapters 20 and 21.
Where there may be a conflict between the business occupancy chapter
and the ambulatory health care occupancy chapter, the more stringent
requirements would apply (LSC sections 20.1.1.1.2 and 21.1.1.1.2). The
requirements of Chapters 20 and 21 are described below.
Chapter 20.1.2.1 and Chapter 21.1.2.1 require 1-hour fire
separation between different occupancies or tenants in a multi-tenant
building. We believe most dialysis facilities currently meet this
requirement because most State building codes already require this
provision.
Chapters 20.2.4 and 21.2.4 require that there be at least two
emergency exits. Emergency lighting is required by Chapters 20.2.9.1
and 21.2.9.1 to ensure that the center is lighted and that egress paths
are illuminated to allow movement during an emergency.
Chapters 20.2.9.2 and 21.2.9.2 require an essential electrical
system. This provision does not apply to dialysis facilities because
dialysis equipment is not life-support equipment under the Life Safety
Code.
Chapters 20.3.4.4 and 21.3.4.4 require the fire alarm system to
provide automatic notification of a fire to emergency forces. This is
of great importance for the protection of patients. Any delay in the
notification of fire and rescue personnel could adversely impact the
health and safety of patients and expose them to a fire, smoke, or
toxic gases created by the fire.
Chapters 20.3.7 and 21.3.7 pertain to smoke compartmentation,
otherwise known as subdivision of building space. Section 3.7 of
Chapters 20 and 21 apply to any dialysis facility that is larger than
5,000 square feet (or 10,000 square feet for facilities with
sprinklers). We believe most dialysis facilities will fall within the
exceptions outlined in this provision. If a dialysis facility is
smaller that 5,000 square feet and protected by an approved, supervised
sprinkler system, then section 3.7 of Chapters 20 and 21 do not apply.
Section 7 of Chapters 20 and 21 specify procedures to assist
outpatient dialysis facilities in providing fire safety. Section 7.1 of
Chapters 20 and 21 propose evacuation plans and fire exit drills and
require staff to practice the
[[Page 6200]]
procedures outlined in the dialysis facilities written emergency plans.
Section 7.1 of Chapters 20 and 21 are appropriate for outpatient
dialysis facilities because there is a possibility a dialysis patient
could lose blood or suffer unnecessary risks if the patient were
removed from the dialysis machine during a fire drill. We believe that
requiring a dialysis facility to stop dialysis treatment and evacuate
all dialysis patients during a fire drill is an unnecessary procedure
that could jeopardize the dialysis patient's health and safety. Annex
A, Explanatory Material to the 2000 NFPA LSC provides guidance for
conducting fire drills when it is inexpedient and impractical to move
patients during a fire drill. Many health care occupancies conduct fire
drills by choosing the location of the simulated emergency in advance;
practicing the movement of simulated patients or empty wheelchairs to
adjacent safe areas, and ensuring that staff have the efficiency,
knowledge, and response capability to implement the facility's fire
emergency plan. Surveyors may determine whether this standard was met
by checking a dialysis facility's records and interviewing staff to
verify that the emergency and fire drills were conducted not less than
once in each 3-month period and that staff are very familiar with the
procedures.
Section 7.1.1 in Chapters 20 and 21 also require that the dialysis
facility prominently post its emergency plan. We expect the plan to
include continuity of essential building operations in the event of an
emergency. Electrical, water, fire protection, ventilation, and
communications systems are some, but not all, areas a dialysis facility
should consider in its disaster plan. A good reference, but not a
requirement for developing an emergency plan for a dialysis facility,
is the NFPA 99--Standard for Health Care Facilities, Chapter 11, Health
Care Emergency Preparedness (NFPA, November 2001). Our intent in
proposing the posting requirement is to ensure patients, staff and the
public have the proper information to quickly evacuate in the event of
an emergency.
The remaining provisions in section 7 of Chapters 20 and 21 include
requirements for the procedures in case of fire (20.7.2 and 21.7.2);
maintenance of exits (20.7.3 and 21.7.3); smoking regulations (20.7.4
and 21.7.4); furnishings, beddings, decorations (20.7.5 and 21.7.5);
maintenance and testing of life safety-related equipment (20.7.6 and
21.7.6); portable space heating devices (20.7.7 and 21.7.7); and
construction, repair and improvement operation (20.7.9 and 21.7.9).
We recognize that for some dialysis facilities it would be
extremely burdensome to adhere strictly to all of the LSC requirements.
For example, older dialysis facilities or facilities leasing space in
an office building may not be able to add sprinkler systems. We are
proposing to retain our existing authority to waive specific provisions
of the LSC on a case-by-case basis, further reducing the exposure to
additional cost and burden for facilities with unique situations that
can justify the application of waivers which we determine will not
endanger the health and safety of patients. We propose that a waiver
may be granted for a specific LSC requirement if: (1) We determine that
the waiver would not adversely affect the patient/staff health and
safety; and (2) we determine that it would impose an unreasonable
hardship on the facility to meet a specific LSC requirement. A provider
may request a waiver from its State Agency. The State Agency will
review the request and make a recommendation to the appropriate CMS
Regional Office. The CMS Regional Office will review the waiver request
and the State Agency's recommendation and make a final decision on the
waiver request. A waiver cannot be granted if patient safety is
compromised in any way.
A State may also request that a State fire and safety code, imposed
by State law, be applicable to all dialysis facilities rather than the
LSC proposed in this rule. The State must submit the request to its CMS
Regional Office and the Regional Office will forward the State's
request to CMS Central office for a final determination.
V. Proposed Part 494 Subpart C (Patient Care)
A. Patients' Rights (Sec. 494.70)
[If you choose to comment on issues in this section please include the
caption ``Patients' Rights'' at the beginning of your comment.]
The existing patients' rights condition, Sec. 405.2138, requires
that the facility's governing body adopt written patients' rights
policies that are administered by the facility's chief executive
officer (CEO). Sections 405.2138(a)(1) through (5) state that patients
must be informed regarding the following: (1) Their rights and
responsibilities; (2) services available at the facility and charges
not covered; (3) their medical condition (by a physician); (4) the
facility's reuse policies; and (5) their suitability for
transplantation or home dialysis. Sections 405.2138(b)(1) and (2)
afford patients the right to participate in planning their medical
treatment; require that a patient may be transferred or discharged for
only medical reasons or for the patient's or other patient's welfare or
nonpayment of fees; and require that patients must be given advance
notice to ensure an orderly transfer or discharge. Section 405.2138(c)
states that patients must be treated with respect and dignity; Sec.
405.2138(d) protects patient confidentiality of personal and medical
records; and Sec. 405.2138(e) states patients must be advised,
encouraged, and assisted in exercising their rights to bring grievances
(through a representative, if desired) without fear of discrimination
or reprisal.
We are proposing to revise the provisions of this condition to
include a number of changes, in keeping with our goals to reduce the
Federal regulatory burden on dialysis facilities, eliminate unnecessary
procedural requirements, and revise the conditions for coverage to be
more outcome-oriented while protecting the basic rights of ESRD
patients.
First, we are proposing at Sec. 494.70 that the facility must
inform patients (or their representatives) of their rights and
responsibilities when they begin their treatment at the facility, and
must also protect and provide for the exercise of those rights. We
believe it is important to take steps to ensure that patients are fully
and promptly informed of their rights. The existing regulatory language
permits a facility an unspecified period of time to complete this
activity. However, we believe that all dialysis patients must be
informed of their rights and responsibilities when they begin their
treatment, which is the standard practice in dialysis facilities, so
they may exercise them from the beginning of their relationship with
the facility.
Existing Sec. 405.2138 provides a list of numerous persons to whom
these written patient rights policies must be ``made available.'' The
list includes patients and guardians, next of kin, sponsoring agencies,
representative payees, and the public. Essentially, the facility must
provide the list of patient rights to anyone who asks to see them.
Rather than specifying a list of people to whom the patients' rights
policies must be made available, we are proposing at Sec. 494.70 that
facilities inform the patients (or their representatives), and at Sec.
494.70(c) that facilities post a copy of the patients' rights in a
prominent location where it can easily be seen and read. This not only
meets the objectives of the current list of disclosures, it also allows
patients
[[Page 6201]]
to review their rights at any time during the course of their care at
the dialysis facility.
Section 405.2138 also states that the CEO is responsible for the
development of, and adherence to, procedures implementing the patients'
rights policies. In Sec. 494.70, we are proposing to change this
requirement by holding the facility accountable for the outcome, which
is to ensure that each patient's rights and the ability to exercise
them are protected.
We are proposing to retain the patients' rights enumerated in Sec.
405.2138(a)(1) through (a)(5) and include them in the proposed Sec.
494.70(a).
Proposed Sec. 494.70(a)(1) requires the dialysis facility to
inform patients of their right to be treated with respect, dignity, and
recognition of their individuality and personal needs as well as
sensitivity to the patients' psychosocial needs and ability to cope
with ESRD.
Proposed Sec. 494.70(a)(2) requires a dialysis facility to provide
information to patients in an understandable manner. The existing
requirement at Sec. 405.2138(c) requires dialysis facilities to
provide translators ``where a significant number of patients exhibit
language barriers.'' Presumably, under this existing requirement, if a
single patient has language difficulty, the facility does not need to
act to address this patient's needs. We are proposing to modify this
requirement. Since written information is not required, the dialysis
facility has the flexibility to decide the best vehicle for providing
information to patients. We believe this more outcome-oriented
requirement provides a facility with the latitude to devise its own
means to ensure the outcome is met.
Proposed Sec. Sec. 494.70(a)(3) and (4) would require a dialysis
facility to inform patients regarding privacy and confidentiality, and
also expands those rights to include specific references to privacy and
confidentiality in all aspects of the patient's treatment as well as
the patient's medical records. These requirements include existing
provisions from Sec. 405.2138(c) and (d). Staff should be instructed
that any discussions with dialysis patients or relatives regarding
treatment, the patient care plan, and medical conditions should be held
in private and kept confidential. There should be reasonable
precautions to keep both written and verbal patient information
private. Staff should be aware of the need to speak at a volume and at
a proximity to patients such that privacy is reasonably protected.
Facility staff must make efforts to protect patient information and
physical privacy. While recognizing the patient's right to privacy and
confidentiality, we are not necessarily advocating physical barriers in
the dialysis clinical area that provide patient privacy because
patients should be in view of staff at all times during treatment to
ensure safety. However, in situations when there is patient body
exposure during therapy, the staff should be instructed to provide
temporary screens, curtains, or blankets.
We are proposing at Sec. 494.70(a)(5) to retain the existing
requirement under Sec. 405.2138(b)(1) that describes the right of
patients to participate in the planning of their medical treatment and
to refuse to participate in experimental research (or any part of their
care). Section 494.70(a)(5) requires a facility to inform patients
regarding their right to participate in all aspects of their care.
Although we recognize that a facility cannot require its patients to
participate in the care process, we expect the facility to work closely
with patients and encourage patient participation to ensure that a care
plan is developed that is suitable to the needs and concerns of both
the patient and staff. The facility should notify patients in advance,
if possible, of any changes in the treatment plan recommended by the
physician and the basis for the changes. The facility should also
encourage patients to disclose any concerns they may have with the
proposed changes.
Proposed Sec. 494.70(a)(5) would also require the facility to
inform patients of the right to establish an advance directive. Advance
directives establish in writing an individual's preference with respect
to the degree of medical care and treatment desired or who should make
treatment decisions if the individual should become incapacitated and
lose the ability to make or communicate medical decisions. Advance
directives include written documents including living wills and durable
powers of attorney for health care, as recognized by State law.
Congress passed section 4206 of the Omnibus Budget Reconciliation
Act of 1990 (OBRA 1990) (Pub. L. 101-508) to ensure that patients
receive information regarding their right to execute or not to execute
advance directives. While the OBRA 1990 requires hospitals, skilled
nursing facilities, HHAs, managed care plans, and hospice programs
participating in the Medicare program to establish and maintain written
policies and procedures regarding advance directives, it does not
specifically mention dialysis facilities.
In proposing to add advance directives to the patients' rights
condition for coverage we took several factors into consideration.
First is the chronic nature of ESRD. Kidney impairment is irreversible
and permanent, and a regular course of dialysis or transplantation is
essential to maintain life. In addition, we considered the amount of
time a patient spends in the dialysis unit, and also the rapidly
changing demographics of the ESRD patient population. The average age
of the ESRD patient population is increasing annually. Elderly ESRD
patients now comprise a large percentage of the total ESRD patient
population. Data compiled by the United States Renal Data System, from
1990 to 2001, shows the following rate of new cases of ESRD for
patients 65 years of age and older:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year
Age (in years) -----------------------------------------------------------------------------------------------------------
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001
--------------------------------------------------------------------------------------------------------------------------------------------------------
65-69....................................... 7,177 7,982 8,597 8,895 9,852 9,643 10,390 10,829 11,078 11,225 11,415 11,545
70-74....................................... 6,159 7,260 8,093 8,533 9,664 9,678 10,753 11,248 11,648 12,005 12,276 12,367
75-79....................................... 4,587 5,367 5,997 6,293 7,243 7,404 8,481 9,339 10,133 11,170 11,407 11,408
80-84....................................... 2,386 2,754 3,228 3,427 4,051 4,290 4,959 5,725 6,125 6,785 7,349 7,477
85+......................................... 961 1,113 1,277 1,481 1,659 1,833 2,248 2,598 3,110 3,587 3,870 4,146
--------------------------------------------------------------------------------------------------------------------------------------------------------
The emergence of an older, sicker ESRD patient population has
motivated the Renal Physicians Association (RPA) and the NKF to develop
guidelines for implementation of advance directives in dialysis
facilities, and we are encouraging dialysis facilities to adopt
voluntary consensus guidelines for advance directives. The guidelines
can be obtained through the NKF's Web site at: http://www.kidneyva.org/public_ed/orderforms.pdf
and through the RPA
[[Page 6202]]
Web site at http://www.renalmd.org/publications/index.cfm.
After taking these factors into account, we believe it is prudent
to consider adding advance directives as a requirement in the patients'
rights condition of this proposed rule.
Existing Sec. 405.2138(a)(5) requires that patients be informed of
their suitability for transplantation or home dialysis. We have
strengthened this requirement at Sec. 494.70(a)(6) by proposing that
patients be informed about alternative treatment modalities by
requiring dialysis facilities to address all treatment choices. The
treatment modality selected may directly affect the quality of life for
dialysis patients. This choice is a very personal one, with important
implications for how likely the patient is to be rehabilitated to the
highest possible level. To assist dialysis patients in achieving the
optimal quality of life, patients need education about each modality
and must have access to the widest array of treatment choices possible.
For example, a successful kidney transplant is the most desirable
treatment for many ESRD patients and facilities should make every
effort to both educate and inform patients regarding the
transplantation option. Also, forms of dialysis that can be performed
at home have been shown to have a positive influence on the patient's
quality of life. Home dialysis affords patients' control over
scheduling and setting, and it can be done in comfortable, familiar
surroundings. Also, home dialysis is generally perceived to be less
disruptive to family life and employment. We propose to require that a
facility inform patients about all available treatment modalities and
settings, so patients can make an informed decision regarding the most
appropriate course of treatment that meets their needs.
Open communication between the facility staff and the patient and
patient access to treatment information are vital tools for enhancing
the patient's participation in his or her coordinated care planning.
Proposed Sec. 494.70(a)(7) requires that patients be informed of the
facility's patient care policies, including its patient isolation
policies.
Proposed Sec. Sec. 494.70(a)(8) through (10) retain existing
requirements in Sec. 405.2138(a)(2) through (4) that patients be fully
informed regarding the facility's reuse of dialysis supplies, including
hemodialyzers; be informed by a physician regarding his or her own
medical condition unless contraindicated; and be informed of services
available in the facility and charges not covered by Medicare.
Proposed Sec. 494.70(a)(11) would require that patients be
informed of the right to receive the necessary services outlined in the
patient plan of care in proposed Sec. 494.90. The importance of the
patient plan of care is discussed in section V.C. of this preamble.
Proposed Sec. 494.70(a)(12) would retain the existing requirement
at Sec. 405.2138(a)(1) that patients be informed of the rules and
expectations of the facility regarding patient conduct and
responsibilities. The success of the dialysis treatment is as
contingent upon patients adhering to their responsibilities as it is
upon other important factors. There is a discussion of the dialysis
facility's responsibility regarding disruptive and difficult patients
in section VI.E.9. of this preamble.
Proposed Sec. 494.70(a)(13) would require facilities to inform
patients regarding the facility's internal grievance process and their
right to express grievances against the facility using the internal
grievance process through a representative chosen by the patient (if so
desired).
Proposed Sec. 494.70(a)(14) strengthens the existing requirement
for facilities to inform patients regarding the various external
grievance mechanisms available to them, including how to contact the
ESRD network and the State survey agency, and how to file external
grievances without reprisal or denial of services, through a
representative chosen by the patient or anonymously (if so desired). We
believe that patients must be made aware of every grievance option
available to them, including, at a minimum, contacting the two entities
with the statutory responsibility under Federal law for addressing
patient grievances (that is, the ESRD networks and the State survey
agencies).
In proposed Sec. Sec. 494.70(b)(1) and (2), we would require a
facility to inform patients regarding its transfer and discharge
policies and provide 30 days notice in advance of reducing or
terminating patient care services following the discharge and transfer
procedure outlined in Sec. 494.180(f). The facility would be exempt
from the 30-day notification requirement in cases when there was an
immediate threat to the health and safety of others. Proposed
Sec. Sec. 494.70(b)(1) and (b)(2) and the procedure outlined at Sec.
494.180(f) have been proposed, in part, in response to the
``disruptive'' or ``challenging'' patient issue. Increasing numbers of
staff and patient grievances presented to the ESRD networks and the
State survey agencies involve allegations of disruptive behavior by
patients and allegations of inappropriate patient discharges from
facilities for noncompliance or disruptive behavior. We would not
expect a patient to be involuntarily discharged from a dialysis
facility for failure to follow the instructions of a facility staff
member. However, it may be necessary to discharge a disruptive patient
in order to protect the rights and safety of other patients in the
facility, or to protect the safety of facility staff.
We believe that a dialysis facility has both the resources and a
responsibility to make a good faith effort to work with every patient,
including patients perceived to be disruptive or challenging, to
provide the necessary assessment, training, knowledge, and motivation
to facilitate good outcomes of care. This process begins when the
facility interdisciplinary team performs the comprehensive patient
assessment described in proposed Sec. 494.80, with periodic
reassessments as needed; continues through the care planning process
described in proposed Sec. 494.90; as well as the facility's quality
assessment and performance improvement (QAPI) program described in
proposed Sec. 494.110. We believe the disruptive or challenging
patient problem is multifaceted, and even conscientious assessments,
care planning, and QAPI programs by a facility will not always be
successful in mitigating the disruptive behavior of some patients. In
those instances when good faith efforts by a facility have been
unsuccessful and the facility has determined that it wants to discharge
or transfer the patient, facilities must follow the procedure outlined
in proposed Sec. 494.180(f), and arrange to transfer or discharge the
patient, as appropriate.
We also recognize there will be rare instances when a facility must
act immediately to discharge a patient. Such instances could be, for
example, when a patient physically harms or threatens other patients
and staff, a patient who brings weapons or illegal drugs into a
facility, or a patient who is verbally abusive and disruptive to such
an extreme degree that the facility is unable to operate effectively.
In those and comparable circumstances, we would propose to shorten the
30-day notification requirement. We are soliciting comments on the
proposed Sec. Sec. 494.70(b)(1) and (b)(2), as well as suggestions for
addressing the disruptive or challenging patient issue in the proposed
ESRD conditions.
If a patient chooses not to use a facility's internal grievance
process, or when grievances cannot be resolved at the facility level,
the patient may elect to register a grievance with the
[[Page 6203]]
appropriate ESRD network or make a complaint directly to the State
survey agency at any time. We believe it is essential that we require
that patients be informed of every grievance and complaint option
currently available to them under the law.
Proposed Sec. 494.70(c) would require dialysis facilities to
prominently display a copy of the patients' rights as well as the
telephone numbers for the appropriate ESRD network and State survey
agency in order to afford patients the opportunity to contact either
entity, if desired. Dialysis patients have the right to be advised of
and to use grievance processes developed by the facility, the ESRD
network and the State survey agency.
B. Patient Assessment (Proposed Sec. 494.80)
The proposed patient assessment condition at Sec. 494.80
underscores our belief that systematic patient assessment is essential
to improving quality of care and patient outcomes. The information
generated from the patient assessment is a vital tool for developing a
patient's care plan and subsequent treatment. A comprehensive patient
assessment allows the dialysis facility to monitor the patient's
progress toward achieving the desired care outcomes and adjust the plan
of care and treatment prescription as necessary.
The existing regulations in part 405 subpart U do not state that a
patient will receive a comprehensive assessment. However, two sections
of the existing regulations, Sec. Sec. 405.2136(g)(1) and
405.2137(b)(1), provide a basis for a patient assessment. For example,
Sec. 405.2136(g)(1) holds the patient's physician responsible to
prescribe a planned regimen of care, ``which covers indicated dialysis
and other ESRD treatments, services, medications, diet, special
procedures recommended for the health and safety of the patient, and
plans for continuing care and discharge.'' That section also states
that such plans are made with the input of the professional personnel
providing care to the patient. Existing Sec. 405.2137(b)(1) states
that a patient care plan ``reflects the psychological, social, and
functional needs of the patient,'' and indicates ESRD and other care
needed to achieve the long- and short-term treatment goals.
Therefore, while the existing regulations indicate that a
specialized care plan must be developed based upon the nature of the
patient's illness, the treatment prescribed, and an assessment of the
patient's needs, it does not specify the criteria that a facility must
include in a patient assessment. Over the past 25 years, research has
improved our knowledge of the components important to assessing and
treating the dialysis patient so that improvements in quality of life
and morbidity and mortality rates have been achieved.
We believe that a comprehensive patient assessment that includes
clinical interaction with the patient is a prerequisite for the
delivery of quality care and is the basis for determining a patient's
functional status and identifying the services necessary to address the
patient's needs. Accurate and accessible patient information generated
from the comprehensive assessment is critical to the development of a
successful patient care plan and the achievement of desired patient
outcomes.
We do not believe that expanding the existing requirements in this
proposed condition will impose any additional burden on facilities.
Rather, we believe quality-oriented facilities already routinely
perform comprehensive patient assessments upon initiating treatment.
Further, we believe most facilities already have this information in
different parts of the medical record since an appropriate and
effective treatment plan cannot be developed without an initial
assessment.
We are proposing at Sec. 494.80 to add a patient assessment
condition for coverage that would make the ESRD facility, through the
patient's interdisciplinary team, responsible for providing each of its
patients with an individualized and comprehensive assessment of his or
her needs. The members of the interdisciplinary team (see proposed
Sec. 494.10) would include the patient (if he or she chooses), a
registered nurse, a physician, a social worker, and a registered
dietitian. With the team concept, the goal is to obtain input from each
designated health professional as well as from the patient to develop
an assessment that identifies the patient's needs and allows for
planning for necessary services. The proposed team members represent
vital components of the patient's medical treatment and psychosocial
development. These professionals are also key to a successful
transition to dialysis as well as to maintaining the patient's quality
of life. An assessment that involves the patient as a key member of the
interdisciplinary team is important to the successful delivery of
service and the patient's adherence to the program.
In proposed Sec. 494.80(a), we list the assessment criteria. The
minimum proposed elements of a patient's assessment include the
following:
Evaluation of current health status, including comorbid
conditions and medical condition.
Evaluation of the appropriateness of the dialysis
prescription, blood pressure control, and fluid management needs.
Laboratory profile and medication history.
Evaluation of factors associated with anemia, such as
hematocrit, hemoglobin, iron stores, and potential treatment plans for
anemia, including administration of recombinant erythropoietin.
Evaluation of factors associated with renal bone disease.
Evaluation of nutritional status.
Evaluation of psychosocial needs.
Evaluation of dialysis access type and maintenance.
Evaluation of the patient's ability, interests,
preferences, and goals, including level of participation in the
dialysis care process; modality and setting (for example, home
dialysis, including home hemodialysis or peritoneal dialysis); and
expectations for care outcomes.
Evaluation of suitability for transplantation referral,
based on criteria developed by the transplant surgeon at the transplant
center that would receive such transplantation referral including the
basis for referral or nonreferral.
Evaluation of family and other support systems.
Evaluation of current physical activity level.
Evaluation of vocational and physical rehabilitation
status and potential.
Other information to be included in the initial assessment would be
determined by the interdisciplinary team based on the specific
characteristics and needs of the patient.
We recognize that inclusion of a minimum set of assessment criteria
may appear to be inconsistent with our goal of eliminating
unnecessarily prescriptive and process-oriented requirements. However,
we believe it is appropriate and necessary for every patient assessment
to focus not only on the patient's medical needs, but also on his or
her psychosocial and rehabilitation needs. Further, these assessment
criteria would assure that needed information would be available for
the patient plan of care and the facility's quality assurance and
performance improvement program.
We propose criteria for the frequency of assessment and
reassessment of new patients in Sec. Sec. 494.80(b)(1) and (2). A
timely, comprehensive assessment is critical for planning patient care
and achieving desired patient outcomes. We
[[Page 6204]]
believe this requirement, though process-oriented, is necessary to
prevent harm to the patient. By permitting facilities 20 calendar days
to complete assessments, we are providing a reasonable timeframe for
every member of the team to assess the patient prior to development of
the treatment plan.
We also recognize that patients who are new to dialysis need time
to adjust and adapt to the treatment. Initially, patients may
experience a great deal of anxiety while learning self-care skills,
modifying their diet, changing their behavior, and perhaps dealing with
access issues. The level of compliance with the renal regimen may be
set by the time the person has been on dialysis for 4 to 6 months
(Sciarini, pp. 299-305). Because of this period of adjustment, and the
opportunity to establish the patient's adherence to the renal regimen,
proposed Sec. 494.80(b)(2) would require a follow-up comprehensive
reassessment for new patients within 3 months after the completion of
the initial comprehensive assessment. Three months was chosen so that
the window of opportunity for establishing adherence to the renal
regimen by a new patient is not missed. We recognize the additional
burden this 3-month reassessment will place on the interdisciplinary
team. However, an updated plan of care and the attention to the
patient's adjustment to the renal regimen may prevent problems in the
coming months. The reassessment also ensures the continued accuracy and
effectiveness of the treatment regimen.
Existing Sec. 405.2136(g) states that the physician responsible
for the patient's medical supervision evaluates the patient's needs and
prescribes a planned regimen of care for dialysis. Sections
494.80(c)(1) and (2) propose a schedule for the assessment of the
treatment prescription for hemodialysis and peritoneal dialysis
patients. Studies indicate that ESRD patient mortality is lower when
patients receive sufficient dialysis treatments. There has been
considerable research recently indicating that the dose of dialysis is
an important determinant of survival and morbidity of patients on
hemodialysis ((Held, pp.871-875); (Owen, pp.1001-1006); (Parker,
pp.981-989); and (Parker, pp.670-680)). The delivered dose of dialysis
(Kt/V or an equivalent measure) indicates how well the dialysis
treatment is working. Kt/V is the dialyzer clearance of urea (K) times
the time of treatment (t), divided by the volume of distribution of
urea (V), which yields a dimensionless value. Adequacy of dialysis
clinical practice guidelines are available in the National Kidney
Foundation's Kidney Disease Quality Initiative (NKF-K/DOQI). As
previously discussed in this preamble, the NKF-K/DOQI has established
clinical practice guidelines for ESRD patients. This systematic,
evidence-based approach to developing guidelines used focus workgroups
to identify target issues and conducted extensive literature searches
to extract relevant clinical study reports for each target issue.
Clinical practice guidelines were derived from this information. The
guidelines are available for public review and comment, and they
continue to be reviewed. Health care professionals and providers, ESRD
networks, managed care groups, industry, government, patient
associations and individuals are invited to provide comments to the
NKF-K/DOQI workgroups. These comments are reviewed and when
appropriate, incorporated in future editions.
An important initiative of this project is the development of
guidelines for the dose of dialysis, including standard
methodology(ies) for measuring the dialysis dosage.
To ensure that ESRD patients receive sufficient dialysis, the
delivered dose of dialysis needs to be measured. Therefore, in keeping
with the NKF's K/DOQI clinical practice guidelines, we propose in Sec.
494.80(c) to specify that the delivered dose of dialysis for the
patient's hemodialysis treatment prescription must be measured at least
monthly, and the patient's peritoneal dialysis treatment prescription
should be assessed at least every 4 months. More frequent monitoring
may be necessary for new dialysis patients or when the dialysis
prescription is changed. Less frequent monitoring of the adequacy of
dialysis may compromise the timeliness with which deficiencies in the
delivered dose of dialysis are identified and hence may delay
implementation of corrective action.
In Sec. Sec. 494.80(d)(1) and (2) we propose patient reassessment
timeframes for both stable and unstable patients with respect to the
standards specified in Sec. Sec. 494.80(a)(1) through (a)(13). The
comprehensive assessment process can be seen as part of a cycle.
Through the use of the patient assessment, accurate and timely patient
information is reflected in the plan of care. As the assessment
changes, the plan of care must be revised accordingly. If the patient's
condition is stable, we propose in Sec. 494.80(d)(1) that the facility
must perform comprehensive reassessments at least annually, which
assures that patients are receiving a continuing program of care that
meets their needs. This proposed timeframe minimizes the facility
burden because the existing Sec. 405.2137(b)(4) requires care plan
review every 6 months for stable patients. If the patient is unstable,
we are proposing in Sec. 494.80(d)(2) to require a monthly
reassessment, to allow for the update of the plan of care. Existing
Sec. 405.2137(b)(4) also requires a monthly review of the care plan
for patients whose medical condition has not become stabilized. In
proposed Sec. Sec. 494.80 (d)(2)(i) through (d)(2)(iv), we added
criteria to specify at a minimum, which patients may be considered to
be unstable patients. These criteria include extended or frequent
hospitalizations, marked deterioration in health status, a significant
change in psychosocial needs, or poor nutritional status, with
unmanaged anemia and inadequate dialysis. Extremely frail patients may
need monthly reassessments. However, we are not proposing a specific
requirement for monthly reassessments for frail patients because we
believe this type of requirement would be too prescriptive and limit
the flexibility of dialysis facilities to make clinical determinations
on a case-by-case basis.
The renal community has been unable to reach a consensus regarding
the optimum frequency of assessments. Some believe that the proposed
time periods create a strain on facilities, while others have
encouraged us to propose more stringent timeframes. Because of the wide
range of opinion in this matter, we are specifically soliciting public
comments on whether the proposed 3-month timeframe for reassessment of
new patients is reasonable and consistent with meeting the patient's
needs.
C. Patient Plan of Care (Proposed Sec. 494.90)
[If you choose to comment on issues in this section please include the
caption ``Plan of Care'' at the beginning of your comments.]
The patient assessment serves as the basis for the patient plan of
care. Existing Sec. 405.2137 contains a large number of prescriptive
requirements for the development of patient care plans. These
requirements specify that there needs to be a patient long-term program
and a patient care plan.
The patient long-term program described in existing Sec. Sec.
405.2137(a)(1) through (a)(4) relates to the selection of a suitable
treatment modality and treatment setting by the treatment team. It also
requires active participation by the physician director in the unit
where the patient is being treated, a formal review of the written
long-term plan by the team every 12 months, patient involvement in the
plan's development,
[[Page 6205]]
and a requirement to send the plan to the receiving facility within 1
day of an interfacility transfer.
The patient care plan in existing Sec. 405.2137(b) requires a
written care plan based on the nature of the patient's illness, the
treatment prescribed, and an assessment of the patient's needs.
Additional requirements in existing Sec. Sec. 405.2137(b)(1) through
(b)(7) include a personalized care plan reflecting the patient's needs,
a care plan developed by a professional team (including the physician
responsible for the patient's care), the involvement of the patient (or
the patient's parent or legal guardian), a monthly review for unstable
patients, a 6 month review for stable patients, sending the plan to the
receiving facility within one day for interfacility transfers, periodic
monitoring of home dialysis patients, and monitoring for home dialysis
patients who use erythropoietin.
In accordance with our goal of reducing Federal regulatory burden,
we have simplified the proposed patient care plan condition (Sec.
494.90) by eliminating the separate requirement for a patient long-term
program.
We propose to retain some of the existing requirements of Sec.
405.2137 in the patient assessment condition (proposed Sec. 494.80).
We believe that the patient assessment and patient care planning
processes are inextricably linked. That is, each patient assessment
must be followed with a review and revision, if necessary, of the
patient's plan of care.
The comprehensive plan of care is an individualized program that
ensures that each dialysis patient receives personalized and
appropriate patient care within the selected modality and setting of
treatment. In proposed Sec. 494.90 we would specify that the patient's
plan of care must include measurable and expected outcomes and
estimated timetables to meet the patient's medical and psychosocial
needs as identified in the initial and subsequent comprehensive
assessments. This section would also specify that the patient's plan of
care must address all the services that are to be furnished to achieve
and maintain the expected outcomes of care.
Existing Sec. Sec. 405.2137(a)(1) and 405.2137(b)(2) specify the
composition of the professional team responsible for the preparation of
the long-term and the patient care plans. The facility's professional
team currently writes a patient long-term program and a short-term care
plan. However, proposed Sec. 494.90 would require that a single
patient plan of care be developed and this plan would address all of
the patient's needs. We are proposing in Sec. 494.90 to retain the
existing requirement that the patient plan of care to be developed by
the interdisciplinary team. Although we would retain the existing
Sec. Sec. 405.2137 (a)(1) and (2), we have chosen to use the term
``interdisciplinary team.'' The term ``interdisciplinary team'' is
defined Sec. 494.10 and described in Sec. 494.80. In Sec. 494.80, we
are proposing that the interdisciplinary team consist of, at a minimum,
the patient (if he or she desires) or his/her designee, a registered
nurse, a nephrologist or physician treating the patient for ESRD, a
social worker, and a dietitian. We are using the term
``interdisciplinary team'' instead of ``professional team'' because the
term ``interdisciplinary team'' is commonly used in health care
settings, including dialysis facilities.
Although existing Sec. 405.2137(a)(1) specifies a transplant
surgeon as a member of the professional team, we did not include a
transplant surgeon as a member of the interdisciplinary team as defined
in proposed Sec. 494.10 and described in proposed Sec. 494.80. We
believe all eligible ESRD patients must be referred for
transplantation. However, it may not be reasonable to have transplant
surgeons sign every care plan. The existing interpretive guidelines for
surveyors (Survey Procedures and Interpretive Guidelines for End-Stage
Renal Disease Facilities, Appendix H, State Operations Manual) allow a
transplant surgeon's designee, who could be a transplant coordinator or
the treating nephrologist, to screen patients in the long-term care
plan process (DHHS/CMS, April 1995). The designee would have to use
screening criteria developed by the transplant surgeon. Because not
every patient is medically suited for a transplant, we believe the
transplant surgeon need not be involved with the team unless a possible
candidate has been identified. We are proposing that the dialysis
facility must have inclusion/exclusion criteria, defined by the
transplant surgeon based at the transplant center that would receive
the transplantation referral, to use in the evaluation of patients for
transplant referral. Therefore, we propose to delete the requirement
that a transplant surgeon directly sign the care plan. We believe
transplant referral tracking must be part of the comprehensive plan of
care condition (see Sec. 494.90(c)), and we have also proposed to
strengthen this requirement in the patient assessment (Sec. 494.80)
and patient's rights (Sec. 494.70) conditions. We are soliciting
comment on the appropriate role of the transplant surgeon in developing
the patient plan of care.
Existing Sec. 405.2137(a)(1) also requires that the facility
medical director and a physician from a facility that offers home
dialysis (if the patient's present facility does not) be included in
the team that develops the patient's long-term program. While we
believe the involvement of these physicians would be valuable in most
cases, we recognize that there are situations when the services of
these physicians may not be needed. Thus, in keeping with our goal of
eliminating unnecessary process requirements, proposed Sec. 494.10
specifies the definition of ``interdisciplinary team'' without
including the facility medical director and the home dialysis
physician. Nonetheless, we encourage facilities to expand the
interdisciplinary team to include as many health professionals as
necessary to furnish the best care possible to their patients.
As required in existing Sec. 405.2137 and in proposed Sec.
494.10, a physician is part of the interdisciplinary team. We propose
retention of this requirement because we believe the physician must
play an integral role on the interdisciplinary team. The physician
responsible for the patient's dialysis treatment works with the other
team members to ensure the development of an appropriate care plan for
the patient. We also expect the physician to see the patients and
monitor their care.
Existing Sec. 405.2137(b)(3) specifies that the patient may be
involved in the development of the care plan and consideration is given
to the patient's preferences. The patient's right to be informed about
and participate within the interdisciplinary team is encompassed in
proposed Sec. 494.70(a)(5). The patient or his/her designee, if he or
she desires, as a member of the interdisciplinary team, must
collaborate to design a plan of care that enables the patient to reach
his or her desired level of general health, activity, and quality of
care. When a patient communicates his or her goals regarding their
medical treatment, he or she plays a more active role in improving
their quality of life. We have eliminated the phrase ``due
consideration is given to [the patient's] preferences'' because we
believe it implies the patient (or the patient's designee) is not an
equal member of the team. Each patient must be given the opportunity to
participate with the interdisciplinary team. However, we would not
require them to do so in the proposed requirements because we recognize
that some patients may not wish to participate in the team process. We
are proposing that the patient or
[[Page 6206]]
designee must sign the plan of care to assure the patient is aware of
treatment plans and goals regardless of whether the patient has opted
to participate in the care planning team process.
The patient plan of care must include measurable and expected
outcome targets or goals for each patient based on the individual
patient's assessment. These outcome targets must allow the patient to
achieve current evidence-based community-accepted standards. Currently,
the K/DOQI clinical practice guidelines are the community-accepted
standards for individual patient care and we expect ESRD facilities to
reflect the current standards of care for dialysis adequacy and anemia
management in the patient plan of care. As additional evidence-based
community-accepted standards become evident, they could be targeted in
the patient plan of care as well.
We propose that allowing the patient to achieve current evidence-
based community-accepted standards for dialysis adequacy and anemia
means (at Sec. 494.90(a)(1)), that the patient plan of care should
specify a minimum delivered threshold for Kt/V of at least 1.2 (single
pool) for hemodialysis patients (NKF, Guideline 4); 1.7 (weekly) for
continuous ambulatory peritoneal dialysis (NKF, Guideline 15); 2.1
(weekly) for continuous cycling peritoneal dialysis patients (NKF,
Guideline 16); and 2.2 (quarterly) for intermittent peritoneal dialysis
patients (NKF, Guideline 16). For anemia management (proposed Sec.
494.90(a)(3)), the minimum specified threshold levels in the patient
plan of care are: a hemoglobin level of 11 gm/dL or comparable
hematocrit of at least 33 percent (NKF, Guideline 4).
There is significant correlation between achieving recommended NKF-
K/DOQI values for the adequacy of dialysis and anemia management
measures with positive outcomes in mortality, hospitalization, and/or
quality of life. Thus, the advantages of assigning patient-level
minimum targets and thresholds is that we would establish a process
when patients whose values do not meet the criteria are evaluated for
possible further intervention so that they can achieve values that are
associated with better outcomes. It is understood that guidelines and
standards, although evidence-based, are not appropriate for all
patients in all situations. Thus these minimum thresholds serve as
indicators for potential quality improvement activity.
We are proposing that outcomes specified in the patient plan of
care must allow the patient to achieve current evidence-based
community-accepted standards.
However, we are soliciting public comments on this issue, and we
will be guided by those comments in reaching a final determination on
whether to require minimum threshold values for the patient plan of
care as we develop the final rule for new ESRD conditions for coverage.
1. Development of the Patient Plan Of Care (Proposed Sec. 494.90(a))
In developing this proposed rule, we determined that there is
sufficient evidence to support the inclusion of minimum set of
evaluative categories in the patient plan of care that have been shown
by independent medical research to be important in achieving desirable
patient outcomes. We are proposing (in Sec. 494.90) that the patient
plan of care must, at a minimum, address: (1) Dose of dialysis; (2)
nutritional status; (3) anemia; (4) vascular access; (5)
transplantation status; and (6) rehabilitation status. Each of these
elements is discussed below.
a. Dose of Dialysis (Proposed Sec. 494.90(a)(1))
There is a consensus in the renal community that adequacy of
dialysis in terms of a Kt/V is an important clinical performance
measure and the vast majority of dialysis facilities do use minimal
target levels or goal levels or both to ensure delivery of quality
care. We are proposing in Sec. 494.90(a)(1) that the patient's
interdisciplinary team assist and support the hemodialysis and
peritoneal dialysis patient in achieving and maintaining an adequate
dose of dialysis that meets evidence-based community-accepted standards
as specified by the Secretary. We are soliciting comments on the
possible use and appropriate minimum threshold values for the adequacy
of dialysis.
b. Nutritional Status (Proposed Sec. 494.90(a)(2))
Existing Sec. 405.2163(d) states that the dietitian, in
consultation with the attending physician, is responsible for assessing
the nutritional and dietetic needs of each patient, recommending
therapeutic diets, counseling on prescribed diets, and monitoring
adherence and response to diets.
Our proposed requirement on nutrition at Sec. 494.90(a)(2) would
require the interdisciplinary team to provide the necessary care and
services to achieve and sustain an effective nutritional status.
Effective nutritional status encompasses acceptable levels of protein,
calorie, and fluid intake as well as acceptable levels of nutrients in
the blood. We did specify that one patient plan of care nutritional
measure, the serum albumin (a marker of visceral protein stores), must
be monitored on a monthly basis to reflect current standards of
practice.
The National Institutes of Health (NIH), in its Consensus
Conference Report entitled ``Morbidity and Mortality of Dialysis,''
identified nutritional status as an important indication of the renal
patient's health (DHHS/NIH, pp.1-33). We recognize that nutrition plays
an important role in the management of renal disease. However, we have
found diverse opinions about using an objective measure as a clinical
outcome measure for nutritional status. Potential clinical outcome
measures of nutritional status include anthropometric measures,
clinical signs of nutrient deficiency, urea kinetic modeling,
prognostic nutrition indexing, and measurement of biochemical
parameters. The NKF-K/DOQI clinical practice guidelines for Nutrition
of Chronic Renal Failure (Guideline 1) state that, ``there is no single
measure that provides a comprehensive indication of protein-energy
nutritional status.'' (NKF, pp. S17.) NKF-K/DOQI guideline 3 further
states that, ``serum albumin is a valid and clinically useful measure
of protein-energy nutritional status in maintenance dialysis
patients.'' (NKF, pp. S20.)
We invite comments on whether any additional specific nutritional
outcome measures, such as other biochemical parameters of serum protein
(total protein, transferrin, or prealbumin), or the protein catabolic
rate or protein equivalent of total nitrogen appearance measure should
be used as a patient plan of care outcome measure.
c. Anemia (Proposed Sec. 494.90(a)(3))
Proposed Sec. 494.90(a)(3) uses anemia, as measured by the
hematocrit (or comparable hemoglobin) level, as a specified patient
outcome. There is a consensus in the community that the use of
hemoglobin, hematocrit or both to monitor anemia management are
important clinical performance measures and the vast majority of
dialysis facilities do use minimal target levels or goal levels or both
for these measures to manage anemia in the dialysis patient. In Sec.
494.90(a)(3) we propose that the patient's interdisciplinary team
assist and support the hemodialysis and peritoneal dialysis patient in
achieving and maintaining the expected hemoglobin/hematocrit level. The
hemoglobin or hematocrit level must be measured at least monthly, as is
the current standard practice. We are soliciting comments on
[[Page 6207]]
the possible use and appropriate minimum threshold values for anemia
management.
Existing Sec. 405.2163(g) address the patient's hematocrit or
comparable hemoglobin level as a marker for the necessity for
administering erythropoietin at home. The assessment criteria include:
(1) Preselection monitoring (lab values and blood pressure); (2)
hematocrit or comparable hemoglobin level less than 30 percent or
medical justification for a higher hematocrit or comparable hemoglobin
level; (3) a target hematocrit or comparable hemoglobin range for a
patient receiving erythropoietin of 30 to 33 percent; and (4) the
patient is under the care of a physician responsible for dialysis-
related services. There are also additional process requirements. We
are eliminating some of these process requirements and proposing that
each patient be evaluated for anemia as specified in the patient
assessment condition at Sec. 494.80(a)(4). We are also proposing that
any patient with a hematocrit of less than 33 percent or a hemoglobin
of less than 11 gm/dL must be evaluated as a candidate for
erythropoietin use. For home dialysis patients, we are proposing that
the facility evaluate whether the patient can be trained to safely,
aseptically and effectively administer erythropoietin, and store
erythropoietin under refrigeration. The patient's response to
erythropoietin, including blood pressure levels and the patient's
utilization of iron stores, must be monitored on a routine basis.
Section 1881(b)(1)(C) of the Act specifies that the patient self-
administering erythropoietin must be able to safely and effectively
administer the drug in accordance with the applicable methods and
standards established by the Secretary. Section 1861(s)(2)(O) of the
Act states that Medicare will pay for erythropoietin as ``medical and
other services'' if the patient self-administers the drug ``subject to
methods and standards established by the Secretary by regulation for
the safe and effective use of such drug. * * *'' Section 405.2163(g)(2)
and (3) of the existing regulations specify the applicable methods as
established by the Secretary. In keeping with our outcome-oriented
focus, we are proposing to retain only those specific evaluation
criteria that are clinically necessary and supported by the NKF-K/DOQI
Clinical Practice Guidelines for Anemia of Chronic Kidney Disease, 2000
Update. Also, we are not proposing to retain all of the requirements in
existing Sec. 405.2137(b)(7) relating to the plan providing for
monitoring home use of erythropoietin. We believe these requirements
are unduly prescriptive and may not reflect the most appropriate items
to monitor for each individual patient. We want to provide flexibility
to a facility to develop its own criteria to monitor all patients who
are using erythropoietin.
In Sec. 494.90(a)(3) we are proposing to provide the facility with
the flexibility to develop their own assessment and patient plan of
care criteria for patients for whom the use of erythropoietin would be
appropriate. In addition, we are proposing in Sec. 494.90(a)(3) that a
dialysis patient's response, including blood pressure and utilization
of iron stores, to erythropoietin must be monitored on a routine basis.
The patient plan of care should ensure that the patient is trained and
is competent to safely, aseptically, and effectively administer the
drug; provide for monitoring and safe refrigerated storage for home use
of erythropoietin; and target appropriate hematocrit or hemoglobin
levels.
d. Vascular Access (Proposed Sec. 494.90(a)(4))
Our existing regulations do not contain any specific requirements
pertaining to hemodialysis vascular access. We note that the
hemodialysis procedure is dependent on the availability of a patent
vascular access. According to data from the United States Renal Data
System access failure is the second most frequent cause of
hospitalization among ESRD patients. Access failure is also one of the
significant contributors to hemodialysis patient morbidity. The costs
of vascular access failure are also significant. In 1999 the total
Medicare ESRD program expenditure for vascular graft failure was more
than $97 million. Dialysis facilities may not have complete control
over the type and placement of the access. However, it has been
demonstrated that efforts to improve access patency can help to extend
the life of an access. The NKF-K/DOQI provides vascular access clinical
practice guidelines that address the importance of access monitoring
and methods for improving the quality of patient care in this area
(NKF, pp. S137-S181).
Therefore, we are proposing in Sec. 494.90(a)(4) to include
vascular access as a component of the patient plan of care with the
following requirements for the interdisciplinary team:
Evaluation of the hemodialysis patient for the appropriate
vascular access type, taking into consideration co-morbid conditions
and other risk factors.
Support and assist the patient in achieving and
maintaining vascular access patency.
Routinely monitor the hemodialysis patient's vascular
access to prevent access failure, including routine monitoring of
artiovenous grafts and fistulae for stenosis.
e. Transplantation Status (Proposed Sec. 494.90(a)(5))
Although we are proposing to remove the existing requirements for a
separate long-term program from the conditions (see Sec. 405.2137), we
are proposing in Sec. 494.90(a)(5) to retain the concept of transplant
planning. Within the plan of care, the interdisciplinary team must
address whether the patient is a transplant candidate and identify the
plan for obtaining a transplant. The plan and the actions necessary to
make the transplant a reality must be addressed in the plan of care.
Necessary actions would include, for example, patient transplant
referral for evaluation by a transplant center, communication with the
transplant center, and monthly blood draws for antigen/antibody
testing. We are soliciting public comment on whether the ``necessary
actions'' listed above should be a requirement for dialysis facilities.
When the patient is not suitable for transplantation referral
evaluation, the reason for nonreferral must be written in the patient's
assessment and notated in the patient plan of care. The reason(s) for
nonreferral must be consistent with the criteria developed by the
prospective transplantation center and surgeon. In cases when the
patient meets the transplantation criteria but declines referral, there
must be documentation in the patient plan of care that the patient has
made an informed decision to decline renal transplantation.
f. Rehabilitation Status (Proposed Sec. 494.90(a)(6))
Existing Sec. 405.2163 includes rehabilitation-related activities
under the minimal service requirements for social services. Advances in
technology and pharmacology have offered the possibility of significant
improvements in the well-being of dialysis patients. More efficient
dialysis equipment, the development of the synthetic hormone
erythropoietin and active vitamin D, for example, represent important
breakthroughs in quality-of-life areas. However, despite this improved
potential for restoration, it is generally acknowledged that renal
rehabilitation has not yet been addressed nationally in
[[Page 6208]]
a consistent, integrated fashion. Therefore, we are proposing to focus
on rehabilitation outcomes through this requirement.
For dialysis patients, rehabilitation means restoring the mind and
body to encourage the individual to maintain as full and active a life
as possible. The Life Options Rehabilitation Advisory Council has
defined the ideal process of rehabilitation for a dialysis patient as a
coordinated program of adequate dialysis, education, counseling, and
dietary regimens designed to maximize the vocational potential,
functional status, and quality of life of dialysis patients (The Life
Options Rehabilitation Advisory Council, p. 20). The ultimate goals of
renal rehabilitation include employment for those who can work,
enhanced physical fitness, increased individual control over the
effects of kidney disease and dialysis, and the ability to maintain as
active a lifestyle as possible. Many renal professionals equate
successful renal rehabilitation with employment, in part because
employment can be readily measured and documented, but factors other
than employment must be examined in a complete discussion of
rehabilitation or functional status of dialysis patients.
Comprehensive rehabilitation efforts can make the difference
between an acceptable quality of life and mere existence. The improved
overall health and outlook of successfully rehabilitated patients may
have positive cost implications as well (Stewart, pp. 907-913).
Patients who are rehabilitated to the point of employment may be able
to offset Medicare costs, subject to Part 411, Subpart F, of our rules,
if they have health insurance through their employment that would cover
the costs of ESRD treatment in place of Medicare. Patients whose
physical health improves to the point when they can manage self-care
activities may allow an adult caregiver to re-enter the workforce. Even
patients who cannot care for themselves, but whose outlook and quality
of life are improved, can experience positive health consequences that
reduce costs; thus keeping patients at home rather than in nursing
homes decreases the costs of care as well. And costs notwithstanding,
the achievement of these improvements in the patient's condition is
inherently invaluable. (The Life Options Rehabilitation Advisory
Council, p. 20).
Rehabilitation cannot be ``done to'' the patient. Active patient
participation in rehabilitation is key to the success of any
rehabilitation effort. Facility staff must inform and educate patients
that their participation in rehabilitation programs is critical to
their well being, ongoing treatment, and attainment of a successful
adjustment to their condition. The patient's responsibility to
participate in rehabilitation efforts is no less essential than her or
his compliance with any aspect of the management of her or his care.
In this proposed rule, we are separating the rehabilitation
requirements (proposed Sec. 494.90(a)(6)) into a distinct plan of care
category, and we are implicitly extending the definition of
rehabilitation to include education. We have chosen to include
rehabilitation as a specific category because we want the
interdisciplinary team to focus on providing patients with the
opportunity and the education for rehabilitation. In addition, staff
attitudes about rehabilitation may have a correlation to patients' own
attitudes about their potential to regain functional status.
It is not sufficient for facility staff to merely provide
information about rehabilitation to patients. Rather, the essential
role of rehabilitation in the treatment and recovery process must be
continuously conveyed to patients and their families. To that end, the
proposed requirement for rehabilitation status requires that the
interdisciplinary team play a critical role in supporting the patient
and advising the patient on his or her rehabilitative efforts.
Specifically, the interdisciplinary team must provide the necessary
care and services for the patient to achieve and maintain an
appropriate level of productive activity, including vocational, that
permits the patient to resume, to the extent feasible, activities
engaged in prior to kidney failure. As part of this requirement,
rehabilitation should be included in the patient's treatment
prescription; the patient's involvement in rehabilitation activities
should be incorporated in patient education materials; and facility
patient support groups focusing on rehabilitation activities could be
offered. Under this condition, facility staff should encourage and
educate patients on the benefits of rehabilitation. The importance of
rehabilitation as part of the treatment and recovery process must be
conveyed, so patients come to recognize it as a benefit to themselves.
The team must reinforce activities that lead to successful
rehabilitation. The interdisciplinary team must provide care and
services to younger patients to enhance the possibility of a successful
transition to adult life and responsibilities. Although rehabilitation
services may not be needed by pediatric patients, there may be
educational needs and developmental needs that the interdisciplinary
team must consider when writing and implementing the patient plan of
care.
This proposed condition does not hold facilities accountable for
rehabilitative outcomes that are beyond their control; instead, this
proposed standard requires that interdisciplinary team staff use a
combination of medical treatment, education, counseling, and dietary
regimens to maximize dialysis patients' rehabilitation activity.
Patients may be able to lead more active and productive lives if other
rehabilitation interventions such as physical, occupational, and
recreational therapy, counseling, and education are made available to
them on a regular basis. Joint goal-setting by informed patients and
the facility staff assists this process. We believe the
interdisciplinary team should refer patients to appropriate agencies
and health professionals for additional services that the facility
cannot provide.
This proposed rule does not incorporate the use of any particular
measure of rehabilitation status because we do not believe there is
consensus in the renal community about a specific measurement at this
time.
g. Social Services
We would like to specify social service outcomes that must be
included in the patient plan of care. However, we believe the social
worker should identify social service outcomes based on the patient
assessment (described at Sec. 494.80(a)) as part of the plan of care
goals for each patient.
Complex emotional and social factors affect the dialysis patient,
including, but not limited to, changes in self-image, loss of
independence, changes in financial security, loss of physical
integrity, problems with sexual functioning, changes in roles, and
coping with the anxiety and discomfort associated with treatment. We
believe that the interdisciplinary team could influence many of these
factors. We are soliciting comment regarding the most effective way to
address these factors within a patient plan of care requirement that
supports an effective level of emotional and social well-being for the
patient.
Work is being done on a variety of assessment instruments that
could measure the emotional and social well-being of patients. We
considered the current experiences with such instruments as the Kidney
Dialysis Quality of Life instrument, the RAND Short Form-36, and the
Duke Health Profile ((Hays, pp. 329-338); (Rand Corporation, (1997));
and (Parkerson, pp. 1056-1069), respectively). However, at this time we
do not believe that there
[[Page 6209]]
is a consensus on a single instrument or a level of psychosocial
achievement for dialysis patients that could be included as a specific
measure for a patient plan of care requirement.
As specified in existing Sec. 405.2163(c), the social worker is
responsible for counseling the patient and the patient's family,
assisting the patient with the emotional adjustment to ESRD and
dialysis treatment, performing crisis intervention, coordinating
referrals and other community services, and arranging other benefits.
Social workers can, in some instances, provide some of the necessary
care and services for the patient to achieve and sustain an effective
level of emotional and social well-being. For example, a necessary care
and services component of social services is facility staff counseling
and educating the patient and providing necessary information for the
patient to have a smooth transition to life on dialysis. The social
worker has an important role in addressing patient behavior that may be
challenging or disruptive. The social worker is uniquely qualified to
provide counseling, anger management, and emotional support services to
patients with ESRD. In cases in which the social worker is not able to
provide the necessary services for the patient to adapt to dialysis
treatment, the social worker should refer patients to appropriate
agencies and health professionals for additional services. We are
soliciting comments regarding the potential for an outcome-based
requirement for social services in the patient plan of care.
2. Implementation of the Patient Plan of Care (Proposed Sec.
494.90(b))
The patient plan of care stems from the patient comprehensive
assessment that identifies patient care needs. Proposed Sec.
494.90(b)(1) would require that the patient's plan of care be completed
by the interdisciplinary team, signed by the patient or the patient's
designee, and implementation must begin within 10 calendar days after
an assessment is completed. As stated in the patient assessment
condition, the facility interdisciplinary team has 20 days from the
initiation of dialysis treatment to complete the comprehensive
assessment. After the assessment has been completed, the
interdisciplinary team has 10 days to develop the patient's plan of
care. This gives the dialysis facility a maximum of 30 days to complete
the comprehensive assessment and the patient plan of care. We selected
10 days for completion of the patient care plan because the plan
directs the patient's treatment, and therefore, the plan of care should
be initiated as soon as possible. Clearly, we are limiting a facility's
flexibility when we identify a timeframe for development of the plan of
care. However, we believe that a timely, accurate, comprehensive plan
of care is critical for planning patient care and achieving desired
health care outcomes. We believe that a maximum of 30 days to complete
the assessment and patient plan of care is ample time, considering the
seriousness of the condition that necessitates the dialysis. We are
soliciting comments on both the appropriateness of prescribing a
timeframe as well as the suitability of the proposed timeframe.
We propose at Sec. 494.80(d) that patients be reassessed as needed
but no less frequently than annually. The patient plan of care would
also be reviewed at least annually since we are proposing that every
comprehensive assessment must be followed by completion and
implementation of the plan of care. Existing Sec. 405.2137(b)(4)
states that care planning is conducted monthly for unstable patients
and every 6 months for those patients who have become stabilized. While
we have retained patient plan of care monthly timeframes for unstable
patients (proposed at Sec. 494.80(d)(2)), we believe that the 6-month
review requirement for stable patients may be unnecessarily burdensome.
The individualized patient plan of care is not static and will
require adjustments as the needs of the patient change, particularly if
the patient is not stable. We propose at Sec. 494.90(b)(3) that the
interdisciplinary team must adjust the patient plan of care to achieve
and sustain the specified patient outcomes goals. New strategies may
need to be implemented as assessment, response, and patient preference
information requires. If the targeted plan of care goal is achievable
but is not being attained, the facility must implement an improvement
plan to reach the goal.
We recognize that patient outcomes are determined in part by
factors outside of the dialysis facility's control, such as
demographics, the systemic effects of the underlying renal disease, and
patient preferences and compliance. Further, we recognize that health
care delivery is dynamic and that all patients may not be achieving for
example, the expected delivered dose of dialysis at any specific point
in time. If the patient is unable to achieve the desired health
outcomes, the plan of care should be adjusted to reflect the patient's
condition along with an explanation, and any opportunities for
improvement in the patient's health should be identified. The
explanation for not achieving the specific level of care may include
patient preferences and patient noncompliance.
Proposed Sec. 494.90(b)(4) would specify that the facility must
ensure every patient is seen at least monthly by a physician providing
the ESRD care as evidenced by a monthly progress note that is either
written in the beneficiary's medical record by the physician or
communicated from the physician's office and placed in the
beneficiary's medical record. We are proposing this requirement based
on a continuing concern of beneficiaries regarding the amount of
interaction between patients and their physicians. We chose the time
period of at least once a month because physicians have traditionally
been paid for their services to renal patients on a monthly basis
through the monthly capitation payment. Patients who are not stable
will need to see the physician more frequently than our proposed
minimal timeframe. According to preliminary information from the
Dialysis Outcomes and Practice Patterns Study (DOPPS), better patient
outcomes are associated with high levels of patient contact from the
physician. Almost 70 percent of the dialysis patients sampled in the
United States, as part of the DOPPS, see their physician once per week
or more frequently, as reported by the nurse. However, we are concerned
about the suggestion that as many as 5 percent of the dialysis patients
may see their physician less often than once a month. While we are
proposing a minimum monthly physician visit (without specifying any
duration for the visit itself), we do not want to discourage more
frequent visits. On November 7, 2003, we published a final rule (68 FR
63196, 63216) regarding the revisions to the payment policies under the
physician fee schedule for calendar year 2004. This rule aligns payment
incentives with the frequency of the physician's evaluation of the
dialysis patient. In addition, the rule assigned new G codes that
associate a higher payment to a physician who provides more visits
within each month to an ESRD patient. Physicians should see patients
and monitor their care as often as is medically necessary to ensure
that they are progressing towards the specified outcomes.
We believe it is important for physicians to see in-center
hemodialysis patients periodically while they are undergoing dialysis
in order to monitor the quality of care they are receiving and to
address the patient's particular clinical concerns and needs while in
the treatment environment. We believe
[[Page 6210]]
periodic in-center monitoring by the patient's hemodialysis physician
is an accepted medical practice and would not impose any additional
burden on dialysis facilities. We are soliciting comments regarding
whether physicians should be required to see their in-center patients
periodically while those patients are being dialyzed in the dialysis
facility. Such in-center visits would not be in addition to the monthly
requirement proposed in Sec. 494.90(b)(4).
3. Transplantation Referral Tracking (Proposed Sec. 494.90(c))
We are proposing at Sec. 494.90(c) that the interdisciplinary team
track the results of each kidney transplant center referral and monitor
the status of any facility patients who are on the transplant wait
list. The routine exchange of information between the dialysis facility
and the transplant center is important so that both facilities know who
is active on the transplant wait list, who is temporarily or
permanently inactive, and who is under evaluation. In addition, there
may be a need to coordinate histocompatibility testing, which must be
completed on a monthly basis. We invite comment on the coordination of
the transplant process and the method and frequency of communication
with the transplantation center.
4. Patient Education and Training (Proposed Sec. 494.90(d))
The existing regulations do not specifically address patient
education and training for in-center patients. However, in Sec.
494.90(d), we are proposing to stipulate that the patient plan of care
must include, as applicable, education and training for patients and
families in all relevant aspects of the dialysis experience, dialysis
management, quality of life, rehabilitation, and education regarding
renal transplantation. When kidneys fail, the resulting physical
changes stimulate a chain of psychological and physiological events
that alter the lives of the affected individuals and their families.
The education of patients and their families goes beyond providing the
necessary information for patients to make an informed choice regarding
treatment modality. Because the life changes associated with beginning
dialysis are so profound, patients and their families need to be
educated and trained about strategies for successful adaptation to
dialysis, optimizing functional status, employment options, and many
other issues. Patients and their families must learn about the disease
and the possibilities of life beyond it and then assume responsibility
for their own health by complying with the treatment plan and
participating actively in rehabilitation activities. Educating and
training patients and their families is key to a successful transition
to a life with dialysis.
However, not all elements of the existing Sec. 405.2137 will be
retained in proposed Sec. 494.90. In accordance with our approach to
consolidate all similar standards, we propose to move the requirements
in existing Sec. 405.2137(b)(5) regarding the transfer of the
patient's medical records to the proposed medical records condition for
coverage (Sec. 494.170), and move the requirements in existing Sec.
405.2137(b)(6) regarding the monitoring of home dialysis patients to
the proposed Care at Home condition for coverage (Sec. 494.100). We
believe that this reclassification will improve the proposed
regulation's organization.
D. Condition: Care at Home (Proposed Sec. 494.100)
[If you choose to comment on issues in this section please include the
caption ``Care at Home'' at the beginning of your comments.]
1. Dialysis of the ESRD Patient in the Home Setting
Home dialysis has been shown to have a positive effect on a
patient's quality of life. Home dialysis affords the patient control
over the scheduling and setting; it can be done in comfortable,
familiar surroundings; and it is less disruptive to family life and
employment than in-center dialysis.
The existing requirements for home dialysis are located in four
sections: (1) Definitions (Sec. 405.2102); (2) patient care plan
(Sec. 405.2137(b)); (3) medical records (Sec. 405.2139); and (4)
minimal service requirements (Sec. 405.2163(e) and (g)).
Existing Sec. 405.2102 defines home dialysis as dialysis performed
by an appropriately trained patient at home.
Existing Sec. 405.2137(b) states that home dialysis patients will
receive a written care plan with the same criteria that are specified
for in-center patients. Section 405.2137(b)(6) requires the ESRD
facility to conduct periodic monitoring of the patient's home
adaptation, including visits to the home by ``qualified facility
personnel'' as appropriate. Section 405.2137(b)(7) contains patient
care plan requirements that apply to home dialysis patients who use
erythropoietin, including: (1) Monitoring diet and fluid intake; (2)
medication usage; (3) hematocrit and iron stores; (4) reevaluations of
the dialysis prescription; (5) a method for physician follow-up on
blood tests and a mechanism to inform the physician of the results; (6)
training the patient to identify signs of hypotension and hypertension;
and (7) decreasing or discontinuing erythropoietin usage if
hypertension is uncontrolled.
Existing Sec. 405.2139 requires facility to maintain ``complete
medical records'' on all patients, including its home patients. Section
405.2139(d) contains requirements regarding medical records information
generated by self-dialysis patients and entries of medical records
information by trained self-dialysis patients, or ``trained
assistants,'' countersigned by facility staff.
Existing Sec. Sec. 405.2163(e)(1) through (6) list a facility's
home dialysis support services including: (1) Surveillance of the
patient's home, including periodic visits; (2) consultation for the
patient with a qualified social worker and qualified dietitian; (3) a
record keeping system that assures continuity of care; (4) installation
and maintenance of equipment; (5) testing and appropriate treatment of
the water; and (6) ordering supplies on an ongoing basis.
Existing Sec. 405.2163(g)(1) through (4) requires the facility or
physician responsible to make a comprehensive patient assessment that
includes the following: (1) Preselection monitoring, including the
patient's hematocrit (or hemoglobin), serum iron, transferrin
saturation, serum ferritin, and blood pressure; (2) conditions the
patient must meet, including a hematocrit (or comparable hemoglobin)
hematocrit level of 30 percent (for patients initiating erythropoietin
treatment), or a level of 30 to 33 percent (for patients already under
the care of a dialysis facility or physician); (3) a requirement that
patients or caregivers must be trained to inject erythropoietin, read
and understand drug labeling, and observe aseptic techniques; and (4)
the assessment must find that erythropoietin can be refrigerated in the
patient's residence and potential risks and hazards related to the drug
and syringes are understood by the patient.
In Sec. 494.100, we proposed requirements that are only applicable
to home dialysis. Since not every facility chooses to provide home
dialysis, this condition would apply only to a facility that provides
these services.
We propose in the opening paragraph of Sec. 494.100 to retain the
implicit requirement in existing Sec. 405.2163 that services to home
patients are at least equivalent to those provided to in-center
patients. Home dialysis patients are patients of the ESRD facility; and
therefore, they are entitled to the same rights, services, and efforts
to achieve
[[Page 6211]]
expected patient outcomes as any other patient of the facility.
We are proposing to address home dialysis training in Sec.
494.100(a). In our deliberations regarding home dialysis training
requirements, we took into account the considerable lifestyle changes
associated with initiating home dialysis and the unique needs of
patients and caregivers engaged in home dialysis. Patients and their
caregivers need to be trained and educated about strategies for
successfully adapting to dialysis at home, ways to optimize functional
status, proper self-dialysis procedures, and many other issues.
Therefore, the processes of educating and training patients and their
caregivers are crucial to a successful transition to a life with
dialysis and to achieving good patient care outcomes.
In the opening paragraph of Sec. 494.100(a), we are proposing that
before the initiation of home dialysis, when the caregiver changes, or
when the home modality changes, that the facility's interdisciplinary
team is responsible for providing self-dialysis training to the home
patient, the patient's designated caregiver, or both. Self-dialysis (as
defined in existing Sec. 405.2102(b)(2)(ii) and proposed Sec. 494.10)
means dialysis performed with little or no professional assistance by
an ESRD patient who has completed an appropriate course of training.
Home dialysis training may be only be provided by a dialysis facility
certified to provide home dialysis services. Durable medical equipment
(DME) companies cannot provide home dialysis training. We are proposing
in Sec. 494.100(a)(1) to modify the existing requirement at Sec.
405.2102(d)(3) that self-dialysis training must be conducted by a
registered nurse with 18 months of clinical experience and at least 3
months of specialized experience in training dialysis patients in self-
care. We are proposing to modify these requirements to state that self-
care training must be conducted by a registered nurse who meets the
personnel qualifications specified in Sec. 494.140(b)(2) (that is, 12
months clinical experience and an additional 3 months of clinical
experience in the specific modality for which the registered nurse will
provide training). As previously stated, home dialysis training is
crucial to achieving desired patient outcomes; and therefore, we
believe the initial training a patient receives must be provided by an
experienced health care professional.
Existing Sec. 405.2102 requires that a facility provide a training
program for self-dialysis and home dialysis patients, if it chooses to
provide this service, but it does not specify the content of that
training program. Therefore, we are proposing the following subject
areas for home dialysis training programs in Sec. Sec.
494.100(a)(3)(i) through (a)(3)(x). These types of programs would, at a
minimum, be required to provide training in the following:
The nature and management of ESRD.
The full range of techniques associated with the
applicable type of home dialysis, including effective use of dialysis
supplies and equipment in achieving the physician's prescription of Kt/
V or URR, and effective erythropoietin administration (if prescribed)
to achieve a hematocrit level of at least 33 percent or a hemoglobin
level of 11 gm/dl.
Nutritional care planning.
Achieving and maintaining emotional and social well-being.
How to detect, report, and manage potential complications.
Availability of support services and how to access and use
available support services.
How to self-monitor health status and record and report
health status information.
How to handle medical and non-medical emergencies.
Infection control precautions.
Proper waste storage and disposal procedures.
While we recognize that specifying the topics for a training
program appears to be inconsistent with our goal of reducing process-
oriented requirements, we believe it is critical and necessary that the
items listed above be required, so that patients and caregivers are
fully informed regarding the health and safety procedures that must be
followed and precautions that must be taken when providing dialysis at
home.
Home patients are not seen 3 times a week by facility staff like
in-center patients; and therefore, the quality and content of home
training given to patients and their caregivers is an extension of the
care and monitoring that would normally be provided in the dialysis
facility. In addition, the facility is responsible for ensuring that
home dialysis patients are achieving the desired outcomes, and this
training will inform home care patients or their caregivers or both of
the plan of care that must be followed (see proposed Sec. 494.90) to
achieve the expected results.
We propose in Sec. Sec. 494.100(b)(1) through (3) that the
dialysis facility: (1) Record who received the training described in
Sec. 494.100(a)(3) and indicate that the patient or caregiver
demonstrated adequate comprehension; (2) retrieve and review self-
monitoring data from patients or caregivers at least every 2 months;
and (3) maintain this information in the patient's medical record. The
goal of the proposed standards is that facilities effectively
coordinate the care of all patients, including home dialysis patients,
to achieve the desired outcomes. As previously stated, we recognize
that home patients do not see facility staff as frequently as in-
facility patients, so the purpose of this proposed requirement is to
ensure that the facility's interdisciplinary team periodically monitors
the care of home dialysis patients' plans of care.
Existing Sec. 405.2139(d) requires dialysis facilities to collect
medical information generated by self-dialysis patients, but it does
not specify the frequency of the data collection. By proposing at Sec.
494.100(b)(2) that the home patient's facility collect and review
information at least every 2 months, we ensure the interdisciplinary
team can determine if the patient is having problems with any aspect of
the dialysis therapy at regular intervals. We would recommend that the
facility collect data that will enable it to determine if home patients
are adhering to the plan of care and achieving expected outcomes. Based
on the data received, the facility staff can determine if the patient
or caregiver needs to be retrained or, in some cases, determine that
the patient is no longer a suitable candidate for self-care dialysis.
As with in-facility patients, the goal of collecting data on home
dialysis patients is to ensure that they are achieving the expected
outcomes.
We propose to retain many of the existing support services
requirements at Sec. 405.2163(e) in proposed Sec. 494.100(c). We have
always taken the view that the law and the regulations require that the
facility provide all of these support services, regardless of whether
the dialysis supplies are provided by the dialysis facility or a
durable medical equipment (DME) company, to the extent that they are
medically necessary for a beneficiary's care. In addition to meeting
other requirements, the proposed Care at Home condition is intended to
assure that home dialysis patients, including those residing in nursing
facilities (NFs) or skilled nursing facilities (SNFs), are receiving
care that is comparable to the care provided to in-facility patients.
Thus, the support services provided to home dialysis patients should
parallel the treatment provided to patients in a dialysis facility.
We are proposing in Sec. 494.100(c)(1)(i) to retain the existing
requirements at
[[Page 6212]]
Sec. 405.2137(b)(6) regarding periodic surveillance of the patient's
home adaptation, including provisions for visits to the home by
facility personnel.
In addition, we are proposing in Sec. Sec. 494.100(c)(1)(ii)
through (iv) to retain existing requirements in Sec. Sec. 405.2137(b)
and 405.2163(e) to: (1) Coordinate the home patient's care by a member
of the facility interdisciplinary team; (2) develop and periodically
review the patient's plan of care (see Sec. 494.90) to address the
patient's needs and achieve expected outcomes of care; and (3) consult
with the members of the interdisciplinary team as needed.
Existing Sec. 405.2163(e)(2) requires consultation with a
qualified social worker and dietitian. We are proposing in Sec.
494.100(c)(1)(iv) to strengthen this requirement by including any
member of the patient's interdisciplinary team because some home
dialysis patients may experience problems or have needs that require
consultation with several members of the interdisciplinary team, and we
do not want to limit their access to appropriate care. In addition, we
recognize that patients who are new to dialysis therapy need a period
to adjust and adapt to their treatment. Initially patients may
experience anxiety while learning self-care skills, how to perform the
dialysis treatment, how to modify their diet, and how to change their
behavior.
We also believe the interdisciplinary team must be responsible for
the development and periodic review of the patient's individualized,
comprehensive care plan based on the comprehensive assessment (see
Sec. 494.80) that specifies the services necessary to address the
patient's needs and includes measurable and expected outcomes. We are
proposing in Sec. 494.100(c)(1)(iii) to expand the existing
requirements by including a statement that the patient's comprehensive
plan of care will be developed and reviewed by the interdisciplinary
team to address the patient's needs and to achieve the expected
outcomes of care. To that end we are encouraging and recommending that
dialysis facilities adopt the same clinical performance measures for
home patients as those that are used for in-center patients. As
previously stated in the discussion of the patient plan of care
condition for coverage (Sec. 494.90), the goal is to obtain input from
each member of the interdisciplinary team as well as from the home
patient so as to develop a comprehensive plan of care that indicates
the services necessary to address the home patient's needs. The home
dialysis patient's plan of care should stipulate the services that are
to be furnished to achieve and maintain the expected outcomes of care.
We are proposing in Sec. 494.100(c)(1)(v) to retain and expand the
existing requirement at Sec. 405.2163(e)(5) to monitor the quality of
the water used by home hemodialysis patients. We are specifically
including onsite evaluation of the water system. Since we have
incorporated by reference the AAMI standards regarding water quality at
Sec. 494.40(a)(1)(i) and (ii), we are also proposing that a facility
adhere to the applicable AAMI guidelines in determining whether the
home dialysis patient's water system meets acceptable standards. If
water supplies are biologically or chemically contaminated,
contaminants may be passed to the patient during the dialysis session,
leading to infection or other adverse consequences. Therefore, a
dialysis facility must monitor the quality of water used in treatments,
as well as monitor the equipment used in water treatment. Because water
is one of the most important aspects of health and safety, we are
proposing in Sec. 494.100(c)(l)(v) to require that the facility
conduct onsite evaluation of the patient's water system if the AAMI-
specified analysis of the water quality indicates contamination or if
the home patient demonstrates clinical symptoms associated with water
contamination. The dialysis facility must ensure that any problems with
the water treatment system are corrected. If the problem cannot be
corrected immediately, the dialysis facility must arrange for backup
dialysis until the water quality at the patient's home can be
adequately restored.
We are proposing in Sec. 494.100(c)(1)(vi) to retain the existing
requirements of section 1881(b)(9) of the Act and Sec. Sec.
405.2163(e)(4) and (e)(6) of the regulations that require the facility
to install and maintain medically necessary home dialysis supplies and
equipment prescribed by the attending physician. In addition, for those
home patients not receiving equipment and supplies from a DME company
the dialysis facility must also purchase and deliver the necessary home
dialysis supplies and equipment.
Furthermore, we propose in Sec. 494.100(c)(1)(vii) to require the
facility to plan for and arrange for emergency backup dialysis
services. This plan should address how emergency situations will be
dealt with, and should hemodialysis be required, include a plan for
obtaining this service.
We are proposing in Sec. 494.100(c)(2) to retain the requirement
at Sec. 405.2163(e)(3) that a facility maintain a record keeping
system that promotes continuity of care. The medical record is used for
diagnosing, treating, and caring for the patient. We believe this
requirement is vital to the effective coordination of services provided
to home dialysis patients because the medical record indicates what
care has actually been provided and what outcomes have been achieved.
The medical record documents the services provided by the
interdisciplinary team members and provides an accurate picture of the
patient's progress in achieving care goals. Further, it provides the
data for evaluation and documentation of the quality and
appropriateness of care delivered. Adequate record keeping is vital to
ensure continuity of care and to ensure that the home dialysis patient
is receiving quality care.
In addition, the patient's supplier is often not part of the
facility staff; and therefore, it may be difficult to ascertain the
services they provide the home patient. In some instances, the services
of home patients are not effectively coordinated. As a result, the
facility staff is often not able to provide comprehensive care to home
patients, and the quality of care suffers. In an effort to encourage
facilities to coordinate services effectively, Sec.
414.330(a)(2)(ii)(C) would require that the patient's supplier report
to the facility, every 30 days, all services and items furnished to the
beneficiary so that the information can be documented in the patient's
medical record. One of our primary goals is to have the care of home
patients parallel the care of in-facility patients, and this can only
be accomplished if all information on patient care is reported to the
facility. We selected 30 days because monthly reporting and billing is
commonly used by dialysis facilities and by suppliers and we believe
that this will not produce additional burden. All patient data are
necessary to effectively evaluate the patient's dialysis prescription
and make changes to the patient plan of care. A less frequent reporting
timeframe would compromise efforts to correct deficiencies in the
patient's plan of care (for example, adjustments to the dialysis
prescription) by the patient's physician and other necessary corrective
actions by the patient's interdisciplinary team. We welcome comments on
the proposed timeframe for the patient's supplier to report to the
facility.
2. Dialysis of ESRD Patients in Nursing Facilities and Skilled Nursing
Facilities
The existing regulations allow hemodialysis to be provided within
NFs and SNFs when there is a certified
[[Page 6213]]
hemodialysis facility on-site or adjoining the NF or SNF and when the
patient is a home dialysis patient who has been appropriately trained.
In a March 19, 2004 letter to State survey agency directors entitled,
``Clarification of Certification Requirements and Coordination of Care
for Residents of Long-term (LTC) Facilities Who Receive End Stage Renal
Disease (ESRD) Services'' (Reference: S&C-04-24), we clarified
certification requirements and coordination of care expectations for
residents of LTCs who receive dialysis. On July 8, 2004, we sent State
survey agency directors and addendum to the March 19, 2004 letter that
included as an attachment follow-up questions and answers regarding the
scope of the guidance and the responsibilities of the providers
(Reference: S&C-04-37). In this proposed rule, we are soliciting
comments on a wide range of issues affecting the population of patients
who are nursing home residents and who desire to be dialyzed in the
nursing home. We have received inquiries as to whether an
institutionalized setting such as a long-term care facility may be
considered to be a beneficiary's ``home'' for self-dialysis purposes.
In the past we have provided guidance in response to these inquiries.
Home dialysis is currently only an option for NF or SNF patients when
certain conditions are satisfied: (1) The NF or SNF must be considered
to be the patient's home (for short NF or SNF stays, such as
rehabilitation or brief recovery time admissions, the nursing home
would not be considered the patient's home since the expectation is
that the patient would soon be discharged and return to their own
home); (2) the patient (and his or her family member or caregiver) must
complete the home dialysis training; (3) all home dialysis patients
must have their own dialysis machine, equipment, and supplies; and (4)
home dialysis patients must receive their support services from a
certified dialysis facility.
Currently the NF or SNF patient who requires hemodialysis may be
transported to a certified outpatient hemodialysis facility or may
receive treatment from a certified hemodialysis facility available
within or adjoining the NF or SNF. We recognize the hardship placed on
long-term care patients who must be transported to offsite dialysis
facilities 3 times per week. Since there is potential growth for home
dialysis in NFs and SNFs because of changing demographics in both the
ESRD population and the general population, it may be appropriate for
us to provide further guidance regarding the regulatory expectations
for the provision of dialysis in the NF or SNF.
Dialyzing patients in NFs or SNFs without a certified ESRD facility
within or adjoining the NF or SNF may present both opportunities and
risks. Dialysis patients who remain in the NF or SNF are less likely to
miss medication administration, treatment regimens, meals or planned
activities during time that would otherwise be spent in waiting and
transportation to and from a dialysis facility. We know that some
patients would prefer to stay in their residence and dialyze while
others would prefer to be transported to a certified dialysis facility
for care. We believe that both choices should be available for NF or
SNF residents, and we believe that both choices should provide patient
protections for health and safety. In addition, we believe that
patients receiving dialysis in a NF or SNF should not be deprived of
essential services that they would normally receive in an outpatient
dialysis facility. Finally, we need to assure that, in providing
hemodialysis treatments in a NF or SNF, the care of other residents in
the NF or SNF not requiring dialysis is not negatively impacted. We are
soliciting comments on whether the current home dialysis regulations
need to be modified to protect this vulnerable population, and if so,
in what ways and under what particular set of circumstances.
In the current ESRD regulations, the home dialysis training
requirement presents a significant barrier in providing home dialysis
to NF or SNF residents as the patient may be untrainable and may not
have a ready caregiver who could be co-trained to assist the resident
in performing dialysis. The patient's role in home dialysis is defined
at Sec. 405.2102 under the definitions section of the requirements.
The regulations require the patient to take part in the training. We
have received correspondence requesting that the home-dialysis training
requirement be waived for NF or SNF residents. It has been our long-
standing policy to encourage home dialysis. We are also aware of the
current limitations relative to severely debilitated patients who are
ineligible for home dialysis based on the training requirement. Given
the relative acuity of nursing home patients, there are safety concerns
associated with allowing patients in nursing homes to be home dialysis
patients. These patients may be less able to voice symptoms/problems
then the typical ESRD home patient. In addition, the dialysis care of a
patient who requires nursing home services may be more complex than the
dialysis care of an independent home dialysis patient, and given their
frailty, these patients may be more vulnerable than an independent home
dialysis patient. Because of this, we have significant safety concerns
about encouraging home dialysis, provided by multiple caregivers, who
may not have any dialysis experience, in this setting.
Home dialysis patients may choose to obtain their dialysis supplies
and equipment from either the dialysis facility that provides the home
training and support services (Method I payment) or from a DME company
(Method II payment). The dialysis facility may have more patient
contact and be more able to determine that necessary supplies are
provided at the right time and in the right amounts to meet the needs
of home patients due to the enhanced patient contact. If hemodialysis
were provided to NF or SNF residents within the home dialysis model,
these patients would continue to be able to choose between Method I and
Method II.
In order to address the issue of home dialysis in the NF or SNF, we
believe there needs to be clarity about the various roles and
responsibilities of the certified ESRD facility providing dialysis care
and the responsibilities of the NF or SNF when there is no certified
ESRD facility onsite or adjoining the NF or SNF. While we have
addressed many of these concerns relative to the existing regulations
through guidance to the State survey agency directors, the important
issues that we would have to address through new rulemaking and the
issues on which we request comment are discussed below.
a. Delineation of Responsibility
We believe the home hemodialysis services provided in a NF or SNF
should be provided under the direction of a certified dialysis facility
that is responsible for the dialysis care provided to the ESRD
patients, for assuring that the NF or SNF is capable of providing
appropriate pre- and post-dialysis care, and for assuring that there is
coordination of care between the two entities, that is, the nursing
home and the ESRD facility. In order to assure that roles and
responsibilities are clearly delineated prior to the initiation of
care, we believe there should be a written agreement (specifying
responsibilities and the coordination of care) between all parties
providing the care, including the NF or SNF (and the DME supplier, if
applicable).
[[Page 6214]]
b. Applicable ESRD Conditions for Coverage
Consideration must be given as to whether home dialysis care
provided in a NF or SNF must comply with all of the proposed conditions
for coverage, except Sec. 494.120, that governs special purpose
dialysis facilities and the specification at Sec. 494.180(d) that
services must be provided on or contiguous with the premises.
c. Nursing Coverage
The existing regulations (Sec. 405.2162(b)) require that a
licensed health professional (for example, physician, registered nurse,
or licensed practical nurse) experienced in rendering ESRD care is on
duty to oversee ESRD patient care whenever patients are being dialyzed.
This proposed rule would require (proposed Sec. 494.180(b)(2)) that a
registered nurse be on the premises whenever in-center patients are
being treated. We believe that there would be a comparable risk to
patient health and safety if a licensed nurse was not on the premises
of the NF or SNF and available during multiple simultaneous home NF or
SNF dialysis treatments. Consideration must be given as to whether this
registered nurse could be a NF or SNF registered nurse trained by the
ESRD facility, or a registered nurse provided by the ESRD facility to
be available during NF or SNF hemodialysis treatments.
If the NF or SNF were allowed to provide this registered nurse to
be available during hemodialysis treatments then the implications for
care (requiring registered nurse attention) provided to other NF or SNF
residents must be considered. We are considering whether a limitation
of the NF or SNF registered nurse's duties is necessary, so that the
nurse is available to meet dialysis needs while another nurse tends to
the NF or SNF residents (for example, such as the absence of direct NF
or SNF resident care responsibilities and allowance of only
administrative duties). When considering whether the NF or SNF
registered nurse may be the licensed individual responsible for
overseeing resident care when residents are being dialyzed, the
provision of training by the ESRD facility for this individual also
must be addressed.
While the registered nurse would oversee the dialysis, a trained
caregiver would administer the dialysis treatment. In a typical home
dialysis patient situation, the ratio of patient to caregiver is one-
to-one. We solicit comments on whether we should address patient to
caregiver ratios in a situation when the NF or SNF is considered the
patient's residence.
d. Training
We believe that training provided by the certified ESRD facility
should be specified and the ESRD facility should be responsible for
providing training to NF or SNF staff and to all caregivers who will be
working with the ESRD patients. These caregivers could possibly include
the nursing and support staff of the residential institution, dialysis
facility nurses and patient care technicians, and the caretaker that
may be provided by the DME supplier, if available and the patient is a
Method II home dialysis patient. We note that Medicare does not provide
additional reimbursement for caregiver services within the current
payment system. We believe that caregiver-training requirements that
are similar to the training specifications for home dialysis patients
may be appropriate.
e. Monitoring
If we were to propose requirements on this topic, we believe that
the certified ESRD facility should be responsible for monitoring the
care of the ESRD patient in the NF or SNF. We also believe that the
dialysis facility should assure that trained caregivers be present in
the room with the patient at all times while the hemodialysis is being
provided. This ensures that a knowledgeable individual is available to
assist the patient if any problems arise.
We believe that the ESRD facility should--(1) periodically assess
the ability of the staff (NF or SNF staff and caregiver) responsible
for care of the ESRD patient to assure that they are competent in their
tasks; (2) retrieve and review complete data, including laboratory
data, clinical data, outcome data, and interdisciplinary team notes to
assure that adequate care is being provided; (3) monitor the care of
the patients, using appropriate clinical standards; and (4) work with
the NF or SNF staff to monitor whether dialysis treatments being
provided in the nursing home negatively impact the care of other NF or
SNF residents and correct such impact as appropriate.
We believe that the dialysis facility should ensure that care being
provided to patients receiving dialysis in a NF or SNF is comparable to
the care provided to facility patients. Thus, the support services
provided to NF or SNF residents should parallel the treatment provided
to patients in a dialysis facility. Therefore, we believe that the
dialysis facility providing dialysis in a NF or SNF must also: (1)
Provide periodic monitoring of the institutional residence to assure
that appropriate care is being provided; (2) provide monitoring of
supplies and equipment; (3) maintain medical records in both the NF or
SNF and at the certified ESRD facility; and (4) assure that patient
rights are protected as they would be in a dialysis facility, including
access to a formal grievance process by the patient or the patient's
guardian or advocate.
We want to ensure that the health and safety of NF or SNF
hemodialysis patients is protected and so we are soliciting comment on
the provision of hemodialysis in the NF or SNF on the issues discussed
above. Specifically, we solicit comment on what competency requirements
and experience/qualifications should be proposed for the caregiver (who
is not a patient's family member) and for the registered nurse, what
restrictions should be placed on the caregiver or the registered nurse
or both, and whether caregiver to patient ratio limits should be
proposed. We are interested in any suggestions regarding this issue to
provide for the specific needs of this vulnerable population, and on
how we can make these requirements more flexible to meet the needs of
the providers, while providing appropriate patient protections.
E. Condition: Quality Assessment and Performance Improvement (Proposed
Sec. 494.110)
[If you choose to comment on issues in this section please include the
caption ``QAPI'' at the beginning of your comment.]
An integral part of our effort to move toward a patient outcome-
based system is the facility level quality assessment and performance
improvement (QAPI) program. We propose to require that a dialysis
facility create its own tailored program for quality improvement based
on the framework provided in this condition. Existing Sec. Sec.
405.2112(c) and 405.2113(a) address quality standards for patient care
in the context of the ESRD network organization's role. Although Sec.
405.2134 requires each dialysis facility to participate in network
activities and to pursue network goals, there is currently no clear
Federal requirement for an ongoing facility-specific, patient-centered
continuous quality improvement program. The focus on outcomes in this
proposed rule is a result of the fundamental shift in approach to
performance expectations within the health care industry and efforts
within the renal community to define and examine outcomes.
[[Page 6215]]
In 2000, the Office of the Inspector General (OIG) of the
Department of Health and Human Services (DHHS) conducted an extensive
review to ascertain the effectiveness of our monitoring of the ESRD
program. Their subsequent report was entitled ``External Quality Review
of Dialysis Facilities: A Call for Greater Accountability'' (DHHS/OIG,
June 2000). The purpose of this review was to ``assess external
mechanisms HCFA relies upon to monitor the quality of care provided by
dialysis facilities to Medicare beneficiaries with ESRD.'' This OIG
report provides a thorough review of the external quality oversight of
dialysis facilities in the United States and the roles played by CMS,
the State survey agencies, and the ESRD networks. The OIG recommended
that dialysis facilities be required to conduct their own quality
improvement programs. The OIG also recommended that facilities be
required to establish internal systems for identifying and analyzing
the causes of medical injuries and medical errors. Another
recommendation was to require facilities to monitor patient
satisfaction. The Institute of Medicine's (IOM) 1991 report, ``Report
on Kidney Failure and the Federal Government'' suggests that relating
the conditions for coverage to patient outcomes would assist the
quality assurance efforts of the ESRD program (IOM, 1991).
The 2001 IOM report, ``Crossing the Quality Chasm: A New Health
System for the 21st Century'' addresses the need to narrow the quality
chasm between the potential benefits of medical science and technology
and the actual level of health care provided in the United States (IOM,
2001). The report offers a strategy and action plan for building a
stronger health system over the coming decade. The report presents
multiple challenges to health care leaders and points out that all
organizations can improve their performance by incorporating care
process and outcome measures into their daily work. In addition, many
renal groups (including the RPA, the American Nephrology Nurses
Association, the NKF, and the American Association of Kidney Patients)
have developed similar positions. We believe that the quality
improvement activities in this proposed rule and the data systems of
the future will provide an opportunity to focus more closely on patient
outcomes. We believe that it is critically important that dialysis
facilities examine the adequacy of their information technology and
identify opportunities to improve and expand the use of such
technologies to prevent medical errors and improve the quality of care.
This Administration is committed to working with other public and
private stakeholders to develop means for improving and expanding the
use of information technologies (such as bar coding and computerized
physician order entry systems) in health care settings.
Proposed Sec. 494.110 would require that a facility develop,
implement, maintain, and evaluate an effective, data-driven, quality
assessment and performance improvement program that reflects the
complexity of the dialysis facility's patient population and its
processes of care. The dialysis facility must take actions that result
in performance improvements in the quality of patient care. We believe
that dialysis facilities need to have a continuous quality improvement
system in place to continually assess and improve health care delivery.
The facility's quality improvement program should monitor the systems
and processes of care that are used to achieve the targeted patient
outcomes. This approach calls for facilities to systematically collect
and analyze clinical data about the components of their care processes.
The majority of facilities already collect clinical performance
measures as described in the 2002 OIG report, which describes the
quality improvement programs of large dialysis corporations (DHHS/OIG,
January 2002). The 5 largest dialysis corporations (representing 67
percent of the total number of dialysis facilities) routinely collect
data on at least 14 clinical performance measures; and therefore,
requiring collection of those clinical performance data would not
impose an additional data collection burden on most dialysis
facilities. These types of data can be used to assess facility care
processes and to identify opportunities for improvement. Once the
opportunity has been identified, the facility should develop and
implement an intervention strategy that focuses on the processes that
need improvement, and then evaluate whether the improvement strategy
achieved the desired results. The facility should reexamine goals that
have been achieved and, if applicable, undertake new interventions to
further increase the quality of care processes, outcomes, and patient
satisfaction. The facility must continue to track its performance to
assure that improvements in patient outcomes and patient satisfaction
are sustained. This is what is meant by the cycle of continuous quality
improvement.
This QAPI approach demands an evaluation of organizational
performance and a patient-centered focus. The evaluation includes
measuring actual performance, as well as the impact of the performance
on patient outcomes and satisfaction. The evaluation answers the
question: ``Did that process, treatment or procedure produce the
targeted outcomes?'' The approach gives the facility the ability to
analyze interdependent processes of care and adjust them to optimize
the system for providing care.
1. Program Scope (Sec. 494.110(a))
We are proposing in Sec. 494.110(a) to require that the dialysis
facility's QAPI program address at least the following areas: (1)
Adequacy of dialysis; (2) nutritional status; (3) anemia management;
(4) vascular access; (5) medical injuries and medical errors
identification; (6) hemodialyzer reuse program (if applicable); and (7)
patient satisfaction and grievances. We believe that these areas are
reflective of: (1) the degree to which the facility achieves desirable
patient outcomes; the extent of patient safety within the facility; and
(2) the level of satisfaction attained as the patient experiences the
continuum of care.
Adequacy of dialysis has become an important clinical performance
measure for benchmarking the quality of dialysis care. We believe that
it is appropriate and necessary to consider using consensus performance
measures in our health and safety standards for facilities. The NKF-K/
DOQI guidelines for hemodialysis adequacy (guideline 4) provide minimal
adequacy of hemodialysis levels of Kt/V of 1.2 and URR of 65, but do
not suggest optimal dialysis target levels, based on their conclusion,
after a literature review, that there is not sufficient data to make
that determination (NKF, 2000).
The Hemodialysis Study sponsored by the National Institutes of
Health began in 1995 and was a comprehensive randomized clinical trial
of dose and flux interventions to identify improvements in therapy that
will reduce hemodialysis mortality. The study entitled ``Effect of
Dialysis Dose and Membrane Flux in Maintenance Hemodialysis,''
confirmed that the minimum dosage of thrice weekly hemodialysis as
stated in the NKF-K/DOQI Guideline 4 (that is, Kt/V of 1.2 and URR of
65) is adequate and that, in general, a high dosage and special high-
flux filters provide no added benefit in terms of survival, rate of
hospitalization, and albumin levels to patients (Eknoyan, pp. 2010-
2019). The Hemodialysis Study also found statistically nonsignificant
data suggesting that higher dialysis dosage
[[Page 6216]]
appeared to reduce mortality and hospitalization for women in those who
had been receiving hemodialysis longer than 3.5 years when they joined
the study (DHHS/NIH, 2002).
A recent retrospective study suggests that the recommended minimal
urea reduction ratio of 65 percent may be too low to provide for an
optimal mortality benefit (Szczech, pages 738 through 745). Also, we
recognize that there are several possible methods for calculating Kt/V.
In addition, a major concern for accurate measurement of either URR or
Kt/V is that small differences in the method and timing of the blood
draw used for the postdialysis blood urea nitrogen (BUN) blood sample
can make clinically important differences in the resulting hemodialysis
adequacy estimates.
We acknowledge the need for consistency in the techniques used for
blood withdrawal as well as the method or formula used to calculate the
Kt/V value. We considered proposing requirements that specified pre and
postdialysis blood draw methods and Kt/V calculation methods that might
allow for more accurate benchmarking. However, we are not proposing a
specific methodology at this time, because we believe it would be more
appropriate to recommend and encourage dialysis facilities to adopt the
methodology(ies) recommended by a consensus process such as the NKF-K/
DOQI.
Despite these difficulties, dialysis facilities do use adequacy of
dialysis as one of their benchmarks when evaluating the quality of
peritoneal and hemodialysis patient care. The CMS ESRD CPM Project
calculates the adequacy of dialysis measures for hemodialysis and
peritoneal dialysis patients (that is, URR and Kt/V) that can be used
by facilities and ESRD networks for benchmarking and comparison
purposes. The CMS ``Dialysis Facility Compare'' website provides
facility-specific adequacy-of-dialysis information in terms of what
percentage of patients are receiving at least the minimal dose of
dialysis (defined as a URR >= 65 percent). The use of minimal
performance levels for adequate dialysis is widely used to allow for
comparisons. However, facilities are encouraged to evaluate the needs
of individual patients and to deliver the amount of dialysis that will
promote optimal health outcomes for that patient.
In addition, we are proposing in Sec. 494.110(a)(2)(ii) that the
dialysis facility's QAPI program must also address nutrition. The
nutritional status of the dialysis patient impacts the patient's
morbidity, mortality, and overall quality of life. The nutritional
status of the patient may be affected by medical symptoms,
physiological responses to ESRD, the dialysis process itself, anemia,
endocrine disorders, etc. The importance of nutritional status in
dialysis patients is recognized in the K/DOQI clinical practice
guidelines for nutrition of chronic renal failure and in the ESRD CPM
Project's inclusion of serum albumin levels. Under the plan of care
condition (proposed Sec. 494.90) we are proposing that the serum
albumin level be monitored on a monthly basis. The facility may track
the serum albumin levels or any other pertinent markers of nutritional
status as part of its QAPI program. The goal is to identify care system
opportunities for improving patient nutritional outcomes and then
develop and implement interventions that will potentially achieve the
targeted outcomes.
We are also proposing in Sec. 494.110(a)(2)(iii) that the QAPI
program must include anemia management. Existing Sec. Sec. 405.2137(b)
and 405.2163(g) address the patient's hematocrit level as the indicator
for the necessity for administering erythropoietin. In 1996, anemia was
the subject of the first National Cooperative Project conducted by the
ESRD networks. The reasons for selecting anemia both for the study and
as an outcome measure included: (1) The prevalence of anemia among the
Medicare population; (2) a consensus among the renal community that
anemia is a major quality-of-life problem for dialysis patients and
that proper drug manipulation can improve this condition; (3) the fact
that commonly used measures of anemia (hematocrit and hemoglobin
levels) are routinely collected by us when facilities bill Medicare for
erythropoietin on the outpatient billing form; and (4) the relatively
straightforward and easily accomplished process for monitoring
hematocrit (or hemoglobin) levels.
The United States Renal Data System (USRDS) Annual Data Report and
the ESRD CPM Project provides regional and national anemia data that
allow for facility benchmarking. The NKF-K/DOQI clinical practice
guidelines for Anemia of Chronic Kidney Disease (Guideline 4) recommend
an evidence-based target for hemoglobin of 11-12 g/dL (and hematocrit
of 33 to 36 percent) for erythropoietin therapy. In May 2000, according
to the 2001 Atlas of ESRD in the United States (USRDS), 12 percent of
prevalent dialysis patients (that is, patients who have received
chronic renal replacement therapy for at least 90 days) with
erythropoietin claims had hematocrits less then 30 percent and the risk
of hospitalization is increased with hematocrit levels less than 30
percent. The 2001 ESRD Clinical Performance Measures (CPM) Project
Annual Report revealed that 74 percent of in-center hemodialysis
patients who were prescribed erythropoietin during the last 3 months of
2000 had a mean hemoglobin of equal to or greater than 11gm/dL (which
is approximately equal to a hematocrit of 33 percent). This same report
reveals that 63 percent of peritoneal dialysis patients prescribed
Erythropoietin during the study period had a mean hemoglobin of equal
to or greater than 11 gm/dL. This proposed rule uses anemia, as
measured by the hematocrit or hemoglobin level, as an element of
patient outcomes for both hemodialysis and peritoneal dialysis
patients.
Vascular access insertions and complications (for example,
infection) have received increasing attention over the past few years.
The current ESRD network quality improvement project, Fistula First, is
focused on vascular access. Complications associated with vascular
access account for about 18.3 percent of ESRD patient hospitalizations
(USRDS data from 2000) and is associated with high financial costs and
diminished quality of life for the hemodialysis patient. Therefore, we
are proposing in Sec. 494.110(a)(2)(iv) that vascular access
management be included in the facility's QAPI program. Facilities
should look for opportunities to improve patient outcomes related to
vascular access by reviewing ESRD Fistula First data and ESRD CPM
Project data in conjunction with the NFK-K/DOQI clinical practice
guidelines for vascular access. The ESRD CPM Project and the USRDS
Annual Data Report provide regional and national data pertaining to
vascular access. The NKF-K/DOQI clinical practice guidelines for
vascular access provide valuable information useful to a facility QAPI
program regarding vascular access management.
We are proposing in Sec. 449.110(a)(2)(v) to require a patient
safety component specific to medical injuries and medical errors
identification as part of each facility's QAPI program. The IOM
published a report entitled ``To Err is Human: Building a Safer Health
System,'' that focused on the magnitude of medical errors, serious
adverse events and the risks of medical care in the United States (IOM,
2000). Medical injuries and medical errors were also identified by the
OIG as areas in which we should facilitate the development of publicly
accountable means for identifying serious medical injuries and
analyzing their causes. The OIG found
[[Page 6217]]
that medical injuries are not systematically monitored in dialysis
facilities.
The Renal Physicians Association (RPA), in partnership with the
Forum of ESRD networks and the Patient Safety Foundation, has formed a
Patient Safety Committee to address patient safety in dialysis
facilities. The Committee's report describes the work of 42 stakeholder
representatives from 34 organizations as they engage in collaborative
action planning (The Renal Physicians Association, 2001). The group
identified challenges in improving patient safety, action options, and
priorities. These participants have expressed their commitment to
interorganizational collaboration on selected actions in the launch of
the next phase of this initiative. The Phase I Report supports for the
incorporation of patient safety activities into the conditions for
coverage for ESRD, to encourage universal engagement in patient safety
participation. This initiative provides resource information that may
be useful to facilities as they develop their QAPI program to reduce
medical errors and injuries.
We propose in Sec. 494.110(a)(2)(vi) that if a dialysis facility
reprocesses hemodialyzers they must include reuse systems in their QAPI
program. The AAMI Reuse of hemodialyzers RD47 chapter (incorporated by
reference in both the existing and the proposed conditions) includes
guidelines for a reuse quality assurance program under section 14.
Section 14 outlines quality assurance program areas that include: (1)
Records that serve as the quality assurance foundation; (2) schedule of
quality assurance activities; (3) patient considerations; (4)
equipment; (5) physical plant; (6) supplies; (7) dialyzer labeling; and
(8) reprocessing and preparation for dialysis. Since these activities
are the same in the proposed conditions for coverage as in the existing
conditions for coverage, there is no additional regulatory burden.
Continuous quality management in the reuse area is important to
ensuring patient safety.
Assessment of patient satisfaction was identified by the OIG as a
means of identifying patient concerns often missed by the complaint
process. The OIG recognized that patients play an increasingly
important role in their own health care, and that techniques of
assessing patient satisfaction have become increasingly sophisticated.
We concurred with the OIG's recommendation. Therefore in Sec.
494.110(a)(2)(vii), we are proposing that dialysis facilities include
patient satisfaction in their QAPI programs. The OIG further
recommended that we exert leadership to facilitate the development of a
common instrument that facilities and others could use to assess
patient satisfaction. Many facilities do currently use a patient survey
as a means to assess patient satisfaction and some have experience in
utilizing the results for quality improvement efforts.
We are proposing that facilities monitor patient satisfaction and
grievances as part of the QAPI program and have the flexibility to use
the method of their choice to meet this requirement. Tracking patient
satisfaction and grievances allow the facility to identify any areas in
which patients have expressed concerns. The facility can analyze this
information and determine what aspect of facility operations needs
improvement. CMS has an Intra-agency Agreement with AHRQ to develop a
standardized patient experience of care instrument and survey protocol.
In 2003, AHRQ conducted a feasibility study to assess the feasibility
and applications (that is, quality improvement and public reporting) of
a survey that measures dialysis patients' experience of care in renal
dialysis facilities. In the August 25, 2003 Federal Register (68 FR
51017), AHRQ published a notice that identified and cataloged existing
surveys and survey results made available to the team and presented the
exhaustive literature review that was performed. In addition, a
Technical Expert Panel consisting of ESRD patients and professionals
was consulted. AHRQ's ESRD Consumer Assessment of Health Plan Survey
(CAHPS) Feasibility Final Report and the CMS response can be found on
http://www.cms.hhs.gov/quality (follow the ESRD link to the CAHPS
link).
In the Feasibility Report, AHRQ recommended that a standardized
survey for measuring in-center hemodialysis (ICH) patients' experience
and ratings of their care be developed that could serve several
important and distinct purposes. An ICH CAHPS survey would provide
information for consumer choice, reports that facilities can use for
internal quality improvement and external benchmarking against other
facilities, and finally, information that we can use for public
reporting and monitoring purposes. The survey would be in the public
domain and consist of a core set of questions that could be used in
conjunction with existing surveys.
In a January 30, 2004 Federal Register notice (69 FR 4520)
published as part of the Paperwork Reduction Act (PRA) process, a draft
survey and pilot test plan were issued. On July 23, 2004, a second
Federal Register notice (69 FR 44012) was published and the package
including the draft survey and pilot test plan was submitted to OMB at
that time.
We will take into consideration the practical difficulties and
potential burden on facilities that may result from requiring the use
of a common instrument for assessing patients' experience of care.
However, we invite comment on the value of utilizing one common survey
that can yield information permitting comparisons of facilities across
the nation.
We are also interested in how facilities will assess the
effectiveness of their internal grievance adjudication process, track
the outcomes of patient grievances, and identify meaningful criteria
for evaluation and tracking purposes. We are soliciting comment on how
evaluating and tracking grievances can be used to improve patient
outcomes of care.
2. Monitoring Performance Improvement (Proposed 494.110(b))
We will specifically expect a facility whose treatment outcomes
vary significantly from accepted standards to identify the reasons for
poor outcomes and implement improvement projects to achieve expected
outcomes. Therefore, we are proposing in Sec. 494.110(b) that the
dialysis facility must take actions that result in performance
improvements and must track performance to assure standards are met and
that improvements are sustained over time. This action stimulates the
provider to continuously examine and improve performance. In addition,
we are retaining the requirement in existing Sec. 405.2134 that
requires a dialysis facility to participate in ESRD network activities
and pursue Network goals.
3. Prioritizing Improvement Activities (Proposed 494.110(c))
The principal focus of the facility's continuous quality
improvement program should be to establish a strategy to prioritize
improvements in facility services so that performance improvements lead
to better outcomes of care and increased satisfaction for patients. To
this end, the proposed Sec. 494.110(c) requires the dialysis facility
to set priorities for performance improvement, considering prevalence
and severity of identified problems and giving priority to improvement
activities that affect clinical outcomes. The facility must immediately
correct any identified problems that directly or potentially threaten
the health and safety of patients. Under the continuous quality
improvement system, facilities should be analyzing care processes that
[[Page 6218]]
determine how the facility's performance has affected--positively and
negatively--patients, especially in terms of what the patient actually
experiences. This proposed requirement emphasizes the need for the
facility to focus on the areas of performance where problems have been
specifically identified, especially in areas relating to outcomes of
patient care. By prioritizing areas of improvement, facilities can: (1)
Identify areas where outcomes indicate a need for improvement; (2)
define measures to improve outcomes; (3) review implementation of
improvement actions; and (4) determine the success of the actions
implemented to improve the performance measures.
With an effective QAPI program, the dialysis facility can identify
and reinforce the activities that it is performing well and seek and
respond to opportunities for improvement on a continuous basis. We
intend that as a result of this proposed requirement the facility
itself will be the catalyst that precipitates continuous improvements.
The dialysis facility may choose to inform their patients of facility's
quality improvement activities and may want to engage patients who are
dialyzing in their facility of these activities. The patient's role in
achieving quality improvement goals in areas such as adequacy of
dialysis and vascular access should be acknowledged. Partnering with
the patients to make improvements may be an important aspect of a
successful QAPI program.
The proposed QAPI Condition discussed in this section of the
preamble encompasses a facility's internal approach to improving the
quality of dialysis care. We are considering putting into place, within
these conditions, minimum clinical standards that would serve as
external stimuli for further improvements in the quality of dialysis
services. The following is a discussion of how minimum clinical
standards could be implemented and specific areas for which we are
soliciting public comment.
4. Facility Specific Standards for Enforcement
In this proposed rule, we have discussed and taken an approach to
quality assurance that relies exclusively upon the facility's own
process for setting, monitoring, and maintaining clinical standards as
the basis for evaluating its performance. This approach is consistent
with our overall approach to quality improvement. However, dialysis
care is provided in as homogeneous a medical context as any service and
may well be susceptible to measurement against baseline clinical
expectations.
The OIG's Report of 2000 on External Quality Review of Dialysis
Facilities: A Call for Greater Accountability encourages the use of
standardized performance measures to hold individual facilities
accountable for quality of care. OIG also recommends an approach that
reflects a balance between collegial and regulatory modes of oversight.
Their report addresses the use of standardized performance measures
both to engage in quality improvement activities and to enforce minimum
standards.
Supporters of an approach requiring adherence to clinical standards
for ESRD facilities argue that: (1) There is specificity and relative
homogeneity in the services delivered; (2) there are significant risks
to patient safety if care is not delivered appropriately; (3) the renal
community has been proactive in defining and using clinical standards;
(4) there are correlations between having acceptable NKF-K/DOQI-derived
measures for adequacy of dialysis and anemia and positive outcomes for
individual patients; and (5) the data systems supporting ESRD program
operations are comprehensive and unique.
We are soliciting comments on the feasibility of using commonly
agreed-upon clinical standards in our requirements and enforcement
efforts. In setting the minimum clinical standards for performance, we
would use selected clinical practice guidelines developed by the NKF-K/
DOQI, which were developed with broad community input and consensus,
and have gained extensive national and international acceptance. We
would initially establish minimal expectations about adequacy of
dialysis rates and anemia levels, but we would continuously look to
science for updated standards.
The method for applying these standards would be to require that a
dialysis facility must maintain minimum clinical standards (that is,
adequacy of dialysis and anemia levels) for all patients. If the
patient's outcomes did not meet the clinical expectations, the
interdisciplinary team would be required to make adjustments. If the
patient is unable to achieve the minimum expected clinical outcomes, a
member of the interdisciplinary team would need to enter an explanation
in the patient's medical records. If the minimum expected clinical
outcome is achievable but is not being achieved, the interdisciplinary
team would be expected to develop and implement an improvement program
to achieve and maintain the expected outcome.
We would periodically establish our requirements and publish them
in the Federal Register. The standards that we would use if this
approach were adopted are as follows:
The minimum delivered threshold for Kt/V is--
--1.2 (single pool) for hemodialysis patients (as specified in the NKF-
K/DOQI Clinical Practice Guidelines For Hemodialysis Adequacy: Update
2000, Guideline 4);
--1.7 (weekly) for continuous ambulatory peritoneal dialysis patients
(as specified in the NKF-K/DOQI Clinical Practice Guidelines for
Peritoneal Dialysis Adequacy: Update 2000, Guideline 15);
--2.1 (weekly) for continuous cycling peritoneal dialysis patients (as
specified in the Peritoneal Dialysis Adequacy: Update 2000, Guideline
16); and
--2.2 (weekly) for intermittent peritoneal dialysis patients (as
specified in the Peritoneal Dialysis Adequacy: Update 2000, Guideline
16).
For anemia management, the minimum required levels would
be--
--A hemoglobin level of 11 gm/dL (as specified in the NKF-K/DOQI
Clinical Practice Guidelines for Anemia of Chronic Kidney Disease:
Update 2000, Guideline 4); or
--A comparable hematocrit of at least 33 percent (as specified in the
NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney
Disease: Update 2000, Guideline 4).
To make this approach work, we would need to address and mitigate
the disadvantages that arise from assigning minimum numerical target
values. We would be required to go through a rulemaking process each
time we wanted to update the numerical values to correspond with any
scientific advances. NKF-K/DOQI clinical practice guidelines for
adequacy of dialysis and anemia are designed for assessing individual
patient care based on individual patient characteristics. We would need
to address the issue of using these as measures for facility-wide
performance. Can this effectively be done or would a risk adjustor need
to be developed to avoid disadvantaging facilities that have a
different case mix? We are also soliciting comments on methods for
using current NKF-K/DOQI clinical practice guidelines as facility-wide
measures. For example, comments on the use of the statistically based
threshold measures of performance would be especially helpful. Under
such an approach, facilities in which a predetermined portion of
patients fail to
[[Page 6219]]
meet the selected clinical standards over some period of time, using a
standard deviation, percentile-based, or some other method, need to
develop a corrective action plan. We are specifically soliciting
comments on this issue.
If we were to codify a clinical standards condition, the text would
read as follows:
Condition: Clinical Standards
The dialysis facility must maintain minimum clinical standards for
all patients. If the patient's care does not meet such standards, the
interdisciplinary team must make adjustments. If the patient is unable
to achieve the minimum expected clinical outcomes, a member of the
interdisciplinary team must provide an explanation in the patient's
medical records. If the minimum expected clinical outcome is achievable
but is not being achieved, the interdisciplinary team must develop and
implement an improvement program to achieve and maintain the patient's
expected level of general health.
Standard: Performance Expectations
(a) Dose of dialysis. The interdisciplinary team must assist and
support facility patients in achieving and maintaining the expected
dose of dialysis as specified by the Secretary and published in
accordance with the notification requirements in paragraph (d)(i) of
this section.
(b) Anemia. The interdisciplinary team must assist and support
facility patients in achieving and maintaining the expected hematocrit/
hemoglobin level as specified by the Secretary and published in
accordance with the notification requirements in paragraph (d)(i) of
this section. The patient's hematocrit/hemoglobin levels must be
measured at least monthly.
(c) Additional clinical standards. Facilities are responsible for
assuring that their patients achieve at least a minimum performance
level on additional clinical standards that may be selected by the
Secretary. The methodology and minimum performance expectations will be
determined in accordance with the NTTAA guidelines.
(d) Notification. CMS will publish a Federal Register document that
proposes or finalizes--
(i) The current minimum expected outcomes for dose of dialysis and
anemia referenced in paragraphs (a) and (b) of this section.
(ii) Other standards upon development and acceptance of the
standards by the Secretary.
F. Condition: Special Purpose Renal Dialysis Facilities (Proposed Sec.
494.120)
[If you choose to comment on issues in this section please include the
caption ``Special Purpose Renal Dialysis Facilities'' at the beginning
of your comment.]
Special purpose renal dialysis facilities are dialysis units
approved on a short-term basis (currently, for no more than 8 months)
to provide dialysis services to a group of patients otherwise unable to
obtain treatment in the geographic area served by the facility.
The existing requirements for special purpose renal dialysis units
are in Sec. 405.2164. That section states that special purpose units
must comply with the conditions specified at Sec. Sec. 405.2130
through 404.2164, with the exception of Sec. Sec. 405.2134 to 405.2137
(that is, conditions relating to participation in network activities
and the patient long-term care program). Existing Sec. 405.2164(b)
requires a special purpose facility to consult with the patient's
physician to ensure that care provided is consistent with the care plan
and long-term care plan required in existing Sec. 405.2137. Existing
Sec. 405.2164(c) requires the ``period of approval'' (that is,
Medicare certification), not to exceed 8 calendar months.
In the May 11, 1983 Federal Register (48 FR 21254), we published a
final rule that provided for time-limited approval of special purpose
renal dialysis facilities. These facilities were established for two
purposes: (1) To serve ESRD patients in a vacation area (such as a
vacation camp) when the area is too remote from existing approved
facilities to allow convenient access by patients; or when a convenient
approved facility does not have sufficient available capacity to serve
a number of vacationing patients; and (2) to serve ESRD patients on an
emergency basis when approved permanent facilities close due to natural
disasters, strikes, or bankruptcies, and the backup facilities in the
area cannot accommodate the patients of the closed facilities. In the
May 11, 1983 final rule, the last provision was added specifically,
``to ensure continuous access to care in the event that an approved
permanent facility is closed because it cannot achieve adequate
revenues under the prospective reimbursement system.'' The
certification period of 8 months was determined to be appropriate in
response to public comments urging that the original temporary
certification proposal (of 6 months) be extended.
Following the publication of the May 11, 1983 final rule, we
developed a certification and approval process and a separate series of
provider numbers for ESRD facilities approved as special purpose renal
dialysis facilities.
In our deliberations regarding any possible revisions to this
condition, we found that very few vacation camps have requested
approval for certification as special purpose renal dialysis
facilities. In March 2001, for example, Medicare records indicated that
only one vacation camp in the United States was certified as a special
purpose renal dialysis facility. We now question whether the
requirements for vacation camp renal facilities to be certified as a
special purpose renal dialysis facility are too onerous.
A search on the web lists 36 camps for ESRD patients throughout the
United States. Some of the camps do not accept hemodialysis patients or
accept hemodialysis patients for weekend only camps. These camps do not
have a need for hemodialysis services. Other camps provide
transportation to a certified hemodialysis facility off the
campgrounds. Since the number of United States certified hemodialysis
facilities has doubled in the last decade to approximately 4,000,
transporting campers to a nearby dialysis facility may be feasible in
many locations. It is not clear whether there remains a need to
continue to establish vacation camp special purpose renal dialysis
facilities in the conditions for coverage.
However, we are proposing to retain this condition in order to
address the possible needs of patients who, as a result of the
emergency conditions listed above, or participation in a remote
vacation camp, need dialysis services on a short-term basis, and to
ensure that facilities providing this type of care are properly
certified for participation in the Medicare program. We are also
proposing to reduce the burden of the requirements that a vacation camp
must meet in order to be certified as a special purpose renal facility.
Vacation camps generally operate during the summer months, when schools
are closed, and usually offer sessions lasting up to 2 weeks. The task
of meeting the ESRD conditions for coverage in order to offer a few
camp sessions each year (with the exception of the conditions relating
to participation in network activities and the patient long-term care
program), may deter vacation camps from providing hemodialysis services
and seeking Medicare certification.
Therefore, we are proposing in Sec. 494.120 that a special purpose
renal dialysis facility would be approved to furnish dialysis at
special locations, that is, vacation camps that serve ESRD patients in
a temporary residence, or
[[Page 6220]]
facilities established to serve ESRD patients under emergency
circumstances. A vacation camp must be operated under the direction of
a certified renal dialysis facility that assumes full responsibility
for the care provided to patients.
Proposed Sec. 494.120(a) maintains the 8-month approval period in
the existing Sec. 405.2164(c). In view of the history of the few
Medicare-certified special purpose dialysis facilities, we believe a 8-
month approval period is adequate.
Proposed Sec. 494.120(b) would retain the existing service
limitation requirement (specified in Sec. 405.2164(d)) that limits the
special purpose unit to providing services only to those patients who
would otherwise be unable to obtain treatments in the geographic
locality served by the facility.
In addition, we are proposing in Sec. 494.120(c)(1) that a special
purpose renal dialysis facility would be approved as a vacation camp by
demonstrating compliance with the following standards and conditions
for coverage:
Infection control (Sec. 494.30)).
Water quality (Sec. 494.40); if the facility uses home
portable water treatment systems, the facility would instead comply
with the provision regulating home monitoring of water quality (Sec.
494.100(c)(1)-(v)).
Reuse of hemodialyzers and other dialysis supplies if
reuse is performed (Sec. 494.50).
Patients' rights (Sec. Sec. 494.70(a) and (c)).
Laboratory services (Sec. 494.130); a facility would be
required to have a plan for obtaining laboratory services for cases
when it is necessary for patient safety.
Medical director responsibilities for patient care
policies and procedures (Sec. 494.150(c) and (d)).
Medical records (Sec. 494.170).
We are proposing in Sec. 494.120(c)(2) to specify that a special
purpose renal dialysis facility certified due to emergency
circumstances may provide services only to those patients who would
otherwise be unable to obtain treatments in the geographical areas
served by the facility and is approved by demonstrating compliance with
Sec. 494.120(c)(1) and the following additional conditions:
Compliance with Federal, State, and local laws and
regulations (Sec. 494.20).
Physical environment (Sec. 494.60).
Patients' rights (Sec. Sec. 494.70(a) through (c)).
Personnel qualifications (Sec. 494.140).
Medical director (Sec. 494.150).
Governance (Sec. 494.180).
While the certification of a special purpose unit is time-limited
and the patient's treatment in the unit will be limited, we believe
that every effort must be made to ensure that the quality of care
provided is comparable to that provided to any dialysis patient in a
Medicare-approved unit. However, we believe requiring compliance with
any additional requirements would be too burdensome for a special
purpose unit.
We are proposing in Sec. 494.120(d) to retain the existing
requirement that a special purpose unit consult with the patient's
physician, with an added provision that this consultation must occur
before the initiation of dialysis in the special purpose unit. This
provision is added to ensure that the special purpose unit is fully
aware of the patient's current medical condition and that the special
purpose unit can provide dialysis services consistent with the
patient's plan of care described at Sec. 494.90.
In addition, we are proposing in Sec. 494.120(e) to require the
special purpose unit to document care provided to the patient and
forward that documentation to the patient's regular dialysis facility
within 30 days of the last scheduled treatment in the special purpose
unit.
We are soliciting comments on whether vacation camps should
continue to be included under the special purpose renal dialysis
facility condition for coverage.
G. Laboratory Services (Proposed Sec. 494.130)
[If you choose to comment on issues in this section please include the
caption ``Laboratory Services'' at the beginning of your comment.]
In 1994, we revised existing Sec. 405.2163 to stipulate that the
dialysis facility must make available laboratory services (other than
tissue pathology and histocompatibility) and that all laboratory
services must be performed by an appropriately certified laboratory in
accordance with the Clinical Laboratory Improvement Amendments (CLIA)
regulations at 42 CFR 493. Existing Sec. 405.2163(b) also requires a
dialysis facility that furnishes laboratory services to furnish these
services in accordance with applicable requirements established for
certification of laboratories under the CLIA. Independent dialysis
facilities must be certified under CLIA to perform and bill most
laboratory tests to the Medicare program. This section also allows a
dialysis facility that does not provide laboratory services to make
arrangements to obtain these services with a laboratory certified under
CLIA.
We are proposing in Sec. 494.130 to retain the existing
requirements governing laboratory services in Sec. 405.2163(b) without
change.
VI. Provisions of Proposed Subpart D: Administration
A. Personnel Qualifications (Proposed Sec. 494.140)
[If you choose to comment on issues in this section please include the
caption ``Personnel Qualifications'' at the beginning of your comment.]
The existing personnel qualifications of dialysis facility staff
can be found in Sec. 405.2102. Those requirements list the education
and experiential requirements for chief executive officers, physician-
directors, nurses responsible for nursing services, dietitians, medical
records practitioners, transplantation surgeons, and social workers.
In existing Sec. 405.2102(e), a physician-director must be board
eligible or board certified in internal medicine or pediatrics with at
least 12 months of experience or training in the care of patients at
ESRD facilities.
Existing Sec. 405.2102(d) defines the nurse ``responsible for
nursing service'' as a person who is licensed as a registered nurse by
the State in which practicing, with at least 12 months experience in
clinical nursing, with at least 6 months experience in nursing care of
patients with permanent kidney failure or patients undergoing kidney
transplantation, or 18 months of experience in nursing care of the
patient on maintenance dialysis. This section also states that if the
same individual is assigned responsibility for self-care dialysis
training, that individual must have at least 3 months experience in
training ESRD patients for self-care.
Existing Sec. 405.2102(b) defines a dietitian as a person who--
Is eligible for registration by the American Dietetic
Association under its requirements in effect on June 3, 1976 and has at
least 1 year of experience in clinical nutrition; or
Has a baccalaureate or advanced degree with major studies
in food and nutrition or dietetics and at least 1 year of experience in
clinical nutrition.
Existing Sec. 405.2102(f) defines a social worker as a person who
is licensed in the State in which practicing, has completed a course of
study with specialization in clinical practice at, and holds a masters
degree from, a graduate school accredited by the Council on Social Work
Education, or has served for at least 2 years as a social worker with
at least 1 year in a dialysis or
[[Page 6221]]
transplantation program before September 1, 1976 and consults with a
social worker holding a masters degree.
ESRD is an extremely complex disease requiring highly technical and
complex treatment, and patients with this disease have special needs
that require highly specialized care that can only be provided by
qualified personnel. As the demographics of the dialysis population
continue to change, producing a more elderly patient population with
more co-morbid conditions, direct patient care needs and the skill
needed to meet those needs will continue to increase. Also, as we move
away from unnecessary process and procedural requirements in the
conditions for coverage towards better patient outcomes, it becomes
even more important to have qualified, experienced, and well-trained
staff to achieve the targeted clinical outcomes for each patient.
In the past, industry representatives have supported the retention
of minimum personnel qualifications in the conditions, and we are
proposing to retain most of the existing personnel qualifications
requirements in this proposed rule. We are also proposing changes where
we believe they are needed, and those changes are discussed in the
preamble discussion that follows.
In Sec. 494.140, we are proposing to consolidate all of the
personnel qualifications requirements into a single condition, entitled
``Personnel qualifications.'' In addition, proposed Sec. 494.140 would
require that a dialysis facility's staff (whether employees or
contractors) meet the personnel qualifications and demonstrated
competencies necessary to serve the general needs of its patients. We
also propose that the dialysis facility's staff must have the ability
to sustain and demonstrate the skills needed to perform the specific
duties of their positions.
We recognize that facilities are not always able to directly employ
individuals to perform all required services; and therefore, facilities
may continue to furnish services through qualified personnel by
arrangement. Any position in a facility may be filled by a contracted
employee, but the contracted employees must meet the personnel
requirements as well as the demonstrated skills and competencies in
proposed Sec. 494.140 to ensure that patients receive quality care
from all personnel.
The expected outcome is the coordinated, comprehensive
interdisciplinary delivery of appropriate and effective services
provided by skilled professionals. These professionals would meet the
requirements in this proposed rule and would adhere to the facility's
policies and procedures. The dialysis facility has the flexibility to
assign specific duties to each staff member (either employee or
contractor) who provides services in the facility, as long as the
required outcomes required are being met.
1. Medical Director (Proposed Sec. 494.140(a))
In proposed Sec. 494.140(a) we would maintain some of the
qualification requirements for a physician director. However, we
propose to change the word ``physician'' to ``medical'' to be
consistent with current standards of practice in the industry. The
medical director of a facility is responsible for the development of
patient care policies and the delivery of services. For this reason, we
chose to require that the medical director be trained in nephrology and
have experience in the care of dialysis patients to emphasize the need
for experience in managing dialysis care and associated medical
conditions. The medical director of a dialysis unit must have a
thorough knowledge and understanding of the complexity of ESRD and its
effects on the dialysis patient.
The existing regulation at Sec. 405.2102 requires that the
director of the facility be either board certified or board eligible.
There has been considerable disagreement within the medical community
as to whether board certification or eligibility is an important
indicator of professional competence. In view of the diversity of
opinion in the industry and the absence of any indication that the
quality of care would decline if this requirement were deleted, we are
proposing to eliminate the requirement that the medical director be
either board certified or board eligible. Thus, we propose to require
only that the medical director be a physician who has completed a
board-approved training program in nephrology and has at least 12
months experience providing care to patients receiving dialysis. We are
retaining the alternate option for situations when a physician who
meets this criterion is not available that allows another physician to
direct the facility, subject to the approval of the Secretary. In the
absence of a compelling reason for maintaining the grandfathering
provision for the physician director under Sec. 405.2102(e)(2), we
have not incorporated this provision in our proposed personnel
qualifications for the medical director at Sec. 494.140(a).
2. Nursing Services (Proposed Sec. 494.140(b))
In Sec. 494.140(b) we propose a Nursing Services standard that
would include the necessary qualifications for 4 nurse categories: (1)
The nurse responsible for nursing services in the facility; (2) the
nurse responsible for training in self-care; (3) the charge nurse with
responsibility for each patient shift; and (4) any nurse who provides
care and treatment in the unit.
We are proposing in Sec. 494.140(b)(1)(i) to retain the existing
requirement at Sec. 405.2162(a) that each facility employ at least 1
full time qualified nurse responsible for nursing service in the unit.
In proposed Sec. 494.140(b)(1)(ii) and (iii) we would maintain the
existing requirements that the nurse responsible for nursing services
in the unit be a registered nurse who meets the practice requirements
of the State in which he or she is employed, and has at least 12 months
of experience in clinical nursing with an additional 6 months of
experience in providing nursing care to patients on maintenance
dialysis.
We are proposing in Sec. 494.140(b)(2) to specify the requirements
for the nurse responsible for training in self-care. For a detailed
discussion of these nursing requirements see section V.D.1. of this
preamble.
We are proposing in Sec. 494.140(b)(3)(i) to retain with minor
modifications the existing requirement at Sec. 405.2162(b)(1) that the
individual responsible for each shift be a licensed health professional
such as a registered nurse (RN) or a licensed practical nurse (LPN) who
meets the practice requirements of the State in which he or she is
employed. We recognize that in some instances, a licensed practical
nurse is able to demonstrate the knowledge, training, and experience to
serve as the charge nurse in a dialysis unit and this is currently the
practice in some units. In proposed Sec. 494.140(b)(3)(ii) we would
specify that the charge nurse must have at least 12 months experience
in nursing care, including 3 months of specialized experience in
providing clinical nursing care to patients on maintenance dialysis.
We are proposing in Sec. 494.140(b)(4) that each nurse who
provides care and treatment to patients must be either a registered
nurse or a licensed practical nurse who meets the practice requirements
of the State in which he or she is employed.
3. Dietitian (Proposed Sec. 494.140(c))
Renal dietitians are important and necessary members of the
patient's interdisciplinary care team. Some of the
[[Page 6222]]
responsibilities of the renal dietitian are: (1) Counseling patients on
management of protein, sodium, potassium, phosphorus, and fluid
controlled diets, translating the chemistry of these limits into meals
for patients; (2) monitoring vitamin and mineral supplementation,
including iron levels and their effect on erythropoietin; (3) managing
glycemic control of diabetic patients by manipulation of diet; and (4)
assessing nutritional status by using clinical and biochemical
measures.
We believe that these kinds of activities will require a dietitian
with specialized experience in clinical nutrition. The specialized
training and experience would ensure that dialysis facilities have a
dietitian knowledgeable about medical nutrition therapy, physiology,
and food composition. This specialized knowledge is critical if a
dietitian is to effectively manage the complex tasks necessary in
treating a dialysis patient, so the patient is able to manage his or
her own disease.
We are proposing in Sec. 494.140(c) to retain requirements
comparable to the existing requirements laid out under the definition
of ``qualified personnel'' at Sec. 405.2102(b). We propose that the
dialysis facility dietitian be a registered dietitian with the
Commission on Dietetic Registration, the official credentialing agent
for the American Dietetic Association. We also propose that the
dietitian meet the practice requirements of the State in which he or
she is employed and have a minimum of 1 year of professional work
experience in clinical nutrition as a registered dietitian in order to
qualify to perform the special responsibilities of renal dietitians
discussed above.
4. Social Worker (Proposed Sec. 494.140(d))
We are proposing in Sec. 494.140(d) to retain the existing
requirements for social workers at Sec. 405.2102(f), except for the
``grandfather clause'' which exempted individuals hired prior to the
effective date of the existing regulations (that is, September 1, 1976)
from the social work master's degree requirement and substituted an
experience criterion, which is 1 year in a dialysis setting; and a
criterion requiring including a consultative relationship with a social
worker with a master's degree. Since this clause only applied to social
workers without a master's degree, already employed in a dialysis or
transplantation setting as of 1975, we question whether there is any
need to retain it.
We recognize the importance of the professional social worker, and
we believe there is a need for the requirement that the social worker
have a master's degree. Since the extension of Medicare coverage to
individuals with ESRD, the ESRD patient population has become
increasingly more complex from both medical and psychosocial
perspectives. In order to meet the many and varied psychosocial needs
of this patient population, we believe qualified master's degree social
workers (MSW) trained to function autonomously are essential. Social
workers must have knowledge of individual behavior, family dynamics,
and the psychosocial impact of chronic illness and treatment on the
patient and family. The dialysis patient needs psychosocial
evaluations, a treatment plan based on the patient's current
psychosocial needs, and direct social work interventions. Facility
social worker services include counseling services, long-term
behavioral and adaptation therapy, and grieving therapy. We believe
that MSW training provides the necessary education and experience in
these areas. We have removed the requirement for specialization in
clinical practice, because this designation is not available in all
States and may prove to be a barrier to social workers entering
practice in the dialysis arena.
While nonprofessional personnel may serve in a supportive capacity,
we do not believe they can be employed in place of a fully-credentialed
MSW. We recognize that dialysis patients also need other essential
services including transportation and information on Medicare benefits,
eligibility for Medicaid, housing, and medications, but these tasks
should be handled by other facility staff in order for the MSW to
participate fully with the patient's interdisciplinary teams so that
optimal outcomes of care may be achieved.
5. Dialysis Technicians (Proposed Sec. 494.140(e))
There are no Federal requirements for dialysis technicians in the
existing ESRD conditions for coverage with the single exception of
reuse technicians, who are covered by the AAMI guidelines. When the
existing conditions for coverage were published in 1976, dialysis
technicians were an emerging occupation. At that time it was common for
one nurse to provide dialysis care to two dialysis patients at a time.
Currently, dialysis patient care technicians are the primary caregivers
in most facilities and it is not unusual for a single technician to
provide dialysis care to three or four patients at a time.
The discussion that follows applies primarily to dialysis
technicians who provide direct patient care. Training and other
requirements for reuse technicians are described in specific sections
of the AAMI guidelines, which have been incorporated by reference in
existing Sec. 405.2150(a)(1) and in this proposed rule (see Sec.
494.50).
As we researched this issue, we reviewed past and current efforts
by the States to regulate dialysis technicians. The States are
currently using a variety of approaches and methodologies to regulate
dialysis technicians, including minimum qualification requirements,
mandatory competency testing, registration, licensure, and
certification. We also looked at the typical scope of practice for this
occupation in dialysis facilities, and took into account the public
policy positions and statements from national associations and
organizations that advocate uniform Federal guidelines for dialysis
technicians.
Arizona, Ohio, and Oregon now require dialysis technician
certification via a nationally standardized examination. California and
Texas require specific training and testing, but allow a nationally
standardized certification examination to be substituted for their
training and testing requirements. Georgia identifies a standardized
training program for hemodialysis patient care technicians (PCTs), but
does not require technicians to pass a national certification test
unless a facility's training program fails to provide adequate
training. The three organizations that provide nationally recognized
standardized certification examinations are listed later in this
section of the preamble.
Other States including Connecticut, South Dakota, Kentucky, Utah,
Virginia, Washington, New Mexico, and the District of Columbia require
certain training and competencies for dialysis technicians. States with
past or ongoing efforts to regulate the practice of unlicensed dialysis
technicians and technical staff include Colorado, Illinois, Louisiana,
Maryland, New York and Oklahoma.
Some national associations (for example, the American Nephrology
Nurses Association (ANNA) and the National Association of Nephrology
Technicians (NANT)) have advocated uniform training and certification
requirements for dialysis technicians for several years and continue to
advocate for these measures at the State and national level. Their
primary concern is to ensure that care is provided by qualified and
trained health care workers who are able to demonstrate the necessary
competencies to perform the assigned duties of their positions.
[[Page 6223]]
Since 1990, NKF's Public Policy Board has been interested in
evaluating and defining the proper role of, and training needed by,
dialysis technicians. In 1992, NKF's Dialysis Technician Task Force
published an extensive list of tasks that define the ``patient care
role description'' as well as the appropriate areas of required
training (NKF, pp. 229-232). The authors of that article advocated,
among other things, that technicians should have at least a high school
diploma or equivalency; take training courses in the basic sciences;
report directly to a registered nurse; and be able to effectively
perform specific tasks, subject to individual State licensure and scope
of practice laws and regulations. The article also recommended a basic
training course curriculum for renal technicians which included, among
other things: (1) An introduction to dialytic therapies; (2) principles
of hemodialysis; (3) the effects on the patient of kidney failure; (4)
dialysis procedures; (5) hemodialysis devices; (6) water treatment; (7)
reprocessing (if applicable); (8) patient education; (9) infection
control; and (10) the techniques used in quality assurance and
continuous quality improvement.
The adverse outcomes for dialysis patients of improper care from
inadequately trained dialysis technicians could include blood leaks,
access damage, incorrect dialysis concentrate, infection, and
hypotension. Increased numbers of patient hospitalizations, which in
turn result in higher costs to both public and private payers, could
also be a direct outcome of poor patient care from dialysis
technicians.
In most dialysis facilities, renal technicians now provide a large
percentage of direct patient care services. In most instances, care is
provided under the supervision of a registered nurse. However, the
degree of supervision and the technician-to-patient ratio will often
vary from facility to facility.
A wide variety of tasks are performed by dialysis technicians,
depending on the limitations of State law. These tasks include, but are
not limited to the following:
Preparing dialysis apparatus.
Performing equipment safety checks.
Initiating dialysis (including cannulation and venipucture
with large gauge needles).
Intravenous administration of heparin and sodium chloride
solutions.
Subcutaneous or topical administration of local
anesthetics in conjunction with placement of fistula needles.
Intraperitoneal administration of sterile electrolyte
solutions and heparin for peritoneal dialysis.
Monitoring patients during dialysis.
Taking vital signs.
Documenting tasks and patient observations.
Equipment maintenance and repair.
Water systems monitoring and maintenance.
Quality control measures.
Inventory.
One of the options we considered was requiring certification for
dialysis technicians. Certification is a voluntary process by which
recognition is granted to an individual who has met certain
qualifications. Certification is typically awarded upon the successful
completion of an approved competency examination. The goal would be a
national, standardized requirement for education, training, and
competency testing for dialysis technicians. In considering this
option, we noted that some States have chosen to develop their own
competency examinations or to recognize competency examinations
prepared and administered by one of the three national organizations
that provide competency testing and certification for dialysis
technicians. Those organizations are the Nephrology Nursing
Certification Commission (NNCC), the Board of Nephrology Examiners
Nursing and Technology (BONENT), and the National Nephrology
Certification Organization (NNCO). The common goal of these
organizations is to administer an effective test that serves as a basis
to certify technicians for initial or more advanced competencies in
knowledge, skill and abilities.
In our deliberations on whether to propose Federal requirements for
dialysis technicians engaged in direct patient care, we are reminded
that Medicare has had a longstanding policy of respecting State control
and oversight of health professionals. The Congress has left this
licensure function to the States and Medicare recognizes State-defined
scope-of-practice laws under which health care professionals are
licensed in the United States.
After careful consideration, we do not believe it would be prudent
to propose a national certification requirement for dialysis
technicians at this time. We take this position for several reasons.
First, there is no consensus within the renal community regarding the
efficacy of technician certification to produce improved patient
outcomes of care. Second, there is no standardized national
certification test at this time, and the individuals and organizations,
including the States, who advocate or have adopted certification are
not in agreement regarding which certification test is the most
effective. Some States have designed, or are in the process of
designing, their own competency examinations, while others have
recognized one or more of the existing examinations as evidence of
compliance with their requirements. Finally, a Federal certification
requirement entailing mandatory competency examinations would
necessitate additional costs for transportation, lodging, fees, and
preparatory materials associated with the examination. Those costs
would have to be borne by either the individuals seeking certification,
the dialysis facilities, or both. Without clear evidence that
certification would produce better patient outcomes, we are reluctant
to propose any new requirements that would drive up costs for
technicians in current practice, dialysis facilities, or both.
Therefore, for these reasons, we believe it is more prudent at this
time, not to propose a national certification requirement for dialysis
technicians. Instead, we are proposing in Sec. 494.140(e) a set of
minimum qualifications for dialysis technicians that will include a
minimum education requirement, minimum requirements for on-the-job
training and experience, and proposals for the composition of an
effective technician-training program.
We are proposing in Sec. 494.140(e)(1) to specify that dialysis
technicians meet all applicable State requirements (for example,
credentialing, certification, and licensure) in the State in which they
are employed. As stated above, we believe technicians in any Medicare-
approved facility should comply with any existing State requirements
for their profession.
In proposed Sec. 494.140(e)(2) we would require dialysis
technicians to have at least a high school diploma or equivalency. We
are proposing this criterion for two reasons. First, some of the States
that regulate dialysis technicians (for example, Connecticut and Ohio)
require dialysis technicians to have a high school education or
equivalency.
Second, other States (for example, Texas, California, Oregon, and
New Mexico) that require (among other options) certification by one of
the national certification organizations (that is, NNCC, NNCO, BONENT)
also require a high school diploma or equivalency because that is a
prerequisite for taking the certification examination. We concur with
the position taken by States that regulate dialysis technicians and the
national technician certification organizations because we believe a
[[Page 6224]]
minimal education requirement is appropriate and necessary to enable an
individual to complete the wide variety of patient care functions.
We are proposing in Sec. 494.140(e)(3) to require that each
technician complete at least 3 months experience, following the
facility's training program (also required by Sec. 494.180(b)(5)).
This experience must be gained under the direct supervision of a
registered nurse with a focus on the operation of kidney dialysis
equipment and machines and providing direct patient care with
particular sensitivity to the management of difficult patients. We see
dialysis technician training as a cycle that proceeds from written
instruction that would provide a basic foundation of knowledge, to a
necessary period of on-the-job training under the supervision of a
knowledgeable professional trained in all aspects of patient care,
including medical emergencies.
While written instruction is essential, we also believe properly
supervised on-the-job training must follow to allow the technician to
take maximum advantage of the information provided in the training
program before the dialysis technician is allowed to provide direct
patient care with minimal supervision. We believe 3 months of effective
on-the-job, supervised training is necessary before a technician is
permitted to care for patients without close and direct supervision.
We have made this proposal for several reasons. As discussed in
section VI.A.2 of this preamble, a registered nurse has the necessary
professional training and expertise to coordinate care in the unit,
perform patient assessments, respond to clinical questions from staff
and patients, and coordinate ongoing care. Dialysis technicians, as the
primary caregivers in most dialysis units, function as extensions of
the unit's professional nursing staff. We believe it is essential that
a unit's registered nurse provide the ``hands-on'' direct supervision
to impart this training to new dialysis technicians. For example, in
the patient outcomes environment these regulations are designed to
encourage, it is essential that technicians understand the significance
of continuous quality improvement (that is, collecting data, keeping
logs, the clinical importance and meaning of target patient outcome
measures, and recognizing and reporting medical errors). We also
believe a registered nurse can be very effective in instructing new
dialysis technicians in necessary aspects of patient care, such as
ensuring patient privacy and confidentiality, and demonstrating good
interpersonal skills when dealing with patients, including disruptive
or challenging patients. In addition, a registered nurse is best
equipped, through training and experience, to ensure that every
technician can demonstrate the basic skills needed to provide routine
patient care (for example, initiating, monitoring, and terminating
dialysis; proper aseptic techniques; recognizing and reporting medical
errors; and dealing with medical emergencies). For all of these
reasons, we believe a 3-month period of direct supervision by a
registered nurse is essential to ensure patient health and safety and
to ensure that dialysis technicians that provide direct patient care
can do their part to ensure that the unit meets its patient outcomes
goals. We invite comments on the 3-month training proposal.
We are proposing implementation of a training program that is
specific to technicians who monitor the water treatment system. Water
purity is important to protecting patient safety and the water must be
adequately monitored and properly collected for testing as specified at
proposed Sec. 494.40. The technician who carries out water testing and
monitoring of the water treatment system must be appropriately trained
following a program that has been approved by the medical director and
governing body. Typically, facility patient care technician training
programs contain a water treatment system training module. This module
may form the basis of a training program that could be used to train a
water treatment technician.
6. Other Personnel Issues
Existing Sec. 405.2136(f)(1)(vi) requires the facility have
patient care policies that cover pharmaceutical services. There is
currently no Federal requirement for a pharmacist to play a role on the
multidisciplinary team within the dialysis facility. The dialysis
facility generally has some access to the pharmacist who is dispensing
outpatient medications to the dialysis patient. A hospital-based
dialysis unit might be able to use the hospital pharmacist as a
resource. There may also be limited pharmacy resources available to the
average dialysis facility that is administering intravenous drugs and
making adjustments to a patient's medication regimen. It has been
suggested by some in the renal community that there should be a
requirement within the proposed conditions for coverage for each
dialysis facility to ensure a routine assessment of patient medications
by a pharmacist. The reasons for this recommendation are: (1) Most
dialysis patients take an average of 12 medications, which increases
the risk of adverse drug events; and (2) the patients' have complex
pathophysiology, which affects how medications can be used safely
(Kaplan, pp. 316-319). There are a number of publications that describe
the contributions of pharmacists to the improved care of various
patient populations while simultaneously reducing medication-related
costs.
Therefore, we have proposed, as part of the new patient assessment
condition at Sec. 494.80(a)(3), that facilities conduct a laboratory
profile and medication history on each patient as part of their
comprehensive patient assessment. However, we have not proposed a
specific requirement for pharmaceutical services. We invite comments
regarding what role, if any, the pharmacist should play within the
dialysis facility as well as the facility's appropriate responsibility
for pharmaceutical services and the efficient use of medications in the
new conditions for coverage.
B. Condition: Responsibilities of the Medical Director (Proposed Sec.
494.150)
[If you choose to comment on issues in this section please include the
caption ``Responsibilities of the Medical Director'' at the beginning
of your comment.]
The requirements for the director of a renal dialysis facility are
found in existing Sec. 405.2161. Section 405.2161 requires the
director to be a physician who devotes sufficient time to his or her
director responsibilities to plan, organize, conduct, and direct the
professional ESRD services of the facility. Existing Sec. 405.2161
also states that the physician-director may also serve as the chief
executive officer (CEO) of the unit.
Existing Sec. 405.2161(a) states that the director must meet the
qualifications described in Sec. 405.2102 (that is, be board eligible
or board certified and have at least 12 months of experience or
training in the care of patients in ESRD facilities). Existing Sec.
405.2161(b) requires the physician-director to: (1) Participate in the
selection of a suitable treatment modality for all patients treated in
the unit; (2) assure adequate training of nurses and technicians in
dialysis techniques; (3) assure adequate monitoring of the patient and
the dialysis process, including periodic monitoring of self-dialysis
patients; (4) assure the development of a patient care policy and
procedures manual and its implementation; and (5) assure that patient
teaching materials are made available for self-dialysis and home
dialysis patients.
[[Page 6225]]
The June 2000 OIG Report was an extensive review to ascertain our
effectiveness in monitoring the ESRD program. The report contained
several recommendations regarding ways we should revise the ESRD
conditions for coverage in order to strengthen the accountability of
dialysis facilities that participate in the Medicare program. One of
those recommendations was to reinforce the accountability of the
dialysis facility's medical director for the provision of patient care.
Specifically, the report stated the following: ``While the governing
body of the facility is the basic source of accountability, the medical
director should clearly be empowered as the on-site agent most directly
responsible for the quality of care being delivered. In this capacity,
the medical director should clearly have the authority to develop and
monitor quality improvement efforts, to serve as an educational
resource for medical and nursing staff, and, when individual staff are
not performing adequately, to bring that to the attention of the
facility's designated governing authority.''
In response to the OIG's recommendations, we are proposing in Sec.
494.150 to retain medical director as a separate condition for coverage
and strengthen the medical director's role. Section Sec. 494.150 would
require each dialysis facility to have a medical director who meets the
qualifications for that position at Sec. 494.140(a) and who is
responsible for the delivery of patient care and patient outcomes in
the facility.
We are proposing in Sec. 494.150(a) to assign the operational
responsibility for the facility's quality assessment and performance
improvement (QAPI) program (Sec. 494.110) to the medical director.
While the facility's governing body is ultimately responsible for
allocating the necessary resources (for example, dedicated staff and
computers) to establish a QAPI program, we believe the medical director
is best qualified to ensure that the facility's QAPI program is
effectively developed, implemented, maintained, and periodically
evaluated. We are also proposing that the medical director ensure that
all clinical staff in the facility, including attending physicians,
actively participate in achieving the performance goals and objectives
specified in the facility's QAPI program. It is essential for an
effective QAPI program that the attending physician and nonphysician
staff, who treat patients in the facility, ``buy-in'' to the facility's
quality improvement initiatives and actively participate in achieving
the facility's QAPI goals. In order for this to happen, we believe the
medical director should be given the responsibility to ensure that all
staff that treat patients actively participate in the facility's QAPI
program. In that capacity we would expect the medical director to make
a special effort to educate and encourage facility staff, including
attending physician and nonphysician staff, who have not actively
participated in the facility's QAPI program. In those rare instances
when in-house or attending physician or nonphysician staff will not
actively participate in the facility's QAPI program, we would expect
the medical director to refer those individuals to the facility's
governing body through its CEO or administrator. The governing body
(see Sec. 494.180) has the final legal responsibility and authority
for the operation of the facility and the ultimate responsibility for
the facility's compliance with Federal Medicare regulations.
In assuming operational responsibility for QAPI, this requirement
emphasizes the importance of the medical director utilizing the best
practices within a strong QAPI program. Under this requirement, we
would expect the facility's medical director to seek and use
comparative data with other facilities when available and use the
facility's historical data to demonstrate internal improvements in
outcomes over time. This standard also underscores the medical
director's ongoing responsibility to ensure that each patient treated
in the facility achieves the best possible outcomes of care.
We propose in Sec. 494.150(b) to retain the existing requirement
at Sec. 405.2161(b)(2) for the medical director to ensure that staff
in the unit are adequately trained. We believe that all patient care
personnel in the facility should receive the necessary education and
ongoing training to furnish services effectively, efficiently, and
completely.
We are proposing in Sec. 494.150(c)(1) to retain the existing
requirement Sec. 405.2161(b)(4) for the medical director to assure the
development of a ``patient care policies and procedures manual'' for
the facility. While our goal throughout this proposed rule has been to
eliminate unnecessary process requirements, we believe that a
comprehensive patient care policies and procedures manual within a
dialysis unit is an essential reference for clinical staff within the
unit. The manual is also an opportunity for the medical director to
incorporate improved treatment methodologies and current medical
practices into day-to-day patient care within the facility in order to
ensure better outcomes of care.
We are proposing in Sec. 494.150(c)(1) that the medical director
participate in the development, periodic review, and approval of the
patient care policies and procedures manual. We are also proposing in
Sec. 494.150(c)(2) that the medical director, as the individual with
direct responsibility for the manner in which patient care is
administered within the facility, be responsible to ensure that these
patient care policies and procedures are adhered to by staff who treat
patients in the dialysis facility, including attending physician and
nonphysician staff. In those instances when facility staff or attending
physicians or nonphysicians have not, or will not, follow the
facility's written patient care policies and procedures, we would
expect the medical director to educate and encourage those individuals
to follow facility policies and procedures. In those rare instances
when the medical director has been unsuccessful in achieving
compliance, we would expect the medical director to refer the matter to
the facility's governing body (see Sec. 494.180).
We are proposing in Sec. 494.150(c)(2)(ii) that the medical
director ensure that the interdisciplinary team follows the facility's
patient discharge and transfer policies and procedures described in
Sec. 494.180(f). In section VI.E9 of this preamble, we proposed that
all patients be informed of a facility's transfer and discharge
policies and be given 30 days notice in advance of a facility reducing
or terminating on-going care. In addition, we are proposing that the
medical director monitor and review each involuntary patient discharge
to ensure that the patient's interdisciplinary team has performed the
tasks required in Sec. 494.180(f).
In a January 2002 report (Building on the Experiences of Dialysis
Corporations, OEI-01-99-0052), the OIG recommended that the ESRD
conditions for coverage specify the responsibilities of the Medical
Director in situations when there is a quality problem related to an
ESRD facility physician. The OIG recommendation follows:
CMS should also address in the Conditions what medical directors
are expected to do when a quality problem is attributable to an
attending physician who is not performing adequately. It should make
clear that: (1) Medical directors have the authority to conduct or
initiate peer review and to address performance problems through
directed education, and (2) for more serious situations, the medical
director's responsibility to report a physician to an authoritative
body, such as the End-Stage Renal Disease Network and/or the State
Medical Board.
[[Page 6226]]
We are soliciting comments on adding language to this regulation
under the Medical Director condition to more specifically state Medical
Director responsibilities in regard to ESRD facility attending
physicians.
C. Relationship With ESRD Network (Sec. 494.160)
[If you choose to comment on issues in this section please include the
caption ``ESRD Network'' at the beginning of your comment.]
Existing Sec. Sec. 405.2110 through 405.2113 contain provisions
that relate to the designation of the ESRD networks, the functions of
the ESRD networks, and the role of the medical review boards. These
provisions focus primarily on the role and responsibilities of the ESRD
networks, rather than establishing conditions for Medicare coverage
that must be met by dialysis facilities. Therefore, we are not
incorporating these requirements in the proposed ESRD conditions for
coverage. These regulations will remain in part 405 and any revisions
will be addressed in a separate notice of proposed rulemaking.
While we believe that the role and responsibilities of the networks
do not need to be included in the proposed conditions for coverage, we
believe that dialysis facilities must continue to share information
with the networks. Thus, we propose to require at Sec. 494.160 that
each facility cooperate with the ESRD network serving its designated
area in fulfilling the terms of the Network's scope of work contract
with CMS, similar to the requirement under existing Sec. 405.2134
concerning participation in network activities. In addition, we believe
that this proposed condition pertains directly to the dialysis facility
rather than the network and is a condition that a dialysis facility
must meet in order to qualify for Medicare approval.
D. Condition: Medical Records (Sec. 494.170)
[If you choose to comment on issues in this section please include the
caption ``Medical Records'' at the beginning of your comment.]
The patient's medical record presents a total picture of the care
provided by the dialysis facility. The medical record--
Serves as an organized plan for treatment and is used for
diagnosing, treating, and caring for the patient;
Facilitates communication among the various health care
professionals providing services to the patient;
Provides a focal point for coordinating the actions of the
interdisciplinary team;
Provides an accurate picture of the patient's progress in
achieving care goals;
Provides the team interdisciplinary members with data for
evaluating and documenting the quality and appropriateness of care
delivered; and
Provides evidence of the facility's implementation of
policies and procedures relating to patient care.
The existing Medical records requirements at Sec. 405.2139 contain
a large number of prescriptive requirements. These requirements include
the following:
Requires that each medical record contain sufficient
information to identify the patient, justify the diagnosis and
treatment, and document the results accurately.
Prescribes the content of the medical record to include,
for example, patient assessment information, evidence the patient was
informed of the assessment, identification and social data, consent
forms, medical and nursing history, diagnostic and therapeutic orders,
observations and progress notes, laboratory results, and, if necessary,
a discharge summary.
Requires written policies and procedures to protect
medical records information.
Requires the facility to designate a medical records
supervisor and includes a list of duties and responsibilities for that
individual.
Requires medical records to be completed promptly and
states that all clinical information pertaining to the patient be
maintained in a centralized location.
Requires facilities to maintain medical records in
compliance with State laws, or for 5 years in the absence of State
requirements.
Requires a facility to maintain adequate facilities,
equipment, and space conveniently located, to provide efficient
processing, viewing, filing, and prompt retrieval of medical records.
Requires that a facility provide for the interchange of
medical and other information ``necessary or useful'' in the care and
treatment of patients transferred between treating facilities.
In keeping with our goals to eliminate unnecessary requirements and
to reduce burden on dialysis facilities, we are retaining only those
minimum facility requirements that we believe would be necessary in a
patient outcome-oriented environment.
In the proposed medical records condition for coverage (Sec.
494.170), we would state that the facility must maintain complete,
accurate, and accessible medical records on all patients, including
home dialysis patients for whom the facility has signed a backup
agreement with a DME supplier to provide support services to the
patient or whose care is under their supervision. The proposed rule
emphasizes that a facility must maintain complete medical records for
all patients under its supervision, including home patients.
We propose to no longer prescribe the elements that facilities must
include in the patient medical record. Instead, we believe that
facilities should have the flexibility to decide what information must
be included in the medical record as long as the services provided are
consistent with the patient's diagnosed condition. We believe
facilities will document patient outcomes (such as Kt/V and hematocrit
levels), results of assessments and reassessments (see Sec. 494.80),
changes in the care plan (see Sec. 494.90), and other pertinent
information even though the elements are not prescribed, because this
information is necessary to track patient progress, implement the
patient care plan, record information needed to comply with the patient
discharge or transfer procedure (see Sec. 494.150(e)), and effectively
manage a facility quality assessment and performance improvement
program (see Sec. 494.110). The patient's plan of care condition (see
Sec. 494.90(b)) would require the facility to monitor and track
patient progress toward the desired outcomes, and inherent in these
requirements is the need to document patient results in some form.
We are proposing at Sec. 494.170(a)(1) to retain the existing
Sec. 405.2139(b) that requires a facility to protect its patients'
medical records against loss, destruction, or unauthorized use because
the records are crucial to the patient's care.
However, we propose to eliminate the requirement at Sec.
405.2139(b) that the facility must have written policies and procedures
for recordkeeping. We believe this existing requirement is too
restrictive and inflexible. The facilities must protect medical record
information and keep all patient records confidential. Therefore, as
long as there is a system in place to achieve the outcome, we believe
that it is not necessary to require the facility to have written
policies. However, facilities may find it necessary to have written
procedures to ensure that they achieve the expected outcome.
The existing requirement at Sec. 405.2139(b) mandates
confidentiality in the handling of patient information
[[Page 6227]]
and requires facilities to safeguard patients' records by making them
available only to authorized individuals. Under this requirement, a
patient may refuse release of records to any individual outside the
facility, except in specific situations such as a patient's transfer to
another health facility or the release of information required by law.
We are proposing in Sec. 494.170(a)(2) that the patient's medical
record be released only under the following circumstances: (1) The
transfer of the dialysis patient to another facility; (2) certain
exceptions provided for in law; (3) provisions allowed under a third
party payment contract; (4) approval by the patient; or (5) inspection
by authorized agents of the Secretary as required for the
administration of the Medicare program.
We are proposing in Sec. 494.170(a)(3) to maintain the existing
requirement at Sec. 405.2139(b) that the facility obtain written
authorization of the patient or legal representative for release of
information not required or authorized to be released by law.
We are proposing in Sec. 494.170(b)(1) to retain the existing
requirement at Sec. 405.2139(d) that current medical records and those
of discharged patients are completed promptly. In a dialysis unit, it
is essential that each clinical event be documented as soon as possible
after its occurrence. Documentation must be current so that the medical
records provide an up-to-date picture of the status of the patient at
all times. We recognize that stating that medical records should be
completed promptly is somewhat vague and subject to interpretation. We
invite comments on the addition of a specific timeframe for the
completion of patient medical records.
In proposed Sec. 494.170(b)(2) we would maintain the existing
requirement at Sec. 405.2139(d) that all clinical information
pertaining to a patient is centralized. Regardless of how the medical
record is completed and maintained (on paper or electronically), each
member of the interdisciplinary team has access to the most recent
information on the patient's condition and prescribed treatment.
We are also proposing, in Sec. 494.170(b)(3), that the dialysis
facility is responsible for completing, maintaining and monitoring
medical records for its Method II home dialysis patients and its other
home patients. Under Method II, home dialysis patients elect to receive
all equipment and supplies from a DME company. The DME supplier must
have a backup agreement with a dialysis facility that provides support
services to the patient. We have mentioned Method II specifically in
this proposed requirement because Method II requires that the patient's
ESRD facility is fully aware of the equipment and supplies being used
by the patient in order to accurately update the patient's medical
record. Our new focus on achieving better patient outcomes is
contingent upon accurate and current medical records for Method II and
all other home dialysis patients.
In proposed Sec. 494.170(c), we would make minor revisions to the
existing requirement at Sec. 405.2139(e) that medical records be
retained for a period of time not less than that determined by State
statute governing records retention or statute of limitations; or in
the absence of a State statute, 5 years from the date of discharge; or,
in the case of a minor, 3 years or until the patient becomes of age
under State law, whichever is longer. The facility's policy for the
retention and preservation of records must conform to the requirements
of State law or regulations. In this case, the date of discharge means
the latest date the patient was discharged from any type of service
provided by the dialysis facility.
As previously stated, existing Sec. 405.2139(f) requires the
dialysis facility to maintain adequate facilities, equipment, and space
conveniently located, to provide efficient processing of medical
records (for example, reviewing, filing, and prompt retrieval) and
statistical medical information (for example, required abstracts,
reports). The rationale for this requirement was that patient records
should be easily retrievable and available to all facility staff and
that medical records of patients undergoing treatment should be located
close to the treatment area so that no time is lost in obtaining
records for review and documentation. Although we agree that patient
medical records should be accessible, we do not believe the
prescriptive requirements in existing Sec. 405.2139(f) are necessary.
As a result, we are proposing to eliminate this requirement. We believe
that facilities already provide easy access to all patient medical
records to ensure that all staff can promptly retrieve and review
patient information.
In Sec. 494.170(d) we are proposing to retain the requirement in
existing Sec. 405.2139(g) that requires the facility to provide for
prompt transfer of medical information between treatment facilities.
The intent of this requirement is to facilitate continuation of care
whenever a patient has to either temporarily leave the facility (for
example, for vacation or hospitalization) or transfer permanently to a
new facility. We believe that it is essential to the continuation of
care that a patient's medical history and plan of treatment follow the
patient. In addition, we are proposing to require that the facility
exchange all medical records within 1 working day. The requirement that
information be transferred within 1 working day is in existing Sec.
405.2137(b)(5) (Patient long-term program and patient care plan), which
states that if the patient is transferred to another facility, the care
plan is sent with the patient or within 1 working day of the transfer.
However, we believe the requirement should apply not only to the care
plan, but to any medical record information, including, but not limited
to, nutritional information, social work services, and rehabilitation
status.
Because dialysis patients must receive frequent treatments at
prescribed intervals, this proposed requirement would minimize
disruption in care. Without the medical information, the patient might
receive inappropriate treatment. Requiring that the facility transfer
information within 1 working day would minimize the possibility of a
breakdown in communication between facilities. It would also ensure
that the patient continues to receive care in accordance with his or
her designed plan of treatment.
Finally, we are proposing to eliminate the requirement at existing
Sec. 405.2139(c) that the facility designate a staff member to serve
as the medical records supervisor to facilitate the recordkeeping
process. The current functions of the medical record supervisor
include, but are not limited to: (1) Ensuring that the medical records
are documented, completed, and maintained in accordance with accepted
professional standards and practices; (2) safeguarding the
confidentiality of the records in accordance with established policy
and legal requirements; (3) ensuring that the records contain pertinent
medical information and are filed for easy retrieval; and (4) obtaining
the services of a qualified medical records practitioner when
necessary. In keeping with our goal of eliminating process requirements
that are not predictive of good outcomes for patients or necessary to
prevent harmful outcomes for patients, we are proposing to eliminate
the requirement that a facility designate a medical records supervisor.
E. Condition: Governance (Proposed Sec. 494.180)
[If you choose to comment on issues in this section please include the
caption
[[Page 6228]]
``Governance'' at the beginning of your comment.]
1. Existing Requirements for Governing Bodies
The existing requirements for the dialysis facility's governing
body are found at Sec. 405.2136. Section 405.2136 states that the
facility governing body or designated person(s) so functioning has the
full legal authority and responsibility for the governance and
operation of the facility. The governing body adopts and enforces rules
relative to its own governance and to the health and safety of
patients, acts upon recommendations from the Networks, and appoints a
CEO who is responsible for the overall management of the facility.
Existing Sec. 405.2136(a) covers the full disclosure of ownership
for facilities that are independently owned, controlled by a
partnership, or wholly or partially owned by corporate entities.
Existing Sec. 405.2136(b) requires the governing body to develop,
delineate, and review annually written operational objectives for the
facility. These objectives apply to, among other things, services
provided and admission criteria.
Existing Sec. 405.2136(c) requires the appointment of a full-time
or part-time CEO who acts as the facility's administrator. The CEO's
responsibilities for the operation of the facility include the
following:
Implementing facility policies.
Coordinating administrative functions.
Authorizing expenditures.
Familiarizing staff with facility policies, rules and
regulations and applicable Federal, State and local laws and
regulations.
Maintaining and submitting required records and reports.
Developing, negotiating and implementing contracts.
Developing and implementing accounting and reporting
systems, an annual budget, tracking expenses and revenues, submitting
reports;
Ensuring the facility employs the necessary number of
qualified personnel, that those personnel are assigned appropriate
duties, and have opportunities for continuing education and related
developmental activities.
Existing Sec. 405.2136(d) requires the governing body, through the
CEO, to develop and implement personnel policies and procedures,
covering, for example, assigned duties, health and safety hazards,
supervising trainees, maintaining personnel records for staff,
maintaining written personnel policies, orientation and in-service
education, and maintaining written personnel manuals.
Existing Sec. 405.2136(e) requires the facility to develop
detailed, written arrangements for the use of outside resources, as
needed, through its CEO who will serve as a consultant with the
responsibility to continually assess performance and use documentation
(that is, dated, signed reports).
Existing Sec. 405.2136(f) specifies that the ESRD facility must
have written patient care policies, and that policies are--
Developed by the physician responsible for supervising or
directing the provision of ESRD services or the facility's organized
medical staff (if there is one) with the advice of (and with provision
for review of such policies from time to time, but at least annually,
by) a group of professional personnel associated with the facility,
including but not limited to, one or more physicians and one or more
registered nurses experienced in rendering ESRD care; and
Approved by the governing body. The governing body is also
responsible for periodic review of the implementation of policies to
ensure that the intent of the policies is carried out.
Under this section patient care policies must include the
following: (1) Scope of services; (2) admission and discharge policies;
(3) medical supervision and physician services; (4) patient long-term
programs and care plans; (5) medical and other emergencies; (6)
pharmaceutical services; (7) medical records; (8) administrative
records; (9) maintenance of the physical plant; (10) consultant
qualifications and activities; and (11) home dialysis support services.
This standard also requires the medical director to execute these
patient care policies, schedule hours of operation (when feasible) that
are convenient to patients, and evaluate patients' progress toward
goals in their long-term programs and care plans.
Existing Sec. 405.2136(g) requires the governing body to ensure
that every patient is under the continuing care of a physician and that
a physician is available in emergency situations. This standard
requires the physician responsible for the patient's care to evaluate
the patient's immediate and long-term needs and prescribe a planned
regimen of care. The standard also requires the governing body to
ensure that there is always medical care available for emergencies with
a list of physicians to contact posted at the nursing/monitoring
station.
Existing Sec. 405.2136(h) requires the governing body to designate
a qualified physician as director of the ESRD facility and establish
written policies regarding how medical appointments should be
developed, maintained, and if necessary, terminated.
2. Overview of the Proposed Governance Requirements
Consistent with the shift from process-oriented requirements to a
more patient-centered, outcome-oriented approach, we are proposing
significant revisions to the governance condition. In developing these
proposed revisions for the Governance condition we sought to identify
requirements that are covered in other parts of this proposed rule, as
well as any other redundant, unnecessary or overly burdensome
requirements that are unrelated to better patient outcomes. At the same
time, we want to retain those structural requirements that might be
indicative of better patient outcomes or offer necessary protections to
patient health and safety. We also want to be responsive to a
recommendation from the OIG (in its June 2000 report) to ``strengthen
the accountability of the dialysis facility governing body'' (DHHS/OIG,
June 2000). In that report, the OIG made the following recommendation:
``The governing body should be held clearly accountable for the overall
quality outcomes provided by the facility. Moreover, since most
dialysis facilities are now part of national or multi-national
corporations, the governing bodies should ensure that authoritative
representatives are readily available to respond to queries and/or
visits by State survey agencies or Networks.'' (DHHS/OIG, June 2000.)
We believe that the performance of certain basic organizational
functions is a minimum condition for an environment in which
appropriate patient-centered care can occur. Therefore, the proposed
Governance condition, Sec. 494.180, requires the necessary minimum
administrative features to allow the governing body to safely and
effectively run a facility in an outcomes environment while being
responsive to the patients and to the OIG's recommendation to
strengthen the accountability of the governing body.
3. Governance Condition (Proposed Sec. 494.180)
In proposed Sec. 494.180 we state the dialysis facility must be
under the control of an identifiable governing body, or designated
person(s) so functioning, with full legal authority and responsibility
for the governance and operation of the facility. The
[[Page 6229]]
Medicare program requires that each dialysis facility be independently
certified, and therefore, each facility must independently achieve
compliance with the conditions for coverage. It is essential that
surveyors and networks be able to identify the group or individual with
legal responsibility and accountability for managing patient health
care, safety, and protection of patient rights and for the operation of
each dialysis facility.
4. Designating of a Chief Executive Officer or Administrator (Proposed
Sec. 494.180(a))
Proposed Sec. 494.180(a) retains the existing requirement for the
governing body or responsible party(ies) to appoint an individual who
will serve as the facility's CEO or administrator. We are proposing to
use these terms interchangably (that is, CEO and administrator) because
the duties would be the same regardless of the title assigned. We have
previously proposed that the facility's medical director (see Sec.
494.150) assume certain clinical responsibilities for the care provided
within the unit. We recognize that in smaller units it would be
possible for the same individual to perform the duties of both medical
director and CEO/administrator and these regulations do not preclude
that. However, in a typical unit we believe the volume, scope, and
complexity of administrative, financial, and operational
responsibilities requires the day-to-day attention of a separate CEO/
administrator position. Therefore, we are proposing to retain this
position and the performance of certain duties and responsibilities by
the occupant of this position in these proposed conditions.
We are proposing in Sec. 494.180(a) that the CEO/administrator
exercise overall management responsibility for the facility and oversee
staff appointments, fiscal operations, the relationship with the ESRD
network, and the allocation of necessary staff and other resources for
the facility's QAPI program (see Sec. 494.110).
5. Adequate Number of Qualified and Trained Staff (Sec. 494.180(b))
Proposed Sec. 494.180(b) would retain and consolidate some of the
existing requirements at Sec. Sec. 405.2136(c)(3)(viii) and
405.2162(b)(2).
We propose at Sec. 494.180(b)(1) to retain the existing
requirement at Sec. 405.2162(b)(2) that a dialysis facility ensure an
adequate number of qualified personnel are present whenever patients
are undergoing dialysis. Under the existing requirement, every approved
dialysis facility must maintain staff-to-patient ratios that are
appropriate to the level of dialysis care being given in order to meet
the needs of its patients. The determination and allocation of
appropriate staff-to-patient ratios is left to each dialysis facility.
State agency surveyors would assess facility compliance with this
requirement by evaluating whether routine care is being delivered,
assessments are conducted as the patient's condition changes, routine
monitoring adheres to facility policy, and patients care provided by
staff during surveys (for example, equipment alarms are responded to
promptly). In our deliberations regarding ``adequate staff'', we noted
that there is no national consensus within the dialysis industry
regarding the appropriate staff-to-patient ratios. We also noted the
wide variety of State staff-to-patient ratio requirements. For example,
some States have staff-to-patient ratio requirements for registered
nurses. Connecticut requires that 50 percent of a dialysis unit's
patient care staff be registered nurses. New Jersey requires a
registered nurse for the first nine patients in the unit. Georgia and
South Carolina mandate a registered nurse for every 10 patients, while
Texas requires a registered nurse for every 12 patients. Washington
requires two registered nurses per shift. Oregon requires that a
written staff plan for registered nurses be on file with the State.
Some States have staff-to-patient ratios for patient care
technicians. Maryland, Massachusetts, New Jersey, Washington, Puerto
Rico, and the Virgin Islands require a three-to-one patient-to-staff
care technician ratio. Georgia, South Carolina, and Texas require a
four-to-one patient-to-patient care technician ratio. Nevada has a 100
to 1 patient-to-staff ratio for social workers and renal dietitians.
Further complicating the wide variation in State regulations are
decisions involving scope of practice and the various nurse practice
acts administered by the State boards of nursing. For the reasons cited
above, we are not proposing any Federal staff-to-patient ratios.
However, we are interested in strengthening the existing
requirement while at the same time preserving the facility's
flexibility in determining the appropriate staff-to-patient ratio.
One alternative to mandated staff-to-patient ratios is an acuity-
based staffing system developed by each dialysis facility. This type of
system would take into account the number of patients treated on each
shift, individual patient characteristics, patient needs, the expertise
and experience levels of facility staff, the physical layout of the
facility, available technology, and the availability of support
services. An acuity-based staffing plan, including some or all of the
criteria listed above, could be developed by the nurse responsible for
nursing services in the facility and approved by the medical director.
It could also be incorporated into the facility's QAPI program (see
Sec. 494.110) as a means of achieving desired outcomes of care
specified in the facility's individual patient plans of care (see Sec.
494.90). We are soliciting public comment on whether we should include
a requirement for an acuity-based staffing plan in Sec. 494.180(b)(1)
to ensure that every dialysis facility has ``adequate staffing'' and
appropriate staff-to-patient ratios to meet the needs of its patients.
We are proposing in Sec. 494.180(b)(2) that a registered nurse
must be present in the facility at all times that patients are being
treated. We have made this proposal for several reasons. As previously
discussed in this preamble, the rapidly changing demographics of the
dialysis patient population has resulted in an older, sicker patient
population. An older patient population with more serious co-morbid
conditions elevates the potential for medical emergencies (for example,
heart attack, stroke, severe reactions to chemicals). A registered
nurse has the professional training and expertise to properly react to
these types of emergencies. Properly trained dialysis technicians and
licensed practical nurses may be effective in providing day-to-day
patient care, but may lack the training and expertise to react to
critical medical emergencies. Therefore, we believe that having a
registered nurse on the premises when treatment is being provided is a
necessary health and safety measure for dialysis patients. Registered
nurses, by training and professional expertise, are also needed to
provide other important patient care functions that occur routinely
while patients are being dialyzed. Those functions include: (1)
Assessing patient needs; (2) developing treatment plans; (3)
coordinating ongoing care in the unit; (4) continually evaluating the
ability of the other nursing and technical staff to use the most
current skills and techniques; (5) answering clinical questions from
patients and staff; (6) and providing direct supervision for dialysis
technicians during their 3-month training period (see proposed Sec.
494.140(e)(3)).
At Sec. 494.180(b)(3), we are proposing to retain the existing
requirement that all employees have appropriate orientation to the
facility and their work responsibilities upon employment. In addition,
at Sec. 494.180(b)(4), we are
[[Page 6230]]
proposing to retain the existing requirement that all employees have an
opportunity for continuing education and related development
activities.
At Sec. 494.180(b)(5), we are proposing a new requirement for a
written approved training program, designed by the facilities, that is
specific to dialysis technicians. As discussed earlier in this
preamble, dialysis technicians are now the primary caregivers in many
dialysis units, and we have proposed minimum Federal requirements for
this occupation because we believe properly trained dialysis
technicians are essential in achieving good patient outcomes of care
(see Sec. 494.140(e)). Many States that regulate dialysis technicians
require training programs that include: (1) The initiation of dialysis;
(2) monitoring and termination of dialysis; (3) possible complications
of dialysis; (4) water treatment; and (5) infection control procedures.
We are proposing that every dialysis patient care technician-
training program contain criteria that would provide at least a minimal
set of skills. When State requirements meet or exceed these proposed
patient care technician-training requirements, the State requirements
would have to be met. The criteria we are proposing include the
following competencies: (1) Principles of dialysis; (2) care of the
patient with kidney failure, including interpersonal skills; (3)
dialysis procedures and documentation, including initiation,
monitoring, and termination of dialysis; (4) possible complications of
dialysis; (5) water treatment; (6) infection control; (7) safety; and
(8) dialyzer reprocessing, if applicable. We invite public comment on
the basic criteria proposed for Sec. 494.180(b)(5)(i) through (viii).
6. Medical Staff Appointments (Proposed Sec. 494.180(c))
In Sec. 494.180(c) we propose to retain some of the existing
requirements at Sec. 405.2136(h) that the governing body be
responsible to oversee appointments to medical staff. We propose to
expand this requirement to include all medical staff appointments,
including appointments and credentialing for attending physicians,
physician assistants, and nurse practitioners. However, consistent with
our goal to reduce unnecessary process-oriented requirements and
regulatory burden, we are not proposing to retain the existing
requirement in Sec. 405.2136(h) for the governing body to establish
written policies regarding the development, negotiation, consummation,
evaluation, and termination of appointments to the medical staff (if
the facility has a medical staff). Consistent with the new patient
outcomes in this regulation, we are proposing to add a new requirement
at Sec. 494.180(c)(2) that the governing body be responsible for
ensuring that all attending physicians, physicians assistants, and
nurse practitioners who provide care in the facility are informed
regarding all patient care policies and procedures as well as the QAPI
program. We believe adding this new requirement will assist the
facility medical director in achieving better patient outcomes through
direct care and through the QAPI program without adding any unnecessary
burden to a dialysis facility. We are soliciting comments on our
proposal to delete process requirements for medical staff appointments
and add a new governing body requirement to inform the facility's
medical staff regarding the facility's patient care policies and the
facility's quality assurance and performance improvement program.
7. Furnishing Services (Proposed Sec. 494.180(d))
Proposed Sec. 494.180(d) would retain the existing requirement
Sec. 405.2102 for the governing body to ensure that (except for home
care services provided pursuant to Sec. 494.100) services are
furnished directly (see Sec. 494.10) on its main premises or on other
premises that are contiguous with the main premises under the direction
of the same professional staff and governing body as the main premises.
We believe this requirement is essential to ensure that dialysis
services are not provided in uncertified locations.
8. Internal Grievance Process (Proposed Sec. 494.180(e))
In Sec. 494.180(e), we are proposing to require that facilities
have an internal grievance process. We believe a good internal
grievance process is an invaluable tool in resolving patient grievances
in a positive and expeditious manner for both the patient and the
facility. The grievance process must include a clearly explained
procedure for the submission of grievances, timeframes for reviewing
the grievance, and a description of how the patient or the patient's
designated representative will be informed of steps taken to resolve
the grievance. The grievance process must be implemented so that the
patient may file a grievance with the facility without reprisal or
denial of services.
9. Discharge and Transfer Policies and Procedures (Proposed Sec.
494.180(f))
We are also proposing that the facility's discharge and transfer
policy be designed to ensure that no patient, including disruptive or
noncompliant patients, is discharged or transferred from the facility
unless one of the following situations applies:
The patient or payor will no longer reimburse the facility
for covered services;
The facility ceases to operate;
The transfer is necessary for the patient's welfare
because the facility can no longer meet the patient's documented
medical needs;
The facility has determined the patient's behavior is so
disruptive or abusive that the facility is unable to deliver care to
the patient or to operate effectively.
We are proposing that the governing body assign the medical
director the responsibility to monitor and review every patient
discharge of an abusive or disruptive patient to ensure that the
patient's interdisciplinary team has reassessed the patient and
documented the ongoing problem(s) and efforts to resolve the
problem(s); obtained a written physician's order which must be signed
by the medical director and (if applicable) the patient's attending
physician; and that a documented attempt has been made to place the
patient in another facility. The State survey agency and the ESRD
network must be notified of the involuntary discharge of any patient.
We believe, as the individual in charge of patient care in the
facility, the medical director (see proposed Sec. 494.150(c)(2)(ii))
is the appropriate individual to ensure that a patient's
interdisciplinary team has followed the procedure described in Sec.
494.180(f) before any transfers or discharges from the facility. We
also believe it is important to allow facilities the flexibility to
make these determinations on a case-by-case basis without the
imposition of prescriptive criteria that would define disruptive or
abusive behavior. However, the facility's interventions and reasons for
involuntary discharge of a disruptive or abusive patient must be
clearly documented in the patient's medical record. We invite comments
on our proposal to hold the dialysis facility accountable for their
staff adherence to facility's patient discharge or transfer policies
and procedures.
10. Emergency Coverage (Proposed Sec. 494.180(g)
Proposed Sec. 494.180(g) would require the governing body to be
responsible for emergency coverage. Emergency coverage is not the same
thing as emergency preparedness (see Sec. 494.60(d) in the proposed
physical environment condition). As previously
[[Page 6231]]
discussed, emergency preparedness applies to medical and nonmedical
emergencies related to fire, equipment or power failures, care-related
emergencies, water supply interruptions, and natural disasters. The
emphasis in emergency preparedness is on the facility staff's ability
to manage and respond appropriately to these facility-wide problems.
Emergency coverage, as proposed in Sec. 494.180(g), relates only to
patient medical emergencies. Specifically, proposed Sec. 494.180(g)(1)
would require the governing body to ensure that patients and staff have
written instructions for obtaining emergency medical care. We believe
giving patients and staff written instructions is both prudent and
necessary to ensure that every patient has the necessary information if
and when a medical emergency should arise.
Proposed Sec. 494.180(g)(2) would retain the existing provision at
Sec. 405.2136(g)(2) that requires the dialysis facility to post, at
the nursing/monitoring station, a roster of physician names to be
called for emergencies, when they can be reached, and how they can be
reached.
Proposed Sec. 494.180(g)(3) retains and combines existing
provision at Sec. 405.2136(g)(2) which requires the governing body to
ensure emergency care is always available, and existing Sec. 405.2160
which requires the facility to have an agreement with a hospital to
provide inpatient care and other services to patients at all times.
However, our proposed agreement requirement at Sec. 494.180(g)(3) is
much less prescriptive than the existing requirement at Sec. 405.2160,
which is a condition-level requirement. For example, Sec. 405.2160
requires a dialysis facility to have an agreement with a renal dialysis
center, which is defined in existing Sec. 405.2102 as a hospital that
is qualified to provide the full spectrum of diagnostic, therapeutic,
and rehabilitative services required for the care of ESRD dialysis
patients. Existing Sec. 405.2160 also contains explicit requirements
for the affiliation agreement, that is, the agreement must (1) include
the basis for working relationships between staff of both facilities to
ensure that services are available promptly; (2) specify transfers for
only medically appropriate circumstances as determined by the medical
director or attending physician; (3) prescribe an interchange (within 1
working day) between facilities of the patient's long-term plan and
patient care plans; and (4) specify security and accountability for
patients' personal effects. Our proposal, at Sec. 494.180(g)(3) states
simply that the dialysis facility must have an arrangement with a
hospital that can provide inpatient care, other hospital services, and
emergency services which are available 24 hours a day, 7 days a week;
services will be made available promptly; and there are reasonable
assurances in the agreement that patients from the dialysis facility
will be accepted and treated in emergencies. This is consistent with
our goal of transitioning from unnecessary procedural and process
requirements to a patient-outcomes environment in which a dialysis
facility will have more flexibility in determining how necessary
services, including emergency services, are provided to its patients.
11. Furnishing Data and Information for ESRD Program Administration
(Proposed Sec. 494.180(h)
We propose in Sec. 494.180(h) that dialysis facilities furnish
data and information electronically and in intervals that conform to
specifications established by the Secretary. While reporting data and
information is an existing requirement in Sec. 405.2133, the proposal
to require the ESRD CPM data and to require electronic data reporting
are new requirements. The CPM project, a quality improvement initiative
between CMS, the ESRD networks, and ESRD facilities was discussed in
section II.E.4.1 of this proposed rule. Currently, dialysis facilities
participate in this project voluntarily. We are proposing full
participation in reporting the existing CPMs by all dialysis
facilities. We have received recommendations from the OIG ``External
Quality Review of Dialysis Facilities/A Call For Greater
Accountability,'' the IOM ``Crossing the Quality Chasm, 2001'', and
Medicare Payment Advisory Commission (MedPAC) ``Improving Quality
Assurance for Institutional Providers'' to require facilities
participating in Medicare to report on performance measures to
stimulate improvements in the quality of care and to achieve a degree
of accountability for performance ((DHHS/OIG, 1999), (IOM, 2001), and
(MedPAC, 2000) respectively). The requirement for full CPM reporting is
an important step in moving in that direction.
Section 4558(b) of Pub. L. 105-33 requires us to develop a method
to measure and report the quality of dialysis services provided in the
Medicare program. To comply with this requirement, we developed the
CPMs from the NKF-DOQI (now NKF-K/DOQI) clinical practice guidelines.
The CPM project assists providers in the assessment of care provided to
ESRD patients and stimulates improvement in that care. The processes
used to develop the CPMs and the DOQI guidelines were also discussed in
section II.E.3 and 4 of this preamble.
Dialysis facilities and ESRD networks have used the ESRD CPM
project annual reports for benchmarking purposes and as a means of
identifying opportunities to improve care. The approach of this
proposed rule is to decrease process requirements and instead look to
outcomes of patient care so that quality may be assessed and reported.
The CPMs will be a part of the vehicle by which we measure and report
on the quality of dialysis services provided in the Medicare program.
The CPM data collection tools were briefly described in section
II.E.5 of this preamble. Data elements included on these forms are
intermediate outcome measures and process markers for adequacy of
hemodialysis and peritoneal dialysis, anemia management, nutrition
(albumin), and vascular access management.
The CMS VISION software will provide the electronic means for
collection of the ESRD administrative forms (that is, CMS-2728, CMS-
2746, and CMS-2744) as well as the CPM data (CMS-820 and CMS-821). In
the future, CMS VISION software may also collect other information such
as patient experience of care survey data. The VISION program will
utilize an encryption technology that assures privacy, confidentiality,
and security for electronic communications. The requirement for full
CPM reporting on all patients by all facilities will be implemented
only when the VISION software is fully operational. Vision software
will be provided to independent dialysis facilities and small to medium
size corporate dialysis facilities at no cost. Specifications are being
provided for developing an interface between the major corporate
dialysis facilities' databases and the CMS database to enable ESRD
administrative data and CPM data to be transmitted electronically with
minimal effort from dialysis facility staff. There are initial costs
for major corporate dialysis facilities as they develop the software
interface and for initial training. For a more detailed discussion of
these costs see section IX. of this preamble.
The Secretary will determine the frequency of CPM data collection.
Facilities currently report (via billing submissions) monthly URR
values for all hemodialysis patients and monthly hematocrit levels for
all patients receiving erythropoietin.
The CPM data collection would provide a means for the reporting of
facility-specific performance measures capturing information related to
the
[[Page 6232]]
quality of care delivered. This kind of information is especially
important if a fully-bundled payment system for the ESRD program
expands the composite rate structure to include all outpatient routine
dialysis payments. We are concerned that this change in the payment
structure could provide financial incentives to reduce services
provided to ESRD beneficiaries; thereby compromising quality of care.
Any shift in payment policy necessitates a strong external monitoring
process to ensure that an acceptable level of care continues. The
reporting of facility-specific performance measures and the development
of standards would provide us with the means externally to evaluate and
monitor dialysis facilities to ensure that the necessary services have
been provided and to assist patients to reach optimal outcomes.
We are looking at the feasibility of developing minimum performance
standards. There are widely accepted (K/DOQI) clinical practice
guidelines and clinical performance measures (CPMs) in existence.
However, there is no consensus for minimum performance standards.
Dialysis facility performance is generally compared to performance of
other facilities in the network or to national performance data.
Facilities whose performance measures fall well below the comparison
group are generally identified as needing improvement. However, we do
not have defined thresholds that tell us, for example, that if a
dialysis facility provided a KT/V of 1.2 or higher to at least 85
percent of its hemodialysis patients, that facility is providing an
acceptable level of care.
An additional problem in using minimum standards for accountability
purposes is the possibility of ``cherry picking'' and decreased access
to dialysis for some patients. Dialysis facilities may have a
disincentive to accept patients likely to be more difficult to manage
as well as patients that are more resource-intensive and who are less
likely to achieve acceptable levels on the performance measures. This
raises the issue of the necessity of risk adjusters to be used in
developing the bundled payment rate, as well as developing performance
standards for accountability. We are looking at these difficult issues
and considering the implications of any changes in payment and
performance accountability. We are soliciting comments on how the
incentives to ``cherry pick'' could be minimized. Any performance
standards that we may use for dialysis facilities would be developed in
conjunction with the NTTAA process discussed in section II.E.6 of this
preamble.
This proposal, which requires CPM reporting, is specific to the
CPMs as they currently exist. The process for updating, revising, and
expanding the CPMs will be done in conjunction with the NTTAA process.
A voluntary consensus standards body, which as yet has not been
identified, would likely plan, develop, establish, or coordinate
voluntary consensus standards using agreed upon procedures in
conjunction with the NTTAA.
In the February 19, 1998 Federal Register (63 FR 8546), the Office
of Management and Budget published a notice regarding the Federal
participation in the development and use of voluntary consensus
standards. We will use the policies established in this publication and
the Administrative Procedure Act (APA) when adopting voluntary
consensus standards. If we adopt voluntary consensus standards that are
not legally binding, we would publish them as a notice in the Federal
Register.
The ESRD CPM project data, which would provide the use patterns of
100 percent of dialysis patients, would provide an array of
possibilities for facilities to compare performance and practice
patterns at facility, State, network, and national levels in order to
identify opportunities for improvement in the care of dialysis
patients.
This information would provide independent dialysis facilities with
the same type of information that some dialysis chain corporations have
been able to collect on their own dialysis facilities across the
nation. These CPM data would expand the breadth of data that have been
previously available even to the large dialysis corporations.
The ESRD networks would use the CPM data elements and calculated
measures in order to assist dialysis facilities with quality
improvement activities and as a benchmark to look at their own
performance.
The State survey agencies would receive facility profiles as well
as data for dialysis adequacy, vascular access, anemia management, and
nutrition for use in their survey activities.
At a minimum, we would use the following facility-specific
information for public reporting on our Dialysis Facility Compare Web
site:
Number of patients included in each calculation.
Percent of patients treated in the facility with a Kt/V >=
1.2.
Percent of patients treated in the facility with a
hemoglobin >= 11 gms/dL.
Public reporting of performance measures provides an important
resource to dialysis patients and their families. The Dialysis Facility
Compare website provides detailed information about Medicare-certified
dialysis facilities and allows for comparison of facility
characteristics and quality measures. We are evaluating the information
reported on the Dialysis Facility Compare website for usability and to
ensure that the publicly reported information meets the needs of the
beneficiary. The availability of information will permit patients to
become more active participants in their facilities' quality
improvement process. Informed patients make better health care choices
and are more active participants in their medical care.
12. Disclosure of Ownership (Proposed Sec. 494.180(i))
In Sec. 494.180(i) we are proposing to retain the existing Sec.
405.2136(a) that the dialysis facility must provide complete
information to the State survey agency regarding persons who have any
direct or indirect ownership of the facility in whole or in part in
compliance with the requirements of Sec. Sec. 420.200 through 420.406.
This requirement, reporting ownership interests of 5 percent or more,
is a conforming change to comport with the existing requirements in
Sec. 420.201, which have been in effect since 1992.
VII. Other Proposed Changes and Issues
A. Proposed Cross-Reference Changes
[If you choose to comment on issues in this section please include the
caption ``Cross-Reference Changes'' at the beginning of your comment.]
We are proposing to make technical changes in the following
sections of the regulations to correct cross-references to the sections
in part 405, subpart U that are proposed to be relocated or deleted:
Sec. Sec. 410.5, 410.50, 410.52, 410.152, 410.170, 413.170, 413.172,
413.198, and 414.330.
B. Proposed Additions to Part 488
[If you choose to comment on issues in this section please include the
caption ``Part 488'' at the beginning of your comment.]
We are proposing to add a new subpart H to part 488. Proposed
subpart H would consist of the existing sanction provisions in part 405
subpart U. The existing sanction provisions are in Sec. Sec. 405.2180,
405.2181, 405.2182, and 405.2184 and are summarized as follows:
Section 405.2180 specifies the basic sanction, which is
termination of Medicare coverage, and the basis for reinstatement of
coverage after termination.
Section 405.2181 specifies the alternative sanctions
denial of payment
[[Page 6233]]
of any patients accepted for care after the effective date of the
sanction, and gradual reduction of payments for all patients) and the
circumstances under which they might be imposed.
Section 405.2182 specifies the notice procedures that we
will follow and the appeal rights of sanctioned suppliers.
Section 405.2184 specifies (in greater detail) the rights
of suppliers that appeal proposed imposition of an alternative
sanction.
We propose to redesignate these provisions (with technical and
cross-reference changes) as Sec. Sec. 488.604, 488.606, 488.608, and
488.610 respectively.
VIII. Reference Materials
A. New Provisions of Part 494
This proposed rule contains a number of requirements that are not
included in the existing regulations. For information and ease of
reference, outlined below is a list of the new provisions, grouped by
condition:
------------------------------------------------------------------------
Condition New provisions
------------------------------------------------------------------------
Infection control (Sec. 494.30). Sec. 494.30(a)--Infection control
procedures (including the
Recommended Infection Control
Practices for Hemodialysis Units At
a Glance CDC guidelines).
Sec. 494.30(a)(2)--Patient
isolation procedures.
Water quality (Sec. 494.40)..... Sec. 494.40--Incorporates by
reference the updated 2001 American
National Standard/Association for
the Advancement of Medical
Instrumentation guidelines for
water purity.
Physical environment (Sec. Sec. 494.60(e)--Fire safety.
494.60).
Patient rights (Sec. 494.70).... Sec. 494.70(a)(5)--Advance
directives.
Sec. 494.70(a)(14)--Complaint
systems.
Sec. 494.70(b)--Discharge and
transfer policies.
Sec. 494.70(d)--Posting of rights.
Patient assessment (Sec. 494.80) Sec. 494.80(a)(2)--Appropriateness
of dialysis prescription.
Sec. 494.80(a)(5)--Renal bone
disease.
Sec. 494.80(a)(8)--Dialysis access
type and maintenance.
Sec. 494.80(a)(10)--Suitability
for transplantation referral,
including basis for referral or
nonreferral.
Sec. 494.80(b)--Frequency of
assessment.
Sec. 494.80(c)--Assessment of
treatment prescription.
Sec. 494.80(d)--Patient
reassessment.
Patient plan of care (Sec. Sec. 494.90(a)(1)--Dose of
494.90). dialysis.
Sec. 494.90(a)(2)--Nutritional
status.
Sec. 494.90(a)(3)--Anemia.
Sec. 494.90(a)(4)--Vascular
access.
Sec. 494.90(a)(5)--Transplantation
status.
Sec. 494.90(a)(7)--Rehabilitation
status.
Sec. 494.90(b)--Implementation of
patient plan of care.
Sec. 494.90(b)(3)--Direct
physician/patient interaction.
Sec. 494.90(c)--Transplantation
referral tracking.
Care at home (Sec. 494.100)..... Sec. 494.100(a)--Training.
Sec. 494.100(b)--Home dialysis
monitoring.
Sec. 494.100(c)--Support services.
Quality assessment and performance Sec. 494.110(a)--Program scope.
improvement (Sec. 494.110). Sec. 494.110(a)(2)(i)--Adequacy of
dialysis.
Sec. 494.110(a)(2)(ii)--
Nutritional status.
Sec. 494.110(a)(2)(iii)--Anemia
management.
Sec. 494.110(a)(2)(iv)--Vascular
access.
Sec. 494.110(a)(2)(v)--Medical
injuries and medical error
identification.
Sec. 494.110(a)(2)(vi)--
Hemodialyzer reuse.
Sec. 494.110(a)(vii)--Patient
satisfaction.
Sec. 494.110(b)--Monitoring
performance improvement.
Sec. 494.110(c)--Prioritizing
improvement activities.
Special purpose renal dialysis (Sec. 494.120)--Definition.
facilities (Sec. 494.120).
Personnel qualifications (Sec. Sec. 494.140(b)--Nursing services.
494.140). Sec. 494.140(e)--Dialysis
technicians.
Responsibilities of the medical Sec. 494.150(a)--Quality
director (Sec. 494.150). assessment and performance
improvement program.
Sec. 494.150(b)--Staff education,
training, and performance.
Sec. 494.150(c)--Patient care
policies and procedures.
Governance (Sec. 494.180)....... Sec. 494.180(c)--Medical staff
appointments.
Sec. 494.180(d)--Furnishing
services.
Sec. 494.180(e)--Internal
grievance process.
Sec. 494.180(f)--Discharge and
transfer policies and procedures.
Sec. 494.180(g)--Emergency
coverage.
Sec. 494.180(h)--Furnishing data
and information for ESRD program
administration.
------------------------------------------------------------------------
B. ESRD Crosswalk (Cross Refers Existing Requirements to Proposed
Requirements)
[[Page 6234]]
----------------------------------------------------------------------------------------------------------------
Existing conditions (part 405, Proposed conditions
subpart U) Existing citation (part 494) Proposed citation
----------------------------------------------------------------------------------------------------------------
Scope of subpart..................... 405.2100(a)............ Basis and scope........ 494.1
405.2100(b)............ Deleted................
Objectives of ESRD program........... 405.2101............... Deleted................
Definitions.......................... 405.2102............... Definitions............ 494.10
Agreement........................ ....................... Deleted................ .......................
Arrangement...................... ....................... Deleted................ .......................
Dialysis......................... ....................... Deleted................ .......................
End-stage renal disease.......... ....................... Deleted................ 406.13(b)
ESRD facility (introductory text) ....................... ....................... .......................
(a) Renal transplantation ....................... Retained in 405, 494.10
center. Subpart U.
(b) Renal dialysis center.... ....................... Deleted............... .......................
(c) Renal dialysis facility.. ....................... Definitions............ 494.10
(d) Self-dialysis unit....... ....................... Deleted................ .......................
(e) Special purpose renal ....................... Special purpose renal 494.120
dialysis facility. dialysis facilities.
ESRD service (introductory text). ....................... Retained in 405, .......................
Subpart U.
(a) Transplantation service.. ....................... Deleted................ .......................
(b) Dialysis service......... ....................... Deleted................ .......................
(1) Inpatient dialysis... ....................... Deleted................ .......................
(2) Outpatient dialysis.. ....................... Deleted............... .......................
(i) Staff-assisted ....................... Definitions............ .......................
dialysis.
(ii) Self-dialysis... ....................... Deleted................ 494.10
(3) Home dialysis........ ....................... Care at home........... .......................
(c) Self-dialysis and home ....................... Deleted................ 494.100
dialysis.
Furnishes directly............... ....................... Governance............. .......................
Furnishes on the premises........ ....................... Retained in 405, 494.180(d)
Subpart U.
Histocompatibility testing....... ....................... Deleted................ .......................
Medical care criteria............ ....................... Deleted................ .......................
Medical care norms............... ....................... Deleted................ .......................
Medical care standards........... ....................... Deleted................ .......................
Medical care evaluation study.... ....................... Deleted................ .......................
Network ESRD..................... ....................... Retained in 405, .......................
Subpart U.
Network organization............. ....................... Retained in 405, .......................
Subpart U.
Organ procurement (introductory ....................... Deleted................ .......................
text). Governance.............
(a) Chief executive officer.. ....................... Personnel 494.190(a)
qualifications.
(b) Dietitian................ ....................... Deleted................ 494.150(c)
(c) Medical record ....................... Personnel .......................
practitioner. qualifications.
(d) Nurse responsible for ....................... Personnel 494.150(b)
nursing services. qualifications.
(e) Physician-director....... ....................... Personnel 494.150(a)
qualifications.
(f) Social worker............ ....................... Retained in 405, 494.150(d)
Subpart U.
(g) Transplantation surgeon.. ....................... ....................... .......................
Designation of ESRD networks......... 405.2110............... Retained in 405, .......................
Subpart U.
[Reserved]........................... 405.2111............... Deleted................ .......................
ESRD network organizations........... 405.2112............... Retained in 405, .......................
Subpart U.
Medical review board................. 405.2113............... Retained in 405, .......................
Subpart U.
[Reserved]........................... 405.2114............... Deleted................ .......................
Minimum utilization rates: General... 405.2120............... Retained in Subpart U.. .......................
Basis for determining minimum 405.2121............... Retained in Subpart U.. .......................
utilization rates.
Types and duration of classification 405.2122............... Retained in Subpart U.. .......................
according to utilization rates.
Reporting of utilization rates for 405.2123............... Retained in Subpart U.. .......................
classification.
Calculation of utilization rates for 405.2124............... Retained in Subpart U.. .......................
comparison with minimum utilization
rate(s) and notification of status.
Minimum utilization rates............ 405.2130............... Retained in Subpart U.. .......................
Provider status: renal 405.2131............... Retained in 405, .......................
transplantation center or renal Subpart U.
dialysis center.
[Reserved]........................... 405.2132............... Deleted................ .......................
Furnishing data and information for 405.2133............... Governance............. 494.190(f)
ESRD program administration.
Participation in network activities.. 405.2134............... Relationship with ESRD 494.170
network.
Compliance with Federal, State, and 405.2135............... Compliance with 494.20
local laws and regulations. Federal, State, and
local laws and
regulations.
Governing body and management........ 405.2136............... Governance............. 494.180 (introductory
text)
(a) Disclosure of ownership...... 405.2136(a)............ Governance............. 494.180(g)
(b) Operational objectives....... 405.2136(b)............ Deleted................ .......................
(c) Chief executive officer...... 405.2136(c)............ Governance............. 494.180(a)
(d) Personnel policies and 405.2136(d)(1,3-5,7)... Deleted................ .......................
procedures.
(d)(2) Infection control/Incident 405.2136(d)(2)......... Infection control and 494.30(a) &
reports. Quality assessment and 494.110(a)(5)
performance
improvement.
[[Page 6235]]
(d)(6) Facility personnel 405.2136(d)(6)......... Personnel 494.140(e)
educational programs. qualifications.
(e) Use of outside resources..... ....................... Medical Director....... 494.150(c)
(f) Patient care policies........ 405.2136(e)............ Deleted................ .......................
(g) Medical supervision and 405.2136(f)............ Medical Director....... 494.150(d)
emergency coverage. 405.2136(g)(1)......... Patient plan of care... 494.90 (introductory
text)
(h) Medical staff................ ....................... Care at home and 494.100(c) & 494.180(b)
Governance.
494.2136(g)(2)......... Governance............. 494.180(e)
405.2136(h)............ Governance............. 494.180(c)
Patient long-term program and patient 405.2137 (introductory Patient care plan...... 494.90 (introductory
care plan. text). text)
(a) Patient long-term program.... 405.2137(a)............ Deleted................ .......................
(b) Patient care plan............ 405.2137(b)............ Patient care plan...... 494.90 (introductory
text)
(b)(1) Personalized care plan.... 405.2137(b)(1)......... Patient care plan...... 494.90 (introductory
text)
(b)(2) Developed by a 405.2137(b)(2)......... Patient care plan...... 494.90 (introductory
professional team. text)
(b)(3) The patient is involved... 405.2137(b)(3)......... Patient rights......... 494.70(a)(5)
(b)(4) Frequency of care plan 405.2137(b)(4)......... Patient plan of care... 494.90(b), (1)
review.
(b)(5) Transfer of care plan..... 405.2137(b)(5)......... Medical records........ 494.170(d)
(b)(6) Care plan for the home 405.2137(b)(6)......... Care at home........... 494.100 (introductory
dialysis patient. text)
(b)(7) Erythropoietin for the 405.2137(b)(7)......... Patient plan of care... 494.90(a)(3)
home dialysis patient.
Patient's rights and responsibilities 405.2138(a)-(d)........ Patient rights and 494.70(a) and
medical records. 494.170(a)
405.2138(e)............ Patient rights......... 494.70(c) (13 and 14)
Medical records...................... 405.2139............... Recordkeeping.......... 494.170 (introductory
text)
(a) Medical record contents...... 405.2139(a)............ Deleted................ .......................
(b) Protection of medical record 405.2139(b)............ Recordkeeping.......... 494.170(a)
information.
(c) Medical record supervisor.... 405.2139(c)............ Deleted................ .......................
(d) Completion and centralization 405.2139(d)............ Recordkeeping.......... 494.170(b)
(e) Retention and preservation... 405.2139(e)............ Recordkeeping.......... 494.170(c)
(f) Location and facilities...... 405.2139(f)............ Deleted................ .......................
(g) Transfer of medical 405.2139(g)............ Recordkeeping.......... 494.170(d)
information.
Physical environment................. 405.2140(a) Physical environment... 494.60 (introductory
(introductory text). text)
(a) Building and equipment....... 405.2140(a)(1)......... ....................... .......................
(a)(1) Fire...................... 405.2140(a)(2), (3).... Physical environment... 494.60(e)
(a)(2), (3) Equipment and areas ....................... Physical environment... 494.60(a), (b)
are hazard free.
(a)(5) Water quality requirements 405.2140(a)(5)......... ....................... .......................
(b) Favorable environment for 405.2140(b) Water quality.......... 494.40
patients. (introductory text).
(b)(1) Infection prevention...... ....................... Physical environment... 494.60(c)
(b)(2)(4) Adequate treatment 405.2140(b)(1)......... Infection control...... 494.60(c)
areas/Heating and ventilation 405.2140(b)(2)(4)...... Physical environment... 494.60(c)
systems.
(b)(3) Nursing station........... ....................... ....................... .......................
(b)(5) Special dialysis solutions 405.2140(b)(3)......... Deleted................ .......................
(c) Contamination prevention..... 405.2140(b)(5)......... Deleted................ .......................
405.2140(c)............ Infection control and 494.30(a) and 494.40
Reuse of.
(d) Emergency preparedness....... 405.2140(d)............ Hemodialyzers.......... (introductory text),
(a)
Physical environment... 494.60(d)
Reuse of hemodialyzers and other 405.2150 (introductory Reuse of hemodialyzers 494.50 (introduction)
dialysis supplies. text). and Bloodlines.
(a) Hemodialyzers................ 405.2150(a)(1-3)....... Reuse of hemodialyzers 494.50 (introduction),
and Bloodlines. (a), (b)
(b) Transducer filters........... 405.2150(b)............ Infection Control...... 494.30(a)(1)
(c) Bloodlines................... 405.2150(c)............ Resuse of hemodialyzers 494.50(c)
and Bloodlines.
Affiliation agreement or arrangement. 405.2160 (a), (b)(1), Governance............. 494.180(e)(3)
(b)(3).
405.2160(b)(2)......... Medical records........ 494.170(d)
Director of a renal dialysis facility 405.2161............... Personnel 494.140(a)
or renal dialysis center. qualifications.
Medical Director....... 494.150
Staff of a renal dialysis facility or 405.2162 (stem Governance............. 494.180(b)
renal dialysis center. statement).
Adequate numbers of personnel are 405.2162(a)............ Governance............. 494.180(b)
present to meet patient needs.
(a) Registered nurse............. 405.2162(b)............ Personnel 494.140(b) & (e)
qualifications.
(b) On-duty personnel............ 405.2162(b)............ Governance............. 494.180(b)
(c) Self-care dialysis training 405.2162(c)............ Care at home........... 494.100(a)
personnel.
Minimal service requirements for a 405.2163............... Patient plan of care... 494.90 (introductory
renal dialysis facility or renal text)
dialysis center.
(a) Outpatient dialysis services. 405.2163(a)............ Patient plan of care... 494.90
Care at home........... 494.100
(b) Laboratory services.......... 405.2163(b)............ Laboratory services.... 494.130
(c) Social services.............. 405.2163(c)............ Patient Assessment..... 494.80(a)
[[Page 6236]]
Patient plan of care... 494.90(a)
Care at home........... 494.100(a)
(d) Dietetic services............ 405.2163(d)............ Patient Assessment..... 494.80(a)
Patient plan of care... 494.90
(e) Self-dialysis support 405.2163(e)............ Care at home........... 494.100(c)
services.
(f) Participation in recipient 405.2163(f)............ Patient plan of care... 494.90(c)
registry.
(g) Use of erythropoietin at home 405.2163(g)............ Patient Assessment..... 494.80(a)(4)
Patient plan of care... 494.90(a)(3)
Care at home........... 494.100(a)(2)
(h) Responsibilities of the 405.2163(h)............ Care at home........... 494.100(b)(2)
physician/facility for use of
erythropoietin at home.
Conditions for coverage of special 405.2164............... Special purpose renal 494.120
purpose renal dialysis facilities. dialysis facilities.
Director of a renal transplantation 405.2170............... Retained in 405, .......................
center. Subpart U.
Minimal service requirements for a 405.2171 (introductory Retained in 405,
transplantation center. text). Subpart U.
405.2171(a)-(e)........ ....................... .......................
Termination of Medicare coverage..... 405.2180............... Termination of Medicare 488.604
coverage.
Alternative sanctions................ 405.2181............... Alternative sanctions.. 488.606
Notice of sanction and appear rights: 405.2182............... Notice of appeal 488.608
Termination of coverage. rights: Termination of
coverage.
Notice of appeal rights: Alternative 405.2184............... Notice of appeal 488.610
sanctions. rights: Alternative
sanctions.
----------------------------------------------------------------------------------------------------------------
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Guideline 4.
--Peritoneal Dialysis Adequacy Guidelines. 1997 (updated June 2000).
Guidelines 15 and 16.
--Guidelines for Advance Directives. 2000. (Available at
http://www.kidneyva.org/public ed/orderforms.pdf.)
--``Kidney/Disease Outcomes Quality Initiative Clinical Practice
Guidelines for Vascular Access.'' American Journal of Kidney
Diseases 37 (supplement 1) (2001): S137-S181.
--``Disease Outcome Quality Initiative Clinical Practice Guidelines
for Hemodialysis Adequacy, Peritoneal Dialysis Adequacy, Vascular
Access, and Anemia for Chronic Kidney Disease.'' American Journal of
Kidney Diseases 37 (supplement 1) (January 2001): S182-S238.
``National Kidney Foundation Dialysis Technician Task Force.''
American Journal of Kidney Diseases. 21 (1993): 2.
Owen, W.F., Jr., Lew, N.L., Lui, Y., et al. ``The Urea Reduction
Ratio and Serum Albumin Concentration as Predictors of Mortality in
Patients Undergoing Hemodialysis.'' New England Journal of Medicine
329 (1993): 1001-1006.
Parker, T.F., III. ``Role of Dialysis Dose on Morbidity and
Mortality in Maintenance Hemodialysis Patients.'' American Journal
of Kidney Diseases 24 (1994): 981-989.
Parker, T.F., III, Husni, L., Haugn, W., et al. ``Survival of
Hemodialysis Patients in the United States is Improved with a
Greater Quantity of Dialysis.'' American Journal of Kidney Diseases
23 (1994): 670-680.
Parkerson, G.R. et al. ``The Duke Health Profile: A 17-Item Measure
of Health and Dysfunction.'' Medical Care 28.11 (1990): 1056-1069.
RAND Corporation. ``Kidney Dialysis Quality of Life Short Form,
Version 1.3: A Manual for Scoring.'' 1997.
The Renal Physicians Association. The Collaborative Leadership for
ESRD Patient Safety, Phase I Report of the National Patient Safety
Consensus for the Community of Stakeholders in End Stage Renal
Disease. Patient Safety Committee Report. 2001.
Sciarini, P. and Dungan, J.M. ``A Holistic Protocol for Management
of Fluid Volume Excess in Hemodialysis Patients'' Nephrology Nursing
Journal 23.3 (1996): 299-305.
Stewart, A.L. et al. ``Functional Status and Well-Being of Patients
with Chronic Conditions.'' Journal of the American Medical
Association 262.7 (1989): 907-913.
Szczech, L.A. ``Changing Hemodialysis Thresholds for Optimal
Survival.'' Kidney International 59 (2001): 738-745.
VIII. Collection of Information Requirements and Response to Comments
A. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements:
Section 414.330 Payment for home dialysis equipment, supplies and
support services. Suppliers must report to the ESRD facility providing
support services, every 30 days, all data for each patient regarding
services and items furnished to the patient in accordance with Sec.
494.100(c)(2) of this chapter.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, exempts the
burden associated with this requirement from the PRA as stipulated
under 5 CFR 1320.3(b)(2).
Section 488.60 Special procedures for approving end stage renal
disease facilities. An ESRD facility that wishes to be approved or that
wishes an expansion of dialysis services to be approved for coverage,
in accordance with part 494, must submit the documents and data as
outlined in Sec. 488.60(a)(1) through (a)(4).
We estimate that it will take 250 facilities on an annual basis 40
hours each to gather and submit the necessary documentation for
consideration of approval.
Section 494.30 Condition: Infection control. The dialysis facility
must maintain current infection control information including the most
current CDC guidelines for the proper techniques in the use of vials
and ampules containing medication. In addition, facilities must report
infection control issues to the dialysis facility's chief executive
officer or administrator (see Sec. 494.180(a)) and the quality
improvement committee.
While these requirements are subject to the PRA, the fact that they
are usual and customary business practices, exempts the burden
associated with these requirements from the PRA as stipulated under 5
CFR 1320.3(b)(2).
The facility must document the incidence of infection to identify
trends and establish baseline information on infection incidence,
develop recommendations to prevent infection transmission and take
corrective actions to reduce future incidents, and report incidences of
communicable diseases as required by Federal, State and local laws.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice and may be
required under State or local law, exempts the burden associated with
this requirement from the PRA as stipulated under 5 CFR 1320.3(b)(2) or
(b)(3) or both.
Section 494.40 Condition: Water quality. If the test results from
the last component or carbon tank are greater than the parameters for
chlorine or chloramine described at Sec. 494.30(c)(2)(i) the facility
must immediately notify the medical director.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, exempts the
burden associated with this requirement from the PRA as stipulated
under 5 CFR 1320.3(b)(2).
Section 494.50 Condition: Reuse of hemodialyzers and bloodlines.
The dialysis facility must monitor patient reactions, undertake
evaluation of its dialyzer reprocessing and water purification system,
and report any adverse outcomes to FDA and other Federal, State, or
local governments agencies as required by law.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice and is required
under other Federal, State, and local laws, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
Section 494.70 Condition: Patients' rights. The dialysis facility
must inform patients (or their representatives) of their rights and
responsibilities when they begin their treatment. The facility must
also inform patients of the facility's policies for transfer,
discharge, and discontinuation of services to patients.
[[Page 6238]]
We estimate that 4,317 facilities will need 8 hours each on an
annual basis to disclose the necessary information. This is based on
the belief that the materials will be standardized and incorporated
into the facility's entrance materials.
In addition, the dialysis facility must prominently display a copy
of the patients' rights in the facility. These rights must include the
current State agency and ESRD network telephone compliant numbers and
it must be posted in a place where it can be easily seen and read by
patients.
We estimate that 4,317 facilities will need 1 hour each on an
annual basis to comply with this requirement.
Section 494.90 Condition: Patient plan of care. The
interdisciplinary team must develop and implement a written,
individualized comprehensive plan of care that meets the requirements
of Sec. 494.90.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
Section 494.100 Condition: Care at home. The dialysis facility must
document in the patient's medical record, that the patient, the
caregiver, or both received and comprehended required training. In
addition, the facility must document, in the patient's medical record,
that the self-monitoring data and other information from self-care were
reviewed, at least every 2 months.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
Section 494.110 Condition: Quality assessment and performance
improvement. The dialysis facility must develop, implement, maintain,
and evaluate an effective, data-driven interdisciplinary quality
assessment and performance improvement program that reflects the
complexity of the dialysis facility's organization and services.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
Section 494.120 Condition: Special purpose renal dialysis
facilities. Facilities must contact the patient's physician prior to
initiating dialysis in the special purpose renal dialysis facility, to
discuss the patient's current condition to assure care provided in the
special purpose renal dialysis facility is consistent with the plan of
care (specified in Sec. 494.90).
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
Facilities must document all care provided in the special purpose
facility and forward the documentation to the patient's dialysis
facility within 30 days of the last scheduled treatment in the special
purpose renal dialysis facility.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
Section 494.170 Condition: Medical records. The dialysis facility
must maintain complete, accurate, and accessible records on all
patients, including home patients who elect to receive dialysis
supplies and equipment from a supplier that is not a provider of ESRD
services and all other home dialysis patients whose care is under the
supervision of the facility.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
The dialysis facility must obtain written authorization from the
patient or legal representative before releasing information that is
not compelled by law.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, exempts the
burden associated with this requirement from the PRA as stipulated
under 5 CFR 1320.3(b)(2).
Patient records must be retained for a period of time not less than
that required by State law, or in the absence of State law, 5 years
from the date of discharge, including death for adults and 3 years for
minors or until the patient reaches legal age under State law,
whichever is longer.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
When a dialysis patient is transferred, the transferring facility
must provide the receiving facility with all medical records and other
information necessary or useful in the patient's care or treatment.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
Section 494.180 Condition: Governance. The dialysis facility must
have available at the nursing/monitoring station, a roster with the
names of physicians to be called for emergencies, when they can be
called, and how they can be reached.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
The dialysis facility must have a written agreement, that meets the
requirements in Sec. 494.180, with a hospital that can provide
inpatient care, other hospital services, and emergency medical care
that is available 24 hours a day, 7 days a week.
While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice, or is required
under other Federal, State, and local laws, or both, exempts the burden
associated with this requirement from the PRA as stipulated under 5 CFR
1320.3(b)(2) or (b)(3) or both.
The facility must provide each patient with written notice 30 days
in advance of the facility reducing or terminating ongoing care after
following the procedure specified in Sec. 494.180(f).
We estimate that 500 facilities will need 1 hour on an annual basis
to provide the required disclosure. This is
[[Page 6239]]
based on the assumption that the disclosure will be standardized and
will not be required by the majority of facilities.
The dialysis facility must furnish data information electronically
to CMS at intervals specified by the Secretary, which meet the
requirements referenced in this section.
While these requirements are subject to the PRA, they are currently
approved under the following OMB approval numbers: 0938-0046, 0938-
0360, 0938-0386, 0938-0657, and 0938-0658.
In accordance with Sec. Sec. 420.200 through 420.206 of this
chapter, the governing body must report ownership interests of 5
percent or more to its State survey agency.
While these requirements are subject to the PRA, it is currently
approved under OMB approval number 0938-0086.
We have submitted a copy of this proposed rule to OMB for its
review of the information collection requirements in Sec. Sec.
414.330, 488.60, 494.40, 494.50, 494.70, 494.80, 494.90, 494.100,
494.110, 494.120, 494.170, and 494.180. These requirements are not
effective until they have been approved by OMB.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Regulations Development and
Issuances Group, Attn: Dawn Willinghan, Room C4-26-05, 7500 Security
Boulevard, Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Christopher J. Martin, CMS Desk Officer,
Christopher_J._Martin@omb.eop.gov. Fax: (202) 395-6974.
B. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the major comments in the preamble to that
document.
X. Regulatory Impact Analysis
[If you choose to comment on issues in this section please include the
caption ``Impact Analysis'' at the beginning of your comment.]
A. Overall Impact
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Public Law 96-
354), section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). This rule is
a proposed revision of the Medicare conditions for coverage for end-
stage renal disease (ESRD) facilities. The conditions for coverage are
the basic health and safety requirements that an ESRD supplier of
services must meet in order to receive payment from the Medicare
program. This proposed rule would incorporate new scientific advances
and current medical practices in treating ESRD while removing numerous
burdensome process and procedural requirements contained in the
existing conditions for coverage. While it is not possible at this
point to determine definitively the additional costs to the Medicare
program resulting from this rule, we believe that the impact will be
below the $100 million threshold; and therefore, believe that this
proposed rule is not a major rule.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations and government agencies.
Individuals and States are not included in the definition of small
entity. According to the latest numbers from the Small Business
Administration's North American Industrial Classification System, 37
percent (1,751) of dialysis facilities have revenues of $29 million or
less annually; and therefore, are considered to be small entities.
Thirty of these facilities have annual revenue less than $100,000. It
is possible that this proposed regulation could cost some of these
small facilities an additional $6,545 (about 6.5 percent of $100,000).
However, this is an essential upgrading necessary to bring these
facilities into conformity with what is becoming standard practice in
the renal field and to provide essential quality in health care,
potentially saving lives. For these reasons, we are not preparing
analyses for either the RFA or section 1102(b) of the Act because we
have determined, and we certify, that this rule will not have a
significant economic impact on a substantial number of small entities
or a significant impact on the operations of a substantial number of
small rural facilities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. Since
this rule applies only to dialysis facilities, it has no impact on
small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditures in any one year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $110 million. This rule has no impact on the
expenditures of State, local or tribal governments, and the impact on
the private sector is estimated to be less than $110 million.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This rule will not have any effect on State and local
governments. The costs associated with treating ESRD are currently a
Medicare-covered benefit for individuals with ESRD. This rule will not
increase the costs of the Medicare program.
B. Impact of the Proposed Policy Changes
1. Retained Requirements
We note that we have retained a number of requirements from the
existing regulations in this proposed rule. Therefore, these
requirements do not add any new financial burden for dialysis
facilities. These requirements include the following:
Special procedures for approving end stage renal disease
facilities.
Infection control.
Water quality.
Reuse of hemodialyzers.
Patient plan of care.
[[Page 6240]]
2. Physical Environment and Emergency Preparedness
The existing regulations require dialysis facilities to have
written policies and procedures for handling emergencies with annual
reviews, testing, and revisions, and staff training to handle any
emergency or disaster. Facilities are now expending resources to
develop procedures and train staff for natural disasters that had never
been known to occur in their region. The proposed rule requires only
that the staff be able to demonstrate the ability to manage emergencies
that are likely to occur in the facility's geographic area. Although an
annual review would still be required, the proposed rule does not
require the involvement of the CEO in this activity. We estimate a
typical facility will expend 4 hours less of staff time for this
activity at $50 per hour, with a net savings of $200 per year for an
overall savings of $947,000.
The proposed rule requires that the facility meet the 2000 edition
of Life Safety Code (LSC) requirements of the National Fire Protection
Association. Most dialysis facilities currently meet most of the
provisions required in Chapter 21 of the LSC because of State and local
building codes as well as facilities' own liability purposes. However,
there may be some burden for existing facilities in regard to the
installation and maintenance of the fire department alarm connection.
We estimate that approximately 1,136 facilities will need to be
upgraded to meet this requirement. The one-time cost to install a fire
department or central monitoring station connection is estimated to be
$1,000 per facility. The monthly fee for the monitoring station and
telephone cost is estimated to be about $80. Thus, we estimate the
additional overall cost of compliance for facilities in the first year
will be $2,226,500, with the annual cost thereafter being $1,090,560
($80 month X 12 months X 1,136 facilities).
This estimate does not take into account any specific waivers or
acceptance of a State code in lieu of the LSC that may decrease the
burden. If the health and safety of patients and staff are not
adversely affected, the proposed rule would permit us to waive specific
provisions of the LSC, which, if rigidly applied, would result in an
unreasonable hardship on the facility. In addition, the proposed rule
specifies that the Secretary, may accept a State code in lieu of the
LSC, if it adequately protects patients.
The proposed rule requires that every dialysis facility have access
to a defibrillator. As discussed earlier in this preamble, USRDS data
on causes of death among hemodialysis patients between 1997 and 1999
indicates that nearly half (49 percent) of the deaths were attributable
to cardiovascular conditions, with cardiac arrest ranking first among
the specified causes.
One study found that the typical dialysis facility faces one
cardiac arrest each year (Becker, pp. 1509-1512). The study estimated
the cost of AEDs at $3,000, with a useful life of 10 years, that is,
$300 annually for each life potentially saved. Currently, AEDs can be
purchased for $2,000 with a useful life of 10 years (that is, an AED
can be use at a cost of $200 each year for 10 years).
Since 19 percent of dialysis facilities are hospital-based, it is
presumed that these facilities have already met the requirement, since
they have access to an in-hospital defibrillator. However, we assume
that all of the remaining 81 percent of facilities would have to
acquire this piece of equipment. The only ongoing annual costs for
maintaining the equipment are those for testing and replacing
batteries, and these costs are negligible. The cost of AEDs in 81
percent of dialysis facilities is estimated to be $7,670,700. We have
requested public comment regarding the AED proposal as well as comments
regarding the appropriateness of waivers or a phase-in period or both
for small rural dialysis facilities.
3. Patients' Rights
The existing regulations require dialysis facilities to have
written patients' rights policies and procedures and a list of numerous
persons to whom the patient rights policies must be made available. The
proposed rule details basic information that must be provided to
patients (for example, advance directives and how to contact entities
in regard to complaints) but only requires that patient rights be
prominently displayed. Proposing minimum contents in the patients'
rights condition, and proposing only that these rights be posted, will
limit the administrative burden. We estimate that this will save the
typical facility about 2 hours of staff time at $15 per hour, that is,
$30 annually, for an overall savings of $142,050.
The existing regulations require translators when a significant
number of patients exhibit language barriers. The proposed rule would
delete this requirement and specify information be given to patients in
a manner that assures their understanding. However, translators could
still be used and facilities would have more flexibility in overcoming
language barriers in lieu of hiring translators. This results in a net
reduction in facility costs.
The existing regulations require that advance notice be given to
patients who are being terminated from a dialysis facility. The
proposed rule is more specific and requires that written notice be
given 30 days in advance. However, since involuntary terminations are a
relatively infrequent occurrence, we consider the financial impact on
dialysis facilities to be negligible.
We estimate that 569 facilities will need 1 hour at $15 an hour on
an annual basis to provide the required disclosure for a total annual
cost of $8,535 (569 x 1 x 15). This is based on the assumption that the
disclosure will be standardized and will not be required by the
majority of facilities.
4. Quality Assessment and Performance Improvement
Existing regulations are not comparable to the proposed rule's
requirement that the facility develop, implement, maintain, and
evaluate a data-driven QAPI program. However, quality improvement
efforts are considered part of the professional staff's job and the
renal community has developed considerable consensus in recent years in
regard to clinical performance data. The top 5 dialysis chains,
representing two-thirds of all dialysis facilities are already
collecting and reporting standardized data on 14 data elements, some of
which are reported to the USRDS.
This proposed rule simply requires the facilities to use this data
internally, in a formal QAPI program that each facility has the
flexibility to develop to suit its own purposes. The two-thirds of
dialysis facilities in the top five chains are already complying with
this requirement and many others also consider use of this data as part
of their standard practice. We estimate that the QAPI requirements
would impose a burden on no more than 10 percent of the dialysis
facilities (that is, 473 facilities).
Assuming that a facility were initiating a QAPI program only as a
result of this proposed rule, this may entail a 1-hour meeting of 4
staff persons quarterly, with each staff person having an additional
hour of work each month beyond the meeting (that is, 16 staff hours of
meeting time + 48 staff hours beyond meetings = 64 hours annually).
Assuming that the average staff cost is $25, the total additional cost
to the facility would be $1,600 annually. The total cost for 473
facilities would be $756,800.
[[Page 6241]]
5. Medical Records
In the proposed rule, essential requirements in regard to
retention, preservation, and transfer of medical records would be
retained. However, the existing regulations are highly prescriptive in
not only requiring the designation of a medical records supervisor, but
in detailing that person's duties, specifying categories of information
to be included in the medical record, requiring written policies and
procedures to protect medical records information, and even addressing
spatial issues in regard to the maintenance and processing of medical
records. The proposed rule would delete many of these requirements,
giving the facility flexibility in deciding how the medical records are
to be maintained and what is to be in them, as long as they facilitate
positive patient outcomes. This reduces burden on the dialysis
facilities. We estimate that this will save the typical facility about
40 hours of a medical records professional's time, at $15 per hour,
that is, $600 annually for an overall savings of $2,841,000.
6. Governance
The existing regulations specify the minimum requirements for CEO
education and experience, whereas the proposed rule would delete these
requirements.
However, the proposed rule would add new requirements, for a
training program for water treatment system technicians and a written
training program for dialysis patient care technicians, in regard to
the operation of kidney dialysis equipment and machines and the
provision of patient care. This training program would be developed or
adopted by the facility and must be approved by the medical director
and the governing body of the facility. The water system training
program may be written, audiovisual, or computer based. Since the major
dialysis chains all have training programs for their dialysis patient
care technicians and water treatment technicians, and the majority of
dialysis facilities are affiliated with these chains, a large portion
of facilities already meet this requirement. In addition, at least 11
States already have some form of credentialing (training; competency
exam; certification) requirements for dialysis patient care
technicians, so dialysis facilities in these States, if they are
unaffiliated with a major chain, may simply declare that meeting the
State credentialing requirement is equivalent to completion of their
training program. Even facilities that are not affiliated with a major
dialysis chain and are in a State where there are no credentialing
requirements for dialysis technicians, are not likely to be burdened
with the requirement to develop a dialysis training program, since they
can request medical director and governing body approval to use a
packaged curriculum that includes a water treatment system module,
which has been developed by organizations in the renal field and is
available to any dialysis facility without cost.
7. Clinical Performance Measures
The proposed rule would add a requirement that all dialysis
facilities electronically collect and report ESRD CPM Project data on
all patients. The data include several measures of dialysis adequacy,
vascular access, anemia management and nutrition.
Any potential burden added by this requirement is mitigated by the
following:
More than half the dialysis facilities already collect
data on at least 14 clinical performance measures, including measures
that evaluate adequacy of dialysis treatment, anemia, nutritional
level, vascular access, bone disease, and hypertension. Many units
affiliated with the major dialysis chains have integrated their
electronic data systems for quality management with their data systems
for patient management, to minimize the data reporting burden. These
facilities understand that it is important to collect and to use the
data to allow an accurate comparison of the facility's performance
relative to that of its peers, since these comparisons can serve to
identify significant opportunities for improvement.
CPM data is already reported to CMS on a voluntary basis
for a 5 percent national sample of patients, so many facilities are
already familiar with the data reporting and collection process.
The CPM data set will become a part of the Consolidated
Renal Operations in a Web-enabled Network (CROWN) data system, and CMS
will supply VISION software free to dialysis facilities to permit them
to enter CPM data electronically directly into the system. VISION is
available for general use and is currently being used by 138
independent dialysis facilities. Any dialysis facility that chooses to
voluntarily participate in the CPM Project will be allowed to do so
before the publication of a final rule. This could substantially reduce
the number of facilities that need to be brought on line before the
effective date of the final rule.
Training for purposes of implementing the CPM requirement
will be provided by CMS and its ESRD Networks without cost to the
dialysis industry, and some of the training will be done using an
Internet Web tool.
However, we do estimate that there will be some additional costs
involved in: (1) Travel costs to training sites for some dialysis
facility or chain representatives; (2) computer hardware and Internet
Service Provider (ISP) connections for some facilities; and (3)
collecting and transmitting data on the residual patients who are not
served by the major dialysis chains and who are not part of the 5
percent sample of patients in the current CPM project. The detail in
these estimates is as follows:
Estimated costs for travel to training sites will be
approximately $200 for each facility/chain representative and we
estimate that 2,000 persons will be sent for training, most
representing chains of dialysis facilities. The total cost of travel to
training would, then, be $400,000, and this would be only for the
initial year of implementation;
Very few dialysis facilities would have to purchase
computer hardware to implement this requirement, possibly no more than
142 (3 percent of total facilities). We estimate the cost of this
purchase to be $1,000. Thus, the total cost for purchasing hardware
would be $142,000, and this would be only in the initial year of
implementation. We estimate ISP costs to be $150 annually ($150 x 142
facilities = $21,300);
The estimated 5 percent annual growth rate in the ESRD
population would mean that in 2005 there will be approximately 337,839
ESRD beneficiaries. We believe that the larger chains are already
collecting CPM data on approximately 65 percent of these patients.
Since the CPM project requires submission of this data on a 5 percent
sample, we assume that the burden is only in regard to 95 percent of
the remaining 35 percent of patients. Thus, we estimate that additional
CPM data collection and reporting will be required for 112,331 patients
annually (337,839 x .35 x .95). Based on current CPM project norms, we
assume: One-half hour to abstract the data from the medical record by
staff who are typically paid $25 per hour, for a cost of $1,404,142
(112,331 x .5 x $25) annually; and key-entry at the rate of 12 patients
per hour by staff who are typically paid $12 per hour, for a cost of
$112,331 annually.
Thus, in the first year of implementation, the total financial
impact on the dialysis facilities of implementing the CPM requirement
is estimated to be $2,079,774; thereafter, the cost would be
approximately $1,537,774 ($1,404,142 + $112,331 + $21,300) annually for
collecting and
[[Page 6242]]
transmitting the data and paying the ISP.
Cost Estimate for the Collection of CPM Data
------------------------------------------------------------------------
------------------------------------------------------------------------
$400,000 for travel to training (first year).
$142,000 for computer hardware (first year).
$1,537,474 for abstracting & key-entry of CPM data and
ISP annually.
----------------------------
$2,079,774 Total
------------------------------------------------------------------------
The following chart provides an overall estimate of the impact of
the proposed rule:
Overall Impact of the Proposed Rule on the Economy
------------------------------------------------------------------------
-------------------------------------------------------
$30.............................................
CPM reporting requirement (detailed above)....... = 2,079,774
-----------------
Total impact on the economy.................. = +8,812,319
------------------------------------------------------------------------
C. Anticipated Effects of the Revised ESRD Conditions on Suppliers of
ESRD Services
The Medicare conditions for coverage for ESRD facilities have not
been revised in their entirety since their original publication in
1976. The revisions in this proposed rule reflect, for the most part,
advances in dialysis technology and standard care practices. Transplant
centers will not be affected because they are not included in this
rule. One of the major purposes of this revision is to be responsive to
regulatory reform initiatives, eliminating unnecessary procedural
requirements and focusing on better patient outcomes of care.
D. Alternatives Considered
1. Maintenance of Existing Regulations
One alternative would be to keep the existing regulations. However,
the current regulations inhibit our ability to ensure better outcomes
of patient care, collect electronic data for quality assurance and
quality improvement, incorporate new CDC and AAMI guidelines and fire
safety standards and reduce current facility burden by eliminating
numerous process and procedural requirements.
2. Infection Control
One alternative was not proposing an exception to the CDC
recommendation for monthly and semiannual screening for hepatitis C. We
retained the exception because blanket screening for hepatitis C is not
a Medicare-covered service.
Another alternative was to propose compliance with all of the CDC
guidelines in the RR05 report rather than just the crucial
``Recommended Infection Control Practices for Hemodialysis Units At a
Glance'' (At a Glance) requirements. However, although we encourage
compliance with the entire report, we decided against proposing
compliance with the entire report. Our rationale was compliance with
guidelines in the entire report would reduce flexibility and add
unnecessary burden for dialysis facilities since some of the guidelines
exceed the scope of these health and safety requirements.
A third alternative was to propose compliance with AIA Guidelines
for Design and Construction of Hospitals and Health Care Facilities.
The AIA guidelines provide instructions regarding dialysis unit design
as it relates to infection control. While some states have adopted
specific AIA guidelines as minimal standards, we believe it would be
too burdensome on dialysis facilities to propose to incorporate AIA
guidelines as federal requirements.
3. Water Quality
One alternative was to propose to continue to require compliance
with portions of the current AAMI guidelines,--ANSI/AAMI RD5: 1992
Appendix B5. However, we decided to propose compliance with portions of
the newer AAMI document--RD62: 2001 and additional requirements that
are compatible with ANSI/AAMI RD52: 2004 because RD62 and RD52, are the
state-of-the-art water quality guidelines. We have asked for comments
on this proposal.
4. Reuse of Hemodialyzers and Bloodlines
One potential cost-saving alternative was to remove the proposal
that dialyzers exposed to more than one germicide were acceptable for
reuse. We decided against this proposal because exposure to different
germicides may cause membrane leaks and we have no scientific evidence
to support the safety of using dialyzers exposed to more than one
germicide.
5. Physical Environment and Emergency Preparedness
One alternative was to remove the proposal that every dialysis
facility have a defibrillator. We retained this proposal because a
Seattle study (Becker, pp. 1509-1512) identified dialysis centers as
having a relatively high incidence of cardiac arrests over a 7-year
period. Also, automated external defibrillators are now required on
airliners and in other public places because the technology is simple
to use, staff can be trained on the use of such equipment, and the
technology has been proven to save lives.
A second alternative was to propose a waiver or phase-in period for
defibrillators in small rural satellite
[[Page 6243]]
dialysis facilities with very low utilization. We are considering this
alternative and have requested public comments on the defibrillator
proposal.
6. Patients' Rights
One alternative was to remove the proposal for advance directives.
We retained this proposal because of the nature of ESRD and the aging
dialysis population.
Another alternative considered was not proposing that dialysis
facilities have an internal grievance procedure. We did not adopt this
alternative because we believe an internal grievance process is
essential to allow patients to express their concerns directly to the
facility in which they receive dialysis.
7. Patient Assessment
One alternative was to include ``extremely frail patients'' in the
proposal to reassess unstable patients monthly. This proposal was not
adopted in order to ensure that dialysis facilities retain the
flexibility to make clinical determinations on a case-by-case basis.
Another alternative was to remove the proposal for a 3-month
timeframe to reassess new patients. We are aware that the dialysis
industry has not reached consensus regarding the appropriate frequency
for reassessments, and therefore, we have requested comments on the
current proposal to reassess new patients 3 months after starting
dialysis.
8. Patient Plan of Care
One alternative was to retain the existing requirement for an
individualized care plan with a 6-month review and a long-term program
with an annual review. We did not adopt this approach because it was
less burdensome to propose a single individualized plan of care
(without a long-term program) to be reviewed annually.
Another alternative was to propose to adopt specific evidence-based
NKF-K/DOQI clinical practice guidelines as numerical minimum target
values within the patient plan of care condition (that is, adequacy of
dialysis and anemia management). This issue is discussed in detail in
the preamble and we are requesting public comments on the issue.
9. Quality Assessment and Performance Improvement
One alternative was to propose a QAPI program without specific
threshold criteria. We determined, based on the work of the NFK-K/DOQI
committees (adequacy, nutrition, anemia, and vascular access), AAMI
guidelines (reuse), and specific recommendations from the OIG (medical
error identification and patient satisfaction) that there was
sufficient basis to include 7 basic criteria. We have requested public
comment on QAPI.
10. Special Purpose Renal Dialysis Facilities
One alternative was to remove this condition entirely based on
historically low levels of participation. We determined that
eliminating this condition would be detrimental to the small number of
vacation camps that choose to participate and it would also inhibit
access to care during natural disasters.
Another alternative was to retain the current 8-month certification
period and the current certification requirements. We believe that the
current certification requirements are onerous; we believe that this is
demonstrated by the lack of participation in Medicare by vacation
camps. We believe proposing to reduce the number of certification
requirements addresses this issue. The existing 8-month certification
period is also excessive (that is, vacation camps are typically not
open for 8 months and natural emergencies are of shorter duration). The
current proposal represents a significant reduction in administrative
burden for special purpose units.
11. Personnel Qualifications
One alternative was to retain the existing requirement that at
least a licensed practical nurse must be on the premises during
dialysis. We decided to propose that a registered nurse be on the
premises during dialysis to protect patient health and safety and
because this did not represent an increase in burden for dialysis
units.
Other options were to propose no Federal requirements for dialysis
technicians, or, to propose minimal Federal requirements for dialysis
technicians and include proposals for competency testing and
certification. A detailed discussion of this issue is in section VI.A.5
of this preamble. We determined that minimal Federal requirements are
needed at this time because dialysis technicians are the primary
caregivers in most dialysis facilities. However, we did not propose
competency testing or certification and have requested public comment.
12. Medical Director
One alternative was to propose to eliminate the medical director
condition and propose that other health care professionals run dialysis
facilities. However, a June 2000 OIG report strongly recommended that
we strengthen the role of the facility's medical director. In response
to that recommendation, we proposed to retain the condition with a
clarification of the medical director's responsibilities to include
overseeing both the QAPI program and all involuntary patient transfers
or discharges. We do not believe that this approach would impose an
additional cost burden on dialysis facilities. We have requested public
comments on these proposals.
13. Governance
One alternative considered was to remove the proposal for a 30-day
advanced notice before involuntary patient discharge or transfer and
retain the existing requirement (see Sec. 405.2138(b)(2)) for patients
to be ``given advance notice to ensure orderly transfer or discharge.''
We did not adopt this alternative because: (1) A 30-day advance notice
for discharge and transfer has been consistent with the existing
requirements in NFs, SNFs, and hospital swing-beds for over 12 years;
(2) the dialysis patient population is increasingly older and many are
nursing home residents with co-morbid conditions; and (3) large
dialysis chains have emerged that can offer more flexibility and
options for a patient involuntarily discharged from a facility by
providing numerous units nearby or within commuting distance of that
patient's place of residence. We have added a proposal to waive the 30-
day notice under unusual circumstances.
This proposed rule contains a requirement for every dialysis
facility to report ESRD CPM Project data to CMS. One option considered
was to propose that less than 100 percent of facilities be required to
participate. However, section 4558(b) of Pub. L. 105-33 requires CMS to
monitor the quality of care delivered to dialysis patients. To date,
CMS has been collecting a 5 percent CPM patient sample on a voluntary
basis. CPM electronic data collection has been pilot-tested and is
expected to be ready for general use in 2005. A gradual voluntary
phase-in will be undertaken for facilities that want to participate
before full implementation. We believe that 100 percent CPM data
collection is necessary to comply with the intent of the statute. The
large chain dialysis facilities and many other dialysis facilities
already collect this data for benchmarking and quality improvement
purposes, and therefore, this will not create a significant new burden
for the industry. However, small rural facilities may have a difficult
time coming into compliance, and therefore,
[[Page 6244]]
we are considering a phase-in period for these facilities.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 410
Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural
areas, X-rays.
42 CFR Part 413
Health facilities, Kidney diseases, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 414
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 488
Administrative practice and procedure, Health facilities, Medicare,
and Reporting and recordkeeping requirements.
42 CFR Part 494
Health facilities, Kidney diseases, Medicare, Reporting and
recordkeeping requirements.
For the reasons stated in the preamble of this proposed rule, the
Centers for Medicare & Medicaid Services proposes to amend 42 CFR
chapter IV as follows:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart U--Conditions for Coverage of End-Stage Renal Disease
(ESRD) Services
1. The authority citation for part 405, subpart U continues to read
as follows:
Authority: Secs. 1102, 1138, 1861, 1862(a), 1871, 1874, and 1881
of the Social Security Act (42 U.S.C. 1302, 1320b-8, 1395x,
1395y(a), 1395hh, 1395kk, and 1395rr), unless otherwise noted.
2. The title of the subpart is revised to read as follows:
Subpart U--Conditions for Coverage for Suppliers of Renal
Transplantation Services and Requirements for ESRD Networks
Sec. Sec. 405.2100, 405.2101, 405.2135 through 405.2164, and 405.2180
through 405.2184 [Removed and Reserved]
3. Sections 405.2100, 405.2101, 405.2135 through 405.2164, and
405.2180 through 405.2184 are removed and reserved.
4. Section 405.2102 is revised to read as follows:
Sec. 405.2102 Definitions.
As used in this subpart, the following definitions apply:
ESRD Network organization. The administrative governing body to the
network and liaison to the Federal government.
Histocompatibility testing. Laboratory test procedures which
determine compatibility between an organ donor and a potential organ
transplant recipient.
Network, ESRD. All Medicare-approved ESRD facilities in a
designated geographic area specified by CMS.
Organ procurement. The process of acquiring donor organs. (See
definition of Organ procurement organization in Sec. 486.302 of this
chapter.)
Renal transplantation center. A hospital unit which is approved to
furnish directly transplantation and other medical and surgical
specialty services required for the care of the ESRD transplant
patients, including inpatient dialysis furnished directly or under
arrangement. A Renal Transplantation Center may also be a Renal
Dialysis Center.
Transplantation service. A process by which (1) a kidney is excised
from a live or cadaveric donor, (2) that kidney is implanted in an ESRD
patient, and (3) supportive care is furnished to the living donor and
to the recipient following implantation.
Transplantation surgeon. A person who--
(1) Is board eligible or board certified in general surgery or
urology by a professional board; and
(2) Has at least 12 months training or experience in the
performance of renal transplantation and the care of patients with
renal transplants.
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
1. The authority citation for part 410 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Sec. 410.5 [Amended]
2. In Sec. 410.5(a), the reference ``Part 405, subpart U'' is
revised to read ``Part 494''.
Sec. 410.50 [Amended]
3. In Sec. 410.50(b), the reference ``Sec. 405.2163(b)'' is
revised to read ``Sec. 494.130''; and the reference ``subpart M of
part 405'' is revised to read ``part 494''.
Sec. 410.52 [Amended]
4. Section 410.52 is amended as follows:
a. In paragraph (a)(4), the reference to ``Sec. 405.2163'' is
revised to read ``Sec. 494.90(a)(3)''.
b. In paragraph (b), the parenthetical statement ``(Section
405.2137 of this chapter contains specific details.)'' is revised to
read ``(Section 494.90 of this chapter contains details on patient
plans of care.)''
Sec. 410.152 [Amended]
5. In Sec. 410.152(e)(1), ``subpart U of part 405'' is revised to
read ``part 494''.
Sec. 410.170 [Amended]
6. In Sec. 410.170(c), the reference to ``Sec. 405.2137(b)(3)''
is revised to read ``Sec. 494.90''.
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED
PAYMENT RATES FOR SKILLED NURSING FACILITIES
1. The authority citation for part 413 continues to read as
follows:
Authority: Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i),
(n), 1861(v), 1871, 1881, 1883, and 1886 of the Social Security Act
(42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n),
1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww).
2. In Sec. 413.170, paragraph (a) is revised to read as follows:
Sec. 413.170 Scope.
This subpart implements sections 1881(b)(2) and (b)(7) of the Act
by--
(a) Setting forth the principles and authorities under which CMS is
authorized to establish a prospective payment system for outpatient
maintenance dialysis furnished in or under the supervision of a
dialysis facility under part 494 of this chapter (referred to as
``facility''). For purposes of this section and Sec. Sec. 413.172
through 413.198, ``outpatient maintenance dialysis'' means outpatient
dialysis provided by a dialysis facility, home dialysis or self-
dialysis as defined in
[[Page 6245]]
Sec. 494.10 of this chapter and includes all items and services
specified in Sec. Sec. 410.50 and 410.52 of this chapter.
* * * * *
3. In Sec. 413.172, paragraph (b) is revised to read as follows:
Sec. 4l3.172 Principles of prospective payment.
* * * * *
(b) All approved ESRD facilities must accept the prospective
payment rates established by CMS as payment in full for covered
outpatient maintenance dialysis. Approved ESRD facility means--
(1) Any independent or hospital-based facility (as defined in
accordance with Sec. 413.174(b) and (c) of this part) that has been
approved by CMS to participate in Medicare as an ESRD supplier; or
(2) Any approved independent facility with a written agreement with
the Secretary. Under the agreement, the independent ESRD facility
agrees--
(i) To maintain compliance with the conditions for coverage set
forth in part 494 of this chapter and to report promptly to CMS any
failure to do so; and
(ii) Not to charge the beneficiary or any other person for items
and services for which the beneficiary is entitled to have payment made
under the provisions of this part.
* * * * *
Sec. 413.198 [Amended]
4. In Sec. 413.198(a), the phrase ``approved under subpart U of
part 405,'' is revised to read ``under part 494''.
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
1. Part 414 is amended as follows:
1a. The authority citation for part 414 continues to read as
follows:
Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).
Sec. 414.330 [Amended]
2. In Sec. 414.330(a)(2)(iii)(B), the reference ``subpart U of
part 405'' is revised to read ``part 494''; and in Sec.
414.330(a)(2)(iii)(B)(l), the reference to ``subpart U'' is changed to
read ``part 494''.
3. In Sec. 414.330(a)(2)(iii)(B)(1) the references ``subpart U''
are revised to read ``part 494'.
4. In Sec. 414.330(a)(2)(iii)(B)(7) the references ``subpart U''
are revised to read ``part 494'.
5. Section 414.330(a)(2)(iii)(C) is added to read as follows:
Sec. 414.330 Payment for home dialysis equipment, supplies, and
support services.
(a) * * *
(2) * * *
(iii) * * *
(C) Agrees to report to the ESRD facility providing support
services, every 30 days, all data for each patient regarding services
and items furnished to the patient in accordance with Sec.
494.100(c)(2) of this chapter.
* * * * *
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
1. The authority citation for part 488 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1895hh).
2. In Sec. 488.60 paragraph (a) is revised to read as follows:
Sec. 488.60 Special procedures for approving end stage renal disease
facilities.
(a) Consideration for approval. An ESRD facility that wishes to be
approved or that wishes an expansion of dialysis services to be
approved for coverage, in accordance with part 494 of this subchapter,
must secure a determination by the Secretary. To secure a
determination, the facility must submit the following documents and
data for consideration by the Secretary:
(1) Certification by the State agency referred to in Sec. 488.12
of this part.
(2) Data furnished by ESRD network organizations and
recommendations of the Public Health Service concerning the facility's
contribution to the ESRD services of the network.
(3) Data concerning the facility's compliance with professional
norms and standards.
(4) Data pertaining to the facility's qualifications for approval
or for any expansion of services.
* * * * *
3. A new subpart H, consisting of Sec. Sec. 488.604, 488.606,
488.608, and 488.610, is added to read as follows:
Subpart H--Termination of Medicare Coverage and Alternative Sanctions
for End Stage Renal Disease (ESRD) Facilities
Sec.
488.604 Termination of Medicare coverage.
488.606 Alternative sanctions.
488.608 Notice of alternative sanction and appeal rights:
Termination of coverage.
488.610 Notice of appeal rights: Alternative sanctions.
Subpart H--Termination of Medicare Coverage and Alternative
Sanctions for End Stage Renal Disease (ESRD) Facilities
Sec. 488.604 Termination of Medicare coverage.
(a) Except as otherwise provided in this subpart, failure of a
supplier of ESRD services to meet one or more of the conditions for
coverage set forth in part 494 of this subchapter will result in
termination of Medicare coverage of the services furnished by the
supplier.
(b) If termination of coverage is based solely on a supplier's
failure to participate in network activities and pursue network goals,
as required at Sec. 494.160 of this subchapter, coverage may be
reinstated when CMS determines that the supplier is making reasonable
and appropriate efforts to meet that condition.
(c) If termination of coverage is based on failure to meet any of
the other conditions specified in part 494 of this subchapter, coverage
will not be reinstated until CMS finds that the reason for termination
has been removed and there is reasonable assurance that it will not
recur.
Sec. 488.606 Alternative sanctions.
(a) Basis for application of alternative sanctions. CMS may, as an
alternative to termination of Medicare coverage, impose one of the
sanctions specified in paragraph (b) of this section if CMS finds
that--
(1) The supplier fails to participate in the activities and pursue
the goals of the ESRD network that is designated to encompass the
supplier's geographic area; and
(2) This failure does not jeopardize patient health and safety.
(b) Alternative sanctions. The alternative sanctions that CMS may
apply in the circumstances specified in paragraph (a) of this section
include the following:
(1) Denial of payment for services furnished to patients first
accepted for care after the effective date of the sanction as specified
in the sanction notice.
(2) Reduction of payments, for all ESRD services furnished by the
supplier, by 20 percent for each 30-day period after the effective date
of the sanction.
(3) Withholding of all payments, without interest, for all ESRD
services furnished by the supplier to Medicare beneficiaries.
(c) Duration of alternative sanction. An alternative sanction
remains in effect until CMS finds that the supplier is in substantial
compliance with the
[[Page 6246]]
requirement to cooperate in the network plans and goals, or terminates
coverage of the supplier's services for lack of compliance.
Sec. 488.608 Notice of alternative sanction and appeal rights:
Termination of coverage.
(a) Notice of alternative sanction. CMS gives the supplier and the
general public notice of the alternative sanction and of the effective
date of the sanction. The effective date of the alternative sanction is
at least 30 days after the date of the notice.
(b) Appeal rights. Termination of Medicare coverage of a supplier's
ESRD services because the supplier no longer meets the conditions for
coverage of its services is an initial determination appealable under
part 498 of this subchapter.
Sec. 488.610 Notice of appeal rights: Alternative sanctions.
If CMS proposes to apply an alternative sanction specified in Sec.
488.606(b), the following rules apply:
(a) CMS gives the facility notice of the proposed alternative
sanction and 15 days in which to request a hearing.
(b) If the facility requests a hearing, CMS provides an informal
hearing by a CMS official who was not involved in making the appealed
decision.
(c) During the informal hearing, the facility--
(1) May be represented by counsel;
(2) Has access to the information on which the allegation was
based; and
(3) May present, orally or in writing, evidence and documentation
to refute the finding of failure to participate in network activities
and pursue network goals.
(d) If the written decision of the informal hearing supports
application of the alternative sanction, CMS provides the facility and
the public, at least 30 days before the effective date of the
alternative sanction, a written notice that specifies the effective
date and the reasons for the alternative sanction.
1. Part 494 is added to read as follows:
PART 494--CONDITIONS FOR COVERAGE FOR END STAGE RENAL DISEASE
FACILITIES
Subpart A--General Provisions
Sec.
494.1 Basis and scope.
494.10 Definitions.
494.20 Condition: Compliance with Federal, State, and local laws and
regulations.
Subpart B--Patient Safety
494.30 Condition: Infection control.
494.40 Condition: Water quality.
494.50 Condition: Reuse of hemodialyzers and bloodlines.
494.60 Condition: Physical environment.
Subpart C--Patient Care
494.70 Condition: Patient rights.
494.80 Condition: Patient assessment.
494.90 Condition: Patient plan of care.
494.100 Condition: Care at home.
494.110 Condition: Quality assessment and performance improvement.
494.120 Condition: Special purpose renal dialysis facilities.
494.130 Condition: Laboratory services.
Subpart D--Administration
494.140 Condition: Personnel qualifications.
494.150 Condition: Medical director.
494.160 Condition: Relationship with the ESRD network.
494.170 Condition: Medical records.
494.180 Condition: Governance.
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart A--General Provisions
Sec. 494.1 Basis and scope.
(a) Statutory basis. This part is based on the following
provisions:
(1) Section 299I of the Social Security Amendments of 1972 (Pub. L.
92-603), which extended Medicare coverage to insured individuals, their
spouses, and their dependent children with ESRD who require dialysis or
transplantation.
(2) Section 1138(a)(1)(B) of the Act, which requires hospitals to
be members and abide by the rules and requirements of the Organ
Procurement and Transplantation Network.
(3) Section 1861(e)(9) of the Act, which requires hospitals to meet
such other requirements as the Secretary finds necessary in the
interest of health and safety of individuals who are furnished services
in the institution.
(4) Section 1861(s)(2)(F) of the Act, which describes ``medical and
other health services'' covered under Medicare to include home dialysis
supplies and equipment, self-care home dialysis support services, and
institutional dialysis services and supplies.
(5) Section 1862(a) of the Act, which specifies exclusions from
coverage.
(6) Section 1881 of the Act, which authorizes Medicare coverage and
payment for the treatment of ESRD in approved facilities, including
institutional dialysis services, transplantation services, self-care
home dialysis services, and the administration of recombinant epoetin
alpha (EPO).
(7) Section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (Pub. L. 104-113), which requires Federal
agencies to achieve greater reliance on voluntary standards and
emphasize, where possible, the use of standards developed by private,
consensus organizations.
(b) Scope. The provisions of this part establish the conditions for
coverage of services under Medicare and are the basis for survey
activities for the purpose of determining whether an ESRD facility's
services may be covered.
Sec. 494.10 Definitions.
As used in this part--
Dialysis facility means an entity that provides (1) outpatient
maintenance dialysis services; or (2) home dialysis training and
support services; or (3) both. A dialysis facility may be an
independent or hospital-based unit (as described in Sec. 413.174(b)
and (c) of this chapter), or a self-care dialysis unit that furnishes
only self-dialysis services.
Discharge means the termination of patient care services by a
dialysis facility.
Furnishes directly means the ESRD facility provides the service
through its own staff and employees or through individuals who are
under direct contract to furnish these services personally for the
facility.
Home dialysis means dialysis performed at home by an ESRD patient
or caregiver who has completed an appropriate course of training as
described in Sec. 494.100(a) of this part.
Interdisciplinary team means the group of persons, specified Sec.
494.80 of this part, responsible for providing patient care to each
dialysis patient.
Self-dialysis means dialysis performed with little or no
professional assistance by an ESRD patient or caregiver who has
completed an appropriate course of training as specified in Sec.
494.100(a) of this part.
Transfer means a temporary or permanent move of a patient from one
dialysis facility to another that requires a transmission of the
patient's medical record to the facility receiving the patient.
Sec. 494.20 Condition: Compliance with Federal, State, and local laws
and regulations.
The facility and its staff must operate and furnish services in
compliance with applicable Federal, State, and local laws and
regulations pertaining to licensure, staff licensure and other
personnel staff qualifications, fire safety, equipment, building codes,
drugs, medical device usage, and any other relevant health and safety
requirements.
Subpart B--Patient Safety
Sec. 494.30 Condition: Infection control.
The dialysis facility must provide and monitor a sanitary
environment to minimize the transmission of infectious agents within
and between the unit and
[[Page 6247]]
any adjacent hospital or other public areas.
(a) Standard: Procedures for infection control. The facility must
demonstrate that it follows standard infection control precautions by
implementing--
(1) The ``Recommended Infection Control Practices for Hemodialysis
Units at a Glance,'' with the exception of screening for Hepatitis C,
found in ``Recommendations for Preventing Transmission of Infections
Among Chronic Hemodialysis Patients' Morbidity and Mortality Weekly
Report, volume 50 number RR05, April 27, 2001, pages 20 and 21,
developed by the Centers for Disease Control and Prevention, which are
incorporated by reference, to prevent and control cross-contamination
and the spread of infectious agents. Incorporation by reference of the
CDC ``Recommended Infection Control Practices for Hemodialysis Units at
a Glance,'' was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.\1\
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\1\ This publication is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Central
Building, Baltimore, MD and at the National Archives and Records
Administration (NARA). For availability of this material at NARA,
call 202-741-6030, or got to http://www.archives.gov./ federal--
register/code lowbar;of--federal--regulations/ ibr--locations.html.
---------------------------------------------------------------------------
(2) Patient isolation procedures to minimize the spread of
infectious agents and communicable diseases; and
(3) Maintaining procedures, in accordance with applicable State and
local laws and accepted public health procedures, for the--
(i) Handling, storage, and disposal of potentially infectious
waste; and
(ii) Cleaning and disinfection of contaminated surfaces, medical
devices, and equipment.
(b) Standard: Oversight. The facility must--
(1) Monitor and implement biohazard and infection control policies
and activities within the dialysis unit; and
(2) Designate a registered nurse as the infection control or safety
officer, responsible for--
(i) Maintaining current infection control information including the
most current Centers for Disease Control and Prevention guidelines for
the proper techniques in the use of vials and ampules containing
medication;
(ii) Reporting infection control issues to the dialysis facility's
chief executive officer or administrator (see Sec. 494.180(a) of this
part) and the quality improvement committee; and
(iii) Making recommendations regarding infection control training
and improvements.
(c) Standard: Monitoring. The facility must--
(1) Analyze and document the incidence of infection to identify
trends and establish baseline information on infection incidence; and
(2) Develop recommendations to minimize infection transmission and
take actions to reduce future incidents.
(d) Standard: Reporting. The facility must report incidences of
communicable diseases as required by Federal, State, and local
regulations.
Sec. 494.40 Condition: Water quality.
The facility must be able to demonstrate the following:
(a) Standard: Water purity. Water used for dialysis meets the
following water quality standards and equipment requirements of the
Association for the Advancement of Medical Instrumentation (AAMI)
published in ``Water Treatment Equipment for Hemodialysis
Applications,'' ANSI/AAMI RD62: 2001, which are incorporated by
reference. Incorporation by reference of the AAMI Water Treatment
Equipment for Hemodialysis Applications, was approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51.\2\
---------------------------------------------------------------------------
\2\ This publication is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Central
Building, Baltimore, MD and at the National Archives and Records
Administration (NARA). For availability of this material at NARA,
call 202-741-6030, or go to http://www.archives.gov./federal_register/
code--of--federal--regulations/ ibr--locations.html.
Copies may be purchased from the Association for the Advancement of
Medical Instrumentation, 3300 Washington Boulevard, Suite 400,
Arlington, VA 22201-4598.
---------------------------------------------------------------------------
(1) Incorporated water quality requirements are those listed in
sections--
(i) 4.2.1 and 5.2.1, Water Bacteriology;
(ii) 4.2.2 and 5.2.2 Maximum Level of Chemical Contaminants; and
(iii) 4.3, Water Treatment Equipment requirements.
(2) The requirements for frequency of water purity testing to
insure meeting the AAMI limits specified in paragraphs (a)(1)(i) and
(ii) of this section are as follows:
(i) Bacteria and bacterial endotoxin levels of water/dialysate must
be monitored--
(A) In established systems at least monthly;
(B) In newly-installed systems at least weekly until an established
pattern of compliance can be demonstrated;
(C) In accordance with the requirements of AAMI published in
``Dialysate for Hemodialysis,'' ANSI/AAMI RD52:2004 section 7.2.1,
which are incorporated by reference. Incorporation by reference of the
AAMI Dialysate for Hemodialysis was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51.\3\
---------------------------------------------------------------------------
\3\ This publication is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Central
Building, Baltimore, MD and at the National Archives and Records
Administration (NARA). For availability of this material at NARA,
call 202-741-6030, or got to http://www.archives.gov./federal_register/
code--of--federal--regulations/ ibr--locations.html.
Copies may be purchased from the Association for the Advancement of
Medical Instrumentation, 3300 Washington Boulevard, Suite 400,
Arlington, VA 22201-4598.
---------------------------------------------------------------------------
(ii) Chemical analysis of water purity must be done at least once a
year and when--
(A) The system is installed;
(B) Membranes are replaced, if using a reverse osmosis system;
(C) Seasonal variations in source water suggest worsening water
quality;
(D) Reverse osmosis rejection rates, which are monitored daily
using continuous-reading monitors that measure product water
conductivity, fall below 90 percent.
(b) Standard: Reverse osmosis or deionization. Each water treatment
system must include reverse osmosis membranes or a deionization
component with resistivity monitors.
(c) Standard: Chlorine/chloramines. The facility must ensure, on a
daily basis, that the source water does not contain chlorine/
chloramines or the facility must ensure that--
(1) The water treatment system includes a component or carbon tank
which removes chlorine/chloramine along with a backup component or
second carbon tank for chlorine/chloramine removal; and
(2) The water from the exit port of the first component or carbon
tank which removes chlorine/chloramine is tested for chlorine/
chloramine levels, at a minimum, before each patient shift or every 4
hours, whichever is shorter, during operation of the water treatment
system.
(i) If the test results are greater than 0.50 mg/L for free
chlorine or 0.10 mg/L for chloramines from the port of the initial
component or carbon tank then the second component or carbon tank which
removes chlorine/chloramine must be tested; and
(ii) If the test results from the last component or carbon tank are
greater than the parameters for chlorine or chloramine specified in
paragraph (c)(2)(i) of this section the facility must--
(A) Immediately terminate dialysis treatment to protect patients
from exposure to chlorine/chloramine;
[[Page 6248]]
(B) Immediately notify the medical director; and
(C) Take corrective action.
(d) Standard: Corrective action plan. Water testing results
including, but not limited to, chemical, microbial, and endotoxin
levels which meet AAMI action levels or deviate from the AAMI standards
must be addressed with a corrective action plan that ensures patient
safety.
(e) Standard: Adverse events. A dialysis facility must maintain
active surveillance of patient reactions during and following dialysis.
When clinically indicated (for example, after adverse patient
reactions) the facility must --
(1) Obtain blood and dialysate cultures;
(2) Undertake evaluation of the water purification system; and
(3) Take corrective action.
(f) Standard: Unused bicarbonate. Once mixed, bicarbonate
concentrate must be used within the timeframe specified by the
manufacturer of the concentrate.
Sec. 494.50 Condition: Reuse of hemodialyzers and bloodlines.
The dialysis facility that reuses hemodialyzers or bloodlines must
meet the requirements of this section. Failure to meet any of these
requirements constitutes grounds for denial of payment for the dialysis
treatment affected and termination from participation in the Medicare
program.
(a) Standard: General requirements for the reuse of hemodialyzers
and bloodlines. Certain hemodialyzers and bloodlines--
(1) May be reused for certain patients with the exception of
Hepatitis B positive patients;
(2) Must be reused only for the same patient; and
(3) Must be labeled for multiple reuse in accordance with the
premarket notification provisions of section 501(k) of the Food, Drug,
and Cosmetics Act and 21 CFR 876.5860.
(b) Standard: Reprocessing requirements for the reuse of
hemodialyzers and bloodlines. A dialysis facility that reuses
hemodialyzers and bloodlines must adhere to the following reprocessing
guidelines:
(1) Meet the requirements of AAMI published in ``Reuse of
Hemodialyzers,'' third edition, ANSI/AAMI RD47:2002/A1:2003, which is
incorporated by reference. Incorporation by reference of the ``Reuse of
Hemodialyzers, third edition, RD47:2002/A1:2003'' was approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51.\4\
---------------------------------------------------------------------------
\4\ This publication is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Central
Building, Baltimore, MD and at the National Archives and Records
Administration (NARA). For availability of this material at NARA,
call 202-741-6030, or got to: http://www.archives.gov./federal_register/code_of_federal_regulations/ibr_locations.html.
Copies
may be purchased from the Association for the Advancement of Medical
Instrumentation, 3300 Washington Boulevard, Suite 400, Arlington, VA
22201-4598.
---------------------------------------------------------------------------
(2) Reprocess hemodialyzers and bloodlines--(i) By following the
manufacturer's recommendations; or
(ii) Using an alternate method and maintaining documented evidence
that the method is safe and effective.
(3) Not expose hemodialyzers to more than one chemical germicide,
other than bleach, during the life of the dialyzer. All hemodialyzers
must be discarded before a different chemical germicide is used in the
facility.
(c) Standard: Monitoring, evaluation, and reporting requirements
for the reuse of hemodialyzers and bloodlines. In addition to the
requirements for hemodialyzer and bloodline reuse specified in
paragraphs (a) and (b) of this section, the dialysis facility must
adhere to the following:
(1) Monitor patient reactions during and following dialysis.
(2) When clinically indicated (for example, after adverse patient
reactions), the facility must--
(i) Obtain blood and dialysate cultures; and
(ii) Undertake evaluation of its dialyzer reprocessing and water
purification system. When this evaluation suggests a cluster of adverse
patient reactions is associated with hemodialyzer reuse, the facility
must suspend reuse of hemodialyzers until it is satisfied the problem
has been corrected.
(iii) Report the adverse outcomes to the FDA and other Federal,
State or local government agencies as required by law.
Sec. 494.60 Condition: Physical environment.
The dialysis facility must be designed, constructed, equipped, and
maintained to provide dialysis patients, staff, and the public a safe,
functional, and comfortable treatment environment.
(a) Standard: Building. The building in which dialysis services are
furnished must be constructed and maintained to ensure the safety of
the patients, the staff, and the public.
(b) Standard: Equipment maintenance. The dialysis facility must
implement and maintain a program to ensure that all equipment
(including emergency equipment, dialysis machines and equipment, and
the water treatment system) are maintained and operated in accordance
with the manufacturer's recommendations.
(c) Standard: Patient care environment. (1) The space for treating
each patient must be sufficient to provide needed care and services,
prevent cross-contamination, and to accommodate medical emergency
equipment and staff.
(2) The dialysis facility must--
(i) Maintain a temperature within the facility that is comfortable
for the majority of its patients; and
(ii) Make reasonable accommodations for the patients who are not
comfortable at the temperature that is comfortable for the majority.
(d) Standard: Emergency preparedness. The dialysis facility must
implement processes and procedures to manage medical and nonmedical
emergencies that are likely to threaten the health or safety of the
patients, the staff, or the public. These emergencies include, but are
not limited to, fire, equipment or power failures, care-related
emergencies, water supply interruption, and natural disasters likely to
occur in the facility's geographic area.
(1) Emergency preparedness of staff. The dialysis facility must
provide appropriate training and orientation in emergency preparedness
to the staff. Staff training must be provided and evaluated at least
annually and include the following:
(i) Ensuring that staff can demonstrate a knowledge of emergency
procedures, including informing patients of--
(A) What to do;
(B) Where to go;
(C) Whom to contact if an emergency occurs while the patient is not
in the dialysis facility; and
(D) How to disconnect themselves from the dialysis machine if an
emergency occurs.
(ii) Ensuring that, at a minimum, patient care staff maintain
current CPR certification; and
(iii) Ensuring that nursing staff are properly trained in the use
of emergency equipment and emergency drugs;
(2) Emergency preparedness patient training. The facility must
provide appropriate orientation and training to patients, including the
areas specified in paragraph (d)(1)(i) of this section.
(3) Emergency equipment and plans. Emergency equipment, including,
but not limited to, oxygen, airways, suction, defibrillator, artificial
resuscitator, and emergency drugs, must be on the premises at all times
and immediately available. The facility must--
[[Page 6249]]
(i) Have a plan to obtain emergency medical system assistance when
needed; and
(ii) Evaluate at least annually the effectiveness of emergency and
disaster plans and update them as necessary.
(e) Standard: Fire safety. (1) The dialysis facility must meet
applicable provisions of the 2000 edition of the Life Safety Code of
the National Fire Protection Association (which is incorporated by
reference in Sec. 403.744(a)(1)(i) of this chapter).
(2) Chapter 5 of the 2000 edition of the Life Safety Code does not
apply to a dialysis facility.
(3) If CMS finds that a State has a fire and safety code imposed by
State law that adequately protects a dialysis facility's patients, CMS
may allow the State survey agency to apply the State's fire and safety
code instead of the Life Safety Code.
(4) After consideration of State survey agency recommendations, CMS
may waive, for appropriate periods, specific provisions of the Life
Safety Code if the following requirements are met:
(i) The waiver would not adversely affect the health and safety of
the dialysis facility's patients; and
(ii) Rigid application of specific provisions of the Life Safety
Code would result in an unreasonable hardship for the dialysis
facility.
Subpart C--Patient Care
Sec. 494.70 Condition: Patients' rights.
The dialysis facility must inform patients (or their
representatives) of their rights (including their privacy rights) and
responsibilities when they begin their treatment and must protect and
provide for the exercise of those rights.
(a) Standard: Patients' rights. The patient has the right to--
(1) Respect, dignity, and recognition of his or her individuality
and personal needs, and sensitivity to his or her psychological needs
and ability to cope with ESRD;
(2) Receive all information in a way that he or she can understand;
(3) Privacy and confidentiality in all aspects of treatment;
(4) Privacy and confidentiality in personal medical records;
(5) Be informed about and participate, if desired, in all aspects
of his or her care, including advance directives, and be informed of
the right to refuse treatment and to refuse to participate in
experimental research;
(6) Be informed about all treatment modalities and settings,
including but not limited to, transplantation, home dialysis modalities
(home hemodialysis, intermittent peritoneal dialysis, continuous
ambulatory peritoneal dialysis, continuous cycling peritoneal
dialysis), and in-facility hemodialysis;
(7) Be informed of facility policies regarding patient care,
including, but not limited to, isolation of patients;
(8) Be informed of facility policies regarding the reuse of
dialysis supplies, including hemodialyzers;
(9) Be informed by a physician of his or her own medical status as
documented in the patient's medical record unless the medical record
contains a documented contraindication to do so;
(10) Be informed of services available in the facility and charges
for services not covered under Medicare;
(11) Receive the necessary services outlined in the patient plan of
care described in Sec. 494.90 of this part;
(12) Be informed of the rules and expectations of the facility
regarding patient conduct and responsibilities;
(13) Be informed of the facility's internal grievance process;
(14) Be informed of external grievance mechanisms and processes,
including how to contact the ESRD Network and the State survey agency;
(15) Be informed of his or her right to file internal grievances or
external grievances or both without reprisal or denial of services; and
(16) Be informed that he or she may file internal or external
grievances, personally, anonymously or through a representative of the
patient's choosing.
(b) Standard: Right to be informed regarding the facility's
discharge and transfer policies. The patient has the right to--
(1) Be informed of the facility's policies for transfer, discharge,
and discontinuation of services to patients; and
(2) Receive written notice 30 days in advance of the facility
reducing or terminating ongoing care after following the procedure
described in Sec. 494.180(f) of this part. In the case of immediate
threats to the health and safety of others, a shortened discharge
procedure may be allowed.
(c) Standard: Posting of rights. The dialysis facility must
prominently display a copy of the patient's rights in the facility,
including the current State agency and ESRD network telephone complaint
numbers, where it can be easily seen and read by patients.
Sec. 494.80 Condition: Patient assessment.
The facility's interdisciplinary team, consisting of, at a minimum,
the patient (if the patient chooses) or the patient's designee, a
registered nurse, a nephrologist or the physician treating the patient
for ESRD, a social worker, and a dietitian, is responsible for
providing each patient with an individualized and comprehensive
assessment of his or her needs. The comprehensive assessment must be
used to develop the patient's treatment plan and expectations for care.
(a) Standard: Assessment criteria. The patient's comprehensive
assessment must include, but is not limited to, the following:
(1) Evaluation of current health status and medical condition,
including co-morbid conditions.
(2) Evaluation of the appropriateness of the dialysis prescription,
blood pressure, and fluid management needs.
(3) Laboratory profile and medication history.
(4) Evaluation of factors associated with anemia, such as
hematocrit, hemoglobin, iron stores, and potential treatment plans for
anemia, including administration of erythropoietin.
(5) Evaluation of factors associated with renal bone disease.
(6) Evaluation of nutritional status.
(7) Evaluation of psychosocial needs.
(8) Evaluation of dialysis access type and maintenance (for
example, arteriovenous fistulas, arteriovenous grafts, and peritoneal
catheters).
(9) Evaluation of the patient's ability, interests, preferences,
and goals, including level of participation in the dialysis care
process; modality and setting, for example, home dialysis, including
hemodialysis or peritoneal dialysis; and expectations for care
outcomes.
(10) Evaluation of suitability for a transplantation referral,
based on criteria developed by the prospective transplantation center
and its surgeon(s). If the patient is not suitable for transplantation
referral, the basis for nonreferral must be documented in the patient's
medical record.
(11) Evaluation of family and other support systems.
(12) Evaluation of current patient physical activity level.
(13) Evaluation of vocational and physical rehabilitation status
and potential.
(b) Standard: Frequency of assessment for new patients.
(1) An initial comprehensive assessment must be conducted within 20
calendar days after the first dialysis treatment.
(2) A follow up comprehensive reassessment must occur within 3
months after the completion of the initial assessment to provide
information to adjust the patient's plan of care specified in Sec.
494.90 of this part.
(c) Standard: Assessment of treatment prescription.
[[Page 6250]]
The adequacy of the patient's dialysis prescription, as described
in Sec. 494.90(a)(1) of this part, must be assessed on an ongoing
basis as follows:
(1) Hemodialysis patients. At least monthly by calculating
delivered Kt/V or an equivalent measure.
(2) Peritoneal dialysis patients. At least every 4 months by
calculating delivered weekly Kt/V or an equivalent measure.
(d) Standard: Patient reassessment. In accordance with the
standards specified in paragraphs (a)(1) through (a)(13) of this
section, a comprehensive reassessment of each patient and a revision of
the plan of care must be conducted--
(1) At least annually for stable patients; and
(2) At least monthly for unstable patients including, but not
limited to, patients with--
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Poor nutritional status, with unmanaged anemia and inadequate
dialysis.
Sec. 494.90 Condition: Patient plan of care.
The interdisciplinary team must develop and implement a written,
individualized comprehensive plan of care that specifies the services
necessary to address the patient's needs, as identified by the
comprehensive assessment and changes in the patient's condition, and
must include measurable and expected outcomes and estimated timetables
to achieve these outcomes. The outcomes specified in the patient plan
of care must allow the patient to achieve current evidence-based
community-accepted standards.
(a) Standard: Development of patient plan of care. The
interdisciplinary team must develop a plan of care for each patient.
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the
necessary care and services to achieve and sustain the prescribed dose
of dialysis.
(2) Nutritional status. The interdisciplinary team must provide the
necessary care and services to achieve and sustain an effective
nutritional status. A patient's albumin level must be measured at least
monthly.
(3) Anemia. The interdisciplinary team must provide the necessary
care and services to achieve and sustain the expected hemoglobin/
hematocrit level. The patient's hemoglobin/hematocrit must be measured
at least monthly. If a patient has hemoglobin less than 11 gm/dL or
hematocrit of less than 33 percent, the dialysis facility must conduct
an evaluation to determine whether the patient is an erythropoietin
candidate. For a home dialysis patient, the facility must evaluate
whether the patient can safely, aseptically, and effectively administer
erythropoietin and store erythropoietin under refrigeration. The
patient's response to erythropoietin, including blood pressure levels
and utilization of iron stores, must be monitored on a routine basis.
(4) Vascular access. The interdisciplinary team must provide the
necessary care and services to achieve and sustain vascular access. The
hemodialysis patient must be evaluated for the appropriate vascular
access type, taking into consideration co-morbid conditions and other
risk factors. The patient's vascular access must be monitored to
prevent access failure, including monitoring of ateriovenous grafts and
fistulae for stenosis.
(5) Transplantation status. When the patient is a transplantation
referral candidate, the interdisciplinary team must develop plans for
pursuing transplantation. The patient's plan of care must include
documentation of the--
(i) Plan for transplantation, if the patient accepts to
transplantation referral;
(ii) Patient's decision, if the patient is a transplantation
referral candidate but declines the transplantation referral; or
(iii) Reason(s) for the patient's nonreferral as a transplantation
candidate as documented in accordance with Sec. 494.80(a)(10) of this
part.
(6) Rehabilitation status. The interdisciplinary team must provide
the necessary care and services for the patient to achieve and sustain
an appropriate level of productive activity, including vocational, as
desired by the patient, including the educational needs of pediatric
patients (patients under the age of 18 years).
(b) Standard: Implementation of the patient plan of care.
(1) The patient's plan of care--
(i) Must be completed by the interdisciplinary team;
(ii) Must be signed by the patient or the patient's designee.
(2) Implementation of the plan of care must begin within 10
calendar days after completion the patient assessment as specified in
Sec. 494.80 of this part.
(3) If the expected outcome is not achieved, the interdisciplinary
team, must adjust the patient's plan of care to achieve the specified
goals.
(4) The dialysis facility must ensure that all dialysis patients
are seen by a physician providing the ESRD care at least monthly, as
evidenced by a monthly progress note placed in the medical record, and
periodically, while the hemodialysis patient is receiving in-facility
dialysis.
(c) Standard: Transplantation referral tracking. The
interdisciplinary team must track the results of each kidney transplant
center referral and must monitor the status of any facility patients
who are on the transplant wait list. The team must communicate with the
transplant center regarding patient transplant status at least
quarterly or more frequently if necessary.
(d) Standard: Patient education and training. The patient care plan
must include, as applicable, education and training for patients and
family members or caregivers or both, in aspects of the dialysis
experience, dialysis management, quality of life, rehabilitation, and
transplantation.
Sec. 494.100 Condition: Care at home.
A dialysis facility that is certified to provide services to home
patients must ensure, through its interdisciplinary team that home
dialysis services are at least equivalent to those provided to in-
facility patients.
(a) Standard: Training. The interdisciplinary team must provide
training to the home dialysis patient, the designated caregiver, or
self-dialysis patient before the initiation of home dialysis or self-
dialysis (as defined in Sec. 494.10 of this part) and when the home
dialysis caregiver or home dialysis modality changes. The training--
(1) Must be provided by a dialysis facility that is approved to
provide home dialysis services;
(2) For self-care, must be conducted by a registered nurse who
meets the requirements of Sec. 494.140(b)(2) of this part; and
(3) Must be conducted for each home patient and address the
specific needs of the patient, in the following areas:
(i) The nature and management of ESRD;
(ii) The full range of techniques associated with treatment
modality selected, including effective use of dialysis supplies and
equipment in achieving and delivering the physician's prescription of
Kt/V or URR, and effective erythropoietin administration (if
prescribed) to achieve and maintain a hematocrit level of at least 33
percent or a hemoglobin level of 11 gm/dL;
(iii) Implementation of a nutritional care plan;
[[Page 6251]]
(iv) How to achieve and maintain emotional and social well-being;
(v) How to detect, report, and manage potential dialysis
complications;
(vi) Availability of support resources and how to access and use
resources;
(vii) How to self-monitor health status and record and report
health status information;
(viii) How to handle medical and non-medical emergencies;
(ix) Infection control precautions; and
(x) Proper waste storage and disposal procedures.
(b) Standard: Home dialysis monitoring. The dialysis facility
must--
(1) Document in the medical record that the patient, the caregiver,
or both received and demonstrated adequate comprehension of the
training;
(2) Retrieve and review complete self-monitoring data and other
information from self-care patients or their designated caregiver(s) at
least every 2 months; and
(3) Maintain this information in the patient's medical record.
(c) Standard: Support services.
(1) A dialysis facility must furnish directly home dialysis support
services regardless of whether dialysis supplies are provided by the
dialysis facility or a durable medical equipment company, that include,
but are not limited to, the following:
(i) Periodic monitoring of the patient's home adaptation, including
visits to the patient's home by facility personnel in accordance with
the patient's plan of care.
(ii) Coordination of the home patient's care by a member of the
dialysis facility's interdisciplinary team.
(iii) Development and periodic review of the patient's
individualized comprehensive plan of care that specifies the services
necessary to address the patient's needs and meet the measurable and
expected outcomes as specified in Sec. 494.90 of this part.
(iv) Patient consultation with members of the interdisciplinary
team, as needed.
(v) Monitoring of the quality of water used by home hemodialysis
patients in accordance with the requirements specified in Sec.
494.40(a)(1)(i) and (ii) of this part and conducting an onsite
evaluation of the water system. The dialysis facility must correct the
water quality of the home hemodialysis patient, and if necessary,
arrange for backup dialysis until the problem is corrected if--
(A) Analysis of the water quality indicates contamination; or
(B) The home hemodialysis patient demonstrates clinical symptoms
associated with water contamination.
(vi) Purchasing, delivering, installing, repairing and maintaining
medically necessary home dialysis supplies and equipment (including
supportive equipment) prescribed by the attending physician.
(vii) Identifying a plan and arranging for emergency back-up
dialysis services when needed.
(2) The dialysis facility must maintain a recordkeeping system that
ensures continuity of care and patient privacy. This includes items and
services furnished by durable medical equipment (DME) suppliers
referred to in Sec. 414.330(a)(2) of this chapter.
Sec. 494.110 Condition: Quality assessment and performance
improvement.
The dialysis facility must develop, implement, maintain, and
evaluate an effective, data-driven, interdisciplinary quality
assessment and performance improvement program. The program must
reflect the complexity of the dialysis facility's organization and
services (including those services provided under arrangement), and
must focus on indicators related to improved health outcomes and the
prevention and reduction of medical errors. The dialysis facility must
maintain and demonstrate evidence of its quality improvement and
performance improvement program for review by CMS.
(a) Standard: Program scope. (1) The program must include, but not
be limited to, an ongoing program that achieves measurable improvement
in health outcomes and reduction of medical errors by using indicators
or performance measures associated with improved health outcomes and
with the identification and reduction of medical errors.
(2) The dialysis facility must measure, analyze and track quality
indicators or other aspects of performance that the facility adopts or
develops that reflect processes of care and facility operations. These
performance components must influence or relate to the desired outcomes
or be the outcomes themselves. The program must include, but not be
limited to, the following:
(i) Adequacy of dialysis.
(ii) Nutritional status.
(iii) Anemia management.
(iv) Vascular access.
(v) Medical injuries and medical errors identification.
(vi) Hemodialyzer reuse program, if the facility reuses
hemodialyzers.
(vii) Patient satisfaction and grievances.
(b) Standard: Monitoring performance improvement. The dialysis
facility must continuously monitor its performance, take actions that
result in performance improvements, and track performance to ensure
that improvements are sustained over time. Each facility must
participate in ESRD network activities and pursue network goals.
(c) Standard: Prioritizing improvement activities. The dialysis
facility must set priorities for performance improvement, considering
prevalence and severity of identified problems and giving priority to
improvement activities that affect clinical outcomes or patient safety.
The facility must immediately correct any identified problems that
threaten the health and safety of patients.
Sec. 494.120 Condition: Special purpose renal dialysis facilities.
A special purpose renal dialysis facility is approved to furnish
dialysis on a short-term basis at special locations. Special purpose
dialysis facilities are divided i