20370 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

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

and 494 

[CMS–3818–F] 

RIN 0938–AG82 

Medicare and Medicaid Programs; 

Conditions for Coverage for End-Stage 

Renal Disease Facilities 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This rule finalizes the 

February 4, 2005 proposed rule entitled 

‘‘Medicare Program; Conditions for 

Coverage for End-Stage Renal Disease 

Facilities.’’ It establishes new conditions 

for coverage that dialysis facilities must 

meet to be certified under the Medicare 

program. This final rule focuses on the 

patient and the results of care provided 

to the patient, establishes performance 

expectations for facilities, encourages 

patients to participate in their plan of 

care and treatment, eliminates many 

procedural requirements from the 

previous conditions for coverage, 

preserves strong process measures when 

necessary to promote meaningful 

patient safety, well-being, and 

continuous quality improvement. This 

final rule reflects the advances in 

dialysis technology and standard care 

practices since the requirements were 

last revised in their entirety in 1976. 

DATES: The provisions of this final rule 

are effective October 14, 2008. 

Compliance with § 494.30(a)(1)(i) and 

§ 494.60(e)(1) is not required until 

February 9, 2009. In addition, the 

compliance with § 494.180(h) is 

effective on February 1, 2009. The 

incorporation by reference of certain 

publications listed in the regulations is 

approved by the Director of the Federal 

Register as of October 14, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Lynn Riley, (410) 786–1286, Stefan 

Miller, (410) 786–6656, Lauren Oviatt, 

(410) 786–4683, Judith Kari, (410) 786– 

6829, (Survey and Certification), Teresa 

Casey, (410) 786–7215, (Issues related to 

Quality Assessment Performance 

Improvement). 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. Introduction 

B. Legislative History 

C. Existing ESRD Regulations 

D. The Establishment of Central 

Requirements 

II. Summary of the Proposed Provisions and 

Response to Comments on the February 

4, 2005 Proposed Rule 

A. Part 414—Payment for Part B Medical 

and Other Health Services; Payment for 

Home Dialysis Equipment, Supplies, and 

Support Services (Proposed § 414.330) 

B. Part 488—Survey, Certification, and 

Enforcement Procedures; Special 

Procedures for Approving End-Stage 

Renal Disease Facilities (Proposed 

§ 488.60) 

C. Part 494—Conditions for Coverage for 

End-Stage Renal Disease Facilities 

1. Subpart A—General Provisions 

a. Basis and Scope (Proposed § 494.1) 

b. Definitions (Proposed § 494.10) 

c. Compliance With Federal, State, and 

Local Laws and Regulations (Proposed 

§ 494.20) 

2. Subpart B—Patient Safety 

a. Infection Control (Proposed § 494.30) 

b. Water and Dialysate Quality (Proposed 

§ 494.40) 

c. Reuse of Hemodialyzers and Bloodlines 

(Proposed § 494.50) 

d. Physical Environment (Proposed 

§ 494.60) 

3. Subpart C—Patient Care 

a. Patients’ Rights (Proposed § 494.70) 

b. Patient Assessment (Proposed § 494.80) 

c. Patient Plan of Care (Proposed § 494.90) 

d. Care at Home (Proposed § 494.100) 

e. Quality Assessment and Performance 

Improvement (Proposed § 494.110) 

f. Special Purpose Renal Dialysis Facilities 

(Proposed § 494.120) 

g. Laboratory Services (Proposed § 494.130) 

4. Subpart D—Administration 

a. Personnel Qualifications (Proposed 

§ 494.140) 

b. Responsibilities of the Medical Director 

(Proposed § 494.150) 

c. Relationship With the ESRD Network 

(Proposed § 494.160) 

d. Medical Records (Proposed § 494.170) 

e. Governance (Proposed § 494.180) 

D. Other Proposed Changes and Issues 

1. Proposed Cross-Reference Changes 

2. Proposed Additions to Part 488 

E. Survey & Certification Comments 

F. Impact Analysis Comments 

III. Provisions of the Final Rule 

IV. Effective Dates for the Final Rule 

V. Reference Materials 

A. Provisions of Part 494 

B. ESRD Crosswalk 

VI. Collection of Information Requirement 

VII. Regulatory Impact Analysis 

Regulations Text 

Acronym List 

AAMI Association for the Advancement of 

Medical Instrumentation 

ACLS Advanced Cardiac Life Support 

ADA American Dietetic Association 

AED Automated external defibrillator 

AIA American Institute of Architects 

AHA American Heart Association 

ALT Alanine Aminotransferase 

APA Administrative Procedures Act 

ANSI American National Standards 

Institute 

BMI Body mass index 

BONENT Board of Nephrology Nursing 

Examiners Nursing and Technology 

BSW Bachelor’s degree social worker 

CADE Commission on Accreditation for 

Dietetics Education 

CAHPS Consumer Assessment of Health 

Plans Survey 

CCHT Certified Clinical Hemodialysis 

Technician 

CDC Centers for Disease Control and 

Prevention 

CEO Chief executive officer 

CLIA Clinical Laboratory Improvement 

Amendments 

CMS Centers for Medicare and Medicaid 

Services 

CNSW Council of Nephrology Social 

Workers 

CPG Clinical practice guidelines 

CPM Clinical performance measures 

CRAFT CROWN Responsiveness and 

Feedback Tree 

CROWNWeb Consolidated Renal 

Operations in a Web-enabled Network 

DFC Dialysis Facility Compare 

DHHS Department of Health and Human 

Services 

DOPPS Dialysis Outcomes and Practice 

Patterns Study 

DOQI Disease Outcomes Quality Initiative 

DTR Dietetic Technician, Registered 

EDI Electronic Data Interchange 

EMS Emergency medical system 

ESRD End-Stage renal disease 

FDA Food and Drug Administration 

HBsAg Hepatitis B surface antigen 

HIPAA Health Insurance Portability and 

Accountability Act 1996 

HBV Hepatitis B virus 

HCV Hepatitis C virus 

HICPAC Healthcare Infection Control 

Practices Advisory Committee 

HMO Health Maintenance Organization 

ICC International Code Council 

ICH In-center hemodialysis 

IOM Institute of Medicine 

KCP Kidney Care Partners 

KDOQI Kidney Disease Outcomes Quality 

Initiative 

K/DOQI Kidney Disease Outcomes Quality 

Initiative 

LAL Amoebocyte lysate 

LDO Large dialysis organization 

LPN Licensed practical nurse 

LVN Licensed vocational nurse 

LSC Life Safety Code 

MedPAC Medicare Payment Advisory 

Commission 

MNT Medical nutrition therapy 

MPD Mission and Priority Document 

MSW Master’s degree social worker 

NCD National Coverage Determination 

NF Nursing Facility 

NKF National Kidney Foundation 

NKF–KDOQI National Kidney Foundation’s 

Kidney Disease Outcomes Quality 

Initiative 

NNCC Nephrology Nursing Certification 

Commission 

NNCO National Nephrology Certification 

Organization 

NQF National Quality Forum 

NTTAA National Technology Transfer and 

Advancement Act of 1995 

OIG Office of the Inspector General 

PA Physician assistant 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20371 

PCT Patient care technician 

QAPI Quality assessment and performance 

improvement 

QIS Quality Infrastructure Report 

RD Registered dietitian 

RN Registered nurse 

REMIS Renal Management Information 

System 

RO Reverse osmosis 

RPA Renal Physicians Association 

SGA Subjective global assessment 

SHEA Society for Healthcare Epidemiology 

of America 

SNF Skilled nursing facility 

SOW Scope of work 

STIC Safe and Timely Immunization 

Coalition 

TEP Technical Expert Panel 

VISION Vital Information System to 

Improve Outcomes in Nephrology 

I. Background 

A. Introduction 

End-Stage Renal Disease (ESRD) is a 

kidney impairment that is irreversible 

and permanent and requires either a 

regular course of dialysis or kidney 

transplantation to maintain life. Dialysis 

is the process of cleaning the blood and 

removing excess fluid artificially with 

special equipment when the kidneys 

have failed. Our existing ESRD services 

conditions for coverage were originally 

adopted in 1976 (41 FR 22502). In our 

existing requirements for dialysis 

facilities at 42 CFR part 405, subpart U, 

we emphasize the policies and 

procedures that must be in place to 

support good patient care, and we focus 

on a facility’s capacity to furnish quality 

care. To determine if a facility meets 

ESRD conditions for coverage, the State 

survey agency performs an on-site 

survey of the facility. If a survey 

indicates that a facility is in compliance 

with the conditions, and all other 

Federal requirements are met, we then 

certify the facility as qualifying for 

Medicare payment. Medicare payment 

for outpatient maintenance dialysis is 

limited to facilities meeting these 

conditions. We have made several 

changes to our ESRD requirements since 

they were first adopted in 1976. 

However, they have not been 

comprehensively revised since that 

time. 

On February 4, 2005, we published in 

the Federal Register a proposed rule 

entitled ‘‘Conditions for Coverage for 

End-Stage Renal Disease Facilities’’ (70 

FR 6183). In that rule, we proposed 

revisions to the requirements that ESRD 

dialysis facilities must meet in order to 

be certified under the Medicare 

program. 

Our decision to propose major 

changes to the existing conditions was 

based on several considerations. 

Revising the ESRD requirements is part 

of our effort to modernize regulations 

and improve the availability of qualityof-care information; to promote 

transparency; and to move toward a 

patient outcome-based system that 

focuses on quality assessment and 

performance improvement. We believe 

that revising the conditions for coverage 

would encourage improvement in 

outcomes of care for beneficiaries. We 

wish to incorporate the most recent 

medical and scientific guidelines and 

recommendations for dialysis facilities 

from the Centers for Disease Control and 

Prevention (CDC), the Association for 

the Advancement of Medical 

Instrumentation (AAMI), and recognize 

current practice guidelines and 

professional standards of practice such 

as the National Kidney Foundation’s 

Kidney Disease Outcomes Quality 

Initiative (NKF–K/DOQI) clinical 

practice guidelines (CPGs). 

B. Legislative History 

Section 299I of the Social Security 

Amendments of 1972 (Pub. L. 92–603) 

originally extended Medicare coverage 

to insured individuals, their spouses, 

and their dependent children with 

ESRD who require dialysis or 

transplantation. The ESRD program 

became effective July 1, 1973, and 

initially operated under interim 

regulations published in the Federal 

Register on June 29, 1973 (38 FR 17210). 

In the July 1, 1975 Federal Register (40 

FR 27782), we published a proposed 

rule that revised sections of the ESRD 

requirements. On June 3, 1976 the final 

rule was published in the Federal 

Register (41 FR 22501). Subsequently, 

the ESRD Amendments of 1978 (Pub. L. 

95–292), amended title XVIII of the 

Social Security Act (the Act) by adding 

section 1881. Sections 1881(b)(1) and 

1881(f)(7) of the Act further authorize 

the Secretary to prescribe health and 

safety requirements (known as 

conditions for coverage) that a facility 

providing dialysis and transplantation 

services to dialysis patients must meet 

to qualify for Medicare payment. In 

addition, section 1881(c) of the Act 

establishes ESRD Network areas and 

Network organizations to assure that 

dialysis patients are provided 

appropriate care. 

We know, based on comments, that 

many in the community support the 

overall shift in the ESRD conditions for 

coverage from an emphasis on processoriented requirements to a more patientcentered, outcome-oriented approach. 

Further, we believe that virtually all 

members of the community support a 

quality assessment and performance 

improvement requirement and the 

development of a comprehensive data 

set that will contain information 

including the characteristics of ESRD 

facilities, their patient populations, as 

well as outcome measures of patient 

care. 

The fundamental principles that 

guided us during this collaborative 

effort to develop new conditions were as 

follows: 

• Ensure that patients’ rights and 

physical safety are protected; 

• Stress continuous quality 

assessment and performance 

improvement, incorporating, to the 

greatest extent possible, outcomeoriented, data-driven measures; 

• Facilitate flexibility in how dialysis 

facilities meet our performance 

requirements; 

• Eliminate unnecessary 

administrative policies. Processoriented standards are only included 

where we believe they are essential to 

protect patient health and safety; 

• Focus on the continuous, 

interdisciplinary, integrated care system 

that a dialysis patient experiences, 

centered around patient assessment, 

care planning, service delivery, and 

quality assessment and performance 

improvement; and 

• Stress patient satisfaction and 

ongoing patient involvement in the 

development of the care plan and 

treatment. 

• Finally, in order for the ESRD 

facility conditions for coverage to move 

from a process and structure orientation 

toward a more patient-centered, 

outcome-oriented approach, individual 

patient and facility-specific outcome 

measures must be identified and 

evaluated, or in the absence of existing 

measures, they must be developed and 

validated with community input to 

ensure they are clinically meaningful 

and reflect current scientific knowledge. 

C. Existing ESRD Regulation 

The requirements from section 

1881(b), (c), and (f)(7) of the Act are 

implemented in regulations at 42 CFR 

part 405, subpart U, ‘‘Conditions for 

Coverage of Suppliers of End-Stage 

Renal Disease (ESRD) Services.’’

The existing regulations describe the 

health and safety requirements that 

dialysis facilities must meet to furnish 

care to Medicare beneficiaries. The 

regulations in part 405, subpart U also 

include the provision that dialysis 

facilities be organized into Network 

areas and describe the role that 

Networks play in the ESRD program. 

Networks are defined at § 405.2110 as 

‘‘CMS designated ESRD Networks in 

which the approved ESRD facilities 

collectively provide the necessary care 

for ESRD patients.’’


PWALKER on PROD1PC71 with RULES2
20372 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

The purpose of the existing 

conditions for coverage (also known as 

conditions) is to protect dialysis 

patients’ health and safety and to ensure 

that quality care is furnished to all 

patients in Medicare-approved dialysis 

facilities. 

The ESRD conditions for coverage 

(health and safety provisions for dialysis 

facilities) will be moved from existing 

42 CFR part 405, subpart U, to a new 42 

CFR part 494, where they will follow 

regulations establishing standards for 

other Medicare providers, such as the 

conditions of participation for hospitals 

(42 CFR part 482), long-term care 

facilities (42 CFR part 483), and home 

health agencies (42 CFR part 484). The 

termination of Medicare coverage and 

alternative sanctions conditions at 

§ 405.2180 through § 405.2184 will be 

recodified at § 488.604 through 

§ 488.610. Since many of the existing 

ESRD conditions will be revised, 

consolidated with other conditions, or 

deleted, we are renumbering and 

reorganizing the requirements. 

D. The Establishment of Central 

Requirements 

Our 2005 proposed rule proposed 

new conditions for coverage for ESRD 

facilities that revise or eliminate many 

of the existing requirements and 

establish critical central requirements. 

The central requirements of this rule 

were grouped into three broad 

categories: (1) Patient safety; (2) patient 

care; and (3) administration. Subpart A 

contained general provisions, for 

example, statutory authority, 

definitions, and requirements for 

compliance with Federal, State and 

local laws and regulations. Subpart B 

(Patient Safety), and subpart C (Patient 

Care) of the proposed conditions for 

coverage focused on the actual care 

delivered to the patients, the 

performance of the dialysis facility, and 

the impact of the treatment furnished by 

the dialysis facility on the health status 

of its patients. Subpart D contained 

personnel, ESRD Network, medical 

records and governance requirements. 

In subpart B (Patient Safety), we 

proposed to retain and strengthen some 

process-oriented patient safety 

provisions that we believe remain 

highly predictive of ensuring desired 

outcomes and preventing harmful 

outcomes. Accordingly, the proposed 

patient safety requirements incorporated 

current CDC infection control 

procedures, retained and updated our 

incorporation by reference of the AAMI 

standards and guidelines for water 

quality and dialysate, hemodialyzer 

reuse practices, and incorporated by 

reference applicable current Life Safety 

Code (LSC) provisions. 

Subpart C (Patient Care) included 

provisions: (1) Emphasizing a dialysis 

facility’s fundamental responsibility to 

respect and promote the rights of each 

patient (patient rights); (2) requiring a 

facility to perform a comprehensive 

assessment to determine appropriate 

treatments and achieve desired health 

outcomes (Patient Assessment); (3) 

requiring an interdisciplinary team 

approach to providing dialysis services 

to patients; and specifying the process 

by which the interdisciplinary team 

would achieve effective patient health 

outcomes (Patient Plan of Care); (4) 

requiring a quality assessment and 

performance improvement program 

which would charge each dialysis 

facility with carrying out a program of 

its own design to continually improve 

quality outcomes and patient 

satisfaction; and (5) consolidating 

various aspects of home dialysis care 

into a single condition (Care at home). 

Subpart D (Administration) covered 

the operation of the dialysis facility in 

a patient outcome-oriented 

environment, including: (1) Minimum 

personnel qualifications; (2) the role of 

the medical director; (3) the facility’s 

relationship with its servicing ESRD 

Network; (4) medical recordkeeping; 

and (5) minimum operating 

responsibilities of the facility, including 

data collection and reporting 

requirements (Governance). 

On August 22, 2006, President Bush 

signed Executive Order 13410, entitled 

‘‘Promoting Quality and Efficient Health 

Care in Federal Government 

Administered or Sponsored Health Care 

Programs’ (71 FR 51089, August 28, 

2006). In order to empower Americans 

to find better health care value and 

better health care, they should know 

their health care options in advance. 

Patients need access to information 

regarding the quality of doctors, 

hospitals, dialysis facilities and other 

providers in their area, as well as the 

costs of various medical procedures. 

The August 2006 executive order directs 

agencies to increase transparency in 

pricing by sharing pricing information 

with patients; to increase transparency 

in quality by sharing information with 

patients on the quality of services 

provided by doctors, hospitals, ESRD 

facilities, and other health care 

providers; to encourage the adoption of 

health information technology systems 

that meet recognized interoperability 

standards; and to provide patients with 

options that promote quality and 

efficiency in health care, by developing 

and identifying approaches that 

facilitate high quality and efficient care. 

Building on efforts of quality alliances 

that include a broad range of healthcare 

stakeholders, we will work 

collaboratively to improve quality and 

cost information. Patients will be able to 

access this information from a variety of 

potential sources, including insurance 

companies, employers, and Medicare 

sponsored Web sites. In order to help 

dialysis patients make more informed 

health care decisions and to increase 

transparency, this final rule promotes a 

patient-centered approach and focuses 

on disclosing relevant information 

regarding care to patients. 

We believe that transparency will also 

be improved by the implementation of 

an electronic Web-based data collection 

system, Consolidated Renal Operations 

in a Web-enabled Network 

(CROWNWeb), which is designed to 

collect clinical performance measures 

(CPMs) data from dialysis facilities. 

CPM data are used to monitor the 

performance of Medicare-certified 

dialysis facilities on a national and local 

level. These data are also used to 

provide information to individuals who 

have or may develop ESRD and their 

caregivers to assist them in making 

health care decisions; to allow the 

identification of opportunities for 

quality improvement at a national, 

regional, or dialysis facility-level; and to 

calculate case-mix adjustments and the 

potential future use of value based 

purchasing. 

Dialysis Facility Compare (DFC) is an 

online tool at http://www.medicare.gov 

available for dialysis patients and their 

caregivers, which serves to enhance 

public accountability in healthcare by 

increasing transparency regarding the 

quality of dialysis facility care. DFC 

allows patients and caregivers to find 

and compare information about the 

services and quality of care provided at 

dialysis facilities in any State. Important 

information and resources regarding 

chronic kidney disease is also available 

on the DFC Web site. 

II. Summary of the Proposed Provisions 

and Response to Comments on the 

February 4, 2005 Proposed Rule 

The comment period for the February 

4, 2005 proposed rule was 90 days, and 

closed on May 5, 2005. We received 

over 3,000 public comments, but many 

were form letters, so that the total 

number of discrete comments was 

approximately 315. Interested parties 

that commented included the American 

Association of Kidney Patients, the 

American Kidney Fund, the American 

Nephrology Nurses Association, the 

American Society of Nephrology, the 

American Healthcare Association, the 

Association of Dialysis Advocates, the 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20373 

Association for the Advancement of 

Medical Instrumentation, the American 

Society of Pediatric Nephrology, the 

American Dietetic Association, DaVita, 

Inc., Dialysis Centers Inc., Fresenius 

Medical Care North America, Gambro 

Healthcare, Kidney Care Partners, Life 

Options Rehabilitation Advisory 

Council, the National Kidney 

Foundation, the National Renal 

Administrator’s Association, the 

National Association of Nephrology 

Technicians, the Renal Care Group, the 

Renal Physicians Association, the Renal 

Support Network, Medical Education 

Institute, Inc., state survey agencies, 

ESRD Networks and the Forum of ESRD 

Networks, healthcare professionals, 

administrators, academics, dialysis 

patients, pharmaceutical and dialysis 

product companies, and hospital-based 

and non-hospital-based dialysis 

providers. Many commenters applauded 

the long overdue modernization of the 

ESRD conditions for coverage, even 

though they may have disagreed with a 

specific requirement or concept. Below 

we provide a brief summary of each 

proposed provision, a summary of the 

public comments we received, and our 

responses to the comments. 

We received several comments on 

issues outside of the scope of this final 

rule, which we will not address. Please 

note, that in this final rule we have 

revised the title of subpart U from 

‘‘Conditions for Coverage for Suppliers 

of End-Stage Renal Disease’’ to read 

‘‘Requirements for End-Stage Renal 

Disease Facilities.’’ We are changing this 

final rule because the ‘‘Hospital 

Conditions of Participation: 

Requirements for Approval and Reapproval of Transplant Centers to 

Perform Organ Transplants’’, published 

on March 30, 2007 (72 FR 15198) 

updated and recodified the kidney 

transplant center conditions for 

coverage and the remaining provisions 

only apply to the ESRD Networks. 

A. Part 414—Payment for Part B 

Medical and Other Health Services; 

Payment for Home Dialysis Equipment, 

Supplies, and Support Services 

(Proposed § 414.330) 

We proposed a new 

§ 414.330(a)(2)(iii)(C) that would require 

the patient’s home dialysis medical 

equipment supplier to report to the 

facility, every 30 days, all services and 

items furnished to the beneficiary, so 

that the information could be 

documented in the patient’s medical 

record. 

Comment: Two commenters 

supported the proposed requirement for 

a 30-day reporting timeframe for durable 

medical equipment suppliers who 

provide support services to home 

dialysis patients. Several other 

commenters suggested that the 30-day 

timeframe was inappropriate and 

restrictive and recommended we allow 

45 days in the final rule. 

Response: We agree with both sets of 

comments because we believe that all 

information showing what supplies and 

services were provided to the patient 

and when each was provided should be 

reported to the ESRD facility on a 

regular basis. However, we agree with 

the second group of commenters that 

the 30-day timeframe is restrictive. 

Therefore, to allow greater flexibility, 

we have modified the final rule at 

§ 414.330(a)(2)(iii)(C) to allow durable 

medical equipment suppliers to report 

to the ESRD facility providing support 

services at least once every 45 days. 

B. Part 488—Survey, Certification, and 

Enforcement Procedures; Special 

Procedures for Approving End-Stage 

Renal Disease Facilities (Proposed 

§ 488.60) 

We proposed to retain the procedures 

for approving ESRD facilities as 

specified at § 488.60. We received one 

public comment pertaining to the 

procedures for approving ESRD 

facilities. The comment and response 

are found at the end of this section. We 

have recodified § 405.2180, § 405.2181, 

§ 405.2182, and § 405.2184 as § 488.604, 

§ 488.606, § 488.608, and § 488.610, 

respectively. These provisions were 

relocated without any modifications. 

Comments pertaining to hemodialyzer 

reuse sanctions are addressed in the 

§ 494.50, ‘‘Reuse of hemodilayzers and 

bloodlines’’ discussion, later in this 

preamble. 

Comment: One commenter expressed 

concern regarding the certification 

process for ESRD facilities. The 

commenter remarked that facilities 

applying for initial approval may not 

have all of the data required by the 

conditions for coverage in accordance 

with § 488.60(a). 

Response: Although we understand 

the commenter’s concern that a new 

provider may not have all of the 

required data available, data are 

important for use in improving quality 

outcomes and play an important part in 

the management and oversight of the 

ESRD facilities. Therefore, we are 

retaining the provisions of § 488.60(a) as 

proposed. In addition, the absence of 

data would not necessarily result in the 

denial of certification. If an ESRD 

facility is unable to supply all of the 

data required in § 488.60(a), the facility 

could be cited at a standard deficiency 

level, thus emphasizing the importance 

of the data, but not precluding the ESRD 

facility from receiving approval to 

operate in the Medicare program. 

C. Part 494—Conditions for Coverage for 

End-Stage Renal Disease Facilities 

1. Subpart A (General Provisions) 

a. Basis and Scope (Proposed § 494.1) 

We proposed a new organizational 

format for the conditions for coverage, 

which permitted the elimination of 

almost all of § 405.2100, Scope of 

subpart. This section consists largely of 

a description of the contents of the 

existing ESRD conditions for coverage. 

We proposed at § 494.1 to identify the 

statutory authority for the revised 

regulations, and to state that provisions 

of part 494 would serve as the basis for 

survey activities for determining 

whether a dialysis facility met the 

conditions for coverage under the 

Medicare program. We received no 

comments on this section. 

b. Definitions (Proposed § 494.10) 

We proposed to recodify § 405.2102 as 

§ 494.10, with an abbreviated set of 

definitions. While § 405.2102 defined 32 

terms, we proposed to define only 7 

terms at § 494.10. We proposed to 

eliminate several terms that were selfevident and others that would not be 

utilized in these revised conditions. In 

addition, we did not believe it would be 

appropriate to have substantive 

requirements contained within 

definitions, so we proposed to move 

definitions that contained qualification 

requirements, such as the term 

‘‘interdisciplinary team,’’ to the 

appropriate conditions in the final rule. 

Comment: A few commenters 

suggested revisions to the proposed 

definition for ‘‘dialysis facility.’’ One 

commenter recommended we adopt the 

phrase ‘‘chronic kidney dialysis 

facility’’ and two other commenters 

suggested the addition of ‘‘self-care 

dialysis’’ to the current list of services 

provided by the facility. 

Response: Adding the word 

‘‘chronic,’’ we believe, would add no 

value to the term ‘‘dialysis facility’’

since kidney disease requiring 

outpatient dialysis is chronic by nature. 

The proposed definition for ‘‘dialysis 

facility’’ does recognize self-care 

dialysis. Self-care dialysis is a modality 

described in section 1881 of the Act. We 

believe the proposed definition of 

‘‘dialysis facility’’ is sufficient. 

Therefore, we adopt this definition as 

proposed. 

Comment: Two commenters suggested 

adding language to clarify that a facility 

that taught a patient how to selfcannulate would not need to obtain 


PWALKER on PROD1PC71 with RULES2
20374 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

certification as a self-dialysis unit 

exclusively because of such instruction. 

Response: We agree with the 

commenters that any dialysis facility 

that is Medicare-certified to provide 

outpatient dialysis services may include 

instruction in self-cannulation in its 

dialysis program. We do not require any 

additional certifications, nor is a 

separate ‘‘self-dialysis’’ certification 

category available. Dialysis facilities 

receive Medicare certification to provide 

in-center dialysis or home dialysis 

training and support services, or both. 

We are not adding a regulatory 

statement regarding the absence of a 

self-dialysis certification category to this 

final rule. 

Comment: One commenter requested 

additional clarification regarding what 

would constitute ‘‘discharge’’ (for 

example, ‘‘30 days after departure from 

a facility for any reason’’). 

Response: Our intent was to describe 

the cessation or end of patient care 

services for patients who either 

voluntarily leave the facility or for 

patients who are discharged for reasons 

listed at § 494.180(f). To address the 

commenter’s concern, we have added 

clarifying language at § 494.10 to read, 

‘‘Discharge means the termination of 

patient care services by a dialysis 

facility or the patient voluntarily 

terminating dialysis when he or she no 

longer wants to be dialyzed by that 

facility.’’

Comment: We requested comments 

regarding whether to reference nursing 

facilities (NFs) and skilled nursing 

facilities (SNFs) in the definition for 

‘‘home dialysis.’’ We received many 

comments regarding the definition of 

‘‘home dialysis.’’ Some commenters 

questioned the definition of ‘‘home,’’

while others commented that nursing 

homes and other institutional settings 

were appropriate for home dialysis. Yet 

others stated that nursing homes and 

other institutional settings were 

inappropriate for home dialysis. One 

commenter expressed concern regarding 

permanent versus temporary residence 

status within a nursing facility. One 

commenter suggested we adopt a new 

term, ‘‘institutional home dialysis,’’ to 

describe patients in a nursing home 

setting. Other commenters suggested a 

separate definition for dialysis provided 

in a nursing home setting that would be 

distinct from ‘‘home dialysis.’’

Many commenters noted the nursing 

home setting is different from the 

typical dialysis facility setting, and that 

the needs of the NF/SNF patient 

population are unique. One commenter 

proposed the term ‘‘staff assisted 

nursing home dialysis’’ be used. Other 

topics of concern included training 

course specifications, recommendations 

about peritoneal dialysis and 

hemodialysis modalities, and the 

burden associated with including NFs 

and SNFs in the definition. 

Some commenters believed that 

neither short nor long-term stays in 

NFs/SNFs should be considered a 

patient’s home for purposes of home 

dialysis, while others took the opposite 

view. Other commenters responded that 

only a long-term stay in a NF/SNF 

should be considered a patient’s home 

for purposes of home dialysis. Major 

dialysis associations and a major 

nursing home association urged Centers 

for Medicare and Medicaid Services 

(CMS) not to classify NF/SNF as the 

patient’s ‘‘home’’ in this final rule, but 

to convene an expert panel to study this 

complex issue and then address it in a 

separate rule at a later date. 

Response: We understand the 

concerns of commenters. Currently a 

SNF may be considered a patient’s 

home for self-dialysis, as noted in the 

Medicare Claims Processing Manual, 

which can be found at http:// 

www.cms.hhs.gov/manuals/downloads/ 

clm104c20.pdf and as noted in the 

Program Integrity Manual, Chapter 5 at 

http://www.cms.hhs.gov/manuals/ 

downloads/pim83c05.pdf. 

We recognize that the provision of 

hemodialysis to nursing home patients 

presents unique challenges, given this 

frail population. We note that there was 

no consensus within either the renal 

community or the medical community 

at large as to the inclusion of SNFs or 

NFs in the definition of ‘‘home 

dialysis.’’ A more detailed discussion of 

this issue can be found later in this 

preamble under the ‘‘Care at home’’

condition (§ 494.100). Given the variety 

of differing comments, we believe that 

a regulation regarding NF/SNF dialysis 

would be premature. Therefore, we will 

consider addressing this issue at a later 

date, and the current guidance for 

dialysis in a nursing home environment 

will remain in effect at this time. 

Comment: Three commenters 

suggested that the definition for 

‘‘interdisciplinary team’’ use the same 

language as that of § 494.80, and that the 

definitions be cross-referenced 

throughout the text. 

Response: The composition of the 

interdisciplinary team is a minimum 

requirement of this final rule. We are 

not including requirements in the 

definition section. We are defining the 

‘‘interdisciplinary team’’ in the ‘‘Patient 

assessment’’ condition opening 

paragraph at § 494.80. We have also 

added the requirement to the ‘‘Patient 

plan of care’’ condition at § 494.90, to 

include the same language describing 

the composition of the team. The 

definition for ‘‘interdisciplinary team’’

appearing under § 494.10 in the 

proposed rule has been removed from 

this final rule. 

Comment: We received several 

comments regarding the definition of 

‘‘self-dialysis.’’ Two commenters 

suggested changing the definition from 

‘‘dialysis performed with little or no 

professional assistance’’ to ‘‘dialysis 

performed with limited or no 

professional assistance * * *.’’ Some 

commenters stated the definition should 

not reference the training requirement at 

§ 494.100(a) since such requirement 

would not apply to all self-dialysis, and 

that many patients would perform some 

level of self-care in the facility. One 

commenter recommended that we issue 

interpretive guidelines to address the 

issue of patients that would perform 

self-care dialysis in a facility. Another 

commenter suggested dropping ‘‘selfdialysis’’ terminology from the 

definition section of this final rule. 

Response: ‘‘Self-dialysis’’ is addressed 

in section 1881 of the Act and the 

Secretary has the discretion to define 

‘‘self-dialysis services’’ in regulations. 

We are retaining the proposed language, 

which contains the term ‘‘little’’ because 

we believe ‘‘limited’’ may imply the 

necessity of a potentially higher degree 

of professional assistance for selfdialysis patients than envisioned by the 

statute. Interpretive guidelines will be 

developed to instruct the surveyors how 

to review facilities for compliance with 

the requirement. 

Comment: Several commenters 

requested clarifications of terminology 

and additional definitions in the final 

rule such as: New patient; first dialysis; 

direct supervision; and grievance. 

Response: The terms ‘‘first dialysis’’

and ‘‘new patient’’ are clarified in the 

section in which the terms are used. For 

example, ‘‘new patient’’ is now clarified 

in the ‘‘Patient assessment’’ condition at 

§ 494.80(b). The term ‘‘direct 

supervision’’ has been deleted from the 

final rule, as explained in the preamble 

discussion for ‘‘Personnel 

qualifications’’ at § 494.140(e)(3). 

‘‘Grievance’’ is discussed in the 

preamble for ‘‘Patients’ rights’’ at 

§ 494.70. 

Comment: A renal association 

recommended that we define the term 

‘‘standards’’ in the final rule since we 

used that term in the preamble of the 

proposed rule. The commenter noted 

that the use of the term ‘‘standards’’ is 

significant and should be explicitly 

defined to ensure consistency 

throughout the regulation. The 

commenter also noted that each of the 

NKF’s clinical practice guidelines 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20375 

contains a disclaimer stating that 

guideline is ‘‘not intended to define a 

standard of care, and should not be 

construed as one.’’

Response: The term ‘‘standards’’

appears throughout the regulation, as it 

is used to identify levels of 

requirements within each condition for 

coverage. Historically, our conditions of 

participation and conditions for 

coverage are written in hierarchical 

form of conditions, with standards and 

elements (or factors) contained within 

the conditions. For the most part they 

are written as individual, surveyable 

requirements. Merriam-Webster’s 

Collegiate Dictionary defines 

‘‘standards’’ as ‘‘something established 

by authority, custom, or general consent 

as a model or example.’’ This definition 

matches how the term ‘‘standards’’ is 

used in this final rule. When using the 

term ‘‘standards’’ as applied to care of 

patients, we expect that professionals 

would rely upon principles and 

practices of care that are, for example, 

widely used and supported by 

professional organizations, academic 

institutions, and recognized standardsetting organizations. We recognize that 

professionals may vary in their use of 

particular ‘‘standards.’’ We assume the 

commenter is concerned about the use 

of the terms ‘‘standards’’ as used in the 

preamble discussion of facility-wide 

standards to be used for enforcement. 

Any facility-level standards for 

Medicare participation developed 

subsequent to publication of this final 

rule, will be developed in accordance 

with the National Technology Transfer 

and Advancement Act of 1995 (NTTAA) 

process adopted by the Secretary, as 

discussed in the ‘‘Governance’’

condition at § 494.180. 

c. Compliance With Federal, State, and 

Local Laws and Regulations (Proposed 

§ 494.20) 

We proposed a slightly broader 

version of § 405.2135 in our February 

2005 proposed rule. While § 405.2135 

specifies applicable laws and 

regulations pertaining to licensure, fire 

safety, equipment, and other relevant 

health and safety requirements with 

which a facility had to comply, we 

proposed that, additionally, facilities 

specifically comply with State and local 

building codes, and any laws regulating 

drugs and medical device usage. 

Comment: Several commenters 

suggested deleting the reference to 

‘‘drugs’’ at proposed § 494.20. 

Commenters are concerned that this 

reference to drugs would restrict 

physicians’ use of Medicare Part B 

covered drugs for ‘‘off label’’ use. 

Response: We agree with the 

commenters. The reference to ‘‘drugs’’

has been removed from § 494.20 of the 

regulation text. Medicare contractors 

may make reasonable and necessary 

determinations regarding off-label uses 

of drugs pursuant to instructions 

published in program manuals. 

Additionally, we removed the phrase 

‘‘staff licensure and other personnel 

staff qualifications’’ from § 494.20, as 

this requirement may be found in 

‘‘Personnel qualifications’’ at § 494.140. 

We removed the phrase ‘‘fire safety, 

equipment, building codes’’ from 

§ 494.20, as these issues are addressed 

in the ‘‘Physical environment’’

condition at § 494.60. In addition, we 

removed the phrase ‘‘medical device 

usage’’ from § 494.20, as it is covered 

under the condition for ‘‘Water and 

dialysate quality’’ at § 494.40, the 

condition for ‘‘Reuse of hemodialyzers 

and bloodlines’’ at § 494.50, the 

‘‘Physical environment’’ condition at 

§ 494.60(b), and in the ‘‘Care at home’’

condition at § 494.100. 

Comment: A commenter stated that 

water treatment systems are ‘‘medical 

devices’’ and fall under Food and Drug 

Administration (FDA) regulations. The 

commenter stated that the proposed rule 

preamble suggests that water systems 

would have to meet FDA guidance 

document requirements even if installed 

before May 1997. The commenter is 

concerned that replacement of water 

systems with ‘‘510(k) cleared’’ systems 

would incur needless expense. 

Response: As explained above, we 

have removed the words ‘‘equipment’’

and ‘‘medical device usage’’ from 

§ 494.20 and do not single out these 

categories of law. Facilities are expected 

to comply with all Federal, State and 

local laws regarding health and safety. 

Under current FDA regulations, all 

water treatment systems installed after 

May 30, 1997 must meet review 

requirements under section 510(k) of the 

Food, Drug, and Cosmetic Act (21 U.S.C. 

sec. 360(k)) as described in Guidance for 

the Content of Premarket Notifications 

for Water Purification Components and 

Systems for Hemodialysis (http:// 

www.fda.gov/cdrh/ode/hemodial.pdf). 

This document is intended to provide 

guidance in the preparation of a 

regulatory submission and reflects the 

current FDA review guidance for water 

purification components and systems 

for hemodialysis. Water purification 

systems installed before May 30, 1997 

are not affected by this guidance; 

however, all systems installed after this 

date must meet FDA requirements. 

Regardless of when a water purification 

system was installed, the system must 

yield water and dialysate that meets 

AAMI standards and must be monitored 

and maintained in accordance with the 

AAMI RD52 guidelines, which are 

incorporated by reference in this final 

rule at § 494.40. 

Comment: A number of commenters 

recommended we include a reference to 

the Americans with Disabilities Act of 

1990 (Disabilities Act) within this 

condition. The rationale is that patients 

must be accommodated for mobility, 

hearing, vision, or other disabilities or 

language barriers. 

Response: A specific reference to the 

Disabilities Act is not necessary since 

ESRD facilities must comply with all 

applicable Federal, State, and local 

laws, including the Disabilities Act. The 

Department of Justice, Civil Rights 

Division, is charged with oversight and 

enforcement of the Disabilities Act. We 

would also continue to support the 

enforcement of the Disabilities Act 

provisions through the survey process 

under § 494.20. 

2. Subpart B—Patient Safety 

a. Infection Control (Proposed § 494.30) 

We proposed a separate condition for 

coverage for infection control 

requirements, to update the provisions 

currently found at § 405.2140(b) and 

§ 405.2140(c). We proposed 

incorporating by reference 

‘‘Recommended Infection Control 

Practices for Hemodialysis Units at A 

Glance’’ precautions found in the CDC 

publication ‘‘Recommendations for 

Preventing Transmission of Infections 

Among Chronic Hemodialysis Patients’’

(DHHS/CDC, pages 20–21), with the 

exception of the screening 

recommendations for hepatitis C. We 

proposed that dialysis facilities 

implement appropriate procedures for 

patient isolation; for the handling, 

storage, and disposal of waste; and the 

disinfection of surfaces, devices, and 

equipment. We proposed the 

appointment of an infection control 

officer registered nurse (RN) to ensure 

oversight of the facility’s infection 

control program, maintenance of current 

infection control information, reporting 

of infection control issues to the facility 

chief executive officer (CEO) or 

administrator and the facility 

improvement committee, and the 

development of facility infection control 

improvement recommendations. We 

also proposed monitoring and reporting 

standards that would require the facility 

to analyze and document the incidence 

of infection to identify trends, establish 

baselines, take action to reduce future 

infection control incidents, and report 

incidences of communicable diseases as 


PWALKER on PROD1PC71 with RULES2
20376 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

required by Federal, State, and local 

regulations. 

Comment: We received numerous 

comments on § 494.30 ‘‘Infection 

control’’ condition. Many commenters 

agreed with the inclusion of the CDC 

infection control precautions for 

hemodialysis settings. Some 

commenters recommended that we 

incorporate in the final rule the entire 

CDC (RR05) document entitled, 

‘‘Recommendations for Preventing 

Transmission of Infections Among 

Chronic Hemodialysis Patients’’

(published on April 27, 2001), rather 

than only the ‘‘At A Glance’’ section. 

A number of commenters referenced 

particular infection control precautions 

included in the ‘‘At A Glance’’ section 

and requested clarification or raised 

issues related to the cost or logistics of 

implementing the specific precaution in 

a hemodialysis facility. The precautions 

referred to in these comments include: 

use of disposable items, use of clothcovered blood pressure cuffs, use of 

leak-proof containers for used 

hemodialyzers, specifications for 

medication carts, carrying supplies or 

medications in the pockets of staff, and 

isolation room requirements. Some 

commenters stated that there was no 

need for every new dialysis unit to have 

an isolation room. Two commenters 

supported having separate staff to care 

for hepatitis B-positive patients, but 

other commenters stated the cost of 

separate staff for this would be 

prohibitive. 

Response: We appreciate the support 

for inclusion of the CDC hemodialysis 

infection control precautions in this 

final rule. Based on the comments, it is 

apparent that clarifications are needed 

for the ‘‘At A Glance’’ guidelines, which 

are an abbreviated version of the CDC 

RR05 ‘‘Recommendations for Preventing 

Transmission of Infections Among 

Chronic Hemodialysis Patients.’’ The 

majority of comments concerning 

specific precautions are addressed in 

the CDC narrative section entitled 

‘‘Recommendations’’ on pages 18 

through 28 of ‘‘Recommendations for 

Preventing Transmission of Infections 

Among Chronic Hemodialysis Patients.’’

In order to better clarify the 

requirements of the infection control 

precautions, we are expanding our RR05 

incorporation by reference to include 

the entire ‘‘Recommendations’’ narrative 

section of the document (pages 18–28) 

in the final rule, with one exception 

(hepatitis C screening), as discussed 

below. The introduction and 

background sections of the RR05 

document (pages 1–17) provide the 

evidentiary basis for the recommended 

precautions. The entire CDC RR05 

document provides rich background 

information and rationale for the 

recommended practices; we encourage 

facilities to use the entire document as 

a resource. 

The RR05 CDC infection control 

precautions state that items taken into 

the dialysis station should be disposed 

of, dedicated for use only on a single 

patient, or cleaned and disinfected 

before being taken to a common clean 

area or used on another patient. Items 

that cannot be cleaned and disinfected 

(for example, adhesive tape, clothcovered blood pressure cuffs) should be 

dedicated for use only on a single 

patient. Blood pressure cuff covers may 

be more cost-effective and may be used 

for blood pressure cuffs that cannot be 

decontaminated easily between patients. 

In contrast, rolls of tape cannot be 

decontaminated and can serve as a 

source of contamination for both facility 

personnel and patients. Tape rolls must 

be dedicated to a single patient, or 

disposed of after patient use. 

Hemodialyzers carried to the reuse 

area should always be in a leak-proof 

container. We wish to prevent a bloodcontaminated item from potentially 

contaminating the treatment (and clean) 

areas as it is carried from a patient’s 

station. A container could be a plastic 

bag. We believe that the practice of 

carrying a contaminated hemodialyzer 

to the reuse room without the use of a 

leakproof container does not adequately 

prevent contamination. 

Although one commenter stated that 

banning a medication cart and taping 

medication to the hemodialysis machine 

would ‘‘waste’’ RN time, the CDC has 

made clear that patient safety is best 

protected and risk of crosscontamination reduced when 

medications are prepared and 

distributed from a centralized clean area 

dedicated to that purpose. Another 

commenter argued that staff should 

have immediate access to gloves for 

times when a patient suddenly starts to 

bleed, and that staff members should be 

allowed to carry extra gloves in their 

pockets. The CDC precautions do not 

allow this practice. Instead, the facility 

should have gloves strategically placed 

so that staff has adequate access to them 

for both routine and emergency use. 

Regarding the treatment of hepatitis 

B-positive patients, many commenters 

provided alternative isolation room 

recommendations and requested 

clarification of the isolation room 

requirement for new units as well as for 

existing units. The ‘‘At A Glance’’ page 

states (under ‘‘Management of HBsAgPositive Patients’’) that the dialysis 

facility should dialyze hepatitis B 

surface antigen (HBsAg) positive 

patients in a separate room using 

separate machines, equipment, 

instruments, and supplies; and that staff 

members caring for HBsAg-positive 

patients should not care for hepatitis B 

virus (HBV) susceptible patients at the 

same time (for example, during the same 

shift or during patient change-over). 

CDC language from page 27 of the CDC 

RR05 document states, ‘‘For existing 

units in which a separate room is not 

possible, HBsAg-positive patients 

should be separated from HBVsusceptible patients in an area removed 

from the mainstream of activity and 

should undergo dialysis on dedicated 

machines. If a machine that has been 

used on an HBsAg-positive patient is 

needed for an HBV-susceptible patient, 

internal pathways of the machine can be 

disinfected using conventional 

protocols and external surfaces cleaned 

using soap and water or a detergent 

germicide.’’ Therefore, we are 

incorporating this section by reference 

into the ‘‘Infection control’’ condition at 

§ 494.30, as it is found in the 

‘‘Recommendations’’ narrative section 

of the CDC ‘‘At A Glance’’ infection 

control precautions. However, we are 

allowing dialysis facilities extra time to 

come into compliance with the 

provision requiring a separate isolation 

room (recommendation found on pages 

27 and 28 under the ‘‘HBV-Infected 

Patient’’ section header of RR05), since 

in some cases the provision would 

require that a facility retrofit its 

building, which would necessitate 

project development, architectural 

design, contractor bids, building 

permits, and time to complete the job. 

Therefore, we are allowing dialysis 

facilities 300 days after the publication 

of this final rule in the Federal Register 

to comply with the requirements of this 

provision. In addition, any HBsAgpositive patient in an existing dialysis 

facility should be separated from 

hepatitis B-susceptible patients either 

by a buffer zone of hepatitis B-immune 

patients or by a demarcated physical 

space at least equal to the width of one 

dialysis station. Separate dedicated 

supplies and equipment must be used to 

provide care to the HBsAg-positive 

patient. Note that ‘‘separate equipment’’

includes glucometers. Use of an ‘‘end of 

row’’ hemodialysis station can facilitate 

the separation of the area from the 

mainstream of the dialysis facility’s 

activities and decreases the number of 

adjacent dialysis stations. If this space is 

needed for both HBsAg-positive as well 

as HBsAg-negative patients on other 

shifts, the space may be disinfected 

using conventional protocols and used 

for both types of patients at different 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20377 

times. If a facility does not have any 

HBsAg-positive patients, this space may 

be used by non-HBsAg-positive patients 

on a normal basis. Every facility must 

have the capacity to separate HBsAgpositive patients in the facility. 

In response to comments that not 

every new unit should be required to 

have an isolation room due to the low 

incidence of hepatitis B in hemodialysis 

patients, we have added a waiver 

provision at § 494.30(a)(1)(ii) that states, 

‘‘When dialysis isolation rooms as 

required by (a)(1)(i) are available locally 

that sufficiently serve the needs of 

patients in the geographic area, a new 

dialysis facility may request a waiver of 

such requirement. Such waivers are at 

the discretion of and subject to such 

additional qualifications as may be 

deemed necessary by the Secretary.’’

The CDC infection control 

precautions specifically call for separate 

staff to care for hepatitis B-positive 

patients to prevent infection of 

susceptible dialysis patients. According 

to the CDC, using separate staff is a very 

effective method to reduce the spread of 

HBV. One staff person may care for a 

HBsAg-positive patient and immune 

patients at the same time, but may not 

simultaneously care for hepatitis Bsusceptible patients. Section 494.30 

requires dialysis facilities to implement 

this infection control precaution. 

Comment: Two commenters pointed 

out that the RR05 ‘‘At A Glance’’ section 

uses the word ‘‘should’’ and seems to 

allow less than full compliance with the 

infection control precautions. 

Response: We recognize that the RR05 

CDC document uses the word ‘‘should’’

when describing implementation of the 

infection control precautions, for 

example, ‘‘clean areas should be clearly 

designated for the preparation, handling 

and storage of medications * * *’’ The 

CDC document is written as guidelines 

and therefore guideline language is 

used. For purposes of these Conditions 

for Coverage, the CDC infection control 

precautions, which are incorporated by 

reference, are mandatory and must be 

adhered to and demonstrated within the 

dialysis facility. The regulation states, 

‘‘the facility must demonstrate that it 

follows standard infection control 

precautions’ by implementing the CDC 

hemodialysis infection control practices 

found in the RR05 document. The 

guidelines incorporated by reference 

will be deemed mandatory in the survey 

process. 

Comment: One commenter asked 

whether a reverse isolation negative 

pressure room would be required. 

Response: The RR05 CDC 

recommended infection control 

practices incorporated by reference 

address the unique needs of a 

hemodialysis unit and include contact 

precautions. When airborne pathogens 

are discovered within the dialysis unit, 

the CDC infection control 

recommendations regarding airborne 

pathogens should be consulted and the 

proper measures taken to protect 

patients and staff from exposure. This 

could mean that the affected patient is 

transferred to a setting that provides the 

necessary isolation precautions for the 

pathogen. The facility may want to have 

an agreement with a hospital if the 

facility discerns that this is necessary; 

however, we are not incorporating this 

provision into the Medicare ESRD 

conditions for coverage. 

Comment: One commenter asked 

whether staff cover gowns are required. 

Response: Staff scrubs or uniforms are 

sufficient attire within the dialysis unit, 

except for times when one might expect 

to be exposed to a blood spattering. 

Cover gowns primarily serve to protect 

a staff member from exposure to blood 

within the dialysis unit. This is 

addressed on page 22 of RR05 CDC 

document. 

Comment: We received more than a 

dozen comments regarding the CDC 

RR05 recommendation for hepatitis C 

screening of dialysis patients. Most of 

the comments supported the CDC 

recommendation and several suggested 

that Medicare pay for hepatitis C 

screenings. Commenters stated that 

hepatitis C is an important pathogen for 

dialysis patients, screening would allow 

for early detection, and would alert the 

facility to significant breaks in use of 

infection control precautions. Some 

commenters did not support hepatitis C 

screening by the dialysis facility, and 

one noted that a positive diagnosis 

would not change treatment or patient 

care within the dialysis facility. 

Response: In the proposed rule, we 

specified an exemption for hepatitis C 

screening, since Medicare only covers 

diagnostic hepatitis C testing when 

indicated, and does not cover general 

screening for hepatitis C. A patient with 

a hepatitis C positive test is treated in 

the dialysis facility with the same 

protocols as a patient who is not 

positive for hepatitis C. However, 

transmission of hepatitis C serves as a 

marker to evaluate the adequacy of 

infection control practices within a 

dialysis facility. Medicare generally 

covers preventive care and screenings if 

stipulated in law, including diagnostic 

testing. We will continue to omit from 

our incorporation by reference the CDC 

RR05 sections that specify hepatitis C 

screening. 

On December 14, 2005, we published 

a coverage decision memo (CAG–

00304N) that allows Medicare coverage 

of hepatitis panel testing when there is 

an elevation of liver enzyme levels. The 

memo title is ‘‘Decision Memo for 

Addition of ICD–9–CM code 790.4, 

Nonspecific Elevation of Levels of 

Transaminase or Lactic Acid 

Dehydrogenase, as a Covered Indication 

for the Hepatitis Panel/Acute Hepatitis 

Panel National Coverage Determination’’

and may be found at http:// 

www.cms.hhs.gov/mcd/ 

viewdecisionmemo.asp?id=173. 

Elevated liver enzymes, with or without 

other signs or symptoms of hepatitis, is 

a covered indication for the hepatitis 

panel. Most hemodialysis patients with 

newly acquired Hepatitis C virus (HCV) 

infection have elevated serum 

transaminase levels. Elevations in serum 

transaminase levels often precede antiHCV seroconversion. Monthly serum 

ALT (a transaminase) determination is 

included in the composite payment to 

renal dialysis facilities. Consequently, if 

a beneficiary has an elevated ALT, the 

provider may order a diagnostic 

hepatitis panel, which includes a 

hepatitis C antibody test as part of the 

panel. The hepatitis panel National 

Coverage Determination (NCD) does not 

require the physician to order all of its 

constituent component tests. Thus, a 

provider may order a hepatitis C 

antibody test when the beneficiary’s 

serum ALT, ordered and covered for 

monthly testing in the composite rate, is 

elevated. 

Comment: A few commenters referred 

to the CDC guidelines regarding 

injectable medications and disagreed 

with the established protocol that 

allows re-entry of single-use medication 

vials. 

Response: The April 27, 2001/50 

(RR05); 1–43 CDC infection control 

guidelines, ‘‘Recommendations for 

Preventing Transmission of Infections 

Among Chronic Hemodialysis Patients’’

(http://www.cdc.gov/mmwr/preview/ 

mmwrhtml/rr5005a1.htm) state: 

‘‘Intravenous medication vials labeled 

for single use, including erythropoietin, 

should not be punctured more than 

once (196,197). Once a needle has 

entered a vial labeled for single use, the 

sterility of the product can no longer be 

guaranteed. Residual medication from 

two or more vials should not be pooled 

into a single vial.’’

We have retained the intent of this 

policy and the proposed requirement at 

§ 494.30(b)(2), regarding current 

infection control information including 

the most current CDC guidelines for the 

proper techniques in the use of vials 

and ampules containing medication. 

However, we have modified the 

wording slightly because we have 


PWALKER on PROD1PC71 with RULES2
20378 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

removed the proposed infection control 

officer requirement, as discussed below. 

Under the ‘‘Oversight’’ standard at 

§ 494.30(b)(2) we are requiring the 

clinical staff to ‘‘demonstrate 

compliance with current aseptic 

technique when dispensing and 

administering intravenous medications 

from vials and ampules.’’

Comment: Several comments were 

submitted in response to our solicitation 

as to whether we should incorporate by 

reference the Healthcare Infection 

Control Practices Advisory Committee’s 

(HICPAC) ‘‘Hand Hygiene in Healthcare 

Settings’’ guidelines and the ‘‘Guideline 

for Preventing Intravascular DeviceRelated Infections.’’ Comments were 

evenly divided regarding incorporation 

of the hand hygiene guidelines. Two of 

the commenters stated there is no 

consensus between HICPAC hand 

hygiene guidelines and guidelines 

developed by Society for Healthcare 

Epidemiology of America (SHEA) 

regarding standards of care for 

preventing nosocomial transmission of 

staph aureus and enterococcus. While 

one commenter did not support 

incorporation of the intravascular 

device guidelines, there was some 

support for their inclusion, notably from 

the American Nephrology Nurses 

Association. 

Response: We would expect that 

dialysis facilities demonstrate 

adherence to professional standards of 

practice for infection control, which 

include adherence to hand hygiene 

guidelines. This expectation is included 

in the stem statement of the infection 

control condition: ‘‘The dialysis facility 

must provide and monitor a sanitary 

environment to minimize the 

transmission of infectious agents within 

and between the unit and any adjacent 

hospital or other public areas.’’ The 

expectation of acceptable hand hygiene 

extends to all healthcare providers. We 

will not specifically incorporate by 

reference the HICPAC hand hygiene 

standards, but we do expect compliance 

to the hand hygiene professional 

standards of practice. 

We do not agree that the guidelines 

developed by SHEA regarding standards 

of care for preventing nosocomial 

transmission of staph aureus and 

enterococcus conflict with the HICPAC 

hand hygiene standards. We note that 

the SHEA guidelines are not specific to 

dialysis facilities where contact 

precautions are recommended, but 

address infection control issues in the 

hospital setting. The SHEA guidelines 

reflect the general lack of adherence by 

health care workers to hand hygiene 

standards and recommend additional 

measures, such as surveillance cultures, 

to prevent and monitor crosscontamination. Facilities have the 

flexibility to use appropriate resources 

to assist in the development and 

implementation of their hand hygiene 

infection control and prevention 

program. 

Catheter infections continue to be a 

concern in hemodialysis facilities and 

lead to hospitalizations. HICPAC states 

in its ‘‘Guidelines for the Prevention of 

Intravascular Catheter-Related 

Infections’’ RR–10 document (http:// 

www.cdc.gov/mmwr/preview/ 

mmwrhtml/rr5110a1.htm) (page 11), 

that the use of catheters for 

hemodialysis is the most common factor 

contributing to bacteremia in dialysis 

patients and the relative risk for 

bacteremia in patients with dialysis 

catheters is sevenfold the risk for 

patients with primary arteriovenous 

fistulas. In § 494.30(a)(2) we are 

incorporating by reference the pertinent 

hemodialysis catheter use sections 

(pages 13–14, and 17–18) of RR–10, 

2002, ‘‘Guidelines for the Prevention of 

Intravascular Catheter-Related 

Infections.’’ These guidelines describe 

appropriate health-care worker 

education and training, surveillance, 

hand hygiene (I–III, page 16), aseptic 

technique (IV, page 16), hemodialysis 

catheter exit site care (section III–V, 

page 21), and catheter-site dressing 

regimens (section VI, C, page 22), and 

are the nursing standard of practice for 

catheter care. We expect that 

incorporation of these guidelines will 

increase staff awareness of the 

protections needed for hemodialysis 

patients with catheters and lead to 

reduced catheter infections. 

Comment: Few commenters 

responded to our solicitation for 

comment regarding whether we should 

incorporate by reference the American 

Institute of Architects (AIA) Guidelines 

for Design and Construction of Hospitals 

and Health Care Facilities, which 

outline building requirements pertinent 

to dialysis facilities. Comments were 

split between supporting and rejecting 

AIA guidelines, and incorporation by 

reference if adopting the guidelines. 

Response: We have not incorporated 

the AIA building standards in our final 

rule. However, facilities must comply 

with all State and local building codes/ 

requirements. 

Comment: Several commenters 

addressed our proposed infection 

control officer requirement at 

§ 494.30(b)(2). Some supported having 

an RN assume the role of the infection 

control officer. Others believed that a 

staff member other than an RN should 

assume the role. Some commenters 

stated this role was not the best use of 

RN time, and a few cited cost concerns. 

Several commenters stated that 

oversight of infection control should be 

performed by the medical director or 

that the medical director should be 

notified of infection control issues at 

proposed § 494.30(b)(2)(ii) instead of 

our proposed notification of the chief 

executive officer or administrator and 

the quality improvement committee. 

Response: We understand that 

dialysis facilities may face a shortage of 

RNs and that in many facilities RNs 

must be used to perform duties that only 

an RN can perform. While comments 

supported infection control to protect 

patient safety, several alternatives to an 

RN infection control officer were 

suggested. In response to comments and 

in order to increase facility flexibility in 

assigning staff roles, we have removed 

the infection control officer requirement 

from § 494.30(b)(2), and added infection 

control to the quality assessment and 

performance improvement (QAPI) 

condition at § 494.110(a)(2)(ix) as a 

required topic. This change requires that 

infection control be addressed within 

the action-oriented, data-driven QAPI 

program, which is under the direction of 

the medical director and requires RN 

and interdisciplinary team 

participation. 

In response to comments we have also 

modified the proposed requirement at 

§ 494.30(b)(2)(ii) (now § 494.30(b)(3)), to 

require that clinical staff report 

infection control issues to the dialysis 

facility’s medical director and the 

quality improvement committee instead 

of the chief executive officer or 

administrator. The medical director has 

a critical role in addressing infection 

control issues in the dialysis facility and 

§ 494.150(c)(2)(i) now requires the 

medical director to ensure that staff 

adhere to infection control policies and 

procedures. 

Comment: We received a few 

comments regarding the role of the 

patient and patient perceptions of 

infection control practices in dialysis 

facilities. One patient stated that 

patients should be fully informed about 

infection control so they can protect 

themselves and be aware of staff 

infection control violations. Another 

patient’s observation was that facility 

staff has no training regarding infection 

control and no one seems to worry 

about its ramifications. 

Response: We agree that the dialysis 

patient has a role in assisting the staff 

in preventing the spread of infection. It 

is appropriate for the patient to be 

educated regarding infection control. 

We have added ‘‘infection prevention 

and personal care’’ to the Patient 

Education standard under § 494.90(d) in 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20379 

the ‘‘Patient plan of care’’ condition. 

The facility should provide information 

to dialysis patients on topics including 

current infection control precautions, 

the facility’s infection control practices, 

and the role of the patient in preventing 

the spread of infection. As explained 

above, we have strengthened infection 

control by making it a condition for 

coverage and expect that dialysis staff 

will comply with the hemodialysis 

infection control precautions developed 

by the CDC and required by this rule. 

Comment: One commenter asked 

whether State surveyors could enforce 

local regulations and laws pertaining to 

disposal of hazardous wastes. 

Response: Surveyors make referrals 

regarding unlawful disposal of 

hazardous wastes to the appropriate 

local authorities. If there is a problem, 

it can be cited by the surveyor under 

§ 494.20, ‘‘Compliance with Federal, 

State, and local laws and regulations,’’

when local authorities confirm 

infringement. 

Comment: It was suggested that the 

final rule require more surveillance, 

include septicemia and infection data 

elements, include an added CPM or 

standard for infection control, and 

require mandatory reporting of such 

data on the DFC Web site. 

Response: As stated above, the facility 

must address infection control within 

the action-oriented, data-driven QAPI 

program. Surveillance and use of 

infection data will be necessary 

components of QAPI. We will consider 

the ‘‘reporting’’ as appropriate when 

developing new CPMs and adding new 

measures to the DFC Web site. We are 

not requiring new performance 

measures that have not been fully 

developed in this regulation. 

b. Water and Dialysate Quality 

(Proposed § 494.40) 

We proposed a separate condition for 

coverage to update the water purity 

requirements that were incorporated by 

reference into part 405, subpart U 

(§ 405.2140(a)(5)) in 1995. AAMI has 

since rescinded the document from 

which the sections were incorporated 

(ANSI/AAMI RD5:1992, Hemodialysis 

Systems, second edition) and published 

updated AAMI guidelines in 2001. We 

proposed to incorporate sections from 

the new AAMI document, ‘‘Water 

Treatment Equipment for Hemodialysis 

Applications’’ (ANSI/AAMI 

RD62:2001), to update the bacterial and 

chemical concentrations allowed in 

water used in hemodialysis. The new 

AAMI guidelines established action 

levels for contaminants in addition to 

merely identifying unsafe contaminant 

levels. At ‘‘action levels,’’ the facility 

must implement corrective actions to 

prevent contaminants from reaching 

unsafe levels. We also proposed water 

treatment equipment requirements and 

water testing frequency and sample sites 

that are consistent with the new AAMI 

document, ‘‘Dialysate for Hemodialysis’’

(ANSI/AAMI RD52:2004). We proposed 

chlorine and chloramine testing 

frequency, thresholds, and actions for 

unacceptable high levels to prevent the 

occurrence of hemolytic anemia in 

patients. We proposed corrective action 

plan and adverse event standards to 

further protect patient safety. We 

additionally proposed that facilities use 

bicarbonate dialysate, which has the 

potential for high levels of bacterial 

contamination, within the timeframe 

specified by the manufacturer. 

Comment: We received many 

comments regarding § 494.40 ‘‘Water 

quality’’ condition. The comments were 

unanimous in supporting incorporation 

of AAMI water quality guidelines. 

Several of the comments recommended 

that the more recent 2004 ANSI/AAMI 

RD52 ‘‘Dialysate for hemodialysis’’

guidelines, written for water treatment 

system users, be incorporated by 

reference, rather than the 2001 ANSI/ 

AAMI RD62 ‘‘Water treatment 

equipment for hemodialysis 

applications,’’ which are addressed 

primarily to the manufacturers of 

equipment. A commenter associated 

with the AAMI Renal Disease and 

Detoxification Committee stated that the 

2001 ANSI/AAMI RD62 guidelines are 

slated to be revised in the near future. 

Response: We agree with the 

commenters that ANSI/AAMI 

RD52:2004 ‘‘Dialysate for hemodialysis’’

is the more appropriate set of guidelines 

to incorporate by reference into these 

conditions for coverage. In fact, the 

RD52 guidelines addressing water 

purity monitoring and equipment 

parameters are similar to the 

requirements we proposed at 

§ 494.40(a), § 494.40(b), and parts of 

§ 494.40(c). Therefore, we are 

incorporating the AAMI guidelines 

(ANSI/AAMI RD 52:2004) by reference 

at § 494.40(a). These RD52 guidelines 

are compatible with the RD62 

guidelines that we proposed to 

incorporate by reference, and are the 

standard of practice in dialysis facilities. 

We have removed the redundant 

sections of proposed § 494.40(a) through 

§ 494.40(c) from the regulation, since 

the ANSI/AAMI RD52:2004 

incorporation by reference addresses 

this issue. We are also renaming this 

condition ‘‘Water and dialysate quality’’

to more closely reflect the requirements 

of this condition. 

Comment: One commenter 

recommended that we define 

‘‘established pattern’’ (as related to 

collecting cultures for new water 

systems) (proposed § 494.40(a)(2)(i)(B)), 

as being on a weekly basis until an 

established pattern can be 

demonstrated. 

Response: We agree. This issue is 

addressed in ANSI/AAMI RD52 (section 

6.1—page 19; table 4), which, as 

discussed above, we are incorporating 

by reference. This section states that 

cultures should be drawn ‘‘weekly until 

a pattern of consistent compliance with 

limits can be demonstrated.’’ We have 

removed proposed § 494.40(a)(2)(i)(B). 

Comment: One commenter stated that 

§ 494.40(a)(2)(ii)(C) and (D) are 

redundant since the ‘‘seasonal 

variations in source water’’ specified as 

a trigger for chemical analysis at (C) will 

cause the reverse osmosis (RO) rejection 

rate to fall below 90 percent, the trigger 

listed at (D). A second commenter stated 

that RO is monitored by both rejection 

rate and dissolved solids or resistivity, 

and all of these types of monitoring 

should be indicated as acceptable. 

Response: RO monitoring is addressed 

by ANSI/AAMI RD52 section 5.2.7 (page 

10) and section 6.1 (pages 18–19), which 

we are incorporating by reference. As 

explained above, we have removed the 

redundant language from 

§ 494.40(a)(2)(ii)(C) and 

§ 494.40(a)(2)(ii)(D). Facilities also must 

follow the manufacturers’ instructions 

for feed water treatment and monitoring. 

In the absence of manufacturer’s 

recommendations, the AAMI guidelines 

require facilities to monitor product 

water conductivity, total dissolved 

solids or resistivity, and calculated 

rejection at a frequency and using 

thresholds provided by the 

manufacturer. 

Comments: Many commenters made 

recommendations or requested 

clarification regarding carbon tank 

requirements at proposed § 494.40(c)(1). 

Many commenters supported a two 

carbon tank requirement, and some 

opposed it. A few commenters agreed 

with the 10-minute empty bed contact 

time, while one commenter said that the 

‘‘adequate’’ empty bed contact time 

standard was too subjective. One 

commenter recommended that we 

clarify that the second carbon tank is in 

series with the first, and that we require 

the first tank to be replaced if test 

results are above the specified 

permissible levels. A few commenters 

pointed out that high chloramine levels 

may be mitigated with the use of 

ascorbic acid. 

Response: Section 5.2.1 of the 

‘‘Dialysate for hemodialysis’’ ANSI/ 


PWALKER on PROD1PC71 with RULES2
20380 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

AAMI RD:52 guidelines specify, 

‘‘Whether a device is included in a 

particular water purification system will 

be dictated by local conditions.’’ Since 

comments overwhelmingly supported 

two carbon tanks in series due to patient 

safety concerns and the fact that carbon 

tanks also remove organic contaminants 

from water, we will require at least two 

carbon tanks or equivalent components 

at § 494.40(b)(1) of our final rule 

(proposed § 494.40(c)(1)). Section 5.2.5 

of ANSI/AAMI RD52 clarifies that two 

carbon tanks must be placed in series 

and that the carbon bed must be 

replaced in the first tank when depleted. 

We have added the phrase ‘‘in series’’ to 

our carbon tank requirement at 

§ 494.40(b)(1), as suggested by the 

commenter. This RD52 section also 

clarifies that empty bed contact time 

must be at least 5 minutes in each bed. 

The empty bed contact time is an 

indicator of how much water contact 

with the particles in the carbon bed 

occurs so that there is adequate binding 

and removal of impurities. 

AAMI does refer to use of ascorbic 

acid to correct chloramine/chlorine 

levels in RD62 (section A.4.3.9), though 

only in reference to portable water 

treatment systems. In RD52 (section 

5.2.5 and appendix section A.5.2.5), 

AAMI also acknowledges the 

supplementation of carbon adsorption 

with other methods of chloramine 

removal. 

In response to comments regarding an 

alternate means of correcting 

chloramine/chlorine breakthrough that 

would permit the continuation of 

hemodialysis, we have added a 

provision to the final rule at 

§ 494.40(b)(2)(ii)(A) to allow immediate 

corrective action, and confirm through 

testing that the corrective action has 

been effective. We will not limit the 

means by which chloramines/chlorine 

levels are brought back into compliance 

at § 494.40(b)(2)(ii)(A). This regulation 

allows for use of other proven methods 

to remove chloramines including 

ascorbic acid and new technologies that 

may be developed. When using alternate 

methods to remove chloramines/ 

chlorine, the facility must perform the 

required testing to ensure the successful 

removal of harmful chloramine/ 

chlorine. After measures have been 

taken to resolve the immediate problem 

of chloramine/chlorine breakthrough, 

the facility must implement actions to 

maintain long-term compliance with 

acceptable chloramines/chlorine levels. 

We have added a provision at 

§ 494.40(b)(2)(ii)(D), which requires 

facility action to ensure ongoing 

compliance. This provision reads, ‘‘The 

facility must * * * Take corrective 

action to ensure ongoing compliance 

with acceptable chlorine and 

chloramine levels as described in 

paragraph (b)(2)(i) of this section.’’

Comment: Many comments addressed 

our proposed requirement for chlorine/ 

chloramine testing (proposed 

§ 494.40(c)(2)) before each patient shift 

or every 4 hours, whichever was shorter. 

The majority of comments favored 

chlorine/chloramine testing only before 

every shift and not every 4 hours. One 

commenter recommended we change 

the 4 hours to 6 hours and retain the 

requirement, while another suggested 

we delete the phrase ‘‘whichever is 

shorter.’’ A few commenters agreed with 

the testing frequency of every 4 hours. 

Response: According to ANSI/AAMI 

RD52, section 6.2.5 (page 20), testing 

should be done at the beginning of the 

day and again before each shift, and if 

there are no set shifts, then every 4 

hours. We refer to this section, which 

has been incorporated by reference, at 

§ 494.40(b)(2)(i), and we believe it 

provides sufficient clarification. We 

have deleted the proposed requirement 

at § 494.40(c)(2). 

Comment: One commenter stated the 

regulation should include maximum 

carbon tank limits on usage time, flow, 

volume, and that testing for iodine 

should be required. 

Response: The AAMI guidelines call 

for chlorine/chloramine testing every 

shift to monitor carbon tank 

performance. We are not aware of any 

evidence suggesting that these 

precautions are insufficient. We believe 

the commenter is suggesting that a 

minimum iodine number for the carbon 

should be required. Section 5.2.5 of the 

AAMI RD52 document states that 

‘‘When granular activated carbon is 

used as the medium, it shall have a 

minimum iodine number of 900.’’

Comment: A few commenters stated 

that chlorine/chloramine testing 

requirements should also allow the 

testing for total chlorine with a limit of 

0.10 mg/L. 

Response: This suggestion 

corresponds with ANSI/AAMI RD52 

section 6.1; table 4 (page 8) which 

allows total chlorine levels of less than 

0.1 mg/L. This section is now 

incorporated by reference. We have 

modified proposed § 494.40(c)(2)(i), 

now § 494.40(b)(2)(i) to allow total 

chlorine testing with acceptable levels 

of less than 0.1 mg/L as an alternative 

to testing free chlorine and chloramine 

levels. 

Comment: One commenter stated that 

chlorine/chloramine requirements at 

proposed § 494.40(c)(2)(ii) do not 

account for facilities with a holding 

tank, and we should allow water in the 

holding tank to be used if testing shows 

this water contains total chlorine < 0.1 

mg/L. 

Response: Water in the holding tanks 

may be used during failure of carbon 

tanks only if testing indicates the 

holding tank water meets AAMI 

chlorine/chloramines standards of < 0.1 

mg/L total chlorine OR < 0.50 mg/L free 

chlorine AND < 0.1 mg/L chloramines 

and no additional water is allowed to 

enter the tank. Revised 

§ 494.40(b)(2)(ii)(B) (proposed (c)(2)(ii)) 

allows use of purified water in the 

holding tank when it meets the AAMI 

standards at § 494.40(b)(2)(i). 

Comment: One commenter 

recommended that endotoxin levels be 

measured in addition to blood and 

dialysis cultures when there is an 

adverse event (proposed at 

§ 494.40(e)(1)), since cultures may be 

negative even with high endotoxin 

levels. 

Response: We agree with the 

commenter that measurement of 

dialysate endotoxin levels should be 

performed along with dialysate cultures 

when a suspected adverse event occurs. 

We note that the AAMI guidelines call 

for dialysate bacterial cultures to be 

accompanied by endotoxin level testing. 

The AAMI guidelines state that 

endotoxin testing, if performed in the 

dialysis facility, can give results in 

about 1 hour, eliminating the long delay 

between sampling and obtaining a result 

(ANSI/AAMI RD52:2004, section A.1.4). 

We have added endotoxin testing to the 

blood and dialysate culture requirement 

at § 494.40(d)(1) (proposed 

§ 494.40(e)(1). 

Comment: Two commenters requested 

that we clarify the language of proposed 

§ 494.40(e) ‘‘Adverse events’’ (now 

§ 494.40(d)), regarding the active 

surveillance of patient reactions during 

and following dialysis. One commenter 

suggested that the word ‘‘following’’ be 

defined to mean ‘‘after post-dialysis 

assessment with subsequent discharge 

by nurse or caregiver.’’

Response: We appreciate the 

comment; however, we believe that the 

suggested definition is too narrow, since 

not every adverse advent will be limited 

to the time period the patient is 

physically in the dialysis unit. 

‘‘Following dialysis’’ runs from the 

moment when the treatment session 

ends through the time the patient leaves 

the unit and beyond. In addition, when 

the patient calls and/or when the 

patient returns for the next dialysis 

session, if there are symptoms that are 

correlated with a water purity adverse 

event, then cultures and endotoxin 

testing must be performed. 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20381 

Comment: Many comments reflected 

concern regarding the proposed 

requirement at § 494.40(f) that mixed 

bicarbonate concentrate be used within 

the timeframe specified by the 

manufacturer of the concentrate, and the 

accompanying preamble statement that 

fresh bicarbonate must not be mixed 

with other batches of fresh bicarbonate. 

Several commenters stated that mixing 

batches of bicarbonate concentrate may 

be unavoidable due to mixing processes 

and the use of holding tanks. Two 

commenters agreed with limiting use of 

bicarbonate to the time limit given by 

the manufacturer, while others stated 

that it was only necessary to use 

bicarbonate the same day it was mixed. 

Some commenters stated that 

bicarbonate is the most vulnerable part 

of dialysis solutions. 

Response: AAMI addresses 

procedures for bicarbonate concentrate 

in ANSI/AAMI RD52, section 7.1 (page 

24), stating, ‘‘Storage times for 

bicarbonate concentrate should be 

minimized, as well as the mixing of 

fresh bicarbonate concentrate with 

unused portions of concentrate from a 

previous batch.’’ Section 5.4.4.3 (page 

15), also states, ‘‘Once mixed, 

bicarbonate concentrate should be used 

within the time period recommended by 

the manufacturer of the concentrate. 

The concentrate shall be shown to 

routinely produce dialysate meeting the 

recommendations of 4.3.2.1.’’ ANSI/ 

AAMI RD52 stipulates the use of 

bicarbonate concentrate within the time 

period recommended by the 

manufacturer and does not expressly 

prohibit the mixing of bicarbonate 

concentrate. If the first batch of 

bicarbonate concentrate has not yet 

expired, it could be mixed with a 

second batch, provided the first batch 

had not expired in accordance with the 

manufacturer’s time limitations before it 

was used. We have removed the 

proposed water and dialysate quality 

standard at § 494.40(f), regarding 

unused bicarbonate, since we are 

instead incorporating ANSI/AAMI RD52 

by reference. 

Comment: We received many 

comments regarding whether we should 

include requirements related to 

ultrapure dialysate. Although two 

commenters (including a large patient 

organization) supported ultrapure 

dialysate requirements, a number of 

commenters opposed such 

requirements, citing a lack of evidence 

that supported the use of ultrapure 

dialysate. One commenter stated that in 

light of new findings showing that 

ultrapure dialysis could be beneficial to 

hemodialysis patients, ultrapure 

dialysate should be strongly 

encouraged. Another commenter, who 

was a national expert in the area of 

dialysis water treatment systems, 

suggested that we require that all new 

water systems installed after publication 

of the final rule be capable of delivering 

ultrapure dialysate. This would allow 

facilities to provide ultrapure dialysate 

in the future should an evidentiary basis 

be solidified. A few comments 

suggested that if we require ultrapure 

dialysate, Medicare should provide 

corresponding reimbursement. 

Response: We appreciate the 

comments; however, we are not 

requiring dialysis facilities to provide 

ultrapure dialysate in this final rule. 

Current information shows promise of 

ultrapure dialysate, but we believe that 

sufficient evidence is lacking. We will 

revisit this issue in the future when 

more evidence is available, recognizing 

that dialysis patients are in favor of a 

lower permissible level of bacterial 

contamination in the dialysate. If 

additional evidence supports the use of 

ultrapure dialysate, we may undertake 

the necessary rulemaking to incorporate 

the requirement at a later date. Facilities 

choosing to provide ultrapure dialysate 

must meet section 4.3.2.2 of the ANSI/ 

AAMI RD52 guidelines. 

Comment: Some commenters 

suggested that we avoid codifying dates 

and values in the regulations, as these 

may change before the regulation 

changes. 

Response: We believe that the 

avoidance of values and use of general 

language for Medicare patient safety 

requirements may create confusion and 

allow less than full compliance with 

these conditions for coverage. There are 

currently clear thresholds and standards 

for dialysis water purity, which we have 

included. Where necessary, we will 

consider updating specific dates and 

values via future rulemaking, as 

appropriate. 

Comment: Two commenters pointed 

out that the AAMI guidelines for 

bacteria and bacterial toxin sample sites 

were misquoted in the proposed rule 

preamble bullets (70 FR 6195) as 

follows: 

• Outlet of the water storage tanks if 

used 

• Concentrate or from the bicarbonate 

concentrate mixing tank. 

Response: The commenters are 

correct. The bullets above do not 

accurately reflect the guidelines. 

However, the language will not appear 

in this final rule since the issue is 

covered in ANSI/AAMI RD52; section 

7.2.1 (page 25), incorporated by 

reference at § 494.40(a) in this final rule, 

which addresses collection sites for 

water/dialysate samples. 

Comment: One commenter stated that 

the final rule should require a water 

quality technician who would be 

independent from the primary 

caregivers. 

Response: Provisions regarding the 

water treatment system technicians are 

found at § 494.140(f); water treatment 

system technicians must complete a 

training program that has been approved 

by the medical director and governing 

body. Section 9 of AAMI RD52 calls for 

a training program that includes 

‘‘quality testing, the risks and hazards of 

improperly prepared concentrate, and 

bacterial issues.’’ Section 9 also states, 

‘‘Operators should be trained in the use 

of the equipment by the manufacturer or 

should be trained using materials 

provided by the manufacturer. The 

training should be specific to the 

functions performed (that is, mixing, 

disinfection, maintenance, and repairs). 

Periodic audits of the operators’

compliance with procedures should be 

performed. The user should establish an 

ongoing training program designed to 

maintain the operator’s knowledge and 

skills.’’ The dialysis facility has 

flexibility with staff assignments and 

the water quality technician may or may 

not be independent of the primary 

caregivers. As noted, we are 

incorporating these provisions by 

reference. 

Comment: One commenter objected to 

the RO/deionization component 

requirement at § 494.40(b), which it 

believed could preclude use of new/ 

improved technologies. 

Response: We have removed this 

language from § 494.40(b). At 

§ 494.40(a), we have incorporated by 

reference ANSI/AAMI RD52, which 

states in section 5, ‘‘Equipment’’ (page 

8): 

Since feed water quality and product water 

requirements may vary from facility to 

facility, not all of the components described 

in the following clauses will be necessary in 

every purification and distribution system. 

Components must be included, which would 

allow product water and dialysate to meet 

the AAMI standards specified at 4.1.2, 4.2.1, 

and 4.3.2.1. 

Comment: One commenter objected to 

the requirement to assay cultures within 

24 hours since this may not be realistic 

on weekends. The commenter suggested 

allowing a 48-hour time period for 

cultures. 

Response: The proposed rule did not 

prescribe culture assay timelines. 

However, the ANSI/AAMI RD52 

guidelines at section 7.2.3 state that 

samples that cannot be cultured within 

1–2 hours can be refrigerated for up to 

24 hours. Samples that are held longer 

than 24 hours do not accurately measure 


PWALKER on PROD1PC71 with RULES2
20382 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

the degree of contamination against the 

established AAMI standards. We have 

incorporated ANSI/AAMI RD52 

standards into this final rule by 

reference at § 494.40(a). 

Comment: One comment stated that 

facilities should be able to substitute a 

reuse water sample from the site where 

the dialyzer connects to the reuse 

system for a sample taken from the 

entrance to the reprocessing equipment 

(described at 70 FR 6195). 

Response: AAMI specifies collection 

of water samples from the outlets 

supplying the reuse equipment (ANSI/ 

AAMI RD52 section 6.3.3, page 22). We 

will adhere to this AAMI guideline. We 

have incorporated ANSI/AAMI RD52 by 

reference at § 494.40(a) in this final rule. 

Comment: One commenter suggested 

the requirement for a water sample at 

the outlet of the water storage tank be 

deleted, since this is only necessary 

initially and when trouble-shooting. 

Response: The commenter refers to 

proposed rule preamble language (70 FR 

6195) describing RD52 sample sites and 

is correct in observing that samples are 

taken from the outlet of the water 

storage only initially and when 

troubleshooting. This matter is 

addressed in section 7.2.1 of AAMI 

RD52, which we are incorporating into 

this final rule by reference. 

Comment: One commenter stated that 

when referring to water samples from 

the distribution ‘‘loop’’ we should 

change our wording, as a ‘‘loop’’ has no 

‘‘beginning’’ or ‘‘end’’. 

Response: We refer the commenter to 

AAMI RD52 section 6.3.3 (page 22), 

which states that samples should be 

taken from the first and last outlets of 

the water distribution loop and the 

outlets supplying the reuse equipment 

and bicarbonate mixing tanks. We have 

incorporated ANSI/AAMI RD52 by 

reference at § 494.40(a) into this final 

rule. We believe that the AAMI language 

is generally understood. 

Comment: We received comments 

regarding the quality of home 

hemodialysis water, recommending that 

there be separate water purity standards 

for home dialysis systems due to the 

availability of new technology and the 

cost burden associated with the 

proposed water quality requirements. 

Response: We acknowledge that the 

AAMI RD52 water and dialysate purity 

guidelines were not intended by AAMI 

for home dialysis or portable systems. 

However, in the absence of water purity 

guidelines for home hemodialysis, we 

believe that the AAMI RD52 water and 

dialysate purity guidelines offer the best 

protection for use in preconfigured 

systems. 

Therefore, the dialysis facility must 

monitor the quality of water and 

dialysate used by home hemodialysis 

patients, and conduct an onsite 

evaluation and testing of the water and 

dialysate system. The water and 

dialysate monitoring must be in 

accordance with the system’s 

manufacturer instructions at 

§ 494.100(c)(1)(v)(A), and the system’s 

FDA approved labeling for 

preconfigured systems designed, tested, 

and validated to meet AAMI quality 

(which includes standards for chemical 

and chlorine/chloramine testing) water 

and dialysate. The facility must meet 

testing and other requirements of AAMI 

RD52:2004 for water and dialysate. In 

addition, bacteriological and endotoxin 

testing must be performed at least 

quarterly, or on a more frequent basis, 

as needed, to ensure that the water and 

dialysate are within AAMI standards at 

§ 494.100(c)(1)(v)(B). 

In cases where these new 

preconfigured hemodialysis machines 

are used in a dialysis facility, the home 

dialysis requirements do not apply. 

Therefore, we have added the following 

language at § 494.40(e) to address incenter use of these machines: ‘‘When 

using a preconfigured, FDA-approved 

hemodialysis system designed, tested, 

and validated to yield AAMI-quality 

(which includes standards for chemical 

and chlorine/chloramine testing) water 

and dialysate, the system’s FDAapproved labeling must be adhered to 

for machine use and monitoring of the 

water and dialysate quality. The facility 

must meet AAMI RD52:2004 

requirements for water and dialysate. 

However, the facility must perform 

bacteriological and endotoxin testing on 

a quarterly or more frequent basis, as 

needed, to ensure that the water and 

dialysate are within AAMI limits.’’

Comment: One commenter 

recommended that we require facilities 

to use only certified labs for analysis of 

bacteria growth and limulus amoebocyte 

lysate (LAL) testing. 

Response: We are aware that many 

facilities do their own water and 

dialysate cultures and endotoxin testing 

on-site. The AAMI RD52 guidelines 

address the monitoring of water and 

dialysate systems for bacteria and 

endotoxin levels. Section 7.2.3 states 

that ‘‘Dip samplers may be used for 

bacterial surveillance. However, they 

should be used only in conjunction with 

a quality assurance program designed to 

ensure their appropriate use.’’ Section 

7.2.4 addresses in-house testing for 

endotoxin levels. We have not modified 

the requirements as the RD52 document 

provides guidance regarding cultures 

and endotoxin testing. 

c. Reuse of Hemodialyzers and 

Bloodlines (Proposed § 494.50) 

We proposed to update our condition 

for coverage at § 405.2150, ‘‘Reuse of 

hemodialyzers and other dialysis 

supplies’’, by replacing it with a new 

condition for coverage at § 494.50. The 

ANSI/AAMI ‘‘Reuse of Hemodialyzers’’

guidelines (ANSI/AAMI RD47: 1993, 

second edition), incorporated by 

reference in 1995, were revised in 2002 

and amended in 2003. We proposed 

incorporation by reference of the third 

edition of ‘‘Reuse of Hemodialyzers’’

(ANSI/AAMI RD47: 2002/A1: 2003). We 

proposed that only hemodialyzers and 

bloodlines labeled for reuse could be 

reprocessed and that reprocessing 

would have to meet the AAMI 

guidelines and adhere to the 

manufacturer’s recommendations, 

unless an alternate method, documented 

to be safe and effective, was employed. 

The prohibition on reuse of 

hemodialyzers for hepatitis B patients 

was retained in the proposed rule, to 

protect staff from exposure to the 

hepatitis B virus. The requirement that 

the facility use only one germicide for 

each reprocessed hemodialyzer was 

retained in the proposed rule, to ensure 

integrity of the dialyzer membrane; we 

added a clarification that bleach would 

not be considered a germicide in this 

context. We proposed monitoring, 

evaluation, and reporting requirements 

to ensure surveillance for adverse 

patient reactions to reuse, and proposed 

that the facility suspend reuse when a 

problem was suspected or discovered. 

We also proposed that when required by 

law, adverse outcomes would have to be 

reported to the FDA and other Federal, 

State, or local government agencies. 

We received more than two dozen 

comments on the Reuse condition. The 

comments support inclusion of the 

updated 2002/2003 AAMI ‘‘Reuse of 

hemodialyzers’’ guidelines. 

Comment: Several commenters 

addressed the first provision of this 

condition, which states, ‘‘The dialysis 

facility that reuses hemodialyzers or 

bloodlines must meet the requirements 

of this section. Failure to meet any of 

these requirements constitutes grounds 

for denial of payment for the dialysis 

treatment affected and termination from 

participation in the Medicare program.’’

Some of the commenters suggested 

deletion of this statement, while others 

suggested stronger penalties. One 

commenter stated this statement merely 

repeated proposed § 488.604, while 

another suggested the penalty was too 

drastic. 

Response: The language regarding 

penalties for failure to meet the reuse 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20383 

requirements is consistent with section 

1881(f)(7) of the Act, which directly 

addresses dialyzer filter reuse. However, 

denial of payment for discrete instances 

of reuse non-compliance, authorized by 

section 1881(f)(7)(C) of the Act, has not 

been implemented, due to 

administrative difficulties associated 

with identifying which particular 

treatments would be associated with 

any specific denial of payment when 

there is a reuse problem. Currently, 

when a compliance problem is 

identified, the surveyor cites the facility 

and the facility must develop and 

implement a corrective action plan. If 

the facility does not make the necessary 

corrections then the facility is put on a 

termination track. This process has been 

effective in protecting patient health 

and safety when hemodialyzers are 

reused and will continue under this 

final rule. Therefore, we have removed 

the undesignated paragraph ‘‘Failure to 

meet any of these requirements 

constitutes grounds for denial of 

payment for the dialysis treatment 

affected and termination from 

participation in the Medicare program’’

from § 494.50. 

We believe dialysis facility 

termination for reuse deficiencies and 

non-compliance fulfills the statutory 

requirement at section 1881(f)(7)(C) of 

the Act, that CMS deny payment for 

hemodialyzer reuse non-compliance. 

Under the current process, when a reuse 

problem is confirmed by a surveyor, we 

require immediate corrective action, 

which protects patient safety. If the 

reuse problem presented immediate 

jeopardy to patient safety, we would 

shut down the reuse program 

immediately until the facility could 

demonstrate that the problem had been 

corrected. CMS also has the authority to 

withhold payment from a facility when 

it has determined that there have been 

specific violations of this provision. If 

the facility were to continue to 

compromise patient safety, we would 

put the facility on a termination track. 

We believe that termination procedures 

provide more incentive to return to 

compliance than the denial of payment 

alternative sanction. 

Comment: One commenter asked how 

the proposed rule ensures patient 

consent for dialyzer reuse. 

Response: Our requirement for patient 

consent for dialysis reuse is located at 

§ 494.70(a)(9), which states the patient 

has the right to be informed of facility 

policies regarding the reuse of dialysis 

supplies, including hemodialyzers. 

Patients may want to discuss this aspect 

of their medical treatment with their 

physician. 

Comment: An organization 

representing kidney disease patients 

expressed concern regarding the large 

number of times a hemodialyzer is 

reused (up to 30 times), and requested 

that CMS convene a technical expert 

panel to examine all facets of reuse and 

make recommendations to improve 

current practice. 

Response: We have added 

incorporation by reference the AAMI 

reuse guidelines, ANSI/AAMI 

RD47:2002 & RD47:2002/A1:2003 

‘‘Reuse of hemodialyzers’’ to this final 

rule at § 494.50(b)(1). The AAMI 

guidelines, which represent the 

consensus of technical experts, include 

dialyzer performance measurements 

(that is, total cell volume) that must be 

met in order for a dialyzer to be reused. 

Currently these parameters do not 

include a maximum number of 

allowable reuses. We may consider 

updates to this final rule through 

separate rulemaking when AAMI 

updates its reuse guidelines. 

Comment: A few commenters 

disagreed with some of the AAMI 

hemodialyzer reuse guidelines. One 

commenter recommended that we 

require immediate disinfection of 

dialyzers and not allow the refrigeration 

of dialyzers; another commenter 

suggested that we ban the reuse of 

bloodlines, since AAMI is withdrawing 

the bloodline reuse guidelines. A third 

commenter recommended that dialyzer 

heat disinfection be prohibited. 

Response: We defer to the AAMI 

guidelines on each of these reuse issues. 

Section 11 of the AAMI reuse 

guidelines, ANSI/AAMI RD47:2002 & 

RD47:2002/A1:2003 ‘‘Reuse of 

hemodialyzers,’’ incorporated into this 

final rule by reference, describes the 

approved processes for cleaning and 

disinfecting dialyzers, including heat 

disinfection. The guidelines also permit 

refrigeration of hemodialyzers that 

cannot be reprocessed within 2 hours, 

in order to inhibit bacterial growth. The 

AAMI guidelines allow disinfection 

procedures that have been shown to 

accomplish at least high-level 

disinfection when tested in dialyzers 

artificially contaminated with the 

relevant types of microorganisms. The 

guidelines also state that the 

disinfection process shall not adversely 

affect the integrity of the dialyzer. To 

date, AAMI has not rescinded the 

bloodline reuse guidelines and this final 

rule requires facilities that reuse 

bloodlines to follow them. 

Comment: Two commenters 

recommended a further clarification of 

the requirement we proposed at 

§ 494.50(b)(3), which stated that 

facilities will ‘‘Not expose 

hemodialyzers to more than one 

chemical germicide, other than bleach, 

during the life of the dialyzer.’’ One 

suggestion was to insert a clarifying 

parenthetical phrase so that this 

requirement would read, ‘‘Not expose 

hemodialyzers to more than one 

chemical germicide, other than bleach 

(used as a cleaner in this application), 

during the life of the dialyzer.’’ This 

commenter suggested that without 

adding this phrase the statement would 

be misleading, as it implied that bleach 

could be used as a disinfectant, which 

could damage the dialyzer if used longterm in such a manner. 

Response: We agree with the 

commenter. We have revised 

§ 494.50(b)(3) to clarify that bleach is 

considered a ‘‘cleaner’’ and not a 

disinfectant in this context. 

Comment: We received a few 

comments regarding § 494.50(c), 

‘‘Monitoring, evaluation, and reporting 

requirements for the reuse of 

hemodialyzers and bloodlines.’’ Some 

commenters recommended clarifying 

the phrase ‘‘cluster of adverse patient 

reactions’’ and two commenters 

supported a requirement that a blood 

test be done whenever a febrile reaction 

occurs, not just when there is a cluster. 

Another commenter cited a 1987 study 

published in the Journal of the 

American Medical Association that 

established a direct relationship 

between endotoxin levels and febrile 

reactions caused by poor reuse 

reprocessing techniques and 

recommended that endotoxins be 

measured in addition to blood and 

dialysis cultures since cultures may be 

negative with high endotoxin levels. 

Response: ‘‘A cluster of adverse 

patient reactions’’ means a set of 

undesirable events affecting the health 

of dialysis patients that could be 

clinically related to dialyzer reuse 

practices. In such cases, the physician 

responsible for the hemodialyzer 

reprocessing program must act in 

accordance with the AAMI guidelines 

found at ANSI/AAMI RD47:2002 & 

RD47:2002/A1:2003. If a single patient 

has a suspected adverse reaction, the 

physician should evaluate the incident 

and order testing as appropriate in his 

or her clinical judgment. 

The requirements of section 494.50(c) 

(regarding obtaining blood and dialysate 

cultures and evaluation of dialyzer 

reprocessing and water purification 

systems) would apply if a group of 

patients (that is, a cluster) was 

suspected of having adverse reuse 

reactions. We agree with the commenter 

that facility personnel should perform 

dialysate endotoxin level tests along 

with dialysate cultures when a 


PWALKER on PROD1PC71 with RULES2
20384 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

suspected adverse event occurs; this is 

consistent with our requirement in the 

‘‘Adverse events’’ standard in the 

‘‘Water and dialysate quality’’ condition 

at § 494.40. Therefore we have added 

endotoxin testing requirements at 

§ 494.40(d)(1) and § 494.50(c)(2)(i). 

A dialysis facility that uses outside 

hemodialyzer reprocessing services is 

responsible for fully protecting patient 

health and safety and ensuring 

compliance with these conditions for 

coverage and AAMI reuse guidelines as 

well as carrying out appropriate testing 

and evaluation of reuse processing and 

water purification systems when a 

cluster of adverse events occurs. 

d. Physical Environment (Proposed 

§ 494.60) 

We proposed to update the § 405.2140 

‘‘Physical environment’’ requirements, 

which address facility building safety, 

equipment maintenance, the patient 

care environment, emergency 

preparedness, and fire safety, at new 

§ 494.60. The proposed rule was 

consistent with part 405, subpart U 

provisions in requiring that a facility be 

constructed, equipped, and maintained 

to provide dialysis patients, staff, and 

the public a safe, functional, and 

comfortable environment. The proposed 

rule further addressed patient comfort 

by requiring that the facility 

temperature be comfortable for the 

majority of its patients or that 

reasonable accommodations be offered. 

We proposed that the dialysis facility 

implement processes and procedures to 

manage medical and nonmedical 

emergencies (including fire, equipment 

or power failures, care-related 

emergencies, water supply interruption, 

and natural disasters) that are likely to 

threaten the health or safety of the 

patients, the staff, or the public. The 

proposed rule would require emergency 

preparedness training for staff and 

patients, and would specify the 

emergency equipment that would have 

to be available in the dialysis facility 

(including oxygen, airways, suction, 

defibrillator, artificial resuscitator, and 

emergency drugs). The proposed fire 

safety requirements called for facility 

compliance with applicable provisions 

of the 2000 edition of the LSC of the 

National Fire Protection Association. 

The LSC waiver provisions were 

included in the proposed rule for those 

instances when, in the view of CMS, 

LSC compliance would result in 

unreasonable hardship and patient 

health and safety would not be 

adversely affected; or when a State had 

fire and safety codes that adequately 

protected dialysis patients. For a 

detailed discussion of our proposed 

physical environment provisions at 

§ 494.60, see the February 4, 2005 

proposed rule (70 FR at 6197). 

Comment: Under the ‘‘Equipment 

maintenance’’ standard at § 494.60(b), 

one commenter suggested that 

equipment be maintained according to a 

regular maintenance schedule rather 

than the manufacturer’s 

recommendations. The commenter was 

concerned that the manufacturer might 

overstate the amount of maintenance 

required. 

Response: Our intent was to ensure 

that all dialysis facility equipment was 

adequately maintained and working 

properly. We proposed that ‘‘The 

dialysis facility must implement and 

maintain a program to ensure that all 

equipment (including emergency 

equipment, dialysis machines and 

equipment, and the water treatment 

system) is maintained and operated in 

accordance with the manufacturer’s 

recommendations.’’ It is expected that 

routine maintenance be performed so 

that the risk of equipment malfunction 

is small. The facility will need to use 

the manufacturer’s recommendations as 

a reference and guide. We have retained 

§ 494.60(b) as proposed. 

Comment: While the majority of 

commenters support our proposed 

requirement at § 494.60(c)(2) (that the 

facility maintain a room temperature 

that would be comfortable for patients, 

and make reasonable accommodations 

for the patients who might not be 

comfortable at the temperature that is 

comfortable for the majority), several 

commenters disagreed with this 

requirement. Some thought the proposal 

was too prescriptive, ignored the needs 

of staff (who are required to wear 

protective clothing), and allowed 

patients to dictate staff working 

conditions. Commenters noted that 

facilities already strive to keep patients 

comfortable, and stated that patients 

should be educated as to why body 

temperature drops during dialysis. 

Response: Room temperature is a 

source of frequent tension in a 

hemodialysis facility. Generally, the 

sedentary patients undergoing treatment 

prefer a warmer room temperature, 

while staff who are engaged in activity 

and wearing protective coverings prefer 

a cooler room temperature. The 

proposed requirement would have tilted 

the room temperature in favor of the 

patients without consideration of the 

needs of the staff. In response to 

comments, we have modified the 

requirement to acknowledge the room 

temperature needs of staff. The intent of 

the new requirement is to have facilities 

arrive at a middle ground so that the 

room temperature is at least marginally 

acceptable to both patients and staff. 

Patients who continue to feel cold could 

use coverings or blankets. Regardless of 

the room temperature, patients should 

not be deprived of the ability to use 

covers or blankets. The dialysis facility 

may allow patients to bring their own 

blanket or may opt to provide a cover. 

In either case, adequate infection 

control precautions must be taken 

considering the risk of blood spatter. 

Additionally, the access sites and line 

connections should remain uncovered 

to allow staff to visually monitor these 

areas to ensure patient safety. In 

response to comments, we have revised 

§ 494.60(c)(2)(i) by removing the phrase 

‘‘that is comfortable for the majority of 

its patients’’ and inserted the word 

‘‘comfortable’’ earlier in the sentence. 

Section § 494.60(c)(2)(i) and 

§ 494.60(c)(2)(ii) now requires a facility 

to maintain a comfortable temperature 

within the facility; and make reasonable 

accommodations for the patients who 

are not comfortable at this temperature. 

Comment: Many commenters 

recommended that we add privacy 

requirements to allow facility staff to 

conduct confidential interviews with 

patients, and to ensure that facilities 

utilized physical barriers whenever 

body exposure necessitated usual 

privacy. Commenters who supported a 

confidential area for patient interviews 

cited the April 14, 2003 Health 

Insurance Portability and 

Accountability Act (HIPAA) fact sheet 

(http://www.hhs.gov/news/facts/ 

privacy.html) which outlines patient 

information privacy protections, 

including the patient’s right to request 

confidential communications. 

Response: HIPAA requirements 

protecting patient privacy apply to 

dialysis facilities. Two provisions of the 

proposed rule would support the 

patient’s right to privacy. Proposed 

paragraph § 494.70(a)(3) stated that the 

patient would have the right to privacy 

and confidentiality in all aspects of 

treatment. Likewise, proposed 

§ 494.70(a)(4), stated that the patient 

would have the right to privacy and 

confidentiality in personal medical 

records. Our preamble discussion of this 

requirement in the proposed rule (70 FR 

6201) clearly stated our belief that any 

staff discussion with dialysis patients 

regarding treatment, the patient care 

plan, and medical conditions should be 

held in private and kept confidential, 

using reasonable precautions. We also 

pointed out that in situations when 

there was patient body exposure, the 

staff would be instructed to provide 

temporary screens, curtains, or blankets 

to protect patient privacy. To respond to 

these comments and to further 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20385 

strengthen the patient’s right to physical 

privacy, we have added a new provision 

at § 494.60(c)(3), stating that ‘‘The 

dialysis facility must make 

accommodations to provide for patient 

privacy when patients are examined or 

treated and body exposure is required.’’

This provision also protects those 

patients who do not wish to intrude on 

another patient’s privacy. 

Comment: Several commenters 

objected to the deletion of the 

centralized nursing monitoring station 

requirement in the proposed rule, 

formerly at § 405.2140(b)(3), as they 

believe a monitoring station is needed to 

support adequate surveillance of 

patients receiving dialysis. One 

commenter suggested that patient call 

buttons be required. Another 

commenter suggested retaining the 

concept of the nursing station 

requirement by adding the language, 

‘‘Patients should be in view of staff at 

all times during treatment to ensure 

patient safety.’’

Response: We had proposed deleting 

the centralized nursing station 

requirement in order to increase facility 

flexibility in designing the clinical area. 

Patients undergoing hemodialysis 

require surveillance and continuous 

monitoring. Without vigilant monitoring 

it is possible for a dialysis needle to 

become dislodged, which could result 

in patient death from blood loss in just 

minutes. The suggested call button 

would place responsibility on the 

patient to alert staff to a problem; 

however, we expect continual 

monitoring of the patient, which would 

make a call button unwarranted. We are 

not restoring the requirement for a 

‘‘nursing station’’ to allow maximum 

facility flexibility, but will require staff 

surveillance of in-center hemodialysis 

patients during treatment. Therefore, we 

have added a new provision at 

§ 494.60(c)(4), ‘‘Patients must be in view 

of staff during hemodialysis treatment to 

ensure patient safety (video surveillance 

will not meet this requirement).’’

Comment: We received several 

comments regarding ‘‘Emergency 

preparedness’’ at § 494.60(d). Two 

commenters objected to having specific 

types of emergencies ‘‘spelled out’’ in 

regulation while another commenter 

recommended that bioterrorism be 

added to the list of emergencies for 

which facilities would be required to be 

prepared. 

Response: In the proposed rule, the 

list of emergencies at § 494.60(d) for 

which dialysis facilities must be 

prepared ‘‘include, but are not limited 

to, fire, equipment or power failures, 

care-related emergencies, water supply 

interruption, and natural disasters likely 

to occur in the facility’s geographic 

area.’’ This list clarifies for facilities 

what types of emergencies must be 

addressed in the emergency plans. 

Facilities may prepare for many types of 

emergencies, including bioterrorism, 

which are identified as a risk after the 

performance of a facility risk 

assessment. We are retaining the 

proposed list of emergencies in this 

final rule. 

Comment: Some commenters 

concurred with the standard as 

proposed. Two commenters advocated 

for a back-up generator requirement. 

Others requested clarification of 

proposed requirement for periodic 

training of staff and patients. 

Response: The proposed emergency 

preparedness standard was designed to 

allow dialysis facilities maximum 

flexibility in meeting our requirements, 

which could include a back-up 

generator or other means of supplying 

needed power to the facility. 

As for training, our final staff training 

requirements (§ 494.60(d)(1)) state that 

the dialysis facility must ‘‘provide 

appropriate training and orientation in 

emergency preparedness to the staff. 

Staff training must be provided and 

evaluated at least annually * * *.’’ The 

regulation goes on to specify what 

topics must be included in the training 

and the patients’ instruction. The 

frequency of this training must be 

sufficient so that staff and patients are 

able to implement emergency 

procedures at any time. We are adopting 

§ 494.60(d) introductory text and 

§ 494.60(d)(1) introductory text as 

proposed. We believe this addresses the 

commenter’s concern. 

Comment: After the tragic hurricane 

events of 2005 (Hurricanes Katrina, Rita, 

and Wilma) we received some 

additional comments and 

recommendations from the national 

ESRD disaster response workgroup 

related to natural disaster preparedness, 

as these experiences led to new ‘‘lessons 

learned.’’ One recommendation was to 

add a requirement that would enable 

patients to contact their dialysis facility 

during a disaster, such as requiring each 

facility to provide an emergency tollfree phone number where patients could 

obtain critical medical information. A 

second recommendation was to include 

evacuation procedures in the disaster 

plan. A third recommendation was to 

require not only a plan, but also to 

require facilities to have a procedure in 

place to obtain back-up utilities, 

including agreements with utility 

companies for water and energy. A 

fourth suggestion was to require dialysis 

facilities to contact local disaster 

management officials at least annually, 

to ensure that local disaster aid agencies 

were aware of the dialysis facility’s 

patients’ needs in the event of an 

emergency. 

Response: The final emergency 

preparedness standard includes 

requirements for the emergency 

preparedness of staff and patients and 

addresses instructions that are provided 

to dialysis patients. We have revised 

§ 494.60(d)(1)(i)(B) to require that staff 

inform patients of where to go during an 

emergency, including evacuation 

instructions for emergencies in which 

geographic area of the dialysis facility 

must be evacuated. 

We believe it is reasonable for dialysis 

facilities to provide an alternate phone 

number if the phone is not being 

answered, and/or the facility is not 

functioning during a disaster. We have 

added this requirement at § 494.60 

(d)(1)(i)(C). This additional requirement 

reads, ‘‘This contact information must 

include an alternate emergency phone 

number for the facility for instances 

when the dialysis facility is unable to 

receive phone calls due to an emergency 

situation (unless the facility has the 

ability to forward calls to a working 

phone number under such emergency 

conditions) * * *.’’

A disaster plan must include 

procedures and processes for use in the 

event of power or water source loss, or 

a disaster that would make the dialysis 

facility inoperable. We believe that it is 

reasonable for a dialysis facility to 

establish at least annual contact with its 

local disaster management agency to 

ensure that the agency is aware of the 

dialysis facility’s needs in the event of 

an emergency. This pre-emptive contact 

could facilitate the meeting of dialysis 

patient needs during a disaster. We have 

added a new provision, codified at 

§ 494.60(d)(4)(iii), requiring the dialysis 

facility to, ‘‘Contact its local disaster 

management agency at least annually to 

ensure that such agency is aware of 

dialysis facility needs in the event of an 

emergency.’’

We did not modify the final rule in 

response to the disaster response 

workgroup’s recommendation that we 

require facilities to have a procedure in 

place to obtain back-up utilities, 

including agreements with utility 

companies for water and energy. This 

final rules requires that dialysis 

facilities develop an emergency plan 

that addresses emergency situations that 

may occur. These emergencies include 

power failure and water supply 

problems. The dialysis facility has 

flexibility in designing an emergency 

plan for these types of emergencies. The 

plan may include agreements with 

utility companies or alternative 


PWALKER on PROD1PC71 with RULES2
20386 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

interventions. We will not prescribe the 

methods that must be employed in 

responding to the various types of 

emergencies. The emergency plan must 

provide sufficient guidance to staff in 

preparing for emergencies and carrying 

out the plan. 

Comment: A few comments were 

specific to proposed § 494.60(d)(1)(iii), 

requiring the facility to ensure that 

nursing staff are properly trained in the 

use of emergency equipment and 

emergency drugs. Two commenters 

objected to such nurse training, because 

it ‘‘placed an emergency room-type 

burden on them.’’ Other commenters 

suggested that the relevant emergency 

drugs be specified, and that suction 

devices be specifically excluded from 

the definition of ‘‘emergency 

equipment.’’

Response: We believe it is reasonable 

for dialysis facility nurses to be trained 

and prepared to handle emergencies 

that are likely to occur within the 

dialysis facility, and to require the 

facility to have equipment available for 

treating these emergencies. Suction 

machines are necessary medical devices 

used to clear a patient’s airway of 

secretions or vomit. In the absence of 

these medical devices, it is possible that 

the patient’s airway could not be 

cleared. Therefore, we are not deleting 

this requirement. The specific 

emergency drugs that are to be available 

should be determined by the medical 

director and described in the facility’s 

policies and procedures. We are making 

no changes based on these comments. 

Comment: We received many 

comments regarding the proposed 

defibrillator requirement at 

§ 494.60(d)(3). The vast majority of 

commenters support inclusion of a 

defibrillator requirement, but 

recommended that an automated 

external defibrillator (AED) be an 

acceptable option. Commenters stated 

that AEDs were preferable because they 

are easy to use, more affordable, and do 

not require the extensive Advanced 

Cardiac Life Support (ACLS) training 

and certification that a non-automated 

defibrillator would require. Commenters 

did not support a defibrillator exception 

for small rural dialysis facilities, stating 

that these more remote facilities do not 

have nearby emergency medical services 

(EMS) and have a greater need for an inhouse AED. A few commenters objected 

to the defibrillator requirement because 

they saw this as an unfunded mandate. 

One commenter said defibrillators 

should only be required if Medicare 

funds them, while another dissenting 

commenter said the need for a 

defibrillator should be based on the 

facility’s proximity to EMS. The 

American Heart Association (AHA) 

commented on this issue and strongly 

supported a defibrillator requirement 

and AEDs in dialysis units, and 

suggested that AED training be 

combined with cardiopulmonary 

resuscitation training. The AHA pointed 

out that defibrillators have been shown 

to save lives in a variety of settings 

including office buildings, airplanes, 

and stadiums, where survival rates 

without AEDs are otherwise 1 percent. 

The AHA also noted that cardiac disease 

accounts for 43 percent of deaths in 

ESRD patients (United States Renal Data 

System 2003 Annual Data Report). The 

AHA recommended no exemptions for 

small, rural units but suggested a 1-year 

phase-in period for these types of 

dialysis facilities. 

Response: We received substantial 

support from commenters for requiring 

a defibrillator, specifically an AED. In 

response to comments, we will require 

a defibrillator or an automated external 

defibrillator in our ‘‘Emergency 

equipment’’ standard at § 494.60(d)(3). 

However, we are not allowing a ‘‘1-year 

phase-in period’’ for small, rural units 

as suggested by one commenter. This is 

because we believe that a small, rural 

unit is likely to be further from 

emergency services and/or ambulance 

services, and as such, we believe that 

having a defibrillator or AED on hand 

would greatly increase the chance of 

survival for a dialysis patient in the 

event of a cardiac arrest. We believe that 

facilities will have sufficient time to 

purchase a defibrillator or AED and to 

train staff, since this regulation is 

effective 180 days after publication in 

the Federal Register. 

Comment: We received many 

comments on proposed § 494.60(e) ‘‘Fire 

safety.’’ Several commenters concurred 

with the standard as proposed. We 

received many comments objecting to 

the proposed LSC provisions that 

require sprinklers and central 

monitoring systems in dialysis facilities. 

The commenters felt that LSC 

provisions should apply only to new 

facilities that are built after the effective 

date of the final rule. Several 

commenters felt that requiring the 

installation of sprinkler and a central 

monitoring system would be costly and 

burdensome. Some stated this could 

impose excessive burdens on leased 

dialysis facilities, building landlords, 

multi-story buildings and multi-tenant 

buildings, where sprinkler systems 

would need to be installed in a general 

retrofit for the entire structure. 

Commenters stated that since existing 

dialysis facilities occupied buildings 

that met the building codes in effect at 

the time of construction, they should be 

grandfathered for the 2000 LSC 

requirements, as long as State codes 

were met. 

Response: The proposed LSC 

requirements provide significantly 

greater protection to dialysis patients 

than the fire protection provisions of 

part 405, subpart U at § 405.2140(a) and 

§ 405.2140(c). Commenters objected 

most strongly to the LSC requirement 

for a sprinkler system in certain existing 

buildings. The 2000 LSC only requires 

buildings with certain structural 

configurations to have sprinkler 

systems. Specifically, 2000 LSC requires 

that only Type II (000) and ordinary 

constructed Type III (200) buildings, 

and Type V (000) buildings of two or 

more stories must be protected 

throughout by an approved, supervised 

automatic sprinkler system (2000 LSC 

section 21.1.6.3). We acknowledged in 

the proposed rule preamble that for 

some existing dialysis facilities it could 

be overly burdensome to comply with 

certain LSC requirements, and provided 

the sprinkler requirement as an example 

(70 FR 6200). We indicated that this 

could be a situation where a waiver 

might be warranted. However, the 

January 10, 2003 final rule, ‘‘Fire Safety 

Requirements for Certain Health Care 

Facilities,’’ allowed the grandfathering 

of existing facilities for the sprinkler 

systems requirement (as long as the 

facility was not undergoing 

renovations), without the imposition of 

a waiver process (68 FR 1375). Likewise, 

we will only apply the sprinkler 

provisions called for in the 2000 LSC to 

new dialysis facilities and existing 

facilities that are undergoing extensive 

renovations. Therefore, in new 

§ 494.60(e)(2), we are exempting dialysis 

facilities in operation on the effective 

date of this rule and utilizing facilities 

built before January 1, 2008 from 

installing sprinkler systems if State law 

so permits. However, no dialysis facility 

may open and/or move to a location 

without a sprinkler system after the 

effective date of this rule. All other 2000 

LSC provisions found in chapters 20 

and 21 (New and Existing Ambulatory 

Health Care Occupancies) will be 

applied to dialysis facilities, including 

the provisions regarding automatic 

notification-equipped fire detection and 

alarm systems. However, in recognition 

of the possible extra expense and time 

required to review current building 

leases and fire codes, and if necessary, 

to make changes in the building 

structure, we are allowing dialysis 

facilities 300 days after the publication 

of this final rule in the Federal Register 

to comply with the requirements found 

at § 494.60(e)(1). 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20387 

The stipulation at § 494.60(e)(4) 

regarding the waiver process for other 

provisions of the LSC has been retained 

in this final rule. A dialysis facility may 

apply for a waiver after receiving a 

notice of deficiency resulting from a 

survey by the State agency. The State 

agency will review the request and may 

seek guidance from the State fire 

marshal to make recommendations to 

the appropriate CMS Regional office. 

Our regional office will review the 

request and all associated 

documentation and make a final 

decision on the waiver. 

Comment: Several commenters asked 

why ESRD facilities would have to meet 

State and local fire codes along with 

Federal fire safety standards. Many 

commenters requested waivers or 

extensions of the implementation date 

and stated that if presented with an 

option, they would prefer to follow 

State and local fire codes in lieu of the 

Federal standards. 

Response: This final rule provides for 

a statewide waiver of any provision of 

the LSC (see § 494.60(e)(3) through 

§ 494.60(e)(4)) that would not adversely 

affect patient health and safety, if 

endorsed by State survey authorities 

and approved by CMS. Any statewide 

waiver granted would apply to both new 

and existing facilities in the state. 

Individual waivers can be requested by 

both new and existing facilities. In 

States receiving a CMS-approved LSC 

waiver, dialysis facilities will only need 

to meet State fire safety provisions. 

Additionally, we have removed our 

proposed language at § 494.60(e)(2), 

which proposed that Chapter 5 of the 

2000 edition of the LSC would not 

apply to a dialysis facility. Use of 

Chapter 5 of the LSC allows a dialysis 

facility a performance-based option for 

meeting the LSC occupant protection, 

structural integrity, and systems 

effectiveness goals and objectives. This 

change allows the design of a LSCcompliant dialysis facility building 

using a performance-based template that 

employs a computer-based 

methodology. This requirement is 

consistent with our LSC provisions for 

other provider-types and increases 

flexibility for dialysis facilities. 

Comment: One commenter suggested 

that an emergency evacuation chair 

should be required for dialysis facilities 

in multi-level buildings. 

Response: We appreciate the 

comment; however, we do not agree that 

an emergency evacuation chair should 

be required. We believe that LSC 

protections at § 494.60(e)(1) will provide 

an adequate level of safety. Dialysis 

facilities should develop a disaster 

preparedness plan as required at 

§ 494.60(d) that includes evacuation 

procedures. Facilities may choose to 

have an emergency evacuation chair if 

necessary. 

Comment: Many commenters objected 

to removing patients from dialysis 

equipment and evacuating them in 

order to comply with the fire drill 

requirement. It was felt that this 

exercise was unreasonable and 

medically unsafe. Many commenters 

preferred annual fire drills instead of 

quarterly fire drills. 

Response: We agree with the 

commenters regarding removal of 

patients during fire drills. As we 

indicated in the preamble of the 

proposed ESRD conditions for coverage 

(70 FR 6200), we are not going to require 

that patients be physically removed 

during a fire drill. Fire drills may be 

conducted using simulated patients or 

empty wheelchairs. According to the 

LSC 2000, quarterly fire drills are not 

required. Instead, section 4.7.2 of the 

LSC—Drill Frequency states, 

‘‘Emergency egress and relocation drills, 

where required by chapters 11 through 

42 or the authority having jurisdiction, 

shall be held with sufficient frequency 

to familiarize occupants with the drill 

procedure and to establish conduct of 

the drill as a matter of routine.’’

3. Subpart C—Patient Care 

a. Patients’ Rights (Proposed § 494.70) 

We proposed to update the existing 

condition for coverage at § 405.2138, 

‘‘Patients’ rights,’’ by replacing it with a 

new condition for coverage at § 494.70. 

We proposed that patients or their 

designated representatives be informed 

of their rights and responsibilities when 

beginning treatment in the facility. The 

essence of the provisions in existing 

§ 405.2138 was retained in the new 

condition for coverage under 

§ 494.70(a), ‘‘Patients’ rights.’’ In 

addition to these provisions, new 

§ 494.70(a)(6) states that patients must 

be informed about their right to have 

advance directives. Patients must also 

be informed of all modality choices, 

including home hemodialysis. The 

provision that patients must be 

informed of facility policies regarding 

patient care, including, but not limited 

to, isolation of patients, was proposed at 

§ 494.70(a)(7). We also proposed 

changes to the existing grievance 

mechanism requirements at 

§ 405.2138(e). The proposed rule would 

require facilities to inform patients of 

internal and external grievance 

processes, including how to contact the 

ESRD Network and State survey agency. 

Standard (a) also proposed that 

patients be informed that they could file 

grievances personally, anonymously, or 

through a representative, and could do 

so without reprisal or denial of services. 

We also proposed a new standard at 

494.70(b) to guarantee the patient’s right 

to be informed regarding the facility’s 

discharge, transfer, and discontinuation 

of services policies. This proposed 

standard also would have required 

facilities to provide a written notice to 

patients 30 days in advance of the 

facility terminating care, but would 

provide that in the case of immediate 

threats to the health and safety of others, 

an abbreviated discharge procedure 

could be allowed. We also proposed to 

require the facility to prominently 

display a copy of the patients’ rights in 

the facility where patients could easily 

see and read it. We proposed that this 

posted information also include up-todate State agency and ESRD Network 

telephone complaint numbers. 

The Children’s Health Act amended 

the Public Health Service Act by (among 

other things) adding a new section 591 

(Pub. L. 106–310, section 3207; 42 

U.S.C. 290ii); this section requires 

health care facilities to protect and 

promote the rights of residents to be free 

from restraint and seclusion imposed for 

purposes of discipline or convenience. 

The law applies to any ‘‘public or 

private general hospital, nursing facility, 

intermediate care facility, or any other 

health care facility that receive support 

in any form from any program 

supported in whole or in part with 

funds appropriated to any Federal 

department or agency * * *.’’ Section 

591(d)(1) of the Public Health Service 

Act defines restraint as any mechanical 

or personal restriction that immobilizes 

or reduces the ability of an individual 

to move freely or a drug or medication 

that is used as a restraint to control 

behavior or restrict freedom of 

movement. Seclusion is defined as any 

behavior control technique involving 

locked isolation, not including a time 

out. 

While we believe that section 591 of 

the Public Health Service Act applies to 

Medicare-participating dialysis 

facilities, this final rule does not address 

these specific restraint and seclusion 

provisions because these issues are 

being considered under a separate 

rulemaking. Therefore, the patient rights 

section does not contain any restraint or 

seclusion requirements at this time. 

Comment: We received many public 

comments regarding the rights of 

patients. There was overall support for 

the condition as a whole, as well as 

many recommendations and 

suggestions. 

Some commenters recommended that 

we mandate that facilities inform 


PWALKER on PROD1PC71 with RULES2
20388 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

patients of their rights at the start of care 

or within 30 days after the start of care. 

Others suggested that these rights be 

reviewed with the patient at least 

annually, or more frequently depending 

on patient need. One commenter 

suggested patient rights be reviewed 

during the first dialysis treatment and 

reviewed in detail by a social worker 

within the first month, while another 

suggested that a summary of patient 

rights would be sufficient. A number of 

commenters suggested the addition of 

language to mandate that facilities 

inform patients of facility policies, 

including discharge policies. 

Response: Patients are entitled to be 

informed of their rights at the start of 

care, meaning within the first 3 

treatments in the facility, which, we 

believe, will allow patients to exercise 

their rights and make choices regarding 

their care immediately. We are not 

prescribing the level of detail for a 

patient’s rights review, nor which 

facility staff members must perform the 

review. The facility has flexibility in 

meeting the intent of this provision, so 

long as the facility sufficiently informs 

the patient so that he or she may 

exercise his or her rights early in 

dialysis care. The professionals at the 

dialysis facility should determine the 

most appropriate time for a more 

detailed review of patient’s rights 

(including discharge policy information) 

according to individual patient’s needs. 

Patients must also be informed of 

dialysis facility discharge policies as 

required at § 494.70(b)(1), and we expect 

all information would be provided at 

one time. We believe requiring a facility 

to provide patient’s rights information 

within 3 treatments is reasonable, given 

that dialysis is normally performed 3 

times per week for approximately 3 to 

4 hours per session. 

Comment: We received several 

comments regarding possible 

misinterpretations by State surveyors as 

to what is meant by patients being 

‘‘informed’’ of facility policies. 

Response: The word ‘‘inform’’ simply 

means to communicate knowledge. We 

have not dictated the mode of 

communication. Patient rights 

information may be presented to 

patients in writing, orally, in 

audiovisual form, etc. Since the means 

by which information is communicated 

to the patient is not specified, facilities 

and their staff have the necessary 

flexibility to comply within the intent of 

the condition. Our interpretive 

guidelines for surveyors will reflect the 

intent of the final rule. 

Comment: We received several 

comments regarding discrimination and 

harassment. Some commenters 

specifically recommended that we add 

language that states patients have the 

right to be free from verbal, physical, 

sexual abuse, intimidation, and 

harassment. 

Response: The ‘‘Patients’ rights’’

condition specifies the patient’s right to 

dignity and respect. Moreover, section 

494.20 states that facilities and staff 

must comply with applicable Federal, 

State, and local laws, and these laws 

and protections apply to dialysis 

patients. Illegal acts must not be 

tolerated in dialysis facilities and 

should trigger notification of 

appropriate law enforcement officials. 

We have not expanded ‘‘Patients’

rights’’ as suggested by the commenters; 

we believe sufficient safeguards, laws, 

and regulations are already in place. 

Comment: Two commenters suggested 

additional language for the protection of 

patients’ rights and dignity. The 

commenters explained that some 

patients are disconnected from a 

dialysis machine only after being made 

to sign a ‘‘Leaving Against Medical 

Advice’’ waiver of liability, for such 

activities as using the restroom, taking 

pain medications, or eating or drinking. 

The commenters suggested that the 

‘‘Patients’ rights’’ condition include 

protection for these patients whose 

rights and dignity are being violated. 

Response: At § 494.70(a)(1) patients 

have the right to receive respect for their 

personal needs. The intent of this 

standard is that all facilities must 

respect patients and their individual 

characteristics or unique needs. For 

instance, facilities may want to develop 

policies for a variety of situations, such 

as patient restroom use during a dialysis 

session, to ensure that their patients’

rights are protected. We do not expect 

that patient signatures on liability 

waivers are necessary or appropriate in 

most cases. When a patient needs to use 

the restroom, that time should not be 

deducted from the dialysis treatment 

session. Facilities should schedule 

patients in such a way so that patients 

are not forced to give up prescribed 

services for which Medicare provides 

payment. In addition, CMS considers 

facilities that fail to schedule patients 

appropriately and thus, force patients to 

give up prescribed services, to be a 

serious matter of program integrity. 

Comment: Several commenters 

suggested that current subpart U 

regulatory language, requiring a facility 

to use translators where a significant 

number of patients exhibit language 

barriers, remain in the final rule. Two 

commenters suggested language be 

added to specify that a facility must 

make a clear, reasonable effort to 

provide information in a language the 

patient can understand and to document 

such provision in the patient’s record. 

Two commenters suggested that 

facilities be required to provide 

information in the appropriate language 

and in a culturally sensitive manner. 

Additionally, several commenters 

suggested that a facility confirm that 

patients understand the information 

they receive. 

Response: The intent of the proposed 

rule language was to provide the facility 

with flexibility in meeting the 

requirement that it provide information 

in a way the patient understands. If a 

facility needs to obtain the use of a 

translator service to provide information 

to a patient and respond to questions, 

then we expect the facility to obtain that 

service. The suggestion to add language 

that requires information to be provided 

in a culturally sensitive manner, as well 

as in the appropriate language, would be 

redundant, since this is required as part 

of § 494.70(a)(2). The information 

required to be provided under § 494.70 

would include all the information 

patients need to understand their rights 

and participate in their care if they 

choose (see § 494.70(a)(5)). 

Comment: One commenter suggested 

that specific language be added to state 

that a social worker should have the 

ability to assess a patient’s 

psychological needs in a private 

environment. 

Response: The intention of 

§ 494.70(a)(3) and § 494.70(a)(4) is that 

all facilities must respect privacy and 

confidentiality for all patients; therefore 

social worker-patient interactions that 

require privacy should be conducted in 

private. 

Comment: A number of commenters 

stated that patient participation can 

optimize care. One commenter 

suggested language to specify that 

patients and their family members 

participate in their care and training. 

Several other commenters suggested we 

state that patients have some obligation 

to take part in, and be accountable for 

their care, and that patients must be 

fully aware of and engaged in their 

course of treatment. 

Response: The ‘‘Patients’ rights’’

condition requires that patients or their 

representatives be informed about 

patient rights and responsibilities. 

Section 494.70(a)(5) states that patients 

have the right to participate in all 

aspects of care. It may be desirable that 

patients participate fully in their care; 

however, neither CMS nor a facility can 

demand full patient participation. 

Additionally, we cannot mandate the 

involvement of patient representatives 

in the care of patients. We do require 

that patients have the opportunity to 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20389 

participate in their care. Patients have 

the right to accept or decline to 

participate. 

Comment: Two commenters suggested 

that we add language to specify that a 

patient has the right to attend care 

planning meetings and that a patient 

also has the right to request a care 

conference that would include his or 

her care team members. One commenter 

stated that there was no regulatory 

language that provides that a patient has 

the right to be involved in care 

planning, and that the language only 

required the patient to be informed of 

care planning. 

Response: Patients have the right to be 

involved in their care planning as part 

of the interdisciplinary team, which is 

defined at § 494.80 and § 494.90. 

Because patients have the right to be 

part of the interdisciplinary team, they 

have the opportunity to participate in 

all aspects of care, which includes, but 

is not limited to, care planning. The 

language in the final rule allows for 

flexibility in the way a facility 

demonstrates that a patient has had 

sufficient opportunity to participate as 

part of the team. Care plan meetings or 

conference calls that allow the patient to 

call in from home would allow the 

patient to participate. The dialysis 

facility must encourage patient 

participation in care planning. 

Comment: Some commenters, 

including patients, suggested language 

be added to state that a patient has the 

right to refuse cannulation by specific 

nurses or patient care technicians 

(PCTs) if problems cannulating his or 

her access site have occurred with that 

staff member. Some patients have 

experienced situations causing them 

fear and/or discomfort due to 

cannulation by specific members of a 

facility’s staff. 

Response: Patients have the right to be 

informed of the right to refuse 

treatment, as required at § 494.70(a)(5). 

However, this final regulation includes 

new minimum qualifications for PCTs, 

who frequently cannulate patients 

during in-center hemodialysis sessions. 

Dialysis facilities will now be required 

to employ trained and certified patient 

care technicians. We have added 

‘‘proper cannulation techniques’’ as part 

of the technician training program at 

§ 494.140(e)(3)(iii). We would anticipate 

patients having less difficulty with 

cannulation due to the more stringent 

technician training requirements 

required for certification. Additionally, 

‘‘Fistula First’’ is a nationwide initiative 

that promotes the adoption of 

recommended ‘‘best practices,’’

including cannulation methods, in 

dialysis facilities. Facilities are 

encouraged to implement these 

practices, including increased selfcannulation. The initiative encourages 

self-cannulation with the appropriate 

course of training, as part of an 

emphasis on broader patient 

involvement in care. 

Comment: A number of comments 

reinforced the importance of advance 

directives. Many comments support the 

inclusion of providing advance 

directives information in the ‘‘Patients’

rights’’ condition. A few comments 

requested that the proposed advance 

directives language be strengthened by 

adding discussion of ‘‘end of life’’

options. Another commenter suggested 

the intent of the regulation text could be 

clarified further by adding language to 

require that facilities provide an 

advance directive planning process. One 

commenter remarked that patients 

should not be required to have an 

advance directive on file. Additionally, 

a few comments suggested that patients 

be educated about advance directives 

rather than just informed. 

Response: The large number of 

supportive comments regarding advance 

directives is appreciated. We believe 

that it is important to include this 

language in the final regulation for 

several reasons, not the least of which 

is that while ESRD treatment has 

prolonged life, the typical patient 

receiving dialysis treatment is often 

afflicted with multiple co-morbidities. 

We are not mandating that facilities 

discuss ‘‘end of life’’ options, requiring 

units to provide advance directives 

planning assistance, or requiring 

patients to complete advance directive 

documents. We are requiring in the final 

rule at § 494.70(a)(6) that facilities 

inform patients of their right to have 

advance directives and inform patients 

of the facility’s policies regarding 

advance directives. While the actions 

suggested by commenters might assist in 

the planning process, we believe 

requirements such as these would 

extend beyond the scope of a facility’s 

expertise and responsibility, as well as 

beyond the scope and intent of these 

regulations. Patients requiring 

assistance in advance directive 

preparation should look to the facilities’

social workers for guidance, as social 

work professionals are trained to use 

their clinical judgment to evaluate, 

provide information and make referrals 

if necessary. 

Comment: Several commenters 

suggested that we strengthen and clarify 

the advance directives language by 

adding specific requirements to the 

regulation text. One commenter 

suggested that patients be required to 

identify a preferred surrogate decisionmaker, complete an advance directive 

and durable power of attorney, as well 

as indicate the amount of leeway for 

their chosen surrogates. Another 

commenter suggested that the social 

worker be required to inform, 

encourage, and assist in completion of 

advance directives. 

Response: We appreciate the 

comments; however, we will not require 

specific professionals to be responsible 

for encouraging patients to complete 

advance directives. The dialysis facility 

staff must assess individual patient 

needs, and determine if there is a need 

for further clarification or discussion. 

They may suggest referral to a resource, 

lawyer, or other appropriate 

professionals if indicated. Some patients 

may desire to execute very detailed 

directions and advance directives while 

other patients may not. We are not 

specifying patient advance directive 

execution requirements in this final 

rule. 

Comment: Many commenters 

suggested that we require a facility to 

honor an advance directive, including 

‘‘do-not-resuscitate’’ orders. Two 

commenters suggested that the rule state 

that, if a facility could not honor the 

wishes of an advance directive, the 

facility would have to notify the patient 

and transfer patient to a facility that was 

able to honor those wishes. 

Response: The ‘‘Patients’ rights’’

section of the proposed rule would 

allow patients the right to be informed 

of their ability to execute an advance 

directive. In response to comments, we 

have added a provision stating that 

patients have the right to be informed of 

the facility’s policy regarding advance 

directives. The advance directive 

language at § 494.70(a)(5) in the 

proposed rule has been revised and 

relocated. We have redesignated 

proposed § 494.70(a)(6) through 

§ 494.70(a)(16) as § 494.70(a)(7) through 

§ 494.70(a)(17) and have added a new 

§ 494.70(a)(6) to require facilities to 

ensure that a patient is informed about 

his or her right to execute advance 

directives and the facility’s policy 

regarding advance directives. We have 

also added language to the ‘‘Medical 

records’’ condition at § 494.170(b)(2) to 

require that facilities document in the 

patient’s medical record whether or not 

an advance directive has been executed 

by the patient. The facility should 

address advance directives in their 

policies and procedures, which must be 

available to patients as required in the 

‘‘Patients’ rights’’ condition. We expect 

facilities to make patients aware of their 

policies regarding honoring properly 

executed advance directives. If a facility 

does not honor advance directives, we 


PWALKER on PROD1PC71 with RULES2
20390 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

expect it to make the patient aware of 

that policy. In addition, we believe that 

the facility should develop a protocol 

for patient transfer, if a facility does not 

intend to honor advance directives. 

Some patients will opt to be treated in 

a facility that will honor their advance 

directives. 

Comment: One commenter suggested 

there is a need for national guidelines 

for advance directives specific to 

dialysis services. 

Response: Advance directive 

guidelines developed by national 

organizations, such as the Renal 

Physicians Association (RPA) and the 

National Kidney Foundation (NKF) 

already exist. Although we will not 

require adherence to RPA and NKF 

advance directive guidelines, we 

encourage facilities to use these 

valuable resources. 

Comment: Many commenters 

concurred that information on all 

modalities should be presented to all 

patients. One commenter remarked that 

family members should also be 

presented with information on all 

modalities. Another suggested we 

require facilities to inform patients 

about all modalities at least annually. 

Response: The ‘‘Patients’ rights’’

condition at § 494.70(a)(7) requires that 

the patient or his or her representative 

be informed of patient rights, including 

information about treatment modalities 

and settings. Patients must decide what 

is in their best interest and they should 

have the flexibility to include family 

members in their decisions regarding 

dialysis modalities as they see fit. 

Patients are periodically reassessed, as 

required under the condition for patient 

assessment at § 494.80(d). The patient’s 

suitability for various dialysis 

modalities and/or transplantation are 

assessed by the interdisciplinary team, 

which may include the patient if 

desired, and reviewed with the patient 

each year. Consequently, we believe it 

would be redundant to add the 

suggested language under the ‘‘Patients’

rights’’ condition, since the requirement 

already exists elsewhere. 

Comment: One commenter suggested 

that modality options be broader to 

allow for new modalities, and that the 

facility offer an option for ‘‘no 

treatment.’’

Response: Individual patients always 

have the choice to not seek treatment. 

As indicated at proposed § 494.70(a)(5), 

patients have the right to refuse 

treatment. If an individual is a patient 

of an ESRD facility, then he or she has 

likely made the decision to treat his or 

her illness. However, the patient’s 

medical condition may change in later 

months or years and there could be a 

time when the patient decides that 

dialysis treatment is no longer 

appropriate. Therefore, in response to 

this comment, we have modified our 

requirement so that a patient must be 

informed of the right to discontinue as 

well as refuse treatment. 

Comment: One commenter suggested 

that the modality discussion include the 

offer of transplant information and 

home dialysis education. 

Response: Transplant information and 

home dialysis education are addressed 

under the condition ‘‘Patient plan of 

care.’’ The standard for patient 

education and training at § 494.90(d) 

mandates that the plan of care include 

education and training in aspects of the 

dialysis experience, dialysis 

management and transplantation, 

among other things. Since transplant 

education for patients is captured as a 

standard level requirement, it would be 

redundant to include the language in 

the ‘‘Patients’ rights’’ section. 

Comment: One commenter suggested 

that all facilities be required to offer 

home dialysis. 

Response: While it may be ideal for 

every dialysis facility to offer home 

dialysis, dialysis facilities have the 

flexibility to choose which modalities to 

offer. However, patients must be 

informed of all possible dialysis 

modalities, and where those modalities 

are offered. We have revised 

§ 494.70(a)(7) to specify that facilities 

must provide resource information 

about those modalities not offered in 

their specific facilities. In addition, 

facilities must provide information 

about alternative scheduling options for 

working patients within and outside 

their own facility. 

Comment: Many commenters 

suggested that facilities be required to 

provide information on where all 

modalities may be obtained, including 

home dialysis options. Some 

recommended that the regulation 

specify that alternate dialysis locations 

be located within 120 miles of the 

facility. 

Response: As noted above, patients 

have the right to receive resource 

information for modalities not offered in 

their facilities. The facility may wish to 

create a resource information packet or 

provide patients with an existing list 

from Medicare’s DFC Web site. This 

resource information may include 

giving the patient a handout, or the DFC 

Web site information. Doing any of 

these things would meet the 

requirement to provide the patient with 

resource information on where they may 

obtain alternate care options. Requiring 

a facility to identify dialysis options 

within a certain geographical limit 

would be a burden without benefit, as 

the suggested 120 mile radius would 

likely be too far for many patients. 

Those patients living in rural areas 

might be more accustomed to traveling 

longer distances for services than those 

residing in more urban areas and as 

such, we expect rural dialysis facilities 

would consider this and make referrals 

as appropriate. 

Comment: A few commenters 

suggested that language be added to 

state that a patient has the right to 

perform self-care after being trained. 

Additionally, a number of comments 

suggested that we add specific language 

to include self-cannulation and self-care 

to the list of modalities at § 494.70(a)(7). 

Response: Some of the comments 

received on this issue were vague, but 

we assume they generally refer to selfcannulation as an example of self-care 

that may be performed by the patient in 

the dialysis facility following training. 

Patients currently are allowed to selfcannulate upon receiving the proper 

training and demonstrating competency. 

The patient’s right to participate in 

aspects of his or her care is addressed 

at § 494.70(a)(5), and as written, is 

flexible enough to include selfcannulation as well as other forms of incenter self-care and home dialysis. 

Comment: Several commenters 

requested that language be added to 

require dialysis facilities to inform 

patients about their right to schedule 

treatments that can accommodate work 

and/or school schedules. Others 

suggested that we add language at 

proposed § 494.70(a)(7) to specify that 

patients have a right to have access to 

a work-friendly dialysis modality or 

schedule that accommodates work and/ 

or school, and if a schedule cannot be 

accommodated within that facility, the 

facility must refer the patients to 

another facility that can meet the 

patients’ needs. Additionally, another 

commenter remarked that CMS should 

not drop the existing requirement that a 

facility accommodate patients who 

work. 

Response: We believe that facilities 

should inform patients about different 

modalities, and where to obtain them. 

This allows patients to make a choice 

about what type of dialysis treatment is 

most convenient for them. Working 

patients do have the option of home 

dialysis, which may be more attractive 

because of the more flexible treatment 

schedule. Facilities generally are willing 

to work with patients who have other 

medical appointments that may affect 

their dialysis schedule. Facilities with a 

full patient census may have limited 

ability to change the dialysis schedule 

but will try to switch dialysis session 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20391 

appointments when other patients are 

agreeable. Dialysis patients who work or 

attend school should be encouraged to 

continue doing so and dialysis facilities 

should recommend the most 

appropriate modality and setting for 

dialysis. While we are not requiring a 

facility to provide every modality or 

schedule to accommodate patients’

unique schedules, we are now requiring 

that facilities inform the patient where 

such accommodations may be obtained. 

We have added new language at 

§ 494.70(a)(7), giving the patient the 

right to receive resource information 

about dialysis modalities not offered by 

that facility, including alternative 

scheduling options for working patients. 

Accommodations for working patients 

may include, for example, home 

hemodialysis, peritoneal dialysis, or 

extended facility hours. 

Comment: One commenter objected to 

the proposal that facilities be required to 

fully inform all patients about isolation, 

stating that the regulation should ensure 

that patients have access to policies but 

not require all policies be provided to 

all patients. 

Response: This requirement is not a 

new mandate, but has been retained 

from part 405, subpart U, the ESRD 

Conditions for Coverage. Open 

communication between the facility 

staff and the patient, as well as patient 

access to information, are both 

important for enhancing the patient’s 

participation in his or her care; this 

requirement will remain in the final 

rule. 

Comment: Two commenters 

recommended that the facility inform 

the patient about the health and safety 

risks involved in reusing dialyzers, 

provide accurate reuse data, provide the 

patient with treatment options other 

than reuse, and notify the patient that 

reuse is a patient choice. Another 

commenter stated that patients should 

have the right to decline reuse and 

receive single use dialyzers in a facility. 

One commenter questioned whether 

there should be a reuse consent form, 

while another asked how patient choice 

would be protected. 

Response: Reuse is a safe practice 

when performed correctly. Reuse 

language at proposed § 494.50 was 

retained from existing regulation and 

now requires ESRD facilities reusing 

hemodialyzers to meet the new 

guidelines and standards adopted by 

AAMI. Additionally, section 1881(f)(7) 

of the Act directly addresses dialyzer 

reuse. Reuse is a care decision that is to 

be made between the patient and his or 

her physician. Patients also have the 

option to seek treatment in a facility that 

exclusively uses new dialyzers. 

Comment: One commenter suggested 

deletion of the requirement that 

facilities inform patients of their own 

medical status. Another suggested that 

we add broader language in the 

regulation text, which would allow 

physicians, nephrologists, nurse 

practitioners or physician assistants to 

provide patients with their own medical 

information. 

Response: Providing the patient with 

his or her medical information is an 

existing requirement and is found at 

§ 405.2138(a)(3). The commenter 

provided no rationale for the deletion of 

this standard language and thus, the 

language has been retained. We have 

added the nurse practitioner, clinical 

nurse specialist and/or physician’s 

assistant treating the patient for ESRD to 

the list of authorized personnel at 

§ 494.70(a)(10), which now states that 

patients have the right to be informed by 

the physician, nurse practitioner, 

clinical nurse specialist, or physician’s 

assistant treating the patient for ESRD of 

his or her own medical status as 

documented in his or her medical 

record, unless the medical record 

contains a documented 

contraindication. Individual facilities 

may determine policies and procedures, 

in accordance with the State Boards of 

Practice, regarding the practice of 

advance practice nurses and PAs in the 

facility. 

Comment: A commenter objected to 

the requirement that facilities fully 

inform patients about charges not 

covered by Medicare. Another 

commenter suggested that trained and 

informed staff should explain noncovered charges. 

Response: The intent of the existing 

subpart U language at § 405.2138(a)(2) 

was carried over into the proposed 

language at § 494.70(a)(10), now 

redesignated as § 494.70(a)(11) in this 

final rule, which requires facilities to 

tell patients what services are available 

in the facility, and inform them of 

charges for services not covered under 

Medicare. Additionally, if a facility 

plans to bill a patient for items and/or 

services which are usually covered by 

Medicare, but which may not be 

considered reasonable and necessary for 

a particular situation (according to 

section 1862 of the Act), an advanced 

beneficiary notice must be given 

pursuant to section 1879 of the Act. 

Comment: A few commenters 

suggested that regulatory language 

require that patients be given access to 

social work and psychological services, 

psychosocial counseling, and 

nutritional counseling. Some 

commenters suggested that language be 

added to the ‘‘Patients’ rights’’ condition 

that specifies that patients would have 

access to, and receive counseling from, 

a qualified social worker and a dietitian. 

Some commenters recommended that 

patients have the right to receive a 

referral for mental health services, 

physical or occupational therapy and/or 

vocational rehabilitation, as needed. 

Another commenter suggested the 

addition of language that would 

stipulate that patients would have the 

right to receive necessary services, as 

authorized by their insurance plan. 

Response: The ‘‘Patient assessment’’

and the ‘‘Patient plan of care’’

conditions for coverage (§ 494.80 and 

§ 494.90, respectively), require input by 

an interdisciplinary team. This team of 

professionals includes, at minimum, a 

registered nurse, physician, social 

worker and dietitian. The team is 

responsible for properly assessing and 

treating the patient, which would 

include identifying additional treatment 

needs, such as psychosocial counseling, 

etc. Therefore, we believe that 

expanding the language at 

§ 494.70(a)(12) to include social work 

and psychological services, 

psychosocial counseling and nutritional 

counseling, as suggested by these public 

comments, would be redundant under 

the final rule. Under the final rule, 

following the comprehensive 

assessment required at § 494.80, a plan 

of care for each patient must be 

implemented, which must include care 

and services deemed necessary by the 

interdisciplinary team. The 

requirements for the provision of 

services under the ‘‘Plan of care’’

condition at § 494.90, do include 

nutritional and social services, such as 

psychosocial and nutritional 

counseling. Furthermore, the ‘‘Patients’

rights’’ condition at § 494.70(a)(11) 

requires facilities to inform patients of 

their right to be informed of services 

available in the facility and the charges 

for services not covered under 

Medicare. At § 494.70(a)(12), patients 

have the right to receive the necessary 

services outlined in the patient plan of 

care. Therefore, we believe the concerns 

of commenters are adequately addressed 

at § 494.70, § 494.80 and § 494.90. 

Comment: Some commenters 

suggested adding language to specify 

that facilities must inform patients of 

their responsibilities, including 

punctuality, following dietary/fluid 

restrictions, following treatment 

regimens, exhibiting appropriate 

personal behavior, informing the team 

of scheduling problems, and issues in 

filling prescriptions. Other commenters 

stated that facilities should inform 

patients that the patients have a 

responsibility to listen and ask 


PWALKER on PROD1PC71 with RULES2
20392 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

questions when they do not fully 

understand their rights or 

responsibilities. Another commenter 

stated that CMS should clarify patient 

responsibilities in the standard for 

patient rights. 

Response: Patient responsibilities are 

addressed at § 494.70(a)(13). We have 

retained the existing requirement found 

at § 405.2138(a)(1), which states that 

patients must be informed of the rules 

and expectations of the facility 

regarding patient conduct and 

responsibilities. The proposed language 

has been retained in the final rule. It is 

essential to recognize that positive 

patient behavior may be encouraged but 

cannot be regulated. 

Comment: One commenter suggested 

that we add regulatory language to 

clarify that there needs to be a balance 

between providers’ duties and patient 

rights. 

Response: Proposed section 

494.70(a)(12), now § 494.70(a)(13) of 

this final rule, requires that the dialysis 

facility inform patients of their rights, 

including rules and expectations 

regarding patient conduct and 

responsibilities. Moreover, facilities 

must protect and provide for the 

exercise of patient rights. Informing 

patients of their responsibilities 

promotes and supports patient 

involvement in their care. We will not 

attempt to address unique individual 

situations in this regulation, but we 

expect that while facility staff informs 

patients of their rights and 

responsibilities, we also expect patients 

to try to adhere to facility rules and 

guidance from facility staff, which 

would help patients maintain optimal 

health while receiving facility services. 

Comment: We received many 

comments in support of more patientprotection requirements regarding 

facility internal grievance processes. 

Commenters supported the proposed 

requirement for facilities to post 

information on how to file a grievance. 

Some commenters specifically 

supported requiring the posting of 

Network and State Agency phone 

numbers and/or mailing addresses. 

Response: We agree that it would be 

in the best interest of patients that 

Network and State Agency mailing 

addresses and phone numbers be 

posted. Posting the additional patient 

rights information will not be a 

significant burden upon facilities. We 

have revised § 494.70(c) to include 

‘‘mailing addresses.’’

Comment: One commenter suggested 

that CMS establish a separate definition 

of ‘‘grievance.’’ Another remarked that 

the term ‘‘grievance’’ should always be 

used carefully and with full 

understanding of its seriousness. One 

commenter suggested that facilities be 

required to review the grievance process 

with patients on a regular basis. One 

commenter suggested adding language 

requiring a facility to ‘‘attempt to 

resolve’’ grievances. 

Response: We appreciate the 

comment, as well as the suggestions 

regarding the grievance procedure. We 

believe the term ‘‘grievance’’ is a 

commonly understood term and we did 

not receive substantial public comment 

indicating this to be a particularly 

difficult concept to understand within 

the renal community. We disagree with 

the commenter and have not added a 

definition for the term ‘‘grievance’’ in 

the ‘‘Patients’ rights’’ condition at 

§ 494.70. Whether patients use the term 

‘‘complaint’’ or ‘‘grievance,’’ they have 

the right to be informed of and use 

established internal and external 

grievance procedures. The proposed 

language was added to inform patients 

about external mechanisms for filing a 

grievance and how to contact the ESRD 

Network and State survey agency; the 

language strengthens the existing 

requirements. We believe that it is 

imperative that all patients be made 

aware of every grievance option 

available to them. Mandating regular 

review of patient rights information 

with patients, we believe, would be an 

unnecessary burden since patient rights 

information must be prominently 

displayed within the dialysis facility, as 

required at § 494.70(c), and is thus 

available for review at any time. We 

expect that the internal facility 

grievance procedures would aim to 

resolve patient grievances. The 

provision at § 494.180(e) requires 

facility-level internal grievance 

processes. 

Comment: One commenter sought 

clarification of the phrase 

‘‘appropriateness of discharge.’’ Another 

commenter suggested that the final rule 

clarify what we meant by stating that we 

would ‘‘hold the facility responsible’’

for ensuring that patients were notified 

about their rights. 

Response: The phrase 

‘‘appropriateness of discharge’’ did not 

appear in the proposed rule text; 

however, clarification may be found in 

the ‘‘Governance’’ condition at 

§ 494.180, which does address the 

discharge procedure. This section 

specifies the acceptable circumstances 

for an involuntary discharge or transfer 

of a patient, as well as the required 

actions that must be completed by the 

interdisciplinary team prior to ceasing 

treatment within the facility. Regarding 

our intentions regarding the facility’s 

involuntary discharge responsibilities at 

§ 494.180(f), facilities are required to 

inform patients of their rights and 

protect patients’ rights; in the event a 

facility fails to do so, the facility will be 

cited as being out of compliance during 

a survey. In addition to the provision at 

§ 494.180(f), patients also have the 

‘‘right to be informed of the facility’s 

policies for transfer, routine or 

involuntary discharge, and 

discontinuation of services to patients’’

at § 494.70(b). 

Comment: Some commenters 

recommended the addition of language 

that would require facilities to provide 

information on topical analgesics for 

needle pain. 

Response: Facilities have the 

flexibility to inform patients about 

topical analgesics. We do not believe 

this should be a regulatory requirement. 

We are not adopting this 

recommendation. 

Comment: A commenter remarked on 

the issue of disruptive and challenging 

dialysis patients and indicated that 

there is existing case law regarding this 

topic, illustrating the inability of the law 

to assist the abandoned patient who 

manifests extreme non-compliance. The 

commenter specifically cited Payton v. 

Weaver, 131 Cal. App. 3d 38, 182 Cal. 

Rptr. 225 (1982), and Brown v. Bower, 

No. J86–0759(B) (S.D. Miss., Dec. 21, 

1987). Another commenter suggested 

the addition of language to specify that 

patients have a right to receive 

counseling and support from the team 

in order to resolve behavioral issues and 

be informed of appropriate/ 

inappropriate behaviors, prior to being 

discharged from a dialysis facility. 

There were a large number of comments 

regarding discharge policies within the 

dialysis facility. Some comments 

supported a 30-day notice for 

involuntary discharge. Several other 

comments supported the proposed 

involuntary discharge guidelines 

regarding an immediate threat. Many 

commenters suggested the addition of 

language to specify that patients could 

not be involuntarily discharged for 

noncompliant behaviors/non-adherence 

to medical regimens. A few comments 

supported the waiver of discharge 

policies and procedures in the face of an 

‘‘immediate threat.’’

Response: We appreciate the 

comments regarding involuntary 

discharge. While we appreciate the 

comment regarding Payton v. Weaver 

and Brown v. Bower, the cases cited do 

not appear to be applicable to this 

rulemaking. Patients are to be reassessed 

by the interdisciplinary team, including 

a Master’s degree social worker (MSW) 

at least monthly when a patient exhibits 

significant changes in psychosocial 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20393 

needs (as required at § 494.80(d)(2)(iii)), 

manifested by, for example, issues such 

as disruptive behavior, that could result 

in discharge. In § 494.180(f), we are 

requiring facilities to have discharge 

policies and to manage involuntary 

discharge issues according to facility 

protocols. Language at § 494.180(f)(4)(i) 

through § 494.180(f)(4)(v) responds to 

the ‘‘disruptive’’ or ‘‘challenging’’

patient issue. We have also added 

language to § 494.70(b)(1) in response to 

comments, to clarify that patients must 

be informed of routine as well as 

involuntary discharge policies. As 

stated in the proposed rule preamble, 

we do not expect that a patient should 

be involuntarily discharged from a 

dialysis facility merely for failure to 

follow the instructions of a facility staff 

member. However, we recognize it may 

be necessary to discharge a disruptive 

patient in order to protect the rights and 

safety of other patients and staff in the 

facility. If, for instance, a patient 

physically harms or threatens other 

patients and/or staff, brings weapons or 

illegal drugs into a facility, or verbally 

abuses and disrupts the facility to a 

degree that the facility is unable to 

operate effectively, then the 30-day 

discharge notice policy could be 

abbreviated pursuant to § 494.180(f)(5). 

This issue is further discussed later in 

this preamble under the ‘‘Governance’’

condition. 

Comment: One commenter noted that 

some facilities already have policies in 

place regarding discharge and transfer 

policies as well as policies regarding 

patient conduct, and questioned 

whether federal requirements were 

needed. 

Response: We are aware that some 

facilities already have policies in place 

regarding discharge and transfer of 

patients. Many of these facilities have 

established protocols regarding how 

staff must deal with patient conduct. It 

is not our intent to create more 

prescriptive requirements in this area, 

but to ensure that all dialysis facilities 

review any established documentation 

and policies to make certain they meet 

the minimum discharge and transfer 

requirements set forth at § 494.180(f). 

Comment: Two commenters 

recommended that we delete the phrase 

‘‘reducing or terminating ongoing care.’’

The concern was that the phrase was too 

indefinite. 

Response: We agree that the wording 

in the proposed rule was unclear. 

Therefore we have modified 

§ 494.70(b)(2) to require that patients 

receive written notice 30 days in 

advance of an involuntary discharge 

following the procedures described in 

§ 494.180(f)(4)(i). 

Comment: One commenter 

recommended that we require posted 

patient rights to be written in English at 

a 7th to 9th grade level and translated 

into a patient’s native language if 

possible. Many other comments 

suggested that we require facilities to 

have an ‘‘alternate method’’ to inform 

patients who cannot read posted 

information. 

Response: The concerns raised in 

these comments have already been 

addressed at § 494.70(a)(2). The 

‘‘Patients’ rights’’ condition requires 

that all patients receive information in 

a way they can understand. Facilities 

have the flexibility to provide 

information to patients in the most 

appropriate manner based upon patient 

needs. The qualified professionals at the 

facility are capable of evaluating an 

individual patient’s level of 

understanding and making a 

determination regarding the needs of 

that patient. We have retained the 

proposed language. 

Comment: One commenter suggested 

that the criteria for transplantation be 

posted at the dialysis facility along with 

a copy of the patient rights, which we 

proposed at 494.70(c). 

Response: Dialysis facilities have the 

flexibility to post transplant criteria 

within the facility. At § 494.70(a)(7), it 

is required that patients be informed 

about transplantation as a modality. 

Additionally, the ‘‘Plan of care’’

condition at § 494.90(d) of this final rule 

requires that patients and caregivers be 

provided with education and training 

on several topics, including 

transplantation. These requirements 

will provide patients and their 

caregivers with increased awareness of 

transplantation. 

Comment: A commenter suggested 

that we add language that would 

specifically state that patients have the 

right to know the identity of their 

facility caregivers and the nature of their 

credentials. Another commenter 

suggested that facility staff be required 

to wear nametags. 

Response: The issue of staff nametags 

should be addressed in facility-level 

policies and procedures. While it is 

desirable for staff to wear nametags, we 

would like to allow flexibility within 

this health and safety regulation. We 

would expect that facility staff 

introduce themselves; however, we do 

not believe that it is necessary or 

appropriate to add this prescriptive 

requirement to this final rule. 

Comment: One commenter 

recommended that CMS use an 

ombudsman to build relationships with 

ESRD patients and their families. 

Response: Section 923 of the 

Medicare Prescription Drug 

Improvement and Modernization Act of 

2003 (Pub.L. 108–173)(MMA), 

mandated the creation of the Medicare 

Beneficiary Ombudsman in section 

1808(c) of the Act, to ensure that people 

with Medicare get the information and 

help they need to understand their 

Medicare options and to apply their 

rights and protections. A Medicare 

Beneficiary Ombudsman Open Door 

Forum has been established to provide 

an opportunity for beneficiaries, their 

caregivers and advocates, to publicly 

interact with the Medicare Beneficiary 

Ombudsman to discuss issues and 

concerns regarding ways to improve the 

systems and processes within the 

Medicare program. Information on the 

Office of the Medicare Ombudsman may 

be found at http://www.cms.hhs.gov/ 

center/ombudsman.asp. 

Comment: One commenter suggested 

that the language in the final rule 

include some mention of senile 

dementia and how it relates to consent 

forms. 

Response: Dialysis facilities employ 

professionals who must assess whether 

a patient is competent to make medical 

decisions and assess patients’ mental 

capacities in general. This issue is 

present across provider settings and we 

do not believe it is appropriate to 

implement a new provision of this 

nature within these conditions for 

coverage. Facilities may wish to address 

such issues and concerns in their own 

policies. 

b. Patient Assessment (Proposed 

§ 494.80) 

We proposed to add a ‘‘Patient 

assessment’’ condition for coverage at 

§ 494.80 that would make the ESRD 

facility, through the patient’s 

interdisciplinary team, responsible for 

providing each patient with an 

individualized and comprehensive 

assessment of his or her needs. This 

condition would define the 

interdisciplinary team to include, at 

minimum, the patient (or patient 

designee), a registered nurse, a 

physician, a qualified social worker, and 

a registered dietitian. The proposed rule 

would expand the existing requirements 

to specify the criteria that a facility must 

include in a comprehensive patient 

assessment. We believe that these 

criteria would be necessary in order to 

develop a specialized care plan that is 

based upon the nature of the patient’s 

illness, the treatment prescribed, and 

patient needs. The frequency of patient 

assessment was also addressed in the 

proposed rule. We proposed that the 

facility conduct an initial 


PWALKER on PROD1PC71 with RULES2
20394 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

comprehensive assessment within 20 

calendar days of the first treatment and 

that the facility conduct a follow up 

comprehensive assessment within 3 

months after the completion of the 

initial assessment. We also proposed 

that the facility assess the adequacy of 

the treatment prescription at least 

monthly for hemodialysis and at least 

every 4 months for peritoneal dialysis. 

Finally, we proposed patient 

reassessment timeframes for both stable 

and unstable patients. We proposed that 

the facility perform comprehensive 

assessments at least annually when the 

patient is stable; if unstable, the facility 

must reassess monthly. In addition, the 

proposed rule also added criteria to 

specify which patients would be 

considered to be unstable. 

We received more than 100 comments 

regarding the ‘‘Patient assessment’’

condition at § 494.80. Many commenters 

supported the condition as proposed, 

while others supported the condition 

with minor revisions. 

Comment: A few commenters 

recommended we subsume standards 

(b), (c) and (d) of proposed § 494.80 

‘‘Patient assessment’’ condition into the 

‘‘Patient plan of care’’ condition at 

§ 494.90 and delete the assessment 

criteria at § 494.80(a). Some commenters 

opposed the assessment criteria at 

standard (a), stating that it was 

unnecessary to require assessment 

criteria because assessments using such 

criteria are already being performed in 

their facilities. 

Response: We appreciate the support 

for § 494.80 ‘‘Patient assessment.’’ We 

purposely linked the ‘‘Patient 

assessment’’ and ‘‘Patient plan of care’’

requirements, as evidenced by the 

inclusion of both under subpart C 

‘‘Patient care.’’ The ‘‘Patient 

assessment’’ condition provides a set of 

criteria for the evaluation of all ESRD 

patients. The condition promotes an 

interdisciplinary approach to evaluating 

and treating patients in order to achieve 

better outcomes. Measuring patient 

outcomes of care is our goal, and 

outcome measures are inherently linked 

to patient assessment tools. It is possible 

that these dialysis patient assessment 

criteria will lead to the development of 

a standardized assessment tool, which 

we hope that facilities would use in the 

future to meet QAPI requirements. We 

expect that quality-oriented facilities 

already are performing comprehensive 

patient assessments that meet these new 

conditions. 

We are retaining the proposed 

condition for coverage in the final rule. 

A large number of commenters agreed 

that a comprehensive patient 

assessment for each patient is critical to 

developing an appropriate plan of care. 

The assessment criteria required at 

§ 494.80(a) are necessary to ensure 

consistent assessments for all patients, 

ensuring that all important assessment 

areas are addressed for every patient. 

The comprehensive assessment is the 

tool used to develop a plan of care based 

upon patient needs. In addition, the 

comprehensive assessment criteria 

promote less fragmented care and will 

assist the facility’s QAPI program as a 

clinical data source. 

Comment: Two commenters suggested 

CMS mandate that a physician or an RN 

conduct the patient assessment. Other 

commenters suggested the final rule 

allow nurse practitioners and 

physician’s assistants to conduct the 

physician portion of the assessment. 

Response: The interdisciplinary team 

must include a physician and a 

registered nurse, and these individuals 

are responsible, along with other team 

members identified at § 494.80, for 

providing each patient with an 

individualized and comprehensive 

assessment. This final rule retains the 

proposed requirement at § 494.80 

regarding the composition of the 

interdisciplinary team. We expect every 

patient to be assessed by the 

interdisciplinary team physician or 

‘‘physician extender’’ (that is, a nurse 

practitioner, clinical nurse specialist, or 

a physician assistant (PA)), if a state 

practice act allows such physician 

extenders to conduct the physician 

portion of the patient assessment. 

Although a physician extender may 

conduct an assessment in some states, 

the physician providing ESRD care must 

participate in the assessment by 

reviewing and approving the 

assessment. 

Comment: A few commenters 

recommended the addition of the term 

‘‘qualified,’’ when referring to the social 

worker, and the term ‘‘registered,’’ when 

referring to the dietitian, who are 

members of the interdisciplinary team 

as required in the first paragraph at 

§ 494.80. 

Response: The dietitian and social 

worker specified under the ‘‘Patient 

assessment’’ and ‘‘Patient plan of care’’

conditions must possess the 

professional qualifications set forth at 

§ 494.140(c) and § 494.140(d), 

respectively. We do not agree with the 

commenters that further clarification is 

necessary regarding the qualifications of 

the interdisciplinary team members. 

However, to further clarify the dietitian 

and social worker duties required in the 

‘‘Patient assessment’’ condition, we 

have modified § 494.80(a)(6) to require 

that the assessment include evaluation 

of nutritional status by a dietitian, and 

modified § 494.80(a)(7) to require the 

assessment to include evaluation of 

psychosocial needs by a social worker. 

Comment: Two commenters suggested 

that we specify in the final rule that the 

interdisciplinary team’s nephrologist 

must be the facility medical director or 

treating nephrologist. The commenters 

were concerned that the proposed 

phrase at § 494.80, which would require 

‘‘a nephrologist or the physician treating 

the patient for ESRD’’ to be a member 

of the interdisciplinary team was 

unclear. Commenters suggested that this 

phrase could mean that any 

nephrologist, not necessarily a 

nephrologist treating the patient, could 

participate on the interdisciplinary 

team. 

Response: Because the public may 

interpret the proposed language to mean 

that any nephrologist may participate on 

the interdisciplinary team, as opposed 

to the patient’s treating nephrologist, we 

have modified the introductory 

paragraph at § 494.80 to include ‘‘the 

physician treating the patient’’ and 

removed our reference to the 

nephrologists, since the term 

‘‘physician’’ includes nephrologists. 

Comment: A few commenters 

suggested clarification regarding the 

patient participation on the 

interdisciplinary team. The suggested 

modification was ‘‘the patient or the 

patient’s designee (if the patient 

chooses)’’ in order to clarify that the 

patient not only has the choice to 

participate, but also has the choice to 

have a designee participate as part of the 

interdisciplinary team. Another 

commenter suggested that facilities be 

required to document patient 

participation and the reasons patients 

do not participate on the 

interdisciplinary team. 

Response: Patients have the right to be 

informed about and participate, if 

desired, in all aspects of care, as 

required in the ‘‘Patients’ Rights’’

condition at § 494.70(a)(5). The ‘‘Patient 

assessment’’ condition at § 494.80 states 

that the interdisciplinary team includes 

the patient or a patient designee if 

chosen by the patient. Patients must 

have the option to participate in the 

facility’s interdisciplinary team. 

Conversely, the patient has the right not 

to participate or to designate another 

individual to participate on his or her 

behalf on the interdisciplinary team. 

Although patient participation on the 

interdisciplinary team is important and 

should be encouraged, we do not want 

to mandate patient participation. We 

have modified the provision at § 494.80, 

which proposed to require that the 

facility provide every patient the 

opportunity to participate with the 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20395 

interdisciplinary team. The modified 

language in the first paragraph of 

§ 494.80 clarifies that the patient may 

choose whether he or she wants to 

identify a designee to participate in the 

interdisciplinary team. 

We note that the facility must 

demonstrate that the patient has been 

provided the opportunity to participate 

in the interdisciplinary team. The 

facility may develop policies and 

procedures regarding standard 

documentation of patient participation 

and may document the reasons for 

patient non-participation. If, for 

instance, a facility has a low level of 

patient participation in the 

interdisciplinary team, the facility may 

choose to document and monitor 

reasons for patient non-participation as 

part of a quality assessment and 

performance improvement plan. 

Comment: We received two comments 

that suggested that the final rule specify 

that individual assessments be 

conducted by all members of the 

interdisciplinary team. Additionally, the 

commenters requested that the final rule 

clarify that face-to-face meetings 

between the patient and the 

interdisciplinary team would be 

required. Another commenter 

recommended that we eliminate team 

assessment altogether and only require 

use of individual assessments by each 

discipline. 

Response: The entire interdisciplinary 

team is responsible for ensuring that 

each patient is individually assessed 

and his or her needs identified, as 

required at § 494.80. We agree that in 

order to conduct a clinical assessment, 

the patient must have face-to-face 

contact with the other interdisciplinary 

team members. We expect all 

professional members of the 

interdisciplinary team to complete the 

portions of the comprehensive patient 

assessment that are within their 

respective scopes of practice. It is not 

necessary for each professional team 

member to individually complete the 

entire comprehensive assessment and 

thereby duplicate efforts. Professional 

interdisciplinary team members might 

choose to conduct one-on-one 

interviews with patients to complete the 

assessments. The team may also opt to 

set up team meetings, which would 

include the patient, in order to collect 

the appropriate assessment information. 

We expect facilities to determine the 

best way to manage this process, and 

create policies and procedures to 

accurately and effectively collect patient 

assessment information. The assessment 

information is used to develop the 

patient’s treatment plan and 

expectations for care, and thus it is 

critical for the members of the 

interdisciplinary team to participate. 

Comment: One commenter 

recommended that the final rule be 

modified to include advance directive 

planning as part of the patient 

assessment at § 494.80(a). 

Response: Patients are entitled to be 

informed about their right to have an 

advance directive, as required at 

§ 494.70(a)(6). Additionally, if a patient 

has an advance directive, this 

information must be recorded in his or 

her medical record, as required at 

§ 494.170(b)(2). In some cases, it may be 

appropriate for a patient to be assessed 

for advance directives and facilities 

should use their professional judgment 

to evaluate and determine if such an 

assessment is appropriate. We are not 

requiring advance directive planning as 

part of the patient assessment, but are 

allowing facilities the flexibility to 

include it in the patient assessment 

when deemed appropriate. 

Comment: We received a comment 

recommending that language be added 

to the final rule to ‘‘allow the Secretary 

to modify or update these ‘elements’

with new technology and knowledge.’’

Response: We believe the commenter 

is referring to the assessment criteria 

found at § 494.80(a), and we also believe 

the commenter would like to see 

language that allows for updates 

without rulemaking. We have not 

modified this final rule to allow for 

automatic updates for assessment 

criteria because the Administrative 

Procedure Act (APA) requires 

rulemaking with public notice and 

comment if and when new regulatory 

requirements are proposed. 

Comment: One commenter suggested 

the final rule at § 494.80(a)(1) be 

modified specifically to include chest 

auscultation, visual observance, 

gastrointestinal evaluation, access site 

evaluation, and patient symptoms 

between treatments as part of the 

evaluation of current health status and 

medical condition. 

Response: Professional standards of 

practice require clinicians to perform 

appropriate clinical assessments and 

use their clinical judgment when caring 

for patients. The expectation is that 

these standards of practice will be 

employed by all clinicians. We have 

retained the proposed language at 

§ 494.80(a)(1). Evaluation of current 

health status and medical condition, 

including co-morbid conditions, would 

include the techniques, specific 

evaluations and symptoms 

recommended by the commenter. 

Comment: A few commenters 

recommended that the final rule include 

an assessment criterion for 

cardiovascular disease. 

Response: Dialysis patients are at risk 

for cardiovascular disease, which is 

affected not only by individual risk 

factors, but also by renal bone disease, 

blood pressure and fluid management. 

These patients may have a number of 

co-morbid conditions and this final rule 

requires the interdisciplinary team to 

assess the patient’s medical history, 

including any co-morbid conditions 

(§ 494.80(a)(1)). Since cardiovascular 

disease is a co-morbid condition we 

expect it would be assessed as 

appropriate for individual patients in 

order to comply with § 494.80(a)(1). 

Comment: It was recommended by 

one commenter that ‘‘intradialytic 

symptom frequency, causes, prevention, 

and tracking symptoms’’ be added to 

this condition as new assessment 

criteria. Another commenter suggested 

that dialysis adequacy be specifically 

referenced in the assessment criteria. 

Response: Patients must be assessed 

for the appropriateness of the dialysis 

prescription, blood pressure and fluid 

management at § 494.80(a)(2), which 

encompasses intradialytic symptoms 

and issues, such as cramping, as well as 

dialysis adequacy. 

Comment: Many commenters 

suggested minor edits to the ‘‘Patient 

assessment’’ condition, but concurred 

with the condition as a whole and 

agreed with our belief that systematic 

patient assessment is essential to 

improving quality of care and patient 

outcomes. We received a comment from 

the Safe and Timely Immunization 

Coalition (STIC), which is facilitated by 

the Southeastern Kidney Council, Inc. 

(ESRD Network 6). This comment 

presented the benefits of immunization 

including prevention of illness and 

hospitalizations. The commenter stated 

that immunization is one of the most 

cost effective strategies to prevent 

unnecessary hospitalizations and 

deaths, and that immunization is 

currently a Government Performance 

and Results Act of 1993 (Pub. L. 103–

62 (1993)) and Healthy People 2010 

goal. According to the commenter, the 

current rates of immunizations for 

influenza, pneumococcal and hepatitis 

B immunizations nationwide are lower 

than 50 percent. STIC recommended 

adding influenza, pneumococcal, and 

hepatitis requirements to this final rule. 

The suggested requirements are 

consistent with the immunization 

requirements for long-term care 

facilities. The recommended provisions 

address: (1) The offering of influenza, 

pneumococcal and hepatitis B 

immunizations to the patient (or legal 

representative) at appropriate times and 


PWALKER on PROD1PC71 with RULES2
20396 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

frequencies; (2) a process for patient 

immunization refusal; and (3) 

documentation parameters. 

Response: We agree with commenters 

that the systematic approach to patient 

assessment is essential for improving 

quality of care and patient outcomes. 

We appreciate the work of STIC and 

their recommendations for specific 

immunization requirements. In order to 

promote the immunization initiative 

and the ongoing cooperative effort 

between CMS and the dialysis industry 

to screen patients for their 

immunization needs, we have modified 

the final rule at § 494.80(a)(3) to include 

immunization history as part of the 

assessment criteria. We believe it is 

reasonable for facilities to include 

immunization history as part of the 

comprehensive assessment at least 

annually so that immunization needs 

may be identified. However, we have 

not added the extensive provisions 

recommended by the commenter. If we 

determine that further immunization 

requirements are warranted, we will 

undertake rulemaking at a future date 

and provide the public the opportunity 

to comment on any new proposed 

provisions. 

Comment: One commenter 

recommended that erythropoietin not be 

specifically referenced in the ‘‘Patient 

assessment’’ condition in the final rule, 

so as not to limit the use of other 

erythropoiesis-stimulating drugs. 

Response: We agree with the 

commenter and in order to allow 

flexibility for other medications that 

stimulate erythropoietin, as well as new 

developments in the future, we have 

modified the final rule to eliminate 

specific references to erythropoietin, 

and instead will use the term 

erythropoiesis-stimulating agent(s).’’

The new language at § 494.80(a)(4) 

reads: ‘‘including administration of 

erythropoiesis-stimulating agent(s).’’

Comment: We received several 

comments suggesting that bone disease 

be retained and added to the assessment 

criteria in the final rule. 

Response: The proposed rule 

included bone disease as part of the 

assessment criteria. The final rule will 

retain the language at § 494.80(a)(5), 

which reads: ‘‘Evaluation of factors 

associated with renal bone disease.’’

Comment: We received several 

comments regarding the evaluation of 

nutritional status, which is required as 

part of the comprehensive patient 

assessment. Two commenters suggested 

we modify the final rule to add more 

specificity regarding nutritional status, 

suggesting the use of K/DOQI 

guidelines, to insure uniformity in 

assessment. One commenter suggested 

that serum albumin not be used as a sole 

indicator and another commenter 

suggested specific nutritional 

parameters for growth assessment for 

pediatric patients be added to the final 

rule. 

Response: The K/DOQI guidelines are 

clinical practice guidelines developed 

by the NKF via a technical expert 

workgroup and consensus process 

(http://www.kidney.org/ 

PROFESSIONALS/kdoqi/ 

guidelines.cfm). In order to allow for 

flexibility and professional clinical 

judgment we are not adding specific 

criteria to the evaluation of nutritional 

status requirement in this final rule at 

§ 494.80(a)(6). We discuss ‘‘nutrition’’

and nutritional indicators under the 

‘‘Patient plan of care’’ (§ 494.90(a)(2)) 

condition discussion in the preamble 

below. 

Comment: We received many 

comments suggesting revisions to the 

final rule regarding the evaluation of 

psychosocial needs. Many commenters 

recommended the addition of a 

standardized survey tool to be used in 

assessing the psychosocial status of 

dialysis patients, namely the SF–36 or 

another instrument advocated by 

National Kidney Foundation Life 

Options subgroup. One commenter 

suggested the final rule be modified so 

that § 494.80(a)(7) would specifically 

require ‘‘evaluation of psychosocial 

needs, functioning and well-being using 

the SF–36 or other standardized 

survey.’’ Two commenters suggested the 

final rule specify a list of psychosocial 

needs to be assessed, such as mood 

changes and coping with chronic 

illness. We received suggestions 

regarding additional forms that could be 

used for assessing psychosocial status. 

One commenter suggested that 

‘‘depression’’ be added as a separate 

assessment criterion. 

Response: In response to concern 

regarding the psychosocial status of 

dialysis patients, we have modified the 

‘‘Patient assessment’’ condition and 

strengthened the ‘‘Patient plan of care’’

condition. At § 494.80(a)(7) we have 

added the phrase ‘‘by a social worker’’

to ensure that patients are being 

assessed by an MSW, as defined at 

§ 494.140(d). Additionally, we are 

requiring at § 494.90(a)(6) that a 

standardized tool, chosen by the MSW, 

be used to monitor patient status, and 

that counseling be provided and 

referrals be made as appropriate. There 

is further discussion of the standardized 

tool under the ‘‘Patient plan of care’’

discussion below. 

Comment: One commenter suggested 

that all patients be encouraged to first 

consider home dialysis options when 

evaluating modality and setting. 

Response: We have emphasized 

increasing patient awareness of home 

dialysis options in this final rule. In 

§ 494.70 we require that the patient has 

the right to be informed about all 

treatment modalities and settings, 

including home dialysis. We expect 

facilities to encourage patients to 

consider home dialysis if it is a suitable 

choice. In addition, we encourage the 

use of home dialysis under the ‘‘Patient 

plan of care’’ condition at 

§ 494.90(a)(7)(i). 

Comment: A commenter suggested the 

comprehensive assessment include an 

evaluation of self-care activities the 

patient performs. Another commenter 

remarked that the evaluation of a 

patient’s potential for self-cannulation 

should be part of the assessment, and 

that documentation in the patient record 

should be required if the patient 

chooses not to participate. One 

commenter made a general observation 

that patients are not treated as adults in 

the facility. 

Response: All patients are to be 

encouraged to participate in their own 

care, as ability and interest allows. 

Some patients may be able to selfcannulate, while others may not. Some 

may be able to weigh themselves or they 

may be charged with holding their 

access site to stop bleeding after 

completion of a course of dialysis. 

Regardless of the patient’s level of 

participation, an evaluation of self-care 

activities is encompassed within the 

comprehensive assessment requirement 

at § 494.80(a)(9), which requires 

‘‘Evaluation of the patient’s abilities, 

interests, preferences, and goals, 

including the desired level of 

participation in the dialysis care 

process; the preferred modality 

(hemodialysis or peritoneal dialysis) 

and setting (for example, home dialysis), 

and the patient expectations for care 

outcomes.’’

Comment: We received many 

comments regarding the responsibility 

and basis for transplantation referral of 

dialysis patients. Some commenters 

remarked that ESRD facilities should 

not be responsible for referring patients 

for transplantation. Commenters 

explained that often dialysis units must 

cooperate with multiple transplantation 

centers that may have varied criteria 

and some transplantation centers do not 

have any criteria available on which a 

dialysis facility could base a referral. 

Another commenter suggested that 

referral for transplantation is the 

nephrologist’s and patient’s 

responsibility. 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20397 

Response: The part 405, subpart U 

ESRD conditions for coverage required 

facilities to evaluate patients for 

transplantation referral as part of the 

long-term care program planning 

process. This final rule does not require 

transplantation referral as an activity 

separate from the short-term care plan, 

but rather, it is now encompassed 

within the plan of care. Referrals will 

continue to be a facility-level 

responsibility. We recognize the role of 

the physician as the leader of the 

interdisciplinary team; however, these 

regulations apply to the facility, and the 

interdisciplinary team is responsible for 

patient referral for transplant. 

It is important for dialysis facilities 

and transplantation centers to make a 

concerted effort to communicate and 

cooperate. Two-way communication is 

required not only in this final rule, but 

also within the recently published 

Medicare Transplant Center conditions 

of participation. The March 30, 2007 

transplant center final rule (‘‘Hospital 

Conditions of Participation: 

Requirements for Approval and ReApproval of Transplant Centers to 

Perform Organ Transplants’’ (72 FR 

15276)) requires kidney transplant 

centers to make transplant referral 

criteria available to any requesting 

dialysis center (see § 482.90(a)(4)). The 

purpose of using transplant center 

criteria is to remove and reduce the 

chances of referral bias and transplant 

referral disparities. 

Comment: One commenter suggested 

that the final rule require a written 

agreement between transplant centers 

and dialysis facilities and that such 

agreement contain the transplant center 

criteria for patient referral. 

Response: If a dialysis facility finds it 

useful to have a written agreement with 

the transplant center regarding 

communication and responsibilities of 

each entity, as well as transplant 

criteria, the dialysis facility has the 

flexibility to do so, but we do not 

believe we have sufficient cause to 

require such an agreement of all 

facilities. 

Comment: We received many 

comments regarding the proposed 

requirement that the assessment include 

an evaluation of patient physical 

activity level and rehabilitation status 

(§ 494.80(a)(12) and § 494.80(a)(13)). 

Some commenters agreed with the 

proposed assessment criteria here, while 

others suggested modifications to the 

final rule. Commenters remarked that 

the interdisciplinary team members are 

not qualified or trained to assess a 

patient’s physical activity level or 

rehabilitation status. One commenter 

suggested we modify the final rule to 

specify evaluation of developmental 

progress and educational needs as part 

of the rehabilitative assessment for 

pediatric patients. 

Response: We agree with commenters 

that the proposed language at 

§ 494.80(a)(13), which would require the 

facility to evaluate the vocational and 

physical rehabilitation status and 

potential of patients, is beyond the 

scope of a facility’s responsibilities. The 

professionals who are part of the 

interdisciplinary team do not have 

complete knowledge and training 

necessary to accurately and fully assess 

physical activity level or physical 

rehabilitation status and potential. 

Therefore, we have modified the final 

rule at § 494.80(a)(13) to require the 

interdisciplinary team to evaluate the 

patient for referral to vocational and 

physical rehabilitation services. 

Facilities are expected to evaluate 

whether the patient should be referred 

for services as appropriate, not perform 

a complete physical therapy or 

rehabilitation assessment in the facility. 

Evaluation and referral of 

developmental progress and educational 

needs may be appropriate for some 

patients; however, the final rule will not 

be modified to require that these needs 

be evaluated for all patients. If, during 

the assessment process, either of these 

issues is identified by the 

interdisciplinary team, we expect the 

patient will be referred to the 

appropriate professional for further 

evaluation. 

Comment: One commenter suggested 

that the final rule require the assessment 

elements laid out at § 494.80(a)(11) 

through § 494.80(a)(13) (support 

systems, physical activity level, and 

rehabilitation services) be completed by 

a social worker using a standardized 

assessment instrument that measures 

physical, social, and emotional status. 

Response: Facilities have the 

flexibility to designate staff with the 

appropriate expertise to complete the 

comprehensive assessment. The social 

worker may possess the greatest 

expertise related to these areas; 

however, another team member might 

perform the physical activity level 

assessment. At § 494.80(a)(7), a social 

worker is required to assess the 

psychosocial needs of patients, and 

§ 494.90(a)(6) of the final rule requires 

the plan of care to address psychosocial 

status using a standardized mental and 

physical assessment tool, chosen by the 

qualified social worker. As discussed 

previously, we are not requiring 

facilities to use any specific assessment 

tool. 

Comment: A few commenters sought 

clarification on the meaning of the 

phrase ‘‘new patient’’ at proposed 

§ 494.80(b), ‘‘Frequency of assessment 

for new patients.’’ The commenters 

asked whether ‘‘new patient’’ meant a 

patient new to dialysis or a patient new 

to a particular dialysis unit. Another 

commenter asked if ‘‘new patient’’

referred to a patient receiving his or her 

first treatment in an outpatient dialysis 

unit. 

Response: In order to clarify the 

meaning of ‘‘new patient,’’ we have 

modified the title of § 494.80(b), so that 

it now reads: ‘‘Frequency of assessment 

for patients admitted to the dialysis 

facility.’’ We intend for all dialysis 

patients new to any particular 

outpatient dialysis facility be 

categorized as ‘‘new patients’’ and have 

a comprehensive assessment within the 

specified 30-day timeframe even if they 

are transferring from another dialysis 

facility. This means a comprehensive 

assessment must be done on all transfer 

patients, as well as those new to 

dialysis, within the first 30 days. 

Comment: We received more than 50 

comments regarding the frequency of 

assessment and the timeframe for 

completion of patient assessments. A 

few commenters agreed with the 

proposed timeframe for completing the 

patient assessment; however, the 

majority of commenters were concerned 

that the 20-day proposed timeframe did 

not allow enough time to complete a 

thorough comprehensive assessment. 

Many commenters stated that 

completion of the patient assessment 

within 20 days would be ideal but is 

impractical for staff that often cover 

multiple units and/or cover large 

geographical areas; such a requirement 

would be particularly impractical in 

rural areas. Commenters also stated that 

the proposed timeframe is unrealistic 

for MSWs carrying large patient 

caseloads. Other commenters suggested 

20 days would not be enough time for 

all team members to participate, 

specifically those who work in part-time 

positions. Other commenters were 

concerned that the 20-day timeframe 

was inadequate for complete evaluation 

of all assessment criteria, including 

nutritional status, physical activity level 

or vocational or physical rehabilitation 

status. Commenters offered many 

suggestions regarding the deadline to 

complete the assessment. Some 

suggested alternatives that included 

time periods ranging from 30 to 60 days, 

and assessment timelines based on the 

number of dialysis sessions ranging 

from 6 to 13 sessions. Other suggestions 

included a split assessment with part 1 

completed within 20 to 30 days or 9 

sessions, and part 2 at 3 months. 

Commenters also suggested completing 


PWALKER on PROD1PC71 with RULES2
20398 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

the assessment and plan of care within 

30 days, or allowing medical 

justification for the assessment time 

period to exceed 30 days. 

Response: We agree with many of 

these commenters. A comprehensive 

initial assessment is the basis for an 

effective plan of care and for achieving 

desired patient outcomes. We also 

recognize dialysis facilities may have 

difficulties when conducting 

assessments on patients who face a 

wealth of challenges, including frequent 

hospitalizations; however, these 

difficulties should not outweigh the 

need to complete a comprehensive 

initial assessment within a reasonable 

period of time. If a patient has received 

dialysis for a 1-month period, or 13 

hemodialysis treatments, that in-center 

patient has likely been physically 

present in the facility for at least 40 

hours. We are therefore revising the 

deadline. We believe that, by allowing 

facilities 30 days or 13 hemodialysis 

treatments to complete the assessment 

(whichever is later), we are providing a 

reasonable timeframe for every member 

of the interdisciplinary team to assess 

the patient before developing the 

treatment plan. We have modified the 

final rule at § 494.80(b)(1) ‘‘Patient 

assessment’’ and at § 494.90(b)(2) 

‘‘Patient plan of care’’ so that the 

interdisciplinary team has a timeframe 

of 30 days or 13 outpatient hemodialysis 

sessions, whichever is later, for 

completion of the assessment and 

implementation of the plan of care. 

Because some assessment criteria may 

take a longer period of time to evaluate, 

such as nutritional status and vocational 

and physical rehabilitation status, we 

expect that these areas would be more 

fully covered during the follow-up 

comprehensive reassessment that we are 

requiring for stable patients within 3 

months after the completion of the 

initial assessment, as required at 

§ 494.80(b)(2) and discussed below. 

Comment: We received more than 50 

comments on the proposed 3-month 

follow up comprehensive reassessment 

for dialysis patients. Half of the 

commenters supported the requirement, 

arguing that a follow-up assessment is 

necessary in order to evaluate the level 

of patient adherence to the treatment 

plan, determine whether the care plan is 

effective, and track the patient’s overall 

adjustment to dialysis. One commenter 

supported the 3-month timeframe, 

stating, ‘‘many patients are too sick and/ 

or depressed to participate in lifealtering decisions regarding their care 

and treatment’’ during the initial 

assessment. Two commenters supported 

the 3-month reassessment but suggested 

that it be a ‘‘focused’’ reassessment used 

exclusively to determine whether 

changes would be needed in the plan of 

care. 

The other half of the commenters 

opposed the proposed requirement, 

stating that the requirement was 

redundant, burdensome and of 

‘‘questionable value.’’ Some 

commenters suggested that follow-up 

reassessments be completed after 6 

months to relieve burden, especially in 

rural areas. Some commenters suggested 

the 3-month reassessment timeframe 

would be impractical because many 

new patients do not stabilize for the first 

6 months of dialysis. Some commenters 

suggested that we modify the final rule 

to require a follow-up reassessment 

within 36 hemodialysis treatments 

rather than within the proposed 3- 

month timeframe. One commenter 

suggested that monthly progress notes 

would eliminate the need for the 3- 

month follow-up reassessment. 

Response: We recognize that patients 

who are new to dialysis need time to 

adjust and adapt to the treatment. 

Initially, patients may experience 

anxiety while learning self-care skills, 

modifying their diet, changing their 

behavior, and perhaps dealing with 

access issues. The 3-month 

comprehensive reassessment enables 

the interdisciplinary team to evaluate, 

among other things, the patients’

adherence to treatment plans; the 

accuracy of the patient’s plan of care; 

and the patient’s educational needs, 

rehabilitation needs, nutritional needs, 

quality of life and adjustment to the 

dialysis regimen. We recognize the 

burden this 3-month reassessment 

places on the interdisciplinary team. 

However, the burden has been 

significantly reduced in this final rule 

by eliminating the previous requirement 

that the team review the care plans and 

associated patient assessments of all 

stable patients every six months, which 

was previously required in part 405, 

subpart U. This rule does not preclude 

facilities from performing an assessment 

6 months after the initial assessment, if 

they desire. 

Comment: We received several 

comments regarding the assessment of 

the efficiency of the treatment 

prescription for hemodialysis and 

peritoneal dialysis. One commenter 

believed that proposed § 494.80(c) 

merely repeated § 494.90(a)(1) and 

recommended that the final rule 

combine the two. 

Response: We disagree with the 

commenter regarding redundancy of the 

‘‘Patient assessment’’ and ‘‘Patient plan 

of care’’ provisions. The requirement at 

§ 494.80(c) mandates the frequency of 

assessment of the effectiveness of the 

treatment prescription for both 

hemodialysis patients and peritoneal 

dialysis patients, while § 494.90(a)(1) 

requires the interdisciplinary team to 

develop a patient plan of care to address 

the dose of dialysis and provide the 

necessary care and services to achieve 

and sustain the prescribed dose of 

dialysis. These conditions are also in 

keeping with our payment regulations 

(Medicare Claims Processing Manual, 

Chapter 8, 50.1) (http:// 

www.cms.hhs.gov/manuals/IOM/ 

list.asp). 

Comment: One commenter suggested 

§ 494.80(c), which addresses the 

frequency of dialysis adequacy 

monitoring, be modified to require 

facilities to ‘‘monitor fluid status.’’ The 

commenter cited a study that argued Kt/ 

V levels did not correlate with mortality 

or morbidity and that better methods of 

measuring intravascular volume and 

related blood pressure changes are 

needed. 

Response: Proposed § 494.80(a)(2) 

would require the interdisciplinary 

team to evaluate fluid management 

needs. We have retained this provision 

in this final rule. We have also added, 

‘‘manage the patient’s volume status’’ at 

§ 494.90(a)(1), under the ‘‘Patient plan 

of care’’ condition. 

Comment: One commenter proposed 

that a Kt/V measurement should be 

done every 2 months and that urea 

reduction rate could be used in alternate 

months. The commenter argued that Kt/ 

V measurement was excessively 

burdensome for both patients and staff. 

Response: Monthly monitoring of 

dialysis adequacy for hemodialysis 

patients is consistent with current 

dialysis facility practice and Medicare 

payment policies. We are not making 

any change to § 494.80(c) based on this 

comment. 

Comment: One commenter suggested 

the final rule be reworded at 

§ 494.80(d)(1) to clarify what kind of 

annual reassessment must be 

completed, as required in this 

condition. 

Response: We appreciate the 

comment; however, § 494.80(d) states 

clearly that the reassessment must be 

completed in accordance with the 

standards specified in paragraphs 

494.80(a)(1) through (a)(13). We do not 

believe that further clarification is 

needed. The proposed language has 

been retained in the final rule. 

Comment: We received a comment 

that suggested the final rule require 

‘‘monthly reassessments for all stable 

patients using a simple tool.’’ Another 

commenter remarked that annual 

assessments for stable patients are not 

enough and that co-morbid conditions 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20399 

may necessitate assessments that are 

more frequent. 

Response: While we are requiring 

stable patients to be comprehensively 

reassessed at least annually, we 

recognize that appropriate monitoring of 

patients may require ongoing 

assessments in various areas. We expect 

that patients would be monitored on an 

ongoing basis and expect progress notes 

would be entered in the patient’s 

medical record as needed. The 

interdisciplinary team has the flexibility 

to use its professional judgment 

regarding on-going monitoring methods 

as appropriate for their patients, as 

specified in the patient plan of care. 

Comment: We received many 

comments regarding the monthly 

reassessments for unstable patients. 

Many commenters requested we clarify 

what we meant by ‘‘unstable patients’’

and provide a definition for ‘‘unstable’’

in the final rule, as well as identify what 

the reassessment for such patients 

would specifically need to include. A 

few commenters said ‘‘unstable’’ should 

be clarified to state that all four criteria 

listed at § 494.80(d)(2)(i) through 

§ 494.80(d)(2)(iv) must be present at 

once in order for the patient to be 

considered ‘‘unstable.’’ Another 

commenter suggested § 494.80(d)(2)(iv) 

be modified to add ‘‘and/or’’ so that 

presence of any one of the three criteria 

listed in (iv) (poor nutritional status, 

unmanaged anemia, and inadequate 

dialysis) would deem the patient 

‘‘unstable.’’ A couple of commenters 

recommended modifying the final rule 

to allow each facility to provide its own 

definition of ‘‘unstable’’ as part of their 

facility policies. 

A few commenters recommended that 

nutritional status should not be linked 

with anemia management or dialysis 

adequacy at § 494.80(d)(2)(iv). One 

commenter suggested nutritional status 

should stand alone, as should 

unmanaged anemia. One commenter 

recommended the final rule clarify 

‘‘unmanaged anemia’’ and defer to the 

most recent KDOQI anemia clinical 

practice guidelines. A couple of 

commenters asked whether the 

requirement at § 494.80(d)(2)(iv) 

required all three criteria to be present 

simultaneously. Another commenter 

strongly recommended that the final 

rule clarify that all three parameters of 

(iv), poor nutritional status, unmanaged 

anemia, and inadequate dialysis be 

present to justify the determination that 

the patient was ‘‘unstable.’’ Another 

commenter suggested that ‘‘poor 

nutrition’’ should not be deemed a 

marker for instability, because facilities 

have minimal influence over poor 

nutritional status, which is a chronic 

problem. 

We received many comments from 

social workers suggesting additional 

assessment criteria which would 

indicate that patients were ‘‘unstable,’’

and therefore, trigger the requirement 

for monthly reassessments. These 

suggestions included hemoglobin less 

than 11 gm/dL for more than 8 weeks, 

frail patients, reduced physical and 

mental component summary scores, 

physical debilitation, diminished 

emotional well-being, loss of 

employment, intradialytic symptoms, 

blood pressure, use of certain types of 

hypertensive medications, dry weight 

changes, chronic heart failure 

admissions, depression, and significant 

change in psychosocial needs. 

Response: The comprehensive 

reassessment process can be seen as part 

of a cycle. Through the use of patient 

assessment, accurate and timely patient 

information is reflected in the plan of 

care. As the assessment changes, the 

plan of care must be revised 

accordingly. Once the patient is 

determined to be unstable, a monthly 

reassessment is necessary to update the 

plan of care appropriately. Existing 

regulations at part 405, subpart U 

required the professional care team to 

review the plan of care for an unstable 

patient at least monthly. The proposed 

rule aimed to add clarification and 

guidance as to how to classify a patient 

as unstable, and we specified at 

§ 494.80(d)(2) the minimum criteria 

necessary to consider a patient unstable. 

A patient is unstable if he or she has had 

extended or frequent hospitalizations, or 

a marked deterioration in health status, 

or a significant change in psychosocial 

needs. In addition, a patient is unstable 

when he or she is determined by the 

interdisciplinary team to have poor 

nutritional status, unmanaged anemia, 

and inadequate dialysis concurrently. 

Unstable patients must be reassessed in 

accordance with § 494.80(d), which 

specifies use of the assessment criteria 

at § 494.80(a)(1) through § 494.80(a)(13). 

While a comprehensive reassessment for 

patients classified as unstable is 

required, it is possible that patient 

status may not change in all parts of the 

assessment. Patient status, whether 

changed or unchanged, should be 

clearly reflected in the new assessment. 

This final rule allows facilities the 

flexibility to use their professional 

judgment to develop more stringent 

policies regarding the definition of 

‘‘unstable’’ patient based on their 

unique patient population and patient 

characteristics and to insert additional 

assessment criteria, such as those 

offered by the commenters. 

Comment: One commenter was 

concerned that facilities have previously 

developed their own definitions of 

‘‘unstable patient’’ that ultimately 

classify very few patients as unstable. 

The commenter suggested that this 

trend should be discouraged. 

Response: The proposed rule at 

§ 494.80(d)(2) aimed to specifically 

address these concerns by establishing 

minimum criteria by which to identify 

patients considered ‘‘unstable.’’ As 

stated above, facilities continue to have 

the flexibility to develop their own 

policies and procedures with regards to 

how they define ‘‘unstable’’ patient, as 

long as that definition meets the 

minimum requirements put forth in this 

final rule. 

Comment: One commenter remarked 

that it is unclear how monthly 

reassessments of stable patients 

coordinate with the ‘‘monthly unstable 

care plans.’’ The commenter questioned 

if patients would be considered 

‘‘unstable’’ if care plan goals were not 

met. 

Response: Patients are considered 

unstable if they meet any of the criteria 

listed at § 494.80(d)(2). Implementation 

of the initial and revised plan of care is 

discussed in the ‘‘Patient plan of care’’

section of the preamble below. The 

implementation of an updated plan of 

care, which results from a new patient 

assessment, is addressed at 

§ 494.90(b)(2). 

c. Patient Plan of Care (Proposed 

§ 494.90) 

We proposed a new condition for 

coverage entitled ‘‘Patient plan of care,’’

which would require the 

interdisciplinary team to develop and 

implement a written, individualized 

comprehensive plan of care that 

specified the services necessary to 

address the patient’s needs, as identified 

by the comprehensive assessment and 

changes in the patient’s condition, and 

would have included measurable and 

expected outcomes and estimated 

timetables to achieve these outcomes. 

Proposed components of the patient 

plan of care included dose of dialysis, 

nutritional status, anemia, vascular 

access, transplantation status, and 

rehabilitation status. This proposed 

condition for coverage called for 

documentation of a plan for 

transplantation, or, in the alternative, 

the patient’s decision not to accept 

transplant referral, or documentation of 

the reason for the patient’s nonreferral. 

We proposed implementation of the 

plan of care within 10 days of 

completion of the initial or updated 

patient assessment. We would no longer 

require the separate short-term and 


PWALKER on PROD1PC71 with RULES2
20400 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

long-term care plans required, 

biannually and annually, respectively, 

by part 405, subpart U of our rules. This 

proposed condition for coverage would 

also have required that the facility 

would have to adjust the plan of care if 

the expected outcome was not achieved. 

We proposed that the dialysis facility 

would have to ensure that all dialysis 

patients were seen by a physician 

providing the ESRD care at least 

monthly, that this visit was 

documented, and occurred periodically 

while the patient was receiving dialysis. 

Under the proposed rule, the 

interdisciplinary team would have been 

required to track the results of each 

kidney transplant center referral, 

monitor patient status, and 

communicate with the transplant center 

at least quarterly. The proposed ‘‘Patient 

plan of care’’ condition included a 

patient education and training standard, 

which would have required, as 

applicable, education and training for 

patients and facility members or 

caregivers on the aspects of the dialysis 

experience, dialysis management, 

quality of life, rehabilitation, and 

transplantation. Further discussion of 

§ 494.90 provisions may be found in the 

proposed rule (70 FR 6205). 

We received more than 100 comments 

regarding the ‘‘Patient plan of care’’

condition. The majority supported the 

proposed ‘‘Patient plan of care’’

condition. 

Comment: Dozens of commenters 

made recommendations regarding the 

composition of the interdisciplinary 

team that would develop the plan of 

care. Several commenters agreed with 

the proposed interdisciplinary team 

definition and some suggested that the 

team definition wording at § 494.80 be 

carried over to § 494.90. Two 

commenters supported excluding the 

medical director from the 

interdisciplinary team, while others 

thought the medical director team role 

should be retained from part 405, 

subpart U, or changed to a team 

supervisory role. Commenters disagreed 

as to whether the home dialysis 

physician role on the interdisciplinary 

team should have been deleted in the 

proposed rule. One commenter stated 

that some patients need a physical 

therapist and psychiatrist on the 

interdisciplinary team. Another two 

commenters stated it would be ideal to 

have a vascular access coordinator on 

the interdisciplinary team, although this 

could be a cost issue. A number of 

commenters suggested that a pharmacist 

be included as a member of the 

interdisciplinary team. 

Response: We are specifying the 

multidisciplinary team composition in 

§ 494.90 of the final rule by crossreferencing the wording used at the 

beginning of § 494.80 (introductory 

text). The final rule language at § 494.80 

reads as follows: ‘‘The facility’s 

interdisciplinary team consists of, at a 

minimum, the patient or the patient’s 

designee (if the patient chooses), a 

registered nurse, a physician treating the 

patient for ESRD, a social worker, and 

a dietitian * * *.’’ We do not agree 

there is a need to require that the 

medical director, the home dialysis 

physician or other professional staff be 

members of the interdisciplinary team. 

The medical director role has been 

strengthened at § 494.150 so that the 

medical director is responsible for the 

delivery of patient care and outcomes in 

the facility. In this role, the medical 

director may choose whether to be a 

member of the interdisciplinary team 

and participate in interdisciplinary team 

activities. The patient’s right to be 

informed about home dialysis was 

strengthened both in the ‘‘Patients’’

rights’ (§ 494.70(a)(7)) and ‘‘Patient 

assessment’’ (§ 494.80(a)(9)) conditions, 

so that the patient could be informed of 

home dialysis options whether or not a 

home dialysis physician was included 

in the multidisciplinary team. 

Patients needing physical therapy or 

psychiatric services should be referred 

for these services, as we would not 

necessarily expect the dialysis facility to 

employ these professionals as staff 

members. Facilities may want to have a 

vascular access coordinator. While we 

encourage this, we will not mandate it, 

as dialysis facilities should have the 

flexibility to use other approaches and 

staff as interdisciplinary team members 

in ways that best meet the needs of their 

patient population. 

We have addressed comments related 

to a pharmacist’s role at § 494.140 

‘‘Personnel qualifications’’ discussion 

below. We have defined in regulation 

the minimum staff that must be part of 

the team in order to meet basic dialysis 

patient care needs. This regulation does 

not preclude the use of an expanded 

interdisciplinary team, and dialysis 

facilities always have the flexibility to 

add staff to the interdisciplinary team. 

Comment: Many commenters agreed 

with the proposed modification to the 

provision specifying the role of the 

transplant surgeon in the development 

of the patient’s plan of care. A few 

commenters opposed eliminating the 

requirement that the transplant 

surgeon’s signature be part of the plan 

of care, while some of the comments 

supported transplant surgeon 

involvement via a designee. 

Response: The previous ESRD 

conditions required a transplant surgeon 

to participate in the long-term care 

program planning process. The 

interpretive guidelines used by 

surveyors provided that a transplant 

surgeon designee could be used, and 

this designee was often a transplant 

nurse or the attending dialysis 

nephrologist. We proposed that while 

the transplant surgeon would not be a 

required member of the 

interdisciplinary team, the team must 

use criteria from the transplant center to 

determine whether a patient was a 

transplant referral candidate. The 

majority of comments supported this 

approach; therefore, we will retain the 

proposed requirement, which does not 

include the transplant surgeon. We are 

requiring use of transplant center 

criteria for assessing potential transplant 

candidates (§ 494.80(a)(10)), including 

transplantation status, as a component 

of the patient plan of care 

(§ 494.90(a)(7)(ii)), and the 

transplantation referral tracking 

standard (§ 494.90(c)). 

Comment: A few commenters 

recommended further clarification of 

the term ‘‘current evidence-based 

community-accepted standards’’ at 

proposed § 494.90, and some suggested 

that this be defined as the K/DOQI 

standards. Some felt that the use of the 

word ‘‘community’’ could allow wide 

variation throughout the country as 

different communities embraced 

different standards, some of which 

might not be evidence-based. 

Response: The first provision of the 

proposed ‘‘Patient plan of care’’

condition required that the plan of care 

‘‘include measurable and expected 

outcomes and estimated timetables to 

achieve these outcomes.’’ The outcomes 

specified in the ‘‘Patient plan of care’’

condition must allow the patient to 

achieve ‘‘current evidence-based 

community-accepted standards.’’ The 

phrase ‘‘community-accepted 

standards’’ was intended to mean 

nationally-accepted professional 

standards of practice accepted by the 

renal community at large. ‘‘Community’’

was not intended to mean small local 

geographic groups of people having 

standards unique to that group or area. 

We have modified § 494.90 to better 

clarify our meaning and have replaced 

the phrase with new wording, ‘‘current 

evidence-based professionally-accepted 

clinical practice standards.’’

Comment: One commenter 

recommended that a phrase be added to 

the first paragraph in § 494.90 of the 

‘‘Patient plan of care’’ condition to 

clarify that community-accepted 

standards must reflect joint decisionmaking between the patient and the 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20401 

interdisciplinary team to individualize 

optimal goals for patient. 

Response: We have designated the 

patient as a member of the 

interdisciplinary team (if the patient 

desires) and expect that the patient 

would share in the goal-setting team 

decisions. We do not agree there is a 

need to modify the provision as 

suggested. 

Comment: We received a few 

comments opposing the plan of care 

timetables in § 494.90 because 

commenters believed that the patient 

response to therapy would be 

impossible to predict. A commenter 

recommended that we clarify that the 

facility would not be responsible for 

setting and meeting timetables for 

meeting the patient’s medical and 

psychosocial needs; the commenter 

argued that such policy would 

constitute micromanagement that added 

no value to patient care. The commenter 

stated there was no matrix (or method) 

in the literature that allowed prediction 

of a patient’s response time. A 

commenter stated it was beyond the 

scope of practice for a dialysis center to 

set a timetable for patients to achieve 

‘‘measurable and expected outcomes,’’

especially those with ESRD for more 

than 1 year, since problems are complex 

and professionals cannot predict how 

long they will take to solve. 

Response: It is common practice for a 

plan of care to include the following 

elements for each patient problem or 

medical/nursing need identified: Goal, 

action plan, and target date to either 

meet the goal or check the patient’s 

progress toward that goal. We recognize 

that patient outcomes are determined in 

part by factors outside of the dialysis 

facility’s control, such as demographics, 

the systemic effects of the underlying 

renal disease, and patient preferences 

and adherence. Further, we recognize 

that health care delivery is dynamic and 

that not all patients may be achieving, 

for example, the expected delivered 

dose of dialysis at any specific point in 

time. If the patient is unable to achieve 

the desired health outcomes, the plan of 

care should be adjusted to reflect the 

patient’s condition along with an 

explanation, and any opportunities for 

improvement in the patient’s health 

should be identified. Care plans 

commonly include time frames and care 

plan goals are more meaningful when 

the facility identifies a target date to 

achieve a goal or reassess the patient’s 

status. Therefore, we have adopted the 

provision as proposed. 

Comment: A few commenters were 

concerned about the patient’s ability to 

refuse to comply with the plan of care, 

which could nullify team efforts to meet 

the plan of care goals. One commenter 

suggested that CMS allow facilities to 

demonstrate that a patient’s failure to 

comply with the treatment regimen 

justified failure to meet criteria within 

the plan of care. Another commenter 

recommended that the dialysis 

adequacy regulatory language be more 

flexible to account for patients who 

terminated treatment early, despite team 

intervention. 

Response: These patient compliance 

concerns were discussed in the 

February 4, 2005 proposed rule (70 FR 

6209). As noted above, we recognize 

that patient outcomes are determined in 

part by factors outside of the dialysis 

facility’s control. If the patient is unable 

to achieve the desired health outcomes, 

the plan of care should be adjusted to 

reflect the patient’s condition along 

with an explanation for the patient’s 

inability to achieve the desired 

outcomes, and the team must identify 

any opportunities to improve the 

patient’s health. This clarification has 

been added to the final rule at 

§ 494.90(b)(3). 

The patient is part of the team and 

should be working to meet the plan of 

care goals. We are requiring the 

interdisciplinary team to adjust the 

patient’s plan of care to achieve revised 

goals if initial outcomes are not 

achieved. If a therapeutic goal is not met 

due to patient non-compliance, then 

interventions must be implemented to 

achieve better patient compliance. If 

reasonable measures have been taken 

and lack of patient compliance still 

prevents the goal from being met, the 

facility must document the 

interventions, the results of the 

interventions, and the plan to preserve 

patient health and safety within the 

limitations of poor patient compliance. 

Patient choices that create barriers to 

meeting the targets should be 

documented and addressed to a 

reasonable extent by the team. We are 

not requiring patients to meet plan of 

care goals as a condition for coverage of 

facility services. 

Comment: We received several 

comments regarding § 494.90(a)(1), 

‘‘Dose of dialysis.’’ Most commenters 

recommended using the K/DOQI 

adequacy standards for this 

requirement, and several, including the 

National Kidney Foundation, 

recommended that we add the specific 

K/DOQI guidelines as minimal 

standards to the plan of care 

requirements. Some commenters 

suggested we include patient volume 

status (that is, a measurement of body 

fluid removal) in the adequacy 

requirement. A few commenters 

opposed establishing specific targets in 

the plan of care requirement because 

they stated that would be too 

prescriptive and rigid, future advances 

may outdate targets, facilities would 

have to risk-adjust, and not all patients 

would be able to achieve 100 percent of 

the targets. Commenters suggested 

alternatives, including using guidelines 

of practice or consensus standards (like 

AAMI and CDC guidelines), and 

encouraging, but not requiring, that 

specific targets be met. 

Response: The majority of 

commenters supported adding language 

to § 494.90(a)(1) to specify that the K/ 

DOQI dialysis adequacy guidelines must 

be targeted for all patients. We agree 

that the KDOQI adequacy guidelines are 

the current evidence-based 

professionally-accepted clinical practice 

standards. We have added to 

§ 494.90(a)(1) a reference to the 2006 

KDOQI targets (that is, Kt/V of 1.2 for 

hemodialysis or weekly 1.7 for 

peritoneal dialysis); we are also 

allowing dialysis facilities to meet ‘‘an 

alternative equivalent professionallyaccepted clinical practice standard for 

adequacy of dialysis that would allow 

for future advances in dialysis adequacy 

measurement. 

While there may be a need to riskadjust when measuring facility-wide 

performance, the ‘‘Patient plan of care’’

condition addresses individual patient 

care and allows for unique patient 

characteristics to be considered in the 

development of the plan of care goals, 

alleviating the need to risk-adjust. As 

discussed previously in this preamble, if 

a patient does not meet the plan of care 

goals, appropriate interventions must be 

employed and if the patient still cannot 

meet the goals, a proposed explanation 

of why goals were not met must be 

entered into the plan of care. The rule 

does not require patients to meet plan 

of care goals as a condition for coverage, 

but facilities must demonstrate that they 

are attempting to meet those goals to the 

extent possible. 

Volume control, important to blood 

pressure management and cardiac 

health, is an essential component of 

dialysis care that requires ongoing 

attention from the care team. Therefore, 

we are incorporating it into the ‘‘dose of 

dialysis’’ plan of care element. We have 

modified § 494.90(a)(1) to read, ‘‘The 

interdisciplinary team must provide the 

necessary care and services to manage 

the patient’s volume status; and achieve 

and sustain the prescribed dose of 

dialysis to meet a hemodialysis Kt/V of 

at least 1.2 and a peritoneal dialysis 

weekly Kt/V of at least 1.7 or meet an 

alternative equivalent professionallyaccepted clinical practice standard for 

adequacy of dialysis.’’


PWALKER on PROD1PC71 with RULES2
20402 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

Comment: We received many 

comments regarding § 494.90(a)(2), the 

nutrition component of the ‘‘Patient 

plan of care’’ condition. Several 

commenters supported the inclusion of 

nutrition as a plan of care element. Two 

commenters objected to the use of 

serum albumin as a marker of 

nutritional status, saying it was a poor 

indicator. Other nutritional indicators 

favored by commenters include 

subjective global assessment (SGA), 

normalized protein catabolic rate, 

weight, height and appetite, body mass 

index (BMI), body surface area, lab 

values, prealbumin and cholesterol, and 

the use of multiple nutrition measures, 

and urea kinetic modeling. One 

commenter recommended that the 

nutrition plan of care include target 

outcomes to meet/exceed the K/DOQI 

clinical practice guidelines. Another 

commenter stated that if the target 

albumin level was not met, alternate 

indicators (adequate dialysis and 

normalized protein catabolic rate) 

should be allowed, as albumin is 

affected by inflammation and chronic 

disease. 

Response: Serum albumin levels are 

closely linked to morbidity and 

mortality. According to the K/DOQI 

clinical practice guidelines (CPG), 

serum albumin is a valid and clinically 

useful measure of protein-energy 

nutritional status in maintenance 

dialysis patients, even though it may fall 

in the presence of inflammation and 

stress. Several commenters supported 

inclusion of BMI or body weight as a 

required nutritional indicator. Dialysis 

patients are weighed at least 6 times per 

week and inclusion of body weight does 

not increase burden to facilities. A 

monthly assessment of body weight 

allows facilities to calculate BMI (when 

the height is known), and track changes 

in body mass. 

We agree that the use of multiple 

markers is necessary to adequately 

assess nutritional status. For example, 

the KDOQI CPG encourages facilities to 

perform SGAs bi-annually as they are 

considered to be a valid and clinically 

useful measure of protein-energy 

nutritional status in dialysis patients 

(CPG 9). The CPGs also state that 

catabolic rate or protein equivalent of 

total nitrogen appearance are valid and 

clinically useful measures of net protein 

degradation and protein intake in 

maintenance dialysis patients (K/DOQI 

CPG 8). Serum cholesterol and serum 

prealbumin are valid and clinically 

useful markers of protein-energy 

nutritional status in hemodialysis 

patients (K/DOQI CPG #4 & 6). Facilities 

may use additional markers and 

assessments as deemed appropriate by 

the registered dietitian and physician. 

We are retaining in § 494.90(a)(2) the 

requirement that the interdisciplinary 

team monitor serum albumin (a visceral 

protein) and body weight at least 

monthly as indicators of nutritional 

status. In addition, we are adding 

language to § 494.90(a)(2) to require that 

‘‘Additional evidence-based, 

professionally-accepted nutrition 

indicators may be monitored, as 

appropriate.’’

Comment: Some commenters objected 

to the language in § 494.90(a)(2) that 

requires the interdisciplinary team to 

‘‘provide the necessary care and services 

to achieve and sustain an effective 

nutritional status,’’ because Medicare 

does not cover nutritional supplements. 

One suggestion was to change the 

wording so that the facility ‘‘monitors’’

the patient’s nutritional status. Another 

commenter suggested that facilities be 

allowed to give out supplements 

without being cited for providing 

beneficiaries with an impermissible 

‘‘enticement.’’

Response: Facilities must provide 

nutrition assessment, counseling, and 

ongoing monitoring, and must review 

with the patient monthly laboratory 

blood test results relating to the dialysis 

patient’s nutritional intake and 

nutritional status. The provision of 

nutritional supplements by the dialysis 

facility is not expected or required. To 

clarify this, we have revised the 

wording in § 494.90(a)(2) to read, 

‘‘provide the necessary care and 

counseling services * * *.’’ Depending 

on the facts and circumstances of a 

particular case, a gift of nutritional 

supplements by a provider to a 

beneficiary of a federal health care 

program could violate the prohibition 

on beneficiary inducements (section 

1128A (a)(7) of the Social Security Act), 

42 U.S.C. § 1320a–7a(a)(7)) or the antikickback statute (1128B(b), 42 U.S.C. 

§ 1320a–7b(b)). Questions regarding 

whether a particular arrangement may 

violate these statutes should be directed 

to the HHS Office of Inspector General. 

Comment: We received many 

comments regarding the anemia 

management component of the ‘‘Patient 

plan of care’’ condition. While there was 

some support for § 494.90(a)(3) (now 

§ 494.90(a)(4)) as written, many 

commenters recommended that we 

require that the KDOQI anemia CPGs be 

plan of care targets. One commenter 

urged that we consider having the 

healthcare team consider the new 2006 

KDOQI CPGs as they develop the plan 

of care. One commenter stated the 

hematocrit and hemoglobin targets of 

33.0 percent and 11 g/dl were too low 

and that a hematocrit of 36 percent 

should be the minimum target. 

Response: The proposed rule 

included references to the KDOQI 

minimum target hemoglobin and 

hematocrit levels of 11 g/dL and 33 

percent, respectively, at proposed 

§ 494.90(a)(3) (now § 494.90(a)(4)). 

Although new 2006 KDOQI anemia 

CPGs modified the 2000 version, target 

hemoglobin and hematocrit CPGs 

continue to be evaluated as new 

scientific evidence emerges. We note 

that the FDA issued a November 16, 

2006 alert to provide new safety 

information for erythropoiesisstimulating agents based on information 

reported in two clinical studies in 

patients with chronic renal failure 

treated with an unapproved regimen of 

erythropoiesis-stimulating agent(s). In 

addition, on March 9, 2007, the FDA 

issued a stronger warning, entitled a 

‘‘Black Box’’ warning (see http:// 

www.fda.gov/bbs/topics/NEWS/2007/ 

NEW01582.html). Clinical research data 

continue to emerge and the FDA 

continues to analyze this information. 

In addition, the NKF convened a 

KDOQI workgroup in 2007 to review 

new anemia management information 

and develop an update to the NKF–

KDOQI anemia management guidelines. 

The revised anemia management 

guidelines were published on 

September 10, 2007 (see http:// 

www.kidney.org/professionals/kdoqi/ 

pdf/KDOQI_finalPDF.pdf or the 

American Journal of Kidney Diseases, 

Vol. 50(3), September 2007: pp. 471–

530) and included one clinical practice 

recommendation and one clinical 

practice guideline for dialysis and 

nondialysis patients with chronic 

kidney disease receiving erythropoiesisstimulating agent(s) therapy. They are as 

follows: 

1. ‘‘The selected Hgb target should 

generally be in the range of 11.0 to 12.0 

g/dL;’’ (clinical practice 

recommendation) and 

2. ‘‘The Hgb target should not be 

greater than 13.0 g/dL’’ (clinical practice 

guideline). 

The KDOQI recommendation and 

guideline also discussed the ‘‘need to 

maintain flexibility in medical decision 

making given the breadth of variability 

between patients’ individual needs, 

values, functional status, disease 

burden, prognosis, and responsiveness 

to erythropoiesis-stimulating agent(s) 

therapy.’’

As such, the appropriate minimum 

hemoglobin/hematocrit targets for 

dialysis patients may vary. Therefore, 

the interdisciplinary care team must 

assess each patient to identify his or her 

unique needs for anemia management, 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20403 

considering renal community evidencebased professional standards of practice, 

such as those published by the FDA or 

the NKF’s KDOQI guidelines. 

Because the current science is 

evolving and it is probable that more 

information regarding dialysis patient 

anemia management needs and 

hemoglobin and hematocrit values will 

be forthcoming, we have not included 

hemoglobin/hematocrit target levels in 

the final rule. The plan of care must, 

however, reflect that individual patient 

anemia management is consistent with 

current renal community evidencebased professional standards of practice. 

Comment: A few commenters stated 

that the proposed requirements for 

anemia management in § 494.90(a)(3) 

are not consistent with payment policy, 

since physicians could not start Epogen 

until hematocrit was below 30 percent. 

One commenter stated that the proposed 

requirement would push hematocrits 

above 36 percent and add to 

reimbursement problems (when the 

hematocrit goes above 37.5 percent). 

Another commenter noted that payment 

affects hemoglobin/hematocrit targets. 

Response: The final rule does not 

specify a specific hemoglobin level. 

This change allows physicians and 

clinicians managing the patient to 

determine the hemoglobin/hematocrit 

level appropriate for each patient based 

upon the patient’s comorbidities and 

clinical characteristics. We note that the 

FDA labeling for erythropoiesisstimulating agent(s) (http:// 

www.fda.gov/cder/foi/label/2007/ 

103234s5122lbl.pdf) does not specify 

specific target hemoglobin, but warns 

prescribers to use the lowest dose of 

erythropoiesis-stimulating agent(s) to 

gradually increase the hemoglobin 

levels sufficient to avoid the need for 

red blood cell transfusion. In addition, 

the anemia management section in the 

final regulation decreases the focus on 

erythropoiesis-stimulating agent(s) and 

instead, at § 494.90(a)(4), focuses on the 

patient’s overall anemia management 

needs: ‘‘The interdisciplinary team must 

provide the necessary care and services 

to achieve and sustain the clinically 

appropriate hemoglobin/hematocrit 

level. The dialysis facility must conduct 

an evaluation of the patient’s anemia 

management needs.’’ This evaluation 

would determine whether the patient 

would benefit from supplemental iron, 

erythropoiesis-stimulating agent(s), 

blood transfusions, or other medical 

interventions. 

Comment: One commenter stated 

hemoglobin levels should be used, and 

not hematocrit levels, as the hemoglobin 

levels are more accurate and are not 

affected by blood volume. 

Response: The KDOQI CPGs do 

include a preference for hemoglobin 

readings over hematocrit levels and 

many dialysis facilities have been 

focusing on hemoglobin levels when 

managing anemia, rather than 

hematocrit levels. Some facilities 

multiply the hemoglobin by three to 

arrive at a comparable hematocrit level. 

Currently, Medicare payment systems 

allow both hematocrit and/or 

hemoglobin levels to be reported. 

Therefore, to allow flexibility in this 

health and safety rule, we will allow use 

of either the hemoglobin or the 

hematocrit. 

Comment: A commenter suggested 

that we remove specific references to 

‘‘erythropoietin’’ to allow for possible 

future advances in technology. Another 

commenter recommended that anemia 

management be individualized without 

the use of a range of parameters (that is, 

a sliding scale) necessary for delivering 

medication. 

Response: We agree with the 

commenter that a more general term 

should be used rather than 

‘‘erythropoietin.’’ We have revised 

§ 494.90(a)(4) by removing the term 

‘‘erythropoietin’’ and adding the term 

‘‘erythropoiesis-stimulating agents’’ to 

allow for new technology developments. 

Standing physician orders are used in 

some dialysis units to improve 

efficiency and responsiveness to 

changes in the patient’s anemia markers. 

We do not agree that there is a need to 

prevent facilities from using these types 

of tools to manage anemia in dialysis 

patients, provided the medication dose 

administered and lab tests obtained are 

approved by the physician and are 

appropriate for the individual patient. 

The physician is responsible for 

ordering medications and laboratory 

tests and may or may not prescribe 

standing orders or the use of an 

algorithm. However, medication type 

and quantities billed to Medicare must 

be consistent with the physician’s 

orders. 

Comment: We received many 

comments regarding the vascular access 

component of the patient plan of care. 

While there was support for including a 

vascular access plan of care component, 

several commenters requested 

clarification of what type of vascular 

access monitoring would be required. 

Some noted that a clinical physical 

exam, which included observation, 

auscultation and palpation, would be 

different from mechanical surveillance 

that could include transonic flow 

measurements. The latter, according to 

commenters, would require a change in 

payment policy. One commenter 

recommended referencing K/DOQI 

Vascular Access CPGs #10, 11, and 12 

for specifics regarding monitoring, 

while the NKF suggested that 

monitoring include a clinical physical 

exam at least monthly to detect 

problems or persistent abnormalities 

that should prompt referral for access 

angiography. Another commenter asked 

what CMS meant by its proposed 

requirement that facilities ‘‘provide 

necessary care and services to sustain 

vascular access,’’ and stated that a 

facility could only evaluate, monitor, 

recommend, educate, and refer, but not 

provide all the services and care that 

might be needed. 

Response: The vascular access 

monitoring that must be included in the 

patient plan of care is limited to a 

clinical physical exam, and we expect 

that persistent abnormalities should 

prompt a referral, which is in keeping 

with the K/DOQI Vascular Access CPGs. 

This physical monitoring includes 

clinical observation, auscultation, and 

palpation of the access. Additional 

information can be gained by comparing 

the patient’s expected Kt/V (given the 

current dialysis prescription) to the 

actual Kt/V. When the actual Kt/V is 

significantly lower than the expected 

Kt/V, the facility should investigate 

reasons for the discrepancy, including 

the patency of the vascular access. The 

proposed ‘‘necessary care and services’’

provision in § 494.90(a)(4) of our 

regulation would be limited to those 

vascular access actions that are 

reasonably expected within the dialysis 

facility, (generally, vascular access 

monitoring, and appropriate and timely 

referral). We have modified proposed 

§ 494.90(a)(4), now § 494.90(a)(5), which 

now reads in part, ‘‘The 

interdisciplinary team must provide 

vascular access monitoring and 

appropriate, timely referrals to achieve 

and sustain vascular access.’’ The 

current composite payment includes 

payment for clinical access monitoring. 

When intervention is indicated, 

Medicare covers certain diagnostic 

procedures. 

Comment: A commenter stated that 

the plan of care should address issues 

related to vascular access outcomes and 

the RN should be responsible for access, 

initiating treatments and monitoring 

care. The commenter also suggested that 

vascular access treatment should be 

restricted to RNs or trained LPNs, 

because surgeons often complain of 

vascular access problems in patients 

under their care, which they believe is 

related to inadequate vascular access 

training and care. 

Response: We appreciate the 

comment, however, it is not practical to 

limit cannulation and all access care to 


PWALKER on PROD1PC71 with RULES2
20404 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

RNs and trained LPNs. In many units, 

PCTs perform vascular access tasks 

under the direction of the licensed 

nursing personnel. We have 

strengthened patient care dialysis 

technician certification and training 

requirements at § 494.140(e). Only PCTs 

with proven cannulation competency 

should be inserting hemodialysis 

needles, under the direction of the RN. 

Comment: Two commenters suggested 

that we require a facility to document 

the reason a fistula is not being used to 

provide vascular access, as well as when 

applicable, a plan to place an 

arteriovenous fistula in eligible patients. 

Response: Current standards of 

practice recognize the health and 

economical benefits of arteriovenous 

fistulas over catheters or grafts used for 

hemodialysis. Vascular accesses must be 

patent over long periods of time and 

efforts should be directed towards 

obtaining and maintaining the most 

beneficial access type possible for each 

patient. While not all patients may be 

able to obtain a viable arteriovenous 

fistula, which generally lasts 

significantly longer than other access 

types, each hemodialysis patient should 

be assessed for possible arteriovenous 

fistula placement. To ensure adequate 

care planning for arteriovenous fistulas, 

we have added a phrase to the vascular 

access plan of care component at 

§ 494.90(a)(5), to require the facility to 

evaluate ‘‘whether the patient is a 

potential candidate for arteriovenous 

fistula placement.’’ The 

interdisciplinary team must enter 

documentation into the medical record 

to demonstrate that this requirement has 

been met; this documentation may 

include reasons why a fistula is not 

being used in a particular patient’s case. 

Comment: A commenter 

recommended that evaluation of the 

hemodialysis patient for the appropriate 

vascular access type should be removed 

from the ‘‘Patient plan of care’’

condition, as this would be a 

nephrologist’s responsibility. Another 

commenter asked whether the vascular 

surgeon’s determination of what kind of 

access the patient needs (per K/DOQI 

Vascular Access CPG #10) would meet 

the patient plan of care requirement to 

evaluate the patient for the appropriate 

vascular access type. 

Response: The interdisciplinary team, 

led by the nephrologist, must consider 

any vascular access determinations 

made by the vascular surgeon, but the 

team may not abdicate its role of 

promoting the placement of the safest 

access type possible for their patient. 

Comment: Several commenters did 

not agree with the proposed role of the 

dialysis facility interdisciplinary team 

as related to transplantation referral. 

One commenter stated that transplant 

referral should not be in the plan of care 

condition because it is a transplant 

center responsibility. Several 

commenters stated that accountability 

for transplant referral rests with the 

nephrologist. Two commenters stated 

that the plan of care should simply 

include documentation of the patient’s 

transplant status. Another commenter 

stated that if an eligible patient declines 

a transplant referral, this should be 

documented in the plan of care as an 

informed decision. 

Response: The proposed requirement 

regarding the role of the dialysis facility 

interdisciplinary team in the transplant 

referral process originated with the 

existing requirement in part 405, 

subpart U (§ 405.2137(a)) that required 

the completion of a long-term care 

program that addressed the selection of 

a suitable treatment modality (that is, 

dialysis or transplantation) and dialysis 

setting for each patient. The intent was 

to ensure each patient received the 

appropriate modality of care and the 

appropriate care within that modality. 

The professional team, not solely the 

nephrologist, has historically been 

accountable for developing a plan of 

care that addresses whether the patient 

was a transplant candidate. 

We proposed to clarify what would 

have to be included in the plan of care 

to include the plan for transplantation if 

the patient accepted the referral, the 

patient’s decision if an eligible patient 

declined the transplantation referral, or 

reasons that the patient was not being 

referred as a transplantation candidate, 

as determined during the assessment. 

Many long-term care programs across 

the country address these issues 

currently and it is reasonable that these 

topics be addressed in any valid plan of 

care. 

Facilities may want to develop their 

own policy identifying the role of the 

interdisciplinary team members in 

performing the actual transplant 

referral. The team member may be the 

nephrologist or another team member. 

In any case, the facility will be held 

accountable for ensuring that 

appropriate modalities are employed in 

treating chronic kidney disease patients. 

We are adopting the proposed 

transplant referral requirements at 

§ 494.90(a)(7)(ii) in this final rule. 

Comment: We received many 

comments regarding the proposed 

rehabilitation component of the ‘‘Patient 

plan of care’’ condition at § 494.90(a)(6), 

which read, ‘‘The interdisciplinary team 

must provide the necessary care and 

services for the patient to achieve and 

sustain an appropriate level of 

productive activity, including 

vocational, as desired by the patient, 

including the educational needs of 

pediatric patients (patients under the 

age of 18 years).’’ Many commenters 

supported inclusion of rehabilitation in 

the plan of care, while one commenter 

disagreed. Many commenters stated that 

the provision of necessary care and 

services for rehabilitation was beyond 

the scope of services offered by the 

dialysis facility. A few of these 

commenters stated that a requirement to 

provide rehabilitation services would 

constitute an unfunded mandate, and 

some commenters noted that social 

workers are not trained to do 

rehabilitation. One commenter 

recommended deletion of § 494.90(a)(6) 

(now § 494.90(a)(8)) and suggested that 

rehabilitation referrals be addressed 

under social services. Many commenters 

suggested a rewording of the 

requirement to be more consistent with 

the capabilities of the dialysis facility, 

and provided this wording: ‘‘The 

interdisciplinary team must assist the 

patient to achieve appropriate level of 

rehabilitation and refer the patient to 

necessary services.’’

Response: We concur with comments 

that the provision of the necessary care 

and services for rehabilitation is beyond 

the range of services offered by the 

majority of dialysis facilities. Physical 

therapy, occupational therapy, and 

academic tutoring services (for example) 

cannot realistically be provided by the 

facility staff. Therefore, in response to 

comments, we have changed the 

wording of the ‘‘rehabilitation status’’

component, now at § 494.90(a)(8), to 

read, ‘‘The interdisciplinary team must 

assist the patient in achieving and 

sustaining an appropriate level of 

productive activity, as desired by the 

patient, including the educational needs 

of pediatric patients (patients under the 

age of 18 years), and make rehabilitation 

and vocational rehabilitation referrals as 

appropriate.’’

Comment: A few commenters 

suggested that a staff person be 

identified who would be responsible for 

rehabilitation. One commenter 

suggested that the social worker has a 

major role while another commenter 

recommended that the medical director 

be responsible for ensuring that the 

team assist patients in rehabilitation and 

in making referrals. 

Response: This final rule makes the 

interdisciplinary team responsible for 

the patient plan of care, including 

rehabilitation. Referrals may be made by 

the appropriate team member, which 

may be the physician and/or the nurse 

or social worker. The role of the medical 

director, as described in § 494.150, is to 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20405 

be responsible for the delivery of patient 

care and outcomes in the facility; this 

would include rehabilitation outcomes. 

Comment: One commenter suggested 

that rehabilitation referrals be made 

before starting dialysis, when there is 

the most potential for rehabilitation 

progress. 

Response: While it may be desirable 

in some cases to provide a rehabilitation 

referral to the patient before the start of 

dialysis, this may not be possible 

because of patient illness associated 

with the symptoms of uremia, as well as 

issues related to payment for 

rehabilitation services. 

Comment: A few commenters made 

suggestions regarding patient plan of 

care rehabilitation outcomes. One 

commenter stated that the final rule 

should clarify rehabilitation outcomes 

as broadly as possible, and success 

should be defined differently for each 

patient. Another commenter suggested 

adding sub-criteria for rehabilitation 

outcomes, since the proposed 

rehabilitation requirements were not 

measurable as written. A third 

commenter recommended that the 

optimum rehabilitation outcome would 

be to return the patient to his or her 

former occupation. Another commenter 

suggested that for pediatric patients, the 

rehabilitation goal should be to help the 

patients get a high school diploma/high 

school equivalency diploma (GED), and 

those interventions and any reasons for 

a decline in rehabilitation potential 

should be documented. A few 

commenters recommended that we add 

functional status to the rehabilitation 

section. One commenter stated that a 

shift in rehabilitation focus to 

functionality (activities of daily living) 

would be more appropriate, because the 

age of many patients would suggest that 

rehabilitation might not be realistic for 

them. Another commenter suggested 

that we make maximizing 

physical/mental functioning scores a 

rehabilitation goal, and aim to help 

patients maintain or improve vocational 

status as measured annually, using the 

employment categories on the CMS–

2728 Medical Evidence form at http:// 

www.cms.hhs.gov/cmsforms/ 

downloads/cms2728.pdf. 

Response: The introductory language 

to the ‘‘Patient plan of care’’ condition 

calls for the establishment of 

‘‘measurable and expected outcomes 

and estimated timetables to achieve 

these outcomes.’’ This requirement will 

allow for individualized plans that lead 

to desirable outcomes for patients in all 

care areas listed in the patient’s plan of 

care, including rehabilitation. Outcomes 

listed in the plan of care could include 

such targets as the return of the patient 

to a former occupation, attainment of a 

certification of education, return to 

normal activities within the patient’s 

household, a certain level of 

functionality, or any another outcome 

that the team has determined is 

appropriate for the patient. Dialysis 

facilities have the flexibility to choose 

appropriate rehabilitation outcome 

targets, and we will not narrowly define 

them in this final rule. 

Comment: Two commenters stated 

that any rehabilitation services to which 

a patient might be referred would be 

time-limited, and the patient may not 

reach his or her full rehabilitation level; 

they stated that the regulation would 

need to allow for this. 

Response: If, while pursuing a 

rehabilitation goal, the team 

encountered limits on the patient’s 

eligibility for services (for example, a 

limited number of physical therapy 

sessions), the plan, goals and timetables 

would need to be adjusted and the 

reason noted in the patient’s record, as 

required at § 494.90(b)(3). 

Comment: One commenter suggested 

that the care team be required to discuss 

with the patient whether to seek 

physical therapy, occupational therapy, 

counseling or vocational rehabilitation 

referrals. 

Response: The patient is a member of 

the interdisciplinary team and, as such, 

should participate in team discussions 

regarding rehabilitation potential and 

goals. 

Comment: A commenter 

recommended that we require a separate 

rehabilitation assessment initially and 

again every 3 to 6 months. 

Response: The frequency of the 

rehabilitation assessment will be the 

same as the frequency of the 

comprehensive assessment, since this is 

a component of the assessment. (See 

§ 494.80(b).) 

Comment: We received many 

comments suggesting modifications to 

the components of the patient plan of 

care. Many commenters suggested that 

we add ‘‘mineral metabolism/bone 

disease’’ as a required component of the 

patient plan of care and referred to the 

NKF K/DOQI Clinical Practice 

Guidelines for Bone Metabolism and 

Disease in Chronic Kidney Disease 

(American Journal of Kidney Disease 

42:S1–S202, 2003 (supplement 3)). Two 

commenters specifically suggested that 

we incorporate the K/DOQI CPGs for 

bone metabolism and disease in CKD 

patients. 

Response: In response to comments 

and evidence supporting the importance 

of mineral metabolism management to 

the health of dialysis patients, we will 

add mineral metabolism to the list of 

required components of the plan of care 

by inserting the following language at 

§ 494.90(a)(3): ‘‘Provide the necessary 

care to manage mineral metabolism and 

prevent or treat renal bone disease.’’

Care and services are limited to those 

normally provided by the dialysis 

facility and would include appropriate 

referrals outside the dialysis facility 

when appropriate. Current professional 

practice standards include management 

of renal bone disease in dialysis 

patients, and we agree that mineral 

metabolism and bone disease 

management is well within the purview 

of the dialysis facility. 

Comment: Many commenters 

supported adding a requirement for the 

interdisciplinary team to document in 

the medical record or plan of care the 

reasons a patient was not referred to 

home care, if applicable. Other 

commenters suggested adding 

medication therapy management and 

advance directives as additional plan of 

care components. 

Response: The patient must be 

assessed at least annually for modality 

choice and level of participation in the 

dialysis care process. We agree with 

commenters that it is appropriate to 

have a plan of care component that 

corresponds with the treatment 

modality assessment required at 

§ 494.80(a)(9) and § 494.80(a)(10), and it 

is appropriate to document the barriers 

to home dialysis. Therefore, we have 

added home dialysis to § 494.90(a)(7)(i), 

coupling home dialysis with 

transplantation status (proposed 

§ 494.90(a)(5), now § 494.90(a)(7)(ii)) 

under a ‘‘modality’’ plan of care 

component. This new ‘‘Modality’’ plan 

of care provision reads, ‘‘Modality: (i) 

Home dialysis. The interdisciplinary 

team must identify a plan for home 

dialysis or explain why the patient is 

not a candidate for home dialysis.’’ This 

provision requires that, based on the 

most recent assessment, the plan of care 

must be revised to reflect modalities for 

which the patient is a candidate and the 

patient’s preferences regarding 

modality. 

Advance directives were added under 

the ‘‘Patient’s rights’’ and ‘‘Medical 

records’’ conditions and therefore we 

will not require advance directives 

within the plan of care. Facilities have 

the flexibility to address advance 

directives within the plan of care when 

they deem it appropriate. Medication 

therapy management may be included 

within the action plan for various 

components of the plan of care. 

Comment: A commenter suggested 

that the plan of care address 

cardiovascular health, and referred to 

the NKF K/DOQI Clinical Practice 


PWALKER on PROD1PC71 with RULES2
20406 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

Guidelines for Cardiovascular Disease in 

Chronic Kidney Disease (American 

Journal of Kidney Disease 45:S1–S154, 

2005 (supplement 3)). The commenter 

stated that the NKF recommends that 

electrocardiograms be performed in all 

patients at the initiation of dialysis, 

once patients have achieved dry weight, 

and at 3 yearly intervals thereafter. In 

addition, appropriate blood pressure 

management is an important part of 

dialysis care and contributes directly to 

cardiovascular health. 

Response: Cardiovascular disease is a 

concern for dialysis patients and is 

affected by renal bone disease, blood 

pressure, and fluid management as well 

as any other risk factors the patient may 

have. Dialysis patients often have a 

number of co-morbidities. The patient’s 

medical history and co-morbidities are 

to be assessed as required at 

§ 494.80(a)(1). Any problems identified 

by the comprehensive assessment are to 

be addressed in the patient plan of care 

as required at § 494.90. Since very little 

support came from commenters 

specifically to add a cardiovascular 

disease component to the plan of care, 

we have not added this requirement. 

However, dialysis-related 

cardiovascular health problems must be 

addressed in the plan of care whenever 

it is appropriate for an individual 

patient, as determined by the 

interdisciplinary team. Although core 

components of the plan of care are listed 

in this final rule, the interdisciplinary 

team has flexibility to add areas to the 

plan of care as identified in the 

comprehensive assessment. 

Comment: We received many 

comments regarding whether a social 

services component should be required 

in the ‘‘Patient plan of care’’ condition. 

Most of the comments recommended 

that social services be part of the plan 

of care and referred to current research 

regarding social work services. 

Commenters stated that studies have 

shown that social work intervention 

improves patients’ quality of life, their 

adherence to the ESRD treatment 

regimes and fluid restrictions, and 

improves medication compliance. 

Another example of improved outcomes 

provided by a commenter is that social 

work interventions can reduce patients’

blood pressure and anxiety levels. 

Commenters suggested including 

emotional and social well-being criteria 

in the final rule. Some commenters 

recommended including functional 

status measures that they believe 

correlate with better survival and 

hospitalization rates. Other commenters 

recommended requirements that would 

specify psychosocial criteria along with 

MSW tasks and responsibilities, and 

which would require that MSWs 

provide information and training to 

patients. Some commenters suggested 

adding specific language that would 

address measurable improvement in 

physical, mental, and clinical health 

outcomes * * *,’’ ‘‘psychosocial status 

and appropriate referral for services 

* * *,’’ and would ‘‘provide the 

necessary care and services to achieve 

and sustain effective psychosocial status 

* * *.’’ Many commenters suggested 

that we require use of a tool to assist in 

measuring psychosocial status. Tools 

suggested include the Zung SelfAssessment Depression Scale or 

Hamilton Anxiety Scale, and a qualityof-life tool such as the SF–36, or SF–12 

(version 2.0 tool), that commenters state 

are used to measure depression, 

functional status, and predict mortality 

and morbidity. Commenters cited 

research supporting social work 

interventions that they believe would 

contribute to meeting patient care team 

goals. 

Response: In response to the large 

number of comments, and in light of 

current academic research supporting 

social service interventions to improve 

patient care, we are adding a social 

services component, called 

‘‘psychosocial status’’ to the plan of care 

requirements at § 494.90(a)(6). We are 

requiring that a standardized tool, 

chosen by the social worker, be used to 

monitor patient status, and that 

counseling be provided and referrals be 

made as appropriate. This new 

requirement reads, ‘‘The 

interdisciplinary team must provide the 

necessary monitoring and social work 

interventions, including counseling and 

referrals for social services, to assist the 

patient in achieving and sustaining an 

appropriate psychosocial status as 

measured by a standardized mental and 

physical assessment tool chosen by the 

social worker, at regular intervals, or 

more frequently on an as-needed basis.’’

The standardized tool should be a 

professionally accepted, valid, reliable 

tool, such as the SF–36, and should 

relate to the patient’s functional health 

and well-being. The tool must be used 

as a monitoring aid that assists in 

determining the patient’s psychosocial 

status. The SF–36 model uses metrics 

that measure physical health as related 

to functional level and presence of pain, 

and mental health as related to social 

functioning, emotional and mental 

health. Reliability and validity studies 

have been performed for this 

instrument. More information about the 

SF–36 may be found in numerous 

articles or on the Web at http:// 

www.sf-36.org/tools/sf36.shtml. The SF–

12 survey form was derived from the 

SF–36 form and scales the 36 question 

survey down to a 1-page, 2-minute 

version. However, we are not specifying 

which tool must be used in order to 

allow flexibility and to limit the amount 

of burden. The choice of which 

standardized tool to use is best left to 

the facility social worker. 

Comment: Although most comments 

recommended that social services be 

part of the plan of care, two commenters 

disagreed, stating that social workers 

have too big a caseload and are not 

capable of providing professional 

counseling services. One commenter 

stated that until there is consensus on 

outcomes, CMS should not include an 

outcomes-based social service 

requirement in the plan of care. 

Commenters supporting social services 

in the plan of care submitted a lengthy 

list of references that highlight the 

importance of social services as related 

to improved patient outcomes. 

Response: In the previous conditions 

(§ 405.2162) as well as in this final rule 

(§ 494.180(b)), dialysis facilities are 

required to have adequate staff available 

to meet the care needs of their dialysis 

patients. This requirement applies to the 

provision of social services as well. 

Facilities may want to assess the 

caseloads of social workers to ensure 

there are adequate staff to provide the 

appropriate level of social services, 

including counseling. Social workers 

who meet the qualifications at 

§ 494.140(d) are capable of providing 

counseling services to dialysis patients. 

Furthermore, Medicare payment for 

social worker counseling services is 

included in the dialysis facility 

composite rate. 

We are setting forth some process 

requirements within the ‘‘Patient plan of 

care’’ condition because measurable 

outcomes in all areas are not yet 

available. When evidence-based or 

consensus outcome measures and 

standards become available, we may 

consider whether some process 

requirements may be removed from the 

conditions for coverage in the future. 

Comment: We received a comment 

recommending that consistent language 

be used for all plan of care elements so 

that for all care plan areas the dialysis 

facility ‘‘must provide the necessary 

care and services to achieve and sustain 

an effective (treatment program).’’

Response: Requiring the facility to 

provide all necessary care and services 

for all elements of the patient plan of 

care may overstep the facility’s scope of 

practice in some areas, as pointed out by 

several commenters. 

Comment: One commenter questioned 

the need to list components of the plan 

of care, since a qualified care team 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20407 

would develop an appropriate plan, 

which would include measurable and 

expected patient outcomes conforming 

to community-accepted standards. The 

commenter stated this would not need 

to be mandated, nor should it. 

Response: Although quality-oriented 

facilities may develop meaningful plans 

of care that include measurable 

outcomes, we do not agree that all 

facilities adequately develop and 

implement such a plan of care. This 

patient-centered condition serves to 

protect the health and safety of dialysis 

patients and to ensure that adequate 

patient care services are provided. 

Comment: A commenter suggested 

that when referring to the 

interdisciplinary team implementing the 

plan of care at § 494.90(b)(1)(i) the 

phrase ‘‘inclusive of the patient’’ be 

added. 

Response: The interdisciplinary team 

definition specifically includes the 

patient, and has been added to the first 

paragraph of this condition. We have 

added the phrase ‘‘including the patient 

if the patient desires’’ to § 494.90(b)(1)(i) 

to clarify that we expect that the patient 

will want to participate in devising the 

plan of care. 

Comment: We received many 

comments regarding the proposed 

requirement at § 494.90(b)(1)(ii) 

suggesting that the patient sign the plan 

of care. A few commenters 

recommended the plan of care be signed 

by the patient’s attending physician as 

well as the patient. 

Response: The patient plan of care 

must be completed by the 

interdisciplinary team (§ 494.90(b)(1)(i)). 

It is standard practice for all team 

members, including the treating 

physician, that develop the plan of care 

to sign it, as they would for any other 

entries into the medical record. 

Therefore, we are changing the wording 

at § 494.90(b)(1)(ii) to reflect that all 

team members must sign the plan of 

care. 

Comment: Commenters agreed with 

the proposed rule requirement that the 

plan of care be signed by the patient or 

the patient’s designee. One commenter 

stated that at least one facility, to his or 

her knowledge, limits patient 

involvement exclusively to signing the 

care plan; the staff orders the patient to 

sign and the RN on-duty becomes 

offended if the patient actually reads the 

care plan. The commenter further noted 

that patients should be able to indicate 

the date they signed the care plan. 

Another commenter noted that the 

proposed rule did not require the 

patient to be involved in the 

development of the care plan, but only 

to sign it. This commenter was 

concerned that only paper compliance 

would be achieved with such a 

provision, and that enforcement 

regarding patient involvement would be 

difficult. One commenter recommended 

that facilities be required to conduct 

periodic patient care conferences. The 

commenter further stated that deleting 

survey tag V174 would be detrimental to 

quality of care and CMS should prevent 

a ‘‘pass around the paper’’ meaningless 

care plan development process. 

Response: The role of the patient is 

central to providing quality dialysis 

care. Paper compliance without 

substantive compliance is unproductive. 

Specifically, the patient member of the 

interdisciplinary team has a role in 

converting the comprehensive 

assessment into a meaningful plan of 

care. Whenever possible, the patient (or 

designee) should assist in the 

identification of goals and in 

formulating the action plan to achieve 

these goals. The patient must be 

involved in care planning and actively 

participate in care plan development 

and review. 

Survey tag V174, referred to by the 

commenter, required regularly 

scheduled conferences, with 

participation by the staff involved in the 

patient’s care, to evaluate the progress 

each patient is making towards the goals 

in their long-term care program and 

patient care plan. However, this final 

rule also allows the facility flexibility to 

choose the methods to ensure patient 

participation. One means of providing 

an opportunity for participation is to 

have the patient attend the meeting in 

which the plan of care is developed and 

updated. This final rule makes very 

clear that the patient is part of the care 

team and can participate in the 

assessment and the plan of care 

activities if the patient desires to do so. 

While we have not required monthly 

care plan meetings specifically, the 

facility must demonstrate that there is 

an opportunity for patient involvement 

and participation. The facility has the 

flexibility to design a process. The 

patient signature on the plan of care is 

not sufficient to demonstrate patient 

participation. The new interpretive 

guidelines for this regulation will 

include direction to surveyors regarding 

enforcement of this provision. 

Comment: A few commenters were 

concerned about dialysis facility 

responsibility for patient participation 

in cases where the patient chooses not 

to participate. Some commenters 

suggested that there be a provision in 

this final rule for situations in which the 

patient refused to sign the plan of care. 

The commenter suggested that in such 

cases, documentation provided by the 

facility explain that the patient had 

refused to provide a signature. 

Response: We agree that as long as the 

patient has been provided sufficient 

opportunity to participate with the 

interdisciplinary team, the dialysis 

facility should not receive a citation for 

non-compliance with these conditions 

when the patient has refused to 

participate or sign the plan of care. We 

have modified the language at 

§ 494.90(b)(1)(ii) to indicate that the 

facility must document a patient’s 

refusal to sign the plan of care, along 

with the reason the signature was not 

provided. 

Comment: We received many 

comments regarding the time period for 

commencing implementation of the 

patient plan of care (§ 494.90(b)(2)). The 

proposed rule specified that the plan of 

care would have to be implemented 

within 10 days of any comprehensive 

assessment. While there was some 

agreement with this proposal, many 

commenters stated that 10 days was too 

short. Some commenters suggested that 

we combine the assessment and plan of 

care time period to 30 days. 

Commenters suggested a myriad of 

alternative timeframes for implementing 

the plan of care, such as requiring 

implementation within 15 days of 

assessment completion, within 90 days 

of starting dialysis, within a certain 

number of dialysis treatments (to allow 

for the possibility of patient 

hospitalizations), or at the first team 

meeting following completion of the 

assessment. The reasons facilities gave 

for needing a longer plan of care 

implementation time included the 

shortage of staff, needing time for 

referrals and schedule coordination, the 

need for interpreters, accommodating 

monthly care plan meetings, and the 

difficulties involved in bringing the 

multidisciplinary team together 

monthly. 

Response: We believe we must 

balance the health and safety needs of 

the patient against the staffing 

limitations of the facilities. The case 

loads of staff and constraints of facility 

processes should not outweigh the need 

to develop and implement the plan of 

care within a reasonable period of time. 

If a patient has received in-center 

dialysis for a 1-month period or 13 

(thrice-weekly) hemodialysis 

treatments, that patient has likely been 

physically present in the dialysis 

facility for at least 40 hours. We believe 

that this should provide sufficient time 

for the interdisciplinary team to have 

completed an assessment and developed 

a plan of care that is ready for 

implementation. Thirty days is a 

reasonable timeframe for the initial 


PWALKER on PROD1PC71 with RULES2
20408 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

assessment and implementation of the 

plan of care in order to protect the 

health and safety of patients and 

prevent harm. Facilities may want to reevaluate their processes, resources, and 

adequacy of staff if they find the 30-day 

deadline to be too difficult to meet. We 

have modified the requirement at 

§ 494.90(b)(2), so that the 

interdisciplinary team has a timeframe 

of the latter of 30 days or 13 

hemodialysis treatments from the date 

of admission to complete the assessment 

and implement the plan of care. This 

provision now addresses commenter 

concerns regarding time lapses when a 

patient is in the hospital. Referrals are 

considered to be a part of the 

implementation of the plan of care and 

would not be a reason to allow extended 

time periods to complete and 

implement the plan of care. In addition, 

we will allow a 15 day time period for 

the facility to implement any patient 

plan of care revision due to completion 

of a monthly assessment (done for 

unstable patients) or an annual 

assessment (completed for stable 

patients) (§ 494.90(b)(2)). 

Comment: Many comments addressed 

proposed § 494.90(b)(4), which would 

require the dialysis facility to ensure 

that the patients are seen at least 

monthly by a physician providing ESRD 

care. Some commenters supported this 

provision and a few suggested that the 

visit could take place in the physician’s 

office. Other commenters disagreed with 

the requirement but agreed with the 

intent, saying that physicians should see 

their dialysis patients at least monthly. 

Many commenters strongly disagreed 

with the provision, stating that the 

facility should not be accountable for 

physician visits. A few commenters 

stated that the payment G-codes 

provided enough incentive for facilities 

and that therefore this physician visit 

requirement was not needed. Other 

commenters suggested there was no 

evidence of any benefits that could be 

linked to monthly visits, and this would 

be especially burdensome for rural 

dialysis facilities. One commenter 

recommended that an exception be 

available for facilities in the Pacific 

Islands. Two commenters suggested that 

CMS had no authority to mandate these 

monthly physician visits according to 

section 1801 of the Social Security Act, 

which prohibits the federal government 

from exercising any supervision or 

control over the practice of medicine. 

Response: We believe that it is in the 

best interest of the patient for dialysis 

facilities to ensure that a physician (or 

other practitioner, such as a PA, nurse 

practitioner, or clinical nurse specialist) 

visits each month. The Dialysis 

Outcomes and Practice Patterns Study 

(DOPPS) data demonstrate that 

physician contact correlates with the 

quality of care. The G-codes, established 

in the final rule, ‘‘Medicare Program; 

Revisions to Payment Policies under the 

Physician Fee Schedule for Calendar 

Year 2004’’ published November 7, 2003 

(68 FR 63196, 63216), provide payment 

to physicians in incremental amounts 

depending on whether the patient was 

seen 1, 2–3, or 4 times during a given 

month. Although the payment G-codes 

provide some incentive for attending 

physicians to see their dialysis patients 

more often, physicians may still choose 

not to see their patients for a month or 

more. In this case, the patient still 

receives dialysis for which the facility 

receives payment. We do not believe 

that requiring monthly visits infringes 

on how physicians practice medicine 

and note that physician organizations 

that provided comment on the proposed 

rule supported the provision. We are 

retaining the proposed provision at 

§ 494.90(b)(4) to ensure that patients 

receive face-to-face physician (or, as 

discussed below, ‘‘physician extender’’) 

visits at least monthly. 

Comment: A few commenters 

suggested that physician assistants be 

allowed to perform monthly visits, 

while one commenter favored allowing 

a nurse practitioner to perform monthly 

visits. 

Response: In response to comments, 

we have added nurse practitioners, 

clinical nurse specialists, and physician 

assistants as options for compliance 

with the provision requiring monthly 

visits by a physician. CMS has 

previously issued instructions regarding 

physician visits and payment via Gcodes and these instructions clarify that 

a physician assistant, clinical nurse 

specialist, or a nurse practitioner may 

provide visits to dialysis patients 

instead of a physician. Physicians may 

use nurse practitioners, physician 

assistants, and clinical nurse specialists, 

who are able under the Medicare statute 

to furnish services that would be 

physician services if furnished by a 

physician and who are eligible to enroll 

in the Medicare program, to deliver 

some of the visits during the month. 

Comment: We received many 

comments regarding proposed 

§ 494.90(c), ‘‘Transplantation referral 

tracking,’’ which would require the 

interdisciplinary team to track the 

results of each kidney transplant center 

referral and monitor the status of any 

facility patients who are on the 

transplant wait list. In addition, this 

standard would require the team to 

communicate with the transplant center 

regarding patient transplant status at 

least quarterly or more frequently if 

necessary. Some commenters supported 

this standard as proposed and many 

commenters stated the dialysis facility 

should not be accountable for 

transplantation referral tracking once 

the referral has been made. Commenters 

who disagreed with this proposed 

provision stated that other parties have 

this tracking responsibility, including 

the transplant center, the transplant 

candidate, and/or the physician. Two 

commenters stated that this requirement 

creates a burden for dialysis facilities. 

Some commenters acknowledged that 

the proposed (now final) transplantation 

center conditions of participation, 

published on March 30, 2007, included 

a proposed requirement for transplant 

centers to communicate with dialysis 

centers regarding transplant candidate 

status. A few commenters suggested that 

dialysis facility responsibility be limited 

to maintaining a list of patients on the 

transplant wait list. Several commenters 

stated that some transplant centers did 

not communicate with the dialysis 

facility, or that it was difficult to get 

information from the transplant center. 

One commenter suggested penalties for 

transplant centers that did not 

communicate with dialysis facilities, 

while another commenter suggested that 

incentives be provided to transplant 

centers to share information monthly on 

transplant candidates’ work-up and 

listing status. 

Response: Our intent is to ensure that 

the interdisciplinary team is aware of 

where the patient is in the referral and 

transplant evaluation process so that 

patients do not get ‘‘lost’’ along the way. 

We do not expect that the transplant 

referral tracking responsibilities borne 

by the dialysis facilities would be 

redundant with the responsibilities of 

the transplant center. We would expect 

the interdisciplinary team to be aware of 

whether the patient has completed the 

evaluation process, is wait-listed, 

ineligible for wait listing, or is awaiting 

living donation. Moreover, the dialysis 

facility is expected to alert the 

transplant center about changes in the 

patient’s condition that would affect 

whether a patient was able to receive 

kidney transplantation. The 

transplantation center conditions of 

participation published on March 30, 

2007 (72 FR 15198) require kidney 

transplant centers to communicate 

transplant patient status to the dialysis 

facility at § 482.94(c)(1) and 

§ 482.94(c)(2) so that there is two-way 

communication. 

Comment: A few commenters who 

agreed that there was a need for dialysis 

facility and transplant center 

communication did not agree with the 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20409 

proposed quarterly frequency of this 

communication. One suggestion was to 

remove the ‘‘quarterly’’ language and 

replace it with ‘‘when there is a 

change.’’

Response: We agree. In response to 

comments, we have changed the 

frequency of required communication 

with the transplant center at 

§ 494.90(c)(3) so that the regulation will 

require the interdisciplinary team to 

contact the transplant center ‘‘at least 

annually, and when there is a change in 

transplant candidate status.’’ Although 

the proposed ESRD conditions for 

coverage called for quarterly 

communication with the transplantation 

center, the transplantation center final 

rule (at § 482.94(c)(1)and (2)) requires 

that the transplant center notify the 

dialysis facility of the patient’s 

transplant status only when there are 

changes in such status (72 FR 15276). 

Our purpose here is to provide a means 

by which up-to-date information can be 

made available to the transplant team so 

that eligible patients are wait-listed and 

so that patients offered a donor kidney 

are in a position to accept the 

transplantation. The dialysis team also 

needs up-to-date information so that the 

team can choose the most appropriate 

ESRD modality and setting for the 

patient and assist the patient in 

understanding the process used to 

obtain kidney transplantation. 

Comment: Commenters made several 

additional transplant recommendations. 

One commenter suggested that an RN 

with specific transplant related duties is 

needed to act as transplant coordinator. 

Response: While dialysis facilities 

may find it beneficial to have an RN 

transplant coordinator assist in 

transplant referral tracking, we do not 

believe it should be a requirement. We 

are allowing flexibility so that the 

tracking may be done by staff members 

chosen by the dialysis facility. 

Comment: One commenter suggested 

that the dialysis facility and the 

transplant center have a written 

agreement with each other. 

Response: If a dialysis facility finds it 

useful to have a written agreement with 

the transplant center, the dialysis 

facility has the flexibility to pursue this, 

but we do not believe it is necessary and 

will not require it. 

Comment: One commenter suggested 

that there should be an internet database 

to facilitate communication between 

transplant centers and dialysis facilities. 

Response: While there may be some 

benefit in having an internet database to 

facilitate communication between 

transplant centers and dialysis facilities, 

we will not burden dialysis facilities 

with developing such an internet 

database. We believe an active and 

ongoing communication and 

coordination process will suffice 

currently. As electronic health records 

become a reality in the future, there is 

the possibility that these records could 

facilitate dialysis facility and kidney 

transplant center communications and 

exchange of information. 

Comment: One commenter suggested 

that the transplantation requirements 

should be consistent with the 

recommendations of the 2005 ESRD 

Network technical expert panel (TEP) 

that worked on developing transplant 

referral clinical performance measures. 

Another commenter stated that 

conditions for transplant center, 

physician and patient communications 

should be based on the study and 

endorsement of the American College of 

Physicians and physician organizations. 

Response: The TEP referred to by the 

commenter was charged with 

developing dialysis facility-specific 

kidney transplant referral clinical 

performance measures. These measures 

would track steps in the transplant 

referral process. TEP membership 

included transplant surgeons, 

nephrologists, and dialysis facility 

representatives. The TEP recommended 

that this final rule include the proposed 

transplantation provisions at 494.90(c) 

in order to facilitate implementation of 

the kidney transplant referral CPMs they 

developed. We have adopted the 

proposed transplant provisions and 

believe this will alleviate the concerns 

of the commenters. 

Comment: A few commenters 

responded to our query as to whether 

we should specify actions (that is, 

transplant referral activities and 

monthly blood draws for antigen/ 

antibody testing) that must be included 

in the transplantation action plan. Two 

commenters stated that monthly 

transplant blood drawing should not be 

the responsibility of the dialysis facility. 

One commenter supported the concept 

that facilities should support patients in 

the process of a work-up for a 

transplant, which would include 

tracking tests, communication with 

transplant coordinators/surgeons, etc. 

Response: We will not specify actions 

that must be included in the patient 

plan of care under the transplantation 

component, but encourage dialysis 

facilities to assess the circumstances 

and include appropriate actions in the 

plan of care as needed. 

Comment: We received several 

comments supporting inclusion of the 

‘‘Patient education and training’’

standard at § 494.90(d). Some 

commenters recommended the addition 

of other training topics, including 

patient education regarding 

arteriovenous fistulas, advance 

directives, and more. A commenter 

recommended that we require 

documentation in the medical record 

that patients were informed of the risks 

and benefits of various types of vascular 

access consistent with ‘‘Fistula First’’, 

and provide funding for this if needed. 

Response: We agree that it is a 

reasonable expectation that dialysis 

patients be educated regarding the risks 

and benefits of various access types due 

to the impact of a vascular access on the 

patient’s morbidity and mortality risks. 

Comments on this and other sections of 

these conditions strongly support 

adding a requirement ensuring that 

patients must be educated regarding the 

risks, benefits, and outcomes of various 

access types. These comments are in 

keeping with the National ‘‘Fistula 

First’’ quality initiative. Additionally, 

the Institute of Medicine (IOM) has 

encouraged the empowerment of 

patients to improve the quality of the 

healthcare system. Therefore, we have 

added new language to the ‘‘Patient plan 

of care’’ condition at § 494.90(d), Patient 

education and training, requiring that 

the plan of care include education and 

training on the benefits and risks of 

various vascular access types. We have 

also added infection prevention and 

personal care, and home dialysis and 

self-care training to this provision in 

response to comments as discussed 

under the ‘‘Infection control’’ and ‘‘Care 

at home’’ sections of the preamble. 

Comment: One commenter believes 

that education for all life changes 

associated with dialysis is an unfunded 

mandate that will require additional 

personnel skilled in this training. The 

commenter also stated that patient 

education regarding employment, 

rehabilitation and transplantation is 

beyond the scope of the dialysis center 

nurses and technicians. 

Response: Patient education is 

included in the Medicare composite rate 

paid for dialysis. We expect that the 

interdisciplinary team has the skills and 

expertise needed to educate dialysis 

patients about aspects of the dialysis 

experience, dialysis management, 

quality of life, rehabilitation, and 

transplantation. 

d. Care at Home (Proposed § 494.100) 

We proposed a separate condition for 

coverage for care at home requirements, 

which were previously located in four 

existing sections of 42 CFR part 405, 

subpart U. The requirement that 

services to home patients be at least 

equivalent to those provided to incenter patients was retained from 

existing § 405.2163. We addressed home 


PWALKER on PROD1PC71 with RULES2
20410 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

dialysis training in the proposed rule 

and proposed requiring the 

interdisciplinary team to provide 

training to the patient and/or the 

designated caregiver before the 

initiation of home dialysis. We 

proposed that the home training be 

provided by a facility approved to 

provide home dialysis services and that 

home and self-care training would have 

to be conducted by an RN. The 

proposed training would have to 

address specific needs of patients in 

several subject areas, including the 

nature and management of ESRD, 

techniques associated with the 

treatment modality, nutritional care 

plans, emotional and social well-being, 

methods to detect, report and manage 

potential complications, how to access 

and use available resources, how to selfmonitor health status, how to handle 

emergencies, infection control 

precautions, and proper waste and 

disposal procedures. We also proposed 

a home dialysis-monitoring standard, 

which would have required the dialysis 

facility to document that the patient 

and/or caregiver received and 

demonstrated adequate comprehension 

of the training; retrieve and review selfmonitoring data and other information 

at least every two months; and maintain 

this information in the medical record. 

We proposed to retain many of the 

existing regulations regarding home 

dialysis support services; however, the 

proposed support services standard was 

strengthened by requiring home dialysis 

patient consultation with the 

interdisciplinary team. The team also 

would have been held responsible for 

the development and periodic review of 

the patient’s plan of care based upon the 

comprehensive assessment, and for 

addressing the patient’s needs and 

achieving the expected outcomes of 

care. The proposed rule also would have 

expanded existing requirements to 

monitor the quality of water used by 

home hemodialysis patients. The 

proposed rule specifically included 

onsite evaluation of the water system, as 

well as adherence to applicable AAMI 

guidelines and immediate correction of 

any problems with the water treatment 

system. If problems could not be 

immediately corrected the facility 

would have to arrange for backup 

dialysis until the home dialysis water 

quality could be restored. At 

§ 494.100(c)(1)(vi), the proposed rule 

would retain existing requirements that 

the dialysis facility be responsible for 

‘‘Purchasing, delivering, installing, 

repairing and maintaining medically 

necessary home dialysis supplies and 

equipment (including supportive 

equipment) prescribed by the attending 

physician.’’ The proposed rule also 

would have required facilities to plan 

for and arrange for emergency back-up 

dialysis services when needed. We also 

proposed that the facility maintain 

record-keeping systems that ensured 

continuity of care; this would have also 

been retained from existing provisions 

found at § 405.2163(e)(3). 

Comment: Many commenters strongly 

supported the requirement that home 

dialysis patients receive services that 

are at least equivalent to those provided 

to patients in facilities. One patient 

remarked he felt his peritoneal dialysis 

care was not equivalent to in-center 

hemodialysis. Another commenter said 

home dialysis needs more attention in 

the final rule. 

Response: We appreciate the positive 

response from commenters. All the 

ESRD conditions for coverage must be 

met regardless of whether the setting is 

in-center or at home. We have added 

language to clarify this in the first 

paragraph of § 494.100, to require that 

dialysis facilities meet all applicable 

conditions of this part. We would 

expect that under these new regulations, 

dialysis facilities would make any 

necessary changes to ensure that all 

patients receive the same quality of care 

regardless of the location of the service. 

We have increased the home dialysis 

focus of these conditions by making 

‘‘Care at home’’ a separate condition for 

coverage. 

Comment: A few commenters 

recommended that a new section be 

added to our regulation, to address 

patients performing self-care dialysis in 

the facility, and address policies and 

procedures for self-care in the facility. 

These commenters believed that 

stringent regulation and oversight was 

needed for self-care. One commenter 

suggested there should be requirements 

for self-care training for both patients 

and facility staff and that self-dialysis 

training should include treatment 

monitoring, machine monitoring, needle 

procedures, and infection control. 

Response: We encourage self-care, 

both at home and within the facility, 

whenever the patient has the ability. 

Self-care can be supported in-center by 

Medicare-certified outpatient dialysis 

facilities. Dialysis facilities that provide 

self-care must meet these conditions for 

coverage and protect patient safety. We 

do not agree that additional regulations 

are needed regarding self-care. 

Comment: One commenter remarked 

that the requirements as written would 

require all patient training to be 

completed before the initiation of home 

dialysis, and the commenter suggested 

that this was not practical because 

patients would lose interest in 

performing home dialysis before the 

instruction was complete. 

Response: As required at § 494.100(a), 

the interdisciplinary team must oversee 

the training provided to the home 

dialysis patient and the designated 

caregiver before the initiation of home 

dialysis. Patients should not begin home 

dialysis before adequate training is 

complete and competency has been 

determined. We have maintained the 

language of the proposed rule. 

Comment: One commenter agreed that 

initial home training should be 

conducted by a qualified RN. Some 

commenters remarked that the 

requirement for an RN to train home 

dialysis patients was excessively 

stringent and that an LPN was qualified 

to train these patients. Another 

suggested that an RN be responsible for 

home training but still have the ability 

to delegate parts of the training program 

to a trained LPN or PCT. Two 

commenters suggested the final rule 

allow PCTs, under the supervision of an 

RN, to provide patients with some or all 

home care training, with a final review 

and evaluation done by an RN. One 

commenter strongly opposed the 

provision at § 494.100(a), which 

required that the interdisciplinary team 

be responsible for providing selfdialysis training to home patients. 

Response: The existing requirement at 

§ 405.2162(c) mandates that an RN be in 

charge of self-care training. We believe 

that an RN, as an experienced health 

professional, fully understands the 

complexity and rationale for the dialysis 

process, and is the best-suited expert to 

conduct self-care training to patients. 

The requirement serves to protect the 

health and safety of the patient. 

Therefore, we have retained the 

proposed RN requirement in the final 

rule at § 494.100(a)(2), which stipulates 

that the RN must conduct the home 

training. The RN may use other 

members of the clinical dialysis staff to 

assist in providing the home training. 

However, the RN is responsible to 

ensure that the training is in accordance 

with the requirements at § 494.100. 

In addition, we have modified the 

provision at proposed § 494.100(a), 

which would have required that the 

interdisciplinary team be responsible for 

providing the self-dialysis training to 

home patients, to clarify that the role of 

the interdisciplinary team is to oversee 

the home dialysis training. 

Comment: Several commenters 

suggested that training topics should be 

determined by the facility rather than 

regulation. Some commenters suggested 

removing at least two of the proposed 

training topics (proposed 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20411 

§ 494.100(a)(3)(iii), implementation of a 

nutritional care plan, and 

§ 494.100(a)(3)(iv), how to achieve and 

maintain emotional and social wellbeing), since these topics are proposed 

to be covered in the ‘‘Patient plan of 

care’’ condition. 

Response: Patient education and 

training are addressed in the ‘‘Patient 

plan of care’’ condition, which now 

requires that the care plan include 

education and training regarding home 

dialysis and self care, as appropriate, at 

§ 494.90(d). All dialysis patients, 

whether home or in-center, are to 

receive counseling regarding nutrition 

and psychosocial well-being 

(§ 494.90(a)(2) and (6), respectively). We 

concur with the comments and believe 

it is redundant to include these topics 

under the self-care training standard at 

§ 494.100(a). Therefore, we have 

removed ‘‘implementation of a 

nutritional care plan’’ at proposed 

§ 494.100(a)(3)(iii) and ‘‘how to achieve 

and maintain emotional and social wellbeing’’ at proposed § 494.100(a)(3)(iv). 

Comment: One commenter suggested 

removing the specific level of 

hemoglobin and hematocrit and 

replacing it with reference to evidencebased standards. 

Response: We have modified the final 

rule at § 494.100(a)(3)(ii) because the 

proposed language was redundant. The 

‘‘Patient plan of care’’ condition at 

§ 494.90(a)(4) requires that the 

interdisciplinary team develop a plan of 

care that addresses anemia, and 

specifies the hemoglobin and hematocrit 

targets. In the final rule at 

§ 494.100(a)(3)(ii), we have eliminated 

specific numerical values for hematocrit 

and hemoglobin but require that the 

patient be instructed on how to 

administer erythropoiesis-stimulating 

agent(s) in order to achieve and 

maintain a target level hemoglobin or 

hematocrit, as written in the patient’s 

plan of care at § 494.90. 

Comment: A few commenters 

suggested that the 2-month timeframe 

for monitoring home patients was 

excessively rigid and burdensome. Two 

of those commenters suggested a 

quarterly reporting timeframe that 

would coincide with monitoring. Two 

commenters suggested we change the 

timeframe to require monthly reporting. 

Response: The goal of the standard at 

§ 494.100(b)(2) is to have facilities 

effectively monitor the care of home 

dialysis patients to achieve desired 

outcomes. Monitoring patient records 

allows dialysis facility staff to compare 

the prescribed regimen to actual dialysis 

results. Home patients do not see 

facility staff as frequently as in-facility 

patients do and so we believe the 2- 

month monitoring schedule is 

reasonable. 

Comment: One commenter agreed 

with the proposed rule but pointed out 

that home patients do not always 

provide documentation regarding their 

care at home. Another commenter 

remarked that non-compliant patients 

may not provide the required data and 

other information necessary for staff to 

carry out the mandatory review. This 

commenter suggested we add language 

that would enable staff to be in 

compliance on the basis of having made 

a ‘‘good faith effort.’’

Response: The home dialysis patient 

is part of the interdisciplinary team and 

should be working to meet the home 

dialysis plan of care goals. If home 

dialysis patients exhibit non-compliant 

behavior and/or their care plan goals are 

not met, then facilities must intervene. 

If facilities take reasonable measures 

and lack of patient compliance remains 

a problem, then the interdisciplinary 

team must document the interventions 

to address patient non-compliance, the 

results of the interventions, and the plan 

to protect patient health and safety 

within the limitations of poor patient 

compliance. 

Comment: Several commenters 

remarked on the differences between 

hemodialysis and peritoneal dialysis 

modalities in the home setting. The 

commenters suggested that peritoneal 

dialysis visits only be required when 

medically indicated, since the water 

treatment issues associated with 

hemodialysis do not exist for these 

patients. Two commenters suggested 

that home monitoring visits be at the 

discretion of the interdisciplinary team. 

One commenter suggested that the 

proposal be revised to allow home visits 

‘‘as appropriate.’’ Another commenter 

suggested that the final rule state 

whether the interdisciplinary team 

would be required to perform an 

assessment at a team meeting. Another 

commenter asked for clarification on 

whether the staff must visit a patient’s 

home periodically. A commenter 

suggested that a physician be required 

to visit home patients only as medically 

indicated, while another commenter 

asked whether the physician would be 

required to see the home patient 

monthly. One commenter suggested we 

add a requirement that the home 

consultation be with ‘‘all’’ of the team 

members as needed. Two commenters 

suggested that ‘‘periodic monitoring’’

include ‘‘at least annually.’’ Other 

commenters suggested that the final rule 

specifically state that all home patients 

must be visited in the home at least 

periodically after home training is 

completed. 

Response: Many of these concerns 

from commenters would be addressed 

in the patient’s plan of care at § 494.90, 

which requires an appropriate plan of 

care based upon medically indicated 

needs, treatment, and services. Patient 

needs identified in the plan of care 

should drive the frequency of home 

visits of the interdisciplinary team 

members, including the physician. 

Regular contact with facility staff offers 

the patient an ongoing support service 

and an avenue for communicating 

questions and concerns. Our regulations 

require periodic monitoring and home 

visits by a team member as part of the 

patient plan of care; they are necessary 

in order to protect patient health and 

safety. We would expect that each home 

care patient, in addition to being visited, 

would have regular contact with 

dialysis facility staff. The initial home 

visit allows dialysis facility staff to 

ensure that the home patient has an 

acceptable environment in which to 

perform safe dialysis, and ensure there 

is adequate storage of supplies, etc. The 

dialysis facility should ensure that care 

being provided to home-care patients be 

equivalent to care provided to other 

facility patients. 

Comment: A commenter suggested 

that we require at § 494.100(c)(1)(i) that 

home patient monitoring be completed 

as needed and only if geographically 

feasible, in accordance with the 

patient’s plan of care. Another 

commenter remarked that facility staff 

should not be required to make home 

visits if patients live in dangerous areas 

or if it is unsafe for staff. 

Response: Support services at 

standard (c) are required for all home 

patients, regardless of the setting or 

geographical location. At 

§ 494.100(c)(1)(i), dialysis facility staff 

are required to periodically monitor the 

patient’s home adaptation and visit the 

patient’s home setting in accordance 

with the plan of care. All patients have 

the right to receive equal care that 

protects their health and safety, and 

CMS cannot establish a mandate that 

would allow discrimination in any 

form. 

Comment: Two commenters remarked 

that while the proposed rule provides a 

new level of protection for the patient, 

the requirements would make home 

dialysis more expensive, which could 

be a deterrent for dialysis facilities to 

offer home dialysis. One commenter 

noted that weekly home hemodialysis 

water testing for new systems was too 

expensive, as was monthly bacteria 

testing. The commenter remarked that 

the final rule should recognize 

differences between hemodialysis and 

peritoneal dialysis, and that it is not 


PWALKER on PROD1PC71 with RULES2
20412 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

necessary to monitor water quality/ 

dialyzer reuse with certain new home 

dialysis technologies. One commenter 

suggested that for preconfigured, 510(k) 

cleared systems designed, tested and 

validated to yield AAMI quality water 

and dialysate, that we should merely 

require the facility to monitor water 

quality in accordance with the systems’

FDA-approved labeling under 

§ 494.100(c)(1)(v). Another commenter 

remarked that AAMI recommendations 

were never intended for home 

hemodialysis, stating that home water 

quality should be monitored but not 

with the same frequency as in a facility 

setting. One commenter also asked how 

the conditions would stay current if the 

referenced guidelines were changed or 

updated. 

Response: The subject of water quality 

was addressed in our discussion under 

§ 494.40, where all related issues, 

including home dialysis issues, were 

thoroughly discussed. In accordance 

with that discussion, we have revised 

the final rule at § 494.100(c)(1)(v)(A) 

and § 494.100(c)(1)(v)(B), to require that 

the facility monitor the quality of water 

and dialysate used by home 

hemodialysis patients and conduct 

onsite evaluations and testing of the 

water system in accordance with the 

recommendations specified in the 

manufacturers instructions and the 

system’s FDA-approved labeling for 

preconfigured systems designed, tested 

and validated to yield AAMI quality 

water and dialysate. Bacteriologic and 

endotoxin testing must be performed at 

least quarterly, or on a more frequent 

basis as needed, to ensure that the water 

and dialysate are within AAMI limits. 

We are requiring at least quarterly 

cultures and endotoxin testing to ensure 

that as new technologies come into use, 

the facility monitors home hemodialysis 

water systems so that patient safety is 

protected. As data and information 

become available regarding the longterm use and safety of new technologies, 

we may, in the future, re-evaluate the 

required frequency of water testing for 

these systems based on the scientific 

evidence. 

Comment: One commenter agreed 

with the proposed rule that the dialysis 

facility should provide all support 

services regardless of whether or not 

any durable medical equipment is 

provided by that facility. Another 

commenter suggested adding the 

following language to the final rule at 

§ 494.100(c) for Method I patients: ‘‘The 

dialysis facility must purchase or lease 

and deliver the necessary home dialysis 

supplies and equipment.’’ Two 

commenters remarked that equipment 

rental should be included in the 

proposed list of requirements at 

§ 494.100(c)(2)(iii), as some providers 

rent dialysis equipment. 

Response: We appreciate the positive 

comments regarding the need for 

facilities to provide support services for 

the home patient. Home dialysis 

patients who receive all equipment, 

supplies and support services from their 

ESRD facility are considered ‘‘Home 

Dialysis Method I.’’ Under ‘‘Method II,’’

a durable medical supply company 

provides all necessary equipment and 

supplies to the home dialysis patient, 

and a dialysis facility provides support 

services to the patient. In order to be 

responsive to commenters, we have 

added the terms ‘‘renting’’ and ‘‘leasing’’

to the final rule at § 494.100(c)(1)(vi), 

which now requires services provided 

by the facility to include, ‘‘Purchasing, 

leasing, renting, delivering, installing, 

repairing and maintaining medically 

necessary home dialysis supplies and 

equipment (including supportive 

equipment) prescribed by the attending 

physician.’’

Comment: One commenter suggested 

that we add a requirement that a home 

dialysis provider have its own in-center 

facility within 35–50 miles of the 

patient’s home, or an agreement with a 

designated backup in-center provider, 

including on-call availability of a nurse 

to permit a home patient to have access 

to care when equipment fails or in an 

emergency. 

Response: In the proposed rule at 

§ 494.100(c)(1)(vii), facilities are 

required to identify a plan and arrange 

for emergency back-up dialysis services 

in the event that they may be needed. 

We believe this requirement addresses 

the commenter’s concern, while 

providing flexibility for facilities. 

Emergency preparedness is also 

addressed in the final rule at 

§ 494.60(d), which requires facilities to 

implement processes and procedures to 

manage medical and non-medical 

emergencies that are likely to threaten 

the health or safety of the patients, the 

staff, or the public. 

Comment: One commenter stated that 

requiring facilities to deliver supplies 

and equipment to home patients would 

give an unfair advantage to Method II 

suppliers, especially for a clinic serving 

a large geographic area. Another 

commenter recommended that we 

consider allowing facilities to ‘‘arrange’’

for installation and maintenance of 

supplies and equipment, as it is 

standard industry practice for the 

manufacturer to install dialysis 

equipment. 

Response: It appears these 

commenters may have misinterpreted 

some of the proposed rule language at 

§ 494.100(c). The part 405, subpart U 

requires self-dialysis support services to 

be furnished either directly, under 

agreement or by arrangement with 

another ESRD facility (§ 405.2163(e)). 

We have added language to 

§ 494.100(c)(1) of the final rule to clarify 

that, ‘‘A home dialysis training facility 

must furnish (either directly, under 

agreement or by arrangement with 

another ESRD facility) home dialysis 

support services regardless of whether 

dialysis supplies are provided by the 

dialysis facility or a durable medical 

equipment company.’’

As noted above, home dialysis 

patients who receive all equipment, and 

supplies from one durable medical 

equipment supplier and all other 

support services from their dialysis 

facility have opted for ‘‘Home Dialysis 

Method II.’’ Facilities are accountable 

for arranging and providing services and 

supplies to their patients as required. To 

allow maximum flexibility for facilities 

to carry out this requirement, facilities 

are permitted to determine the most 

effective and efficient way for them to 

operate within the context of the final 

rule. 

Comment: One commenter suggested 

the proposed rule at § 494.100(c)(1)(vii) 

(identifying a plan and arranging for 

emergency backup) be modified to 

require that emergency backup dialysis 

services must be at a location 

convenient to the patient’s home. 

Response: We do not believe it would 

be beneficial to mandate emergency 

back up dialysis services that are 

convenient to the patient’s home. The 

term ‘‘convenient’’ may have a wide 

range of interpretations and depending 

on how it is interpreted, could become 

an access to care barrier that reduces the 

availability of home dialysis. Some 

patients choose home dialysis because 

they live in a remote area where incenter dialysis is not available. If we 

required that back up dialysis for all 

home patients must be ‘‘convenient’’, 

this may cause dialysis facilities to 

discontinue home dialysis for patients 

who live in these remote areas for whom 

there is no convenient dialysis facility. 

We expect providers to work with 

patients, other providers and ESRD 

Networks to best meet the needs of 

patients. Facilities must have a 

reasonable emergency plan to deal with 

patients in need of backup dialysis 

services. 

Comment: Two commenters suggested 

we delete proposed § 494.100(c)(1)(iii) 

through § 494.100(c)(1)(vii) because 

most of the requirements are already 

required of the facility with respect to 

all patients receiving care and services 

through the facility. 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20413 

Response: The support services 

provision in the proposed rule at 

§ 494.100(c)(1)(i) through § 494.100 

(c)(1)(vi) would retain and expand 

existing part 405, subpart U 

requirements, as discussed in the ESRD 

proposed preamble (70 FR 6212). We 

also proposed the addition of 

§ 494.100(c)(1)(vii), which would 

require the facility to plan for and 

arrange for emergency backup dialysis 

services when needed. Support services 

for home care patients are required by 

section 1881 of the Act and are 

necessary to ensure proper care and 

support. We have added a clarification 

to § 494.100(c)(1) to state that any home 

dialysis training facility must also 

‘‘furnish either directly, under 

agreement, or by arrangement with 

another ESRD facility.’’

Comment: Some commenters 

suggested that separate sections were 

needed for home hemodialysis and 

peritoneal dialysis. One commenter 

remarked that this was necessary due to 

water quality issues. Another suggested 

that hemodialysis was more complex 

and that the proposed rule, as written, 

would impose an undue burden on 

peritoneal dialysis care. 

Response: Hemodialysis water quality 

was addressed in the ‘‘Care at home’’

condition at § 494.100(c)(1)(v) in the 

proposed rule. The language in the final 

rule has been modified and is now 

consistent with the requirements in the 

‘‘Water and dialysate quality’’ condition 

at § 494.40. The language at 

§ 494.100(c)(1)(v)(A) and 

§ 494.100(c)(1)(v)(B) requires that 

services include, ‘‘Monitoring of the 

quality of water and dialysate used by 

home hemodialysis patients, including 

conducting an onsite evaluation and 

testing of the water and dialysate system 

in accordance with: (A) The 

recommendations specified in the 

manufacturers’ instructions; and (B) the 

system’s FDA-approved labeling for 

preconfigured systems designed, tested, 

and validated to yield AAMI quality 

water and dialysate; in addition, 

bacteriological and endotoxin testing 

must be performed on a quarterly, or 

more frequent basis as needed, to ensure 

that the water and dialysate are within 

the AAMI limits.’’ We have added a 

reference to dialysate in our final rule to 

be consistent with the AAMI RD52 

guidelines that we have incorporated by 

reference. The interdisciplinary team is 

required to educate the patients or 

caregivers about water quality problems 

as required by § 494.100(a)(3)(iii). 

Comment: One commenter remarked 

that Medicare should ‘‘cover separately 

billable medication and biologicals for 

home patients, as it does for in-center 

patients, to improve their clinical 

outcomes.’’

Response: This regulation does not 

address payment issues. The matter has 

been referred to the appropriate CMS 

coverage staff for consideration. 

Comment: One commenter 

recommended that CMS contract with a 

Network to form a TEP to study current 

guidance for care at home and make 

recommendations. 

Response: A TEP was convened in 

Baltimore on January 20 and 21, 2006, 

after the close of the proposed rule’s 

comment period, to assist ESRD 

Network 9/10 in developing 

recommendations for providing staffassisted dialysis in a long-term care 

facility. TEP members, including 

patients and professionals, represented 

various ESRD stakeholders involved in 

or impacted by dialysis in the LTC 

facility. The TEP’s final 

recommendation to CMS was to suggest 

creation of a new model of care for staffassisted dialysis in long-term care 

facilities, as the current method of home 

dialysis in such facilities did not 

appropriately meet the need. The final 

report ‘‘Delivery of Dialysis Treatment 

Within the Long Term Care Facility’’

can be found on The Renal Network 

Web site at http:// 

www.therenalnetwork.org/PF/ 

LTC_feedback.html. 

Comment: We received many public 

comments regarding the issue of 

institutional dialysis or dialysis in a 

nursing home setting, which was 

discussed in the proposed rule 

preamble. Dozens of members from the 

renal, hospital, and nursing home 

industries commented and many were 

opposed to the current existing (2004) 

nursing home dialysis policy, which can 

be viewed at http://www.cms.hhs.gov/ 

SurveyCertificationGenInfo/downloads/ 

SCLetter04-24.pdf and http:// 

www.cms.hhs.gov/ 

SurveyCertificationGenInfo/downloads/ 

SCLetter04-37.pdf. The majority of 

commenters had major concerns with 

this issue and expressed frustrations 

with existing payment systems. 

Commenters were concerned with the 

financial feasibility of providing dialysis 

to these patients at a certified dialysis 

facility within the nursing home or 

under the home dialysis model. 

Commenters believe that the 

reimbursement system should be 

adjusted for care provided in this 

setting. Accountability is another 

concern, as commenters were not clear 

regarding the division of responsibilities 

between the skilled nursing facility and 

the ESRD facility. Still other 

commenters stated that these patients 

should not be categorized as home-care 

patients because the majority are frail 

and often elderly, cannot participate in 

their own care, and cannot be trained. 

Many commenters suggested that CMS 

convene a Technical Expert Panel to 

address the issue of dialysis for nursing 

home residents and craft a separate rule 

following publication of this final rule. 

Response: The proposed rule solicited 

comment regarding ‘‘whether the 

current dialysis regulations need to be 

modified to protect this vulnerable 

(nursing home) population * * *’’ (70 

FR 6213). Commenters clearly believe 

that current regulations pertaining to the 

provision of dialysis to nursing home 

patients need to be revised. However, it 

is not clear now how we could best 

improve our health and safety 

regulations to meet our goal of 

providing safe, high quality, efficient 

dialysis care to vulnerable nursing home 

patients. Therefore, we are not issuing 

nursing home dialysis regulations in 

this final rule. Given the complex 

programmatic and fiscal issues 

associated with a new nursing home 

dialysis model, we intend to consider 

rulemaking as well as alternative actions 

in the future. Until that time the current 

policy (S&C–04–24 and S&C–04–37) 

will remain in effect. 

e. Quality Assessment and Performance 

Improvement (Proposed § 494.110) 

The February 4, 2005 proposed rule 

included a new condition that would 

require dialysis facilities to develop, 

implement, maintain, and evaluate an 

effective, data-driven, interdisciplinary 

QAPI program. This ongoing internal 

quality oversight program would focus 

on indicators related to improved health 

outcomes and the prevention and 

reduction of medical errors. The QAPI 

program would include adequacy of 

dialysis, nutritional status, anemia 

management, vascular access, medical 

injuries and medical errors 

identification, hemodialyzer reuse, (if 

applicable), and patient satisfaction and 

grievances. The dialysis facility would 

be required, not only to monitor its 

performance, but also to take actions 

that would result in sustained 

performance improvements. Priorities 

would have to be set for performance 

improvement activities, taking into 

consideration the prevalence and 

severity of identified problems and 

affect on clinical outcomes or patient 

safety. We proposed that any identified 

problems that threatened the health and 

safety of patients would be immediately 

corrected. We also proposed retaining 

the part 405, subpart U requirement that 

dialysis facilities participate in ESRD 

Network activities and pursue Network 

goals. 


PWALKER on PROD1PC71 with RULES2
20414 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

We received a large number of 

comments on the QAPI condition. The 

comments generally supported a QAPI 

condition. One commenter applauded 

the proposed requirement for 

prioritizing QAPI improvement 

activities and requiring facilities to have 

a plan for immediate correction of 

problems that might jeopardize patient 

health and safety. 

Comment: A few commenters 

requested clarification of the term 

‘‘interdisciplinary team’’ as used in 

subpart C. 

Response: As stated earlier, we have 

clarified the meaning of 

‘‘interdisciplinary team’’ under the 

‘‘Patient assessment’’ (§ 494.80) and 

‘‘Plan of care’’ (§ 494.90) conditions. 

The first sentence of the QAPI condition 

in the proposed rule required an 

‘‘interdisciplinary’’ QAPI program. We 

have modified this requirement in the 

final rule to make clear that the 

professional members of the 

interdisciplinary team (physician, RN, 

social worker, and dietitian) must 

participate in the QAPI program. The 

facility has the option of including 

facility patients when appropriate. The 

first sentence of § 494.110 now reads, 

‘‘The dialysis facility must develop, 

implement, maintain, and evaluate an 

effective, data-driven quality assessment 

and performance improvement program 

with participation by the professional 

members of the interdisciplinary team.’’

Comment: Two commenters were 

concerned that there was no mechanism 

to update QAPI measures, and suggested 

that CMS develop such a mechanism. 

Response: QAPI measures were not 

proposed; however, QAPI topics were 

proposed at § 494.110(a)(2). Facilities 

may use indicators and measures of 

their choice as appropriate and 

necessary to implement the data driven 

QAPI program. We may update the 

QAPI topics as needed in future 

revisions of the ESRD conditions for 

coverage. Facilities may add topics to 

their QAPI program as needed to meet 

the unique needs of their facility. 

Comment: A commenter suggested 

that if face-to-face QAPI meetings are 

expected, this should be specifically 

required in the regulation. 

Response: The facility has the 

flexibility to develop and implement 

QAPI via processes of their own 

choosing, as long as the efforts result in 

a multidisciplinary, data-driven QAPI 

program that achieves improvement and 

meets the criteria stated in § 494.110. 

This might include face-to-face meetings 

or additional and alternate activities. 

We have not modified the regulatory 

language to specify processes or face-toface meetings. 

Comment: Two commenters suggested 

that we consider increasing the Network 

role in QAPI oversight. 

Response: The Network role regarding 

the quality of ESRD care is defined at 

section 1881(c) of the Act, and 

implemented at 42 CFR 405.2112 and in 

the ESRD Network contract. We expect 

the ESRD Networks and the facilities to 

work collaboratively for the benefit of 

the patients that are being served. These 

conditions for coverage do not affect the 

ESRD Network role or requirements. 

The requirements regarding dialysis 

facility cooperation with its ESRD 

Network have been consolidated at 

§ 494.180(i), as discussed under that 

section of this preamble. 

Comment: A commenter stated that 

standard facility continuous quality 

improvement programs should satisfy 

QAPI requirements. 

Response: We expect that some 

quality-oriented dialysis facilities 

already have in place effective full-scale 

quality improvement programs that 

would meet QAPI requirements. 

Comment: Many commenters 

suggested additional QAPI topics that 

should be required, including: Infection 

control, renal bone disease, 

psychosocial status, transplantation, 

mortality reviews, staffing policy, errors, 

fluid status, staff education, home 

dialysis, surveillance of water treatment, 

venous catheter use reduction, fistula 

use, depression, hospitalizations, 

cardiovascular health, patient 

suggestions for QI and safety, and 

growth and development for pediatric 

patients under the age of 18. A large 

number of the comments supported 

inclusion of infection control and renal 

bone disease. Two commenters 

suggested that we omit the specific 

QAPI elements because while they are 

currently appropriate, they should not 

be codified. 

Response: The proposed QAPI 

elements included adequacy of dialysis, 

nutritional status, anemia management, 

vascular access, medical injuries and 

medical errors identification, 

hemodialyzer reuse program, and 

patient satisfaction and grievances. The 

majority of comments strongly 

supported the QAPI topics that we 

proposed to be included in the facility 

QAPI program. We have added ‘‘mineral 

metabolism and renal bone disease’’ to 

the list of QAPI topics in this final rule 

at § 494.110(a)(2)(iii) due to its 

importance to quality dialysis care, its 

association with cardiac health, and the 

strong support received from 

commenters. Renal bone disease and 

mineral metabolism are routine 

components of dialysis facility QI 

programs and are easily monitored via 

lab values. CMS has recently pilot tested 

mineral metabolism/bone disease 

clinical performance measures and has 

added these as new ESRD clinical 

performance measures. We have also 

added ‘‘infection control’’ at 

§ 494.110(a)(2)(ix), as discussed above 

in connection with § 494.30 ‘‘Infection 

control’’ condition. This QAPI 

component retains the same specificity 

and detail provided in the proposed rule 

under § 494.30. We believe that 

infection control is crucial to protecting 

patient health and safety. We do not 

intend to understate the importance of 

this issue simply because it was 

relocated in this final rule. 

Fistula use and reduction in venous 

catheter use is encompassed by the 

vascular access topic, which is already 

included in the QAPI required topics. 

Therefore, we are not making any 

additional changes. Dialysis facilities 

should focus on the vascular access 

problems that have been identified as a 

priority for their facility. 

Surveillance of the water system is 

already required by this final rule; the 

ANSI/AAMI RD 52 water purity 

guidelines, incorporated by reference in 

the ‘‘Water and dialysate quality’’

condition for coverage at § 494.40(a), 

specify surveillance and quality 

assurance procedures. 

We encourage dialysis facilities to 

include social services and other 

suggested QAPI topics in their program 

when appropriate, but are not requiring 

these additional topics. The facility 

should identify additional QAPI 

components when it prioritizes 

improvement activities in accordance 

with standard § 494.110(c). We expect 

the dialysis facility to devote the needed 

resources to its QAPI program, which 

will be based on such prioritization of 

facility needs. 

Comment: We received several 

comments on various aspects of 

proposed § 494.110(b), which includes 

monitoring performance improvement, 

taking actions that result in performance 

improvements, and tracking 

performance to sustain improvements. 

One commenter stated that when 

evaluating performance, new patients 

should be excluded for the first 3 

months. Another commenter suggested 

that the facility be examined before 

requiring an improvement plan, in order 

for the surveyor to evaluate patient 

characteristics and to decrease risk of 

facilities ‘‘cherry picking’’ the healthiest 

patients. A commenter stated that 

patients will not be able to meet targets 

for albumin and anemia, and certain 

categories of patients should be 

excluded from the quality measure 

patient population. One commenter 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20415 

suggested that it should be sufficient 

that facilities address the quality issues, 

while another stated that the facility can 

only address actionable issues. Some 

commenters said a risk adjustment is 

needed, but one commenter disagreed 

with a need for risk adjustment. Other 

commenters stated that patient noncompliance is a factor in meeting QAPI 

goals. 

Response: The intent of § 494.110(b) 

was explained in the preamble of the 

proposed rule (70 FR 6217) where we 

stated, ‘‘We will specifically expect a 

facility whose treatment outcomes vary 

significantly from accepted standards to 

identify the reasons for poor outcomes 

and implement improvement projects to 

achieve expected outcomes.’’ The QAPI 

program is meant to have a facility-wide 

scope that seeks opportunities for 

improvement, whereas the ‘‘Patient plan 

of care’’ condition focuses on individual 

patient care. Since the QAPI program is 

an internal facility function, facilities 

may use their own risk adjustors and 

incident or prevalent patient designators 

within their QAPI programs as needed. 

However, both adjusted and unadjusted 

QAPI data must be available for our 

review. This QAPI condition does not 

require facilities to report QAPI data, 

although information about quality 

measurement and improvements would 

need to be available to the surveyor who 

assesses whether the QAPI program met 

the requirements of this condition. The 

risk adjustment aspect is discussed 

under the ‘‘minimum facility-wide 

standards’’ discussion below. 

The QAPI requirement provides the 

facility with flexibility in identifying the 

QAPI goals and actions to undertake. 

We would expect the facility to 

undertake activities that are expected to 

improve health outcomes, and prevent 

and reduce medical errors. 

We recognize that patient adherence 

to the treatment plan can be a factor in 

meeting facility QAPI goals. The issue of 

patient compliance was discussed 

earlier in this document under the 

‘‘Patient plan of care’’ condition portion 

of the preamble. We addressed the need 

for interventions when the plan of care 

goals are not met and the required 

documentation of any barriers 

preventing the goals from being met. It 

is possible that some facilities may find 

during their prioritization of 

improvement activities that patient 

compliance trends need to be addressed 

within the QAPI program. 

Comment: Several commenters 

supported a requirement for dialysis 

facilities to use a common patient 

experience of care or satisfaction tool. 

They stated that this would allow 

comparable information and spur 

improved performance, although one 

commenter stated this could be costly 

and burdensome. Two commenters 

support the use of a common tool that 

allows facilities to add unique facilitychosen questions. A few commenters 

supported a patient satisfaction survey, 

but not use of a common tool. While 

there was predominant support for the 

inclusion of patient satisfaction in the 

QAPI program requirement, few 

commenters specified their position on 

whether CMS should mandate the use of 

a common survey tool (that is, In-Center 

Hemodialysis Consumer Assessment of 

Healthcare Providers and Systems (ICH 

CAHPS)). 

One commenter said that CMS should 

only specify that a survey be done and 

within specified intervals. Another 

commenter, opposing a common patient 

satisfaction tool requirement, stated 

regional differences may skew results. A 

large dialysis organization (LDO) stated 

they preferred their own patient 

satisfaction tool, which is used to 

benchmark and allows modifications to 

the questions over time. The LDO 

further stated that ICH CAHPS is not 

operational, and that pilot tests need to 

be reviewed. A few commenters 

recommended that a ‘‘quality of life’’

aspect be included in a patient survey. 

Response: We are requiring that 

dialysis facilities include patient 

satisfaction as a component of their 

QAPI program. At this point in time we 

are strongly encouraging facilities to use 

the standardized ICH CAHPS tool to 

assess in-center hemodialysis patient 

experience of care, but we are not 

requiring use of this instrument. As the 

renal community becomes more 

experienced with using the ICH CAHPS 

instrument and recognizes benefits 

associated with its use, we would 

expect to see widespread voluntary use. 

Providing patient experience-of-care 

information to beneficiaries is a priority 

for CMS as a component of our 

transparency initiative. Many of the 

questions in the Core ICH CAHPS 

Instrument are questions that were 

taken directly from existing surveys 

used by dialysis facilities that 

responded to our call for measures. A 

rigorously tested instrument, based on 

input from stakeholders and facilities, 

would supply valuable feedback to 

facilities for improving quality of 

dialysis care. 

Creation of a standardized patient 

experience-of-care survey for dialysis 

patients is directly responsive to calls 

for CMS and the Secretary to collect this 

type of information in a variety of 

reports. The Office of the Inspector 

General (OIG) Report, entitled ‘‘External 

Review of Dialysis Facilities’’ (June 

2000), recommended that CMS ‘‘require 

dialysis facilities to monitor patient 

satisfaction’’ particularly, as a way of 

bringing forth patient concerns that may 

not be captured by the current 

complaint systems. Likewise, in a 

Report to the Congress entitled 

‘‘Improving Payment for End-Stage 

Renal Disease Services’’ (March 2000), 

the Medicare Payment Advisory 

Commission (MedPAC) recommended 

that CMS collect and analyze 

information on a regular basis on ESRD 

patients’ satisfaction with the quality of 

and access to care. This 

recommendation was reiterated in 

MedPAC’s report to the Congress 

‘‘Modernizing the Outpatient Dialysis 

Payment System’’ (October 2003), which 

recommends that, ‘‘The Secretary 

should also monitor patient satisfaction 

with care and other access indicators to 

determine whether patients face 

obstacles in obtaining needed care.’’

Furthermore, the importance of a 

patient focus in the provision of 

healthcare services was emphasized in 

the IOM 2001 report, ‘‘Crossing the 

Quality Chasm,’’ that established 

patient-centered care as one of the 

industry’s six aims for quality 

improvement. The IOM dimensions of 

patient-centered care include respect for 

patients’ values, preferences, and 

expressed needs; coordination and 

integration of care; information, 

communication, and education; 

physical comfort; emotional support; 

involvement of family and friends; 

continuity and transition; and access to 

care. The ICH CAHPS survey instrument 

addresses all these areas in either the 

Core Instrument or supplemental 

questions. 

Consumer testing of the DFC Web site, 

conducted on behalf of CMS by the 

Research Triangle Institute during 2002 

and 2003, revealed that consumers most 

frequently requested patient satisfaction 

information or patient opinions about 

the care given in dialysis facilities to 

gauge the quality of care provided in a 

dialysis facility. The data collected from 

the core items in a common tool will 

allow consumers to make ‘‘apples to 

apples’’ comparisons among dialysis 

facilities. In addition, such information 

would allow dialysis facilities to 

benchmark their performance at local, 

regional, and national levels. 

The ICH CAHPS core instrument and 

supplemental questions have been 

placed in the public domain. Any 

hemodialysis facility interested in using 

the survey should contact Charles Darby 

at Charles.Darby@ahrq.hhs.gov. The 

Agency for Healthcare Research and 

Quality welcomes input on experiences 


PWALKER on PROD1PC71 with RULES2
20416 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

that dialysis facilities may have in 

implementing the survey. 

Comment: We received many 

comments regarding CMS use of facilityspecific standards for enforcement of 

the conditions for coverage. While 

commenters supported CMS regulations 

that would hold facilities accountable 

for their performance via clinical data, 

there was much disagreement regarding 

the implementation approach. 

Several commenters responded to our 

proposed rule preamble discussion (70 

FR 6218) regarding the use of NKF K/ 

DOQI clinical practice guidelines as the 

facility-specific minimum standards to 

be used for enforcement. One 

commenter recommended that CMS 

adopt evidence-based NKF–K/DOQI 

clinical practice guidelines for 

adequacy, anemia, and vascular access 

as facility-wide targets for enforcement. 

The commenter suggested that if 

problems were found, facilities could be 

required to provide a plan to improve 

care with active Network involvement. 

Two commenters supported minimum 

clinical standards using K/DOQI, stating 

that this could provide a basis for 

quality improvement and patient 

education on expected outcomes or 

goals. One commenter supported 

facility-wide measures without risk 

adjusters, arguing that no patient should 

be exempt from the coverage of 

evidence-based minimum threshold 

values, and pointing out that the 

purpose of QAPI is to identify and solve 

problems. 

Most of the comments submitted on 

this minimum standards issue did not 

support immediate implementation of 

facility-level standards and thresholds 

in this final rule. The NKF 

communicated concerns about CMS use 

of their K/DOQI guidelines for 

enforcement without addressing factors 

such as case mix, effects of patient noncompliance, biologic variability, third 

party reimbursement, large numbers of 

outliers, and the inflexibility of the CMS 

regulation process. Another commenter 

suggested that CMS should be careful to 

avoid overly prescriptive language, 

requirements that create new indirect 

costs, and requirements that hold units 

accountable for things they cannot 

control. A commenter stated that some 

K/DOQI clinical practice guidelines are 

opinion-based, and some requirements 

apply to non-reimbursable practices and 

that only evidence-based criteria 

covered by Medicare should be 

considered for inclusion in the 

conditions for coverage. 

A few commenters stated that not all 

patients would be able to meet the 

numerical outcome targets and should 

not be expected to meet them. Other 

commenters were concerned about 

unintended consequences. A 

commenter suggested that ‘‘cherrypicking’’ and other inadvertent 

consequences will result without an 

effective case-mix adjuster to avoid 

disadvantaging facilities that have a 

challenging case mix. The commenter 

further stated that the current Medicare 

Modernization Act case-mix adjuster 

(used to determine Medicare payment) 

is inadequate, disadvantages frail 

elderly patients, and that minimum 

standards should not be considered 

until an effective case-mix adjuster has 

been developed. Many commenters 

objected to implementation of facilitylevel performance standards without the 

use of case-mix adjusters and objected 

to using clinical practice guidelines 

written for individual patient care as 

facility-wide standards. 

Some commenters noted that the NKF 

workgroups that developed the K/DOQI 

clinical practice guidelines never 

intended that they would be used for 

enforcement and pointed to the K/DOQI 

disclaimer regarding appropriate use of 

the clinical practice guidelines. A 

commenter stated that more study is 

needed to link existing evidence to 

intended outcomes. Another commenter 

stated that CMS needs to differentiate 

between standards and clinical 

guidelines. A commenter suggested that 

‘‘dynamic’’ numerical standards do not 

belong in ‘‘static’’ federal regulations. 

The commenter also noted that no 

methodology exists to update numerical 

values, that serum albumin should not 

be a target marker, and that these values 

are often out of the facility’s control for 

the majority of ESRD patients. 

Commenters urged CMS to avoid 

direct extrapolation of standards from 

existing guidelines until voluntary 

consensus organizations develop real 

evidence-based standards and link a 

standard to a desired outcome. Many 

commenters supported minimum 

facility-level clinical performance 

standards development via a voluntary 

consensus process that allowed input 

from the renal community at large. 

Several commenters specifically 

supported the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) process proposed at 

§ 494.180(h)(3)(iv) as the voluntary 

consensus process to use. A commenter 

urged CMS to develop flexible, 

evidence-based standards with a 

methodology for periodic review. 

Another commenter endorsed the 

concept of using commonly agreed upon 

clinical standards, but was very 

concerned that frequent rulemaking 

would be required. One commenter 

questioned the need for minimum 

standards in these conditions given the 

difficulty of updating the conditions for 

coverage. Another commenter also 

stated that CMS should not link QAPI 

expectations to ‘‘static standards.’’

One commenter stated that the 

minimum facility standards proposal is 

focused totally on lab-based outcomes 

and this focus ignores more important 

clinical issues such as blood pressure 

treatment and cardiovascular disease 

risks that are not tied intimately to 

information technology systems and 

laboratory test outcomes. While 

multiple laboratory results may be 

available, other important factors such 

as the percentage of patients on ACE 

(angiotensin converting enzymes) 

inhibitors or beta-blockers are not 

readily available. Another commenter 

stated that there is an overdependence 

on K/DOQI in the proposal. 

Although commenters agreed that 

CMS should hold dialysis facilities 

accountable for clinical outcomes and 

performance, the majority did not agree 

with implementing facility-level clinical 

performance standards based on the 

NKF K/DOQI clinical practice 

guidelines without a case-mix adjuster 

and without recognition of other factors 

that affect clinical outcomes. 

Response: These conditions for 

coverage are an important component of 

the overall CMS quality improvement 

strategy. We intend to hold dialysis 

facilities accountable for the quality of 

care provided to patients using 

performance measures and clinical data. 

Commenters pointed out some factors 

that may impact a facility’s ability to 

meet K/DOQI targets for 100 percent of 

their patients. While certain dialysis 

patient populations may have some 

unique characteristics, efforts should be 

made by dialysis facilities to meet 

clinical practice guidelines or come as 

close as possible to meeting those 

guidelines for all patients. This is 

required by the ‘‘Patient plan of care’’

condition at § 494.90. We do not intend 

for the implementation of facility-level 

clinical performance standards to 

negatively impact access to dialysis care 

and we do not hold facilities 

accountable for outcomes beyond their 

control. Currently we do not have a 

case-mix adjuster or other analytical 

means to ensure comparability between 

facility performance levels. We would 

like to address the concerns voiced by 

commenters before facility-level 

minimum standards are implemented. 

In response to comments, we will 

develop facility-level clinical 

performance standards via a voluntary 

consensus standards process indicated 

at § 494.180(h)(3)(iv). Once developed, 

these facility-level clinical performance 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20417 

standards will be published in the 

Federal Register as a proposed rule. 

Comment: A few commenters 

responded to our preamble discussion 

(70 FR 6218) regarding how current 

NKF–K/DOQI clinical practice 

guidelines could be used as minimum 

standards and what statistically-based 

thresholds could be employed. 

One commenter who was not in favor 

of using the K/DOQI guidelines as 

minimum facility-level standards 

provided suggestions for possible 

statistical methodologies: using 2 

standard deviations below the mean; or, 

using the 25th percentile for skewed 

distributions or alternatively using 

percentiles; however, using a set 

percentage cut-off as a standard would 

be arbitrary with no basis in science or 

evidence. Another commenter suggested 

that facility-specific ‘‘clinical care 

measures should never appear on the 

oversight radar unless a certain 

percentage of patients fail to meet a 

particular measure.’’ Another 

commenter recommended that facilityspecific standards using K/DOQI be 

identified as goals and expectations ‘‘for 

more than 80 percent’’ of all patients. 

This commenter related concern about 

how minimum standards would be 

applied when facilities are surveyed and 

stated that the final rule must 

acknowledge that 100 percent of 

patients cannot achieve K/DOQI target 

minimums. 

One commenter suggested that CMS 

set minimum outcome goals, then move 

up the thresholds incrementally, with 

annual readjustments. Another 

commenter suggested that facilities 

could develop a corrective action plan 

when a pre-determined portion of 

patients failed to meet selected clinical 

standards. This could be percentilebased or some other methodology but 

would have to be developed in 

collaboration with the dialysis industry. 

Another commenter recommended a 

focused review by the servicing 

Network’s Medical Review Board prior 

to implementation of a corrective action 

plan, to determine whether there may 

have been reasonable justification for 

poor performance. The focused review 

should be consistent with population 

studies, which are statistically sound, 

and not on percentile thresholds. A 

commenter suggested that K/DOQI 

clinical practice guidelines were 

developed only to ‘‘inform and enhance 

decision-making,’’ and believed that any 

process should include a review by 

Network Medical Review Boards prior 

to CMS taking enforcement action. 

One commenter had a number of 

concerns. The first concern was that it 

would be impossible to predict if 

patients could achieve clinical 

outcomes. Another concern was that the 

proposal could create a potential 

paperwork burden. A third concern was 

that no improvement plan should apply 

unless a significant number of patients 

were involved. Another concern was 

that the proposal ignored issues like 

missed sessions and patient noncompliance. The commenter also 

suggested that an improvement plan 

could not guarantee better outcomes, 

and that the renal community should 

develop clinical standards and CMS 

should then incorporate them by 

reference into its regulations. 

A commenter stated that the 

minimum standards proposal confuses 

process with outcomes. While a facility 

can order adequate dialysis, Epogen, 

iron, etc., it could not guarantee that 

numerical targets would be met. 

Documenting interventions and why 

goals were not met should be sufficient, 

not the mandatory requirements 

proposed. 

Response: According to the 2006 

Annual Report, End-Stage Renal Disease 

Clinical Performance Measures Project 

(http://www.cms.hhs.gov/CPMProject), 

which is based on data from October 

2005 through December 2005 for 

hemodialysis patients and October 2005 

through March 2006 for peritoneal 

dialysis patients, reports national rates 

of meeting K/DOQI based performance 

measures using a representative sample, 

91 percent of hemodialysis patients are 

meeting the dialysis adequacy target, 

and 81–84 percent of dialysis patients 

have a hemoglobin of 11 g/dL or better 

are meeting the anemia targets. In 

determining facility-level minimum 

standards, we would not want to set our 

thresholds well below established 

performance levels that could serve to 

undercut current performance levels. 

We have not included minimum 

facility-level clinical standards in this 

final rule. We intend to develop 

minimum facility-level clinical 

standards for enforcement using a 

voluntary consensus standards process, 

as proposed at § 494.180(h)(3)(iv). 

f. Special Purpose Renal Dialysis 

Facilities (Proposed § 494.120) 

We proposed to retain with 

modifications the ‘‘Special purpose 

renal dialysis facilities’’ condition from 

§ 405.2164. This condition addresses the 

needs of patients who need dialysis on 

a short-term basis because of emergency 

conditions, or because they are staying 

at remote vacation camps. We proposed 

that such dialysis facilities would be 

approved to furnish dialysis services at 

special locations and that such vacation 

camps would have to be operated under 

the direction of a certified renal dialysis 

facility that would assume full 

responsibility for the care provided to 

patients. The proposed rule retained the 

limited 8-month approval period and 

the service limitation found at 

§ 405.2164. We proposed that a special 

purpose facility would be approved as 

a vacation camp by demonstrating 

compliance with proposed § 494.30, 

most provisions of § 494.40, § 494.50, 

§ 494.70(a) and § 494.70(c), 

§ 494.100(c)(1)(v), § 494.130, 

§ 494.150(c) and § 494.150(d), and 

§ 494.170. We also proposed that a 

special purpose facility certified due to 

emergency circumstances could provide 

services only to those patients who 

would otherwise be unable to obtain 

treatments in the geographical areas 

served by the facility and was approved 

by demonstrating compliance with 

specified proposed conditions for 

coverage that included § 494.20, 

§ 494.30, § 494.40, § 494.50, § 494.60, 

§ 494.70(a) through § 494.70(c), 

§ 494.130, § 494.140, and § 494.150, 

§ 494.170, and § 494.180. The part 405, 

subpart U requirement, that a special 

purpose unit consult with the patient’s 

physician, was retained; we added a 

provision that this consultation must 

occur before initiation of dialysis in a 

special purpose unit. Additionally, we 

proposed to require the special purpose 

unit to document care provided to the 

patient and forward that documentation 

to the patient’s regular dialysis facility 

within 30 days. 

Comment: Many commenters 

submitted suggestions and 

recommendations regarding 

requirements and/or certification for 

special purpose dialysis facilities, and 

several commenters made positive 

remarks regarding the proposed 

requirements and inclusion of vacation 

camps within this condition, including 

the 8-month approval period for special 

purpose facilities, as required at 

§ 494.120(a). A commenter applauded 

the specific mention of vacation camps 

in this regulation, but advised that these 

vacation camps should be certified as 

‘‘safe environments’’ for campers, while 

another commenter suggested the 

deletion of vacation camps from the 

final rule. One commenter suggested 

that the personnel requirements for the 

ESRD facility medical director, for those 

furnishing nursing services, and for 

patient care and water treatment 

technicians be met by the special 

purpose dialysis facility vacation camp 

if on-site dialysis is performed. 

Another commenter suggested that 

the final rule requirements also address 

backup emergency care, and further 

suggested that the closest hospital and/ 


PWALKER on PROD1PC71 with RULES2
20418 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

or children’s hospital be notified and a 

process for emergency transportation be 

identified. One commenter suggested 

that ‘‘certified facilities not be held 

accountable for services provided 

outside their domain.’’

Response: We appreciate the positive 

comments on the proposed language 

regarding special purpose dialysis 

facility vacation camps. While we 

received a suggestion to delete vacation 

camps in the final rule, the majority of 

comments regarding vacation camps 

were positive. Thus, we will adopt 

vacation camp requirements in the final 

rule at § 494.120. We also received some 

positive remarks regarding the approval 

period of 8 months, discussed at 

proposed § 494.120(a), which will also 

be adopted in the final rule. We agree 

with the commenter that vacation 

camps should be a safe environment for 

campers. The facilities must comply 

with the conditions for coverage set out 

at § 494.120(c) to ensure that the 

vacation camp environment protects the 

health and safety of campers. 

This condition addresses the possible 

needs of patients who, because of 

emergency conditions, or because they 

are staying at a remote vacation camp 

providing such services, need dialysis 

on a short-term basis. The commenters’

concerns regarding certain personnel 

requirements, as well as responsibility 

and accountability for vacation camps, 

is addressed at § 494.120(c)(1). This 

standard mandates that special purpose 

dialysis services, provided at a vacation 

camp facility, be operated under the 

direction of a certified renal dialysis 

facility. The certified renal dialysis 

facility assumes full responsibility for 

the care provided to patients. Vacation 

camps must demonstrate compliance 

with the conditions for coverage set out 

at § 494.120(c)(1)(i) through 

§ 494.120(c)(1)(viii), including infection 

control, water and dialysate quality, 

reuse of hemodialyzers, patients’ rights, 

laboratory services, medical director 

responsibilities, medical records, and 

home monitoring of water quality. We 

agree with the commenter that it is 

important to take into consideration 

emergency backup care in vacation 

camps. Vacation camps will be held 

responsible for the care of their patients 

under § 494.120(c)(1), including 

emergency care when required; 

however, we will not specifically 

mandate that vacation camps notify 

hospitals and develop emergency 

transportation plans in this final rule. 

We believe that the requirement at 

§ 494.120(c)(1) provides adequate 

protection for patients at vacation 

camps. 

Comment: A commenter supported 

the requirements for emergency 

circumstance facilities, noting that 

recent natural disasters underscored the 

necessity for such facilities. Another 

commenter agreed with changes in the 

proposed rule that would make access 

to care for a patient in a disaster 

situation more readily available. One 

commenter suggested the proposed 

language at § 494.120(c)(2) was too 

restrictive and that the final rule should 

be revised by requiring such facilities to 

comply with the specified conditions 

‘‘where feasible.’’ The commenter 

suggested that adding ‘‘where feasible’’

would be necessary in the event of a 

large emergency affecting a broad 

geographical area. 

Another commenter suggested the 

requirement at § 494.120(c)(2)(i) 

regarding compliance with Federal, 

State, and local laws and regulations 

would be redundant for a facility that is 

quickly converted to a special purpose 

facility under emergent circumstances. 

The commenter suggested the adoption 

of State and local codes, as well as the 

International Code Council (ICC) 

requirements, in lieu of the LSC, would 

eliminate this problem of redundancy in 

many states. The ICC is an association 

dedicated to building safety and fire 

prevention, and they develop the codes 

used to construct residential and 

commercial buildings, such as health 

care facilities. Most U.S. cities, counties 

and states that adopt codes choose those 

codes developed by the ICC. 

Response: In the event of a large 

disaster, section 1135 of the Act gives 

the Secretary the authority to waive 

regulatory requirements during national 

emergencies. During natural or manmade disasters, the proposed regulation 

at § 494.120(c)(2) allows for more 

flexibility than part 405, subpart U of 

our previous regulations in managing 

emergent circumstances. These facilities 

must comply with a condensed number 

of conditions, which include: § 494.20, 

compliance with Federal, State and 

local laws and regulations; § 494.60, 

physical environment; abbreviated 

sections of § 494.70, patient’s rights; 

§ 494.140, personnel qualifications; 

§ 494.150, medical director; and 

§ 494.180, governance. While we expect 

that special purpose facilities will 

comply with these requirements, we 

understand that there may be instances 

where this may not be possible and a 

waiver might need to be granted; 

however, we do not agree that the 

suggested language ‘‘where feasible’’

should be added to the final rule. 

Comment: Two commenters agreed 

that physician contact during a disaster 

is ideal; however, they stated it may be 

impossible. These commenters 

recommended the addition of a 

provision to allow another physician to 

provide emergency care in extenuating 

circumstances at § 494.120(d). One 

commenter suggested we modify the 

requirement in the final rule to indicate, 

‘‘Standing orders or the patient’s current 

orders may be followed until the time a 

physician may be reached.’’ Another 

commenter suggested the wording in the 

final rule be changed to require 

‘‘nephrologist contact’’ as opposed to 

‘‘physician contact.’’

Response: We agree that it may not be 

possible to consult with the patient’s 

physician during a disaster. To allow 

greater flexibility, in the event of 

disasters or emergencies, we have 

modified the wording in the final rule 

at § 494.120(d) to indicate that the 

facility must contact the patient’s 

physician ‘‘if possible’’ prior to 

initiating dialysis in the special purpose 

renal dialysis facility. Additionally, we 

will retain the requirement for 

‘‘physician contact’’ as proposed, 

because we believe this language will 

allow more flexibility for facilities. 

Comment: It was suggested by a 

commenter that we modify the final rule 

to require forwarding of documentation 

of care at the special purpose facility to 

the patient’s regular facility within 1 

day of the last scheduled treatment, as 

opposed to 30 days as proposed at 

§ 494.120(e). The rationale given was 

that hospitals as well as transient 

dialysis clinics must transfer patient 

care records within one day. 

Response: It is the responsibility of 

the special purpose facility to 

communicate to the patient’s permanent 

dialysis facility regarding the patient’s 

status, and we recognize that it would 

be most desirable for this information to 

be forwarded in less than 30 days. 

However, we must also keep in mind 

that some circumstances may prevent 

such communication timeframes. For 

example, we have learned through 

recent events, such as Hurricane Katrina 

in 2005, that 30 days may not allow 

enough time for special purpose 

facilities to forward all documentation 

to the patient’s permanent facility. 

Because we recognize this possible 

limitation, we have added language to 

allow greater flexibility for facilities. At 

§ 494.120(e) the language has been 

modified in the final rule to require 

information be forwarded ‘‘if possible’’

within 30 days. 

g. Laboratory Services (Proposed 

§ 494.130) 

We proposed to retain the existing 

requirements governing laboratory 

services previously set out at 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20419 

§ 405.2163(b), with minor revisions. The 

dialysis facility must provide or make 

available laboratory services to meet the 

needs of their patients, and these 

services must be furnished by or 

obtained from a facility that meets the 

requirements for laboratory services in 

accordance with 42 CFR part 493. 

Comment: One commenter 

recommended that we add language in 

the final rule to specify that facilities 

must have an agreement with a primary 

or secondary laboratory that meets the 

Certified Laboratory Improvement 

Amendments of 1988 (CLIA) 

requirement. 

Response: CLIA certification is 

addressed at § 494.130 by reference to 

part 493. It states that all Medicarecertified laboratories performing 

laboratory tests be certified under CLIA. 

Therefore, we have adopted the 

language as proposed. 

Comment: One commenter suggested 

the addition of language to the final rule 

saying that to ‘‘ensure that composite 

rate lab tests for each ESRD beneficiary 

are accounted for in a single, centralized 

database for proper application of ESRD 

laboratory billing rules, composite rate 

lab tests performed by any other 

laboratory must be billed through the 

primary laboratory.’’ Another 

commenter suggested adding language 

to specify that in the event a facility 

uses a secondary laboratory, it must 

enter into an agreement with the facility 

or the facility’s primary laboratory to 

bill the facility or the primary laboratory 

for laboratory tests that are subject to 

ESRD laboratory billing rules. One 

commenter suggested we require a 

facility’s primary laboratory to be the 

single laboratory permitted to bill 

Medicare for tests listed as composite 

rate laboratory tests. Another 

commenter suggested that local 

laboratories (in close proximity to an 

ESRD facility) should be able to bill for 

tests through a ‘‘primary laboratory.’’

One commenter remarked that the final 

regulation should address problems 

with Health Maintenance Organizations 

(HMOs) and mandate that required 

testing be conducted in laboratories 

equipped to do such testing. The 

commenter stated that HMOs often 

refuse referrals to properly equipped 

laboratories affiliated with the patient’s 

ESRD unit. 

Response: The commenters’ concerns 

are related to Medicare payment for 

services and are therefore outside the 

scope of this rule. The commenters’

concerns have been forwarded to the 

appropriate officials within CMS for 

consideration. 

Comment: One commenter suggested 

the regulation require that primary 

laboratories agree to furnish the dialysis 

facility with laboratory test data 

electronically upon request so that the 

data can be submitted to ESRD 

Networks. 

Response: The ESRD Conditions for 

Coverage cover dialysis facilities and do 

not extend to testing laboratories. 

Facilities must provide for or make 

available laboratory services to meet the 

needs of the ESRD patient. Laboratory 

services must be furnished by or 

obtained from, a facility that meets the 

requirements for laboratory services 

specified in part 493 of this chapter 

(§ 494.130). However, dialysis facilities 

may enter into business agreements 

with laboratories willing to provide 

requested data electronically. 

Comment: One commenter stated 

‘‘convenience’’ lab draws need to be 

addressed in the final rule. 

Response: We believe the commenter 

is referring to those laboratory tests, 

such as histocompatability tests, 

ordered by a patient’s outside physician, 

which could be drawn in the ESRD 

facility while a patient is undergoing 

dialysis treatment. Drawing additional 

laboratory tests while the patient is 

undergoing treatment is convenient for 

the patient; individual facilities have 

the flexibility to determine if this is a 

service they wish to offer. 

4. Subpart D (Administration) 

a. Personnel Qualifications (Proposed 

§ 494.140) 

To avoid placing substantive 

requirements within the definitions 

section as written in part 405, subpart 

U (at § 405.2102), we proposed a 

separate condition to set forth 

requirements for dialysis facility staff 

qualifications. We proposed that the 

dialysis facility medical director be a 

physician who has completed a board 

approved training program in 

nephrology and has at least 12 months 

experience providing care to patients 

receiving dialysis. We did not retain 

transplantation experience as a 

qualification, which was previously set 

out at § 405.2102(d), because this rule 

applies to dialysis centers and not to 

transplantation centers. We proposed to 

carry forward the part 405, subpart U 

waiver provision for instances when a 

physician meeting the medical director 

qualifications is not available. We 

proposed that the facility nurse manager 

be an RN and a full time employee, as 

required under part 405, subpart U, and 

have at least 12 months of clinical 

nursing experience and an additional 6 

months of dialysis experience. We 

proposed that the self-care home 

dialysis training nurse be an RN with at 

least 12 months of nursing experience 

and an additional 3 months of dialysis 

experience in the modality for which he 

or she would provide training. We 

proposed new qualifications for the 

charge nurse, who would be required to 

be an RN or licensed practical nurse 

(LPN) with 12 months of nursing 

experience, including 3 months of 

dialysis experience. We also proposed 

new qualifications for the staff nurse, 

who would have to be an RN or LPN 

and meet the State practice 

requirements. The proposed 

qualifications for the facility dietitian 

included the registered dietitian (RD) 

credential and at least one year of 

professional work experience as a RD. 

We proposed social worker 

qualifications that would require the 

social worker to have a master’s degree 

in social work from a school of social 

work accredited by the Council on 

Social Work Education. Our proposed 

social worker qualifications did not 

include the grandfather clause (see 

§ 405.2102, ‘‘Qualified personnel’’

paragraph (f)(2)), which allowed nonmaster’s prepared social workers who 

were employed for at least two-years as 

of September 1976 to hold dialysis 

facility social worker positions when 

there was a consultative relationship 

with a master’s prepared social worker. 

We proposed to recognize patient care 

dialysis technicians for the first time in 

the proposed conditions for coverage, 

and set forth proposed qualifications. 

We proposed that patient care dialysis 

technicians have a high school diploma 

or equivalency and at least 3 months 

experience under the direct supervision 

of an RN, and that they complete a 

training program that would include 

specified topics and be approved by the 

medical director and governing body. 

We proposed that the clinical staff meet 

State practice requirements (§ 494.140) 

and be licensed according to State 

provisions (§ 494.20 and 

§ 494.140(e)(1)). We proposed new 

qualifications for the water treatment 

system technicians, who would 

complete a training program approved 

by the medical director and governing 

body. Personnel qualifications that were 

not carried forward from part 405, 

subpart U, included those for the chief 

executive officer, medical record 

practitioner, and the transplantation 

surgeon. 

We received more comments (more 

than 150) on the proposed ‘‘Personnel 

qualifications’’ condition for coverage at 

§ 494.140 than on any other condition. 

Comment: A large number of 

commenters suggested that the title of 

this condition be changed to ‘‘Personnel 

qualifications and responsibilities’’ and 


PWALKER on PROD1PC71 with RULES2
20420 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

that the specific responsibilities of all 

members of the interdisciplinary team 

be included. Commenters suggested that 

the medical director and patient be 

excluded from assignment of 

responsibilities under the ‘‘Personnel 

qualifications’’ condition. Some 

commenters said that since medical 

director responsibilities were included 

at § 494.150, other team member 

responsibilities should be listed in the 

regulation as well. Some commenters 

stated that it would be helpful if clinical 

social worker responsibilities were 

listed in regulation; they state that social 

workers are unable to provide clinical 

social services to patients because they 

are often tasked with clerical work that 

fills the majority of their time. 

Response: We have sought to be less 

prescriptive in this rule in order to 

allow dialysis facilities flexibility in 

meeting Medicare requirements. We 

expect that as professional caregivers, 

members of the interdisciplinary team 

are aware of their discipline’s 

professional standards of practice and 

provide quality care to their patients in 

keeping with those standards. Under the 

‘‘Patient assessment’’ and ‘‘Patient plan 

of care’’ conditions (§ 494.80 and 

§ 494.90), we require that members of 

the interdisciplinary team complete a 

comprehensive assessment followed by 

a plan of care that identifies goals for 

patient care and the services that will be 

provided in order to meet those goals. 

This includes psychosocial and 

nutrition services to be provided by the 

social worker and the registered 

dietitian. The assessment and plan of 

care requirements necessitate that the 

RN, social worker, and dietitian provide 

appropriate professional care to each 

patient. Specifically, the dialysis facility 

must ensure that the social worker 

provides timely psychosocial 

assessments and social work 

interventions in accordance with the 

plan of care in order to meet these 

conditions for coverage. We are also 

requiring at § 494.140 that the 

interdisciplinary team, which includes 

the RN, social worker, and dietitian, 

play an active role in the QAPI program. 

This final rule requires that the 

interdisciplinary team provide 

appropriate care to dialysis patients and 

improve patient care on an ongoing 

basis. We do not agree that all the 

responsibilities of the entire 

interdisciplinary team need to be 

enumerated in regulation. 

Comment: Many commenters objected 

to the change in medical director 

qualifications, as proposed in standard 

§ 494.140(a), and recommended that the 

medical director be board-eligible or 

board-certified, as previously required 

at § 405.2102(e). These commenters 

included patient organizations, dialysis 

organizations, as well as physicians. 

One commenter stated that nephrology 

is a recognized sub-specialty, which 

requires specialized knowledge and 

training and that removing the ‘‘board 

eligible or board-certified’’ requirement 

could affect the continued existence of 

this sub-specialty. Another commenter 

said this ‘‘board-certified’’ requirement 

is the accepted industry standard for 

evidence of proficiency in a specialty. A 

commenter stated that to lower 

standards could jeopardize patient care 

across the nation and that board 

eligibility and certification needs to be 

recognized. Other commenters object to 

lowering of standards for this important 

position, except on a case-by-case basis. 

One commenter recommended that the 

medical director be required to be a 

nephrologist. Two commenters 

supported our proposed medical 

director qualifications. 

Response: Many commenters 

communicated quality-of-care concerns 

regarding our proposed deletion of the 

requirement under former § 405.2102 

that the facility medical director be 

‘‘board-eligible’’ or ‘‘board-certified’’ in 

internal medicine or pediatrics. Our 

goal is to improve quality of care via 

this final rule and to ensure that the 

medical director has the appropriate 

qualifications. Therefore, in response to 

comments, we have revised the 

proposed requirement in the final rule, 

so that the medical director must be 

‘‘board-certified’’ in internal medicine 

or pediatrics by a nationally recognized 

professional board at § 494.140(a). We 

are not including the term boardeligible,’’ as it is no longer used, 

defined, or recognized by the American 

Board of Internal Medicine (http:// 

www.abim.org/cert/ 

policies_ssneph.shtm). We have 

retained the proposed requirement that 

the medical director complete a boardapproved training program in 

nephrology. 

Comment: A commenter 

recommended that the time period 

during which a physician is in a 

training program and providing care to 

dialysis patients should satisfy the 12- 

month experience requirement for 

medical directors. Another commenter 

requested clarification of whether or not 

experience gained during a training 

program could count towards the 12 

months of experience for medical 

director qualifications. The commenter 

noted that if this time were not counted, 

then nephrologists completing their 

training programs could not become a 

medical director for at least 12 months. 

Response: The required 12 months of 

experience caring for dialysis patients 

may include experience gained while a 

physician is enrolled in a nephrologytraining program. This will be reflected 

in the interpretive guidelines for this 

regulation. 

Comment: A commenter requested 

further clarification of the process that 

would allow a physician who does not 

meet the medical director requirements 

at § 494.140(a)(1) to serve as the medical 

director as permitted at § 494.140(a)(2). 

Response: A physician who does not 

meet § 494.140(a)(1) requirements may 

only serve as the medical director when 

a qualified physician is not available, 

and when approved by the Secretary as 

required at § 494.140(a)(2). This 

provision was retained from part 405, 

subpart U. A dialysis facility seeking to 

place an alternate physician in the role 

of the medical director must contact 

their CMS Regional Office to make a 

request for the Secretary’s approval. 

Comment: While most commenters 

supported the proposed RN 

qualifications at § 494.140(b), one 

commenter suggested an increase in RN 

experience requirement, to 2 years of 

clinical and 1 year of dialysis 

experience. Another suggested that the 

RN experience qualification be reduced 

to 6 months. One commenter asked 

whether one RN could fulfill all four 

roles listed under nursing services 

(§ 494.140(b)) if he or she met all the 

qualifications. 

Response: Very few commenters 

disagreed with the proposed experience 

qualifications for RNs; therefore, we will 

adopt the requirement for 12 months of 

nursing experience and 3 to 6 months of 

dialysis experience (depending on the 

role of the RN) in this final rule. A 

single RN may fulfill multiple nursing 

roles in the dialysis facility if he or she 

possesses the appropriate qualifications 

for each role and if this does not 

jeopardize the facility’s ability to meet 

the staff requirement at § 494.180(b)(1). 

Comment: A few commenters 

suggested a revision of the qualifications 

for the charge nurse. A commenter 

suggested that 12 months of experience 

for charge nurses be changed to 6 

months because the nursing shortage 

necessitates not eliminating new 

nursing graduates from the hiring pool. 

Another commenter stated that 3 

months of dialysis experience should 

not include ‘‘orientation time,’’ as 3 

months of experience is barely 

adequate. Two commenters stated that 

they believe the 3 months of dialysis 

experience to be inadequate and 

recommended that the requirement be 

changed to at least 6 months, since some 

States, such as California, have no 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20421 

minimum training requirements; the 

commenters believe that this 

endangered patients. 

Response: There was disagreement 

among commenters regarding the 

proposed qualifications for charge 

nurses, with some commenters 

advocating longer experience 

requirements and others suggesting 

shorter experience requirements. Our 

goal for this provision is to ensure that 

a qualified nurse who can adequately 

protect patient safety acts as the charge 

nurse. We believe that the level of 

experience for charge nurses as stated in 

the proposed rule (12 months 

experience in providing nursing care, 

including 3 months of dialysis nursing 

care) is reasonable. Given that there is 

disagreement among commenters and 

no evidence was presented supporting a 

modification, we have adopted the 

charge nurse experience requirements as 

proposed at § 494.140(b)(3)(ii). 

Comment: Many commenters objected 

to the proposed charge nurse 

qualifications, which commenters state 

would allow a licensed practical nurse 

to serve as a charge nurse, because state 

practice boards generally do not allow 

an LPN to supervise an RN. Some 

commenters stated that the level of 

responsibility for the charge nurse 

requires an RN, and LPNs are not 

qualified for this position. Other 

commenters stated that experienced 

dialysis LPNs are very capable 

individuals. Two commenters stated 

that due to the nursing shortage, an LPN 

should be allowed to act as the charge 

nurse only when an RN is not available. 

Another commenter stated that the 

nursing shortage should not be used to 

justify use of unqualified personnel. 

One commenter stated that LPNs could 

function as charge nurses without any 

RN supervision on-site, and another 

stated that the LPNs at her facility have 

more experience than the RNs. One 

commenter noted that LPNs are used 

more frequently by LDOs. 

Response: We have revised the 

requirement formerly found at subpart 

U (§ 405.2162), so that an RN must be 

present in the facility, and an LPN could 

still act as a charge nurse if he or she 

met the proposed qualifications. We did 

not intend for a LPN to supervise an RN, 

as suggested by the commenters. 

The RN must be present in the facility 

when patients are being treated, as 

required at § 494.180(b)(2). An LPN 

might act as the charge nurse but would 

not necessarily be supervising an RN. 

All dialysis nurses must adhere to their 

state practice requirements. We have 

modified § 494.140(b)(3)(iii) to clarify 

this by adding language to indicate that, 

if the charge nurse is a licensed 

practical nurse or licensed vocational 

nurse, that he/she must work under the 

supervision of a registered nurse when 

required by the State nursing practice 

act provisions. 

Comment: A few commenters 

objected to proposed § 494.140(b)(1)(i), 

which requires the nurse manager RN to 

be a full-time employee of the facility, 

and recommended deletion of this 

requirement. Two commenters said it 

was unrealistic to require the nurse 

manager to be employed full-time 

because small rural units are only open 

part-time. Some units share the same 

nurse manager. A commenter stated that 

requiring a full-time employee as nurse 

manager would not be a good use of a 

scarce resource. 

Response: The full-time requirement 

is not a new provision (refer to former 

§ 405.2162(a)). Dialysis facilities should 

already be fully compliant with this 

provision. In the case of small dialysis 

facilities that are not open for at least 40 

hours per week the ‘‘full-time nurse’’

would be employed at all times the 

facility is open. For example, a dialysis 

facility that is only open for 24 hours 

per week would only need to employ 

the nurse manager for 24 hours per 

week to satisfy this requirement. We 

have retained this requirement as 

proposed. 

Comment: We received a few 

comments regarding the qualifications 

of the self-care training nurse. 

Response: Please refer to the earlier 

discussion of self-care training nurse 

qualifications found under the 

discussion of § 494.100 in this 

preamble. 

Comment: A commenter suggested 

that we change the position title ‘‘selfcare training nurse’’ to ‘‘self-care or 

home training nurse’’ in order to specify 

that self-care nurses can train patients 

for in-home or in-facility dialysis. 

Response: We agree, and have 

modified the position title at 

§ 494.140(b)(2) to clarify that ‘‘self-care’’

includes home dialysis. The new 

position title is ‘‘self-care and home 

dialysis training nurse.’’

Comment: A commenter suggested 

that staff nurse requirements be the 

same as those proposed for PCTs, which 

are at least 3 months experience, 

following a training program that is 

approved by the governing body. 

Response: We agree that the 

requirements should be similar. We 

have eliminated the experience 

requirements for both staff nurses 

(§ 494.140(b)(4)) and PCTs 

(§ 494.140(e)). Each professional, 

however, will be required to meet the 

training requirements appropriate to 

their specialty. 

Comment: One commenter suggested 

that a statement be added to the final 

rule that would mandate that there 

could be no contract nurse(s) filling the 

roles of the nurse manager, self-care 

training nurse, or the charge nurse. 

Response: We agree, and are adopting 

the proposed requirement at 

§ 494.140(b)(1)(i) that the nurse manager 

be a full-time employee of the facility, 

which means this position cannot be 

filled by a contracted nurse. The selfcare and home dialysis training nurse 

and the charge nurse positions do not 

have this restriction and may be either 

employees or contractors. Employees 

are subject to the following directions of 

an employer relative to what needs to be 

done and how it should be done. 

Contractors, on the other hand, are 

generally not held to how a job is done 

and the methods that are used. A nurse 

manager fills a critical role and it is 

important that his or her actions meet 

the needs of the facility’s governing 

body. If a nurse under contract fills 

these roles, he or she must have the 

proper qualifications and complete the 

orientation for the position as required 

in this final rule at § 494.180(b)(3). 

Comment: A commenter suggested we 

specify that RNs have training in the 

care of patients with chronic disease 

and physical, emotional, and 

psychosocial issues. 

Response: We would expect that RNs 

have received training in each of these 

areas as part of their nursing 

curriculum. We do not agree there is a 

need to specify this training in 

regulation. 

Comment: One commenter suggested 

that advance practice nurses should 

serve as ‘‘case managers’’ and be 

reimbursed for this role. 

Response: This rule does not preclude 

the use of advance practice nurses in 

dialysis facilities, but we do not feel we 

should be this prescriptive because of 

the degree of regulatory burden imposed 

upon facilities. In addition, this final 

rule does not address reimbursement 

issues. 

Comment: We received more than 15 

comments on dietitian qualifications at 

§ 494.140(c). The majority of 

commenters agreed and supported our 

proposal to require a ‘‘minimum of one 

year’s professional work experience in 

clinical nutrition as a registered 

dietitian’’. One commenter suggested 

that the American Dietetic Association 

(ADA) registration is not enough and 

minimum experience criteria are 

needed. 

The ADA agreed with the proposed 

qualifications for dietitians. The ADA 

noted that registered dietitians (RDs) 

also possess clinical knowledge and 


PWALKER on PROD1PC71 with RULES2
20422 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

skills to manage anemia and bone 

disease and to conduct urea kinetic 

analysis. The ADA stated that according 

to the Commission on Dietetic 

Registration, there are more than 72,000 

RDs nationwide, and the supply of RDs 

is well established. 

One commenter stated that 1 year of 

registered dietitian professional work 

experience in clinical nutrition is 

acceptable, but 2 years would be ideal. 

Newly hired RDs without renal 

experience should have a training 

period of at least 2 weeks with an 

experienced renal dietitian. This 

commenter also noted that the role of 

the dietitian has expanded and 

recommended that the responsibilities 

of dietitians include monitoring 

adherence and response to diet, and 

recommending interventions for 

improving nutritional status. The 

commenter provided examples of the 

expanded role of the dietitian, which 

included anemia manager, and bone and 

urea kinetic modeling manager, to 

improve clinical outcomes. 

One commenter agreed with the 

proposed 1-year experience requirement 

since quality care depends on renal 

training and specialization, but said 

facility managers point to the difficulty 

of finding sufficient numbers of 

experienced dietitians. This commenter 

suggested that the one year of 

experience be preferred but not 

required. 

Three commenters disagreed with the 

proposed 1-year professional experience 

requirement. One commenter stated the 

1 year of professional work experience 

is unnecessary; only registration with 

the Commission on Dietetic Registration 

is needed. This commenter stated that 

instead, mentoring and direction from 

an experienced renal dietitian is 

needed. The commenter stated that the 

experience requirement would diminish 

the pool of qualified dietitians. Another 

commenter also stated that adding a 

year of experience as a requirement for 

RDs would create even more of a RD 

shortage and is not necessary given their 

extensive education. 

Another commenter suggested that we 

delete ‘‘as a registered dietitian’’ from 

regulations text, so that experience 

obtained prior to becoming a registered 

dietitian could be counted, and 

professional work experience gained 

during an internship would apply. This 

commenter further suggested that all 

dialysis dietitians be required to 

participate in training from experienced 

dietitians. 

Three commenters recommended that 

the dietitian qualifications match the 

medical nutrition therapy (MNT) 

regulation requirements, which call for 

a bachelor of arts degree or higher, an 

academic program in nutrition or 

dietetics, 900 hours of supervised 

dietetics practice, and being licensed or 

certified as a dietitian or nutritional 

professional by the State in which the 

professional is practicing. One of these 

commenters agreed with requiring a 

minimum of 1 year’s professional work 

experience as a registered dietitian. 

Response: The dietitian qualifications 

in subpart U at § 405.2102(b) specify at 

least 1-year experience in clinical 

nutrition. In this final rule, we 

redesignated proposed § 494.140(c)(3) as 

§ 494.140(c)(2), which requires 1 year of 

professional work experience in clinical 

nutrition as a registered dietitian. Renal 

nutrition is a specialized area within the 

practice of dietetics. The dialysis facility 

dietitian must be able to perform 

independently complex nutritional 

assessments, evaluate laboratory results, 

and assist the interdisciplinary team in 

managing anemia, renal bone disease, 

and performing kinetic modeling. A 

typical therapeutic diet for a 

hemodialysis patient has multiple 

restrictions and is limited in sodium, 

phosphorus, potassium, fluid, and 

includes specified amounts of protein. 

Many patients must follow additional 

dietary restrictions such as low 

cholesterol or diabetic limitations. We 

believe that a registered dietitian would 

need at least one year of experience to 

perform this specialized work. The 

majority of commenters recognized the 

specialized work of a RD in the dialysis 

setting. 

The MNT dietitian qualifications at 42 

CFR 410.134 require the MNT provider 

to be a registered dietitian with the 

Commission on Dietetic Registration or 

to have a bachelor’s degree or higher in 

nutrition or dietetics, 900 hours of 

supervised experience and state 

licensure, if applicable. The MNT 

dietitian qualifications allow a 

nutritionist who is not a registered 

dietitian to provide medical nutrition 

therapy. By contrast, dialysis dietitians 

must be registered dietitians under both 

the previous ESRD regulations and the 

proposed rule. We have not removed the 

registered dietitian qualification 

requirement, as we find no reason to do 

so. 

We do not have evidence that there is 

a shortage of registered dietitians that 

necessitates deletion of the clinical 

experience requirement. While 

mentoring programs are desirable, we 

did not propose them and have not 

added this requirement to the final rule. 

Registered dietitians must be oriented to 

the facility and their work 

responsibilities (§ 494.180(b)(3)) and 

have an opportunity for continuing 

education and related development 

activities (§ 494.180(b)(4)). 

Comment: Two commenters suggested 

including the word ‘‘clinical’’ in the 

‘‘professional work experience’’ phrase 

so that foodservice experience does not 

apply. 

Response: The proposed rule at 

§ 494.140(c)(3), (now § 494.140(c)(2)), 

requires dietitians ‘‘have a minimum of 

one year’s professional work experience 

in clinical nutrition as a registered 

dietitian.’’ This wording would 

preclude a dietitian who only has 

foodservice professional experience 

from qualifying for a position as a 

dialysis dietitian. We do not agree that 

a change in wording is needed here 

because clearly, the experience must be 

in ‘‘clinical nutrition.’’

Comment: One commenter 

recommended that dietitian-to-patient 

caseloads be limited to 90–100 patients 

per dietitian. 

Response: We address adequate 

staffing under the ‘‘Governance’’

condition for coverage at § 494.180(b). 

Some States have implemented staff-todialysis patient ratios, and we defer to 

State provisions on this issue. Dialysis 

dietitian caseloads must not prevent 

RDs from providing care consistent with 

national standards of practice for 

dietitians. National standards have been 

published by the ADA entitled 

‘‘Standards of Practice in Nutrition Care 

and Updated Standards of Professional 

Performance’’ in April 2005 

(Kieselhorst, K.J., Journal of the 

American Dietetic Association, Vol. 105, 

No. 4, April 2005). 

Comment: One commenter suggested 

that dietetic technicians be included in 

the final rule. The commenter stated 

that she strongly supported the use of 

dietetic technicians, registered (DTRs) 

under RD supervision and that DTRs are 

nationally certified and have education 

requirements similar to the RDs. 

Response: We do not agree that RDs 

and DTRs have similar education 

requirements. According to the ADA, 

DTRs must complete at least a 2-year 

associate’s degree while an RD must 

complete a minimum of a bachelor’s 

degree at a U.S. regionally accredited 

college or university. A DTR must 

complete a dietetic technician program 

accredited and approved by the 

Commission on Accreditation for 

Dietetics Education (CADE), including 

450 hours of supervised practice 

experience. An RD must complete a 

CADE accredited supervised practice 

program that typically runs 6 to 12 

months in length. RDs and DTRs also 

have different continuing education 

requirements. 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20423 

This final rule requires an RD to be a 

member of the dialysis facility 

interdisciplinary team, perform patient 

assessments, and participate in patient 

care planning and the QAPI program. 

The RD may use a DTR to provide 

assistance under RD supervision, but it 

is the RD who must meet these 

conditions for coverage. Therefore, we 

have not added DTRs to the ‘‘Personnel 

qualifications’’ condition. 

Comment: We received more than 70 

comments regarding social worker 

qualifications. The vast majority of 

commenters supported the proposed 

social worker qualifications, which 

require a master’s degree in social work 

from a school of social work accredited 

by the Council on Social Work 

Education. 

Commenters stated that dialysis 

patients have highly complex needs and 

require care from an MSW who has a 

‘‘specialization in clinical practice’’

education. Commenters made the 

following statements in support of an 

MSW with a specialization in clinical 

practice. They stated that the 

nephrology social workers must be 

skilled in assessing for psychosocial 

influences and their interrelatedness in 

predicting treatment outcomes, and 

must be able to design interventions 

with the patient, the family, the medical 

team, and community systems at large 

to maximize the effectiveness of ESRD 

treatment. The additional training 

received by MSWs enables them to 

perform these complex professional 

tasks and ensure effective outcomes that 

have a direct relationship to morbidity 

and mortality. Masters-prepared social 

workers are trained to use validated 

tools, such as the SF36 (the Medical 

Outcomes Study 36-item short-form 

health survey) and the KDQOL (Kidney 

Disease Quality of Life), to improve care 

and to monitor the outcomes of directed 

interventions. Most nephrology social 

workers provide psychosocial services 

autonomously as primary providers 

without social work supervision or 

consultation, using highly developed 

social work intervention skills obtained 

in a master’s level curriculum. The 

masters in social work degree provides 

an additional 900 hours of specialized 

training beyond a baccalaureate degree 

in social work. An MSW curriculum is 

the only curriculum that offers 

additional specialization in the BioPsycho-Social-Cultural, Person-inEnvironment model of understanding 

human behavior. Undergraduate degrees 

or other mental health credentials do 

not offer this specialized and 

comprehensive training. The National 

Association of Social Workers Standards 

of Classification considers the 

baccalaureate degree as a basic level of 

practice, while the masters degree is 

considered a specialized level of 

professional practice and requires a 

demonstration of skill or competency in 

performance. These commenters 

provided references and citations along 

with these comments. 

A few commenters suggested that the 

master’s degree qualification be 

eliminated because it is difficult to 

recruit MSWs in some rural areas. A 

commenter stated that in California a 

licensed clinical social worker requires 

2 years of supervision and two 

examinations, which makes it difficult 

to get a licensed clinical social worker 

license. Another commenter suggested 

that we keep the MSW requirement but 

include an ‘‘exceptions process’’ for 

units that cannot hire an MSW. Some 

commenters stated that bachelor’s 

prepared social workers are competent 

as long as they are supervised by an 

MSW. 

Response: We appreciate the large 

degree of support for the MSW 

qualification for social workers. We 

have revised the MSW requirement in 

§ 494.140(d)(1) by adding 

‘‘specialization in clinical practice,’’ as 

specified in part 405, subpart U, as the 

majority of comments supported this. 

The consensus among the commenters 

is that this level of knowledge and skill 

is needed to deal with an increasingly 

older, sicker, more complex dialysis 

patient population. 

Comment: One commenter 

recommended that we delete 

§ 494.140(d) in its entirety or delete any 

preamble references to MSWs 

performing counseling, long-term 

behavioral and adaptation therapy, and 

grieving therapy. The commenter stated 

that such counseling exceeds the 

expertise of MSWs, and that patients 

should be referred outside the units for 

this service. The commenter also 

claimed that an ‘‘expansion’’ of 

counseling requirements represents a 

potential $18 million burden to his large 

dialysis organization. 

Response: The ‘‘Personnel 

qualifications’’ condition for coverage at 

§ 494.140 does not specify tasks or 

responsibilities for dialysis facility 

social workers, but only their education 

and qualifications. The proposed rule 

preamble discussion provided examples 

of social worker services that facilities 

might offer, including counseling 

services, long-term behavioral and 

adaptation therapy, and grieving 

therapy (70 FR 6222) that would require 

the education and training of an MSW. 

The proposed rule’s preamble 

discussion is consistent with part 405, 

subpart U social worker requirements at 

§ 405.2163(c), which state that ‘‘Social 

services are provided to patients and 

their families and are directed at 

supporting and maximizing the social 

functioning and adjustment of the 

patient.’’ Social services needed for each 

patient should be determined during the 

assessment and identified in the plan of 

care. 

Only one commenter suggested 

§ 494.140(d) be deleted in its entirety, 

while a very large number of comments 

supported this requirement, and the 

consensus was to retain MSWs in 

dialysis units. MSWs are trained and 

competent to counsel patients. The 

social worker professional standards of 

practice (http://www.socialworkers.org/ 

practice/standards/ 

NASWHealthCareStandards.pdf) do 

include patient and family counseling 

within the scope of services provided by 

a social worker. MSW services, which 

include counseling, is incorporated into 

the Medicare composite payment rate 

and should not be outsourced or 

separately billed. 

Comment: We received a large 

number of comments regarding our 

proposed deletion of the master’s degree 

‘‘grandfather clause’’ for social workers. 

Many commenters agreed with 

eliminating the ‘‘grandfather clause’’

because ‘‘30 years was more than 

enough time for dialysis social workers 

to obtain masters degree.’’ Commenters 

stated that MSW and BSW tasks could 

be broken out into separate job 

descriptions so that BSWs may assist 

MSWs. Commenters said that there was 

no MSW shortage. 

A larger number of commenters 

suggested that we retain the 

‘‘grandfather clause’’ for non-MSWs so 

that currently employed non-MSWs 

working as dialysis social workers do 

not lose their jobs. Some commenters 

suggested that experienced non-MSW 

social workers were competent and had 

much to offer dialysis patients. A few 

commenters recommended that we 

continue the grandfather clause until 

the year 2015 to allow current nonMSWs who met the subpart U 

requirements to finish out their careers. 

Response: According to the definition 

of ‘‘Qualified personnel’’ at § 405.2102, 

a non-masters degree social worker may 

serve as an ESRD social worker (under 

§ 405.2102(f)(2), qualified personnel) 

when he or she ‘‘has served for at least 

2 years as a social worker, 1 year of 

which was in a dialysis unit or 

transplantation program prior to 

September 1, 1976, and has established 

a consultative relationship with a social 

worker who qualifies under paragraph 

(f)(1) of this definition’’ (that is, has 

completed a course of study with 


PWALKER on PROD1PC71 with RULES2
20424 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

specialization in clinical practice at, and 

holds a masters degree from a graduate 

school of social work). This subpart U 

grandfather clause only applies to nonMSWs who have been practicing social 

work since 1974, and any ESRD social 

workers who do not have 2 years of 

experience prior 1976 must have a 

masters degree. 

While we believe the number of nonmasters-degree social workers still 

practicing over the past 32 years is 

small, we do not intend that these longtime employees should become 

unqualified for their jobs because of 

deletion of the ‘‘grandfather clause.’’ In 

response to comments we will adopt the 

proposed ‘‘grandfather clause’’ and add 

the existing provision from subpart U to 

the final rule at § 494.140(d)(2) to read 

as follows: ‘‘Has served at least 2 years 

as a social worker, 1 year of which was 

in a dialysis unit or transplantation 

program prior to September 1, 1976, and 

has established a consultative 

relationship with a social worker who 

qualifies under § 494.140(d)(1) of this 

part.’’ The grandfather clause may not 

be applied to social workers who do not 

meet the 1976 experience criterion. 

Bachelors-prepared social workers may 

function as assistants to the MSW. The 

MSW is the staff member who must 

satisfy these conditions for coverage. 

Comment: A few commenters 

suggested that we eliminate the 

proposed § 494.140(d)(2) requirement, 

‘‘Meets the practice requirements for 

social services in the State in which he 

or she is employed.’’

Response: Adherence to State scopeof-practice requirements is an 

appropriate minimum requirement for a 

federal health and safety regulation. 

This final rule supports compliance 

with State regulations. The final rule 

provision for meeting applicable scopeof-practice board and licensure 

requirements for dialysis facility 

personnel has been moved to the 

beginning of § 494.140 to avoid 

redundancy within the standards for 

each of the dialysis facility staff 

members. 

Comment: Several commenters 

suggested that we add a social worker 

licensure requirement to § 494.140(d)(2). 

Response: The proposed rule at 

§ 494.20 required licensure for all staff. 

To prevent confusion regarding whether 

licensure is required under personnel 

qualifications, we have moved the 

requirement to the beginning of 

§ 494.140, to read: ‘‘All dialysis facility 

staff must meet the applicable scope of 

practice board and licensure 

requirements in effect in the State in 

which they are employed.’’

Comment: Many social workers as 

well as some commenters who are not 

social workers suggested that a new 

social worker aide personnel standard 

be added to the final rule. The rationale 

given was that this new staff member 

could perform many of the clerical tasks 

(admissions, billing, transportation, 

transient patient paperwork, 

determining insurance coverage) often 

assigned to social workers, so that the 

social worker would be freed up to 

perform clinical social services, such as 

counseling, that would result in 

improved patient care and better 

outcomes. Many commenters stated this 

position should be required for dialysis 

facilities with more than 75 patients. 

Response: This final rule requires 

each facility to have adequate staff to 

meet patient needs. Paragraph 

§ 494.180(b)(1) applies to all dialysis 

staff, including social workers. The use 

of ancillary staff is not precluded by this 

regulation. Some dialysis facilities do 

employ staff to assist the social worker 

with clerical tasks, while other facilities 

may employ more than one social 

worker. Each facility should assess their 

staffing needs and determine 

appropriate staffing levels. While we 

agree that using an MSW to perform 

clerical tasks and manage patient 

financial information may not be the 

most effective or efficient use of trained 

and licensed professional clinical staff, 

we are not requiring that dialysis 

facilities employ social worker aides. 

We encourage dialysis facilities to use 

staff resources in the most effective and 

efficient manner to provide quality care 

to dialysis patients. 

Comment: Many commenters 

suggested that the final rule state that 

MSWs could not be assigned non-MSW 

tasks. These commenters object to the 

number of clerical tasks that are 

assigned to social workers. 

Response: Dialysis facilities have the 

flexibility to assess facility-staffing 

needs and use staff as necessary. This 

final rule requires social workers to 

provide appropriate clinical services to 

dialysis patients under the ‘‘Patient 

assessment’’ and ‘‘Patient plan of care’’

conditions for coverage (§ 494.80 and 

§ 494.90 respectively). The social 

worker must also participate in the 

facility QAPI program (§ 494.110). The 

facility must have a sufficient social 

services staff to meet dialysis patient 

needs as required at § 494.180(b)(1), 

which applies to all dialysis staff, 

including social workers. We would 

expect that any tasks assigned to the 

social worker would not compromise 

the social worker’s ability to meet his or 

her obligations to patients and these 

conditions for coverage. We have not 

added restrictions regarding staff 

assignments to this final rule. 

Comment: Many commenters 

recommended that we specify a 

maximum MSW caseload or an MSWto-patient ratio. 

Response: As discussed above, 

adequate staffing is addressed under the 

‘‘Governance’’ condition for coverage at 

§ 494.180(b). Some states have 

implemented staff-to-dialysis patient 

ratios, and we defer to State provisions 

on this issue. 

Nephrology social workers should 

adhere to the professional standards of 

practice for social workers. The National 

Association of Social Workers published 

‘‘NASW Standards for Social Work 

Practice in Health Care Settings’’ in 

2005. These professional practice 

standards may be found at http:// 

www.socialworkers.org/practice/ 

standards/ 

NASWHealthCareStandards.pdf. The 

National Association of Social Workers 

and Council of Nephrology Social 

Workers jointly published ‘‘NASW/NKF 

Clinical Indicators for Social Work and 

Psychosocial Service in Nephrology 

Settings’’ in October 1994, which may 

be found at http:// 

www.socialworkers.org/practice/ 

standards/nephrologysettings.asp. In 

addition, the NKF has published the 

2003 Council of Nephrology Social 

Workers ‘‘Standards of Practice for 

Nephrology Social Work.’’ These 

standards of practice include guidelines 

for clinical practice, a description of the 

nephrology social work role, as well as 

staffing information. 

Comment: A commenter suggested 

that the final rule state that different 

facilities can share the same renal 

dietitian or social worker. 

Response: Neither part 405, subpart U 

nor the proposed rule precludes facility 

sharing of renal dietitians and social 

workers, as long as each facility has 

adequate staff and staff hours to meet 

patient needs and provide care 

consistent with professional practice 

standards. Please refer to 

§ 494.180(b)(1), which applies to all 

dialysis staff. 

Comment: We received a very large 

number of comments on § 494.140(e), 

addressing patient care dialysis 

technician qualifications. Commenters 

generally supported the addition of 

technician qualifications and training 

requirements to the conditions for 

coverage. 

More than 20 commenters, including 

the National Kidney Foundation, 

American Association of Kidney 

Patients, American Kidney Fund, 

CNSW, some of the ESRD Networks, the 

National Association of Nephrology 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20425 

Technicians/Technologists, the Renal 

Support Network, and various ESRD 

suppliers and professionals, 

recommended that we require PCTs to 

be certified. Commenters stated that 

PCTs are now the predominant 

caregivers in ESRD facilities. 

Certification is necessary to protect 

patient health and safety in view of the 

ongoing nursing shortage. Commenters 

stated that certification is the first step 

towards minimal competency, and is 

the national trend; California, Arizona, 

Oregon, and Ohio now require PCT 

certification. Commenters state that a 

standardized curriculum and 

examination is desirable to improve 

quality of care. 

Kidney Care Partners (KCP), which 

represents a coalition of renal 

stakeholders, including the large 

dialysis organizations; renal physician, 

nurse, and administrator organizations; 

and pharmaceutical companies, stated 

that it supported more consistent 

training and certification for patient care 

dialysis technicians. In the 109th 

Congress, they noted that S. 635 and 

H.R. 1298 introduced by Sens. Rick 

Santorum (R–PA) and Kent Conrad (D–

ND) in the Senate and Reps. Dave Camp 

(R–MI) and William Jefferson (D–LA) in 

the House, would have required that 

patient care dialysis technicians receive 

uniform training and become certified, 

indicating at least a minimum level of 

competency to provide dialysis-related 

services. These technicians would have 

been required to repeat training or 

become recertified if 24 consecutive 

months had passed during which they 

had not performed dialysis-related 

services. Service providers and renal 

dialysis facilities would have been 

required to provide performance 

reviews and in-service education to 

assure ongoing competency. Although 

KCP recognized the importance of 

deferring to the States to regulate health 

care workers, they noted that the 

Medicare program had already 

established similar training 

requirements for unlicensed personnel 

in skilled nursing facilities. They urged 

us to incorporate these substantive 

requirements from the legislation 

(which expired without action at the 

end of the 109th Congress) into our final 

rule. 

A commenter suggested that on-thejob training was only equal to an 

orientation and recommended national 

certification for PCTs. Another 

commenter advocating certification 

stated that dialysis patients have been 

asking for assurances of technician 

competency and certification would 

help assure such minimal competency. 

One state surveyor opposed any 

language permitting the use of 

unlicensed personnel for the practice of 

nursing or medicine, and stated that our 

requirement should not conflict with 

State nursing and medicine practice 

acts. The commenter also argued that 

the use of unlicensed staff was 

dangerous. 

One commenter opposed PCT 

certification, stating that it would not be 

prudent to add this requirement, 

pointing to the ‘‘pro and con’’

certification discussion in the proposed 

rule (70 FR 6223). 

Response: PCTs perform a variety of 

clinical tasks (subject to the limitations 

of State law), that include preparing 

dialysis apparatus, performing 

equipment safety checks, initiating 

dialysis (including cannulation and 

venipucture with large gauge needles), 

intravenous administration of heparin 

and sodium chloride solutions, 

subcutaneous or topical administration 

of local anesthetics in conjunction with 

placement of dialysis needles, 

monitoring patients during dialysis, 

taking vital signs, documenting tasks 

and patient observations, and more. The 

proposed rule preamble discussed PCT 

certification, but recognized some 

barriers to national certification (70 FR 

6223). The large majority of commenters 

did not agree that these potential 

barriers (state control, lack of renal 

community consensus at that time, 

burden and costs) outweighed the 

patient safety benefits of PCT 

certification. 

Therefore, we have revised 

§ 494.140(e) ‘‘Patient care dialysis 

technicians’’ by adding paragraph (e)(4), 

which requires that PCTs, ‘‘Be certified 

under a State certification program or a 

national commercially available 

certification program as follows: (i) For 

newly employed patient care 

technicians, within 18 months of being 

hired as a dialysis patient care 

technician, or (ii) For patient care 

technicians employed on October 14, 

2008, within 18 months after such date. 

We are allowing an 18-month time 

period for certification to ensure that a 

sufficient time period is available for 

PCTs to schedule a date to sit for the 

certification exam. Because we are 

allowing a lengthy time period to 

become certified, we are retaining the 

proposed rule’s training program topics 

to ensure that non-certified PCTs have 

appropriate training before they begin to 

provide patient care as a PCT trainee. 

National commercially available 

certification programs include those of 

the Nephrology Nursing Certification 

Commission (NNCC), the Board of 

Nephrology Examiners Nursing and 

Technology (BONENT), and the 

National Nephrology Certification 

Organization (NNCO). Dialysis facilities 

or dialysis corporations may conduct 

their own in-house certification 

programs and testing but it must be in 

addition to a certification program made 

available by an external body. The 

NNCC offers the Certified Clinical 

Hemodialysis Technician (CCHT) 

examination, which is offered as a valid 

measure of basic competency for 

hemodialysis PCTs. Technicians are 

eligible to take the CCHT examination 

with a suggested minimum of six 

months experience in nephrology 

technology. The CCHT examination 

measures performance in four dialysis 

practice areas: clinical (50 percent), 

technical (23 percent), environmental 

(15 percent), and role (12 percent). 

Information on the CCHT examination, 

a schedule of test sites and dates, and 

applications is available at http:// 

www.nncc-exam.org. If the State has a 

certification and competency-testing 

program in place that is specific to 

dialysis PCTs, then State certification 

also satisfies this requirement. 

We will be reviewing any new 

national commercially available 

certification programs that emerge in the 

future to determine whether a program 

meets the intent of these conditions for 

coverage. Based on these reviews, we 

will determine whether further 

rulemaking is necessary to ensure the 

competency of PCTs and to protect 

patient safety. 

Comment: A small number of 

commenters did not agree that PCTs 

should have 3 months of experience 

following a training program under the 

‘‘direct’’ supervision of an RN. While 

commenters agreed there should be PCT 

training, they did not agree that 3 

months of experience should be under 

the ‘‘direct’’ supervision of an RN. Some 

of the commenters stated that the 3 

months was too long a time period, and 

others said this would demand too 

much RN time. A few commenters 

stated the training program and 3 

months of experience should be allowed 

to occur simultaneously. Some 

commenters sought clarification of the 

term ‘‘direct supervision’’, since RNs 

could supervise without constant oneon-one contact. Some commenters 

stated this was not good use of RN time 

and that other staff, for example, PCTs 

and LPNs, could mentor new PCTs. Two 

commenters agreed with the 3-month 

experience provision. One commenter 

stated that some State nurse practice 

acts delineate delegation of training by 

RNs. 

Response: Since we are requiring that 

new PCTs complete an initial training 


PWALKER on PROD1PC71 with RULES2
20426 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

program and become certified within 18 

months of beginning PCT employment, 

we are not finalizing the requirement 

that the PCT have at least 3 months of 

experience that was proposed at 

§ 494.140(e)(3). In addition, this training 

program includes on-the-job training 

and experience that must be under the 

general supervision of a registered 

nurse. We agree with some commenters 

that PCT trainees may gain patient care 

experience during the up to 18-month 

period under the supervision of an RN 

with mentoring by LPNs, licensed 

vocational nurses (LVNs), and certified 

PCTs. Therefore, we have revised 

§ 494.140(e)(3) to provide this 

clarification. This new wording allows 

new PCTs to be mentored by LPNs, 

LVNs, and certified PCTs under the 

guidance of an RN. Also, once certified, 

PCTs work ‘‘under the direction of a 

registered nurse,’’ instead of ‘‘under the 

direct supervision of a registered 

nurse.’’

We have moved the description of the 

PCT training program from proposed 

§ 494.180(b)(5) to § 494.140(e)(3) in this 

final rule so that the PCT training 

requirements may be located in one 

section of the final rule. 

Comment: One commenter suggested 

that we strengthen the training 

requirement so that training must be 

provided under the direct supervision of 

an ‘‘RN with at least 6 months of 

experience of providing care in 

dialysis.’’

Response: We do not agree with this 

comment. As stated in the previous 

response, PCT trainees may gain patient 

care experience during the up to 18- 

month period under the supervision of 

an RN with mentoring by LPNs, LVNs, 

and certified PCTs. We have revised 

§ 494.140(e)(3) to provide this 

clarification. This new wording allows 

new PCTs to be mentored by LPNs, 

LVNs, and certified PCTs under the 

guidance of an RN. Once certified, PCTs 

work under a nurse’s direction. 

In addition, for nurse manager and 

charge nurse experience in this final 

rule we require all registered nurses to 

have 12 months experience in providing 

nursing care, including 3 months of 

experience in providing nursing care to 

patients on maintenance dialysis. We 

believe that this level of experience is 

sufficient for a nurse manager or charge 

nurse to be able to provide or oversee 

training to a PCT. 

Comment: A commenter suggested 

that we revise proposed § 494.140(e)(3) 

and replace ‘‘patient sensitivity training 

and care of difficult patients’’ with 

‘‘conflict management and patient 

centered care.’’

Response: We do not agree that the 

suggested more general wording adds 

clarification. Therefore, we have 

retained the proposed language. 

Comment: Several commenters 

supported inclusion of § 494.140(f) 

‘‘Water treatment system technicians,’’

as proposed. A few commenters 

suggested that we revise or expand 

§ 494.140(f) to make the educational 

requirements the same as those 

proposed for PCTs. Another commenter 

recommended that water treatment 

training be required for all staff who 

work on the water treatment system. 

Response: We have incorporated the 

AAMI RD52 2004 ‘‘Dialysate for 

hemodialysis’’ guidelines into this final 

rule at § 494.40(a). Section 9 of the 

guidelines entitled ‘‘Personnel’’

includes requirements for water 

treatment staff as follows: 

Policies and procedures that are 

understandable and accessible are 

mandatory, along with a training 

program that includes quality testing, 

the risks and hazards of improperly 

prepared concentrate, and bacterial 

issues. Operators should be trained in 

the use of the equipment by the 

manufacturer or should be trained using 

materials provided by the manufacturer. 

The training should be specific to the 

functions performed (that is, mixing, 

disinfection, maintenance, and repairs). 

Periodic audits of the operators’

compliance with procedures should be 

performed. The user should establish an 

ongoing training program designed to 

maintain the operator’s knowledge and 

skills. 

Any staff who operate the water 

treatment system must complete a 

training program that has been approved 

by the medical director and the 

governing body as required at 

§ 494.140(f). 

Comment: A few commenters 

suggested that advanced practice nurses 

and physician assistants be recognized 

in the final rule as ‘‘physician 

extenders’’ (that is, NPs, CNs, PAs 

(Nurse Practitioners, Clinical Nurse 

Specialists, and Physician Assistants)). 

Some commenters were concerned that 

excluding these professionals from the 

final rule might affect reimbursement. 

Response: We recognize the 

contributions of physician extenders in 

dialysis facilities in providing quality 

dialysis care and note that the Medicare 

payment system recognizes the role of 

physician extenders. While we will not 

require dialysis facilities to have NPs, 

CNs, or PAs, they are subject to our 

requirement at § 494.140, which 

requires that ‘‘all dialysis facility staff 

meet the applicable scope of practice 

board and licensure requirements in 

effect in the State in which they are 

employed.’’ The provisions of this 

section will not affect reimbursement of 

physician extenders. 

Comment: We received a very large 

number of comments regarding the 

proposed rule preamble discussion (70 

FR 6224) regarding what role, if any, the 

pharmacist should play within a 

dialysis facility and what a dialysis 

facility’s appropriate responsibility is 

for pharmaceutical services and the 

efficient use of medication. 

More than 40 pharmacists 

recommended that we include a 

pharmacist on the facility 

interdisciplinary team, and submitted 

comments containing references and 

journal articles. According to the 

commenters, the DOPPS data showed 

that ESRD patients take 9–12 

medications on average, per patient, and 

that there are complex interactions 

between many of these medications. 

Pharmacists receive specialized training 

for renal patient care; and pharmacists 

with such training should prepare 

facility protocols and policies to manage 

medications. Pharmacists believe they 

will be able to coordinate medication 

administered within facilities with 

medications administered outside the 

facility and over-the-counter drugs. The 

commenters stated that dialysis patients 

need comprehensive medication 

reviews at appropriate intervals, similar 

to the CMS-required monthly 

medication reviews in SNFs and ICFs. 

The pharmacists believed they could 

train other staff regarding various 

medications’ relationships, which 

would improve quality of care and 

treatment plans. Pharmacist-consultants 

could work with patients and caregivers 

to coordinate medication use and 

dietary supplements. They observed 

that the Department of Veterans Affairs 

has assigned pharmacists to its dialysis 

clinics. They argued that comprehensive 

medication plans and reviews would 

increase patient safety and reduce 

overall program (Medicare) costs by 

preventing adverse ‘‘medication events’’

and reducing medication costs. They 

noted that expert knowledge of the new 

Part D formulary will be an important 

part of treating dialysis patients. 

One commenter suggested dialysis 

patients should be recipients of dialysisprovided Medication Therapy 

Management Services for third-party 

payers that participate in Part D. In 

addition, the commenter indicated that 

Dialysis pharmacists would like to be 

able to bill for ESRD patient 

consultation using these codes. 

Several commenters did not support 

including pharmacists on the dialysis 

facility interdisciplinary team. These 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20427 

commenters suggested that pharmacist 

consultation should remain an option, 

not a requirement. One commenter 

stated there was no need for pharmacist 

participation. Other commenters stated 

that routine assessment of medications 

should not be required unless it was 

Medicare reimbursable. A commenter 

stated that this would be an 

unnecessary, burdensome requirement 

without benefit, since nephrologists 

have the necessary dosing and 

medication interaction knowledge; the 

average pharmacist salary is $73,000 

annually, which was cost-prohibitive for 

his organization’s 1,200 dialysis 

facilities. Another commenter said that 

RNs were the appropriate professionals 

to monitor patients’ medications and to 

do patient teaching, and believes it 

could be confusing to the patient to 

further fragment care by introducing 

another discipline into the patient care 

scenario. This commenter did not 

believe there was a need for clinical 

pharmaceutical services beyond 

continuing staff education on new 

products for dialysis patients; the 

commenter stated that technology 

would improve medication management 

and safety. One commenter said that 

dialysis facilities lacked the expertise to 

manage a pharmacist properly. Another 

commenter suggested that since 

Medicare did not cover the cost of 

providing treatments and 

pharmaceuticals to patients, this 

suggestion was fiscally unrealistic. 

Several commenters stated that 

pharmacist participation was desirable 

but not practical absent funding. A 

commenter stated that a routine 

pharmacist assessment for patient 

medications would be desirable and 

Medicare payment should be revised to 

allow direct reimbursement outside the 

composite rate. A few commenters 

suggested that we add a requirement for 

routine consultations with pharmacists 

to review policies on medication 

acquisitions, storage, administration, 

and medical record reviews. 

Response: Pharmacists fully support a 

role for the pharmacist on the 

interdisciplinary team, while other 

commenters support an optional role for 

pharmacists in dialysis facilities. 

The Medicare Part D reimbursement 

for pharmacists suggested by one 

commenter is limited, as pharmacist 

charges are paid on a case-by-case basis 

if an individual pharmacy plan has 

agreed to reimburse Medicare for this 

service under Part D. 

Due to a lack of consensus among 

commenters, we are not requiring 

dialysis facilities to include pharmacists 

as members of the dialysis 

interdisciplinary team. We do, however, 

encourage dialysis facilities to use 

pharmacist expertise as appropriate. 

The facility policies and procedures 

referred to at § 494.150(c)(1) must 

include medication policies and 

procedures that adequately protect 

patient safety. 

b. Responsibilities of the Medical 

Director (Proposed § 494.150) 

We proposed to retain the condition 

addressing the facility’s medical 

director (§ 405.2161) as a separate 

condition and strengthen the role of the 

medical director, at § 494.150. The 

medical director would be required to 

meet the qualifications for the position 

at proposed § 494.140(a) and would be 

responsible for the delivery of patient 

care and patient outcomes in the 

facility. The medical director would be 

responsible for operational 

responsibility for the facility’s QAPI 

program. We proposed to retain the 

existing requirement at § 405.2161 for 

the medical director to ensure that staff 

in the facility are adequately trained. 

The existing requirement at § 405.2161 

was modified in the proposed rule to 

require that the medical director 

participate in the development, periodic 

review, and approval of the patient care 

policies and procedures manual. We 

also proposed that the medical director 

be responsible to ensure these patient 

care policies and procedures are 

adhered to by staff who treat patients in 

the dialysis facility, including attending 

physicians and non-physician staff. The 

proposed rule also would require that 

the medical director be responsible for 

ensuring that the interdisciplinary team 

follows the facility’s discharge and 

transfer policies and procedures. 

Comment: Many commenters 

supported the proposed condition for 

the medical director, including the 

responsibilities laid out in the new 

condition. Commenters remarked that 

this condition assigned more 

accountability to the medical director 

for the overall care of patients. 

Several other commenters suggested 

additional language in or revisions to 

the final rule. One commenter remarked 

that there should be a direct line of 

responsibility from the medical director 

to the care provided. One commenter 

suggested clearly delineating 

responsibilities by deleting the phrase 

‘‘but are not limited to’’ in the last 

phrase of the proposed condition stem 

statement. 

Another commenter recommended 

that we clarify that facilities should 

have only one medical director. The 

commenter went on to state that some 

facilities have multiple medical 

directors. Another commenter however, 

suggested it may be advantageous for 

the same individual to hold the medical 

director position for a defined number 

of facilities. 

Response: We appreciate the 

comments regarding the proposed 

medical director condition for coverage. 

In response to comments, we have 

added language at § 494.150 to state 

explicitly that ‘‘The medical director is 

accountable to the governing body for 

the quality of medical care provided to 

patients.’’ In addition, the medical 

director has the responsibility of 

ensuring that all policies and 

procedures relative to patient care and 

safety are followed by all who treat the 

patient, as required at § 494.150(c)(2). 

This modification clearly holds the 

medical director responsible for the care 

that is furnished. Each facility must 

have a single medical director to carry 

out the responsibilities of this position. 

We have retained the language in the 

final rule making the medical director 

responsible for matters that are related 

to health and safety standards for 

patient care. Individual dialysis centers 

may have individual needs that surpass 

these minimum requirements. 

Therefore, we are allowing facilities to 

have flexibility in their dealings with 

their medical directors. Regarding the 

number of facilities for which a 

physician may act as the medical 

director, this regulation requires that the 

medical director meet all conditions and 

responsibilities, regardless of whether 

he or she directs one facility or multiple 

facilities. However, each facility must 

have exactly one specific individual to 

be fully responsible for all matters 

under § 494.150. 

Comment: Several commenters 

supported assigning responsibility for 

QAPI program to the medical director. 

Response: We appreciate the 

supportive comments to retain the 

proposed language regarding 

responsibility for QAPI. Language at 

§ 494.150(a) has been adopted in the 

final rule. 

Comment: One commenter remarked 

that the wording at § 494.150 needs to 

be clarified. The commenter stated that 

‘‘the medical director is acting in an 

administrative leadership capacity’’ and 

thus the final rule needs to take into 

account that responsibilities of the 

medical director should be performed in 

that context. One commenter suggested 

that the medical director undergo 

management training, as staff needs 

‘‘leadership from the top’’ to effect 

necessary changes needed in quality 

control situations. 

Response: The medical director is 

responsible for care provided by the 

facility. The governing body has the 


PWALKER on PROD1PC71 with RULES2
20428 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

flexibility to use the medical director in 

an administrative capacity as long as 

this does not prevent the medical 

director from performing the 

responsibilities required by this final 

rule. The final rule at § 494.180(b)(3) 

requires that the governing body ensure 

that all staff have appropriate 

orientation regarding their employment 

responsibilities, including medical 

directors employed by the facility. This 

requirement does not preclude the 

governing body from requiring that the 

medical director receive additional 

training deemed necessary to perform 

the duties of his or her position. The 

proposed language has been retained in 

the final rule. 

Comment: One commenter suggested 

we add record-keeping to the list of 

responsibilities for which the medical 

director is ultimately held responsible. 

Response: Record-keeping is a 

responsibility that falls under policies 

and procedures relative to patient care, 

and thus is covered under the purview 

of the medical director at 

§ 494.150(c)(2)(i). In addition, there is a 

condition for Medical records, found at 

§ 494.170, which stipulates what is 

required of the dialysis facility with 

respect to record-keeping. Therefore, we 

are not making the suggested additions 

to the final rule. 

Comment: Another commenter 

suggested we add language to require 

the medical director to be present in the 

facility at least once a month. 

Response: Dialysis facilities have the 

flexibility to address this issue in their 

agreement with their medical director. 

The medical director’s presence must be 

frequent enough to perform his or her 

responsibilities as required by these 

conditions. 

Comment: One commenter suggested 

that we add language stating that the 

medical director has the responsibility 

for assuring that pediatric patients have 

regular access to care from a 

nephrologist, dietitian, and a social 

worker with pediatric expertise. 

Response: Dialysis facilities are 

required by this final rule to provide 

quality care and services that meet the 

needs of the patient, as identified during 

the comprehensive assessment and 

addressed in the plan of care. The 

patient assessment and patient plan of 

care required at § 494.80 and § 494.90 

respectively, should accurately reflect 

the needs of all patients, including 

pediatric patients, and the proper 

resources should be obtained and used 

as necessary. 

Comment: Some commenters 

remarked that the medical director 

should bear primary responsibility for 

infection control oversight in the 

dialysis unit, as opposed to a nurse. 

Response: We determined that it 

would be practical to hold the medical 

director accountable for oversight of 

infection control as the leader of the 

quality improvement committee. We 

also proposed that the medical director 

be responsible for assessment and 

performance policies and procedures 

relative to patient care and safety at 

§ 494.150(c)(2)(i). Upon consideration of 

comments, we have added infection 

control to the list of policies and 

procedures for which the medical 

director exercises oversight at 

§ 494.150(c)(2)(i). In addition to this 

new requirement at § 494.150(c)(2)(i), 

we have also added ‘‘patient 

admissions’’ to the list of policies for 

which the medical director is 

responsible. This modification is in 

response to comments received on the 

‘‘Governance’’ condition. Please see the 

‘‘Governance’’ preamble discussion 

below for more information. 

Comment: Some commenters 

expressed concern regarding oversight 

of the medical director’s performance of 

his or her duties under § 494.150. The 

commenters remarked that the only 

mechanism to deal with a poorly 

performing medical director would be to 

dismiss him/her. Commenters went on 

to explain that it could be difficult to fill 

a vacant medical director position, 

which would be required to be done 

quickly in order to continue to be 

reimbursed by Medicare. It was 

recommended that CMS consider 

mechanisms by which medical directors 

who failed to fulfill their 

responsibilities as outlined in the 

conditions for coverage, could be 

disciplined by the facility. Commenters 

suggested perhaps there was a role for 

Network Medical Advisory Boards, 

State Licensing Boards or State 

Professional Boards to assist facilities in 

evaluating medical director performance 

and determining disciplinary action. 

Response: The medical director is 

accountable to the governing body. The 

governing body is responsible for 

communicating expectations to the 

medical staff regarding their 

participation in improving the quality of 

medical care provided to facility 

patients, as required at § 494.180(c)(3). 

The governing body could develop a 

process to improve the medical 

director’s performance. A facility’s 

governing body could also contact the 

appropriate authorities, such as the 

Network Medical Advisory Boards, 

State Licensing Boards, State 

Professional Boards, and any other 

suitable agencies or organizations. We 

feel that this matter is best left to the 

governing body’s discretion. We are 

making no changes based on this 

comment. 

Comment: One commenter concurred 

with the language regarding the medical 

director’s responsibility for managing 

problem nephrologists, but suggested 

that there be some reasonable basis for 

protecting the medical director from 

lawsuits related to this management 

activity. Another commenter asked for 

clarification regarding the legal 

liabilities for medical directors 

employed by large dialysis 

organizations (LDOs). The commenter 

questioned what recourse a medical 

director would have when he or she 

disagreed with the LDO. 

Response: We do not have authority 

through this vehicle to provide legal 

protection for the medical director, 

moreover, these issues are generally 

matters of state law. Medical directors 

employed under a contract may 

negotiate the terms of that contract with 

business owners/center management 

within the state practice limitations, 

including issues such as legal liability, 

but such matters are not under the 

purview of this regulation. 

Comment: Some commenters 

recommended that the medical director 

should have responsibility for ensuring 

that the ESRD facility supports the goals 

of the ESRD Network. 

Response: The Medicare statute 

specifies that facilities must meet 

Network goals (section 1881 of the Act) 

in order to participate in Medicare. We 

do not agree it is necessary to add 

language to the medical director 

condition regarding responsibility for 

Network relationships. As stipulated at 

§ 494.180(i), dialysis facilities must 

cooperate with the ESRD Network in 

fulfilling the terms of the Network’s 

current statement of work. Section 

494.180(a)(3) mandates that the chief 

executive officer or the administrator be 

responsible for the relationship with the 

ESRD Networks. 

Comment: One commenter believed 

that the proposed new responsibilities 

for the medical director were overly 

burdensome with respect to very small 

dialysis units, where the medical 

director might be the only attending 

physician with an internal medicine 

practice. Another commenter disagreed 

with the proposed language, remarking 

that it was too restrictive and confusing 

for multi-facility organizations to have 

the medical director responsibilities 

assigned at the unit level. This 

commenter remarked further that 

policies were made at the corporate 

level and recommended that this 

requirement be removed entirely. 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20429 

Response: As stated earlier, the 

majority of commenters supported the 

‘‘Medical director’’ condition for 

coverage. No evidence was submitted to 

support removing the condition for 

coverage from the final rule. Several 

responsibilities addressed in the 

proposed condition are included in 

existing regulation at § 405.2161(b), and 

thus medical directors have previously 

been expected to ensure that the needs 

of the patient are properly addressed. 

We do not believe that the duties of the 

medical director are too burdensome, 

therefore, the proposed language will be 

retained in the final rule. 

Comment: A commenter 

recommended that we add language in 

the final rule that would allow the 

medical director to have a major role in 

the appointment and selection process 

for hiring individuals who would have 

admitting privileges in the facility 

(specifically physicians, physician’s 

assistants, and nurse practitioners). 

Response: The medical staff 

appointments standard at § 494.180(c) 

places responsibility for medical staff 

appointments with the governing body. 

The governing body would address the 

question of whether medical directors 

would be included in medical staff 

appointment decisions. Regulatory 

language does not preclude the medical 

director from participating in the 

selection process; however, we are not 

going to require that medical directors 

participate in these decisions. 

Comment: One commenter suggested 

changing the language of the final rule 

to reflect that most medical directors 

would normally not participate in 

developing policies and procedures for 

an ESRD facility. A commenter noted 

that policies and procedures are most 

often developed by the large dialysis 

organizations; however, medical 

directors may assist or be asked to assist 

in revisions. The commenter suggested 

we add ‘‘participate in the development 

or refinement (of policies and 

procedures) * * *.’’ in the final rule 

language. Another commenter suggested 

we change the language at 

§ 494.150(c)(2) to indicate that the 

medical director would ‘‘participate 

with the facility staff to ensure’’ that the 

conditions of that paragraph were met. 

Another commenter remarked that the 

medical director could oversee and 

support the facility but could not 

‘‘ensure’’ policies and procedures were 

adhered to by facility staff, as often the 

owner/chain refused to support their 

own policies and procedures. 

Response: Regardless of whether 

policies and procedures are developed 

within the facility or via a corporate 

process, the medical director is 

responsible for ensuring that 

appropriate patient care polices are 

developed and implemented. The 

majority of commenters supported the 

proposed requirement without 

modification. The medical director is 

responsible for the clinical care 

provided in an ESRD facility and thus 

should be held accountable for that care. 

We expect the medical director would 

work with the governing body to ensure 

that appropriate patient care policies are 

developed and implemented within the 

facility. 

Comment: We received many 

comments regarding the medical 

director’s scope of authority within a 

facility. Some commenters 

recommended that the final rule 

mandate that medical directors be given 

the ability and the authority to monitor 

and improve the care provided by 

attending physicians, as well as the 

entire patient care team, including 

nurses, physician’s assistants, dietitians, 

social workers and other staff; these 

commenters thought there ought to be 

more accountability for poor performers 

in the facility. Another commenter 

remarked that if attending physicians 

were uncooperative, then the medical 

director should assume responsibility 

for patient care. The commenter further 

remarked that the final rule language 

needs to be ‘‘grounded in a realistic 

approach’’ by which medical directors 

could influence attending physicians 

with competing goals. Some 

commenters suggested that 

§ 494.150(c)(2)(i) be expanded to allow 

medical directors the ability and 

authority to monitor and improve care 

in the facility, including the care 

provided by attending nephrologists. 

Other commenters supported the idea 

that the unit’s attending physicians be 

subject to peer review, under the 

direction of the medical director, and 

potentially subject to discipline (within 

the framework of due process 

procedures). One commenter remarked 

that governing bodies should be 

required, as part of their policies and 

procedures, to specify the extent of the 

medical director’s authority to manage 

inadequately performing staff and 

attending physicians. 

Response: The medical director is 

responsible for the delivery of patient 

care and outcomes in the facility, which 

includes responsibility for the QAPI 

program, staff education, training and 

performance as well as policies and 

procedures of the ESRD facility. To 

strengthen the ‘‘Responsibilities of the 

medical director’’ condition for 

coverage, we have added language to the 

first paragraph of § 494.150, reading 

‘‘The medical director is accountable to 

the governing body for the quality of 

medical care provided to patients.’’ The 

role of the medical director is also 

strengthened in the final rule at 

§ 494.150(c)(2)(i), to include patient 

admissions and infection control. 

Section 494.150(c)(2)(i) now requires 

the medical director to ensure that all 

policies and procedures relative to 

patient admissions, patient care, 

infection control, and safety are adhered 

to by all individuals who treat patients 

in the facility, including attending 

physicians and non-physician 

providers. We believe that the facility 

governing bodies will provide medical 

directors with adequate institutional 

authority to permit the medical 

directors to perform these duties 

effectively. 

If the medical director is unsuccessful 

in achieving staff compliance or 

managing disciplinary issues involving 

attending physicians and has exhausted 

all options, we expect that the matter 

would be referred to the governing 

body, the ESRD Network or other 

appropriate authorities, such as the state 

agency and state licensing boards. 

Comment: One commenter suggested 

the addition of a new § 494.150(c)(2)(iii) 

to require the medical director to ensure 

that ‘‘staffing is sufficient to meet the 

acuity of patients treated in the facility.’’

Response: We have not added the 

suggested language to the 

‘‘Responsibilities of the medical 

director’’ condition. Staffing concerns 

are addressed under § 494.180(b), which 

pertains to adequate and trained staff in 

an ESRD facility. We also note that the 

medical director may not have the 

organizational authority to determine 

staffing levels within the facility. 

Comment: One commenter suggested 

we add language in the final rule to 

read, ‘‘the medical director will have 

direct communication with the patient’s 

other physicians when new or existing 

co-morbid conditions arise during the 

course of dialysis treatment.’’

Response: We have not added the 

suggested language in the final rule. We 

encourage communication and 

coordination of care among all parties 

involved in the patient’s care and we 

expect this would be an effort of the 

attending physician in order to decrease 

fragmentation of patient care and to 

ensure proper care for each patient. 

Comment: One commenter 

recommended increased cooperation 

between nephrologists and dialysis 

facilities, via the medical director, to 

assist patients with transplant 

eligibility. 

Response: We have added language 

throughout the final rule, such as in 

§ 494.70, § 494.80, and § 494.90, to 


PWALKER on PROD1PC71 with RULES2
20430 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

ensure that patients are aware of their 

modality choices, including transplant 

options. Additionally, the medical 

director is responsible to ensure that all 

policies and procedures affecting 

patient care are adhered to by all 

individuals who treat patients in the 

facility, including attending physicians 

and non-physician providers, as 

required at § 494.150(c)(2)(i). 

c. Relationship With the ESRD Network 

(Proposed § 494.160) 

Requirements found in existing 

§ 405.2110 through § 405.2113, related 

to the designation of ESRD Networks, 

the functions of ESRD Networks, and 

the role of the medical review boards 

will remain unchanged in subpart U. 

These provisions focus primarily on the 

role and responsibilities of the Networks 

rather than dialysis facilities. We 

proposed to require that each facility 

cooperate with the ESRD Network 

serving its designated area in fulfilling 

the terms of the Network’s scope of 

work contract with CMS, consistent 

with the requirement at § 405.2134. 

Comment: Several commenters 

suggested we replace ‘‘statement of 

work’’ with ‘‘goals and objectives.’’

Another commenter suggested we 

expand the requirements beyond the 

contract scope of work to include 

explicit references to local projects. A 

couple commenters recommended we 

retain language from subpart U at 

§ 405.2134 that states that facilities must 

‘‘participate in network activities.’’

Response: We appreciate the positive 

comments. The final rule at § 494.180(i) 

requires that each facility cooperate 

with the ESRD Network serving its 

designated area in fulfilling the terms of 

the Network scope of work contract 

with CMS, which is similar to the 

requirement under existing § 405.2134 

concerning participation in network 

activities. The ESRD Network scope of 

work includes goals, objectives, and 

local projects. Therefore, it is 

unnecessary to modify the requirements 

as suggested by the commenter. 

Facilities must continue to share 

information with the Networks as 

necessary to support Network goals and 

objectives. 

Comment: One commenter 

recommended that we require random 

audits by the ESRD Networks to validate 

the accuracy of self-reported dialysis 

facility data. 

Response: Random audits by ESRD 

Networks are outside the scope of this 

regulation. We are not revising our 

ESRD network regulations at this time. 

Comment: One commenter agreed 

with the proposed language, remarking 

that roles and responsibilities of the 

Network should not be part of the 

conditions for coverage. Two 

commenters supported the requirement 

that mandates each ESRD facility to 

cooperate with its own Network to 

fulfill the terms of the Network contract 

scope of work. A commenter remarked 

that the scope of work should 

emphasize the coordination of Network 

activities across all Networks as well as 

a limited number of local and national 

initiatives. Another commenter 

recommended we require Networks to 

share more information with the State 

agency, especially during a state survey 

of ESRD facilities. 

Response: As noted above, the ESRD 

Network Scope of Work (SOW) is 

outside the scope of this regulation. 

Comment: One commenter 

recommended we expand the language 

in this regulation to include transplant 

centers, as well as dialysis centers, 

using the rationale that ESRD Networks 

provide oversight to both. 

Response: A separate transplant 

center health and safety regulation was 

published on March 30, 2007 (72 FR 

15198), which requires transplant 

centers to participate in Network 

activities. This requirement can be 

found at § 482.104(c). Therefore we are 

not modifying language at proposed 

§ 494.160 to include the suggested 

language in the final rule. We note, that 

for reasons described in that section, we 

have moved the substance of proposed 

§ 494.160 to § 494.180, and removed and 

reserved § 494.160. 

d. Medical Records (Proposed § 494.170) 

In keeping with our goals to eliminate 

unnecessary requirements and to reduce 

burden on dialysis facilities, we 

proposed a modified version of existing 

§ 405.2139. The proposed rule 

emphasized that a facility must 

maintain complete medical records for 

all patients under its supervision, 

including home patients. We proposed 

not to prescribe the elements facilities 

would have to include in the patient 

medical record, as was required in 

subpart U. We proposed to retain with 

modifications a previous requirement at 

§ 405.2139 that requires a facility to 

protect its patients’ medical records 

against loss, destruction, or 

unauthorized use, and proposed to 

eliminate the requirement that the 

facility must have written policies and 

procedures for recordkeeping. We 

proposed an expansion of the existing 

requirements regarding medical record 

release. Medical records could be 

released when the patient transferred to 

another facility; under certain 

exceptions provided for in law; under a 

third party payment contract; subject to 

approval by the patient, or in the course 

of an inspection by authorized agents of 

the Secretary, and as required by the 

Medicare program. We proposed to 

retain with modifications the previous 

requirement at § 405.2139(d) that 

current medical records and those of 

discharged patients be completed 

promptly and that all clinical 

information pertaining to a patient be 

centralized. We proposed that the 

dialysis facility be responsible for 

completing, maintaining and monitoring 

medical records for its Method II home 

dialysis patients and its other home 

patients. Minor revisions were proposed 

to § 405.2139(e) regarding medical 

record retention. We proposed that 

medical records be retained for a period 

of time not less than that determined by 

the applicable State statutes governing 

records retention or the State’s statute of 

limitations. In the absence of State 

statutes, records would be required to be 

retained for 5 years from the date of 

discharge for an adult; or for a minor, 

3 years from date of discharge or until 

the patient becomes of age under State 

law, whichever was longer. We 

proposed the elimination of the 

prescriptive requirements in existing 

§ 405.2139(f) regarding medical record 

accessibility. We proposed to retain the 

existing requirement at § 405.2139(g) to 

require the facility to provide prompt 

transfer of medical information between 

treatment facilities. We also proposed a 

modification of § 405.2137(b)(4) to 

require that the facility exchange all 

medical record information within one 

working day. Finally, we proposed the 

elimination of the existing requirement 

for the designation of a medical records 

supervisor. 

Comment: One commenter fully 

supported the less prescriptive 

approach in the proposed condition, 

while another commenter remarked that 

the proposed reduction of regulatory 

requirements in this condition for 

coverage was too broad. Some 

commenters concurred with the 

deletion of the medical records 

supervisor, while others disagreed with 

the elimination of this position, citing 

that a designated staff member for this 

task is essential to ensure an adequate 

recordkeeping process. 

Response: We appreciate the positive 

comments regarding the elimination of 

the medical records supervisor 

requirement in § 494.170. Eliminating 

process-type requirements is in keeping 

with our overall goals. Additionally, we 

believe that the deletion of the medical 

records supervisor requirement would 

result in a cost savings for facilities. 

There is no evidence that removing this 

requirement would result in poor 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20431 

outcomes. Therefore, the medical 

records supervisor requirement has not 

been included in the final rule. 

Comment: Several commenters 

disagreed with the proposed elimination 

of the requirement that facilities have 

written policies and procedures 

regarding record-keeping. One 

commenter argued that a facility must 

have written policies and procedures for 

record-keeping in order for required 

outcomes to be achieved. This 

commenter argued that allowing 

facilities the flexibility to decide what 

information to include in the medical 

record would not assure that outcomes 

were achieved. 

Response: We have decided not to 

carry over the language from part 405, 

subpart U, in order to decrease 

prescriptive, non-outcome oriented 

requirements and to increase dialysis 

facility flexibility. As long as there is a 

system in place to achieve that outcome, 

we do not believe it is necessary to 

dictate prescriptive requirements. 

Facilities are still required to protect 

medical record information and keep all 

patient records confidential and 

demonstrate that all of these conditions 

for coverage have been met. We do not, 

however, preclude a facility from having 

record-keeping policies and procedures 

as they see fit. 

Comment: Two commenters suggested 

that a reference be added to the final 

rule to state that a medical record could 

always be released to a patient, guardian 

or other legally appointed patient 

representative. 

Response: Patients have the right to 

look at their own medical record. We 

proposed at § 494.170(a)(2) that all 

patient medical record information be 

kept confidential, except when released 

to an authorized person approved by the 

patient. Furthermore, patients have the 

right to be informed of their medical 

status as documented in the medical 

record unless the medical record 

contains a documented contraindication 

to do so, as required at § 494.70(a)(10). 

The proposed language will be retained 

in the final rule, as it protects the 

patient’s medical record information, 

while allowing for the release of 

confidential information to the patient 

or the patient’s representative. We also 

note that many of our protections 

correspond to more general protections 

under HIPAA, found at 45 CFR parts 

160 and 164. 

Comment: One commenter suggested 

proposed language at § 494.170(a)(2) 

and § 494.170(a)(3) was unnecessary 

because of HIPAA protections already in 

place. The commenter suggested we 

retain existing language at § 405.2139(b). 

Response: The proposed language was 

carried through from part 405, subpart 

U, and we believe the language at 

§ 494.170(a)(2) and § 494.170(a)(3) adds 

clarification regarding the 

circumstances under which a patient’s 

medical record may be released and any 

appropriate authorizations that are 

needed for that release. As noted above, 

the proposed language was consistent 

with the HIPAA privacy regulations at 

45 CFR parts 160 and 164 and remains 

in the final rule. 

Comment: A commenter suggested 

adding language at § 494.170(b) to 

require that when records are stored 

electronically, the facility must have 

procedures to protect in-center and 

home dialysis patient information, and 

must back up data daily. 

Response: The concern of this 

commenter is addressed at 

§ 494.170(a)(1), which mandates patient 

records be safeguarded against loss, 

destruction or unauthorized use. This 

requirement must be followed 

regardless of whether a facility uses 

written or electronic medical records. 

Additionally, § 494.170(b)(3) charges 

dialysis facilities with responsibility for 

completing, maintaining and monitoring 

medical records for its home patients. 

Comment: Many commenters made 

remarks regarding what information 

should be required in the patient’s 

medical record. One commenter was 

concerned that the proposed condition 

was reduced too much, stating that 

medical records of ESRD patients were 

even now often incomplete, inaccurate 

and not in accordance with identified 

medical records standards. Two 

commenters suggested that the day-today events should be documented by 

the end of each shift in which they 

occurred, and another commenter 

suggested we retain existing language 

from § 405.2139, which specified the 

information that must be kept in the 

active patients’ chart and readily 

available. Other commenters suggested a 

requirement specifying inclusion of 

treatment information, the treatment 

settings, safety checks, medical events, 

pre/post-patient assessments, 

medications, etc. Another commenter 

recommended that the final rule include 

a requirement for documentation of 

medical injuries and accidents, 

medication changes, as well as patient 

phone numbers and emergency contact 

numbers, which should be entered 

immediately in the patient’s record and 

be updated if they changed. One 

commenter suggested a requirement that 

unusual events during treatment be 

documented. 

Response: The existing part 405, 

subpart U language was removed from 

the proposed rule because we believe 

facilities should have the flexibility to 

decide what information would be 

included in the medical record, as long 

as the patient’s medical needs were 

being addressed and these conditions 

for coverage were met. Medical 

professionals are expected to accurately 

record complete and pertinent 

information in their patients’ medical 

records, including many of the issues 

identified by the commenters. Many of 

the topics identified by the commenters 

would have to be included in the 

patient’s record in order to comply with 

the ‘‘Patient assessment’’ and ‘‘Patient 

plan of care’’ conditions at § 494.80 and 

§ 494.90. All clinical information 

pertaining to a patient must be 

centralized in the medical record 

(§ 494.170(b)(2)). If a facility kept 

incomplete, inaccurate medical records, 

as suggested by the first commenter, this 

‘‘Medical records’’ condition for 

coverage would not be met and would 

be cited during a facility survey. 

Comment: One commenter suggested 

we add language to allow use of 

electronic medical records and 

recognize them as a satisfactory and 

secure system for keeping and 

protecting patient medical records. 

Response: The proposed language at 

§ 494.170(b) does not specify that 

medical records must be in ‘‘hard-copy’’

form only, and thus we see no need to 

make this suggested change in the final 

rule. We allow electronic health records, 

and in fact encourage them. In 2004, the 

President issued an executive order 

calling for the widespread adoption of 

interoperable health records within ten 

years, and the Department of Health and 

Human Services has been leading the 

nation’s efforts in advancing the 

nationwide health IT agenda. 

Comment: We received several 

comments regarding the timeframe for 

completion of medical records. One 

commenter supported a requirement 

that records be up-to-date and accurate. 

Some commenters suggested we specify 

a 30-day timeframe for completion of 

the medical record, while another 

remarked that the medical record 

should be updated within 2–4 days after 

any event so that the information would 

be available by the next dialysis 

treatment. One commenter remarked 

that the proposed language regarding 

prompt completion of medical records 

was sufficient. Another commenter 

suggested that we require all 

assessments to be placed in the front of 

the chart to improve availability. 

Response: To ensure a comprehensive 

and accurate medical record, we feel 

that it is vital that charting be completed 

promptly. The language at proposed 


PWALKER on PROD1PC71 with RULES2
20432 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

§ 494.170(b) was retained from existing 

language in subpart U at § 405.2139(d), 

and we are codifying it in the final rule. 

Each member of the interdisciplinary 

team must have access to the most 

recent information on the patient’s 

condition and prescribed treatment. It is 

a ‘‘best practice’’ to complete charting 

without delay to ensure patient health 

and safety during each treatment. 

Facilities may choose to establish 

policies regarding the method in which 

patient medical records are organized, 

but we will not mandate such a 

requirement in this regulation. 

Comment: Some commenters pointed 

out that according to HIPAA regulation 

at 45 CFR § 164.530(j), documentation 

must be retained for 6 years. 

Response: According to the HIPAA 

Privacy Rule at 45 CFR § 164.530(j)(2), 

certain written communications, 

policies and procedures must be 

retained for 6 years. Therefore, we agree 

with the commenters and we have 

modified standard (c) to stipulate that 

medical record documentation must be 

retained for 6 years for both adults and 

children. Standard (c) now reads as 

follows: ‘‘In accordance with 45 CFR 

164.530(j)(2), all patient records must be 

retained for 6 years from the date of the 

patient’s discharge, transfer, or death.’’

Note, proposed § 494.170(c)(1) has been 

redesignated to standard (c) and 

§ 494.170(c)(2) has been removed. 

Comment: Several commenters argued 

that transferring all medical records 

within one day was unreasonable, 

burdensome, and unnecessary, while 

other commenters supported the 

requirement. Another commenter 

remarked that discharged patient 

records, including mortality reviews, 

should be completed within 30 days. 

This commenter also stated 30 days was 

plenty of time to collect necessary data 

and was within the timeframe of one 

cycle of required monthly patient blood 

work from which thresholds were 

evaluated. One commenter remarked 

that the transfer of medical records 

information should be defined clearly to 

include at least the care plan, the three 

most recent dialysis flow sheets, the 

patient’s medication list, lab reports, the 

comprehensive assessment, and any 

physician order(s). Still another 

commenter suggested the addition of 

language in the final rule to require 

information such as nutritional status, 

psychosocial status, and rehabilitation 

status be transferred within one working 

day. Another commenter suggested that 

it would be helpful to have standard 

criteria and a form for patients to use 

when traveling to another unit, in order 

to ensure that appropriate and 

consistent information is transferred. 

Response: The proposed language at 

§ 494.170(d) required the transfer of all 

medical record and other necessary 

information within one working day. 

We maintain that the requirement 

should apply not only to the care plan, 

but also to all medical record 

information. However, we recognize the 

commenters’ concerns that there may be 

a substantial amount of documentation 

that may require more time for transfer. 

We have therefore revised the language 

at § 494.170(d), which now reads, 

‘‘When a dialysis patient is transferred, 

the dialysis facility releasing the patient 

must send all requested medical record 

information to the receiving facility 

within 1 working day of the transfer.’’

Our goal is to minimize the potential for 

communication breakdown between 

facilities and ensure that patients 

continue to receive the necessary care 

and services. We are therefore requiring 

only that the minimum amount of 

medical information be forwarded as 

appropriate. Some information, such as 

recent lab results, may not be readily 

available within 1 day. This minimum 

information would likely include the 

physician orders, the patient 

assessment, and the patient plan of care, 

insurance information, the last three 

recent dialysis run sheets, and other 

pertinent information as necessary. 

Facilities may wish to create a standard 

medical record information transfer 

form as part of their policies and 

procedures regarding the transfer of 

patients, but we are not mandating it. 

Comment: One commenter suggested 

we add the following language: 

‘‘Patients must have physician orders 

for all treatment parameters and these 

orders must be followed.’’

Response: We expect that the facility 

is following physician orders for all of 

its patients, as required by State Practice 

Acts and in accordance with Federal, 

State and local laws and regulations, as 

required at § 494.20. Therefore, there is 

no need to add the suggested language 

in the medical records condition for 

coverage of this final rule. 

Comment: Two commenters remarked 

that facilities need a centralized 

medication administration record in 

order to identify and track medication 

errors. Another commenter 

recommended that facilities be required 

to work towards a system to improve 

documentation of medication 

administration and decrease the 

incidence of potential medication 

errors. The commenter further suggested 

that the success or failure of these 

systems be followed by a quality 

assessment and performance 

improvement program within the 

facility. 

Response: Under the final QAPI 

condition at § 494.110(a)(2)(vi), facilities 

must measure, analyze, and track 

medical injuries and medical errors. We 

believe this requirement addresses the 

commenters’ concerns. Some facilities 

may choose to put into practice a 

specialized centralized medication 

administration record or some 

alternative process to assist in easier 

detection of medical errors. 

e. Governance (Proposed § 494.180) 

We proposed an updated version of 

§ 405.2136 to modernize the 

requirements and delete unnecessary 

processes where possible. Consistent 

with § 405.2136, we proposed that the 

ESRD facility be under the control of an 

identifiable governing body, or 

designated person, with full legal 

authority and responsibility for the 

governance and operation of the facility. 

The proposed rule retained the 

requirement that a CEO or administrator 

be identified. Proposed administrator 

responsibilities would include 

management of staff appointments, 

fiscal operations, ESRD Network 

relationships, and allocation of staff and 

resources for the QAPI program. We 

proposed a standard similar to 

§ 405.2162(b)(2) that would require that 

the governing body or designated person 

ensure that there was an adequate 

number of qualified and trained staff to 

provide a level of dialysis care to meet 

the needs of patients. The proposed 

licensed person on duty when patients 

were undergoing dialysis would be an 

RN who would be available in the event 

of a patient emergency. We proposed, 

consistent with part 405, subpart U, that 

dialysis facility employees have an 

opportunity for continuing education 

and related development activities. A 

new proposed provision specified a 

governing-body-approved, written 

patient care technician-training program 

that included eight mandatory topics. 

We proposed that the governing body be 

responsible for medical staff 

appointments and credentialing, and 

ensuring that all medical staff providing 

care in the facility were informed of 

facility policies and procedures and the 

QAPI program. 

We proposed that the governing body 

ensure that the dialysis facility 

furnished directly services on its main 

premises or on other premises that were 

at least contiguous with the main 

premises. A new standard was proposed 

that would require the dialysis facility 

to implement an internal grievance 

process that included a procedure for 

the submission of grievances, facility 

timeframes for grievance review, and a 

description of how the patient (or 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20433 

representative) would be informed of 

steps taken to resolve the grievance. The 

proposed rule also addressed a 

procedure that would have to be 

followed before a patient could be 

discharged involuntarily. We proposed 

to retain the § 405.2138(b)(2) provisions 

that allowed patient transfer or 

discharge because of non-payment, or 

because of facility inability to meet the 

patient’s medical needs. We also 

proposed that a patient could be 

discharged or transferred because of 

disruptive patient behavior that 

seriously impaired the facility’s ability 

to operate effectively. We proposed a 

process for involuntarily discharging or 

transferring a patient. These steps 

included reassessing the patient, 

documenting the problem and ongoing 

efforts to resolve the problem, obtaining 

a written discharge or transfer order 

signed by the attending physician and 

the medical director, documenting 

efforts to place the patient in another 

facility, and notifying the State survey 

agency and the ESRD Network. 

The proposed rule included 

emergency coverage provisions at 

§ 494.180(g) that were similar to those at 

§ 405.2136(g)(2) and § 405.2160(a). This 

proposed standard would task the 

governing body with ensuring that 

patients and staff received written 

instructions for obtaining emergency 

medical care, that there was a roster 

with the names of physicians to be 

called for emergencies and their contact 

information, and that there was an 

agreement with a hospital capable of 

providing emergency medical care to 

dialysis patients at any time. 

We specified in the February 4, 2005 

proposed rule at § 494.180(h) that 

dialysis facilities would continue to be 

required to provide to CMS data and 

information for ESRD program 

administration, however, this data 

would be required to be sent 

electronically in a format and at a 

frequency specified by the Secretary. 

We added to the proposed requirements, 

a proposal that facilities submit data 

necessary for existing ESRD clinical 

performance measures, currently only 

collected on a sample of dialysis 

patients, and any future clinical 

performance standards developed in 

accordance with the National 

Technology Transfer and Advancement 

Act of 1995 process adopted by the 

Secretary. The final subsection of 

proposed § 494.180 would update 

§ 405.2136(a)(1) to require the governing 

body to report ownership interests of 5 

percent or more to the State survey 

agency, consistent with § 420.200 

through § 420.206. We received more 

than 100 comments on § 494.180 

‘‘Governance’’ condition. Some 

commenters concurred with the 

condition as proposed, and many 

commenters suggested modifications. 

Comment: Two commenters suggested 

that the final rule (at § 494.180(a)) limit 

the number of facilities a single CEO 

may serve, as it is not unusual for one 

CEO to cover 4 or more units. 

Response: A facility CEO or 

administrator must have available 

sufficient time to carry out his or her 

responsibilities and requirements to 

allow the facility to fully comply with 

§ 494.180. Although the CEO of a large 

facility may not have adequate 

availability to serve multiple dialysis 

facilities, it is possible that a CEO could 

adequately serve more than one small 

facility. We have not added a restriction 

to limit the number of dialysis facilities 

a CEO may serve, but require the CEO 

to satisfactorily fulfill the CEO 

responsibilities listed at § 494.180(a). 

Comment: One commenter suggested 

that we not use the terms ‘‘CEO’’ and 

‘‘administrator’’ interchangeably in the 

final rule. A second commenter 

recommended that we delete the term 

‘‘CEO’’ from the final rule and use the 

term ‘‘administrator.’’ The rationale 

given by one commenter is that the 

terms imply different things; for 

example, an administrator manages a 

unit and a CEO has ultimate authority 

in the organization. 

Response: The proposed rule 

specified that the CEO or administrator 

would exercise responsibility for the 

management of a specific facility and 

the provision of all dialysis services 

including, but not limited to, staff 

appointments, fiscal operations, the 

ESRD Network relationship, and 

allocation of resources. The term 

specifically does not refer to the CEO of 

a parent company or entity that owns or 

controls several facilities. We do not 

expect that there will be confusion 

about the use of the terms ‘‘CEO’’ or 

‘‘administrator,’’ as the responsibilities 

are clearly specified in the final rule. 

Comment: One commenter suggested 

that the CEO or administrator be 

responsible for addressing those 

financial collections issues with 

patients that affect the functioning of 

the facility or jeopardize the 

continuance of provision of dialysis 

services to the patient. 

Response: As stated in the response 

above, the CEO or administrator is 

responsible for the fiscal operations of 

the facility. We are not detailing the 

tasks associated with this function in 

this regulation because financial issues 

are normally a component of the 

facility’s business practices and are 

therefore not within the scope of this 

rule. Discharges of facility patients for 

non-payment are allowed as stated in 

§ 494.180(f)(1), and we believe that 

facilities generally make every effort to 

collect payment for dialysis services. 

Comment: We received more than 70 

comments regarding our proposed 

requirement at § 494.180(b)(1), that the 

governing body ensures that there is an 

‘‘adequate number of trained and 

qualified staff.’’ A few commenters 

concurred with standard (b) as 

proposed. One commenter stated that 

the term ‘‘adequate staff’’ is ‘‘too open 

to interpretation’’ and should be clearer. 

More than 60 commenters 

recommended placing staffing ratios for 

various patient care staff in the final 

rule. Many commenters stated that huge 

case loads are affecting the quality of 

care, and that Medicare should 

designate at least an enforceable upper 

limit on the number of patients for each 

staff member. A commenter stated that 

‘‘California does not have any (staffing 

ratios) for dialysis facilities’’ and she 

has ‘‘seen as much as 1 RN for 21 

patients in facilities by one corporate 

provider.’’ This commenter stated that 

adequate staffing provisions are difficult 

to enforce and she has found facility 

staffing policies that allowed unsafe 

staffing levels. The commenter argued 

that to ensure the safety of the patients, 

minimum staffing ratios are necessary, 

and should be included in the CMS 

regulations. Commenters suggested 

staff-to-patient ratios for various dialysis 

staff; one commenter stated the RN-topatient ratio should not exceed 1:10, 

and other commenters suggested PCTto-patient ratios of 1:4. 

Many commenters suggested a 1:75 

MSW-to-patient ratio, and stated that it 

was impossible for MSWs to do case 

review and counseling with high patient 

ratios. Commenters stated that MSWs 

were assigned large caseloads of 

between 125 and 300 patients each, and 

cited a 2005 study (Bogatz, Colasanto, 

and Sweeney) in support of this 

contention. Some commenters 

recommended that we require use of a 

standardized acuity-based formula for 

adequate staff, such as the NKF Council 

of Nephrology Social Workers’

‘‘Professional Advocacy for the 

Nephrology Social Worker, First Edition 

2002’’ (pages 9–11). One social worker 

stated she had 150 patients in 3 units 

and could therefore only triage and ‘‘put 

out fires.’’

The American Dietetic Association 

voiced concern that inadequate staffing 

would affect the quality of care and was 

aware of many situations where RD-topatient staffing ratios was 1:200. The 

ADA further stated that if CMS did not 

at least reference an optimum RD 


PWALKER on PROD1PC71 with RULES2
20434 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

national staffing ratio, facilities ‘‘will 

demonstrate a lack of restraint for large 

case loads’’ and the positive 

expectations for the new conditions for 

coverage will not be seen and may even 

negatively impact patient-focused 

quality care. Some commenters 

suggested a RD-to-patient ratio of 1:100 

to 125. Some commenters stated that K/ 

DOQI recommends a RD-to-patient ratio 

of 1:100 and no more than 1:150. A 

commenter stated that Texas has 

implemented a RD to patient ratio of 

1:125, and that RDs are increasingly 

directed to do non-RD work that reduces 

the time available for care of patients 

who are older and sicker. Some 

commenters pointed out that dietitians 

and social workers are often shared 

between multiple facilities. 

Several commenters recommended 

adding a new requirement for use of an 

acuity-based staffing model. A 

commenter stated that software was 

available to help establish staff to 

patient ratios based on patient acuity. 

One commenter stated that acuity-based 

staffing would reduce facilities ‘‘cherry 

picking’’ patients that would likely 

occur if minimum facility-level 

standards were implemented. Some 

commenters would like to see staffing 

ratios included in acuity-based staffing 

plans. One commenter suggested 

convening an acuity-based staffing plan 

technical expert panel, and another, an 

acuity-based staffing plan 

demonstration. One commenter 

suggested that we require policies and 

procedures for staffing that identify 

numbers of patients, acuity levels, and 

patient-to-staff ratios. 

Several commenters were opposed to 

both ratios and acuity-based staffing 

models, stating the current proposal 

provided necessary flexibility, and that 

facilities could assign adequate staff 

based on patient acuity. One commenter 

stated that CMS should not lock dialysis 

facilities into a ratio system in 

regulation, because regulations could 

take too long (as much as 20 years) to 

change. Another commenter stated there 

were no data to support mandated staffto-patient ratios, and a case mix 

adjustment formula was needed to avoid 

facilities ‘‘cherry picking’’ patients. One 

commenter stated that acuity-based 

staffing ratios would foster confusion, 

‘‘up-coding,’’ and additional paperwork 

burdens. The commenter further stated 

that if acuity-based ratios were adopted, 

then payment should be adjusted to 

allow providers to accommodate acuitybased staffing needs. A commenter 

stated that acuity-based staffing plans 

have been unsatisfactory and that the 

nursing shortage exacerbated problems. 

Another commenter stated that a federal 

acuity-based system was a bad idea, as 

there were too many variations from 

facility to facility, there would be 

conflicts with many State requirements, 

and this approach was very subjective. 

Response: We solicited public 

comment in the proposed rule regarding 

whether we should include a 

requirement for an acuity-based staffing 

plan. The public comments were split 

on the acuity-based staffing plan issue. 

Clearly staffing is of concern to many 

commenters. While commenters agreed 

with the intent of the proposed adequate 

staff provision at § 494.180(b)(1), there 

was discontent related to how this 

provision would be interpreted and 

enforced. First, we would like to clarify 

that the adequate staff standard applies 

to all clinical patient care staff, 

including nurses, technicians, social 

workers, and dietitians who provide 

services to the dialysis patients. 

Appropriate staffing ratios are affected 

by a number of factors. These factors 

include patient acuity, level of staff 

expertise and skill mix, presence or 

absence of support staff/unlicensed 

personnel, available technology, 

distances between groups of patients 

served, efficiency of systems in place, 

scope of staff duties, degree of team 

work, State requirements, practice 

board-imposed limitations, number of 

meetings in which staff participation is 

required, paperwork demands, etc. We 

do not have a method available to 

identify and account for all of these 

types of characteristics in determining 

staff ratios that balance staff time to 

provide quality care and meet patient 

needs with the economic factors 

associated with dialysis facility labor 

costs. We are also concerned that any 

mandated minimum staffing ratios 

would be interpreted as the ‘‘maximum 

ceiling’’ that must be complied with 

which could lead to a decline in the 

number of patient care staff available. 

‘‘Adequate staff’’ means staffing must 

be sufficient so that quality care is 

provided to dialysis patients that is 

consistent with the patient plan of care 

and professional practice standards. We 

are requiring under the ‘‘Patient 

assessment’’ and ‘‘Patient plan of care’’

conditions (§ 494.80 and § 494.90 

respectively) that members of the 

interdisciplinary team complete a 

comprehensive assessment, followed by 

a plan of care that identifies goals for 

patient care and the services that will be 

provided in order to meet those goals. 

This includes psychosocial and 

nutrition services to be provided by the 

social worker and the dietitian. The 

assessment and plan of care 

requirements necessitate that the RN, 

social worker, and dietitian provide 

appropriate professional care to each 

patient. We are also requiring at 

§ 494.110 that the interdisciplinary 

team, which includes the RN, social 

worker, and dietitian, play an active role 

in the QAPI program. This final rule 

requires that the interdisciplinary team 

provide appropriate care to dialysis 

patients and improve patient care on an 

ongoing basis. The dialysis facility may 

need to evaluate staffing levels as part 

of their action plan for the QAPI 

program. In order to clarify that the 

adequate staffing standard applies to all 

clinical staff, we have added language to 

the requirement at § 494.180(b)(1), 

requiring that the RN, social worker and 

the dietitian be available to meet patient 

clinical needs. 

Comment: Two commenters suggested 

that we hold the medical director 

accountable for adequate staffing. 

Response: We proposed that the 

governing body or designated person 

responsible must ensure adequate 

staffing. The medical director would 

generally not be responsible for hiring 

and firing, and replacing vacant 

positions, or developing the work 

schedules for dialysis facility. The final 

rule will continue to hold the governing 

body or designated person responsible 

for ensuring an adequate number of 

trained and qualified staff. 

Comment: More than 15 commenters 

supported the proposal that an RN be 

present in the facility during dialysis 

(§ 494.180(b)(2)). Two commenters 

requested that this provision be limited 

to hemodialysis because 24-hour RN 

coverage for peritoneal dialysis patients 

would be too burdensome. A few 

commenters recommended that the final 

rule prescribe more than one RN in large 

units. One commenter suggested that 

the final rule state that the RN must not 

be merely ‘‘available’’ but ‘‘a directed 

patient care giver that provides direct 

supervision of care.’’

A few providers opposed the proposal 

that requires the presence of an RN, 

stating that an LPN would be sufficient. 

They suggested that the nursing 

shortage would make this provision 

difficult to meet, especially in rural 

locations, and the LPN was capable of 

fulfilling this role. They further stated 

that this provision could force dialysis 

facilities to close. 

Response: We do not agree with these 

commenters that the RN shortages 

would create an access to care problem. 

Therefore, we are retaining the 

requirement that an RN be present in 

the facility at all times that patients 

were being treated so that a nurse would 

be available who had the experience 

and training to react to patient care 

emergencies that could occur in this 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20435 

increasingly older and medicallycomplex patient population. We believe 

that the RN has a key role in patient 

assessment and supervising LPNs, 

LVNs, and PCTs, and is the appropriate 

staff member to be responsible for the 

nursing care provided. An RN may also 

be needed to answer clinical questions 

from patients and caregivers. The 

rapidly changing demographics of the 

dialysis patient population has resulted 

in an older, sicker patient population 

with more serious co-morbid conditions 

and elevated potential for medical 

emergencies. An RN has the 

professional training and expertise to 

properly react to emergencies. 

Therefore, we believe that having an RN 

on the premises when treatment is being 

provided is a necessary health and 

safety measure for all patients. 

We agree with commenters that large 

dialysis facilities caring for large 

numbers of dialysis patients 

simultaneously could require the 

presence of more than one RN; however, 

we are not mandating more than one 

RN. The presence of one RN is a 

minimum requirement and large 

dialysis facilities have the flexibility to 

schedule more than one RN if patient 

acuity and the number of patients 

dialyzing at one time necessitates it. 

The provision at § 494.180(b)(2) 

regarding RN presence during dialysis is 

applicable to in-center dialysis and does 

not apply to times when peritoneal 

dialysis patients are self-dialyzing at 

home. While an RN may not be 

available at the dialysis center at all 

times that a patient is performing home 

dialysis, there must be an emergency 

plan for when home patients have an 

urgent situation, as required at 

§ 494.180(g). We have clarified the RN 

presence requirement by modifying 

§ 494.180(b)(2)(i), to require a registered 

nurse must be present in the facility at 

all times that ‘‘in-center dialysis 

patients’’ are being treated. We have 

also added the phrase ‘‘responsible for 

the nursing care provided’’ to further 

clarify the role of the RN on duty. 

Comment: One commenter asked 

whether an ESRD facility within a larger 

facility needs to have an RN present 

during dialysis if other RNs are in the 

larger facility. 

Response: This provision requires the 

RN to be present in the dialysis unit 

regardless of where the facility is 

located. 

Comment: A few commenters 

suggested that we require medical 

director training so that the medical 

director is fully informed of the 

expectations associated with her/his 

role. One commenter suggested adding 

a requirement to properly orient, train, 

and inform the medical director. 

Response: We agree that the proposed 

orientation requirement at 

§ 494.180(b)(3) should apply not only to 

employees, but also to the medical 

director and all dialysis facility staff, 

regardless of employee or contractual 

status. In this final rule, we have 

modified this provision to read as 

follows: ‘‘All staff, including the 

medical director, have appropriate 

orientation to the facility and their work 

responsibilities.’’ This requirement now 

applies to all dialysis facility staff. 

Comment: We received several 

comments regarding the proposed 

requirement at § 494.180(b)(4), that ‘‘All 

employees have an opportunity for 

continuing education and related 

development activities.’’

One commenter suggested deletion of 

this requirement because facilities 

should not be ‘‘obligated’’ to provide 

developmental activities without 

funding. 

Response: This continuing education 

provision was previously found at part 

405, subpart U (§ 405.2136(c)(3)(viii)), 

and we are retaining it in the final rule. 

This requirement does not represent a 

new cost to dialysis facilities, since a 

normal cost of doing business is training 

and developing employees. 

Comment: A commenter suggested 

that § 494.180(b)(4) be revised to read, 

‘‘all employees are provided continuing 

education and related developmental 

activities.’’ Another commenter 

recommended the wording be modified 

to state that all employees ‘‘must’’ have 

opportunities for continuing education. 

A commenter suggested that we require 

mandatory training on quality 

improvement, quality standards, and the 

ESRD Network role. One commenter 

stated that § 494.180(b)(4) is vague and 

should include a requirement for 

mandatory continuing education for 

PCTs. 

Response: We do not agree that 

inserting the word ‘‘must’’ after the 

word ‘‘employees’’ adds clarity. This 

provision requires the governing body 

or designated person responsible to 

ensure that employees have the 

opportunity for continuing education 

and development activities, which 

include education that is provided by 

the facility as well as education that is 

available outside the facility. We have 

not modified the wording to more 

narrowly define the continuing 

education opportunities as only those 

‘‘provided’’ by the facility, nor have we 

added prescriptive language to define 

the areas in which the continuing 

education and development activities 

must occur. The facility has the 

flexibility to identify areas on which to 

focus educational efforts. Some areas 

might be identified via the QAPI 

program. Licensed, registered, or 

certified dialysis facility staff must meet 

certain ongoing educational 

requirements to maintain their 

licensures, registrations, and/or 

certifications, which are required under 

the ‘‘Personnel qualifications’’

condition. 

Comment: Two commenters suggested 

that we require mandatory staff 

education on the patients’ right to be 

free of verbal abuse by staff, as there 

have been ‘‘numerous allegations’’ of 

staff verbally abusing patients in the 

absence of such a requirement, and 

there was a need to maintain 

‘‘professionalism’’ in facilities. The 

commenters stated that the line of 

professionalism was often crossed by 

staff in dialysis facilities. 

Response: We are alarmed about 

allegations of dialysis patient abuse by 

facility staff. Any allegations of abuse 

should be immediately reported to the 

State survey agency and appropriate 

local authorities. We agree with the 

commenter regarding the need for staff 

to be knowledgeable about patient 

rights. A dialysis facility must inform 

patients of their rights and the facility 

must protect and provide for the 

exercise of those rights as required 

under the ‘‘Patients’ rights’’ condition 

for coverage at § 494.70. These rights 

include the right to respect and dignity 

(§ 494.70(a)(1)). Dialysis facilities must 

ensure that patient rights are recognized 

and protected by all staff and would 

therefore need to educate staff regarding 

patient rights in order to achieve 

compliance with the conditions for 

coverage. Patient rights must be posted 

prominently in the facility. In addition, 

the medical director at § 494.150(c)(2)(i) 

must ensure all patient care staff adhere 

to all patient care policies. These 

policies would include protection of 

patient rights. We require, at 

§ 494.180(b)(3), that all staff receive 

appropriate orientation to the facility 

and work responsibilities, which would 

include patients’ rights training. 

However, we are not going to mandate 

that the facility provide training to staff 

on this matter because we do not want 

to prescribe or limit the orientation 

topics. Facilities must provide adequate 

staff training to ensure that they meet 

these conditions for coverage. 

Comment: Several commenters 

concurred with the written PCT training 

program proposal at § 494.180(b)(5). 

One commenter was concerned that 

dialysis facilities would be allowed to 

‘‘police’’ their own PCT training 


PWALKER on PROD1PC71 with RULES2
20436 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

programs, which could lead to a lack of 

consistency and validity. 

Response: We appreciate the support 

for the PCT training requirements. We 

discussed PCT qualifications earlier in 

this preamble under ‘‘Personnel 

qualifications.’’ We have relocated the 

PCT training requirements from 

§ 494.180(b)(5) and § 494.180(b)(6), to 

§ 494.140(e)(3) and § 494.140(e)(4) so 

that all of the PCT qualifications may be 

found in one section of these 

conditions. We are requiring national 

PCT certification in this final rule. The 

certification exam would serve as a 

measure of PCT competency, and 

facilities would not be in the position of 

instituting their own certification 

programs. 

Comment: We received many 

comments suggesting revisions to the 

content of the PCT training program. A 

large number of commenters 

recommended that we add a PCT 

training topic regarding patient 

psychosocial needs related to ESRD and 

its treatment regimens, and that this 

training be provided by the MSW. A 

commenter suggested adding 

‘‘communication and interpersonal 

skills, including patient sensitivity 

training and care of difficult patients.’’

Another commenter suggested adding 

training on ethics and professionalism, 

and dealing with conflicts and 

challenging situations. A few 

commenters suggested PCT training on 

patient nutrition and psychosocial 

needs. One commenter recommended 

PCT training regarding possible 

symptoms and complications of 

dialysis, the potential for patients to live 

long and active lives on dialysis, and 

patient expectations. 

Response: We do not agree that there 

is a need to expand the PCT training 

subject matter list. The proposed PCT 

training program (proposed at 

§ 494.180(b)(5)) included the ‘‘care of 

patients with kidney failure, including 

interpersonal skills’’ and ‘‘possible 

complications of dialysis.’’ ‘‘Care of 

patients with kidney failure’’ (proposed 

§ 494.180(b)(5)(ii)) would include 

psychosocial and nutritional aspects of 

care. The ‘‘interpersonal skills’’ training 

would include professional conduct and 

interactions during challenging 

situations. The ‘‘complications of 

dialysis’’ (proposed § 494.180(b)(5)(iv)) 

was already addressed in the proposed 

training topics list. 

As discussed in the ‘‘Personnel 

qualifications’’ section of this preamble, 

we have moved the training list to 

§ 494.140(e)(3). The training program 

must be approved by the medical 

director and the governing body. We are 

requiring certification of PCTs to ensure 

competency. 

Comment: A commenter suggested 

that we retain all or part of existing 

§ 405.2136(d) and § 405.2136(g). 

Response: Standard 405.2136(d) 

required written personnel policies and 

procedures; and standard (g) addressed 

medical supervision and emergency 

coverage. Section 405.2136, standard (d) 

required that facility policies and 

procedures ensure the following: That 

all staff members are qualified to 

perform their duties; that a safe and 

sanitary environment exists for patients 

and staff; that trainees are directly 

supervised; that complete personnel 

records are maintained; that personnel 

policies including grievance policies are 

written and available; that all facility 

personnel are oriented and have 

continuing in-service training that is 

documented, and; that personnel 

manuals are maintained, updated, and 

available. 

This final rule addresses staff 

qualifications at § 494.140, and a safe 

and sanitary facility environment is 

addressed throughout part 494, subpart 

B. Facility staff training and educational 

requirements are set out at § 494.180(b). 

In keeping with our goal of removing 

process requirements, we are not 

including personnel policy provisions 

in the final rule. Personnel policies and 

procedures are maintained as a usual 

business practice and do not need to be 

required by this regulation. 

As for former § 405.2136(g), issues of 

emergency preparedness and emergency 

coverage are addressed in this final rule 

at § 494.60(d) and § 494.180(g), 

respectively. The substantive elements 

of medical supervision are encompassed 

within the ‘‘Patient assessment’’

(§ 494.80), ‘‘Patient plan of care’’

(§ 494.90), and ‘‘Medical director’’

(§ 494.150) conditions. 

Comment: One commenter suggested 

adding a requirement for facilities to 

notify the State agency when there are 

changes in the governing body make-up, 

facility location, or medical staff. 

Response: We do not believe that 

these specific procedural requirements 

should be included in the final rule. 

Communications of this type will be 

addressed via program instructions or 

interpretative guidelines as needed. 

Comment: A commenter suggested 

that we require facilities to report all 

unusual incidents to the State agency. 

Response: The condition at § 494.20 

requires compliance with relevant 

Federal, State and local laws, some of 

which may include reporting 

requirements. We did not propose that 

facilities report unusual incidents to the 

state agency, although we are requiring 

that the State and ESRD Network 

complaint phone numbers be 

prominently posted (§ 494.70(c)). 

Dialysis facilities must report certain 

diseases to the state health department 

and must report certain incidents 

related to equipment failure to the FDA. 

We have not added any further 

reporting requirements to the 

‘‘Governance’’ condition. 

Comment: One commenter suggested 

that patients be able to nominate an 

individual to serve on the facility 

governing body. 

Response: The governing body is an 

entity with full legal responsibility and 

accountability to operate the facility. 

Dialysis facilities have the option of 

having patient representation on their 

governing bodies if they choose. We 

support patient participation and 

encourage facilities to include patients 

in quality assessment and performance 

improvement efforts, and as 

representatives on facility committees 

and boards whenever appropriate. 

Comment: Several commenters 

suggested that we add other staff 

(physician assistants, nurse 

practitioners, and clinical nurse 

specialists) to the § 494.180(c) list of 

medical staff that the dialysis facility 

would appoint and credential. One 

commenter stated that we should only 

refer to physician credentialing unless 

State law allows other professionals to 

be credentialed. 

Response: The proposed rule 

addressed credentialing for physicians, 

physician assistants, and nurse 

practitioners. We have modified the 

language at § 494.180(c)(1) to include 

clinical nurse specialists since some 

dialysis facilities use these 

professionals. We agree with the 

commenter regarding congruency with 

State law. We have also added the 

phrase ‘‘in accordance with State law’’

at § 494.180(c)(1) to indicate that these 

credentialing requirements do not 

supersede State law regarding such 

‘‘physician extenders.’’

Comment: A few commenters agreed 

that the governing body should support 

medical staff appointments. Two 

commenters stated the governing body 

should authorize and require the 

medical director to monitor and 

improve performance of attending 

nephrologists. 

Response: The proposed language at 

§ 494.180(c)(2) would require the 

governing body to ensure that all 

medical staff who provided care in the 

facility were informed of all facility 

policies and procedures, including the 

facility’s quality assessment and 

performance improvement program. The 

medical director is accountable to the 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20437 

governing body for the quality of care 

provided. As discussed earlier in this 

preamble we have modified the 

language at § 494.150 to include, ‘‘The 

medical director is accountable to the 

governing body for the quality of 

medical care provided to patients.’’ In 

recognition of the role of medical staff 

in providing quality care we have also 

added language at § 494.180(c)(3) to 

require the governing body to 

communicate expectations to the 

medical staff regarding staff 

participation in improving the quality of 

medical care provided to facility 

patients. The governing body must 

ensure that adequate resources are 

available to provide quality care. The 

medical director is responsible for 

patient outcomes and must ensure 

adequate cooperation from anyone who 

treats patients in the facility 

(§ 494.150(c)(2)). If the medical director 

is unable to secure cooperation from 

individuals providing treatment, 

including attending physicians, the 

problem should be referred to the 

governing body. If the governing body is 

unable to remedy the problem, the 

medical director should notify the state 

medical board and/or the ESRD 

Network. 

Comment: One commenter suggested 

that more physician accountability 

could be achieved through periodic recredentialing. Another commenter 

stated that facilities had little control 

over physicians, and suggested use of 

hospital credentialing as required by the 

Medicare hospital conditions of 

participation, as a model. The 

commenter also stated that if physicians 

did not participate in QAPI, they should 

lose their credentialing. 

Response: The hospital conditions of 

participation at § 482.22 require that the 

medical staff operate under bylaws 

approved by the governing body, be 

responsible for the quality of medical 

care provided to patients, be composed 

of doctors of medicine or osteopathy 

and in accordance with State law, may 

be composed of other practitioners 

appointed by the governing body, 

conduct periodic appraisals of its 

members, examine credentials of 

candidates and make recommendations 

to the governing body based on 

qualifications established in the medical 

staff bylaws, be well organized and 

accountable to the governing body for 

the quality of care. 

We believe that the proposed rule has 

been strengthened via language in the 

final rule at § 494.150, ‘‘Responsibilities 

of the medical director’’ that states, 

‘‘The medical director is accountable to 

the governing body for the quality of the 

medical care provided to patients.’’ This 

is consistent with the hospital 

conditions of participation. We have 

also added language to § 494.180(c) that 

states not only is medical staff informed 

of facility policies and procedures and 

the QAPI program, but that the 

governing body must communicate to 

all medical staff the expectations for the 

role of the medical staff and required 

participation in improving the quality of 

medical patient care. The governing 

body has the flexibility to perform 

annual credentialing or to choose 

another credentialing frequency. During 

initial credentialing, the governing body 

should review previous medical staff 

positions and whether a physician or 

physician extender has had privileges 

revoked in any other facilities. 

Comment: We received two comments 

regarding § 494.180(d) ‘‘Furnishing 

services.’’ One commenter suggested 

that we define the phrase ‘‘(the 

facility’s) main premises’’ so as to 

include home dialysis, while another 

commenter would like a loosening of 

the ‘‘on-the-premises’’ provision to 

allow ‘‘across the street’’ units. 

Response: The provision at 

§ 494.180(d) that the governing body 

ensure that services are furnished 

directly on its ‘‘main premises’’ or on 

other premises that are ‘‘contiguous’’

with (that is, not physically separate 

from) the main premises, facilitates 

dialysis facility accountability for the 

patient care provided. Therefore, an 

‘‘across the street’’ dialysis facility is not 

considered to be part of another dialysis 

facility but an independent facility. As 

such, it must meet all these conditions 

for coverage and be certified to receive 

Medicare payment. 

Home dialysis services must be 

provided in the certified dialysis facility 

or at the patient’s home, unless the 

patient requests an alternate location. 

Home dialysis by definition includes 

the patient’s home as an acceptable 

location for the performance of dialysis, 

and therefore is an acceptable site for 

the provision of support services. 

Comment: One commenter suggested 

the final rule state (at § 494.180(e)) that 

the facility must accept a grievance in 

any form (oral or written) presented. 

Response: We agree that facilities 

should not limit acceptance of 

grievances to written grievances, and 

therefore, we have added the words 

‘‘oral or written’’ at § 494.180(e) to allow 

patients more flexibility in how they 

communicate a grievance. The sentence 

now reads, ‘‘The facility’s internal 

grievance process must be implemented 

so that the patient may file an oral or 

written grievance with the facility 

without reprisal or denial of services.’’

Comment: Two commenters suggested 

we require the internal grievance 

process to be posted. Another 

commenter recommended patient 

involvement in the design and 

administration of internal grievance 

process. 

Response: We are not prescribing the 

manner in which a facility must make 

its grievance process known. The 

facility has the flexibility to inform 

patients of the grievance process as 

required under the ‘‘Patients’ rights’’

condition at § 494.70(a)(14), using the 

methods of its choice. 

Comment: One commenter 

recommended that we require routine 

reporting to the ESRD Network on the 

number and topics of complaints. A 

second commenter supported the 

concept of an internal grievance 

process, but suggested the addition of an 

expectation of timely investigation, 

documentation, and resolution, along 

with a quality assurance requirement to 

prevent any recurrences. 

Response: Grievances resolved at the 

facility level might not need to be 

escalated to the ESRD Network level. 

Grievances are to be addressed in a 

reasonable fashion in a reasonable 

period of time. The grievance process 

must include a clearly explained 

procedure for the submission of 

grievances, timeframes for reviewing the 

grievance, and a description of how the 

patient or the patient’s designated 

representative will be informed of steps 

taken to resolve the grievance. Dialysis 

facilities must track grievances and 

patient satisfaction as part of the QAPI 

program in which trending and quality 

improvement efforts are expected 

(§ 494.110(a)(2)(viii)). 

Comment: We received many 

comments supporting proposed 

§ 494.180(f), ‘‘Discharge and transfer 

policies and procedures.’’ Several 

commenters endorsed the preamble 

language regarding the 

inappropriateness of patient discharges 

for non-compliance and recommended 

that we add language to the final rule 

stating that a patient cannot be 

discharged for non-compliance. A 

commenter stated that non-compliance 

could be due to lack of education on the 

effects of non-compliance. A few 

commenters suggested that 

recommendations from ‘‘Decreasing 

Dialysis Patient-Provider Conflict 

National Task Force Position Statement 

on Involuntary Discharge’’ developed by 

a national consensus conference held in 

October of 2003, be included. The report 

stated that patient non-adherence to the 

medical regimen was not an appropriate 

reason to discharge a patient, primarily 

because this type of behavior mainly 


PWALKER on PROD1PC71 with RULES2
20438 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

harmed the patient himself and not 

others, and because the patient could 

exercise his right to non-adhere to 

instructions. One commenter 

recommended that we include in the 

final rule the key elements from this 

report, which include the facility’s right 

to refuse to treat violent, physically 

abusive patients; a physician right to 

terminate care only after taking ethical 

steps; and the recognition that both the 

unit and physician have legal 

obligations. 

Some commenters stated that when 

an attending physician discharges a 

patient from care and another physician 

is not found to take over the patient’s 

medical care, the dialysis facility has no 

choice but to discharge the patient. One 

commenter stated discharge should be 

allowed for patients whose behavior 

interferes with the plan of care, 

including non-compliance. 

Response: The background section of 

the ‘‘Decreasing Dialysis PatientProvider Conflict National Task Force 

Position Statement on Involuntary 

Discharge’’ (http:// 

www.esrdnetwork8.org/assets/pdf/ 

DPCPositionStatement06.pdf), adopted 

by the task force in January 2005, 

provides data on involuntary 

discharges. The number of involuntary 

discharges in 70 percent of dialysis 

facilities in 2002 was 458 (0.2 percent 

of 285,982 patients). ‘‘Treatment nonadherence was the leading reason for 

discharge nationally at 25.5 percent (117 

patients), followed by verbal threat at 

8.5 percent (39 patients). Other reasons 

for discharge were lack of payment at 

5.2 percent (35 patients), combinations 

of verbal abuse, verbal threat and 

physical threats at 5.2 percent (24 

patients) and verbal abuse at 5 percent 

(23 patients).’’ The report also stated 

that discharged patients were at high 

risk for morbidity and mortality and an 

unknown number of deaths have 

occurred due to lack of access to 

dialysis. 

Patients may be involuntarily 

discharged for non-compliance by their 

physician because physicians have a 

right to end an established care 

relationship with a patient after 

providing the patient adequate notice 

(30 days) of the termination of the 

medical care and reasonable assistance 

in obtaining care elsewhere. If a 

physician discharges a patient from his 

or her personal care, the dialysis facility 

should locate another attending 

physician in the facility to provide 

ESRD care, or discharge the patient from 

the facility following the process 

required at § 494.180(f)(4). 

The proposed rule preamble (70 FR 

6202) stated, ‘‘We would not expect a 

patient to be involuntarily discharged 

from a dialysis facility for failure to 

follow the instructions of a facility staff 

member.’’ Facilities are expected to 

make ‘‘good faith’’ efforts to mitigate 

problems and prevent an involuntary 

discharge. The proposed circumstances 

under which involuntary discharge 

would be permissible, laid out at 

§ 494.180(f)(1) through § 494.180(f)(4) 

were: Lack of payment; facility closes; 

the transfer is necessary for the patient’s 

welfare because the facility can no 

longer meet the patient’s documented 

medical needs; or the facility has 

reassessed the patient and determined 

that the patient’s behavior is disruptive 

and abusive to the extent that the 

delivery of care to the patient or the 

ability of the facility to operate 

effectively has been seriously impaired. 

The previous conditions for coverage 

at § 405.2138(b)(2), stated that patients 

could be transferred or discharged only 

for medical reasons or for the patient’s 

welfare or that of other patients, or for 

nonpayment of fees (except as 

prohibited by title XVIII of the Act) and 

that facilities would have to provide the 

patients with advance notice to ensure 

orderly transfer or discharge. Neither 

the proposed rule nor subpart U 

encouraged the involuntary discharge of 

patients because of patient noncompliance. Aside from a minor 

grammatical change we have not 

modified the proposed language 

regarding the permissible conditions for 

an involuntary patient discharge in this 

final rule. This final rule requires that 

if there is a problem with noncompliance, the problem must be 

addressed in the plan of care and 

facility staff must take appropriate 

actions. Patient education and social 

work interventions may be appropriate. 

The facility must weigh the ethical 

issues regarding the discharge of a 

patient from a life-saving therapy 

against the gravity and consequences of 

any non-adherence problem. 

Immediate discharge is addressed 

under ‘‘Patients’ rights’’ in this final rule 

at § 494.70(b)(2) and at § 494.180(f)(4) 

and § 494.180(f)(5). Under § 494.70(b)(2) 

the patient has the right to receive 

written notice 30 days in advance of the 

facility terminating care after following 

the procedure described in § 494.180(f). 

Moreover, in the case of immediate 

threats to the health and safety of others, 

an abbreviated discharge procedure may 

be allowed. There may be situations 

where a patient’s behavior is so 

egregious that a facility must discharge 

a patient with less than 30 days notice 

or even immediately. The facility must 

weigh the safety and care of other 

patients and staff against the 

consequences of continuing to provide 

dialysis care or conducting an expedited 

discharge of the patient from a 

lifesaving therapy. We proposed a 

process, which is retained in this final 

rule, that must be adhered to before a 

patient with disruptive or abusive 

behavior may be discharged. 

We encourage facilities to use the 

materials and tool kit developed by the 

‘‘Decreasing Dialysis Patient-Provider 

Conflict National Task Force’’ to 

proactively prevent conflicts and 

disruptive situations and to undertake 

appropriate actions when involuntary 

discharge is being considered. This kit 

is available from the ESRD Networks. 

Comment: One commenter suggested 

revising proposed § 494.180(f)(3) to 

permit transfer under that paragraph 

when the transfer is necessary for the 

patient’s welfare because the facility can 

no longer meet the patient’s medical 

needs and goals as documented in the 

patient’s plan of care as specified in 

§ 494.90. 

Response: The suggested additional 

phrase defines the medical needs as 

those specified in the plan of care and 

would therefore permit a facility to 

involuntarily discharge a patient if he/ 

she did not meet care plan goals. We 

believe that the term ‘‘medical needs’’ is 

commonly understood and do not 

believe that failure to meet the plan of 

care goals should result in discharge of 

a patient. We are making no changes to 

this provision based on this comment. 

Comment: A commenter 

recommended revising 

§ 494.180(f)(4)(iii) to read, ‘‘The 

governing body of facilities approached 

to accept the patient must ensure that 

the patient is not summarily declined a 

transfer without following the 

individual facility’s policies and 

procedures for patient admission 

(including patient interview and 

medical records review, if applicable).’’

Another commenter recommended 

the addition of a requirement for a 

facility admission policy that 

discourages discrimination. The 

commenter asked that our regulations 

address admission restrictions and 

discharges of patients who require a 

higher level of skilled care (ventilator, 

bed-bound, morbidly obese) since some 

current practices have caused access-tocare problems. 

Response: Dialysis facilities should 

not deny admission to their facilities 

because they ‘‘heard’’ the patient was a 

‘‘problem’’ without assessing the 

patient. Patient privacy rules must be 

observed and the admission review 

should include medical record 

information and not ‘‘hearsay.’’


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20439 

Facilities should assess the medical 

needs of patients and the facility’s 

ability to meet these medical needs. 

Facilities must comply with federal civil 

rights and anti-discrimination laws as 

required in § 494.20. Under our 

previous regulation, the facility was 

required to have admission criteria that 

insured equitable access to services, and 

to make such criteria readily available to 

the public (§ 405.2136(b)(3)). While we 

did not carry forward this provision in 

the proposed rule, in the final rule, we 

are holding the medical director 

responsible for the development, 

review, approval, and staff adherence to 

facility policies and procedures 

(§ 494.150(c)). Because facility 

admission policies would fall under the 

responsibilities of the medical director, 

we have added ‘‘patient admissions’’ to 

the list of policies and procedure 

categories for which the medical 

director is responsible 

(§ 494.150(c)(2)(i)). Dialysis facilities 

should offer equitable patient access to 

their facility and should have well 

defined ethical and legal admission 

policies. Facilities will be expected to 

adhere to their written admission 

policies. 

Comment: One commenter agreed that 

both the governing body and the 

medical director should be responsible 

for ensuring that the facility complies 

with the involuntary patient discharge 

process. Another commenter suggested 

that only the governing body should be 

responsible. 

Response: We believe that both the 

medical director and the governing body 

have an obligation to ensure that the 

facility appropriately conducts 

involuntary patient discharges. 

Comment: Two commenters suggested 

adding ‘‘patient choice’’ to reasons for 

discharge so that when a dialysis patient 

voluntarily leaves, the facility does not 

have to implement the involuntary 

discharge procedure. 

Response: We have renamed 

§ 494.180(f) to include the word 

‘‘involuntary.’’ The new title is 

‘‘Involuntary discharge and transfer 

policies and procedures.’’ This clarifies 

that these provisions specifically apply 

to involuntary discharges, not all 

dialysis facility discharges. 

Comment: A few commenters 

supported our proposal at 

§ 494.180(f)(4)(ii), which would require 

both the attending physician and the 

medical director to sign an involuntary 

discharge order. One of the commenters 

stated that some patients have been 

involuntarily discharged from a dialysis 

facility without the attending 

physician’s knowledge. A few other 

commenters suggested that one, not two 

physicians (attending physician and 

medical director), provide the discharge 

signature. Another commenter 

suggested that we only require the 

medical director’s signature for 

involuntary discharges only. 

Response: An involuntary discharge 

of a patient from dialysis, a life-saving 

therapy, is a last-resort action that can 

have grave consequences. We believe 

the responsibility for, and obligations to, 

the patient, are shared between the 

attending physician and the dialysis 

facility. In this situation, the medical 

director represents the dialysis facility. 

The medical director and the attending 

physician should concur that the last 

resort approach is needed before 

discharging the patient; otherwise, the 

involuntary discharge should not occur. 

We agree that the medical director’s 

discharge signature is only necessary 

when the discharge is involuntary. We 

have renamed standard (f) ‘‘Involuntary 

discharge and transfer policies and 

procedures.’’ This clarifies that these 

provisions apply to involuntary 

discharges, and not all dialysis facility 

discharges. The signature requirement 

has been redesignated in the final rule 

as § 494.180(f)(4)(ii). 

Comment: Commenters offered 

varying interpretations of how facilities 

may satisfy the requirement at 

§ 494.180(f)(4)(iii) regarding attempts to 

place the patient in another facility and 

documentation of that effort. One 

commenter stated that a ‘‘good faith 

effort’’ in finding a new facility should 

be enough, and the facility should not 

be held accountable for a patient’s bad 

choices. Another commenter agreed, 

saying that facilities should document 

their attempt to place the patient in a 

new facility, and in some cases, difficult 

patients should make his or her own 

arrangements. Two commenters 

requested clarification of what would be 

required, and stated their belief that the 

responsibility for finding an alternate 

facility rested with the patient. Some 

commenters stated the facility should be 

required to provide a list of other nearby 

dialysis facilities and assistance with 

the transfer. 

A few commenters suggested that the 

facility demonstrate its attempt to find 

an alternate placement ‘‘by direct 

contact with the other facility.’’ This 

suggestion is consistent with the 

‘‘Decreasing Dialysis Patient-Provider 

Conflict National Task Force’’

recommendations. Another commenter 

recommended inclusion of a 

requirement for the discharging facility 

to make arrangements and pay for 

treatment at a hospital for the services 

they are refusing to provide, until a 

hearing is held. 

Response: In response to comments, 

we have revised the provision to require 

that the facility must contact an 

alternate dialysis facility to attempt to 

place the patient who is involuntarily 

discharged and must document that 

effort. 

Comment: We received several 

comments regarding the requirement at 

proposed § 494.180(f)(4)(iv) that the 

facility notify the State survey agency 

and the ESRD Network of an 

involuntary discharge. Several 

commenters suggested that we require 

ESRD Network involvement or a 

mandatory ESRD Network referral 

before an involuntary discharge. Two 

commenters said there should be 

Network notification 48 hours prior to 

an involuntary discharge. A commenter 

stated that notifying the State agency 

and the Network after the fact was too 

late; community human services 

agencies should be notified earlier in 

the process, in order to provide resource 

support to help prevent an involuntary 

discharge. 

Response: We agree that the ESRD 

Network could be of more assistance in 

acting as a resource and resolving 

problems leading up to an involuntary 

discharge if notification were provided 

prior to the discharge. The proposed 

rule required notification of the State 

survey agency and the ESRD Network of 

the involuntary transfer or discharge 

without specifying when notice would 

be given. We have modified standard (f) 

to include a new requirement, now at 

§ 494.180(f)(4)(ii) in this final rule, so 

that the facility must now notify its 

ESRD Network within the same time 

frame in which the patient is given 

written notice of the involuntary 

discharge (that is, 30 days). The 

proposed provisions at § 494.180(f)(4)(ii) 

through § 494.180(f)(4)(iv) have been 

renumbered in this final rule to reflect 

the insertion of the new paragraph (ii). 

Comment: A few commenters 

suggested that the ESRD Network be 

involved in performing audits, patient 

placement, arbitration, and in finding 

alternate solutions related to dialysis 

facility grievances related to involuntary 

discharges. 

Response: The extent of the role of the 

ESRD Network in involuntary 

discharges is defined by the ESRD 

Network scope of work. It would be 

inappropriate in these conditions for 

coverage to address Network authority 

or responsibilities. 

Comment: One commenter stated the 

ESRD Network should be allowed to 

notify the State survey agency so the 

facility does not have to call both 

entities. Another commenter stated that 

notification of both State and Network 


PWALKER on PROD1PC71 with RULES2
20440 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

is too burdensome, and one (the ESRD 

Network) should be enough. 

Response: We believe the burden of 

notifying both the ESRD Network and 

the State survey agency represents an 

acceptable level of burden. We have 

retained ESRD Network and State 

agency notification of an involuntary 

patient discharge in the final rule. 

Comment: A commenter suggested 

facilities be encouraged to develop and 

share discharge criteria with patients to 

ensure they are fully informed of 

expectations, policies, and procedures. 

Response: We refer the commenter to 

the ‘‘Patients’ rights’’ condition. Patients 

have the right to be informed regarding 

the facility’s discharge and transfer 

policies as required at § 494.70(b). 

Facilities must also inform patients of 

the rules and expectations of the facility 

regarding patient conduct and 

responsibilities (§ 494.70(a)(13)). 

Comment: A few commenters 

recommended the addition of a final 

rule provision that would allow 

immediate patient discharge when an 

immediate serious physical threat to 

staff or patients exists. Two commenters 

noted that in these cases, there must be 

thorough documentation and a police 

report is normally filed. 

Response: The proposed rule 

preamble (70 FR 6202) discussion 

recognized that there may be occasions 

when an immediate or an abbreviated 

patient discharge process may be 

appropriate in order to protect other 

patients and staff. We agree that it is 

reasonable to add language under the 

discharge standard in § 494.180. We also 

note that there may be instances when 

local law enforcement officials must be 

notified of questionable behavior. 

Therefore, in response to comments we 

have modified § 494.180(f) by adding, at 

(5) ‘‘In the case of immediate severe 

threats to the health and safety of others, 

the facility may utilize an abbreviated 

involuntary discharge procedure.’’ This 

abbreviated procedure allows less than 

a 30-day time period for the discharge 

notice. The facility must still provide 

patient assessment, interventions, and 

an effort for resolution to the extent 

possible based on the unique situation. 

Documentation in the medical record of 

the events leading up to the involuntary 

discharge is required in every case. 

Comment: Two commenters suggested 

the addition of language to 

§ 494.180(f)(4)(i) that would require 

counseling and support from the team to 

resolve patient behavioral issues and 

also require that the team inform 

patients of behaviors that could lead 

staff to notify police or referral for 

evaluation of risk to self or others. Some 

commenters stated there should be 

social worker involvement before a 

patient is involuntarily discharged. 

Another commenter suggested that we 

add a condition that no patient be 

involuntarily discharged except in an 

emergency situation without 

documentation that a program was 

implemented to resolve inappropriate 

behavior. 

Response: The involuntary patient 

discharge requirements at 

§ 494.180(f)(4)(i) address reassessments, 

ongoing problems, efforts made to 

resolve the problem, and documentation 

in the patient’s medical record. These 

‘‘efforts made to resolve the problem’’

may include counseling and support 

from the team to resolve behavioral 

issues. We are not narrowly defining or 

specifying what the ‘‘efforts made to 

resolve the problem’’ must encompass, 

as patient needs vary. The team must 

assess the patient and use appropriate 

interventions that address the patient’s 

individual issues. 

As stated above, patients have the 

right to be informed regarding the 

facility’s discharge and transfer policies 

as required at § 494.70(b), which 

include policies regarding notification 

and referrals. 

Comment: We received a few 

comments regarding § 494.180(g)(3), 

‘‘Emergency coverage.’’ Some 

commenters supported our proposed 

requirement that each ESRD facility 

have an agreement with a hospital. One 

commenter suggested including a 

provision requiring that the agreement 

address psychiatric emergencies. Two 

commenters recommended requiring the 

facility to make an agreement only with 

hospitals that had the ability to provide 

inpatient dialysis, which the commenter 

argued was especially important in rural 

areas. One commenter stated that 

patients needed to know about the 

nature of the relationship between the 

dialysis unit and the hospital under 

agreement to provide emergency 

services. 

A commenter stated that this 

provision should require the dialysis 

facility and hospital to agree to provide 

mutual aid in the event of a large 

disaster and suggested that each unit 

have one or more ‘‘mutual aid 

agreements’’ with other facilities both 

near and far. The commenter stated that 

the issues facing ESRD patients in the 

event of a disaster are not often 

considered by emergency planners. 

Another commenter questioned the 

need for an agreement with a hospital, 

stating that hospitals were reluctant to 

enter into such agreements and that 

such agreements were not required of 

hospitals in their conditions of 

participation. 

Response: The proposed provision 

regarding the hospital agreement is less 

prescriptive than part 405, subpart U 

requirement formerly found at 

§ 405.2160. Instead of including 

process-oriented requirements, we 

proposed a requirement that was 

aligned with our intent to ensure access 

to suitable inpatient care for dialysis 

patients. We agree with the commenter 

that dialysis care should be available in 

any hospital with which an agreement 

is made. We have revised the final rule 

to require that dialysis facilities must 

have an agreement with a hospital that 

can provide routine and emergency 

dialysis services, and to specify this in 

the agreement. The provision at 

§ 494.180(g)(3) now reads, ‘‘The dialysis 

facility must have an agreement with a 

hospital that can provide inpatient care, 

routine and emergency dialysis and 

other hospital services, and emergency 

medical care which is available 24 

hours a day, 7 days a week * * *.’’

One commenter (a state survey 

agency) noted that hospitals were often 

reluctant to enter into agreements with 

dialysis facilities, but no dialysis 

facilities related any difficulties in this 

regard in their comments. Therefore, we 

do not believe that this is a barrier to 

dialysis facility compliance with this 

provision. 

Our final rule at § 494.60(d)(4)(iii) 

requires a dialysis facility to contact its 

local disaster management agency to 

make the agency aware of dialysis 

facility needs in the event of an 

emergency. This provision will ensure 

at least annual communication between 

the dialysis facility and the local 

disaster management program. We 

believe this addresses the commenter’s 

concern about lack of contact with 

emergency planners. 

Facilities also have the flexibility to 

include any of the additional 

commenter suggestions when writing 

their agreements and to communicate 

emergency services arrangements with 

patients as appropriate. We are not 

mandating these processes in this final 

rule. 

Comment: We received many 

comments regarding proposed 

§ 494.180(h), ‘‘Furnishing data and 

information for ESRD program 

administration,’’ which would require a 

dialysis facility participating in 

Medicare to furnish data and 

information electronically and in 

intervals specified by the Secretary. 

These data would include cost reports, 

administrative forms, patient survival 

data, ESRD clinical performance 

measures and any future standards 

developed in accordance with the 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20441 

NTTAA process adopted by the 

Secretary. 

Many commenters expressed support 

for the proposed electronic data 

collection. Some commenters 

recommended expansion of the 

‘‘Dialysis Facility Compare’’ Web site at 

http://www.cms.hhs.gov/ 

dialysisfacilitycompare/ to include all 

data collected, home dialysis data, 

measurements of patient satisfaction, 

other relevant lab data, and facility 

aggregate functioning and/or well-being 

data. 

Several commenters had concerns 

regarding the burden associated with 

electronic data collection. Two 

commenters stated that VISION (Vital 

Information System to Improve 

Outcomes in Nephrology) is not ready 

for full implementation and may not be 

universally applicable, and therefore a 

data collection requirement should be 

delayed. 

One commenter stated that electronic 

reporting would duplicate the 

information collected by large dialysis 

organization information technology 

systems. A few commenters 

recommended that only one of 

electronic or paper data collection 

should be required, as both would be 

too burdensome. One commenter 

suggested that a timeline was needed to 

implement electronic reporting. 

One commenter stated that providers 

should have the opportunity to provide 

input when CMS defines data collection 

efforts. 

Response: The proposed rule would 

require the electronic submission of 

data necessary for CMS administration 

of the Medicare ESRD program. These 

electronic data specifically include 

administrative data (including, but not 

limited to the CMS–2728, Medical 

Evidence/Medicare entitlement form 

data and CMS–2746, ESRD death 

notification data, and the United States 

Renal Data System data) and the 

existing ESRD Clinical Performance 

Measures (CPM) data (CMS–820 and 

CMS–821), and any data necessary for 

future performance measures developed 

in accordance with a voluntary 

consensus standards process identified 

by the Secretary. 

This final regulation requires facilities 

to provide data and other information 

that are necessary to support 

administration of the ESRD program. In 

order to increase efficiencies and 

improve the usefulness of these data, we 

are requiring electronic submission of 

necessary administrative data as well as 

specified data for calculation of ESRD 

CPMs. 

This electronic data collection is 

consistent with the IOM’s 

recommendation that ‘‘* * * the 

Department of Health and Human 

Services should move forward 

expeditiously with the establishment of 

monitoring and tracking processes for 

use in evaluating the progress of the 

health system in pursuit of the abovecited aims’’ (IOM 2001). It is also 

consistent with White House Executive 

Order 13410, Promoting Quality and 

Efficient Health Care in Federal 

Government Administered or Sponsored 

Health Care Programs, issued on August 

22, 2006, which states: 

‘‘Each agency shall implement programs 

measuring the quality of services supplied by 

health care providers to the beneficiaries or 

enrollees of a Federal health care program. 

Such programs shall be based upon standards 

established by multi-stakeholder entities 

identified by the Secretary or by another 

agency subject to this order. Each agency 

shall develop its quality measurements in 

collaboration with similar initiatives in the 

private and non-Federal public sectors.’’

(http://www.whitehouse.gov/news/ 

releases/2006/08/print/20060822- 

2.html) (71 FR 51089.) 

Finally, it is consistent with 

recommendations from various 

governmental bodies that provide 

oversight of the Medicare program. For 

example, in a recent report (OEI–05–05–

00300) titled ‘‘Availability of Quality of 

Care Data in the Medicare End-Stage 

Renal Disease Program,’’ the Department 

of Health and Human Services’ Office of 

the Inspector General (OIG) 

recommended that CMS ‘‘increase its 

efforts towards regularly collecting data 

from all patients and all facilities on all 

clinical performance measures 

identified by CMS to address quality of 

care issues in the ESRD program’’ (HHS/ 

OIG 2006). We have received 

recommendations to require facilities 

participating in Medicare to report on 

performance measures to stimulate 

improvements in the quality of care and 

to achieve a greater degree of 

accountability for performance. These 

recommendations come from the OIG in 

its reports ‘‘External Quality Review of 

Dialysis Facilities/A Call For Greater 

Accountability’’ and ‘‘Availability of 

Quality of Care Data in the Medicare 

End-Stage Renal Disease Program’’

(DHHS/OIG, 1999, 2006); from the IOM 

in its report ‘‘Crossing the Quality 

Chasm, 2001’’ (IOM, 2001); from the 

Medicare Payment Advisory 

Commission (MedPAC) in its report 

‘‘Improving Quality Assurance for 

Institutional Providers’’ (MedPAC, 

2000); and from the Government 

Accountability Office (GAO) in its 

report ‘‘Dialysis Facilities: Problems 

Remain in Ensuring Compliance with 

Medicare Quality Standards’’ (GAO, 

2004). The requirement to submit data 

necessary to calculate specified CPMs is 

an important step in moving in this 

direction. 

The electronic data provided to CMS 

will be used to monitor the performance 

of the public health system and dialysis 

facilities certified to care for Medicare 

beneficiaries with ESRD. The data will 

also be used to provide information to 

individuals who have or may develop 

ESRD and their caregivers to assist them 

in making health care decisions; to 

allow the identification of opportunities 

for quality improvement at a national, 

regional, or dialysis-facility level; and to 

help align our payment system with 

high-quality care through improvements 

in case-mix adjustment and the 

potential future use of payment for 

performance. 

CMS, the ESRD Networks, dialysis 

facilities, and other interested 

stakeholders have used the ESRD CPMs 

to assess the care of a representative 

sample of individuals with ESRD in the 

areas of adequacy of dialysis, anemia 

management, nutrition (serum albumin), 

and more recently, vascular access 

(Centers for Medicare & Medicaid 

Services. 2005 Annual Report, EndStage Renal Disease Clinical 

Performance Measures Project. Am J 

Kidney Dis 48:S1–106, 2006 (supp. 2)). 

CMS developed the ESRD CPMs to 

implement section 4558(b) of the 

Balanced Budget Act of 1997 (Pub. L. 

105–33), which required the Secretary 

to develop and implement a method to 

measure and report on the quality of 

renal dialysis services provided under 

Medicare no later than January 1, 2000. 

These measures were developed based 

on widely accepted, evidence-based 

clinical practice guidelines and were 

subsequently used to guide national, 

regional, and facility based quality 

improvement efforts. 

Beginning in the mid-1990s, the 

National Kidney Foundation’s (NKF’s) 

Dialysis Outcomes Quality Initiative 

(DOQI) development process released 

guidelines to help shape the 

development of clinical measures based 

on strength of evidence, clinical 

importance and feasibility. The NKF has 

since expanded and updated their early 

efforts and their Kidney Disease 

Outcomes Quality Initiative (K/DOQI) 

guidelines are widely accepted among 

the renal community. These may be a 

source of potential future CPMs that can 

be developed and supported by a broad 

cross-section of stakeholders, including 

clinical practitioners, industry 

representatives, professional 

associations, and others interested in 

assessment and improvement of the care 

provided to individuals with ESRD. 


PWALKER on PROD1PC71 with RULES2
20442 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

1This advanced information capability is detailed 

in the 2002 OIG series, ‘‘Clinical Performance 

Measures for Dialysis Facilities,’’ OEI–01–99–

00052. 

We proposed using the VISION 

application for the provision of 

electronic data but based on 

technological advances and public 

comments, we are implementing a new 

Web-based system, Consolidated Renal 

Operations in a Web-enabled Network 

(CROWNWeb), for this purpose. VISION 

was a patient-specific, stand-alone, 

facility-based information system with 

software that resides on facility 

computers, which presents challenges 

for updating the software. We agree with 

commenters that VISION did not 

represent the best technology for 

widespread collection of data from 

dialysis facilities and large dialysis 

organizations. 

Use of the CROWNWeb system will 

increase the efficiency of data collection 

both for CMS and for facilities, improve 

data quality, and provide a more stable 

and accessible platform for continual 

improvements in functionality. It will 

also complement the advanced 

information infrastructure used by many 

dialysis facilities.1 We believe that 

CROWNWeb will not duplicate 

information technology systems in large 

dialysis organizations, but will facilitate 

data reporting and provide efficiencies. 

We believe that the collection and 

reporting of ESRD CPMs has been an 

effective tool to facilitate ESRD quality 

improvement, and has allowed us to 

track positive improvements in several 

intermediate outcomes for individuals 

with ESRD. Therefore, we are requiring 

under the ‘‘Governance’’ condition for 

coverage (§ 494.180(h)), that the ESRD 

CPMs in effect on the date of the Final 

Rule’s publication be included as the 

initial set of CPMs that all ESRD 

facilities are required to collect for all 

individuals with ESRD and submit to us 

electronically. We will carefully 

evaluate any revisions to current CPMs 

as well as any future CPMs developed 

in accordance with a voluntary 

consensus standards process for 

possible inclusion in these electronic 

reporting requirements. The Secretary 

will provide notice and an opportunity 

for comment in the Federal Register 

before any changes to the electronic 

reporting requirements based on the 

CPMs are enacted. 

We recognize that electronic data 

reporting may result in some additional 

facility burden. However, the 

availability of batch data reporting will 

reduce the level of burden. We believe 

that there is a return on this investment 

for all primary stakeholders, including 

patients, dialysis facilities, and the 

public. CROWNWeb will allow for the 

more timely, accurate, and efficient use 

of data to support administration of the 

ESRD program by replacing the current 

predominately paper process with an 

electronic process that considers the 

capabilities of providers, which has 

tangible benefits for dialysis facilities, 

individuals who have or may develop 

ESRD, and other stakeholders. 

CROWNWeb provides facilities with the 

ability to submit the required data 

directly from their electronic health 

records, thus reducing burden and 

freeing facility personnel to concentrate 

on patient care. Another expectation is 

that claims payment will be improved 

due to improved quality and timeliness 

of patient eligibility and enrollment 

information. Finally, we expect that the 

new system will provide reports that 

will allow facilities to compare 

themselves with their peers. 

CROWNWeb will also increase the 

transparency of the health care system 

for patients and thus, help empower 

patients to find better health care value 

and better health care quality as well as 

help assure appropriate patient access to 

care. For ESRD Networks, CROWNWeb 

will provide more timely, accurate, and 

complete information to inform quality 

improvement, and it would reduce 

Network resource use for data collection 

activities. For example, CROWNWeb 

will be able to recreate the data 

included on the current CMS 2744 

Annual Facility Survey more timely as 

opposed to on the last day of the year 

and it would free up Network resources 

that currently perform a four-month 

manual reconciliation process. In 

addition, for all primary stakeholders, 

we expect that the new system will 

provide more timely report capabilities 

that will allow them to compare 

individual facilities and facility groups 

with various peer groups, national, and 

local benchmarks. 

In February 2007, CMS’ Quality 

Infrastructure Support (QIS) contractor 

held its first CROWNWeb CPM 

technical expert panel, which 

represented initial CROWNWeb users, 

including large and small dialysis 

organizations, dialysis professional 

societies, ESRD Networks, CMS, and 

associated Federal contractors, to survey 

primary stakeholders about desired/ 

expected performance attributes of 

CROWNWeb relative to the CPMs, 

including feedback reporting. Based on 

the input received from members of the 

panel as well as ongoing input from the 

community at large through either 

publicized monthly calls and/or e-mail 

(craft@nw7.esrd.net), CMS’ QIS 

contractor developed draft business 

requirements, which CMS evaluated, 

approved, and forwarded to its IT 

contractor for incorporation into 

CROWNWeb. 

CROWNWeb will also facilitate 

greater transparency for patients 

through more timely, accurate, and 

complete reporting. In September 2002, 

CMS contracted with the Research 

Triangle Institute to conduct an 

evaluation of the content of DFC. The 

Final Report of the Evaluation of the 

Content Dialysis Facility Compare as 

submitted to CMS in March of 2004 

(http://www.cms.hhs.gov/ 

DialysisFacilityCompare/ 

03_Evaluation%20of%20DFC.asp.) A 

revised version of the Web site, based 

on findings from the evaluation and 

integrating more user-friendly ‘‘next 

generation compare’’ software, was 

posted in June 2004 and CROWNWeb 

will provide the infrastructure so that 

DFC can provide additional value for 

persons who have or may develop ESRD 

and the caregivers who assist them in 

making health care decisions. 

The electronic collection and 

reporting of CPM data via CROWNWeb 

for all individuals with ESRD will add 

significant value for facilities and 

individuals who have or may develop 

ESRD in three ways: 

1. Validation and comparative reports 

can be viewed more timely once the 

data submission is complete since the 

CPM data are electronically available. 

2. There is no claims time lag because 

the CPM measures are computed using 

clinical as opposed to administrative 

and claims information. 

3. Facilities can see facility-specific 

information that compares themselves 

to various peer groups because the CPM 

data cover all Medicare-certified 

dialysis facilities and will include all 

patients. 

While submission of data and 

information is an existing requirement 

in § 405.2133 and electronic submission 

of cost report data and information is an 

existing requirement in § 413.24, the 

requirement to provide CPM data is 

new. Additionally, the requirement to 

provide necessary administrative data in 

electronic format is a change from the 

paper-based process that has historically 

been used to support the ESRD program. 

Initially, the data will consist of 

information necessary to calculate the 

ESRD CPMs and administrative data 

elements from existing data collections 

in effect as of publication of this final 

rule. In response to community input 

requesting time to get their information 

systems aligned with this new 

requirement as well as train necessary 

resources, we will delay the 

requirement for reporting the data 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20443 

necessary to calculate the specified 

CPMs and other administrative data 

using the CROWNWeb system until 

February 1, 2009. Thereafter, all 

facilities must collect and report on an 

ongoing basis the necessary 

administrative data, and the CPM data 

at least annually for all eligible ESRD 

patients via CROWNWeb as specified by 

CMS. In the interim, dialysis facilities 

will use existing processes to collect 

and report necessary administrative data 

and data necessary to calculate ESRD 

CPMs for individuals with ESRD that 

are included in the national ESRD CPM 

sample. Thus, 2008 will be the last year 

we will collect data to calculate the 

existing ESRD CPMs on a 5 percent 

representative sample to fulfill section 

4558(b) of the Balanced Budget Act of 

1997 (Pub. L. 105–33). In 2009, we will 

be requiring facilities to collect and 

report CPM data on all ESRD patients in 

their facilities. 

In order to provide support for 

facility-based quality assurance and 

performance improvement as specified 

in § 494.110, facilities may voluntarily 

submit specified CPM data via 

CROWNWeb more frequently than 

annually. In order to support national 

quality improvement efforts (for 

example, the Fistula First Breakthrough 

Initiative) as specified in the 

Relationship with the ESRD Network 

condition at § 494.180(i), facilities may 

be required to submit data for a subset 

of specified CPMs more frequently than 

on an annual basis. Thus, facilities may 

provide a more frequent subset of data 

either voluntarily or as required as part 

of a national quality initiative, but we 

will only require the submission of the 

complete set of data necessary to 

calculate specified CPMs on an annual 

basis in this final rule. 

In response to the comment regarding 

including providers’ input as we define 

data collection efforts, CMS and the 

ESRD Networks have a history of 

collaboratively working with the ESRD 

community on improving data quality. 

Between 2003 and 2005, CMS and the 

ESRD Networks partnered with the 

ESRD community to develop the Core 

Data Set, which created a common 

‘‘kidney data dictionary’’ complete with 

standardized data elements, data 

definitions, and integrity constraints 

necessary for ESRD Networks to 

conduct quality improvement oversight 

activities and for CMS to conduct ESRD 

Program oversight activities. 

In 2006, CMS funded a Quality 

Infrastructure Support (QIS) contractor 

to solidify the early work of the Core 

Data Set by soliciting ongoing input 

from the ESRD Networks and other 

stakeholders and summarizing it in 

recommended business requirements to 

CMS for the new information system. 

The process the QIS contractor used for 

incorporation of community input is 

referred to as CRAFT (CROWN 

Responsiveness and Feedback Tree) and 

includes public presentations (available 

at http://www.esrdnetworks.org/ 

2007CMSForumAMpresentations.htm), 

monthly calls, technical expert panels, 

an e-mail suggestion box, focus groups, 

and site visits. 

CROWNWeb supports the following 

existing systems, all of which will be 

integrated by CROWN, thus reducing 

the federal cost of administering the 

ESRD program. 

• The ESRD Standard Information 

Management System (SIMS). SIMS 

supports the business processes of the 

ESRD Network Organizations and 

allows data exchange among the 

Networks, the facilities and CMS via a 

secure, web-enabled environment called 

the ‘‘QualityNet Exchange.’’

• The Renal Management Information 

System (REMIS). REMIS determines the 

Medicare coverage periods for ESRD 

patients and serves as the primary 

mechanism to store and access 

information in the ESRD program 

Management and Medical Information 

System Database. REMIS includes an 

operational interface to the SIMS 

Central Repository. (REMIS replaces 

REBUS, the mainframe Renal 

Beneficiary and Utilization System.) 

CROWNWeb uses an encryption 

technology that assures privacy, 

confidentiality, and security for 

electronic communications and is 

consistent with applicable HIPAA and 

Privacy Act statutes and related 

regulations and would be available freeof-charge to all dialysis facilities with 

Internet access. CROWNWeb also meets 

applicable security criteria included in 

the CMS Information Security 

Acceptable Risk Safeguards (ARS) 

policy (http://www.cms.hhs.gov/ 

InformationSecurity/ 

14standards.asp#TopOfPage) which 

contains a broad set of CMS security 

controls based upon National Institute 

of Standards and Technology (NIST) 

requirements. We have further 

improved CROWNWeb’s efficiency, 

functionality, and timeliness by working 

with dialysis organizations to develop a 

mechanism for accepting batch data 

submittals. 

Comment: Two commenters stated 

that large dialysis organizations should 

not have to subsidize the small 

independent dialysis facility electronic 

data collections. 

Response: We assume the commenters 

are referring to the proposed rule 

preamble discussion (70 FR 6231 and 70 

FR 6241). The VISION software was 

intended to be available to all dialysis 

facilities. If an LDO opted not to use 

VISION, then file specifications would 

be developed and this approach might 

result in costs to those dialysis facilities. 

We are no longer planning to use the 

VISION software and our approach does 

not call for LDOs to ‘‘subsidize’’ small 

independent facilities. 

Comment: We received several 

comments regarding the content of the 

clinical performance measures. One 

commenter stated support for using the 

same CPMs for home patients and incenter patients. Another commenter 

suggested that special consideration be 

given to small rural units and that we 

consider case-mix when developing 

new measures. 

Some commenters suggested the 

addition of one of the following 

indicators for use as CPMs: Depression 

scale scores, infection control measures, 

K/DOQI Bone metabolism and renal 

bone disease, patient functioning and 

well being, and ESRD Network 9/10 

technical expert panel recommended 

transplant referral measures. 

Response: The development of new 

CPMs is not carried out via the 

conditions for coverage. Historically, we 

have funded the development of 

measures by contracting with an 

organization that possesses the technical 

knowledge and skills and who convenes 

a TEP to assist them in the development 

of the measures or in the review of the 

science or guidelines to determine when 

existing measures need to be updated. 

Facility-level measures that would be 

enforced under the conditions for 

coverage would be developed in 

compliance with the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA) by a voluntary 

consensus standards body 

(§ 494.180(h)(3)(iv)). This process allows 

transparency as the facility-level 

measures and thresholds are developed. 

The implementation of new facilitylevel measures adopted by the Secretary 

will be done via a future rulemaking 

process, which will allow for public 

comment. 

Comment: One commenter stated that 

an outcomes approach requires 

measures and standards. Several 

commenters supported the proposal to 

develop federal standards using a 

voluntary consensus standards body as 

described by the NTTAA. Another 

commenter suggested that any changes 

in the CPMs should be done in 

partnership with nephrologists and key 

stakeholders in the renal community. 

One commenter stated voluntary 

consensus standards and quality 

thresholds should be defined by actual 


PWALKER on PROD1PC71 with RULES2
20444 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

data distributions of outcomes of each 

parameter, denoting thresholds at one 

and two standard deviations. The 

commenter stated clinicians would 

support this approach. 

Response: We agree that an outcomes 

approach requires measures and 

standards. The proposed process of 

using a voluntary consensus standards 

body to arrive at facility-level standards 

has been retained in the final rule. 

Nephrology experts and stakeholders 

should participate in the voluntary 

consensus standards process in which 

the development of facility-level 

thresholds would occur. Public 

comment will also be invited during the 

rulemaking process that implements the 

facility-level measures that are adopted 

by the Secretary. 

Comment: One commenter suggested 

that ownership information be available 

to any member of the public upon 

request. 

Response: The proposed requirement 

at § 494.180(i) has been moved to now 

§ 494.180(j), regarding disclosure of 

ownership, which is consistent with 

§ 420.200 through § 420.206. 

Information subject to public disclosure 

is addressed at § 420.206(a). The public 

may request current dialysis facility 

ownership information from the State 

survey agency. We also refer the 

commenter to 42 CFR 431.115(e)(4) and 

§ 455.104 which describe Medicaid and 

State Children’s Health Insurance 

Program ownership disclosure 

provisions, respectively. 

As stated previously in this section, 

we will delay the requirement for 

reporting the data necessary to calculate 

the specified CPMs and other 

administrative data using the 

CROWNWeb system until February 1, 

2009. The delay affects the specific 

standard found at § 494.180(h). We are 

delaying this requirement in response to 

dialysis facility community input 

requesting time to align their 

information systems with this new 

requirement, as well as train necessary 

staff. 

D. Other Proposed Changes and Issues 

1. Proposed Cross-Reference Changes 

We proposed to make technical 

changes in the following sections of the 

regulations to correct cross-references to 

the sections in part 405, subpart U that 

have been relocated or deleted: § 410.5, 

§ 410.50, § 410.52, § 410.152, § 410.170, 

§ 413.170, § 413.172, § 413.198, and 

§ 414.330. 

2. Proposed Additions to Part 488 

We proposed to add a new subpart H 

to part 488. Proposed subpart H would 

consist of the existing sanction 

provisions in part 405 subpart U. The 

existing sanction provisions are in 

§ 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 

of any patients accepted for care after 

the effective date of the sanction, and 

gradual reduction of payments for all 

patients) and the circumstances under 

which they might be imposed. 

• Section 405.2182 specifies the 

notice procedures that we will follow 

and the appeal rights of sanctioned 

suppliers. 

• Section 405.2184 specifies (in 

greater detail) the rights of suppliers 

that appeal proposed imposition of an 

alternative sanction. 

We proposed to redesignate these 

provisions (with technical and crossreference changes) as § 488.604, 

§ 488.606, § 488.608, and § 488.610 

respectively. 

We did not receive any comments on 

these proposed changes. Therefore, we 

are finalizing these proposals without 

change. 

E. Survey & Certification Comments 

Comment: There were several 

comments, including comments from 

many national organizations, which 

recommended that CMS convene a 

panel of experts, with a broad 

representation of dialysis providers 

including nephrology health care 

professionals and patients, to contribute 

to the development of the Interpretive 

Guidelines for the ESRD conditions for 

coverage. Commenters remarked that 

there is a wealth of expertise available 

in the renal community, which would 

be of great value to CMS. Commenters 

also strongly recommended that CMS 

ensure ‘‘consistency in enforcement 

through the state survey process,’’

stating that there is a need for clear, 

specific interpretations so that national 

consistency can be achieved. 

Response: We have used and will 

continue to solicit input from experts 

from the renal community as well as the 

general public in developing the 

Interpretive Guidelines. 

Comment: Two commenters stated 

that ESRD surveys are not completed 

frequently enough to ensure ongoing 

compliance with the ESRD Conditions 

for Coverage. One national organization 

expressed concern about having 

effective surveillance and enforcement 

of the conditions for coverage. Two 

State health departments suggested CMS 

mandate ESRD facilities be surveyed at 

least every 3 years with follow-up 

surveys for 2 years when a facility has 

been noncompliant with one or more 

conditions. Commenters also 

recommended funding be increased for 

this activity. 

Response: We issue a Mission and 

Priority Document (MPD) each year, 

which prioritizes the survey goals for 

the upcoming fiscal year. Budget 

restrictions, statutorily mandated 

surveys, and CMS initiatives influence 

the survey priorities of the MPD. In 

Fiscal Year 2006, ESRD surveys were 

moved up in priority because safety and 

health can be positively influenced by 

compliance with the conditions for 

coverage. Changes in funding for 

surveys and/or survey mandates would 

likely require Congressional action. 

Comment: Two commenters remarked 

on the redundancies in the format of the 

CMS survey report, Statement of 

Deficiencies. It was pointed out that the 

report is difficult to read and one 

commenter urged that state surveyors be 

instructed to list deficiencies only once 

in the Statement of Deficiencies report 

for corrective action. 

Response: We are working on limiting 

the repetitive citing of a deficient 

practice to egregious cases where 

serious problems must be cited under 

several survey tags. We are aware that 

the format of the survey report, 

Statement of Deficiencies, could be 

improved and are considering the best 

ways to improve it. 

Comment: One commenter asked if 

State laws could only be cited during a 

Federal survey after the law has been 

cited by the appropriate State authority. 

Response: In the CMS Federal survey 

process, citations for a lack of 

compliance with State laws occur after 

the State authority has made a final 

determination regarding compliance 

with State law. 

F. Impact Analysis Comments 

Comment: Many commenters stated 

that the new conditions for coverage 

need to be consistent with payment 

rules. 

Response: Specific commenter 

concerns about proposed rule 

requirements that were perceived to be 

inconsistent with Medicare payment 

policy were addressed in earlier 

sections of this preamble as each 

provision was discussed. We have 

modified requirements to more 

accurately reflect the dialysis facility’s 

role in cases where the proposed 

requirement arguably exceeded the 

scope of services that dialysis facilities 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20445 

provide. For example, in response to 

comments, we revised the patient 

rehabilitation services requirement 

(§ 494.90(a)(8)) so that dialysis facilities 

would provide rehabilitation assistance 

and referral as appropriate, but would 

not be required to provide the actual 

rehabilitation services. Payment 

concerns regarding erythropoietin were 

addressed under the Patient plan of care 

preamble discussion (proposed 

§ 494.90(a)(3)). Physician visit payment 

comments were addressed under the 

proposed § 494.90(b)(4) preamble 

discussion, and the monthly physician 

visit provision was deleted. We 

provided clarification of vascular access 

‘‘monitoring’’ in our earlier preamble 

discussion (proposed § 494.90(a)(4)) so 

that our requirement is clearly aligned 

with payment policy. Concerns 

regarding the costs of LSC compliance 

were addressed under the ‘‘Physical 

environment’’ condition at (§ 494.60) 

and the small number of existing 

dialysis facilities that would have been 

required to retrofit sprinkler systems are 

now exempted from this provision if 

such retrofitting is not required by the 

facility’s State law and CMS finds that 

State law adequately protects facility 

patients. 

Comment: Some commenters 

recommended that Medicare payment 

be adjusted to provide reimbursement 

for dialysis facility costs resulting from 

implementation of the final rule. 

Response: The Medicare 

reimbursement rates for dialysis 

facilities are divided into distinct 

categories. The first category is the 

composite rate that covers the provision 

of dialysis and associated services that 

are enumerated in the Medicare renal 

dialysis facility payment manual. The 

composite rate is set by the Congress, 

and may be influenced by the 

recommendations of MedPAC, which 

performs cost analysis and provides 

annual reports to the Congress. The 

MedPAC analysis includes a review of 

the dialysis facility cost report data, 

which will encompass any new costs 

facilities bear due to compliance with 

the new conditions for coverage, 

including some categories of overhead 

costs. We expect that the MedPAC 

analysis and recommendations will 

reflect any new across-the-board 

dialysis facility costs that are associated 

with this final rule. The second 

reimbursement category focuses on 

separately billable drugs and 

biologicals. The Medicare 

Modernization Act of 2003 (amending 

sections 1842(o) and 1847A of the Act) 

included provisions regarding 

medication and biologicals 

reimbursement rates. The new 

provisions call for the calculation of the 

drug average sales price plus an add-on 

payment that is adjusted on a quarterly 

basis. Dialysis payment adjustments for 

2007 implemented by Medicare were 

published on December 1, 2006 in the 

Physician Fee Schedule rule (71 FR 

69623) and established calendar year 

2007 reimbursement rates. We are not 

making any changes to our payment 

methodologies based on the issuance of 

these conditions for coverage. 

Comment: One commenter requested 

a reimbursement change to allow 

advanced practice nurses to be 

identified and Medicare reimbursed in 

the final rule. 

Response: Services that would be 

provided by advanced practice nurses 

would be included either in the 

physician monthly charges or under the 

dialysis facility composite payment rate, 

depending on the role of the individual. 

Insofar as the commenter is advocating 

a pass-through for APNs, this is not 

being considered in this rule; however, 

we will take the commenter’s suggestion 

under advisement. 

Comment: A few commenters 

suggested that Medicare provide 

funding for the purchase of automated 

external defibrillators (AEDs) if they are 

required in the final rule. 

Response: AEDs would be included 

under ‘‘capital costs’’ in the dialysis 

facility cost report. MedPAC reviews all 

costs and makes recommendations to 

the Congress regarding the appropriate 

dialysis facility payment update. 

Medicare does not pay separately for 

specific dialysis facility capital 

expenditures. 

Comment: Several commenters 

included general remarks regarding the 

overall Medicare payment system. 

Commenters stated that Medicare does 

not appropriately fund the ESRD 

program and that dialysis facilities must 

‘‘subsidize’’ the cost of care provided to 

Medicare beneficiaries. They also 

referred to the ESRD composite rate as 

the only Medicare prospective payment 

system without an annual update 

mechanism to adjust for changes in 

input prices and inflation. Commenters 

discouraged CMS from implementing 

new conditions for coverage that would 

add significant costs to providing care 

without directly providing benefits to 

patients, unless an annual update 

mechanism is established for the ESRD 

composite rate. 

Response: Although an annual 

composite rate update mechanism has 

not been established by Congress, we 

note that the Tax Relief and Health Care 

Act of 2006 (Pub. L. 109–432, Division 

B, Title I, section 103(a)) provided an 

update of 1.6 percent to the composite 

rate component of the basic case-mix 

adjusted prospective payment system 

for dialysis services effective April 1, 

2007. However, the issue of payment 

updates to dialysis facilities is 

determined by Congress and is outside 

the scope of these conditions for 

coverage. We have addressed specific 

concerns of commenters earlier in this 

preamble and have modified proposed 

requirements in several instances so that 

the provisions of this final rule do not 

exceed the scope of services that we 

could expect from Medicare-certified 

dialysis facilities. 

III. Provisions of the Final Rule 

In this final rule we are adopting the 

proposed provisions as set forth in the 

February 4, 2005, proposed rule, subject 

to the following revisions: 

• Amend § 405.2102 ‘‘Definitions’’ by 

removing the definitions for 

‘‘Histocompatibility testing,’’ ‘‘Organ 

procurement,’’ ‘‘Renal transplantation 

center,’’ ‘‘Transplantation service,’’ and 

‘‘Transplantation surgeon,’’ leaving 

‘‘Network requirements’’ the only 

remaining substantive component of the 

subpart. 

• Amend § 405.2180 through 

§ 405.2184 ‘‘Termination of Medicare 

coverage’’ and ‘‘Alternative sanctions’’

by recodifying these sections at 

§ 488.604 through § 488.610 under 

Subpart H—Termination of Medicare 

Coverage and Alternative Sanctions for 

End-Stage Renal Disease (ESRD) 

Facilities. 

• Amend § 414.330 ‘‘Payment for 

home dialysis equipment, suppliers, 

and support services’’ by revising 

paragraph (a)(2)(iii)(C) to change the 

reporting timeframe from every 30 days 

to at least every 45 days. 

• Amend § 494.1 ‘‘Basis and scope’’

by—

+ Removing paragraph (a)(2). 

+ Redesignating paragraphs (a)(3) 

through (a)(7) as (a)(2) through (a)(6), 

respectively. 

+ Replacing the phrase ‘‘recombinant 

epoetin alpha (EPO)’’ with 

‘‘erythropoiesis-stimulating agent(s)’’, in 

paragraph (a)(5). 

+ Revising paragraph (a)(6) to read 

‘‘Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (Pub. L. 104–113), which 

requires Federal agencies to use 

technical standards that are developed 

or adopted by voluntary consensus 

standards bodies, unless their use 

would be inconsistent with applicable 

law or otherwise impractical.’’

• Amend § 494.10 ‘‘Definitions’’ by—

+ Revising the definition for 

‘‘discharge’’ to read ‘‘means the 

termination of patient care services by a 


PWALKER on PROD1PC71 with RULES2
20446 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

dialysis facility or the patient 

voluntarily terminating dialysis when 

he or she no longer wants to be dialyzed 

by that facility.’’

+ Removing the definition for the 

term ‘‘interdisciplinary team.’’

• Amend § 494.20 ‘‘Compliance with 

Federal, State, and local laws and 

regulations’’ by removing the phrase 

‘‘staff licensure and other personnel 

staff qualifications, fire safety, 

equipment, building codes, drugs and 

medical device usage.’’

• Amend § 494.30 ‘‘Infection 

Control’’ by—

+ Expanding our incorporation by 

reference section (pages 20–21) of the 

CDC ‘‘Recommended Infection Control 

Practices for Hemodialysis Units at a 

Glance,’’ to include the corresponding 

narrative section (pages 18–28) with the 

exception of the hepatitis C screening 

found in ‘‘Recommendations for 

Preventing Transmission of Infections 

Among Chronic Hemodialysis Patients,’’

Morbidity and Mortality Weekly Report, 

volume 50, number RR05, April 27, 

2001. The recommendation found on 

pages 27 and 28 under the ‘‘HBVInfected Patient’’ header section of RR05 

requires a separate isolation room. 

Therefore, we are allowing dialysis 

facilities 300 days after the publication 

of the final rule in the Federal Register 

to comply with the requirements of this 

provision at (a)(1)(i). Specifically, this 

provision must be complied with by 

February 9, 2009. 

+ Adding a dialysis isolation room 

waiver provision at (a)(1)(ii), which 

allows a new dialysis facility to request 

a waiver of the isolation room 

requirement, subject to the Secretary’s 

approval, when dialysis isolation rooms 

are available locally that sufficiently 

serve the needs of patients in the 

geographic area. 

+ Redesignating proposed paragraph 

(a)(2) as paragraph (a)(3). 

+ Redesignating proposed paragraph 

(a)(3) as paragraph (a)(4). 

+ Adding a new paragraph (a)(2) 

incorporation by reference for the 

‘‘Guidelines for the Prevention of 

Intravascular Catheter-Related 

Infections’’ sections entitled 

‘‘Recommendations for Placement of 

Intravascular Catheters in Adults and 

Children’’ parts I–IV; and ‘‘Central 

Venous Catheters, Including PICCs, 

Hemodialysis, and Pulmonary Artery 

Catheters, in Adult and Pediatric 

Patients’’ (Morbidity and Mortality 

Weekly Report, volume 51 number RR–

10, pages 16 through 18, August 9, 2002, 

developed by the HICPAC). 

+ Removing the requirement in 

paragraph (b)(2) that an infection 

control officer that is a registered nurse 

be designated as the infection control or 

safety officer, and adding infection 

control as a component of the quality 

assessment and performance 

improvement program required at 

§ 494.110(a)(2)(ix). 

+ Revising the proposed requirement 

at paragraph (b)(2) to clarify that clinical 

staff in a dialysis facility must 

demonstrate compliance with current 

aseptic techniques when dispensing and 

administering intravenous medications 

from vials and ampules. 

+ Redesignating paragraph (b)(2)(ii) 

as paragraph (b)(3) and revising to read 

as follows: ‘‘Require all clinical staff to 

report infection control issues to the 

dialysis facility’s medical director (see 

§ 494.150 of this part) and the quality 

improvement committee.’’

+ Removing and moving the 

monitoring standard paragraph (c) to the 

QAPI condition for coverage at 

§ 494.110(a)(2)(ix). 

+ Redesignating paragraph (d) as 

paragraph (c). 

• Amend § 494.40 ‘‘Water quality’’

by—

+ Revising the title to read ‘‘Water 

and dialysate quality.’’

+ Revising paragraph (a) to read, 

Water and equipment used for dialysis 

meets the water and dialysate quality 

standards and equipment requirements 

found in the Association for the 

Advancement of Medical 

Instrumentation (AAMI) publication, 

‘‘Dialysate for hemodialysis,’’ ANSI/ 

AAMI RD52:2004, which are 

incorporated by reference. Incorporation 

by reference of the AAMI ‘‘Dialysate for 

hemodialysis’’ has been approved by the 

Director of the Federal Register in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51.’’

+ Removing from paragraph (a)(2) the 

requirements for frequency of water 

purity testing. 

+ Removing the proposed 

requirement at paragraph (b). 

+ Redesignating paragraphs (c) 

through (e) as paragraphs (b) through 

(d), respectively. 

+ Removing the stem statement from 

proposed paragraph (c), now paragraph 

(b), chlorine/chloramines. 

+ Removing language from proposed 

paragraph (a)(2)(i)(B). 

+ Removing redundant language at 

proposed paragraphs (a)(2)(ii)(C) and 

(a)(2)(ii)(D). 

+ Clarifying the carbon tank 

requirement at proposed paragraph 

(c)(1), now paragraph (b)(1), so that the 

water treatment system must include a 

component or carbon tank which 

removes chlorine/chloramine, and that 

the backup component or second carbon 

tank must be ‘‘in series’’ with the first 

component. 

+ Adding at redesignated paragraph 

(b)(2)(i) (proposed paragraph (c)(2)(i)) an 

alternative to permit the facility to test 

total chlorine for acceptable levels of 

less than 0.1mg/L as an alternative to 

testing free chlorine and chloramines 

levels, and adding a reference to the 

frequency of water testing specified in 

our incorporation by reference of ANSI/ 

AAM RD52:2004. 

+ Revising redesignated paragraph 

(b)(2)(ii)(A) (proposed paragraph 

(c)(2)(ii)(A)) to allow an alternate action 

to terminating dialysis treatments when 

chlorine/chloramines testing reveals 

high levels. We have added, 

‘‘Immediately take corrective action to 

bring chlorine or chloramine levels into 

compliance with paragraph (b)(2)(i) of 

this section and confirm through testing 

that the corrective action has been 

effective * * *.’’

+ Redesignating proposed paragraph 

(c)(2)(ii)(B) as paragraph (b)(2)(ii)(C). 

+ Revising redesignated paragraph 

(b)(2)(ii) (proposed paragraph (c)(2)(ii)) 

with new language. The provision reads 

‘‘Only allow use of purified water in a 

holding tank, if appropriate, and if 

testing shows water chlorine or 

chloramine levels that are in 

compliance with paragraph (b)(2)(i) of 

this section above * * *.’’

+ Clarifying at redesignated 

paragraph (b)(2)(ii)(D) that corrective 

action taken must ensure ongoing 

compliance with acceptable chlorine 

and chloramines levels. 

+ Adding ‘‘endotoxin levels’’ to the 

testing that must be done (when 

clinically indicated) at redesignated 

paragraph (d)(1), (proposed paragraph 

(e)(1)). 

+ Adding a new standard at 

paragraph (e) that addresses in-center 

use of preconfigured hemodialysis 

systems. The standard requires that 

when facilities use a preconfigured, 

FDA-approved hemodialysis system 

designed, tested and validated to yield 

AAMI quality (which includes 

standards for chemical and chlorine/ 

chloramine testing) water and dialysate, 

the system’s FDA-approved labeling 

must be adhered to for machine use and 

monitoring of the water and dialysate 

quality. The facility must meet all AAMI 

RD52:2004 requirements for water and 

dialysate. Moreover, the facility must 

perform bacteriological and endotoxin 

testing on a quarterly, or more frequent 

basis, as needed, to ensure that the 

water and dialysate are within AAMI 

limits. 

+ Removing proposed standard at 

paragraph (f) regarding unused mixed 

bicarbonate; use of mixed bicarbonate is 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20447 

addressed in the ANSI/AAM RD52:2004 

document, which is incorporated by 

reference. 

• Amend § 494.50 ‘‘Condition: Reuse 

of hemodialyzers and bloodlines’’ by—

+ Removing the undesignated 

paragraph that states, ‘‘The dialysis 

facility that reuses hemodialyzers or 

bloodlines must meet the requirements 

of this section. Failure to meet any of 

these requirements constitutes grounds 

for denial of payment for the dialysis 

treatment affected and termination from 

participation in the Medicare program.’’

+ Incorporating by reference the 

AAMI reuse guidelines, ‘‘Reuse of 

hemodialyzers,’’ ANSI/AAMI 

RD47:2002/AL:2003 at paragraph (b)(1). 

+ Clarifying at paragraph (b)(3) that 

bleach used on hemodialyzers is 

considered to be a ‘‘cleaner’’ in this 

application. 

+ Adding endotoxin levels to the 

blood and dialysate culture testing that 

must be done when clinically indicated 

at paragraph(c)(2)(i). 

• Amend § 494.60 ‘‘Physical 

environment’’ by—

+ Modifying the room temperature 

requirement at paragraph (c)(2) by 

removing the phrase ‘‘that is 

comfortable for the majority of its 

patients’’, so that the facility must 

‘‘Maintain a comfortable temperature 

within the facility and make reasonable 

accommodations for the patients who 

are not comfortable at this temperature.’’

+ Adding a privacy provision at 

paragraph (c)(3), which reads, ‘‘The 

dialysis facility must make 

accommodations to provide for patient 

privacy when patients are examined or 

treated and body exposure is required.’’

+ Adding a new monitoring 

requirement at paragraph (c)(4) that 

states, ‘‘Patients must be in view of staff 

during hemodialysis treatment to ensure 

patient safety (video surveillance will 

not meet this requirement).’’

+ Revising paragraph (d)(1)(i)(B) to 

read, ‘‘Where to go, including 

instructions for occasions when the 

geographic area of the dialysis facility 

must be evacuated.’’

+ Revising the requirement at 

paragraph (d)(1)(i)(C) that the dialysis 

facility contact information must 

include an alternate emergency phone 

number for instances when the dialysis 

facility is unable to receive phone calls 

due to emergency, unless the facility has 

the ability to forward calls to a working 

phone number under such emergency 

conditions. 

+ Revising paragraph (d)(3) by adding 

an automated external defibrillator as an 

alternative to the defibrillator. 

+ Redesignating proposed paragraphs 

(d)(3)(i) and (d)(3)(ii) as paragraphs 

(d)(4)(i) and (d)(4)(ii). 

+ Adding a new requirement at 

paragraph (d)(4)(iii) that the facility 

must, ‘‘Contact its local disaster 

management agency at least annually to 

ensure that such agency is aware of 

dialysis facility needs in the event of an 

emergency.’’

+ Revising paragraph (e)(1) to 

indicate that it is effective February 9, 

2009. 

+ Removing proposed paragraph 

(e)(2). 

+ Adding a new paragraph (e)(2), to 

state that sprinkler systems are not 

required for dialysis providers using 

facilities built before 2008 on the rule’s 

effective date, if their State law so 

permits. 

+ Adding a clarifying phrase ‘‘for 

individual dialysis facilities’’ at 

paragraph (e)(4). 

• Amend § 494.70 ‘‘Patients’ rights’’

by—

+ Revising proposed paragraph (a)(5) 

to add the patients ‘‘right to discontinue 

treatment’’ as an option. 

+ Revising proposed paragraph (a)(5) 

by redesignating the ‘‘advance 

directive’’ policy as paragraph (a)(6), 

and adding the phrase ‘‘and the 

facility’s policy regarding advance 

directives.’’

+ Redesignating proposed paragraphs 

(a)(6) through (a)(16) as paragraphs 

(a)(7) through (a)(17), respectively. 

+ Revising newly redesignated 

paragraph (a)(7), (formerly paragraph 

(a)(6)) to specify that patients have the 

right to receive resource information 

about dialysis modalities and options 

not offered by the facility, including 

alternative scheduling options for 

working patients. 

+ Revising newly redesignated (a)(10) 

(formerly (a)(9)) to clarify that the 

patient has the right to be informed of 

his or her medical status by not only the 

physician, but the ‘‘nurse practitioner, 

clinical nurse specialist or physician’s 

assistant treating the patient for ESRD.’’

+ Adding at paragraph (b)(1) a 

phrase, ‘‘routine or involuntary’’ to 

clarify that patients must be informed of 

both routine and involuntary discharge 

policies. 

+ Removing the words ‘‘reducing or’’

and ‘‘ongoing’’ at paragraph (b)(2), and 

changing the word ‘‘shortened’’ to 

‘‘abbreviated.’’

+ Adding ESRD Network ‘‘mailing 

addresses’’ to the list of information that 

must be posted in the dialysis facility at 

subsection (c). 

• Amend § 494.80 ‘‘Patient 

Assessment’’ by—

+ Clarifying in the introductory 

paragraph that the patient may choose 

whether he or she wants to identify a 

designee to participate in the 

interdisciplinary team. 

+ Clarifying the introductory 

paragraph to include ‘‘a physician 

treating the patient for ESRD’’ and 

removing our reference to the 

nephrologists. 

+ Adding immunization history to 

the assessment criteria at paragraph 

(a)(3). 

+ Modifying our reference to 

erythropoietin at paragraph (a)(4), by 

using the term ‘‘erythropoiesisstimulating agent(s).’’

+ Clarifying at paragraph (a)(6) that 

the evaluation of patient nutritional 

status must be performed by a dietitian. 

+ Clarifying at paragraph (a)(7) that 

the evaluation of patient psychosocial 

needs must be performed by a social 

worker. 

+ Modifying the requirement in 

paragraph (a)(13) for evaluation of 

vocational and physical rehabilitation 

status and potential, so that the 

interdisciplinary team need only 

evaluate the patient for referral to 

vocational and rehabilitation services. 

+ Modifying the title of paragraph (b), 

to clarify the meaning of ‘‘new patient.’’

It now reads ‘‘Frequency of assessment 

for patients admitted to the dialysis 

facility.’’

+ Modifying the time allowed to 

complete the initial patient assessment 

at paragraph (b)(1) from 20 days to 30 

days, which corresponds to the 

implementation time for the plan of 

care. An alternate method of 

determining when the assessment must 

be completed (and plan of care 

implemented) was added; 13 outpatient 

hemodialysis sessions beginning with 

the first outpatient dialysis session to 

allow for occasions (such as 

hospitalizations) when the patient may 

be away from the unit. The assessment 

now must be completed within the 

latter of 30 days or 13 dialysis sessions. 

+ Adding at paragraph (d)(2)(iv) the 

word ‘‘concurrent’’ and deleting ‘‘with’’. 

• Amend § 494.90 ‘‘Patient plan of 

care’’ by—

+ Adding to the introductory text, 

‘‘The interdisciplinary team as defined 

at § 494.80 must develop and implement 

* * *.’’

+ Removing the term ‘‘community 

accepted’’, from the introductory 

statement, and substituting 

‘‘professionally-accepted clinical 

practice,’’ so that the ‘‘outcomes’’

specified in the patient plan of care may 

be ‘‘consistent with current evidencebased professionally-accepted clinical 

practice standards.’’

+ Adding ‘‘manage the patient’s 

volume status’’ at paragraph (a)(1). We 


PWALKER on PROD1PC71 with RULES2
20448 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

are also adding the current NKF–KDOQI 

clinical practice guideline targets for 

dialysis adequacy (Kt/V of 1.2 for 

hemodialysis, and a weekly Kt/V of 1.7 

for peritoneal dialysis), as well as an 

alternative equivalent of professionallyaccepted clinical practice standards for 

adequacy of dialysis. 

+ Revising paragraph (a)(2) to read, 

‘‘The interdisciplinary team must 

provide the necessary care and 

counseling services to achieve and 

sustain an effective nutritional status. A 

patient’s albumin level and body weight 

must be measured at least monthly. 

Additional evidence-based 

professionally-accepted clinical 

nutrition indicators may be monitored, 

as appropriate.’’

+ Adding new paragraph (a)(3), 

requiring the interdisciplinary team to 

provide the necessary care to manage 

mineral metabolism and prevent or treat 

renal bone disease. The remaining plan 

of care components are renumbered to 

reflect the addition of a new paragraph 

(a)(3). 

+ Revising proposed paragraph (a)(3) 

(now paragraph (a)(4)), to read in part, 

‘‘The interdisciplinary team must 

provide the necessary care and services 

to achieve and sustain the clinically 

appropriate hemoglobin/hematocrit 

level. The patient’s hemoglobin/ 

hematocrit must be measured at least 

monthly. The dialysis facility must 

conduct an evaluation of the patient’s 

anemia management needs.’’

+ Modifying the vascular access plan 

of care component at proposed 

paragraph (a)(4), now paragraph (a)(5), 

so that instead of providing the 

necessary care and services to achieve 

and sustain the vascular access, the 

interdisciplinary team must provide 

vascular access monitoring and 

appropriate, timely referrals to achieve 

and sustain vascular access. The 

interdisciplinary team must also 

evaluate whether the patient is a 

potential candidate for arteriovenous 

fistula placement. 

+ Adding a new psychosocial status 

requirement at paragraph (a)(6), 

requiring the interdisciplinary team to 

provide the necessary monitoring and 

social work interventions, including 

counseling and referrals for social 

services, to assist the patient in 

achieving and sustaining an appropriate 

psychosocial status as measured by a 

standardized mental and physical 

assessment tool chosen by the social 

worker, at regular intervals, or more 

frequently on an as-needed basis. 

+ Revising and redesignating 

proposed paragraph (a)(5) (now located 

at paragraph (a)(7)(i)), to require the 

interdisciplinary team to plan for home 

dialysis or explain why the patient is 

not a candidate for home dialysis. 

+ Modifying the rehabilitation plan of 

care requirement, now at paragraph 

(a)(8), to require that the 

interdisciplinary team assist the patient 

in achieving and sustaining an 

appropriate level of productive activity, 

and make rehabilitation and vocational 

rehabilitation referrals as appropriate. 

+ Clarifying at paragraph (b)(i) that 

the patient is to be included (if he or she 

desires) when the interdisciplinary team 

is completing the plan of care. 

+ Clarifying the patient plan of care 

signature requirement (paragraph 

(b)(1)(ii)) to indicate that team members 

must sign the plan of care and, if 

applicable, the facility must document a 

patient’s refusal to sign the plan of care, 

along with the reason the signature was 

not provided. 

+ Modifying the plan of care 

implementation requirements 

(paragraph (b)(2)) so that the 

implementation of the initial plan of 

care must begin within the latter of 30 

calendar days after admission to the 

dialysis facility or 13 outpatient 

hemodialysis sessions beginning with 

the first outpatient dialysis session. 

Implementation of monthly or annual 

updates of the plan of care must be 

performed within 15 days of the 

completion of the additional patient 

assessments specified in § 494.80 of this 

part. 

+ Adding language to paragraph 

(b)(3) that requires the plan of care to be 

adjusted when the plan of care outcome 

targets are not met to reflect the 

patient’s condition along with an 

explanation, and that the team must 

identify opportunities for improvement. 

+ Adding ‘‘nurse practitioner, clinical 

nurse specialist, or physician’s 

assistant’’ as the types of professionals 

who can meet the monthly visit 

requirement at paragraph (b)(4). 

+ Modifying the transplantation 

referral-tracking standard at paragraph 

(c)(3), by requiring that the 

interdisciplinary team communicate 

with the transplant center regarding 

patient transplant status ‘‘at least 

annually, and when there is a change in 

transplant candidate status.’’

+ Revising the standard at subsection 

(d), ‘‘Patient education and training,’’ to 

require that the care plan include 

training in infection prevention and 

personal care, home dialysis and selfcare, and benefits and risks of various 

vascular access types. 

• Amend § 494.100 ‘‘Care at home’’

by—

+ Clarifying in the introductory text 

that care at home services must meet all 

applicable conditions of this part. 

+ Replacing the word ‘‘provide’’ with 

‘‘oversee’’ at paragraph (a). 

+ Replacing ‘‘hematocrit level of at 

least 33 percent or a hemoglobin of at 

least 11 gm/dL’’ at paragraph (a)(3)(ii) 

with the phrase ‘‘target level 

hemoglobin or hematocrit as written in 

the patient’s plan of care.’’ We are also 

replacing ‘‘erythropoietin 

administration’’ with ‘‘administration of 

erythropoiesis-stimulating agent(s).’’

+ Deleting ‘‘implementation of a 

nutritional care plan’’ at proposed 

paragraph (a)(3)(iii). We are also 

deleting ‘‘how to achieve and maintain 

emotional and social well being’’ from 

paragraph (a)(3)(iv). The remaining 

paragraphs have been renumbered to 

reflect these revisions. 

+ Adding that potential dialysis 

complication training includes 

addressing ‘‘water treatment problems’’

(new paragraph (a)(3)(iii)). 

+ Clarifying at paragraph (c)(1) that a 

home dialysis training facility must 

furnish home dialysis support services 

either directly, under agreement, or by 

arrangement with another ESRD facility. 

+ Modifying paragraph (c)(1)(v) to 

specify that the facility must monitor 

the quality of water and dialysate used 

by home hemodialysis patients and 

conduct onsite evaluations and testing 

of the water and dialysate system in 

accordance with (A) the 

recommendations specified in the 

manufacturer’s instructions; and (B) the 

system’s FDA-approved labeling for 

preconfigured systems designed, tested, 

and validated to meet AAMI quality 

(which includes standards for chemical 

and chlorine/chloramine testing) water 

and dialysate. The facility must meet 

testing and other requirements of AAMI 

RD52:2004. In addition, bacteriological 

and endotoxin testing must be 

performed on a quarterly, or more 

frequent basis as needed, to ensure that 

the water and dialysate are within the 

AAMI limits. 

+ Revising paragraph (c)(1)(v) 

(revised as paragraph (c)(1)(v)(C)) to 

change ‘‘the water quality’’ to ‘‘any 

water and dialysate quality problem.’’

+ Adding ‘‘and dialysate’’ at 

paragraphs (c)(1) and (c)(2). 

+ Clarifying at paragraph (c)(2)(vi) 

that the dialysis facility may not only 

purchase, but may also lease or rent 

medically necessary home dialysis 

supplies and equipment. 

• Amend § 494.110 ‘‘Quality 

assessment and performance 

improvement’’ by—

+ Clarifying in the introductory 

paragraph, that the QAPI program 

requires participation by the 

professional members of the 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20449 

interdisciplinary team to meet these 

conditions for coverage. 

+ Adding mineral metabolism and 

renal bone disease to the list of QAPI 

program components at paragraph 

(a)(2)(iii). The subsequent QAPI 

program components have been 

renumbered accordingly. 

+ Adding infection control to the list 

of QAPI program components at 

paragraph (a)(2)(ix). 

• Amend § 494.120 ‘‘Special purpose 

renal dialysis facilities’’ by—

+ Revising standard (d), to require the 

special purpose facility to contact the 

patient’s physician ‘‘if possible’’ prior to 

initiating dialysis. 

+ Revising standard (e), to require the 

special purpose facility patient 

documentation to be forwarded to the 

patient’s usual dialysis facility, if 

possible within 30 days of the last 

scheduled treatment. 

• Amend § 494.140 ‘‘Personnel 

qualifications’’ by—

+ Adding a requirement to the 

introductory text to read, ‘‘All dialysis 

facility staff must meet the applicable 

scope of practice board and licensure 

requirements in effect in the State in 

which they are employed.’’ References 

to State licensure and board of practice 

compliance for dialysis facility staff 

have been removed, where appropriate, 

in the later sections of § 494.140. 

+ Revising paragraph (a)(1), to require 

the medical director be a board-certified 

physician in internal medicine or 

pediatrics by a professional board. 

+ Revising the title of paragraph 

(b)(2) to read, ‘‘Self-care and home 

dialysis training nurse.’’

+ Adding a new provision at 

paragraph (b)(3)(iii) so that a charge 

nurse who is a licensed practical nurse 

or licensed vocational nurse, must work 

under the supervision of a registered 

nurse in accordance with State nursing 

practice act provisions. 

+ Deleting proposed paragraph (c)(2). 

+ Redesignating proposed 

§ 494.140(c)(3) as § 494.140(c)(2). 

+ Adding a ‘‘specialization in clinical 

practice’’ requirement to the social 

worker’s master’s degree provisions at 

paragraph (d)(1). 

+ Adding the grandfather provision 

from part 405, subpart U for nonmaster’s prepared social workers to 

paragraph (d)(2), to allow a dialysis 

social worker to qualify for this position 

if he or she has ‘‘served at least 2 years 

as a social worker, 1 year of which was 

in a dialysis unit or transplantation 

program prior to September 1, 1976, and 

has established a consultative 

relationship with a social worker who 

qualifies under § 494.140(d)(2) of this 

part.’’

+ Revising the patient care technician 

(PCT) qualifications at paragraph (e)(3), 

to remove the proposed requirement 

that the PCT have at least 3 months 

experience, and to require that the 

training program be only ‘‘under the 

direction’’ of a registered nurse, rather 

than ‘‘under the direct supervision of a 

registered nurse.’’

+ Revising paragraph (e)(3), to 

include the training program 

requirements from proposed 

§ 494.180((b)(5). 

+ Adding ‘‘proper cannulation 

techniques’’ to the training program 

subjects redesignated at paragraph 

(e)(3)(iii). 

+ Adding ‘‘and dialysate 

preparation’’ to redesignated paragraph 

(e)(3)(v). 

+ Adding a new requirement at 

paragraph (e)(4) that patient care 

dialysis technicians be certified under a 

State certification program or a national 

commercially available certification 

program. At paragraphs (e)(4)(i) and 

(e)(4)(ii), we are adding that newly 

employed patient care dialysis 

technicians must be certified within 18 

months of being hired as a dialysis 

patient care technician and for dialysis 

patient care technician employed on the 

effective date of this rule within 18 

months of such date. 

• Amend § 494.150 ‘‘Responsibilities 

of the medical director’’ by—

+ Adding to the introductory 

paragraph, ‘‘The medical director is 

accountable to the governing body for 

the quality of medical care provided to 

patients.’’

+ Revising the requirement at 

paragraph (c)(2)(i) to read, ‘‘All policies 

and procedures relative to patient 

admissions, patient care, infection 

control, and safety are adhered to by all 

individuals who treat patients in the 

facility, including attending physicians 

and nonphysician providers.’’

• Amend § 494.160 ‘‘Condition: 

Relationship with the ESRD Network’’

by—

+ Redesignating the ‘‘Relationship 

with the ERSD Network’’ condition (at 

§ 494.160) as § 494.180(i). The language 

for the ESRD Network requirements has 

been retained from the proposed rule. 

+ Reserving section 494.160 without 

requirements. 

• Amend § 494.170 ‘‘Medical 

records’’ by—

+ Adding at paragraph (b)(2) that the 

patient’s record must indicate ‘‘whether 

the patient has executed an advance 

directive.’’

+ Revising language in standard (c) to 

read, ‘‘In accordance with 45 CFR 

164.530(j)(2), all patient records must be 

retained for 6 years from the date of the 

patient’s discharge, transfer, or death.’’

+ Revising language at paragraph (d), 

to require the dialysis transferring a 

patient to send to the receiving facility 

only ‘‘all requested medical record 

information.’’

• Amend § 494.180 ‘‘Governance’’

by—

+ Removing the sentence, ‘‘The 

governing body receives and acts upon 

recommendations from the ESRD 

Network’’ from the introductory 

paragraph. 

+ Adding language at paragraph 

(b)(1), to require that the RN, social 

worker and dietitian members of the 

interdisciplinary team must be available 

to meet patient clinical needs. 

+ Revising paragraph (b)(2) to read, 

‘‘A registered nurse, who is responsible 

for the nursing care provided, is present 

in the facility at all times that in-center 

dialysis patients are being treated.’’

+ Revising paragraph (b)(3) to read, 

‘‘All staff, including the medical 

director, have appropriate orientation to 

the facility and work responsibilities.’’

+ Removing the written training 

program requirements specific to 

dialysis patient care technicians from 

paragraphs (b)(5) and (b)(6) and adding 

them to paragraphs (e)(3) and (e)(4). 

+ Revising paragraph (c), to indicate 

that the governing body is responsible 

for all medical staff appointments and 

credentialing in accordance with State 

law, including clinical nurse specialists. 

+ Adding a new paragraph (c)(3), 

which requires the governing body to 

communicate ‘‘expectations to the 

medical staff regarding staff 

participation in improving the quality of 

medical care provided to facility 

patients.’’

+ Clarifying the standard at 

subsection (e) that patients may file ‘‘an 

oral or written’’ grievance with the 

facility. 

+ Revising the title of standard (f), to 

read ‘‘Involuntary discharge and transfer 

policies and procedures.’’

+ Modifying paragraph (f)(4), to 

clarify the sequence of procedures when 

a patient is involuntarily discharged, 

and to require ESRD Network 

notification at the time the patient is 

provided 30 days advance notice of the 

discharge, instead of at the time of 

discharge or later. New paragraph 

(f)(4)(ii) now requires that the 

interdisciplinary team provides the 

patient with a 30 day notice of the 

planned discharge, and also notifies the 

ESRD Network of the planned 

discharge. The proposed provisions at 

proposed paragraphs (f)(4)(ii) through 

(f)(4)(iv) are renumbered to reflect 

insertion of a new paragraph (ii). 


PWALKER on PROD1PC71 with RULES2
20450 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

+ Revising new paragraph (f)(4)(iv), 

to require a facility contemplating an 

involuntary discharge to contact and 

attempt to place the patient in another 

facility, and to document that effort. 

+ Adding a new provision at 

paragraph (f)(5), which reads, ‘‘In the 

case of immediate severe threats to the 

health and safety of others, the facility 

may utilize an abbreviated involuntary 

discharge procedure.’’

+ Adding ‘‘routine and emergency 

dialysis’’ to the services a hospital 

agrees to provide in an agreement with 

a dialysis facility at paragraph (g)(3). 

+ Revising the proposed paragraph 

(h) introductory text to reflect an 

effective date of February 1, 2009 in the 

Federal Register. 

+ Redesignating proposed paragraph 

(i) as paragraph (j). 

+ Relocating the proposed ESRD 

Network-related requirements (proposed 

§ 494.160) for dialysis facilities at new 

paragraph (i). 

IV. Effective Dates for the Final Rule 

The Administrative Procedure Act 

(APA) does not require that a final rule 

become effective within a certain 

maximum timeframe after publication 

in the Federal Register. However, under 

the APA, the effective date of a 

substantive rule must be no less than 30 

days after its publication date, unless 

there is good cause for an earlier 

effective date (5 U.S.C. 553(b)). This 

final rule will be effective 180 days after 

its publication in the Federal Register. 

We are allowing dialysis facilities 

additional time beyond 180 days to 

come into compliance with three 

specific provisions of this final rule. 

This final rule modernizes the 

existing ESRD dialysis facility 

conditions for coverage originally 

promulgated in 1976, which have not 

been revised in their entirety in 31 

years. The ESRD conditions for coverage 

proposed rule (published on February 5, 

2005 (70 FR 6184)) emphasized a 

patient-centered approach to care, 

thereby decreasing dialysis facility 

structure and process requirements 

while moving to an outcome-based 

orientation. This final rule will 

implement those proposed changes, 

while reflecting current professional 

standards of practice. In addition, they 

will update patient safety standards, 

provide a structure for internal facility 

quality improvement, and add a 

framework for external oversight. 

Because we are changing from a 

process-oriented to patient-centered 

approach, we believe that ESRD facility 

providers will need additional time to 

come into full compliance with the 

requirements of this final rule. 

Under section 494.30(a)(1)(i), 

‘‘Infection control,’’ certain facilities 

could be required to build isolation 

rooms as set out in ‘‘HBV-Infected 

Patients’’ found on pages 27 and 28 of 

RR05 (‘‘Recommendations for 

Preventing Transmission of Infections 

Among Chronic Hemodialysis 

Patients,’’) which has been incorporated 

by reference into our regulations. Some 

facilities would need additional time to 

implement this requirement, since 

construction of isolation rooms would 

require time for project development, 

construction approvals, architectural 

design, contractor bids and obtaining 

building permits. Therefore, we are 

allowing dialysis facilities 300 days 

after publication of this final rule to 

comply with the requirements found at 

§ 494.30(a)(1)(i). 

Under section 494.60(e)(1), ‘‘Physical 

environment,’’ facilities will be required 

to be in compliance with the 2000 

edition of the Life Safety Code. If 

changes are required in the building 

structure, facilities will need time to 

make the appropriate changes. 

Therefore, we are allowing dialysis 

facilities 300 days after publication of 

this final rule time to comply with the 

requirements found at § 494.60(e)(1). 

Under section 494.180(h), 

‘‘Governance,’’ we are requiring 

facilities to submit certain data to CMS 

in an electronic format. Facilities may 

have to develop programs or obtain 

software that can be used to provide the 

data to CMS. This requirement may 

have a financial impact on some 

facilities and may also require them to 

make changes to their data systems to 

capture the data that they will be 

required to submit. We are allowing 

dialysis facilities until February 1, 2009 

to comply with the requirements at 

§ 494.180(h). 

V. Reference Materials 

A. Provisions of Part 494 

This final rule contains a number of 

requirements that are not included in 

the existing regulations. For information 

and ease of reference, outlined below is 

a list of the new provisions, grouped by 

condition: 

Condition New provisions 

Infection control (§ 494.30) .......................................... Infection control procedures (including the Recommended Infection Control Practices for 

Hemodialysis Units At A Glance CDC guidelines). 

§ 494.30(a)(1)(i)—Patient isolation procedures. 

Water quality (§ 494.40) ............................................... Incorporates by reference the updated 2001 American National Standard/Association for 

the Advancement of Medical Instrumentation guidelines for water purity. 

Physical environment (§ 494.60) ................................. § 494.60(e)—Fire safety. 

Patient rights (§ 494.70) ............................................... § 494.70(a)(6)—Advance directives. 

§ 494.70(a)(14)—Complaint systems. 

§ 494.70(a)(15)—Complaint systems. 

§ 494.70(b)—Discharge and transfer policies. 

§ 494.70(c)—Posting of rights. 

Patient assessment (§ 494.80) .................................... § 494.80(a)(2)—Appropriateness of dialysis prescription. 

§ 494.80(a)(5)—Renal bone disease. 

§ 494.80(a)(8)—Dialysis access type and maintenance. 

—Suitability for transplantation referral, including basis for referral or nonreferral. 

§ 494.80(b)—Frequency of assessment. 

§ 494.80(c)—Assessment of treatment prescription. 

§ 494.80(d)—Patient reassessment. 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20451 

Condition New provisions 

Patient plan of care (§ 494.90) .................................... § 494.90(a)(1)—Dose of dialysis. 

§ 494.90(a)(2)—Nutritional status. 

§ 494.90(a)(4)—Anemia. 

§ 494.90(a)(5)—Vascular access. 

§ 494.90(a)(7)—Home dialysis and transplantation status. 

§ 494.90(a)(8)—Rehabilitation status. 

§ 494.90(b)—Implementation of patient plan of care. 

§ 494.90(b)(4)—Direct physician/patient interaction. 

§ 494.90(c)—Transplantation referral tracking. 

Care at home (§ 494.100) ............................................ § 494.100(a)—Training. 

§ 494.100(b)—Home dialysis monitoring. 

§ 494.100(c)—Support services. 

Quality assessment and performance improvement 

(§ 494.110).

§ 494.110(a)—Program scope. 

§ 494.110(a)(2)(i)—Adequacy of dialysis. 

§ 494.110(a)(2)(ii)—Nutritional status. 

§ 494.110(a)(2)(iii)—Mineral metabolism and renal bone disease. 

§ 494.110(a)(2)(iv)—Anemia management. 

§ 494.110(a)(2)(v)—Vascular access. 

§ 494.110(a)(2)(vi)—Medical injuries and medical error identification. 

§ 494.110(a)(2)(vii)—Hemodialyzer reuse. 

§ 494.110(a)(viii)—Patient satisfaction. 

§ 494.110(a)(ix)—Infection control. 

§ 494.110(b)—Monitoring performance improvement. 

§ 494.110(c)—Prioritizing improvement activities. 

Special purpose renal dialysis facilities (§ 494.120) .... § 494.120—Definition. 

Personnel qualifications (§ 494.140) ............................ § 494.140(b)—Nursing services. 

§ 494.140(e)—Dialysis technicians. 

Responsibilities of the medical director (§ 494.150) .... Quality assessment and performance improvement program. 

§ 494.150(b)—Staff education, training, and performance. 

§ 494.150(c)—Patient care policies and procedures. 

Governance (§ 494.180) .............................................. § 494.180(c)—Medical staff appointments. 

§ 494.180(d)—Furnishing services. 

§ 494.180(e)—Internal grievance process. 

§ 494.180(f)—Involuntary discharge and transfer policies and procedures. 

Emergency coverage. 

Furnishing data and information for ESRD program administration. 

Relationship with the ESRD Network. 

B. ESRD Crosswalk (Cross Refers 

Existing Requirements to Final 

Requirements) 

Existing conditions (Part 405, Subpart U) Existing citation Final conditions (Part 494) Final citation 

Scope of subpart ................................................... 405.2100(a) ........................ Statutory basis ........................... 494.1(a). 

405.2100(b) ........................ Scope ........................................ 494.1(b). 

Objectives of ESRD program ................................ 405.2101 ............................ Deleted. 

Definitions .............................................................. 405.2102 ............................ Definitions .................................. 494.10. 

Agreement ...................................................... ............................................. Deleted. 

Arrangement ................................................... ............................................. Deleted. 

Dialysis ........................................................... ............................................. Deleted. 

End-stage renal disease ................................. ............................................. Deleted. 406.13(b). 

ESRD facility (introductory text) ..................... ............................................. Deleted. 

(a) Renal dialysis center ......................... ............................................. Deleted. 

(b) Renal dialysis facility ......................... ............................................. Definitions .................................. 494.10. 

(c) Self-dialysis unit ................................. ............................................. Deleted. 

(d) Special purpose renal dialysis facility ............................................. Special purpose renal dialysis 

facilities.

494.120. 

ESRD service (introductory text) .................... ............................................. Deleted. 

(a) Dialysis service .................................. ............................................. Deleted. 

(1) Inpatient dialysis ................................ ............................................. Deleted. 

(2) Outpatient dialysis ............................. ............................................. Deleted. 

(i) Staff-assisted dialysis ......................... ............................................. Deleted. 

(ii) Self-dialysis ........................................ ............................................. Definitions .................................. 494.10. 

(3) Home dialysis .................................... ............................................. Definitions .................................. 494.10. 

(b) Self-dialysis and home dialysis ......... ............................................. Deleted. 

Furnishes directly ................................................... ............................................. Definitions .................................. 494.10. 

Furnishes on the premises .................................... ............................................. Deleted. 494.180(d). 

Medical care criteria .............................................. ............................................. Deleted. 

Medical care norms ............................................... ............................................. Deleted. 

Medical care standards ......................................... ............................................. Deleted. 

Medical care evaluation study ............................... ............................................. Deleted. 


PWALKER on PROD1PC71 with RULES2
20452 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

Existing conditions (Part 405, Subpart U) Existing citation Final conditions (Part 494) Final citation 

Network, ESRD ...................................................... ............................................. Retained in 405, Subpart U. 405.2102. 

Network, organization ............................................ ............................................. ESRD Network organization ...... 405.2102. 

(a) Chief executive officer .............................. ............................................. Deleted. 

(b) Dietitian ..................................................... ............................................. Personnel qualifications ............ 494.140(c). 

(c) Medical record practitioner ........................ ............................................. Deleted. 

(d) Nurse responsible for nursing services .... ............................................. Personnel qualifications ............ 494.140(b). 

(e) Physician-director ...................................... ............................................. Personnel qualifications ............ 494.140(a). 

(f) Social worker ............................................. ............................................. Personnel qualifications ............ 494.140(d). 

Designation of ESRD networks ............................. 405.2110 ............................ Retained in 405, Subpart U. 

[Reserved] .............................................................. 405.2111 ............................ Reserved in Part 405 Subpart 

U. 

ESRD network organizations ................................. 405.2112 ............................ Retained in 405, Subpart U. 

Medical review board ............................................. 405.2113 ............................ Retained in 405, Subpart U. 

[Reserved] .............................................................. 405.2114 ............................ Reserved in Part 405 Subpart 

U. 

Provider status: renal transplantation center or 

renal dialysis center.

405.2131 ............................ Deleted. 

[Reserved] .............................................................. 405.2132 ............................ Deleted. 

Furnishing data and information for ESRD program administration.405.2133 ............................ Furnishing data and information 

for ESRD program administration.

494.180(h). 

Participation in network activities .......................... 405.2134 ............................ Relationship with ESRD network 494.180(i). 

Compliance with Federal, State, and local laws 

and regulations.

405.2135 ............................ Compliance with Federal, State, 

and local laws and regulations.

494.20. 

Governing body and management (introductory 

text).

405.2136 ............................ Governance (introductory text) .. 494.180 (introductory text). 

(a) Disclosure of ownership ............................ 405.2136(a) ........................ Governance ............................... 494.180(j). 

(b) Operational objectives .............................. 405.2136(b) ........................ Deleted. 

(c) Chief executive officer ............................... 405.2136(c) ........................ Designating a chief executive 

office or administrator.

494.180(a). 

(d) Personnel policies and procedures .......... 405.2136(d)(1) .................... Governance ............................... 494.180(b)(3) and (b)(4). 

405.2136(d)(3–5, 7) ........... Deleted. 

(d)(2) Infection control/Incident reports .......... 405.2136(d)(2) .................... Infection control and Quality assessment and performance 

improvement.

494.30(a) and 

494.110(a)(ix). 

(d)(6) Facility personnel educational programs.405.2136(d)(6) .................... Personnel qualifications ............

Governance ...............................

Infection Control ........................

494.140(e). 

494.180(b)(3) and (b)(4). 

494.30(a). 

(e) Use of outside resources .......................... 405.2136(e) ........................ Deleted. 

(f) Patient care policies ................................... 405.2136(f) ......................... Policies and procedures ............ 494.150(c). 

(g) Medical supervision and emergency coverage.405.2136(g) ........................ Furnishing services ................... 494.180(d). 

405.2136(g)(1) .................... Patient plan of care ................... 494.90 (introductory text). 

405.2136(g)(2) .................... Emergency Coverage ................ 494.180(g). 

(h) Medical staff .............................................. 405.2136(h) ........................ Medical staff appointments ....... 494.180(c). 

Patient long-term program and patient care plan 405.2137 (introductory text) Patient plan of care ................... 494.90 (introductory text). 

(a) Patient long-term program ........................ 405.2137(a) ........................ Deleted. 

(b) Patient care plan ....................................... 405.2137(b) ........................ Patient plan of care ................... 494.90 (introductory text). 

(b)(1) Personalized care plan ......................... 405.2137(b)(1) .................... Patient plan of care ................... 494.90 (introductory text). 

(b)(2) Developed by a professional team ....... 405.2137(b)(2) .................... Patient plan of care ................... 494.90 (introductory text). 

(b)(3) The patient is involved ......................... 405.2137(b)(3) .................... Patient plan of care ...................

Patient’s rights ...........................

494.90(b)(1). 

494.70(a)(5). 

(b)(4) Frequency of care plan review ............. 405.2137(b)(4) .................... Patient plan of care ...................

Patient reassessment ................

494.90(b)(2). 

494.80(d). 

(b)(5) Transfer of care plan ............................ 405.2137(b)(5) .................... Medical records ......................... 494.170(d). 

(b)(6) Care plan for the home dialysis patient 405.2137(b)(6) .................... Development of patient plan of 

care.

Care at home ............................

494.90(a)(4). 

494.100(c)(1). 

(b)(7) Erythropoietin for the home dialysis patient.405.2137(b)(7) .................... Patient plan of care ................... 494.90(a)(4). 

Patients’ rights and responsibilities ....................... 405.2138(a)–(d) .................. Patients’ rights ...........................

Medical records .........................

Posting of rights ........................

494.70(a). 

494.170(a). 

494.70(c). 

405.2138(e). ....................... Internal grievance process ........

Patients’ rights ...........................

Posting of rights ........................

494.180(e). 

494.70(a)(14) and (a)(15). 

494.70(c). 

Medical records ..................................................... 405.2139 ............................ Medical records ......................... 494.170 (introductory text). 

(a) Medical record contents ............................ 405.2139(a) ........................ Medical records ......................... 494.170(b). 

(b) Protection of medical record information .. 405.2139(b) ........................ Protection of patient’s record .... 494.170(a). 

(c) Medical record supervisor ......................... 405.2139(c) ........................ Deleted. 

(d) Completion and centralization .................. 405.2139(d) ........................ Completion of patient records 

and centralization of clinical 

information.

494.170(b). 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20453 

Existing conditions (Part 405, Subpart U) Existing citation Final conditions (Part 494) Final citation 

(e) Retention and preservation ....................... 405.2139(e) ........................ Record retention and preservation.494.170(c). 

(f) Location and facilities ................................ 405.2139(f) ......................... Deleted. 

(g) Transfer of medical information ................ 405.2139(g) ........................ Transfer of patient record information.494.170(d). 

Physical environment ............................................. 405.2140(a) (introductory 

text).

Physical environment ................ 494.60 (introductory text). 

(a) Building and equipment ............................ 405.2140(a)(1) .................... Building ...................................... 494.60(a) and (b). 

(a)(1) Fire ........................................................ 405.2140(a)(2), (3) ............. Fire Safety ................................. 494.60(e). 

(a)(2), (3) Equipment and areas are hazard 

free.

405.2140(a)(2), (3) ............. Equipment maintenance ............ 494.60(b). 

(a)(5) Water quality requirements .................. 405.2140(a)(5) .................... Water and dialysate quality ....... 494.40(a). 

(b) Favorable environment for patients .......... 405.2140(b) (introductory 

text).

Patient care environment .......... 494.60(c). 

(b)(1) Infection prevention .............................. 405.2140(b)(1) .................... Procedures for infection control 494.30. 

(b)(2) and (b)(4) Adequate treatment areas/ 

Heating and ventilation systems.

405.2140(b)(2) and (b)(4) ... Physical environment ................ 494.60 (introductory text) 

and (c). 

(b)(3) Nursing station ...................................... 405.2140(b)(3) .................... Governance ............................... 494.180(g)(2). 

(b)(5) Special dialysis solutions ...................... 405.2140(b)(5) .................... Deleted. 

(c) Contamination prevention ......................... 405.2140(c) ........................ Infection control .........................

Reuse of hemodialyzers ............

494.30(a). 

494.50. 

(d) Emergency preparedness ......................... 405.2140(d) ........................ Emergency preparedness ......... 494.60(d).

Reuse of hemodialyzers and other dialysis supplies.405.2150 (introductory text) Reuse of hemodialyzers and 

bloodlines.

494.50 (introduction). 

(a) Hemodialyzers .......................................... 405.2150(a)(1) and (a)(2) .. Reprocessing requirements for 

the reuse of hemodialyzers 

and bloodlines.

494.50(b). 

405.2150(a)(3) .................... Monitoring, evaluation, and reporting requirements for the 

reuse of hemodialyzers and 

bloodlines.

494.50(c). 

(b) Transducer filters ............................................. 405.2150(b) ........................ Deleted. 

(c) Bloodlines .................................................. 405.2150(c) ........................ General requirements for the

reuse of hemodialyzers and 

bloodlines.

494.50(a). 

Reprocessing requirements for 

the reuse of hemodialyzers 

and bloodlines.

494.50(b). 

Affiliation agreement or arrangement .................... 405.2160(a), (b)(1), (b)(3) .. Governance ............................... 494.180(g)(3). 

405.2160(b)(2) .................... Transfer of patient record information.494.170(d). 

Director of a renal dialysis facility or renal dialysis 

center.

405.2161 ............................ Personnel qualifications ............

Medical director .........................

Responsibilities of the medical 

director.

494.140 (introductory text). 

494.140(a). 

494.150. 

Staff of a renal dialysis facility or renal dialysis 

center.

405.2162 (introductory text) Governance ............................... 494.180(b). 

(a) Registered nurse ....................................... 405.2162(a) ........................ Governance ...............................

Personnel qualifications ............

494.180(b)(2). 

494.140(b)(1). 

(b) On-duty personnel .................................... 405.2162(b) ........................ Governance ............................... 494.180(b)(1). 

(c) Self-care dialysis training personnel ......... 405.2162(c) ........................ Care at Home ............................

Personnel qualifications ............

494.100(a)(2). 

494.140(b)(2). 

Minimal service requirements for a renal dialysis 

facility or renal dialysis center.

405.2163 ............................ Patient plan of care ................... 494.90 (introductory text). 

(a) Outpatient dialysis services ...................... 405.2163(a)(1) .................... Patient plan of care ................... 494.90 (introductory text). 

405.2163(a)(2) .................... Patient plan of care ...................

Care at home ............................

494.90 (introductory text). 

494.100 (introductory text). 

(b) Laboratory services ................................... 405.2163(b) ........................ Laboratory services ................... 494.130. 

(c) Social services .......................................... 405.2163(c) ........................ Assessment criteria ...................

Support services ........................

494.80(a)(7). 

494.100(c). 

Psychosocial services ............... 494.90(a)(6). 

(d) Dietetic services ........................................ 405.2163(d) ........................ Assessment criteria ...................

Patient plan of care ...................

494.80(a)(5) and (a)(6). 

494.90(a)(2) and (a)(3). 

(e) Self-dialysis support services ................... 405.2163(e) ........................ Support services ........................ 494.100(c). 

(f) Participation in recipient registry ................ 405.2163(f) ......................... Deleted. 

(g) Use of erythropoietin at home .................. 405.2163(g) ........................ Patient assessment ...................

Patient plan of care ...................

Care at home ............................

494.80(a)(2), (4). 

494.90(a)(4). 

494.100(a). 

(h) Responsibilities of the physician/facility 

for use of erythropoietin at home.

405.2163(h) ........................ Care at home ............................ 494.100(b) and (c). 

Conditions for coverage of special purpose renal 

dialysis facilities.

405.2164 ............................ Special purpose renal dialysis 

facilities.

494.120. 

(a) Special purpose renal renal dialysis facilities.405.2164(a) ........................ Special purpose dialysis facilities.494.120. 


PWALKER on PROD1PC71 with RULES2
20454 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

Existing conditions (Part 405, Subpart U) Existing citation Final conditions (Part 494) Final citation 

(b) Consult patient’s physician ....................... 405.2164(b) ........................ Physician contact ...................... 494.120(d). 

(c) Approval period ......................................... 405.2164(c) ........................ Approval period ......................... 494.120(a). 

(d) Service limitation ....................................... 405.2164(d) ........................ Service limitation ....................... 494.120(b). 

Termination of Medicare coverage ........................ 405.2180 ............................ Termination of Medicare coverage and alternative sanctions for ESRD facilities.488.604. 

Alternative sanctions .............................................. 405.2181 ............................ Alternative sanctions ................. 488.606. 

Notice of sanction and appeal rights: Termination 

of coverage.

405.2182 ............................ Notice of appeal rights: Termination of coverage.488.608. 

Notice of appeal rights: Alternative sanctions ....... 405.2184 ............................ Notice of appeal rights: Alternative sanctions.488.610. 

VI. Collection of Information 

Requirement 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements: 

A. ICRs Regarding Payment for Home 

Dialysis Equipment, Supplies and 

Support Services (§ 414.330) 

Section 414.330 states that suppliers 

must report to the ESRD facility 

providing support services, at least 

every 45 days, all data for each patient 

regarding services and items furnished 

to the patient in accordance with 

§ 494.100(c)(2) of this chapter. 

The burden to ESRD facilities 

associated with this requirement is the 

time and effort necessary to collect all 

data for each patient receiving home 

dialysis care with respect to services 

and items furnished. We estimate that 

there are approximately 24,657 patients 

receiving home dialysis care 

(approximately 5 percent of all dialysis 

patients), and that it would take a 

dialysis facility 1.5 hours annually to 

collect data for each patient. Therefore, 

we estimate a total annual burden of 

36,986 hours. 

B. ICRs Regarding Special Procedures 

for Approving End-Stage Renal Disease 

Facilities (§ 488.60) 

Section 488.60 states that an ESRD 

facility wishing to be approved, or 

wishing to be approved for an 

expansion of dialysis services, for 

Medicare coverage, in accordance with 

part 494 of this chapter, must submit the 

documents and data as outlined in 

§ 488.60(a)(1) through (a)(4). 

As of the spring of 2007, there were 

4,746 Medicare approved dialysis 

facilities (http://www.medicare.gov/ 

Download/DownloadDB.asp). From 

1998 to 2004, the average yearly growth 

(using USRDS data) in dialysis facilities 

seeking approval was 4.4 percent. We 

anticipate a similar rate of growth in 

dialysis facilities over the next few 

years. Thus, we believe that 218 new 

and renovated dialysis facilities will 

request Medicare approval in 2009 and 

that over the five-year period from 2009 

to 2013 a total of 1,191 new and 

renovated dialysis facilities will request 

Medicare approval. We estimate the 

average number of new facilities per 

year requesting approval would be 238 

facilities per year, over 5 five years. 

Since we are requiring compliance with 

the provisions of this rule 180–300 days 

after publication of this final rule, we 

are using 2009 estimates of the numbers 

for new and renovated dialysis facilities 

for one-time burdens. 

We estimate that it will take 40 hours 

for each of the 238 new and renovated 

facilities to gather and submit the 

necessary documentation for 

consideration by the Secretary. The 

estimated annual burden is 9520 annual 

hours. 

C. ICRs Regarding Infection Control 

(§ 494.30) 

Section 494.30 discusses the 

conditions for infection control 

programs. Specifically, § 494.30(a)(1)(ii) 

states that when dialysis isolation rooms 

as required by § 494.30(a)(1)(i) are 

available locally that sufficiently serve 

the needs of patients in the geographic 

area, a new facility may request a waiver 

of the isolation requirement. The burden 

associated with this requirement is the 

time and effort necessary to draft and 

submit a waiver request to the Secretary. 

We estimate that 90 percent (about 214 

per year) of new dialysis facilities 

would request a waiver. We estimate 

that it will take each facility 

approximately 1 hour to comply with 

this information collection request. The 

total estimated annual burden is 214 

hours. 

Section 494.30(b) outlines the 

standards for infection control program 

oversight. Section 494.30(b)(1) states 

that a facility must monitor and 

implement biohazard and infection 

control policies and activities within the 

dialysis unit. The burden associated 

with this requirement is the time and 

effort necessary to develop, draft, 

implement, and monitor the biohazard 

and infection control policies. This 

requirement is subject to the PRA; the 

burden is currently approved under 

OMB #0938–0386, with an expiration 

date of March 31, 2010. 

Section 494.30(b)(3) states that a 

facility must require all clinical staff to 

report infection control issues to the 

dialysis facility’s medical director and 

the quality improvement committee. We 

estimate that it would take staff 5 

minutes per incident to notify the 

medical director and the quality 

improvement committee. Such infection 

control issues are rare, and so we 

estimate that only 1 percent of facilities 

would experience an incident annually. 

Therefore, for 54 facilities, we estimate 

a total annual burden of 4.5 hours. 

Section 494.30(c) contains a reporting 

requirement. The facility must report 

incidences of communicable diseases as 

required by Federal, State, and local 

regulations. The burden associated with 

this requirement is the time and effort 

necessary to report incidences of 

communicable diseases to the 

appropriate Federal, State, or local 

agency. While this requirement is 

subject to the PRA, we believe the 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20455 

burden is exempt as stated in 5 CFR 

1320.3(b)(3). Facilities must report as 

required by Federal, State, and local 

regulations. The burden associated with 

this reporting requirement would exist 

in the absence of the Federal 

requirement contained in this 

regulation. Consequently, the burden is 

exempt from the PRA. 

D. ICRs Regarding Water and Dialysate 

Quality (§ 494.40) 

Section 494.40(b)(1) states that a 

facility’s water treatment system must 

include a component or carbon tank 

which removes chlorine/chloramines 

along with a backup component or 

second carbon tank in series for 

chlorine/chloramines removal. Section 

494.40(b)(1)(ii) further specifies the 

required course of action if the test 

results from the last component or 

carbon tank are greater than the 

parameters for chlorine or chloramine 

specified in paragraph (b)(2)(i) of this 

section. As stated in § 494.40(b)(1)(ii)(c), 

the facility must immediately notify the 

medical director. We estimate that it 

would take staff 5 minutes per incident 

to notify the medical director. Such 

incidents are rare, and so we estimate 

that only 1 percent of facilities would 

experience an incident annually. 

Therefore, for 54 facilities, we estimate 

a total annual burden of 4.5 hours. 

Additionally, § 494.40(c) requires a 

facility to create a corrective action plan 

that ensures patient safety. Specifically, 

when water testing results, including 

but not limited to chemical, microbial, 

and endotoxin levels which meet AAMI 

levels or deviate from the AAMI 

standards, the dialysis facility must 

develop a corrective action plan. The 

burden associated with this requirement 

is the time and effort necessary to 

develop and implement a corrective 

action plan. We estimate that it would 

take 54 facilities 30 minutes each to 

develop and implement a corrective 

action plan that ensures patient safety. 

Therefore, we estimate a total annual 

burden of 27 hours. 

Section 494.40(d) states that a dialysis 

facility must maintain active 

surveillance of patient reactions during 

and following dialysis. When clinically 

indicated, the facility must perform the 

tasks listed in § 494.40(d)(1)–(3). The 

burden associated with these 

requirements is the time and effort 

required to maintain active surveillance 

of patient reactions during and 

following dialysis. In addition, there is 

burden associated with the tasks listed 

in § 494.40(d)(1)–(3). While all of the 

requirements in § 494.40(d) are subject 

to the PRA, they are exempt as stated 

under 5 CFR 1320.3(h)(5); facts or 

opinions obtained initially or in followon requests, from individuals under 

treatment or clinical examination in 

connection with research on or 

prophylaxis to prevent a clinical 

disorder, direct treatment of that 

disorder, or the interpretation of 

biological analyses of body fluids, 

tissues, or other specimens, or the 

identification or classification of such 

specimens are not subject to the PRA. 

E. ICRs Regarding the Reuse of 

Hemodialyzers and Bloodlines 

(§ 494.50) 

Section 494.50(c)(1) states that a 

dialysis facility must monitor patient 

reactions during and following dialysis. 

As stated in § 494.50(c)(2), a facility 

must obtain blood and dialysate 

cultures and endotoxin levels, and 

undertake evaluation of its dialyzer 

reprocessing and water purification 

system. The burden associated with 

these requirements is the time and effort 

necessary to monitor and record patient 

reactions and to perform the tasks listed 

in § 494.50(c)(2)(i)–(ii). While these 

requirements are subject to the PRA, 

they are exempt as stated under 5 CFR 

1320.3(h)(5); facts or opinions obtained 

initially or in follow-on requests, from 

individuals under treatment or clinical 

examination in connection with 

research on or prophylaxis to prevent a 

clinical disorder, direct treatment of that 

disorder, or the interpretation of 

biological analyses of body fluids, 

tissues, or other specimens, or the 

identification or classification of such 

specimens are not subject to the PRA. 

Section 494.50(c)(2)(iii) requires a 

facility to report any adverse outcomes 

to FDA and other Federal, State, or local 

government agencies as required by law. 

The burden associated with this 

requirement is the time and effort 

necessary to report the adverse 

outcomes to the FDA and other Federal, 

State, or local government agencies as 

required by law. While this requirement 

is subject to the PRA, the burden is 

exempt as stated in 5 CFR 1320.3(b)(3). 

Facilities must report as required by law 

to Federal, State, and local government 

agencies. The burden associated with 

this reporting requirement would exist 

in the absence of the Federal 

requirement contained in this 

regulation. Consequently, the burden is 

exempt from the PRA. 

F. ICRs Regarding Physical Environment 

(§ 494.60) 

As required by § 494.60(b), a dialysis 

facility must implement and maintain a 

program to ensure that all equipment 

(including emergency equipment, 

dialysis machines and equipment, and 

the water treatment system) are 

maintained and operated in accordance 

with the manufacturer’s 

recommendations. The burden 

associated with this requirement is the 

time and effort necessary to develop, 

implement, and maintain a program to 

ensure that all equipment (including 

emergency equipment, dialysis 

machines and equipment, and the water 

treatment system) are maintained and 

operated in accordance with the 

manufacturer’s recommendations. This 

requirement is subject to the PRA; the 

burden is currently approved under 

OMB #0938–0386, with an expiration 

date of March 31, 2010. 

Section 494.60(d) contains the 

standard for emergency preparedness. 

Specifically, § 494.60(d)(1) states that a 

facility must provide appropriate 

training and orientation in emergency 

preparedness to the staff as specified in 

this section. Staff training must be 

provided and evaluated at least 

annually. Section § 494.60(d)(2) states 

that a facility must provide appropriate 

training and orientation in emergency 

preparedness to patients as specified in 

this section. The burden associated with 

this requirement is the time and effort 

necessary to provide emergency 

preparedness training and orientation to 

the staff and patients. This requirement 

is subject to the PRA; the burden is 

currently approved under OMB #0938–

0386, with an expiration date of March 

31, 2010. 

Section 494.60(d)(4)(i)–(iii) lists the 

facility requirements for emergency 

plans. Section 494.60(d)(4)(i) states that 

a facility must have a plan to obtain 

emergency medical system assistance 

when needed. Section 494.60(d)(4)(ii) 

requires a facility to, at least annually, 

evaluate the effectiveness of emergency 

and disaster plans and update them as 

necessary. Section 494.60(d)(4)(iii) 

states that a facility must contact its 

local disaster management agency at 

least annually to ensure that such 

agency is aware of the dialysis facility’s 

needs in the event of an emergency. The 

burden associated with the 

requirements in § 494.60(d) is the time 

and effort necessary to develop, 

maintain, and annually evaluate 

emergency and disaster plans. In 

addition, there is also burden associated 

with contacting its local disaster 

management agency on an annual basis. 

We estimate that it will take each of the 

238 new facilities 5 hours to comply 

with the requirements in this section. 

We estimate that it will take 1 hour each 

for 5,415 existing facilities (estimated 

number of existing facilities per year, 

over five years, assuming 4.4 percent 

growth) to annually comply with the 


PWALKER on PROD1PC71 with RULES2
20456 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

requirements in this section. The total 

estimated annual burden for new and 

existing facilities is 6,605 hours. 

G. ICRs Regarding Patients’ Rights 

(§ 494.70) 

Section 494.70 states that a dialysis 

facility must inform patients (or their 

representatives) of their rights and 

responsibilities when they begin their 

treatment. In addition, the dialysis 

facility must prominently display a 

copy of the patients’ rights in the 

facility, including the current State 

agency and ESRD Network mailing 

addresses and telephone complaint 

numbers, where it can be easily seen 

and read by patients. 

We estimate that it will take 5,415 

facilities (estimated number of existing 

facilities per year, over five years, 

assuming 4.4 percent growth) 1.5 hours 

each on an annual basis to update their 

patient rights materials to comply with 

this requirement. While this 

requirement is subject to the PRA, the 

burden is currently is approved under 

OMB control number 0938–0386 with 

an expiration date of March 31, 2010. 

H. ICRs Regarding Patient Assessment 

(§ 494.80) 

Section 494.80 states that a facility’s 

interdisciplinary team is responsible for 

providing each patient with an 

individualized and comprehensive 

patient assessment of his or her needs. 

Sections 494.80(a) through 494.80(d) 

discuss the standards for the 

components of the patient assessment. 

In addition to meeting the 

aforementioned standards, the 

comprehensive patient assessment must 

be documented and maintained in the 

patient’s medical record. 

The burden associated with the 

requirements in § 494.80 is the time and 

effort necessary for the interdisciplinary 

team to develop and implement an 

individual assessment for each patient 

and maintaining the assessment in the 

patient’s medical record. This 

requirement is subject to the PRA; the 

burden is currently approved under 

OMB #0938–0386, with an expiration 

date of March 31, 2010. 

I. ICRs Regarding Patient Plan of Care 

(§ 494.90) 

Section 494.90(a) states that a 

facility’s interdisciplinary team must 

develop and implement a written, 

individualized comprehensive plan of 

care that meets the all of the 

requirements of § 494.90. The burden 

associated with this requirement is 

approved under OMB #0938–0386, with 

an expiration date of March 31, 2010. 

J. ICRs Regarding Care at Home 

(§ 494.100) 

Section 494.100 details the conditions 

for care at home. Specifically, a facility’s 

interdisciplinary team must provide 

training to the home dialysis patient, the 

designated caregiver, or the self-dialysis 

patient before the initiation of home 

dialysis or self-dialysis (as defined in 

§ 494.10 of this part) and when the 

home dialysis caregiver or home 

dialysis mortality changes. Section 

494.100(a) outlines the standards for 

training. As a requirement of the 

standards for home dialysis monitoring 

discussed in § 494.100(b), the dialysis 

facility must document in the medical 

record that the patient, the caregiver, or 

both received and demonstrated 

adequate comprehension of the training. 

In addition, the facility must retrieve 

and review complete self monitoring 

data and other information from selfcare patients or their designated 

caregiver(s) at least every 2 months and 

maintain this information in the 

patient’s medical record. While these 

requirements are subject to the PRA, 

they are exempt as stated under 5 CFR 

1320.3(h)(5); facts or opinions obtained 

initially or in follow-on requests, from 

individuals under treatment or clinical 

examination in connection with 

research on or prophylaxis to prevent a 

clinical disorder, direct treatment of that 

disorder, or the interpretation of 

biological analyses of body fluids, 

tissues, or other specimens, or the 

identification or classification of such 

specimens are not subject to the PRA. In 

addition, facilities are required to meet 

these requirements as stated under 

Federal, State, and local laws and 

thereby exempt under 5 CFR 

1320.3(b)(3). 

Section 494.100(c) contains the 

standards for support services. As 

required by § 494.100(c)(1)(i), a facility 

must periodically monitor the patient’s 

home adaptation. Section 

494.100(c)(1)(ii) requires a member of 

the facilities interdisciplinary team to 

coordinate the home patient’s care. 

Section 494.100(c)(1)(iii) requires a 

facility to develop and periodically 

review each patient’s plan of care. 

Section 494.100(c)(1)(v) requires that 

the facility must monitor the quality of 

water and dialysate used by home 

hemodialysis patients. The monitoring 

must include onsite evaluations and 

tests of the water and dialysate system. 

We estimate that facilities would have 

to meet these requirements for 24,657 

care at home patients, and that it would 

take them approximately 6 hours per 

patient, per year. We estimate a total 

annual burden of 147,942 hours. 

Section 494.100(c)(2) states that the 

dialysis facility must maintain a 

recordkeeping system that ensures 

continuity of care and patient privacy. 

The burden associated with this 

requirement is the time and effort 

necessary to develop a recordkeeping 

system and to maintain the records to 

ensure continuity of care and patient 

privacy. This requirement is subject to 

the PRA; the burden is currently 

approved under OMB #0938–0386, with 

an expiration date of March 31, 2010. 

K. ICRs Regarding Quality Assessment 

and Performance Improvement 

(§ 494.110) 

Section 494.110 discusses the 

conditions for quality assessment and 

performance improvement. The dialysis 

facility must develop, implement, 

maintain, and evaluate an effective, 

data-driven quality assessment and 

performance improvement program that 

reflects the complexity of the dialysis 

facility’s organization and services. The 

dialysis facility must maintain and 

demonstrate evidence of its quality 

improvement and performance 

improvement program for review by 

CMS. 

Specifically, as part of the program 

scope in § 494.110(a)(2), a dialysis 

facility must measure, analyze, and 

track quality indicators or other aspects 

of performance that the facility adopts 

or develops that reflect processes of care 

and facility operations. The standard for 

monitoring performance improvement, 

§ 494.110(b), states that a facility must 

continuously monitor its performance, 

take actions that result in performance 

improvement, and track performance to 

ensure improvements are sustained over 

time. 

The burden associated with all of the 

requirements of this section is the time 

and effort necessary to develop, 

implement, maintain, evaluate, and 

demonstrate evidence of a quality 

assessment and performance 

improvement program. We believe that 

an overwhelming majority of dialysis 

facilities already have established and 

sustained QAPI programs. We estimate 

that only 10 percent of dialysis facilities 

need to develop and implement QAPI 

programs. It would take 517 facilities 

(10 percent of the estimated number of 

existing facilities in 2009 of 5,173, 

assuming 4.4 percent annual growth) 

each approximately 48 hours to meet 

these requirements. The one-time 

burden associated with this requirement 

is estimated to be 20,016 hours. 

Additionally, all facilities would be 

subject to an annual burden to maintain, 

evaluate, and demonstrate evidence of a 

quality assessment and performance 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20457 

improvement program. The facility must 

analyze and document the incidence of 

infection and identify trends and 

establish baseline information on 

infection incidence; and develop 

recommendations and an action plan to 

minimize infection transmission, 

promote immunization, and take actions 

to reduce future incidents. The burden 

associated with this requirement is the 

time and effort it would take for a 

facility to document the incidence of 

infection and develop recommendations 

and an action plan to reduce future 

incidents. We estimate it would take 

5,415 facilities 12 hours annually each 

to meet this requirement, for a total 

annual burden of 64,980 hours. 

L. ICRs Regarding Special Purpose 

Renal Dialysis Facilities (§ 494.120) 

As required by § 494.120(d), a facility 

must contact the patient’s physician, if 

possible, prior to initiating dialysis in 

the special purpose renal dialysis 

facility, to discuss the patient’s current 

condition to assure care provided in the 

special purpose renal dialysis facility is 

consistent with the plan of care 

(described in § 494.90 of this part). The 

burden associated with this requirement 

is the time and effort necessary to 

contact the patient’s physician to 

discuss the patient’s current condition 

and to ensure that the care provided by 

the special purpose renal dialysis 

facility is consistent with the patient 

plan of care. This requirement is subject 

to the PRA; the burden is currently 

approved under OMB #0938–0386, with 

an expiration date of March 31, 2010. 

Section 494.120(e) requires that a 

facility document all patient care 

provided in the special purpose facility 

and forward the documentation to the 

patient’s dialysis facility, if possible, 

within 30 days of the last scheduled 

treatment in the special purpose renal 

dialysis facility. The burden associated 

with this requirement is the time and 

effort necessary to document the patient 

care and to forward the documentation 

to the patient’s dialysis facility. The 

burden associated with this requirement 

is approved under OMB #0938–0386, 

with an expiration date of March 31, 

2010. 

M. ICRs Regarding Responsibilities of 

the Medical Director (§ 494.150) 

In the proposed rule that published 

February 4, 2005 (70 FR 6184) we 

discussed the responsibilities of the 

medical director. However, we 

erroneously reported that the 

requirements were previously approved 

under OMB control number 0938–0086. 

This section does not impose any 

burden associated with information 

collection requirements. 

N. ICRs Regarding Medical Records 

(§ 494.170) 

Section 494.170 requires that a 

dialysis facility maintain complete, 

accurate, and accessible records on all 

patients, including home patients who 

elect to receive dialysis supplies and 

equipment from a supplier that is not a 

provider of ESRD services, and on all 

other home dialysis patients whose care 

is under the supervision of the facility. 

The burden associated with this 

requirement is the time and effort 

necessary to maintain the required 

documentation in the medical record. 

This requirement is subject to the PRA; 

the burden is currently approved under 

OMB #0938–0386, with an expiration 

date of March 31, 2010. 

Section 494.170(a)(3) requires that a 

dialysis facility obtain written 

authorization from the patient or legal 

representative before releasing 

information that is not authorized by 

law. The burden associated with this 

requirement is the time and effort 

necessary to draft the authorization form 

and to obtain the signature of the patient 

or the patient’s legal representative. 

This requirement is subject to the PRA; 

the burden is currently approved under 

OMB #0938–0386, with an expiration 

date of March 31, 2010. 

Section 494.170(c) contains a 

recordkeeping requirement. Facilities 

must maintain all patient records on file 

for 6 years from the date of the patient’s 

discharge, transfer, or death. The burden 

associated with this requirement is the 

time and effort necessary to maintain 

the patient records for 6 years. While 

the burden associated with this 

requirement is approved under OMB 

#0938–0386, this information must be 

maintained in accordance with other 

Federal, State, and local laws. We 

believe this requirement is exempt 

under 5 CFR 1320.3(b)(3); the burden 

would exist in the absence of the 

Federal requirement contained in this 

regulation. 

Section 494.170(d) states that when a 

dialysis patient is transferred, the 

dialysis facility releasing the patient 

must send all requested medical record 

information to the receiving facility 

within 1 working day of the transfer. 

The burden associated with this 

requirement is the time and effort 

necessary to disclose all requested 

medical record information to the 

receiving facility. This requirement is 

subject to the PRA; the burden is 

currently approved under OMB #0938–

0386, with an expiration date of March 

31, 2010. 

O. ICRs Regarding Governance 

(§ 494.180) 

Section 494.180(e) discusses the 

standard for a facility’s internal 

grievance process. This section requires 

that the facility’s internal grievance 

process be implemented so that the 

patient may file an oral or written 

grievance with the facility without 

reprisal or denial of services. In 

addition, § 494.180(e)(1)–(3) details the 

required contents of the process. The 

burden associated with this requirement 

is the time and effort necessary to 

develop and implement the internal 

grievance process. There is also burden 

associated with making patients aware 

of the process. We believe that all 

existing facilities already have internal 

grievance processes, as they are already 

required in conjunction with 

participation in ESRD Network 

activities. We acknowledge that there 

may be a very small number of facilities 

that do not have grievance processes in 

place, so we estimate that it would take 

2 facilities 1.5 hours each to develop 

grievance processes and inform patients 

about them. Therefore, we estimate a 

total one time burden of 3 hours. 

As required by § 494.180(f)(4), the 

interdisciplinary team must document 

the patient reassessments, ongoing 

problem(s), and efforts made to resolve 

the problem(s) and enter the 

information into the patient’s medical 

record. In addition, the facility must 

notify the patient with a 30-day written 

notice of planned involuntary discharge, 

and also notify the ESRD Network that 

services the area and the State agency of 

the discharge. 

The burden associated with this 

requirement is the time and effort 

necessary to document the 

reassessments in the medical records 

and the time and effort necessary to 

notify the patient and ESRD Network 30 

days prior to the involuntary discharge 

and the State agency at the time of 

involuntary discharge. We estimate it 

would take 10 minutes per incident to 

record the documentation and provide 

such notification. 

While this requirement is subject to 

the PRA, we have no way to accurately 

quantify the number of affected 

individuals. Our best estimate is that 

each facility would have less than one 

patient involuntarily discharged on a 

yearly basis. We estimate that the total 

annual burden for 5,415 facilities would 

be 903 hours. 

The interdisciplinary team must 

obtain a written physician’s order that 

must be signed by both the medical 

director and the patient’s attending 

physician concurring with the patient’s 


PWALKER on PROD1PC71 with RULES2
20458 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

discharge or transfer from the facility. 

They must also document any attempts 

to place the patient in another facility 

and notify the State survey agency of the 

involuntary transfer or discharge. 

The burden associated with this 

requirement is approved under OMB 

#0938–0386, with an expiration date of 

March 31, 2010. However, the 

requirement for the second signature 

from the medical director is new. We 

estimate that it would take 5 minutes for 

the medical director to sign the 

discharge order. While this requirement 

is subject to the PRA, we have no way 

to accurately quantify the burden. Our 

best estimate is that each facility would 

have less than one patient involuntarily 

discharged on a yearly basis. We 

estimate that the total annual additional 

burden for 5,415 facilities would be 451 

hours. 

Section 494.180(g) discusses the 

standard for emergency coverage. As 

required by § 494.180(g)(2), the dialysis 

facility must have available at the 

nursing/monitoring station, a roster 

with the names of physicians to be 

called for emergencies, when they can 

be called, and how they can be reached. 

We estimate that it would take 5,415 

facilities 10 minutes each to develop 

such a roster. We estimate that the total 

one-time burden would be 903 hours. 

Section 494.180(g)(3) contains the 

requirement that a dialysis facility must 

have an agreement with a hospital that 

can provide inpatient care, routine and 

emergency dialysis, and other hospital 

services, and emergency medical care 

that is available 24 hours a day, 7 days 

a week. The burden associated with this 

requirement is the time and effort 

necessary for the dialysis facility to draft 

the agreement and to finalize the 

agreement with hospital. This 

requirement is subject to the PRA; the 

burden is currently approved under 

OMB #0938–0386, with an expiration 

date of March 31, 2010. 

Section 494.180(h) states that a 

dialysis facility must furnish data and 

information electronically to CMS at 

intervals specified by the Secretary, 

which meet the requirements referenced 

in this section. The information 

collection activities discussed in this 

section are approved under the 

following OMB control numbers: 

OMB control No. Collection title Expiration date 

0938–0046 ................... End-Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration 09/30/2010 

0938–0386 ................... Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services & Suppt Regs. 

at 42 CFR 405.2100–.2171.

03/31/2010 

0938–0657 ................... End State Renal Disease Network Semi-annual Cost Report Forms ...................................................... 12/31/2009 

0938–0658 ................... ESRD Network Business Proposal Forms ............................................................................................... 02/28/2010 

These requirements are subject to the 

PRA, and are currently approved under 

the following OMB approval numbers: 

0938–0046, 0938–0360, 0938–0386, 

0938–0657, and 0938–0658. 

Section 494.180(j) contains the 

standard for disclosure of ownership. In 

accordance with §§ 420.200 through 

420.206 of this chapter, the governing 

body must report ownership interests of 

5 percent or more to its State survey 

agency. The burden associated with this 

requirement is the time and effort 

necessary to disclose ownership 

interests to CMS. This requirement is 

subject to the PRA; the burden is 

currently approved under OMB control 

number 0938–0086 with an expiration 

date of December 31, 2008. 

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN

Regulation section(s) OMB control 

number Respondents Responses 

Burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

§ 414.330 .............................................................................. 0938–New 24,657 24,657 1.5 36,986 

§ 488.60(a)(1–4) ................................................................... 0938–New 238 238 40 9520 

§ 494.30(a)(1)(ii) ................................................................... 0938–New 214 214 1 214 

§ 494.30(b)(1) ....................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.30(b)(1(ii)(c) ................................................................ 0938–New 54 54 .05 4.5 

§ 494.40(c) ........................................................................... 0938–New 54 54 .50 27 

§ 494.60(b) ........................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.60(d)(2) ....................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.60(d)(4)(i)–(iii) ............................................................. 0938–New 238/5,415 238/5,415 5/1 6,605 

§ 494.70 ................................................................................ 0938–0386 ........................ ........................ ........................ ........................

§ 494.80 ................................................................................ 0938–0386 ........................ ........................ ........................ ........................

§ 494.90 ................................................................................ 0938–0386 ........................ ........................ ........................ ........................

§ 494.100(c)(1)(i)(ii)(iii)(v) ..................................................... 0938–New 24,657 24,657 6 147,942 

§ 494.100(c)(2) ..................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.110 .............................................................................. 0938–New 5,415 5,415 12 64,980 

§ 494.120 .............................................................................. 0938–0386 ........................ ........................ ........................ ........................

§ 494.120(e) ......................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.170 .............................................................................. 0938–0386 ........................ ........................ ........................ ........................

§ 494.170(a)(3) ..................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.170(c) ......................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.170(d) ......................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.180(e)(1)–(3) .............................................................. 0938–New 2 2 1.5 3 

§ 494.180(f)(4) ...................................................................... 0938–New 5,415 5,415 .10 903 

§ 494.180(f)(4)(iii) ................................................................. 0938–New 5,415 5,415 .10 451 

§ 494.180(g)(3) ..................................................................... 0938–0386 ........................ ........................ ........................ ........................

§ 494.180(h) ......................................................................... 0938–0046 100,000 100,000 .75 75,000 

0938–0657 18 36 3 108 

0938–0658 18 36 30 1080 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20459 

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN—Continued 

Regulation section(s) OMB control 

number Respondents Responses 

Burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

§ 494.180(j) .......................................................................... 0938–0086 125,000 125,000 .5 62,500 

Total .............................................................................. ........................ ........................ ........................ ........................ 336,803 

** There are multiple regulation sections approved under this OMB control number. There is uniform burden per response. 

We have submitted a copy of this final 

rule to OMB for its review of the 

information collection requirements. 

These requirements are not effective 

until they have been approved by OMB. 

In addition, any burden requirements 

previously approved under an OMB 

control number will be re-examined and 

updated during the next OMB PRA 

review cycle. 

VII. Regulatory Impact Analysis 

A. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132 on 

Federalism, and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Order 12866 (as amended 

by Executive Order 13258, which 

merely reassigns responsibility of 

duties) directs agencies to assess all 

costs and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). 

This rule is a revision of the Medicare 

conditions for coverage for end-stage 

renal disease (ESRD) dialysis facilities. 

The conditions for coverage are the 

basic health and safety requirements 

that an ESRD supplier of services must 

meet in order to receive payment from 

the Medicare program. This final rule 

incorporates new scientific advances 

and current medical practices utilized 

in treating ESRD while removing 

numerous burdensome process and 

procedural requirements contained in 

the 42 CFR part 405, subpart U 

conditions for coverage. While it is not 

possible at this point to determine 

definitively the additional costs and 

cost savings to the Medicare program 

resulting from this rule, we do not 

believe that the impact will be above the 

$100 million economically significant 

threshold; and therefore, believe that 

this final rule is not a major rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $6.5 million to $31.5 million in any 

1 year. Kidney dialysis centers with 

revenues at or below $31.5 million are 

small entities http://sba.gov/idc/groups/ 

public/documents/sba_homepage/ 

serv_sstd_tablepdf.pdf, see Sector 62). 

According to 2004 revenue data, nearly 

163 dialysis facilities (5.2 percent of all 

establishments) could be considered to 

be small entities. This rule will not have 

a significant economic impact on small 

entities. This regulation could cost these 

small facilities an average of $2,392 

(about 2.4 percent of $100,000) for 

upgrades and improvements, and save 

small facilities up to $5,043 in the first 

year, resulting in an average net firstyear cost savings of up to $2,651. The 

Secretary certifies that this final rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. Since this final rule applies only 

to dialysis facilities, it has no impact on 

small rural hospitals. The Secretary 

certifies that this final rule will not have 

a significant impact on the operations of 

a substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

That threshold level is currently 

approximately $130 million. This rule 

has no impact on the expenditures of 

State, local or tribal governments, and 

the impact on private sector 

expenditures is estimated to be less than 

$130 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This rule will not have a substantial 

effect on State and local governments. 

B. Anticipated Effects 

1. Subpart A—General Provisions 

Subpart A ‘‘General Provisions,’’

addresses the basis and scope (§ 494.1) 

of this regulation, definitions used in 

the new conditions for coverage 

(§ 494.10), as well as compliance with 

Federal, State, and local laws and 

regulations (§ 494.20). These provisions 

do not result in any new economic 

impact as the definitions do not include 

any new requirements and facility 

compliance with laws and regulations is 

consistent with the existing 

requirements at § 405.2135. We have 

removed the requirements found in 42 

CFR part 405, subpart U, which specify 

qualifications that the dialysis facility 

CEO must have. This change may 

relieve a degree of burden for small 

businesses, as a greater number of 

candidates would qualify for this 

position, thereby affording facilities 

greater hiring flexibility. We have also 

removed the 42 CFR part 405, subpart 

U, medical record practitioner 

requirement (§ 405.2102, definition of 

‘‘Qualified Personnel’’ at (c)). This may 

provide some burden relief specifically 

for small businesses. The medical 

record practitioner cost savings is 

computed in this impact analysis under 

the medical record condition for 

coverage. 

2. Subpart B—Patient Safety 

a. § 494.30 Infection Control 

This final rule requires (at § 494.30(a)) 

compliance with the CDC 

‘‘Recommendations for Preventing 


PWALKER on PROD1PC71 with RULES2
20460 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

Transmission of Infections Among 

Chronic Hemodialysis Patients.’’ Many 

of these infection control precautions 

are standard care practices and do not 

present any additional burden for 

dialysis facilities. We did receive a 

comment regarding the infection control 

precaution that calls for the use of 

disposables or dedication to single 

patient use those items that cannot be 

cleaned and disinfected. This 

commenter stated that use of disposable 

blood pressure cuffs is impractical, as is 

dedication of blood pressure cuffs for 

single patient use, and that disposable 

blood pressure cuff covers are not 

currently available. 

However, according to information 

available on the Internet, disposable 

blood pressure cuffs are available (at a 

cost of approximately $6 each), as are 

disposable blood pressure cuff covers. A 

blood pressure cuff sleeve is available 

for 12 cents. In addition, easy-to-clean, 

one-piece, nylon latex-free blood 

pressure cuffs that are universally 

compatible with all blood pressure 

monitors, are available for about $7.00. 

The estimated burden for complying 

with the CDC infection precautions 

would be $7.00 per dialysis station with 

the cost varying depending on the size 

of the facility. Smaller dialysis facilities 

would have a smaller burden than large 

dialysis facilities. Since the CDC 

‘‘Recommendations for Preventing 

Transmission of Infections Among 

Chronic Hemodialysis Patients’’ were 

published in 2001, some dialysis 

facilities have already updated their 

practices and are adhering to the CDC 

guidelines regarding dedicated use of 

non-cleanable items or use of 

disposables. We estimate that 75 percent 

of dialysis facilities still need to change 

their blood pressure cuff use practices to 

comply with the 2001 CDC infection 

control precautions. We estimate that in 

2008 there will be 70,892 dialysis 

stations (based on an annual growth rate 

of 4.4 percent and USRDS data showing 

79,567 dialysis stations in 2004) that 

need to be upgraded with a cleanable 

reusable blood pressure cuff. The 

associated first year cost is estimated to 

be $496,244 ($7.00 × 70,892 stations). 

The annual cost thereafter is estimated 

to be $49,624, to account for up to 10 

percent of the blood pressure cuffs that 

may need to be replaced annually due 

to extreme contamination or damage. 

One commenter stated that the CDC 

precautions regarding separate staff to 

care for HBV positive and HBV 

negative/susceptible patients will 

produce unintended adverse 

implications for smaller facilities and/or 

smaller dialysis shifts. This commenter 

further stated that this requirement may 

make it cost prohibitive for small 

facilities (< 9 stations) to admit HBV 

positive patients. The CDC 

‘‘Recommendations for Preventing 

Transmission of Infections Among 

Chronic Hemodialysis Patients,’’

incorporated by reference in this final 

rule, state that staff members caring for 

HBsAG-positive patients should not 

care for HBV susceptible patients at the 

same time. This means a staff member 

could care for HBV protected dialysis 

patients who have been vaccinated and 

have developed sufficient antibodies to 

HBV while caring for an HBsAGpositive patient. The prevalence of 

HBsAG positivity and incidence of HBV 

infection in hemodialysis patients was 

1.0 and 0.12 percent, respectively, in 

2002 and had not changed substantially 

during the previous 10 years (Finelli, et 

al., ‘‘National Surveillance of DialysisAssociated Diseases in the United 

States, 2002, Seminars in Dialysis—Vol. 

18, No. 1 (January–February) 2005, pp. 

52–61). We note that the hepatitis B 

vaccination is now administered 

universally in the U.S. as part of 

standard childhood immunizations. 

Dialysis facilities also offer the HBV 

vaccination and the number of patients 

immunized approaches 32 percent in 

hemodialysis patients age 65 and older 

(2004 USRDS data). Therefore, the 

number of dialysis patient acute 

hepatitis B cases is not expected to be 

great and the number of HBV 

immunized patients is expected to grow. 

We believe that when there is 

appropriate patient scheduling, the 

separate staff requirement will present 

minimal burden to dialysis facilities. 

This final rule calls for adherence to 

the pertinent sections of the Healthcare 

Infection Control Practices Advisory 

Committee (HICPAC) guidelines for 

catheter-related infection prevention at 

§ 494.30(a)(2). We heard from 

nephrology nurses in their comments 

that their organization ‘‘has recognized 

the ‘Guideline for Preventing 

Intravascular Device-Related Infections’

as the appropriate standard of care. We 

encourage CMS to do likewise in the 

Final Rule.’’ We believe that these 

HICPAC catheter infection prevention 

guidelines are the professional nursing 

standard of practice and no additional 

burden is imposed by this requirement. 

We are requiring at § 494.30(a) that 

new dialysis facilities have an isolation 

room unless a waiver is requested and 

approved by the Secretary. Section 

494.30(a)(1)(ii) states that when dialysis 

isolation rooms are available locally that 

sufficiently serve the needs of patients 

in the geographic area, a new dialysis 

facility may request a waiver of the 

isolation room requirement, subject to 

the approval of the Secretary. According 

to CDC data, the 2004 reported U.S. rate 

of viral hepatitis B cases was 2.1 per 

100,000 population, and has decreased 

almost every year since a high of 11.5 

per 100,000 in 1985 (http:// 

www.cdc.gov/hepatitis). The prevalence 

of HBsAG positivity and incidence of 

HBV infection in hemodialysis patients 

was 1.0 and 0.12 percent respectively in 

2002 and had not changed substantially 

during the previous 10 years (Finelli, et 

al., ‘‘National Surveillance of DialysisAssociated Diseases in the United 

States, 2002, Seminars in Dialysis—Vol. 

18, No. 1 (January–February) 2005, pp. 

52–61). As stated earlier, the hepatitis B 

vaccination is now administered 

universally as part of standard 

childhood immunizations in the U.S. 

Therefore, the number of dialysis 

patient acute hepatitis B cases is 

expected to be small, and we believe 

that a large number of new dialysis 

facilities will request an isolation room 

waiver. We also believe that this process 

allows for variation in geographic 

isolation room needs that may present 

as the local population changes. We 

expect that the development and 

submission of this waiver will require 

the involvement of the facility 

administrator. This individual will need 

to determine the number of dialysis 

isolation rooms available in the facility’s 

geographic area that could sufficiently 

serve its patients, prepare the waiver 

request, and submit the request to us. 

We believe that these tasks will require 

about 1 hour and should cost about 

$54.81 (http://www.swz.salary.com). 

As of the spring of 2007, there were 

4,746 Medicare approved dialysis 

facilities (DFC data: http:// 

www.medicare.gov/Download/ 

DownloadDB.asp). From 1998 to 2004, 

the average yearly growth (using USRDS 

data) in dialysis facilities was 4.4 

percent. We anticipate a similar rate of 

growth in dialysis facilities over the 

next few years. Thus, we believe that 

218 new dialysis facilities will request 

Medicare approval in 2009 and that over 

the five-year period from 2009 to 2013 

a total of 1,191 new dialysis facilities 

will request Medicare approval. Since 

we are requiring compliance with this 

isolation room requirement 300 days 

after publication of this final rule, we 

are using 2009 estimates of the numbers 

for new and renovated dialysis facilities. 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20461 

COST OF ISOLATION ROOM WAIVER REQUESTS

Year 

New dialysis 

facilities 

(4.4% annual 

increase) 

Ninety percent 

of new dialysis 

facilities 

Estimated total 

cost for waiver requests ($54.81 × 

waiver requests 

from 90% of new 

facilities) 

2009 ....................................................................................................................................... 218 196 $10,743 

2010 ....................................................................................................................................... 228 205 11,236 

2011 ....................................................................................................................................... 238 214 11,729 

2012 ....................................................................................................................................... 248 223 12,223 

2013 ....................................................................................................................................... 259 233 12,771 

Total ................................................................................................................................ 1,191 1,071 1 58,702 

1 5-year cost. 

We believe that approximately 90 

percent of the new dialysis facilities 

will request a waiver of the isolation 

room requirement. Thus, the estimated 

first year cost of complying with this 

waiver requirement is $10,743, and the 

estimated total five-year implementation 

cost for this requirement is $58,702. 

Isolation room waivers may be 

granted at the discretion of, and subject 

to, additional qualifications as may be 

deemed necessary by the Secretary. We 

do not have data that shows the current 

percentage of dialysis providers that 

open new dialysis facilities with 

isolation rooms under the 42 CFR part 

405, subpart U, requirements, nor do we 

currently have data that show whether 

there is a shortage of isolation rooms in 

some areas. The CMS regional offices 

will monitor and evaluate local dialysis 

isolation room needs. Since existing 

facilities may use a separate area, rather 

than an isolation room, it is likely that 

some HBsAg-positive patients dialyze in 

units without isolation rooms. 

Commenters shared concerns about the 

costs involved in converting existing 

dialysis facilities to include an isolation 

room. Some commenters questioned the 

need for an expense of an isolation room 

in all new dialysis units as specified in 

the CDC infection control precautions 

incorporated by reference. We have 

responded to isolation room comments 

by requiring existing facilities only to 

have a separate demarcated area, 

consistent with CDC recommendations, 

and allowing new dialysis facilities to 

request an isolation room waiver. 

We believe the infection control 

provisions at § 494.30(a)(3) and (4) are 

consistent with the requirements at 

§ 405.2140(c) and do not produce 

additional burden. In addition, we have 

moved some of the infection control 

requirements to the QAPI provisions at 

§ 494.110(a)(ix). We have also removed 

the requirement at proposed 

§ 494.30(b)(2) regarding the designation 

of an RN to act as an infection control 

officer. Several commenters stated that 

this proposed requirement would be 

unnecessarily burdensome. One 

commenter stated a burden of $67,000 

in compensation for an additional fulltime RN. We have modified the 

oversight requirements and removed the 

RN infection control officer provision; 

therefore, no additional burden is 

imposed. Infection control issues must 

be reported to the facility medical 

director and the quality improvement 

committee. We believe that it is 

standard practice to track incidents and 

identify problems related to infection 

control and that this requirement will 

not produce any additional burden. 

Dialysis facilities must also report 

incidences of communicable diseases as 

required by Federal, State, and local 

regulations. We expect that facilities are 

already compliant with communicable 

disease reporting requirements and that 

this provision does not represent any 

additional burden. 

b. § 494.40 Water Quality 

The water quality condition for 

coverage requires compliance with the 

ANSI/AAMI RD:52:2004 ‘‘Dialysate for 

hemodialysis.’’ These guidelines 

developed for dialysis facilities are the 

professional standard of practice and 

have been available for about 3 years. A 

facility’s water treatment equipment, 

equipment maintenance and monitoring 

processes, and water testing procedures 

need to be consistent with the RD52 

guidelines to provide sufficiently pure 

dialysate. We believe dialysis facilities 

strive to deliver dialysate for use in 

hemodialysis and in the reuse process 

that meets the AAMI water purity 

guidelines. The American Nephrology 

Nurses Association stated that they 

believe most facilities in the U.S. have 

already implemented a two carbon tank 

water treatment system with a minimum 

of 10 minutes empty bed contact time to 

prevent the exposure of patents to 

chloramines. We received several 

comments regarding the burden 

associated with the proposed frequency 

of chlorine/chloramine testing. We have 

modified the proposed water quality 

requirements and the frequency of 

chlorine/chloramines testing and 

require compliance with the AAMI 

RD:52 guidelines in this final rule. Since 

we believe that the vast majority of 

dialysis facilities adhere to the AAMI 

RD52 guidelines, this requirement 

would result in little additional burden. 

c. § 494.50 Reuse of Hemodialyzers 

and Bloodlines 

The Reuse of hemodialyzers condition 

for coverage requires compliance with 

the AAMI guidelines published in 

‘‘Reuse of Hemodialyzers’’, third 

edition, ANSI/AAMI RD47:2002/ 

A1:2003, which is incorporated by 

reference. These 2003 guidelines update 

RD47, second edition, published in 

1993, which is incorporated by 

reference in 42 CFR part 405, subpart U. 

The majority of dialysis facilities 

choosing to perform hemodialyzer reuse 

likely have already updated their 

procedures and practices to conform to 

the current professional standard of 

practice in the area of reuse. 

At § 494.50(c)(2) we require that blood 

and dialysate cultures and endotoxin 

levels be obtained when clinically 

indicated, while the former requirement 

at § 405.2150(a)(3) requires ‘‘appropriate 

blood cultures’’ and system evaluation. 

The dialysate cultures and endotoxin 

levels to be obtained when an adverse 

patient reaction to reuse is suspected 

may present a small additional burden 

to facilities. A colony count (culture) 

costs approximately $6, while the LAL 

endotoxin test costs about $10 to $35 

per test, depending on the method 

utilized. We expect that since dialysis 

facilities must adhere to the new AAMI 

RD47 guidelines, adverse reactions 

related to hemodialyzer reuse occur 

infrequently and the cost burden is 

small. The remaining provisions of 


PWALKER on PROD1PC71 with RULES2
20462 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

§ 494.50 primarily provide clarifications 

that do not add burden. We did not 

receive any comments related to burden 

imposed by this condition for coverage. 

d. § 494.60 Physical Environment 

The ‘‘Building’’ and ‘‘Equipment 

maintenance’’ standards at § 494.60(a) 

and (b) contain requirements similar to 

some of the provisions at § 405.2140(a), 

and we believe do not impose any 

additional burden. Standard (c) ‘‘Patient 

care environment’’ is consistent with 

requirements at § 405.2140(b)(2). The 

provision regarding a comfortable room 

temperature closely resembles 

§ 405.2140(b)(2). However, the 

requirement to ‘‘make reasonable 

accommodations for the patients who 

are not comfortable at this temperature’’

is new. Facilities could meet this 

requirement by providing blankets to 

patients as many other healthcare 

providers do, which could entail added 

burden, or the facility could simply 

allow patients to bring a clean blanket 

or cover to the dialysis facility. 

Although a facility would be required to 

adhere to infection control precautions 

if a patient’s blanket became soiled 

during the dialysis session, we do not 

believe this second option would add 

any significant burden for the dialysis 

facility. 

We are requiring, similar to 

§ 405.2140(b)(2), that the dialysis 

facility make accommodations to 

provide for patient privacy when 

patients are examined or treated and 

body exposure is required. We believe 

that the vast majority of dialysis 

facilities are equipped with the movable 

privacy screens, partitions, or curtains 

that would be needed in order to meet 

this requirement. 

Emergency preparedness 

requirements are found at § 494.60(d) in 

this final rule and correspond with the 

provisions at § 405.2140(d). The existing 

42 CFR part 405, subpart U regulations 

require dialysis facilities to have written 

policies and procedures for handling 

emergencies with annual reviews, 

testing, and revisions, and staff training 

to handle any emergency or disaster. 

This final rule requires that the staff be 

able to demonstrate the ability to 

manage emergencies that are likely to 

occur in the facility’s geographic area. 

Although an annual review will be 

required, the final rule does not require 

the involvement of the CEO in this 

activity. We estimate that a typical 

facility will expend 4 hours less of 

administrator’s time for this activity at 

$51.93 per hour (http:// 

www.swz.salary.com), with a net 

savings of $207.72 per year per facility 

for an overall savings for 4955 facilities 

of $1,029,253. 

We added a clarification to the 42 

CFR part 405, subpart U requirement 

that the staff inform patients of where to 

go during an emergency. Thus, this final 

rule requires that these instructions 

include direction for when the 

geographic area of the dialysis facility is 

evacuated. Some dialysis facilities may 

already include this level of detail in 

their emergency preparedness 

instructional materials; however, we 

expect that many facilities do not 

include this information. Adding these 

instructions to the patient educational 

materials may present a small burden 

for some dialysis facilities. A staff 

member would need to develop the 

instructions and materials. We estimate 

that it would take 2 to 3 hours to 

develop the instructions and material 

needed. Assuming that 90 percent of the 

dialysis facilities need to add this 

patient training to their program, we 

estimate a first year cost (using $39.14 

per hour compensation (http:// 

www.swz.salary.com) for a RN staff 

nurse) of $523,634 (4955 × 0.90 × 

$117.42). 

The final rule also adds a requirement 

to the 42 CFR part 405, subpart U 

provision that the dialysis staff must 

instruct the patients about who to 

contact during an emergency, so that 

when the dialysis facility is not 

operational, there is an alternate 

emergency telephone number (unless 

the facility has the ability to forward 

calls to another working phone 

number). Some facilities already may 

have a second emergency phone number 

or call forwarding for their patients to 

use in an emergency. Many phone 

service packages include call forwarding 

as a feature. In addition, some facilities 

may have obtained call forwarding or a 

second telephone line following the 

2005 hurricane season in the south. 

Nevertheless, we believe many facilities 

may need to establish a communication 

system that would meet the intent of 

this rule, by for example, obtaining call 

forwarding service or an alternate 

number. Utilizing business phone 

services pricing figures available on the 

Internet, we estimate a monthly fee of 

$6.00 for remote access call forwarding 

services added onto a business phone 

service package. Alternately, we 

estimate the cost of an additional 

separate business phone number at less 

than $50 per month. If 25 percent of all 

dialysis facilities need to set up new 

remote call forwarding and another 25 

percent initiate a new separate 

emergency phone number, we estimate 

the cost of this requirement to be 

approximately $69,384 (1239 × $6, plus 

1239 × $50). 

This final rule requires at 

§ 494.60(d)(1)(ii) that dialysis facility 

patient care staff maintain current 

cardiopulmonary resuscitation (CPR) 

certification. We believe that CPR 

training is provided for direct patient 

care staff in dialysis facilities in the U.S. 

and some units also offer CPR training 

and certification to staff that do not care 

directly for patients. One commenter 

stated that while many providers may 

certify patient care staff in CPR annually 

or every 2 years, there are also many 

who conduct CPR training without the 

expense of actual certification. The 

commenter further stated that CPR 

certification is too onerous and costly 

($67,600 per dialysis facility to cover 

the cost of one full-time RN) as it may 

require a CPR instructor on staff. The 

commenter also stated that there is an 

American Heart Association (AHA) fee 

of $25 per person for certification. A 

search on the Internet reveals that AHAcertified CPR classes for healthcare 

professionals cost an average of $25 per 

person with group discounts available. 

The cost for the class members to 

become certified CPR instructors 

averages about $200 with a certification 

period of up to 2 years. We did not find 

a $25 AHA CPR certification fee that is 

separate from the class fees that are 

charged. Thus, if a dialysis facility 

chose to have a staff RN certified as an 

instructor, it would likely require only 

two to four half-day group CPR classes 

per year. We believe that CPR training 

provided to dialysis facility direct care 

staff should meet AHA standards and 

that CPR training with certification is 

the standard of practice among health 

care providers. We do not have data on 

any dialysis facilities that offer CPR 

training without AHA CPR certification, 

nor did the commenter provide data. No 

other commenters stated concerns about 

CPR certification costs for patient care 

staff. We believe the vast majority of 

dialysis facilities provide AHA certified 

CPR training to protect patient safety 

and to mitigate liability risk, and we 

believe that the costs associated with 

this training and certification are part of 

the usual and customary costs assumed 

by healthcare providers. 

We are requiring that facilities have 

available a defibrillator or an automated 

external defibrillator (AED). Several 

commenters stated that an AED was 

more desirable and less burdensome 

than a traditional non-automated 

defibrillator, because the staff training 

and certification costs are much lower 

when an AED is used. Some 

commenters stated that use of nonautomated defibrillators require staff to 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20463 

be certified in Advanced Cardiac Life 

Support (ACLS) and that ACLS courses 

are not readily available to dialysis 

facilities, and are time consuming and 

costly. Commenters pointed out that 

AED training can be accomplished along 

with the usual CPR staff training. We 

have responded to commenters who 

were concerned about the burdensome 

costs of ACLS certification and training 

costs associated with the use of nonautomated defibrillators by including 

AEDs as an acceptable alternative 

device in this final rule. 

We are also requiring that certain 

emergency equipment be immediately 

available in the facility including 

oxygen, airways, suction, defibrillator or 

AED. The comparable 42 CFR part 405, 

subpart U requirement 

(§ 405.2140(d)(3)) is less specific and 

calls for an on-the-premises emergency 

tray, including emergency drugs, 

medical supplies, and equipment. We 

received comment that all 190 of the 

dialysis facilities owned by Dialysis 

Clinic, Inc. (DCI), a non-profit dialysis 

organization, are equipped with AEDs. 

Comments from Gambro noted that 

more than a third of their facilities are 

equipped with AEDs. According to 

USRDS data, in 2004 there were 585 

Gambro dialysis facilities (34 percent 

equals 198 facilities equipped with 

AEDs). If we use 34 percent as our AED 

equipped estimate for the remaining 

dialysis facilities (1118 Fresenius, 626 

DaVita, 417 Renal Care Group, 27 

National Nephrology Associates, 934 

independent—using 2004 USRDS data) 

the total number of dialysis facilities 

equipped with AEDs would be 1061. We 

presume that the 837 hospital based 

dialysis facilities (2004 USRDS data) 

already may have met the requirement, 

since they likely have immediate access 

to an in-hospital defibrillator. Based on 

the above figures we would expect that 

2,286 dialysis facilities already are 

equipped with AEDs or defibrillators 

(DCI—190, Gambro—198, hospitalbased—837, and 34 percent of all 

others—1061). We estimate that the 

remaining 2,669 dialysis facilities 

would need to purchase an AED or 

traditional defibrillator to comply with 

this final rule. 

Commenters suggest that the cost of 

an AED is approximately $2,500. Our 

research shows that the sales price of an 

AED ranges from $900 to $2,600. Using 

a $2,000 price, we estimate that it will 

cost $5,338,000 for 2,669 dialysis 

facilities to purchase AEDs. One 

commenter stated that we should 

recognize the costs of maintaining an 

AED. The American Heart Association 

Web site suggests that, in general, AEDs 

require fairly low upkeep, but regular 

maintenance will ensure their readiness 

in the event of an emergency. AED 

maintenance includes preventive 

maintenance checks according to the 

manufacturer’s recommendations and 

verifying battery installation and 

expiration, checking the status/service 

indicator light, inspecting exterior 

components and sockets for cracks or 

other damage, and checking AED related 

supplies (http:// 

www.americanheart.org/downloadable/ 

heart/110262192170770- 

2272%20ImplementGuide.pdf). We 

believe these visual checks will take 

about 5 minutes and can be done by a 

biomedical or patient care technician. 

Using an hourly compensation rate of 

$20.45 (http://www.swz.salary.com), 

this 5 minute task will cost $1.70 each 

month, times 12 months to equal $20.45 

annually. If we multiply $20.45 times 

the 2,669 facilities that will need to 

purchase AEDs, the cost will be $54,581 

per year. 

Two commenters stated that suction 

machines are costly to maintain and are 

seldom used. However, suction 

machines are necessary emergency 

medical devices that are used to clear 

the airway of secretions or vomit. To 

comply with 42 CFR part 405, subpart 

U, the huge majority of dialysis facilities 

are equipped with suction machines 

and have the tubing and suction 

catheter available in the packaging 

available for use. 

This final rule requires the facility to 

have a plan to obtain emergency 

medical system assistance when needed 

and to evaluate at least annually the 

effectiveness of emergency and disaster 

plans and update them as necessary, 

consistent with § 405.2140(d) 

requirements. A new provision calls for 

the facility to contact the local disaster 

management official at least annually to 

ensure that the agency is aware of 

dialysis facility needs in the event of an 

emergency. We believe this task will 

require one hour of time from either the 

administrator or the nurse manager. If 

we estimate the total compensation 

(wages plus benefits) for each as $54.81 

and $51.93 respectively (http:// 

www.swz.salary.com), and average 

them, we arrive at a cost of $53.37 per 

hour. Since there would be 4,955 

dialysis facilities that need to comply, 

we estimate the burden associated with 

this requirement to be $264,448 during 

the first year. 

This final rule requires that the 

facility meet the 2000 edition of Life 

Safety Code (LSC) requirements of the 

National Fire Protection Association. 

Most dialysis facilities currently meet 

most of the provisions required in 

Chapter 21 of the LSC, ‘‘Existing 

Ambulatory Health Care Occupancies,’’

because of state and local building 

codes as well as facilities’ interest in 

liability mitigation. Commenters were 

most concerned about the cost of 

retrofitting sprinkler systems in existing 

dialysis facilities and the implications 

for facilities housed in a multi-tenant 

building. Commenters were also 

concerned with the effort and expense 

incurred in submitting a request for a 

LSC sprinkler waiver to the Secretary. In 

response to comments, we are defining 

compliance with the 2000 LSC to 

include ‘‘grandfathering’’ existing 

facilities without sprinkler systems that 

would have needed to comply with the 

LSC sprinkler provision or request a 

waiver. New dialysis facilities or 

facilities undergoing extensive 

renovation would need to install a 

sprinkler system, depending on the type 

of construction materials and facility 

location within the building. An 

example of a dialysis facility that would 

likely require a sprinkler system would 

be one housed in a wooden construction 

three-story building, or in a high rise 

building. High rise buildings are 

generally built with sprinkler systems to 

satisfy State and local regulations. We 

estimate that few newly constructed 

dialysis facilities would be burdened by 

the 2000 LSC sprinkler requirements in 

this final rule because current local and 

state fire safety building requirements 

must be met. However, there may be 

some burden for existing facilities with 

regard to the installation and 

maintenance of the fire department 

alarm connection. Based on information 

we received from the dialysis industry, 

we estimate that approximately 10 

percent of dialysis facilities (496) will 

need to be upgraded to meet this 

requirement. In the proposed rule we 

estimated that the one-time cost to 

install a fire department or central 

monitoring station connection was 

$1,000 per facility and that the monthly 

fee for the monitoring station and 

telephone cost was about $80. We 

received a comment that the installation 

cost of an automated notification system 

in the Orlando, Florida area would 

exceed $3,000 and the monthly 

monitoring costs would be 

approximately $186 per month. The 

commenter stated that the CMS 

calculation was too low because it did 

not include the required back-up phone 

line, which would itself cost about $106 

per month. Another commenter stated 

that the monthly monitoring cost would 

be about $180. Another provider 

informed us that the monthly 

monitoring cost was about $30 and the 

cost of installing a monitoring and 


PWALKER on PROD1PC71 with RULES2
20464 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

automatic notification system ranges 

from $10,000 to $25,000 depending on 

the building characteristics. We will use 

$136 as our estimated monthly cost of 

automatic notification system 

monitoring ($106 phone line fee plus 

$30 monitoring fee), and $5,000 as our 

estimated installation cost. Thus, we 

estimate the additional overall cost of 

compliance for 496 facilities that would 

need to perform upgrades in the first 

year will be $3,289,472 ($2,480,000 

installation cost plus $809,472 

monitoring costs), with the annual cost 

thereafter being $809,472 ($136 per 

month × 12 months × 496 facilities). 

This estimate does not take into 

account any specific waivers or 

acceptance of a State code in lieu of the 

LSC that may decrease the burden. 

Some commenters were concerned 

about the cost of installing smoke 

barriers in buildings that are over 5000 

square feet, which could be a significant 

cost because air ducts for heating and 

air conditioning would have to be 

updated with smoke partitions. If the 

health and safety of patients and staff 

are not adversely affected, this final rule 

would permit us to waive specific 

provisions of the LSC, which, if rigidly 

applied, would result in an 

unreasonable hardship on the facility. In 

addition, the proposed rule specifies 

that the Secretary may accept a State 

code in lieu of the LSC, if it adequately 

protects patients. We cannot estimate 

how many dialysis facilities will request 

a LSC waiver as many facilities already 

meet the 2000 LSC due to State and 

local regulations and liability mitigation 

efforts. Additionally, facilities would 

only consider applying for a waiver after 

a LSC inspection found that LSC 

provisions were not adequately 

implemented. 

e. § 494.70 Patients’ Rights 

The 42 CFR part 405, subpart U 

regulations require dialysis facilities to 

have written patients’ rights policies 

and procedures and sets out a list of 

persons to whom such patient rights 

policies must be made available. This 

final rule details basic information that 

must be provided to patients (to include 

for example, information regarding 

advance directives, how to contact 

entities in regard to complaints, and 

dialysis modalities not offered by the 

facility including scheduling options for 

working patients) and requires that 

patients’ rights be prominently 

displayed. Some commenters stated that 

their facilities have already developed 

advance directive procedures that 

would help the facilities comply to the 

provision as stated in the proposed rule. 

One commenter recognized that many 

facilities are already informing patients 

of their right to have advance directives. 

Requiring minimum contents in the 

patients’ rights condition, and requiring 

only that these rights be posted, will 

limit the administrative burden. We 

estimate that this will save the typical 

facility about 2 hours of staff (social 

worker) time at $34.52 per hour 

(http://www.swz.salary.com), that is, 

$69.04 annually, for an overall savings 

of $342,093 (4,955 facilities times 

$69.04). 

The 42 CFR part 405, subpart U 

regulations required the facility to use 

translators when a significant number of 

patients exhibit language barriers. This 

final rule modifies this requirement and 

specifies that information be given to 

patients in a manner that assures their 

understanding. However, translators 

could still be used and facilities will 

have more flexibility in overcoming 

language barriers in lieu of hiring 

translators. This may result in a net 

reduction in facility costs. 

The previous regulations required that 

advance notice be given to patients who 

are being terminated from a dialysis 

facility. This final rule is more specific 

and requires that written notice be given 

30 days in advance. However, since 

involuntary terminations are a relatively 

infrequent occurrence and we are only 

adding a requirement regarding when 

the advance notice of involuntary 

discharge must be given, we consider 

the financial impact on dialysis 

facilities to be negligible. 

We expect that each facility must 

update their patient rights materials to 

meet the requirements of this final rule. 

If this task required 1 hour of social 

worker time at $34.52 per hour 

compensation, this provision would 

cost $171,047 (4,955 facilities times 

$34.52). 

f. § 494.80 Patient Assessment 

The ‘‘Patient assessment’’ condition 

for coverage includes assessment 

criteria that must be included in each 

comprehensive patient assessment. The 

frequency of assessment is identified as 

initial, 3 months after the initial 

assessment, and annually for stable 

patients and monthly for patients who 

are not stable. The adequacy of the 

patient’s dialysis prescription must be 

assessed at least monthly for dialysis 

patients and every four months for 

peritoneal patients. Commenters agreed 

that quality oriented dialysis facilities 

meet these new requirements already 

and that the patient assessment 

condition for coverage should not 

present any new burden to most dialysis 

facilities. 

g. § 494.90 Patient Plan of Care 

The ‘‘Patient plan of care’’ condition 

for coverage requires that the facility 

write and implement a plan of care after 

performing the comprehensive 

assessment. The facility must address 

eight clinical areas in the plan of care, 

utilizing standards that are consistent 

with accepted professional standards of 

practice. In this final rule, we have 

included a ‘‘psychosocial status’’ care 

plan component that requires that 

professional social work services be 

provided and that a standardized mental 

and physical assessment tool be 

utilized. The 42 CFR part 405, subpart 

U requirements were similar and 

included a provision requiring that the 

qualified social worker be responsible 

for conducting psychosocial evaluation, 

and that the social services provided 

maximize the social functioning and 

adjustment of the patient 

(§ 405.2163(c)). We do not believe that 

this final rule requirement adds new 

burden. 

Title 42 CFR part 405, subpart U 

provisions call for an initial short term 

care plan, an initial long term care plan, 

an updated short term plan of care every 

6 months for stable patients or monthly 

for unstable patients, and an annual 

review of the long-term care plan. The 

short term patient care plan is 

developed by a professional team 

consisting of at least the ESRD 

physician, an RN, the social worker, and 

the dietitian. The annual long-term 

program must be developed by a team 

which includes the dialysis facility 

physician-director, a physician-director 

of a self-care center, a transplant 

surgeon, an RN, a social worker, and a 

dietitian. This final rule removes the 

requirement for a separate long-term 

care program and reduces the frequency 

of formal care planning (after the first 

six months that a patient is on dialysis) 

from biannually to annually and 

reduced the burden of facility staff. We 

estimate that the burden associated with 

formal full interdisciplinary team care 

planning will be lessened by more than 

50 percent starting in the seventh month 

that a stable patient is on dialysis. 

Assuming the team meets formally to 

review and update the plan of care and 

spends at least 15 minutes on each care 

plan we estimate an annual cost savings 

of about $57.11 per patient per year for 

stable patients after the first year of 

dialysis. 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20465 

INTERDISCIPLINARY TEAM SHORT TERM CARE PLANNING COSTS UNDER PREVIOUS REGULATION

Hourly 

compensation 

(swz.salary.com) 

Staff Registered Nurse .......................................................................................................................... $39.14 

Dietitian .................................................................................................................................................. 36.74 

Social Worker ......................................................................................................................................... 34.52 

Attending Physician ............................................................................................................................... 118.05 

Total per hour ................................................................................................................................. 228.45 

per hour 

Cost of 15 minutes 

of team time for 1 

care plan for 1 patient = $57.11. 

According to the USRDS, in 2004 

there were 335,963 dialysis patients. If 

we add a 3 percent annual growth rate, 

our 2008 estimate of patients would be 

378,129. We will assume that about 90 

percent of dialysis patients are stable 

(378,129 × 0.90 = 340,316 stable 

patients). If we multiply the cost savings 

of $57.11 times the estimated number of 

stable point prevalent dialysis patients 

we find an annual costs savings estimate 

of $19,435,447. If we divide this total 

savings by the number of dialysis 

facilities (4,955) we see an average cost 

savings of $3,922 for each dialysis 

facility annually. There are further 

savings not shown here associated with 

the new patient plan of care 

requirements because the self-care 

dialysis physician-director, medical 

director, and the transplant surgeon do 

not need to participate in routine longterm care planning, as was previously 

required. One commenter stated that 

this change ‘‘will be beneficial to 

transform the current paper shuffling 

process into a practical course of 

action.’’ Another commenter stated that 

deletion of care plan review by the 

transplant surgeon is a positive change 

and allows more efficiency. This 

reduction in burden may be particularly 

helpful for small businesses, as process 

is reduced as well as the amount of staff 

time required for care planning, 

allowing more time for direct patient 

care. 

This final rule includes 

transplantation referral tracking, at least 

annual communication with the 

transplant center, and patient education 

and training. In response to comments 

regarding the burden of quarterly 

communications, we are requiring at 

least annual communication with the 

transplant center, rather than quarterly 

contact as in the proposed rule. We 

believe that many dialysis facilities do 

track the status of their transplant 

referred patients and also provide 

patient education on a regular basis. We 

believe these requirements fall within 

the scope of reasonable services that a 

dialysis facility should provide and do 

not represent new burden. We received 

comment that the new patient 

assessment and patient plan of care 

provisions would increase burden 

because dialysis facilities would need to 

redesign their standards and 

procedures, modify their electronic 

medical record systems, develop 

processes for implementing these 

requirements across all facilities, and 

retrain all employees. We expect that 

quality oriented dialysis facilities 

already meet the majority of 

requirements contained in this final 

rule. Dialysis facilities must update 

systems, processes, and staff training on 

a regular basis as part of their usual 

business practices, in order to stay 

current and respond to new technology 

and new medical information that 

becomes available. Our goal is to 

provide a burden analysis of costs that 

are newly required by this final rule. 

Facilities may choose to make 

additional changes to systems, 

processes, and staff’s training that go 

beyond what is specifically required by 

this final rule. These additional costs 

cannot be predicted, and we have not 

included usual or optional facility 

activities and their associated costs in 

this burden analysis. 

h. 494.100 Care at Home 

Many of the requirements in the ‘‘Care 

at home’’ condition for coverage are 

consistent with 42 CFR part 405, 

subpart U requirements and statutory 

provisions and do not represent new 

burdens. New requirements in this final 

rule include the retrieval and review of 

self-monitoring patient data at least 

every 2 months and inclusion of 

services furnished by a durable medical 

equipment supplier in the recordkeeping system. We believe that this 

task would present a minimal burden to 

home dialysis facilities. 

We received comments that the 

economic impact of this condition for 

coverage would be moderate to 

significant because it requires that selfcare training be conducted by a RN, and 

according to the commenter, facilities 

would likely have to hire additional 

personnel. We do not agree with this 

comment that additional burden is 

imposed by this final rule. The 42 CFR 

part 405, subpart U regulations required 

at § 405.2162(c) that ‘‘if the facility 

offers self-care training, a qualified 

nurse is in charge of such training (see 

§ 405.2102).’’ Section 405.2102 requires 

that an RN who is in charge of self-care 

dialysis training must have at least 3 

months of the total required (18 months) 

ESRD experience in training patients in 

self-care. This final rule requires at 

§ 494.140(b)(2) that the self-care training 

nurse be an RN with at least 12 months 

experience in providing nursing care 

and an additional 3 months of 

experience in the specific modality for 

which the nurse will provide self-care 

training (15 months experience in total). 

The requirement at § 494.100 provides 

that self-care training must be 

conducted by a registered nurse who 

meets the requirements of 

§ 494.140(b)(2). In both the previous 

regulations and this final rule, self-care 

dialysis training must be ‘‘conducted,’’

that is, led, guided, and managed by an 

RN with the specified dialysis 

experience. 

i. § 494.110 Quality Assessment and 

Performance Improvement 

This final rule requires dialysis 

facilities to develop, implement, 

maintain, and evaluate an effective, 

data-driven, quality assessment and 

performance improvement program. 

Facilities will use quality data 

internally, in a formal Quality 

Assessment and Performance 

Improvement (QAPI) program that each 

facility has the flexibility to develop in 

accordance with its own priorities. The 

two-thirds of dialysis facilities that are 

part of large dialysis organizations are 

likely already complying with this 

requirement and many other facilities 

also use quality data as part of their 

standard practices. We estimate that the 


PWALKER on PROD1PC71 with RULES2
20466 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

QAPI requirements would impose a new 

burden on no more than 10 percent of 

the dialysis facilities. 

Assuming that a facility was initiating 

a QAPI program only as a result of this 

final rule, this may entail a one-hour 

meeting of four staff persons monthly, 

that is, 48 staff hours of meeting time. 

Assuming a staff cost of $234.83 per 

hour (combined costs using hourly 

compensation figures as follows; nurse 

manager—$41.58, social worker—

$34.52, dietitian—$36.74 and medical 

director—$121.99 per hour), the total 

additional cost to the facility would be 

$2,817.96 annually. The total cost for 

496 facilities would be $1,397,708. 

j. § 494.120 Special Purpose Renal 

Dialysis Facilities 

We do not believe that this condition 

for coverage imposes any new burdens. 

k. § 494.130 Laboratory Services 

We do not believe that this condition 

for coverage imposes any new burdens. 

l. § 494.140 Personnel Qualifications 

This condition for coverage delineates 

the qualifications personnel must have 

to provide care in a Medicare certified 

dialysis facility. We do not believe any 

additional burden is imposed by the 

qualification provisions for medical 

directors, nurses, dietitians, or social 

workers. The final rule patient care 

technician qualifications include new 

requirements including a high school 

diploma or equivalency, completion of 

a training program, and state 

certification within 18 months of being 

hired or within 18 months of the 

effective date of this final rule. 

This final rule adds new technician 

qualification requirements, including 

completion of a training program for 

water treatment system technicians and 

a written training program for dialysis 

patient care technicians that addresses 

operation of kidney dialysis equipment 

and machines and the provision of 

patient care. The training programs 

would be developed or adopted by the 

facility and must be approved by the 

medical director and the governing body 

of the facility. The training program may 

include written, audiovisual, and 

computer based instruction. Since the 

major dialysis organizations all have 

training programs for their dialysis 

patient care technicians and water 

treatment technicians, and the majority 

of dialysis facilities are affiliated with 

these chains, a large portion of facilities 

already meet this requirement. In 

addition, at least 11 States already have 

some form of credentialing (training; 

competency exam; certification) 

requirements for dialysis patient care 

technicians. Even facilities that are not 

affiliated with major dialysis 

organizations and are in a State where 

there are no credentialing requirements 

for dialysis technicians are not likely to 

be burdened with the requirement to 

develop a dialysis training program, 

since they can request medical director 

and governing body approval to use a 

packaged curriculum, which has been 

developed by organizations in the renal 

field and is currently available to any 

dialysis facility without cost. 

During the comment period, many 

commenters voiced concerns related to 

the proposed rule provision that 

required 3 months of dialysis patient 

care technician experience following a 

training program must be under the 

‘‘direct supervision of a registered 

nurse.’’ Commenters asserted that this 

requirement presented a large burden, 

as RNs do not have time to constantly 

directly oversee technicians in training 

and recommended that LPNs and 

experienced technicians be allowed to 

assist with directing patient care 

technician trainees. In response to 

comments, we revised this requirement 

in this final rule, so that the patient care 

technician training program must be 

under the direction of an RN and 

constant one-on-one RN supervision is 

not required (unless mandated by state 

provisions). This would allow other 

staff to act as preceptors under the 

supervision of an RN. State board of 

practice provisions must be adhered to 

so that technicians in training as well as 

experienced technicians function under 

the auspices of licensed nurses. 

Patient care technician certification 

under a state certification program or a 

nationally recognized certification 

program is required in this final rule, in 

response to commenter concerns of 

patient safety and increased risks 

associated with the prevalent and 

increasing use of uncertified personnel 

providing clinical patient care. 

Hemodialysis technicians, who may be 

uncertified and unlicensed, commonly 

perform clinical duties, which include 

dialysis machine setup, clinical 

observations and assessments of 

patients, cannulation, and administering 

local anesthetics, drugs including 

heparin, and saline solutions (subject to 

state nursing board of practice 

provisions). Several states already 

require certification of dialysis patient 

care technicians including California, 

Connecticut, Kentucky, New Mexico, 

Ohio, Oregon, Virginia, and West 

Virginia. According to the Nephrology 

Nursing Certification Commission 

(NNCC) ‘‘2005–2006 Annual Report 

Certification: Your Commitment to 

Quality’’ (www.nncc-exam.org/about/ 

annualReport2007.pdf) as of December 

2005, there were 1,425 Certified Clinical 

Hemodialysis Technicians (CCHT), 

while the Board of Nephrology 

Examiners Nursing and Technology 

(BONENT) states in a private 

communication there are 2,445 

BONENT certified hemodialysis 

technicians. We do not have data on the 

number of National Nephrology 

Certification Organization (NNCO) 

certified nephrology technicians. 

Although there are three different 

certification exams available nationally, 

only one, the Certified Clinical 

Hemodialysis Technician (CCHT) 

examination, is specifically geared 

towards entry level dialysis technicians. 

Eligibility to take the CCHT exam 

includes a recommended six months 

(1,000 hours) of experience in 

nephrology technology, while the other 

two exams (given by BONENT and 

NNCO) require 12 months of experience 

prior to the exam. We would expect that 

the majority of dialysis patient care 

technicians seeking certification to meet 

our requirement would take the CCHT 

examination offered by the NNCC. 

Hemodialysis technicians applying to 

take the CCHT examination must be 

high school graduates or have GEDs, 

successfully complete a training 

program for hemodialysis patient care 

technicians that includes both 

classroom instruction and supervised 

clinical experience, and meet state 

experience requirements. Currently, the 

examination application fee is $125 and 

the certification maintenance fee is $50 

every 2 years. The exam is offered at 

hosting ANNA chapters and dialysis 

facilities around the country, as well as 

in unison with dialysis conferences. A 

dialysis facility may host an 

examination when there are at least five 

participants, and, if there are at least 10 

participants, the NNCC exam manager 

fee of $150 is refunded. We believe that 

the flexibility of CCHT examination 

scheduling will alleviate the need for 

dialysis technicians to travel or incur 

overnight costs in order to become 

certified. We are allowing an 18-month 

time period so that patient care 

technicians have sufficient time to 

successfully complete the certification 

examination. The cost of taking the 

certification examination and 

maintaining certification would likely 

be borne by the technician, just as 

nurses, dietitians, and social workers 

frequently bear the costs of professional 

examination, registration, and licensing 

fees. Dialysis patient care technicians 

will need to complete a training 

program before taking the exam and 

would likely be employed by a dialysis 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20467 

center at the time when taking the 

examination and so would have an 

income from which to pay the necessary 

fee. Dialysis facilities have the option of 

whether to provide a certification fee 

benefit. 

We have retained the proposed 

requirement that water treatment system 

technicians complete a training program 

that has been approved by the medical 

director and the governing body. This 

requirement is in keeping with 42 CFR 

part 405, subpart U requirements 

(§§ 405.2136(c)(3)(viii), 405.2136(d)(6), 

405.2161(b)(2), and 405.2162), which 

specify governing body and medical 

director responsibilities related to 

proper orientation and training of staff, 

and we do not believe that this training 

requirement will result in new burdens. 

m. § 494.150 Responsibilities of the 

medical director 

We have revised and clarified the 

responsibilities (found at §§ 405.2161, 

405.2136(f), and 405.2137(a)(1)) and 

accountability of the medical director in 

this final rule. We do not believe that 

these requirements add new burdens. 

n. § 494.170 Medical Records 

In this final rule, essential 

requirements in regard to retention, 

preservation, and transfer of medical 

records are retained. However, the 

existing regulations are highly 

prescriptive in not only requiring the 

designation of a medical records 

supervisor, but in detailing that person’s 

duties, specifying categories of 

information to be included in the 

medical record, requiring written 

policies and procedures to protect 

medical records information, and even 

addressing spatial issues in regard to the 

maintenance and processing of medical 

records. This final rule deletes many of 

these requirements, giving the facility 

flexibility in deciding how the medical 

records are to be maintained and what 

is to be in them, as long as they facilitate 

positive patient outcomes. This reduces 

burden on the dialysis facilities. We 

estimate that this will save the typical 

facility about 40 hours of a medical 

records professional’s time, at $21.09 

per hour (http://www.swz.salary.com), 

that is, $844 annually, for an overall 

savings of $4,180,038. 

o. § 494.180 Governance 

This condition for coverage updates 

§ 405.2136, entitled ‘‘Governing body 

and management’’ and deletes several of 

the process requirements (for example, 

those under standard (b), ‘‘operational 

objectives,’’ and (d) ‘‘personnel policies 

and procedures’’). We believe the 

updated standards related to the CEO or 

administrator, adequate number of 

qualified and trained staff, medical staff 

appointments, furnishing services, 

emergency coverage, and disclosure of 

ownership do not produce any 

additional burdens over previous 42 

CFR part 405, subpart U requirements. 

We do note that 42 CFR part 405, 

subpart U requires the presence of a 

licensed physician, RN, or LPN when 

patients are being dialyzed, and our 

final rule specifies an RN presence. We 

believe that the majority of dialysis 

facilities strive to maintain a RN 

presence in the facility whenever 

patients are being dialyzed and expect 

that this modification would produce 

little additional burden. 

Standard (e) of the Governance 

condition for coverage requires a facility 

to implement an internal grievance 

process. The previous requirement at 

§ 405.2138(e) stated that all patients 

would be encouraged and assisted to 

understand and exercise their rights, 

and that grievances and recommended 

changes in policies and services could 

be addressed to facility staff, 

administration, the network 

organization, etc. We believe that many 

dialysis facilities have implemented an 

in-house grievance process; however, it 

is likely that approximately 15 percent 

of dialysis facilities may not have 

processes that would meet our new 

requirements. We estimate that it would 

take eight hours for a nurse manager (at 

$41.58 per hour) to develop and 

implement an appropriate grievance 

process at a cost of $333 per facility. 

The estimated total cost for 15 percent 

(743) of facilities to meet this 

requirement is $247,152. 

This final rule implements a 

discharge process that must be used if 

facilities must discharge patients against 

their will. We expect that this process 

would be needed infrequently (less than 

once per year) and only be used as a last 

resort. 

Furnishing Data and Information for the 

ESRD Program 

This final rule requires that all 

dialysis facilities furnish data and 

information electronically and in 

intervals specified by the Secretary, 

including cost reports, administrative 

forms, patient survival data, ESRD 

Clinical Performance Measures (CPMs) 

data, and any future standards 

developed in accordance with a 

voluntary consensus standards process 

identified by the Secretary. While 

submission of data and information is 

an existing requirement in § 405.2133 

and electronic submission of cost report 

data and information is an existing 

requirement in § 413.24, the 

requirement to provide CPM data above 

the national statistical sample is new. 

Additionally, the requirement to 

provide necessary administrative and 

CPM data in electronic format is a 

change from the paper-based process 

that has historically been used to 

support the ESRD program. 

We previously proposed using the 

VISION application as the electronic 

medium for the data collection required 

by the new conditions for coverage (70 

FR 6231). VISION was a patientspecific, stand-alone, facility-based 

information system with software that 

would reside on facility computers, 

which presented challenges for 

updating the software. We agree with 

commenters that VISION did not 

represent the best technology for widespread collection of data from dialysis 

organizations. As discussed earlier in 

this preamble (under section 

§ 494.180(h)), we are now implementing 

a new web-based application, 

CROWNWeb, for this purpose. This new 

approach is superior to the VISION 

application in that it will increase the 

efficiency of data collection, improve 

data quality, provide a more stable and 

accessible platform for continual 

improvements in functionality, and 

complement existing information 

infrastructures used by many dialysis 

facilities. We have recalculated the 

burden and cost savings related to 

electronic data reporting using 

CROWNWeb. 

The collection and reporting of ESRD 

CPMs has, to date, been an effort among 

CMS, the ESRD Networks, dialysis 

facilities, and other interested 

stakeholders to assess the care of a 

representative statistical sample of 

individuals receiving dialysis, and all 

pediatric, and Veteran’s Administration 

dialysis patients, in the areas of 

adequacy of dialysis, anemia 

management, nutrition (serum albumin), 

and more recently, vascular access 

(Centers for Medicare & Medicaid 

Services. 2006 Annual Report, ESRD 

Clinical Performance Measures Project, 

http://www.cms.hhs.gov/CPMProject). 

The ESRD CPMs were developed to 

implement section 4558(b) of the 

Balanced Budget Act (BBA) of 1997 

(Pub. L. 105–33). This provision 

required the Secretary to develop and 

implement a method to measure and 

report on the quality of renal dialysis 

services provided under Medicare no 

later than January 1, 2000. 

The collection and reporting of ESRD 

CPMs has been an effective tool to 

facilitate ESRD quality improvement, 

and has allowed us to track overall 

positive improvements in several 

intermediate outcomes for individuals 


PWALKER on PROD1PC71 with RULES2
20468 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

2These organizations collect data on all 13 CPMs 

and their advanced information capability is 

detailed in the 2002 OIG series, ‘‘Clinical 

Performance Measures for Dialysis Facilities,’’ OEI–

01–99–00052. 

receiving dialysis. We believe an 

expansion of the CPMs from the 

statistical sample of about five percent 

to all individuals with ESRD and 

receiving dialysis will create minimal 

additional burden. During the last 3 

years, over 70 percent of dialysis 

facilities have demonstrated an ability 

to successfully submit data to CMS that 

could be used to compute all 13 of the 

existing CPMs for all their patients.2

Two of the primary reasons provided by 

the large dialysis organizations for their 

participating in this activity included: 

1. They believed it was less of a 

burden to electronically submit data for 

all of their patients than for facility staff 

to spend 30 minutes to fill out each 

entire CPM form for the sample of about 

five percent. 

2. They believed more transparency in 

the ESRD Program would allow 

favorable quality of care comparisons to 

other dialysis organizations. 

We received a comment that this 

electronic data submission requirement 

would produce a burden to dialysis 

facilities due to the need to perform 

information technology enhancements 

for increased data transmission. Two 

commenters stated that the software 

necessary to report data and information 

electronically in the specified format 

should be made available to all dialysis 

providers free of charge. Commenters 

further stated that CMS should also 

provide funding for travel related to 

training and financial relief for the 

abstracting and key-entry of CPM data 

and internet service provider (ISP) costs. 

Some commenters recommended that 

software implementation should not 

require duplicate data entry into 

multiple systems. Commenters did not 

provide data or dollar figures that would 

assist us in determining the cost of our 

electronic data reporting requirement. 

We believe that because of the 

streamlining of data submissions with 

the CROWNWeb application, these new 

requirements for additional electronic 

data will actually result in less overall 

facility burden compared to existing 

data submissions. We also believe this 

activity will lead to a substantial longterm return on investment for all 

stakeholders-patients, facilities, and the 

public. We have invested the necessary 

time and resources to develop a stable 

and accessible platform, CROWNWeb, 

for the submission of electronic data. 

CROWNWeb includes two methods for 

electronically submitting data, a singleuser interface (SUI) and electronic data 

interchange (EDI). With the SUI, users 

can log-on to CROWNWeb and enter 

required data through the interface 

while with EDI, technologically 

advanced users can submit required 

data in batches from their own clinical 

information systems and thus greatly 

reduce any facility burden necessary to 

meet these new requirements. 

CROWNWeb enables the protection of 

the privacy, confidentiality, and 

security of information transmitted 

electronically. It uses Web-based 

technology and is available free-ofcharge to all facilities with Internet 

access and has little to no impact on 

facility computer systems. CROWNWeb 

meets all applicable security criteria 

included in the CMS Information 

Security Acceptable Risk Safeguards 

(ARS) policy (http://www.cms.hhs.gov/ 

InformationSecurity/14_standards.asp), 

which contains a broad set of CMS 

security controls based upon National 

Institute of Standards and Technology 

(NIST) requirements. Additionally, 

CROWNWeb does not leave persistent 

files on a facility’s computer because 

temporary files stored locally during a 

CROWNWeb session are purged when 

the user exits CROWNWeb. The only 

persistent files that will be left on the 

facility’s computer are related to the 

installation of Adobe Acrobat Reader, 

which is a free, universal tool that is 

necessary to view some reports 

generated by CROWNWeb. Also, 

CROWNWeb currently requires a 

Windows XP service pack 2 or greater, 

and Internet Explorer 6 or greater. 

Any potential facility burden related 

to electronic data reporting falls into 

three main categories: (1) Technology 

hardware and enhancements, (2) 

personnel time and travel for training, 

and (3) personnel time for submitting 

the additional data. We believe very few 

dialysis facilities would have to 

purchase computer hardware to 

implement this requirement, possibly 

no more than 155 (3 percent of total 

number of facilities projected in 2009; 

when electronic data submission will be 

required). Our estimate on the number 

of facilities required to purchase 

computer hardware is derived from data 

revealing that a majority of dialysis 

facilities currently submit some kind of 

electronic data to CMS and thus, have 

the necessary computer hardware to 

support CROWNWeb. We estimate the 

cost, with installation to be $1,000. 

Thus, the total cost for purchasing 

hardware would be $155,000, and this 

cost would only apply in the initial year 

of implementation. We estimate new 

ISP costs for a minimal broadband 

connection to be $360 annually ($360 × 

155 facilities = $55,800), and this would 

be an on-going annual cost. Facilities 

without access to a broadband 

connection might have an interruption 

of other services while using 

CROWNWeb, and they may choose 

instead to contract with a third party to 

submit data on their behalf. 

Based on feedback we have received 

from facilities involved in CROWNWeb 

testing, we do not believe dialysis 

facilities will need more than the basic 

training that CMS will provide free-ofcharge over the internet in order to use 

CROWNWeb. CMS will provide 

geographically representative in-person 

training sessions that will be available 

for those facilities who would like to 

receive their training in-person, but we 

do not believe this type of training is 

required in order to use CROWNWeb. 

Additionally, we expect that ESRD 

Networks will play a valuable role in 

educating facilities and that the ESRD 

Networks as well as our IT contractor 

will provide technical assistance to 

facilities. For personnel time, we 

estimate that each of the 5,173 facilities 

(the number of facilities projected in 

2009, using 4.4 percent annual growth 

rate) will have at least one person at the 

level of nurse manager ($41.58) or 

higher that will take the Web-based 

training in order for the facility to meet 

the new requirement. Thus, we estimate 

the cost of training in the initial year to 

be at least $430,187 (5,173 users×2 

hours×$41.58). Many facilities will also 

want to train the unit secretary; 

therefore, we are also adding the 

training costs of $227,612 for secretaries 

who are compensated at approximately 

$22.00 per hour (5,173 facilities×2 

hours×$22.00). Therefore, our total 

training cost estimate is $657,799. 

Table 1 shows the estimated 2009 

costs of the data submissions from 

dialysis facilities, utilizing 2006 

methods. In 2006 data were submitted 

to CMS and the ESRD Networks under 

the following categories: laboratory data, 

Fistula First vascular access data, CPMs, 

quarterly patient rosters, network 

patient activity report (NPAR), the 

medical evidence form (CMS–2728), 

and the death notification form (CMS–

2746). For each category, the table 

shows the associated factors for all the 

2006 methods of submitting data, which 

include paper submissions, EDI 

submissions, and a hybrid combination 

submission method that includes both 

EDI and paper. Column A shows the 

number of dialysis facilities estimated to 

participate in 2009 data submissions, 

while column B shows the number of 

forms submitted for each year. Column 

C reveals the annual frequency of data 

submission. Column D shows the 

estimated number of labor minutes that 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20469 

would be required for the submission of 

a single form. The number of forms; 

times the annual frequency; times the 

number of labor minutes, is totaled and 

converted to hours in column E. Other 

additional facility data reporting costs, 

such as mailing costs, are shown in 

column F. The total dollar figures 

shown in column G reflect the sum of 

the hours shown in column E times 

$22.00 in labor costs; plus the costs 

shown in column F. The $3,966,601 

total at the bottom of table 1 reflects the 

estimated dialysis facility costs of 

submitting data to CMS and the ESRD 

Networks in 2008, using the data 

submission methods available prior to 

implementation of this final rule. 

TABLE 1.—ESTIMATED 2009 ANNUAL FACILITY DATA BURDEN UNDER EXISTING DATA SUBMISSION METHODS

Project (level of data) Method A. Number 

of facilities 

B. Number 

of forms 

C. Data 

frequency 

D. Time to 

collect/enter 

data 

(minus)/ 

each 

E. Total 

labor time 

(approximate hours) 

F. Other facility costs G. Total facility costs 

Lab Data (patient) ................ paper .......

EDI ...........

542 

3622 

41192 

275272 

annual ......

annual ......

25 

0 

17163 

0 

* $1,512 

0 

$379,098 

0 

Fistula First (summary) ........ paper .......

EDI ...........

1551 

3622 

1551 

3622 

monthly ....

monthly ....

10 

0 

3102 

0 

0 

0 

68,244 

0 

CPM <5 percent (patient) ‡ .. paper .......

hybrid .......

1551 

3622 

3655 

8531 

annual ......

annual ......

30 

15 

1828 

2133 

** 5,099 

** 5,927 

45,315 

52,853 

NPAR (patient) ‡‡ ................. paper .......

EDI ...........

5173 

0 

5173 

0 

monthly ....

monthly ....

30 

0 

31038 

0 

0 

0 

682,836 

0 

Quarterly Roster (pt) ‡‡ ........ paper .......

EDI ...........

5173 

0 

5173 

0 

quarterly ...

quarterly ...

120 

0 

41384 

0 

0 

0 

910,448 

0 

2728 (patient) ....................... paper .......

EDI ...........

5173 

0 

111705 

0 

once .........

once .........

15 

0 

27926 

0 

** 623,314 

0 

1,237,686 

0 

2746 (patient) ....................... paper .......

EDI ...........

5173 

0 

91396 

0 

once .........

once .........

10 

0 

15233 

0 

** 254,995 

0 

590,121 

0 

Total .............................. .................. .................... .................... .................. .................... .................... .................... 3,966,601 

Note: For ease of interpretation and since the number of users is very small, this table does not include any consideration of facility-use of 

CROWNWeb’s predecessor software, VISION. 

EDI: Electronic Data Interchange. 

B: For patient-level data, assumes the average facility size of 76 patients. 

E: Total Time (hours) = B * C * D ÷ 60. 

F: Includes mailing costs but not long-distance fax charges or paper/printing costs. Note: certified mailing is in the process of being required for 

all communications involving personal health information. 

G: Total Costs ($) = E * ($22 dollars per hour wage for medical secretary) + F. 

* Assumes first class certified mailing of $2.79 for every facility. 

** Assumes first class certified mailing of $2.79 for each patient and for the 2728, a second mailing to the Social Security Administration (SSA). 

‡ CPM sample has been stable at about 12,000 each year. 

‡‡ With the Network Patient Activity Report (NPAR), facilities notify networks of incremental changes whereas with the Quarterly roster, facilities verify all patients. 

We recreated Table 1 to estimate the 

burden of data submission under this 

final rule using the CROWNWeb process 

(shown in Table 2). Using the new 

process, the personnel time necessary to 

submit data to meet the new 

requirements (columns D and E) is 

markedly decreased. 

TABLE 2.—ANNUAL FACILITY DATA BURDEN UNDER FINAL RULE § 494.180(H) 

Project (level of data) Method A. Number 

of facilities 

B. Number 

of forms 

C. Data 

frequency 

D. Time to 

collect/enter 

data 

(minus)/ 

each 

E. total time 

(approximate hours) 

F. Other 

facility costs 

G. Total 

facility costs 

ClinicalPART (patient) ‡ ....... paper .......

SUI ...........

0 

1035 

0 

78660 

annual ......

annual ......

30 

25 

0 

32775 

$0 

0 

$0 

721,050 

EDI ........... 4138 314488 annual* .... 0 0 0 0 

AdminPART (patient) ‡‡ ....... paper .......

SUI ...........

0 

1035 

0 

1035 

monthly ....

monthly ....

70 

70 

0 

14490 

0 

0 

0 

318,780 

EDI ........... 4138 4138 monthly .... 0 0 0 0 

2728 (patient) ....................... paper .......

hybrid .......

0 

5173 

0 

111705 

annual ......

annual ......

15 

15 

0 

27926 

0 

*306,900 

0 

921,272 

EDI ........... **NA 0 annual ...... 0 0 0 0 

2746 (patient) ....................... paper .......

hybrid .......

0 

5173 

0 

91396 

annual ......

annual ......

10 

5 

0 

7616 

0 

0 

0 

167,552 

EDI ........... **NA 0 annual ...... 0 0 0 0 

Total .............................. .................. .................... .................... .................. .................... .................... .................... 2,128,654 

EDI: Electronic Data Interchange. 

SUI: Single-user web interface. 

B: For patient-level data, assumes the average facility size of 76 patients. 

E: Total Time (hours) = B * C * D / 60. 


PWALKER on PROD1PC71 with RULES2
20470 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

F: Includes mailing costs but not long-distance fax charges or paper/printing costs. Note: certified mailing is in the process of being required for 

all communications involving personal health information. 

G: Total Costs ($) = E * ($22 dollars per hour wage for medical secretary) + F. 

* Assumes first class certified mailing to SSA of $2.79 for each patient. 

** Based on prioritization due to volume, facility preferences, and need to include SSA in EDI, all of the data necessary for the complete submission of the 2728 and 2746 are not included in the EDI functionality for initial CROWNWeb releases. 

*** The Fistula First data included in ClinicalPART will also be required monthly. 

† The required Clinical Patient Attributes and Related Treatment (ClinicalPART) dataset replaces the previous lab data, Fistula First, and CPM 

data submissions. 

‡‡ The required Administrative Patient Attributes and Related Treatment (AdminPART) dataset replaces both the Network Patient Activity Report (NPAR) and the Quarterly roster. 

By creating efficiencies via integrating 

various datasets and complementing the 

advanced information systems used by 

most dialysis facilities, we will be able 

to expand the CPM data collection from 

about a five percent statistical sample to 

100 percent of dialysis patients, while 

also reducing facility data collection 

and data entry burden by about $1.8 

million (the sum of Table 2 subtracted 

from the sum of Table 1 equals 

$1,837,947). Table 3 computes the 

estimated costs discussed above for 

computer hardware, Internet access, 

training costs for two facility staff 

members, and the labor cost savings for 

data entry and data submission. Our 

total of about minus $0.97 million 

reflects an overall first year cost savings 

that accompanies implementation of 

electronic data submission required by 

this final rule. The estimated $1.8 

million annual labor cost savings is 

expected every subsequent year (not 

counting inflation) on an ongoing basis. 

TABLE 3.—COST ESTIMATE FOR § 494.180(H) 

$155,000 ........... Computer hardware (first year). 

55,800 ............... Broadband internet access (first year and ongoing). 

657,799 ............. Training (first year). 

2,128,654 .......... Labor (first year and ongoing) (Represents a savings of $1,837,947 which is the difference between total costs in Table 1 and 

total costs in Table 2). 

$2,997,253 ........ Total Cost (first year). 

$969,348 ........... Total Cost savings (first year) (Represents the difference between total costs in Table 1 and the first year costs of 

$2,997,253). 

In addition to the short-term return on 

investment to facilities, we believe that 

there is also an ongoing return on this 

investment for all other primary 

stakeholders—including patients, 

dialysis practitioners, and the public. 

CROWNWeb will allow for the more 

timely, accurate, and efficient use of 

data to support administration of the 

ESRD program by replacing the 

predominately paper process that 

currently exists with an electronic 

process that respects the capabilities of 

providers and has tangible benefits for 

dialysis facilities, individuals who have 

or may develop ESRD, and other 

stakeholders. CROWNWeb will allow 

facility submission of required data 

directly from their electronic health 

records rather than redundant data 

entry, freeing facility personnel to 

concentrate more on patient care. 

Another expectation is that claims 

payment will be improved due to 

improved quality and timeliness of 

patient eligibility and enrollment 

information. In the future, we expect 

that the system could include claims 

data, and serve to inform a facility of, 

for example, patient hospitalization. A 

major benefit of the new system for 

facilities will be reports that will allow 

facilities to compare their patient 

outcomes with those of their peers. CPM 

electronic data collection for all dialysis 

patients allows facility level 

comparisons and tracking. Information 

about patient outcomes will be available 

in a much more timely fashion than 

currently exists, and performance 

improvement activities may be 

implemented and evaluated in quicker 

succession to optimize patient 

outcomes. For individuals with ESRD, 

CROWNWeb will increase the 

transparency of the health care system 

and empower patients to find better 

health care value and quality, while 

assuring access to care, especially in 

times of disaster/emergency. For ESRD 

Networks, CROWNWeb will not only 

provide timelier, more accurate, and 

more complete information to inform 

quality improvement, it will make 

unnecessary certain activities that 

require a significant amount of Network 

resources. For example, CROWNWeb 

will be able to recreate the data 

included on the CMS 2744 Annual 

Facility Survey in a more timely fashion 

then is currently possible, and will free 

up Network resources that currently 

perform a four month manual 

reconciliation process. And for all 

primary stakeholders, we expect that the 

new system will either facilitate or 

provide timelier reports that will allow 

them to compare individual facilities 

and facility groups with various peer 

groups and national and local 

benchmarks. 

Impact Summary 

The following chart provides an 

overall estimate of the impact of the 

final rule on dialysis facilities: 

Requirement First year 

costs 

Second year 

costs 

BP Cuffs (cleanable or disposable) ......................................................................................................................... $496,244 * $49,624 

Isolation Room Waiver Process .............................................................................................................................. 0 * 10,743 

Evacuation Instructions ............................................................................................................................................ 523,634 0 

Emergency Phone Number ..................................................................................................................................... 69,384 * 69,384 

Automated External Defibrillator (AED) ................................................................................................................... 5,338,000 0 

AED Maintenance .................................................................................................................................................... 54,581 * 54,581 

Contacting Local Disaster Official ........................................................................................................................... 264,448 * 264,448 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20471 

Requirement First year 

costs 

Second year 

costs 

LSC Automatic Notification System ......................................................................................................................... 3,289,472 * 809,472 

Update of Patient Rights ......................................................................................................................................... 171,046 0 

QAPI Program Implementation ................................................................................................................................ 1,397,708 * 1,397,708 

Develop New Grievance Process ............................................................................................................................ 247,151 0 

ESRD CPM Electronic Reporting: 

Hardware .......................................................................................................................................................... ........................ 155,000 

Internet access ................................................................................................................................................. ........................ * 55,800 

Training ............................................................................................................................................................. ........................ 657,799 

Total Cost .................................................................................................................................................. 11,851,668 3,524,559 

Cost savings First year 

savings 

Second year 

savings 

CEO Emergency Preparedness Time ..................................................................................................................... $1,029,253 * $1,029,253 

Patient Rights decreased administrative burden ..................................................................................................... 342,093 * 342,093 

Patient Plan of Care, annually not biennially .......................................................................................................... 19,435,447 * 19,435,447 

Medical Records Personnel no longer required ...................................................................................................... 4,180,038 * 4,180,038 

Data Submission Labor ........................................................................................................................................... ........................ * 1,837,947 

Total Cost Savings ........................................................................................................................................... 24,986,831 26,824,778 

Net Savings ...................................................................................................................................................... 13,135,163 23,300,219 

* Ongoing annual costs/cost savings. 

Effects on the Medicare and Medicaid 

Programs 

This final rule contains provisions 

that will protect patient health and 

safety and lead to improvements in 

patient care. Several of the expected 

improvements in patient care may also 

result in more efficient, cost effective 

care. For example, improved infection 

control practices may lead to fewer 

hospitalizations and better patient 

quality of life. An increased focus on the 

transplantation modality may lead to a 

greater number of patients on the 

transplant list, and perhaps more livingdonor transplantations. 

This final rule contains several 

provisions that directly and indirectly 

promote the use of the most optimal 

dialysis access for each patient. These 

provisions include § 494.80(a)(8), 

§ 494.90(a)(5), § 494.90(d), § 494.110 

(a)(2), § 494.140 (e)(3)&(4), § 494.180 

(c)(3), and § 494.180 (h)(3)(iv). We 

expect that these new requirements are 

improvements that will result in lower 

rates of access failure and an increase in 

the number of working arteriovenous 

fistulas (AVF). AVFs offer the most 

benefits to patients of the three possible 

hemodialysis access types. Examples of 

these benefits include longer average 

patency of all access types, very low rate 

of infection, need for only a minor 

surgery, and healing and sealing postcannulation (http://www.fistulafirst.org/ 

tools.htm#Education). According to the 

2006 USRDS Atlas, the per patient per 

year (pppy) Medicare costs using 2004 

data for dialysis patients with an AVF 

was $55,112; the pppy cost with a graft 

was $65,556; and the pppy costs with a 

catheter $75,345. Although this is raw 

data, we can see that there is a 

significant Medicare savings associated 

with AVF. According to 2005 ESRD 

CPM project, 31 percent of hemodialysis 

patients were dialyzing using an AVF in 

2004 (http://www.cms.hhs.gov/ 

CPMProject). More current Fistula First 

October 2006 data (http:// 

www.simsproject.com/ 

downloads.php?p=ff) shows an AVF 

rate of 44.4 percent for patients. If the 

AVF rate further improves by 5 percent 

in all hemodialysis patients (309,269 in 

2004 according to USRDS data) 15,464 

more patients would have AVFs (with 

an average pppy savings of $15,000). If 

this were to occur the potential 

Medicare savings could be 

approximately $230 million per year. 

For purposes of this Impact Analysis, 

we have used the savings ($230 million) 

that could result from 5 percent 

additional AVF patients. We believe 

savings are possible assuming the 

medical costs associated with creating 

AVFs for these 5 percent additional 

patients are in line with current costs, 

and that the cost differential between 

patients with AVFs and those with 

catheters remain comparable. 

This final rule also promotes patient 

independence and the use of home 

dialysis whenever appropriate. The 

provisions that encourage home dialysis 

include § 494.70(a)(7), § 494.80(a)(9), 

§ 494.90(a)(7), and § 494.90(d). We 

expect that the requirements of this rule 

will increase the percentage of patients 

on home dialysis. According to USRDS 

data the 2004 hemodialysis pppy 

Medicare costs equal $67,733, while the 

peritoneal pppy costs equal $48,796. We 

do not have USRDS home hemodialysis 

pppy Medicare costs although home 

hemodialysis is less costly than incenter hemodialysis and home 

peritoneal dialysis is less costly than 

home hemodialysis. Approximately 92 

percent of U.S. dialysis patients receive 

in-center hemodialysis. Based on the 

difference between 2004 hemodialysis 

and peritoneal pppy costs, savings of as 

much as $18,937 pppy could be 

obtained with patients opting for 

peritoneal dialysis. If 5 percent 

additional patients were to opt for home 

peritoneal dialysis, which provides 

added health and quality of life benefits, 

that could account for 15,464 patients. 

The potential annual savings for these 5 

percent additional patients (15,464 × 

$18,937) could be as much as $295 

million. Combining potential savings 

from 5 percent additional patients who 

opt for AVFs and 5 percent additional 

patients who opt for home dialysis, the 

total Medicare allowed charges could be 

reduced by up to $525 million annually. 

However, these examples are only 

illustrative in nature and are based on 

limited analytics. Therefore, they are 

not incorporated in the quantitative cost 

analysis of the RIA, but are presented to 

illustrate the possibility for Medicare 

savings. 

C. Accounting Statement 

As required by OMB Circular A–4 

(available at http:// 

www.whitehouse.gov/OMB/circulars/ 

A004/A-4.PDF) in the table below, we 

have prepared an accounting statement 


PWALKER on PROD1PC71 with RULES2
20472 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

showing the classification of the 

expenditures and savings associated 

with the provisions of this final 

regulation. This table provides our best 

estimate of the total annualized 

monetized costs and savings. 

PRIMARY ESTIMATE FOR 2008 

Annualized monetized facility 

costs .................................. $11,851,668 

Annualized monetized facility 

cost savings ...................... 24,986,831 

Annualized monetized facility 

net cost savings ................ 13,135,163 

Effects on State, local, and 

tribal governments ............ 0 

Benefit effects on small businesses ............................... 2,651 

D. Alternatives Considered 

1. Maintenance of Existing Regulations 

One alternative would be to keep the 

existing regulations. However, the 

current regulations inhibit our ability to 

ensure better outcomes of patient care, 

collect electronic data for quality 

assurance and quality improvement, 

incorporate new CDC and AAMI 

guidelines and fire safety standards and 

reduce current facility burden by 

eliminating numerous process and 

procedural requirements. 

2. Infection Control 

One alternative was not including an 

exception to the CDC recommendation 

for monthly and semiannual screening 

for hepatitis C. We retained the 

exception because blanket screening for 

hepatitis C is not a Medicare-covered 

service. 

Another alternative was to include 

only the ‘‘Recommended Infection 

Control Practices for Hemodialysis 

Units At a Glance’’ (At a Glance) 

precautions found in the CDC RR05 

report and not including the narrative 

section explaining the infection control 

precautions. Our proposed inclusion of 

only the ‘‘At a Glance’’ two-pager 

synopsis of the CDC hemodialysis 

infection control precautions caused 

confusion as evidenced by the 

comments we received requesting 

clarification of various precautions. A 

third alternative was to require 

compliance with AIA Guidelines for 

Design and Construction of Hospitals 

and Health Care Facilities. The AIA 

guidelines provide instructions 

regarding dialysis unit design as it 

relates to infection control. While some 

states have adopted specific AIA 

guidelines as minimal standards, we 

believe it would be too burdensome on 

dialysis facilities to incorporate AIA 

guidelines as federal requirements. 

Commenters did not support inclusion 

of the AIA guidelines in these 

conditions for coverage. 

3. Water Quality 

One alternative was to require 

compliance with portions of the 

previous AAMI guidelines—ANSI/ 

AAMI RD5: 1992 Appendix B5. 

However, this document has been 

rescinded by ANSI/AAMI and has been 

replaced by updated documents. 

Although we proposed compliance with 

portions of the AAMI document—

RD62: 2001, which is directed to 

manufacturers, we are including in this 

final rule an incorporation by reference 

of ANSI/AAMI RD52:2004. This RD52 

document reflects the state-of-the-art 

water quality guidelines for end users of 

water purification systems. Commenters 

urged us to include the RD52:2004 

incorporation by reference as the most 

appropriate set of recommendations for 

dialysis facilities. 

4. Reuse of Hemodialyzers 

One potential cost-saving alternative 

was to remove the requirement that 

dialyzers exposed to more than one 

germicide were acceptable for reuse. We 

decided against this because exposure to 

different germicides may cause 

membrane leaks and we have no 

scientific evidence to support the safety 

of using hemodialyzers exposed to more 

than one germicide. Commenters agreed 

with this approach. 

5. Physical Environment and Emergency 

Preparedness 

One alternative was to remove the 

requirement that every dialysis facility 

have a defibrillator. We retained this 

proposed provision because a Seattle 

study (Becker, pp. 1509–1512) 

identified dialysis centers as having a 

relatively high incidence of cardiac 

arrests over a seven year period. Also, 

automated external defibrillators are 

now required on airliners and in other 

public places because the technology is 

simple to use, staff can be trained on the 

use of such equipment, and the 

technology has been proven to save 

lives. 

A second alternative was to allow a 

waiver or phase-in period for 

defibrillators in small rural dialysis 

facilities. Many commenters agreed that 

dialysis facilities should be equipped 

with a defibrillator, preferably an AED. 

Commenters urged that a waiver not be 

available to rural facilities and stated 

that these dialysis facilities may have 

the greatest need for AEDs since 

emergency medical technical support 

may be located a long distance from the 

dialysis facility. 

6. Patients’ Rights 

One alternative was to remove the 

patients’ right to be informed of the 

availability of advance directives. We 

retained this proposal nonetheless 

because of the nature of ESRD and the 

aging dialysis population. 

Another alternative considered was 

not including that dialysis facilities 

have an internal grievance procedure. 

We did not adopt this alternative 

because we believe an internal 

grievance process is essential to allow 

patients to express their concerns 

directly to the facility in which they 

receive dialysis. 

7. Patient Assessment 

One alternative was to include 

‘‘extremely frail patients’’ in the 

provision to reassess unstable patients 

monthly. This proposal was not adopted 

in order to ensure that dialysis facilities 

retain the flexibility to make clinical 

determinations on a case-by-case basis. 

Another alternative was to remove the 

proposed 3-month timeframe to reassess 

new patients. However, we believe that 

initial patient adjustment to dialysis is 

crucial in setting the stage for successful 

treatment of ESRD and the reassessment 

done at 3 months will facilitate better 

patient outcomes. 

8. Patient Plan of Care 

One alternative was to retain the 

existing requirement for an 

individualized care plan with a six 

month review and a long-term program 

with an annual review. We did not 

adopt this approach because it was less 

burdensome to include a single 

individualized plan of care (without a 

long-term program) to be reviewed 

annually for stable patients. 

9. Quality Assessment and Performance 

Improvement 

One alternative was to require a QAPI 

program without specific criteria. We 

determined, based on the work of the 

NFK–K/DOQI committees (adequacy, 

nutrition, anemia, and vascular access), 

AAMI guidelines (reuse), specific 

recommendations from the OIG 

(medical error identification and patient 

satisfaction), and public comments on 

our proposed rule, that there was a 

sufficient basis to include basic criteria. 

10. Special Purpose Renal Dialysis 

Facilities 

One alternative was to remove this 

condition entirely based on historically 

low levels of participation. We 

determined that eliminating this 

condition would be detrimental to the 

small number of vacation camps that 

choose to participate and it would also 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20473 

inhibit access to care during natural 

disasters. 

Another alternative was to retain the 

current certification requirements. We 

believe that the current certification 

requirements are onerous; we believe 

that this is demonstrated by the lack of 

participation in Medicare by vacation 

camps. We believe reducing the number 

of certification requirements addresses 

this issue. The final rule requirements 

represent a reduction in administrative 

burden for special purpose units. 

11. Personnel Qualifications 

One alternative was to retain the 

existing requirement that a licensed 

practical nurse, RN, or physician must 

be on the premises during dialysis. We 

are requiring that a registered nurse be 

on the premises during dialysis to 

protect patient health and safety and 

believe that this does not represent a 

significant increase in burden for 

dialysis facilities. In response to 

comments, we included a provision for 

the temporary use of an experienced 

LPN for infrequent occasions when the 

lack of an RN would force the facility 

to close for the day. 

Other options were to propose no or 

merely minimal Federal requirements 

for dialysis technicians. We determined 

that Federal requirements are needed at 

this time because dialysis technicians 

are the primary caregivers in most 

dialysis facilities. Commenters support 

the inclusion of qualification criteria for 

patient care technicians. 

12. Medical Director 

One alternative was to propose to 

eliminate the medical director condition 

and propose that other health care 

professionals run dialysis facilities. 

However, a June 2000 OIG report 

strongly recommended that we 

strengthen the role of the facility’s 

medical director. In response to that 

recommendation, we have retained the 

condition with a clarification of the 

medical director’s responsibilities to 

include overseeing both the QAPI 

program and all involuntary patient 

transfers or discharges. We do not 

believe that this approach would 

impose an additional cost burden on 

dialysis facilities. 

13. Governance 

One alternative considered was to 

remove the proposal for a 30-day 

advance notice before involuntary 

patient discharge or transfer and retain 

the previous requirement (see 

§ 405.2138(b)(2)) for patients to be 

‘‘given advance notice to ensure orderly 

transfer or discharge.’’ We did not adopt 

this alternative because: (1) A 30-day 

advance notice for discharge and 

transfer has been consistent with the 

existing requirements in NFs, SNFs, and 

hospital swing-beds for over 12 years; 

(2) the dialysis patient population is 

increasingly older and many are nursing 

home residents with co-morbid 

conditions; and (3) large dialysis 

organizations have emerged that can 

offer more flexibility and options for a 

patient involuntarily discharged from a 

facility by providing numerous units 

nearby or within commuting distance of 

that patient’s place of residence. We 

have retained the proposed provision to 

waive the 30-day notice under 

extraordinary circumstances. 

This final rule contains a requirement 

for every dialysis facility to report ESRD 

CPM Project data to CMS. One option 

considered was to require that less than 

100 percent of facilities participate. 

However, section 4558(b) of Pub. L. 

105–33 requires CMS to monitor the 

quality of care delivered to dialysis 

patients. To date, CMS has been 

collecting a five percent CPM patient 

sample on a voluntary basis. CPM 

electronic data collection has been pilottested and is expected to be ready for 

general use in 2008. The large dialysis 

organization facilities and many other 

dialysis facilities already collect this 

data for benchmarking and quality 

improvement purposes, and therefore, 

this will not create a significant new 

burden for the industry. However, small 

rural facilities may need time to come 

into compliance, and therefore, we are 

including a phase-in period. 

E. Conclusion 

For these reasons, we are not 

preparing analyses for either the RFA or 

section 1102(b) of the Act because we 

have determined, and the Secretary 

certifies, that this final rule will not 

have a significant economic impact on 

a substantial number of small entities or 

a significant impact on the operations of 

a substantial number of small rural 

hospitals. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects 

42 CFR Part 405 

Administrative practice and 

procedure, Health facilities, Health 

professions, Kidney diseases, Medical 

devices, Medicare, Reporting and 

recordkeeping requirements, Rural 

areas, X-rays. 

42 CFR Part 410 

Health facilities, Health professions, 

Kidney diseases, Laboratories, 

Medicare, Reporting and recordkeeping 

requirements, Rural areas, X-rays. 

42 CFR Part 413 

Health facilities, Kidney diseases, 

Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 414 

Administrative practice and 

procedure, Health facilities, Health 

professions, Kidney diseases, Medicare, 

Reporting and recordkeeping 

requirements. 

42 CFR Part 488 

Administrative practice and 

procedure, Health facilities, Medicare, 

Reporting and recordkeeping 

requirements. 

42 CFR Part 494 

Health facilities, Incorporation by 

reference, Kidney diseases, Medicare, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

Chapter IV as follows: 

PART 405—FEDERAL HEALTH 

INSURANCE FOR THE AGED AND 

DISABLED 

Subpart U—Conditions for Coverage of 

Suppliers of End-Stage Renal Disease 

(ESRD) Services 

■ 1. The authority citation for part 405, 

subpart U is revised to read as follows: 

Authority: Secs. 1102, 1861, 1862(a), 1871, 

1874, and 1881 of the Social Security Act (42 

U.S.C. 1302, 1320b–8, 1395x, 1395y(a), 

1395hh, 1395kk, and 1395rr), unless 

otherwise noted. 

§ 405.2100 and § 405.2101 [Removed and 

Reserved] 

■ 2. Section 405.2100 and § 405.2101 

are removed and reserved. 

■ 3. Section 405.2102 is amended by 

adding the definition of ‘‘ESRD Network 

organization’’ in alphabetical order to 

read as follows: 

§ 405.2102 Definitions. 

* * * * * 

ESRD Network organization. The 

administrative governing body to the 

network and liaison to the Federal 

government. 

* * * * * 

§ 405.2131 and § 405.2133 through 

§ 405.2140 [Removed and Reserved] 

■ 4. Section 405.2131 and § 405.2133 

through § 405.2140 are removed and 

reserved. 


PWALKER on PROD1PC71 with RULES2
20474 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

§ 405.2150 [Removed and Reserved] 

■ 5. Section § 405.2150 is removed and 

reserved. 

§ 405.2160 through § 405.2164 [Removed 

and Reserved] 

■ 6. Sections 405.2160 through 

§ 405.2164 are removed and reserved. 

§ 405.2180 through § 405.2182 [Removed 

and Reserved] 

■ 7. Sections 405.2180 through 

§ 405.2182 are removed and reserved. 

§ 405.2184 [Removed and Reserved] 

■ 8. Section 405.2184 is removed and 

reserved. 

PART 410—SUPPLEMENTARY 

MEDICAL INSURANCE (SMI) 

BENEFITS 

■ 9. The authority citation for part 410 

continues to read as follows: 

Authority: Secs. 1102, 1834, 1871, and 

1893 of the Social Security Act (42 U.S.C. 

1302, 1395(m), 1395hh, and 1395ddd). 

§ 410.5 [Amended] 

■ 10. In § 410.5(a), the reference ‘‘Part 

405, subpart U: End-Stage Renal Disease 

Services,’’ is revised to read ‘‘Part 494: 

End-Stage Renal Disease Facilities.’’

§ 410.50 [Amended] 

■ 11. In § 410.50(b), the reference 

‘‘§ 405.2163(b)’’ is revised to read 

‘‘§ 494.130’’; and the reference ‘‘subpart 

M of part 405’’ is revised to read ‘‘part 

494.’’

§ 410.52 [Amended] 

■ 12. Section § 410.52 is amended as 

follows: 

■ A. In paragraph (a)(4), the reference to 

‘‘§ 405.2163’’ is revised to read 

‘‘§ 494.90(a)(4).’’

■ B. In paragraph (a)(4), the word 

‘‘epoetin (EPO)’’ is revised to read 

‘‘erythropoeisis-stimulating agents.’’

■ C. In paragraph (b), the parenthetical 

statement ‘‘(Section 405.2137 of this 

chapter contains specific details.)’’ is 

revised to read ‘‘(Section 494.90 of this 

chapter contains details on patient plans 

of care).’’

§ 410.152 [Amended] 

■ 13. In § 410.152(e)(1), ‘‘subpart U of 

part 405’’ is revised to read ‘‘part 494.’’

§ 410.170 [Amended] 

■ 14. In § 410.170(c), the reference to 

‘‘§ 405.2137(b)(3)’’ is revised to read 

‘‘§ 494.90.’’

PART 413—PRINCIPLES OF 

REASONABLE COST 

REIMBURSEMENT; PAYMENT FOR 

END-STAGE RENAL DISEASE 

SERVICES; PROSPECTIVELY 

DETERMINED PAYMENT RATES FOR 

SKILLED NURSING FACILITIES 

■ 15. The authority citation for part 413 

continues to read as follows: 

Authority: Secs. 1102, 1812(d), 1814(b), 

1815, 1833(a), (i), and (n), 1861(v), 1871, 

1881, 1883, and 1886 of the Social Security 

Act (42 U.S.C. 1302, 1395d(d), 1395f(b), 

1395g, 1395l(a), (i), and (n), 1395x(v), 

1395hh, 1395rr, 1395tt, and 1395ww); and 

sec. 124 of Public Law 106–133 (113 Stat. 

1501A–332). 

■ 16. In § 413.170, paragraph (a) is 

revised to read as follows: 

§ 413.170 Scope. 

* * * * * 

(a) Setting forth the principles and 

authorities under which CMS is 

authorized to establish a prospective 

payment system for outpatient 

maintenance dialysis furnished in or 

under the supervision of a dialysis 

facility under part 494 of this chapter 

(referred to as ‘‘facility’’). For purposes 

of this section and § 413.172 through 

§ 413.198, ‘‘outpatient maintenance 

dialysis’’ means outpatient dialysis 

provided by a dialysis facility, home 

dialysis or self-dialysis as defined in 

§ 494.10 of this chapter and includes all 

items and services specified in § 410.50 

and § 410.52 of this chapter. 

* * * * * 

■ 17. In § 413.172, paragraph (b) is 

revised to read as follows: 

§ 413.172 Principles of prospective 

payment. 

* * * * * 

(b) All approved ESRD facilities must 

accept the prospective payment rates 

established by CMS as payment in full 

for covered outpatient maintenance 

dialysis. Approved ESRD facility 

means—

(1) Any independent or hospitalbased facility (as defined in accordance 

with § 413.174(b) and § 413.174(c) of 

this part) that has been approved by 

CMS to participate in Medicare as an 

ESRD supplier; or 

(2) Any approved independent facility 

with a written agreement with the 

Secretary. Under the agreement, the 

independent ESRD facility agrees—

(i) To maintain compliance with the 

conditions for coverage set forth in part 

494 of this chapter and to report 

promptly to CMS any failure to do so; 

and 

(ii) Not to charge the beneficiary or 

any other person for items and services 

for which the beneficiary is entitled to 

have payment made under the 

provisions of this part. 

* * * * * 

§ 413.198 [Amended] 

■ 18. In § 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 

■ 19. The authority citation for part 414 

continues to read as follows: 

Authority: Secs. 1102, 1871, and 1881(b)(1) 

of the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr(b)(1)). 

§ 414.330 [Amended] 

■ 20. Section 414.330 is amended as 

follows: 

■ A. In paragraph (a)(2)(iii)(B), the 

reference ‘‘subpart U of part 405’’ is 

revised to read ‘‘part 494.’’

■ B. In paragraph (a)(2)(iii)(B)(1), the 

references ‘‘subpart U (Conditions for 

Coverage of Suppliers of ESRD 

Services)’’ are revised to read ‘‘part 494 

(Conditions for Coverage for End-Stage 

Renal Disease Facilities).’’

■ C. In paragraph (a)(2)(iii)(B)(7), the 

references ‘‘subpart U (Conditions for 

Coverage of Suppliers of ESRD 

Services)’’ are revised to read ‘‘part 494 

(Conditions for Coverage for End-Stage 

Renal Disease Facilities).’’

■ D. Paragraph (a)(2)(iii)(C) is added to 

read as follows: 

§ 414.330 Payment for home dialysis 

equipment, supplies, and support services. 

(a) * * * 

(2) * * * 

(iii) * * * 

(C) Agrees to report to the ESRD 

facility providing support services, at 

least every 45 days, all data (meaning 

information showing what supplies and 

services were provided to the patient 

and when each was provided) for each 

patient regarding services and items 

furnished to the patient in accordance 

with § 494.100(c)(2) of this chapter. 

* * * * * 

PART 488—SURVEY, CERTIFICATION, 

AND ENFORCEMENT PROCEDURES 

■ 21. The authority citation for part 488 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act, unless otherwise noted 

(42 U.S.C. 1302 and 1895hh); Continuing 

Resolution Pub. L. 110–149 H.J. Res 72. 

■ 22. Section 488.60(a) is revised to read 

as follows: 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20475 

§ 488.60 Special procedures for approving 

end-stage renal disease facilities. 

(a) Consideration for approval. An 

ESRD facility that wishes to be 

approved or that wishes an expansion of 

dialysis services to be approved for 

coverage, in accordance with part 494 of 

this chapter, must secure a 

determination by the Secretary. To 

secure a determination, the facility must 

submit the following documents and 

data for consideration by the Secretary: 

(1) Certification by the State agency 

referred to in § 488.12 of this part. 

(2) Data furnished by ESRD network 

organizations and recommendations of 

the Public Health Service concerning 

the facility’s contribution to the ESRD 

services of the network. 

(3) Data concerning the facility’s 

compliance with professional norms 

and standards. 

(4) Data pertaining to the facility’s 

qualifications for approval or for any 

expansion of services. 

* * * * * 

Subpart G [Added and Reserved] 

■ 23. A new subpart G is added and 

reserved. 

■ 24. A new subpart H is added to read 

as follows: 

Subpart H—Termination of Medicare 

Coverage and Alternative Sanctions 

for End-Stage Renal Disease (ESRD) 

Facilities 

Sec. 

488.604 Termination of Medicare coverage. 

488.606 Alternative sanctions. 

488.608 Notice of alternative sanction and 

appeal rights: Termination of coverage. 

488.610 Notice of appeal rights: Alternative 

sanctions. 

Subpart H—Termination of Medicare 

Coverage and Alternative Sanctions 

for End-Stage Renal Disease (ESRD) 

Facilities 

§ 488.604 Termination of Medicare 

coverage. 

(a) Except as otherwise provided in 

this subpart, failure of a supplier of 

ESRD services to meet one or more of 

the conditions for coverage set forth in 

part 494 of this chapter will result in 

termination of Medicare coverage of the 

services furnished by the supplier. 

(b) If termination of coverage is based 

solely on a supplier’s failure to 

participate in network activities and 

pursue network goals, as required at 

§ 494.180(i) of this chapter, coverage 

may be reinstated when CMS 

determines that the supplier is making 

reasonable and appropriate efforts to 

meet that condition. 

(c) If termination of coverage is based 

on failure to meet any of the other 

conditions specified in part 494 of this 

chapter, coverage will not be reinstated 

until CMS finds that the reason for 

termination has been removed and there 

is reasonable assurance that it will not 

recur. 

§ 488.606 Alternative sanctions. 

(a) Basis for application of alternative 

sanctions. CMS may, as an alternative to 

termination of Medicare coverage, 

impose one of the sanctions specified in 

paragraph (b) of this section if CMS 

finds that—

(1) The supplier fails to participate in 

the activities and pursue the goals of the 

ESRD network that is designated to 

encompass the supplier’s geographic 

area; and 

(2) This failure does not jeopardize 

patient health and safety. 

(b) Alternative sanctions. The 

alternative sanctions that CMS may 

apply in the circumstances specified in 

paragraph (a) of this section include the 

following: 

(1) Denial of payment for services 

furnished to patients first accepted for 

care after the effective date of the 

sanction as specified in the sanction 

notice. 

(2) Reduction of payments, for all 

ESRD services furnished by the 

supplier, by 20 percent for each 30-day 

period after the effective date of the 

sanction. 

(3) Withholding of all payments, 

without interest, for all ESRD services 

furnished by the supplier to Medicare 

beneficiaries. 

(c) Duration of alternative sanction. 

An alternative sanction remains in effect 

until CMS finds that the supplier is in 

substantial compliance with the 

requirement to cooperate in the network 

plans and goals, or terminates coverage 

of the supplier’s services for lack of 

compliance. 

§ 488.608 Notice of alternative sanction 

and appeal rights: Termination of coverage. 

(a) Notice of alternative sanction. 

CMS gives the supplier and the general 

public notice of the alternative sanction 

and of the effective date of the sanction. 

The effective date of the alternative 

sanction is at least 30 days after the date 

of the notice. 

(b) Appeal rights. Termination of 

Medicare coverage of a supplier’s ESRD 

services because the supplier no longer 

meets the conditions for coverage of its 

services is an initial determination 

appealable under part 498 of this 

chapter. 

§ 488.610 Notice of appeal rights: 

Alternative sanctions. 

If CMS proposes to apply an 

alternative sanction specified in 

§ 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. 

■ 25. A new part 494 is added to read 

as follows: 

PART 494—CONDITIONS FOR 

COVERAGE FOR END–STAGE RENAL 

DISEASE FACILITIES 

Subpart A—General Provisions 

Sec. 

494.1 Basis and scope. 

494.10 Definitions. 

494.20 Condition: Compliance with 

Federal, State, and local laws and 

regulations. 

Subpart B—Patient Safety 

494.30 Condition: Infection control. 

494.40 Condition: Water and dialysate 

quality. 

494.50 Condition: Reuse of hemodialyzers 

and bloodlines. 

494.60 Condition: Physical environment. 

Subpart C—Patient Care 

494.70 Condition: Patient rights. 

494.80 Condition: Patient assessment. 

494.90 Condition: Patient plan of care. 

494.100 Condition: Care at home. 

494.110 Condition: Quality assessment and 

performance improvement. 

494.120 Condition: Special purpose renal 

dialysis facilities. 

494.130 Condition: Laboratory services. 

Subpart D—Administration 

494.140 Condition: Personnel 

qualifications. 

494.150 Condition: Responsibilities of the 

Medical director. 

494.160 [Reserved] 

494.170 Condition: Medical records. 

494.180 Condition: Governance. 


PWALKER on PROD1PC71 with RULES2
20476 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. l302 and 

l395hh). 

Subpart A—General Provisions 

§ 494.1 Basis and scope. 

(a) Statutory basis. This part is based 

on the following provisions: 

(1) Section 299I of the Social Security 

Amendments of 1972 (Pub. L. 92–603), 

which extended Medicare coverage to 

insured individuals, their spouses, and 

their dependent children with ESRD 

who require dialysis or transplantation. 

(2) Section 1861(e)(9) of the Act, 

which requires hospitals to meet such 

other requirements as the Secretary 

finds necessary in the interest of health 

and safety of individuals who are 

furnished services in the institution. 

(3) Section 1861(s)(2)(F) of the Act, 

which describes ‘‘medical and other 

health services’’ covered under 

Medicare to include home dialysis 

supplies and equipment, self-care home 

dialysis support services, and 

institutional dialysis services and 

supplies. 

(4) Section 1862(a) of the Act, which 

specifies exclusions from coverage. 

(5) Section 1881 of the Act, which 

authorizes Medicare coverage and 

payment for the treatment of ESRD in 

approved facilities, including 

institutional dialysis services, 

transplantation services, self-care home 

dialysis services, and the administration 

of erythropoiesis-stimulating agent(s). 

(6) Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (Pub. L. 104–113), which 

requires Federal agencies to use 

technical standards that are developed 

or adopted by voluntary consensus 

standards bodies, unless their use 

would be inconsistent with applicable 

law or otherwise impractical. 

(b) Scope. The provisions of this part 

establish the conditions for coverage of 

services under Medicare and are the 

basis for survey activities for the 

purpose of determining whether an 

ESRD facility’s services may be covered. 

§ 494.10 Definitions. 

As used in this part—

Dialysis facility means an entity that 

provides outpatient maintenance 

dialysis services, or home dialysis 

training and support services, or both. A 

dialysis facility may be an independent 

or hospital-based unit (as described in 

§ 413.174(b) and (c) of this chapter) that 

includes a self-care dialysis unit that 

furnishes only self-dialysis services. 

Discharge means the termination of 

patient care services by a dialysis 

facility or the patient voluntarily 

terminating dialysis when he or she no 

longer wants to be dialyzed by that 

facility. 

Furnishes directly means the ESRD 

facility provides the service through its 

own staff and employees or through 

individuals who are under direct 

contract to furnish these services 

personally for the facility. 

Home dialysis means dialysis 

performed at home by an ESRD patient 

or caregiver who has completed an 

appropriate course of training as 

described in § 494.100(a) of this part. 

Self-dialysis means dialysis 

performed with little or no professional 

assistance by an ESRD patient or 

caregiver who has completed an 

appropriate course of training as 

specified in § 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. 

§ 494.20 Condition: Compliance with 

Federal, State, and local laws and 

regulations. 

The facility and its staff must operate 

and furnish services in compliance with 

applicable Federal, State, and local laws 

and regulations pertaining to licensure 

and any other relevant health and safety 

requirements. 

Subpart B—Patient Safety 

§ 494.30 Condition: Infection control. 

The dialysis facility must provide and 

monitor a sanitary environment to 

minimize the transmission of infectious 

agents within and between the unit and 

any adjacent hospital or other public 

areas. 

(a) Standard: Procedures for infection 

control. The facility must demonstrate 

that it follows standard infection control 

precautions by implementing—

(1)(i) The recommendations (with the 

exception of screening for hepatitis C), 

found in ‘‘Recommendations for 

Preventing Transmission of Infections 

Among Chronic Hemodialysis Patients,’’

developed by the Centers for Disease 

Control and Prevention, Morbidity and 

Mortality Weekly Report, volume 50, 

number RR05, April 27, 2001, pages 18 

to 28. The Director of the Federal 

Register approves this incorporation by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR Part 51. This 

publication is available for inspection at 

the CMS Information Resource Center, 

7500 Security Boulevard, Central 

Building, Baltimore, MD or at the 

National Archives and Records 

Administration (NARA). Copies may be 

obtained at the CMS Information 

Resource Center. For information on the 

availability of this material at NARA, 

call 202–741–6030, or go to: http:// 

www.archives.gov/federal_register/ 

code_of_regulations/ibr_locations.html. 

The recommendation found under 

section header ‘‘HBV-Infected Patients’’, 

found on pages 27 and 28 of RR05 

(‘‘Recommendations for Preventing 

Transmission of Infections Among 

Chronic Hemodialysis Patients’’), 

concerning isolation rooms, must be 

complied with by February 9, 2009. 

(ii) When dialysis isolation rooms as 

required by (a)(1)(i) are available locally 

that sufficiently serve the needs of 

patients in the geographic area, a new 

dialysis facility may request a waiver of 

such requirement. Isolation room 

waivers may be granted at the discretion 

of, and subject to, additional 

qualifications as may be deemed 

necessary by the Secretary. 

(2) The ‘‘Guidelines for the Prevention 

of Intravascular Catheter-Related 

Infections’’ entitled ‘‘Recommendations 

for Placement of Intravascular Catheters 

in Adults and Children’’ parts I–IV; and 

‘‘Central Venous Catheters, Including 

PICCs, Hemodialysis, and Pulmonary 

Artery Catheters, in Adult and Pediatric 

Patients,’’ Morbidity and Mortality 

Weekly Report, volume 51 number RR–

10, pages 16 through 18, August 9, 2002. 

The Director of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR Part 51. This publication is 

available for inspection at the CMS 

Information Resource Center, 7500 

Security Boulevard, Central Building, 

Baltimore, MD or at the National 

Archives and Records Administration 

(NARA). Copies may be obtained at the 

CMS Information Resource Center. For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal_register/code_of_regulations/ 

ibr_locations.html. 

(3) Patient isolation procedures to 

minimize the spread of infectious agents 

and communicable diseases; and 

(4) Maintaining procedures, in 

accordance with applicable State and 

local laws and accepted public health 

procedures, for the—

(i) Handling, storage, and disposal of 

potentially infectious waste; and 

(ii) Cleaning and disinfection of 

contaminated surfaces, medical devices, 

and equipment. 

(b) Standard: Oversight. The facility 

must—

(1) Monitor and implement biohazard 

and infection control policies and 

activities within the dialysis unit; 

(2) Ensure that clinical staff 

demonstrate compliance with current 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20477 

aseptic techniques when dispensing and 

administering intravenous medications 

from vials and ampules; and 

(3) Require all clinical staff to report 

infection control issues to the dialysis 

facility’s medical director (see § 494.150 

of this part) and the quality 

improvement committee. 

(c) Standard: Reporting. The facility 

must report incidences of 

communicable diseases as required by 

Federal, State, and local regulations. 

§ 494.40 Condition: Water and dialysate 

quality. 

The facility must be able to 

demonstrate the following: 

(a) Standard: Water purity. Water and 

equipment used for dialysis meets the 

water and dialysate quality standards 

and equipment requirements found in 

the Association for the Advancement of 

Medical Instrumentation (AAMI) 

publication, ‘‘Dialysate for 

hemodialysis,’’ ANSI/AAMI RD52: 

2004. The Director of the Federal 

Register approves this incorporation by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR Part 51. This 

publication is available for inspection at 

the CMS Information Resource Center, 

7500 Security Boulevard, Central 

Building, Baltimore, MD or at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal_register/code_of_regulations/ 

ibr_locations.html. Copies may be 

purchased from the Association for the 

Advancement of Medical 

Instrumentation, 3300 Washington 

Boulevard, Suite 400, Arlington, VA 

22201–4598. 

(b) Standard: Chlorine/chloramines. 

(1) The water treatment system must 

include a component or carbon tank 

which removes chlorine/chloramine 

along with a backup component or 

second carbon tank in series for 

chlorine/chloramine removal; 

(2) (i) If the test results from the port 

of the initial component or carbon tank 

referred to in section 6.2.5 of AAMI 

RD52:2004 are greater than 0.5 mg/L for 

free chlorine or 0.1 mg/L for 

chloramines, or equal to or greater than 

0.1 mg/L of total chlorine, then the 

second component or carbon tank 

which removes chlorine/chloramine 

must be tested; 

(ii) If the test results from the last 

component or carbon tank are greater 

than the parameters for chlorine or 

chloramine specified in paragraph 

(b)(2)(i) of this section the facility 

must—

(A) Immediately take corrective action 

to bring chlorine or chloramine levels 

into compliance with paragraph (b)(2)(i) 

of this section and confirm through 

testing that the corrective action has 

been effective, or terminate dialysis 

treatment to protect patients from 

exposure to chlorine/chloramine; 

(B) Only allow use of purified water 

in a holding tank, if appropriate, and if 

testing shows water chlorine or 

chloramine levels that are in 

compliance with paragraph (b)(2)(i) of 

this section; and 

(C) Immediately notify the medical 

director; and 

(D) Take corrective action to ensure 

ongoing compliance with acceptable 

chlorine and chloramine levels as 

described in paragraph (b)(2)(i) of this 

section. 

(c) Standard: Corrective action plan. 

Water testing results including, but not 

limited to, chemical, microbial, and 

endotoxin levels which meet AAMI 

action levels or deviate from the AAMI 

standards must be addressed with a 

corrective action plan that ensures 

patient safety. 

(d) Standard: Adverse events. A 

dialysis facility must maintain active 

surveillance of patient reactions during 

and following dialysis. When clinically 

indicated (for example, after adverse 

patient reactions) the facility must—

(1) Obtain blood and dialysate 

cultures and endotoxin levels; 

(2) Evaluate the water purification 

system; and 

(3) Take corrective action. 

(e) Standard: In-center use of 

preconfigured hemodialysis systems. 

When using a preconfigured, FDAapproved hemodialysis system 

designed, tested and validated to yield 

AAMI quality (which includes 

standards for chemical and chlorine/ 

chloramine testing) water and dialysate, 

the system’s FDA-approved labeling 

must be adhered to for machine use and 

monitoring of the water and dialysate 

quality. The facility must meet all AAMI 

RD52:2004 requirements for water and 

dialysate. Moreover, the facility must 

perform bacteriological and endotoxin 

testing on a quarterly, or more frequent 

basis, as needed, to ensure that the 

water and dialysate are within AAMI 

limits. 

§ 494.50 Condition: Reuse of 

hemodialyzers and bloodlines. 

(a) Standard: General requirements 

for the reuse of hemodialyzers and 

bloodlines. Certain hemodialyzers and 

bloodlines—

(1) May be reused for certain patients 

with the exception of Hepatitis B 

positive patients; 

(2) Must be reused only for the same 

patient; and 

(3) Must be labeled for multiple reuse 

in accordance with the premarket 

notification provisions of section 510(k) 

of the Food, Drug, and Cosmetics Act 

and 21 CFR 876.5860. 

(b) Standard: Reprocessing 

requirements for the reuse of 

hemodialyzers and bloodlines. A 

dialysis facility that reuses 

hemodialyzers and bloodlines must 

adhere to the following reprocessing 

guidelines: 

(1) Meet the requirements of AAMI 

published in ‘‘Reuse of Hemodialyzers,’’

third edition, ANSI/AAMI RD47:2002 

and RD47:2002/A1:2003. The Director 

of the Federal Register approves this 

incorporation by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR Part 51. This publication is 

available for inspection at the CMS 

Information Resource Center, 7500 

Security Boulevard, Central Building, 

Baltimore, MD or at the National 

Archives and Records Administration 

(NARA). For information on the 

availability of this material at NARA, 

call 202–741–6030, or go to: http:// 

www.archives.gov/federal_register/ 

code_of_regulations/ibr_locations.html. 

Copies may be purchased from the 

Association for the Advancement of 

Medical Instrumentation, 3300 

Washington Boulevard, Suite 400, 

Arlington, VA 22201–4598. 

(2) Reprocess hemodialyzers and 

bloodlines—

(i) By following the manufacturer’s 

recommendations; or 

(ii) Using an alternate method and 

maintaining documented evidence that 

the method is safe and effective. 

(3) Not expose hemodialyzers to more 

than one chemical germicide, other than 

bleach (used as a cleaner in this 

application), during the life of the 

dialyzer. All hemodialyzers must be 

discarded before a different chemical 

germicide is used in the facility. 

(c) Standard: Monitoring, evaluation, 

and reporting requirements for the reuse 

of hemodialyzers and bloodlines. In 

addition to the requirements for 

hemodialyzer and bloodline reuse 

specified in paragraphs (a) and (b) of 

this section, the dialysis facility must 

adhere to the following: 

(1) Monitor patient reactions during 

and following dialysis. 

(2) When clinically indicated (for 

example, after adverse patient 

reactions), the facility must—

(i) Obtain blood and dialysate cultures 

and endotoxin levels; and 

(ii) Undertake evaluation of its 

dialyzer reprocessing and water 

purification system. When this 


PWALKER on PROD1PC71 with RULES2
20478 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

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. 

§ 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 crosscontamination, and to accommodate 

medical emergency equipment and staff. 

(2) The dialysis facility must: 

(i) Maintain a comfortable 

temperature within the facility; and 

(ii) Make reasonable accommodations 

for the patients who are not comfortable 

at this temperature. 

(3) The dialysis facility must make 

accommodations to provide for patient 

privacy when patients are examined or 

treated and body exposure is required. 

(4) Patients must be in view of staff 

during hemodialysis treatment to ensure 

patient safety (video surveillance will 

not meet this requirement). 

(d) Standard: Emergency 

preparedness. The dialysis facility must 

implement processes and procedures to 

manage medical and nonmedical 

emergencies that are likely to threaten 

the health or safety of the patients, the 

staff, or the public. These emergencies 

include, but are not limited to, fire, 

equipment or power failures, carerelated emergencies, water supply 

interruption, and natural disasters likely 

to occur in the facility’s geographic area. 

(1) Emergency preparedness of staff. 

The dialysis facility must provide 

appropriate training and orientation in 

emergency preparedness to the staff. 

Staff training must be provided and 

evaluated at least annually and include 

the following: 

(i) Ensuring that staff can demonstrate 

a knowledge of emergency procedures, 

including informing patients of—

(A) What to do; 

(B) Where to go, including 

instructions for occasions when the 

geographic area of the dialysis facility 

must be evacuated; 

(C) Whom to contact if an emergency 

occurs while the patient is not in the 

dialysis facility. This contact 

information must include an alternate 

emergency phone number for the 

facility for instances when the dialysis 

facility is unable to receive phone calls 

due to an emergency situation (unless 

the facility has the ability to forward 

calls to a working phone number under 

such emergency conditions); and 

(D) How to disconnect themselves 

from the dialysis machine if an 

emergency occurs. 

(ii) Ensuring that, at a minimum, 

patient care staff maintain current CPR 

certification; and 

(iii) Ensuring that nursing staff are 

properly trained in the use of emergency 

equipment and emergency drugs. 

(2) Emergency preparedness patient 

training. The facility must provide 

appropriate orientation and training to 

patients, including the areas specified in 

paragraph (d)(1)(i) of this section. 

(3) Emergency equipment. Emergency 

equipment, including, but not limited 

to, oxygen, airways, suction, 

defibrillator or automated external 

defibrillator, artificial resuscitator, and 

emergency drugs, must be on the 

premises at all times and immediately 

available. 

(4) Emergency plans. The facility 

must—

(i) Have a plan to obtain emergency 

medical system assistance when 

needed; 

(ii) Evaluate at least annually the 

effectiveness of emergency and disaster 

plans and update them as necessary; 

and 

(iii) Contact its local disaster 

management agency at least annually to 

ensure that such agency is aware of 

dialysis facility needs in the event of an 

emergency. 

(e) Standard: Fire safety. 

(1) Except as provided in paragraph 

(e)(2) of this section, by February 9, 

2009. The dialysis facility must comply 

with applicable provisions of the 2000 

edition of the Life Safety Code of the 

National Fire Protection Association 

(which is incorporated by reference at 

§ 403.744(a)(1)(i) of this chapter). 

(2) Notwithstanding paragraph (e)(1) 

of this section, dialysis facilities 

participating in Medicare as of October 

14, 2008. Utilizing non-sprinklered 

buildings on such date may continue to 

use such facilities if such buildings 

were constructed before January 1, 2008 

and State law so permits. 

(3) If CMS finds that a fire and safety 

code imposed by the facility’s State law 

adequately protects a dialysis facility’s 

patients, CMS may allow the State 

survey agency to apply the State’s fire 

and safety code instead of the Life 

Safety Code. 

(4) After consideration of State survey 

agency recommendations, CMS may 

waive, for individual dialysis facilities 

and for appropriate periods, specific 

provisions of the Life Safety Code, if the 

following requirements are met: 

(i) The waiver would not adversely 

affect the health and safety of the 

dialysis facility’s patients; and 

(ii) Rigid application of specific 

provisions of the Life Safety Code 

would result in an unreasonable 

hardship for the dialysis facility. 

Subpart C—Patient Care 

§ 494.70 Condition: Patients’ rights. 

The dialysis facility must inform 

patients (or their representatives) of 

their rights (including their privacy 

rights) and responsibilities when they 

begin their treatment and must protect 

and provide for the exercise of those 

rights. 

(a) Standard: Patients’ rights. The 

patient has the right to—

(1) Respect, dignity, and recognition 

of his or her individuality and personal 

needs, and sensitivity to his or her 

psychological needs and ability to cope 

with ESRD; 

(2) Receive all information in a way 

that he or she can understand; 

(3) Privacy and confidentiality in all 

aspects of treatment; 

(4) Privacy and confidentiality in 

personal medical records; 

(5) Be informed about and participate, 

if desired, in all aspects of his or her 

care, and be informed of the right to 

refuse treatment, to discontinue 

treatment, and to refuse to participate in 

experimental research; 

(6) Be informed about his or her right 

to execute advance directives, and the 

facility’s policy regarding advance 

directives; 

(7) Be informed about all treatment 

modalities and settings, including but 

not limited to, transplantation, home 

dialysis modalities (home hemodialysis, 

intermittent peritoneal dialysis, 

continuous ambulatory peritoneal 

dialysis, continuous cycling peritoneal 

dialysis),and in-facility hemodialysis. 

The patient has the right to receive 

resource information for dialysis 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20479 

modalities not offered by the facility, 

including information about alternative 

scheduling options for working patients; 

(8) Be informed of facility policies 

regarding patient care, including, but 

not limited to, isolation of patients; 

(9) Be informed of facility policies 

regarding the reuse of dialysis supplies, 

including hemodialyzers; 

(10) Be informed by the physician, 

nurse practitioner, clinical nurse 

specialist, or physician’s assistant 

treating the patient for ESRD of his or 

her own medical status as documented 

in the patient’s medical record, unless 

the medical record contains a 

documented contraindication; 

(11) Be informed of services available 

in the facility and charges for services 

not covered under Medicare; 

(12) Receive the necessary services 

outlined in the patient plan of care 

described in § 494.90; 

(13) Be informed of the rules and 

expectations of the facility regarding 

patient conduct and responsibilities; 

(14) Be informed of the facility’s 

internal grievance process; 

(15) Be informed of external grievance 

mechanisms and processes, including 

how to contact the ESRD Network and 

the State survey agency; 

(16) Be informed of his or her right to 

file internal grievances or external 

grievances or both without reprisal or 

denial of services; and 

(17) Be informed that he or she may 

file internal or external grievances, 

personally, anonymously or through a 

representative of the patient’s choosing. 

(b) Standard: Right to be informed 

regarding the facility’s discharge and 

transfer policies. The patient has the 

right to—

(1) Be informed of the facility’s 

policies for transfer, routine or 

involuntary discharge, and 

discontinuation of services to patients; 

and 

(2) Receive written notice 30 days in 

advance of an involuntary discharge, 

after the facility follows the involuntary 

discharge procedures described in 

§ 494.180(f)(4). In the case of immediate 

threats to the health and safety of others, 

an abbreviated discharge procedure may 

be allowed. 

(c) Standard: Posting of rights. The 

dialysis facility must prominently 

display a copy of the patient’s rights in 

the facility, including the current State 

agency and ESRD network mailing 

addresses and telephone complaint 

numbers, where it can be easily seen 

and read by patients. 

§ 494.80 Condition: Patient assessment. 

The facility’s interdisciplinary team 

consists of, at a minimum, the patient or 

the patient’s designee (if the patient 

chooses), a registered nurse, a physician 

treating the patient for ESRD, a social 

worker, and a dietitian. The 

interdisciplinary team is responsible for 

providing each patient with an 

individualized and comprehensive 

assessment of his or her needs. The 

comprehensive assessment must be 

used to develop the patient’s treatment 

plan and expectations for care. 

(a) Standard: Assessment criteria. The 

patient’s comprehensive assessment 

must include, but is not limited to, the 

following: 

(1) Evaluation of current health status 

and medical condition, including comorbid conditions. 

(2) Evaluation of the appropriateness 

of the dialysis prescription, blood 

pressure, and fluid management needs. 

(3) Laboratory profile, immunization 

history, and medication history. 

(4) Evaluation of factors associated 

with anemia, such as hematocrit, 

hemoglobin, iron stores, and potential 

treatment plans for anemia, including 

administration of erythropoiesisstimulating agent(s). 

(5) Evaluation of factors associated 

with renal bone disease. 

(6) Evaluation of nutritional status by 

a dietitian. 

(7) Evaluation of psychosocial needs 

by a social worker. 

(8) Evaluation of dialysis access type 

and maintenance (for example, 

arteriovenous fistulas, arteriovenous 

grafts, and peritoneal catheters). 

(9) Evaluation of the patient’s 

abilities, interests, preferences, and 

goals, including the desired level of 

participation in the dialysis care 

process; the preferred modality 

(hemodialysis or peritoneal dialysis), 

and setting, (for example, home 

dialysis), and the patient’s expectations 

for care outcomes. 

(10) Evaluation of suitability for a 

transplantation referral, based on 

criteria developed by the prospective 

transplantation center and its 

surgeon(s). If the patient is not suitable 

for transplantation referral, the basis for 

nonreferral must be documented in the 

patient’s medical record. 

(11) Evaluation of family and other 

support systems. 

(12) Evaluation of current patient 

physical activity level. 

(13) Evaluation for referral to 

vocational and physical rehabilitation 

services. 

(b) Standard: Frequency of 

assessment for patients admitted to the 

dialysis facility. (1) An initial 

comprehensive assessment must be 

conducted on all new patients (that is, 

all admissions to a dialysis facility), 

within the latter of 30 calendar days or 

13 outpatient hemodialysis sessions 

beginning with the first outpatient 

dialysis session. 

(2) A follow up comprehensive 

reassessment must occur within 3 

months after the completion of the 

initial assessment to provide 

information to adjust the patient’s plan 

of care specified in § 494.90. 

(c) Standard: Assessment of treatment 

prescription. The adequacy of the 

patient’s dialysis prescription, as 

described in § 494.90(a)(1), must be 

assessed on an ongoing basis as follows: 

(1) Hemodialysis patients. At least 

monthly by calculating delivered Kt/V 

or an equivalent measure. 

(2) Peritoneal dialysis patients. At 

least every 4 months by calculating 

delivered weekly Kt/V or an equivalent 

measure. 

(d) Standard: Patient reassessment. In 

accordance with the standards specified 

in paragraphs (a)(1) through (a)(13) of 

this section, a comprehensive 

reassessment of each patient and a 

revision of the plan of care must be 

conducted—

(1) At least annually for stable 

patients; and 

(2) At least monthly for unstable 

patients including, but not limited to, 

patients with the following: 

(i) Extended or frequent 

hospitalizations; 

(ii) Marked deterioration in health 

status; 

(iii) Significant change in 

psychosocial needs; or 

(iv) Concurrent poor nutritional 

status, unmanaged anemia, and 

inadequate dialysis. 

§ 494.90 Condition: Patient plan of care. 

The interdisciplinary team as defined 

at § 494.80 must develop and implement 

a written, individualized 

comprehensive plan of care that 

specifies the services necessary to 

address the patient’s needs, as identified 

by the comprehensive assessment and 

changes in the patient’s condition, and 

must include measurable and expected 

outcomes and estimated timetables to 

achieve these outcomes. The outcomes 

specified in the patient plan of care 

must be consistent with current 

evidence-based professionally-accepted 

clinical practice standards. 

(a) Standard: Development of patient 

plan of care. The interdisciplinary team 

must develop a plan of care for each 

patient. The plan of care must address, 

but not be limited to, the following: 

(1) Dose of dialysis. The 

interdisciplinary team must provide the 

necessary care and services to manage 

the patient’s volume status; and achieve 


PWALKER on PROD1PC71 with RULES2
20480 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

and sustain the prescribed dose of 

dialysis to meet a hemodialysis Kt/V of 

at least 1.2 and a peritoneal dialysis 

weekly Kt/V of at least 1.7 or meet an 

alternative equivalent professionallyaccepted clinical practice standard for 

adequacy of dialysis. 

(2) Nutritional status. The 

interdisciplinary team must provide the 

necessary care and counseling services 

to achieve and sustain an effective 

nutritional status. A patient’s albumin 

level and body weight must be 

measured at least monthly. Additional 

evidence-based professionally-accepted 

clinical nutrition indicators may be 

monitored, as appropriate. 

(3) Mineral metabolism. Provide the 

necessary care to manage mineral 

metabolism and prevent or treat renal 

bone disease. 

(4) Anemia. The interdisciplinary 

team must provide the necessary care 

and services to achieve and sustain the 

clinically appropriate hemoglobin/ 

hematocrit level. The patient’s 

hemoglobin/hematocrit must be 

measured at least monthly. The dialysis 

facility must conduct an evaluation of 

the patient’s anemia management needs. 

For a home dialysis patient, the facility 

must evaluate whether the patient can 

safely, aseptically, and effectively 

administer erythropoiesis-stimulating 

agents and store this medication under 

refrigeration if necessary. The patient’s 

response to erythropoiesis-stimulating 

agent(s), including blood pressure levels 

and utilization of iron stores, must be 

monitored on a routine basis. 

(5) Vascular access. The 

interdisciplinary team must provide 

vascular access monitoring and 

appropriate, timely referrals to achieve 

and sustain vascular access. The 

hemodialysis patient must be evaluated 

for the appropriate vascular access type, 

taking into consideration co-morbid 

conditions, other risk factors, and 

whether the patient is a potential 

candidate for arteriovenous fistula 

placement. The patient’s vascular access 

must be monitored to prevent access 

failure, including monitoring of 

arteriovenous grafts and fistulae for 

symptoms of stenosis. 

(6) Psychosocial status. The 

interdisciplinary team must provide the 

necessary monitoring and social work 

interventions. These include counseling 

services and referrals for other social 

services, to assist the patient in 

achieving and sustaining an appropriate 

psychosocial status as measured by a 

standardized mental and physical 

assessment tool chosen by the social 

worker, at regular intervals, or more 

frequently on an as-needed basis. 

(7) Modality. (i) Home dialysis. The 

interdisciplinary team must identify a 

plan for the patient’s home dialysis or 

explain why the patient is not a 

candidate for home dialysis. 

(ii) Transplantation status. When the 

patient is a transplant referral candidate, 

the interdisciplinary team must develop 

plans for pursuing transplantation. The 

patient’s plan of care must include 

documentation of the—

(A) Plan for transplantation, if the 

patient accepts the transplantation 

referral; 

(B) Patient’s decision, if the patient is 

a transplantation referral candidate but 

declines the transplantation referral; or 

(C) Reason(s) for the patient’s 

nonreferral as a transplantation 

candidate as documented in accordance 

with § 494.80(a)(10). 

(8) Rehabilitation status. The 

interdisciplinary team must assist the 

patient in achieving and sustaining an 

appropriate level of productive activity, 

as desired by the patient, including the 

educational needs of pediatric patients 

(patients under the age of 18 years), and 

make rehabilitation and vocational 

rehabilitation referrals as appropriate. 

(b) Standard: Implementation of the 

patient plan of care. 

(1) The patient’s plan of care must—

(i) Be completed by the 

interdisciplinary team, including the 

patient if the patient desires; and 

(ii) Be signed by team members, 

including the patient or the patient’s 

designee; or, if the patient chooses not 

to sign the plan of care, this choice must 

be documented on the plan of care, 

along with the reason the signature was 

not provided. 

(2) Implementation of the initial plan 

of care must begin within the latter of 

30 calendar days after admission to the 

dialysis facility or 13 outpatient 

hemodialysis sessions beginning with 

the first outpatient dialysis session. 

Implementation of monthly or annual 

updates of the plan of care must be 

performed within 15 days of the 

completion of the additional patient 

assessments specified in § 494.80(d). 

(3) If the expected outcome is not 

achieved, the interdisciplinary team 

must adjust the patient’s plan of care to 

achieve the specified goals. When a 

patient is unable to achieve the desired 

outcomes, the team must—

(i) Adjust the plan of care to reflect 

the patient’s current condition; 

(ii) Document in the record the 

reasons why the patient was unable to 

achieve the goals; and 

(iii) Implement plan of care changes 

to address the issues identified in 

paragraph (b)(3)(ii) of this section. 

(4) The dialysis facility must ensure 

that all dialysis patients are seen by a 

physician, nurse practitioner, clinical 

nurse specialist, or physician’s assistant 

providing ESRD care at least monthly, 

as evidenced by a monthly progress note 

placed in the medical record, and 

periodically while the hemodialysis 

patient is receiving in-facility dialysis. 

(c) Standard: Transplantation referral 

tracking. The interdisciplinary team 

must—

(1) Track the results of each kidney 

transplant center referral; 

(2) Monitor the status of any facility 

patients who are on the transplant wait 

list; and 

(3) Communicate with the transplant 

center regarding patient transplant 

status at least annually, and when there 

is a change in transplant candidate 

status. 

(d) Standard: Patient education and 

training. The patient care plan must 

include, as applicable, education and 

training for patients and family 

members or caregivers or both, in 

aspects of the dialysis experience, 

dialysis management, infection 

prevention and personal care, home 

dialysis and self-care, quality of life, 

rehabilitation, transplantation, and the 

benefits and risks of various vascular 

access types. 

§ 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 infacility patients and meet all applicable 

conditions of this part. 

(a) Standard: Training. The 

interdisciplinary team must oversee 

training of the home dialysis patient, the 

designated caregiver, or self-dialysis 

patient before the initiation of home 

dialysis or self-dialysis (as defined in 

§ 494.10) and when the home dialysis 

caregiver or home dialysis modality 

changes. The training must—

(1) Be provided by a dialysis facility 

that is approved to provide home 

dialysis services; 

(2) Be conducted by a registered nurse 

who meets the requirements of 

§ 494.140(b)(2); and 

(3) Be conducted for each home 

dialysis patient and address the specific 

needs of the patient, in the following 

areas: 

(i) The nature and management of 

ESRD. 

(ii) The full range of techniques 

associated with the treatment modality 

selected, including effective use of 

dialysis supplies and equipment in 

achieving and delivering the physician’s 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20481 

prescription of Kt/V or URR, and 

effective administration of 

erythropoiesis-stimulating agent(s) (if 

prescribed) to achieve and maintain a 

target level hemoglobin or hematocrit as 

written in patient’s plan of care. 

(iii) How to detect, report, and 

manage potential dialysis 

complications, including water 

treatment problems. 

(iv) Availability of support resources 

and how to access and use resources. 

(v) How to self-monitor health status 

and record and report health status 

information. 

(vi) How to handle medical and nonmedical emergencies. 

(vii) Infection control precautions. 

(viii) Proper waste storage and 

disposal procedures. 

(b) Standard: Home dialysis 

monitoring. The dialysis facility must—

(1) Document in the medical record 

that the patient, the caregiver, or both 

received and demonstrated adequate 

comprehension of the training; 

(2) Retrieve and review complete selfmonitoring data and other information 

from self-care patients or their 

designated caregiver(s) at least every 2 

months; and 

(3) Maintain this information in the 

patient’s medical record. 

(c) Standard: Support services. 

(1) A home dialysis facility must 

furnish (either directly, under 

agreement, or by arrangement with 

another ESRD facility) home dialysis 

support services regardless of whether 

dialysis supplies are provided by the 

dialysis facility or a durable medical 

equipment company. Services include, 

but are not limited to, the following: 

(i) Periodic monitoring of the patient’s 

home adaptation, including visits to the 

patient’s home by facility personnel in 

accordance with the patient’s plan of 

care. 

(ii) Coordination of the home patient’s 

care by a member of the dialysis 

facility’s interdisciplinary team. 

(iii) Development and periodic review 

of the patient’s individualized 

comprehensive plan of care that 

specifies the services necessary to 

address the patient’s needs and meets 

the measurable and expected outcomes 

as specified in § 494.90 of this part. 

(iv) Patient consultation with 

members of the interdisciplinary team, 

as needed. 

(v) Monitoring of the quality of water 

and dialysate used by home 

hemodialysis patients including 

conducting an onsite evaluation and 

testing of the water and dialysate system 

in accordance with—

(A) The recommendations specified in 

the manufacturers’ instructions; and 

(B) The system’s FDA-approved 

labeling for preconfigured systems 

designed, tested, and validated to meet 

AAMI quality (which includes 

standards for chemical and chlorine/ 

chloramine testing) water and dialysate. 

The facility must meet testing and other 

requirements of AAMI RD52:2004. In 

addition, bacteriological and endotoxin 

testing must be performed on a 

quarterly, or more frequent basis as 

needed, to ensure that the water and 

dialysate are within the AAMI limits. 

(C) The dialysis facility must correct 

any water and dialysate quality problem 

for the home hemodialysis patient, and 

if necessary, arrange for backup dialysis 

until the problem is corrected if—

(1) Analysis of the water and dialysate 

quality indicates contamination; or 

(2) The home hemodialysis patient 

demonstrates clinical symptoms 

associated with water and dialysate 

contamination. 

(vi) Purchasing, leasing, renting, 

delivering, installing, repairing and 

maintaining medically necessary home 

dialysis supplies and equipment 

(including supportive equipment) 

prescribed by the attending physician. 

(vii) Identifying a plan and arranging 

for emergency back-up dialysis services 

when needed. 

(2) The dialysis facility must maintain 

a recordkeeping system that ensures 

continuity of care and patient privacy. 

This includes items and services 

furnished by durable medical 

equipment (DME) suppliers referred to 

in § 414.330(a)(2) of this chapter. 

§ 494.110 Condition: Quality assessment 

and performance improvement. 

The dialysis facility must develop, 

implement, maintain, and evaluate an 

effective, data-driven, quality 

assessment and performance 

improvement program with 

participation by the professional 

members of the interdisciplinary team. 

The program must reflect the 

complexity of the dialysis facility’s 

organization and services (including 

those services provided under 

arrangement), and must focus on 

indicators related to improved health 

outcomes and the prevention and 

reduction of medical errors. The dialysis 

facility must maintain and demonstrate 

evidence of its quality improvement and 

performance improvement program for 

review by CMS. 

(a) Standard: Program scope. 

(1) The program must include, but not 

be limited to, an ongoing program that 

achieves measurable improvement in 

health outcomes and reduction of 

medical errors by using indicators or 

performance measures associated with 

improved health outcomes and with the 

identification and reduction of medical 

errors. 

(2) The dialysis facility must measure, 

analyze, and track quality indicators or 

other aspects of performance that the 

facility adopts or develops that reflect 

processes of care and facility operations. 

These performance components must 

influence or relate to the desired 

outcomes or be the outcomes 

themselves. The program must include, 

but not be limited to, the following: 

(i) Adequacy of dialysis. 

(ii) Nutritional status. 

(iii) Mineral metabolism and renal 

bone disease. 

(iv) Anemia management. 

(v) Vascular access. 

(vi) Medical injuries and medical 

errors identification. 

(vii) Hemodialyzer reuse program, if 

the facility reuses hemodialyzers. 

(viii) Patient satisfaction and 

grievances. 

(ix) Infection control; with respect to 

this component the facility must—

(A) Analyze and document the 

incidence of infection to identify trends 

and establish baseline information on 

infection incidence; 

(B) Develop recommendations and 

action plans to minimize infection 

transmission, promote immunization; 

and 

(C) Take actions to reduce future 

incidents. 

(b) Standard: Monitoring performance 

improvement. The dialysis facility must 

continuously monitor its performance, 

take actions that result in performance 

improvements, and track performance to 

ensure that improvements are sustained 

over time. 

(c) Standard: Prioritizing 

improvement activities. The dialysis 

facility must set priorities for 

performance improvement, considering 

prevalence and severity of identified 

problems and giving priority to 

improvement activities that affect 

clinical outcomes or patient safety. The 

facility must immediately correct any 

identified problems that threaten the 

health and safety of patients. 

§ 494.120 Condition: Special purpose renal 

dialysis facilities. 

A special purpose renal dialysis 

facility is approved to furnish dialysis 

on a short-term basis at special 

locations. Special purpose dialysis 

facilities are divided into two categories: 

vacation camps (locations that serve 

ESRD patients while the patients are in 

a temporary residence) and facilities 

established to serve ESRD patients 

under emergency circumstances. 

(a) Standard: Approval period. The 

period of approval for a special purpose 


PWALKER on PROD1PC71 with RULES2
20482 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

renal dialysis facility may not exceed 8 

months in any 12-month period. 

(b) Standard: Service limitation. 

Special purpose renal dialysis facilities 

are limited to areas in which there are 

limited dialysis resources or access-tocare problems due to an emergency 

circumstance. A special purpose renal 

dialysis facility may provide services 

only to those patients who would 

otherwise be unable to obtain treatments 

in the geographic locality served by the 

facility. 

(c) Standard: Scope of requirements. 

(1) Scope of requirements for a 

vacation camp. A vacation camp that 

provides dialysis services must be 

operated under the direction of a 

certified renal dialysis facility that 

assumes full responsibility for the care 

provided to patients. A special purpose 

renal dialysis facility established as a 

vacation camp must comply with the 

following conditions for coverage—

(i) Infection control at § 494.30; 

(ii) Water and dialysate quality at 

§ 494.40 (except as provided in 

paragraph (c)(1)(viii) of this section); 

(iii) Reuse of hemodialyzers at 

§ 494.50 (if reuse is performed); 

(iv) Patients’ rights and posting of 

patients’ rights at § 494.70(a) and 

§ 494.70(c); 

(v) Laboratory services at § 494.130; 

(vi) Medical director responsibilities 

for staff education and patient care 

policies and procedures at § 494.150(c) 

and § 494.150(d); 

(vii) Medical records at § 494.170; and 

(viii) When portable home water 

treatment systems are used in place of 

a central water treatment system, the 

facility may adhere to § 494.100(c)(1)(v) 

(home monitoring of water quality), in 

place of § 494.40 (water quality). 

(2) Scope of requirements for an 

emergency circumstance facility. A 

special purpose renal dialysis facility 

set up due to emergency circumstances 

may provide services only to those 

patients who would otherwise be unable 

to obtain treatments in the geographic 

areas served by the facility. These types 

of special purpose dialysis facilities 

must comply with paragraph (c)(1) of 

this section and addition to complying 

with the following conditions: 

(i) Section 494.20 (compliance with 

Federal, State, and local laws and 

regulations). 

(ii) Section 494.60 (physical 

environment). 

(iii) Section 494.70(a) through section 

494.70(c) (patient rights). 

(iv) Section 494.140 (personnel 

qualifications). 

(v) Section 494.150 (medical director). 

(vi) Section 494.180 (governance). 

(d) Standard: Physician contact. The 

facility must contact the patient’s 

physician, if possible, prior to initiating 

dialysis in the special purpose renal 

dialysis facility, to discuss the patient’s 

current condition to assure care 

provided in the special purpose renal 

dialysis facility is consistent with the 

patient plan of care (described in 

§ 494.90). 

(e) Standard: Documentation. All 

patient care provided in the special 

purpose facility is documented and 

forwarded to the patient’s usual dialysis 

facility, if possible, within 30 days of 

the last scheduled treatment in the 

special purpose renal dialysis facility. 

§ 494.130 Condition: Laboratory services. 

The dialysis facility must provide, or 

make available, laboratory services 

(other than tissue pathology and 

histocompatibility) to meet the needs of 

the ESRD patient. Any laboratory 

services, including tissue pathology and 

histocompatibility must be furnished by 

or obtained from, a facility that meets 

the requirements for laboratory services 

specified in part 493 of this chapter. 

Subpart D—Administration 

§ 494.140 Condition: Personnel 

qualifications. 

All dialysis facility staff must meet 

the applicable scope of practice board 

and licensure requirements in effect in 

the State in which they are employed. 

The dialysis facility’s staff (employee or 

contractor) must meet the personnel 

qualifications and demonstrated 

competencies necessary to serve 

collectively the comprehensive needs of 

the patients. The dialysis facility’s staff 

must have the ability to demonstrate 

and sustain the skills needed to perform 

the specific duties of their positions. 

(a) Standard: Medical director. 

(l) The medical director must be a 

board-certified physician in internal 

medicine or pediatrics by a professional 

board who has completed a boardapproved training program in 

nephrology and has at least 12-months 

of experience providing care to patients 

receiving dialysis. 

(2) If a physician, as specified in 

paragraph (a)(1) of this section, is not 

available to direct a certified dialysis 

facility another physician may direct the 

facility, subject to the approval of the 

Secretary. 

(b) Standard: Nursing services. 

(1) Nurse manager. The facility must 

have a nurse manager responsible for 

nursing services in the facility who 

must—

(i) Be a full time employee of the 

facility; 

(ii) Be a registered nurse; and 

(iii) Have at least 12 months of 

experience in clinical nursing, and an 

additional 6 months of experience in 

providing nursing care to patients on 

maintenance dialysis. 

(2) Self-care and home dialysis 

training nurse. The nurse responsible 

for self-care and/or home care training 

must—

(i) Be a registered nurse; and 

(ii) Have at least 12 months 

experience in providing nursing care 

and an additional 3 months of 

experience in the specific modality for 

which the nurse will provide self-care 

training. 

(3) Charge nurse. The charge nurse 

responsible for each shift must—

(i) Be a registered nurse, a licensed 

practical nurse, or vocational nurse who 

meets the practice requirements in the 

State in which he or she is employed; 

(ii) Have at least 12 months 

experience in providing nursing care, 

including 3 months of experience in 

providing nursing care to patients on 

maintenance dialysis; and 

(iii) If such nurse is a licensed 

practical nurse or licensed vocational 

nurse, work under the supervision of a 

registered nurse in accordance with 

state nursing practice act provisions. 

(4) Staff nurse. Each nurse who 

provides care and treatment to patients 

must be either a registered nurse or a 

practical nurse who meets the practice 

requirements in the State in which he or 

she is employed. 

(c) Standard: Dietitian. The facility 

must have a dietitian who must—

(1) Be a registered dietitian with the 

Commission on Dietetic Registration; 

and 

(2) Have a minimum of 1 year 

professional work experience in clinical 

nutrition as a registered dietitian. 

(d) Standard: Social worker. The 

facility must have a social worker 

who—

(1) Holds a master’s degree in social 

work with a specialization in clinical 

practice from a school of social work 

accredited by the Council on Social 

Work Education; or 

(2) Has served at least 2 years as a 

social worker, 1 year of which was in a 

dialysis unit or transplantation program 

prior to September 1, 1976, and has 

established a consultative relationship 

with a social worker who qualifies 

under § 494.140(d)(1). 

(e) Standard: Patient care dialysis 

technicians. Patient care dialysis 

technicians must—

(1) Meet all applicable State 

requirements for education, training, 

credentialing, competency, standards of 

practice, certification, and licensure in 

the State in which he or she is 

employed as a dialysis technician; and 

(2) Have a high school diploma or 

equivalency; 


PWALKER on PROD1PC71 with RULES2
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20483 

(3) Have completed a training 

program that is approved by the medical 

director and governing body, under the 

direction of a registered nurse, focused 

on the operation of kidney dialysis 

equipment and machines, providing 

direct patient care, and communication 

and interpersonal skills, including 

patient sensitivity training and care of 

difficult patients. The training program 

must include the following subjects: 

(i) Principles of dialysis. 

(ii) Care of patients with kidney 

failure, including interpersonal skills. 

(iii) Dialysis procedures and 

documentation, including initiation, 

proper cannulation techniques, 

monitoring, and termination of dialysis. 

(iv) Possible complications of dialysis. 

(v) Water treatment and dialysate 

preparation. 

(vi) Infection control. 

(vii) Safety. 

(viii) Dialyzer reprocessing, if 

applicable. 

(4) Be certified under a State 

certification program or a national 

commercially available certification 

program, as follows—

(i) For newly employed patient care 

technicians, within 18 months of being 

hired as a dialysis patient care 

technician; or 

(ii) For patient care technicians 

employed on October 14, 2008, within 

18 months after such date. 

(f) Standard: Water treatment system 

technicians. Technicians who perform 

monitoring and testing of the water 

treatment system must complete a 

training program that has been approved 

by the medical director and the 

governing body. 

§ 494.150 Condition: Responsibilities of 

the medical director. 

The dialysis facility must have a 

medical director who meets the 

qualifications of § 494.140(a) to be 

responsible for the delivery of patient 

care and outcomes in the facility. The 

medical director is accountable to the 

governing body for the quality of 

medical care provided to patients. 

Medical director responsibilities 

include, but are not limited to, the 

following: 

(a) Quality assessment and 

performance improvement program. 

(b) Staff education, training, and 

performance. 

(c) Policies and procedures. The 

medical director must—

(1) Participate in the development, 

periodic review and approval of a 

‘‘patient care policies and procedures 

manual’’ for the facility; and 

(2) Ensure that—

(i) All policies and procedures 

relative to patient admissions, patient 

care, infection control, and safety are 

adhered to by all individuals who treat 

patients in the facility, including 

attending physicians and nonphysician 

providers; and 

(ii) The interdisciplinary team 

adheres to the discharge and transfer 

policies and procedures specified in 

§ 494.180(f). 

§ 494.160 [Reserved] 

§ 494.170 Condition: Medical records. 

The dialysis facility must maintain 

complete, accurate, and accessible 

records on all patients, including home 

patients who elect to receive dialysis 

supplies and equipment from a supplier 

that is not a provider of ESRD services 

and all other home dialysis patients 

whose care is under the supervision of 

the facility. 

(a) Standard: Protection of the 

patient’s record. The dialysis facility 

must—

(1) Safeguard patient records against 

loss, destruction, or unauthorized use; 

and 

(2) Keep confidential all information 

contained in the patient’s record, except 

when release is authorized pursuant to 

one of the following: 

(i) The transfer of the patient to 

another facility. 

(ii) Certain exceptions provided for in 

the law. 

(iii) Provisions allowed under third 

party payment contracts. 

(iv) Approval by the patient. 

(v) Inspection by authorized agents of 

the Secretary, as required for the 

administration of the dialysis program. 

(3) Obtaining written authorization 

from the patient or legal representative 

before releasing information that is not 

authorized by law. 

(b) Standard: Completion of patient 

records and centralization of clinical 

information. 

(1) Current medical records and those 

of discharged patients must be 

completed promptly. 

(2) All clinical information pertaining 

to a patient must be centralized in the 

patient’s record, including whether the 

patient has executed an advance 

directive. These records must be 

maintained in a manner such that each 

member of the interdisciplinary team 

has access to current information 

regarding the patient’s condition and 

prescribed treatment. 

(3) The dialysis facility must 

complete, maintain, and monitor home 

care patients’ records, including the 

records of patients who receive supplies 

and equipment from a durable medical 

equipment supplier. 

(c) Standard: Record retention and 

preservation. In accordance with 45 CFR 

§ 164.530(j)(2), all patient records must 

be retained for 6 years from the date of 

the patient’s discharge, transfer, or 

death. 

(d) Standard: Transfer of patient 

record information. When a dialysis 

patient is transferred, the dialysis 

facility releasing the patient must send 

all requested medical record 

information to the receiving facility 

within 1 working day of the transfer. 

§ 494.180 Condition: Governance. 

The ESRD facility is under the control 

of an identifiable governing body, or 

designated person(s) with full legal 

authority and responsibility for the 

governance and operation of the facility. 

The governing body adopts and enforces 

rules and regulations relative to its own 

governance and to the health care and 

safety of patients, to the protection of 

the patients’ personal and property 

rights, and to the general operation of 

the facility. 

(a) Standard: Designating a chief 

executive officer or administrator. The 

governing body or designated person 

responsible must appoint an individual 

who serves as the dialysis facility’s chief 

executive officer or administrator who 

exercises responsibility for the 

management of the facility and the 

provision of all dialysis services, 

including, but not limited to—

(1) Staff appointments; 

(2) Fiscal operations; 

(3) The relationship with the ESRD 

networks; and 

(4) Allocation of necessary staff and 

other resources for the facility’s quality 

assessment and performance 

improvement program as described in 

§ 494.110. 

(b) Standard: Adequate number of 

qualified and trained staff. The 

governing body or designated person 

responsible must ensure that—

(1) An adequate number of qualified 

personnel are present whenever patients 

are undergoing dialysis so that the 

patient/staff ratio is appropriate to the 

level of dialysis care given and meets 

the needs of patients; and the registered 

nurse, social worker and dietitian 

members of the interdisciplinary team 

are available to meet patient clinical 

needs; 

(2) A registered nurse, who is 

responsible for the nursing care 

provided, is present in the facility at all 

times that in-center dialysis patients are 

being treated; 

(3) All staff, including the medical 

director, have appropriate orientation to 

the facility and their work 

responsibilities; and 


PWALKER on PROD1PC71 with RULES2
20484 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 

(4) All employees have an 

opportunity for continuing education 

and related development activities. 

(c) Standard: Medical staff 

appointments. The governing body—

(1) Is responsible for all medical staff 

appointments and credentialing in 

accordance with State law, including 

attending physicians, physician 

assistants, nurse practitioners, and 

clinical nurse specialists; and 

(2) Ensures that all medical staff who 

provide care in the facility are informed 

of all facility policies and procedures, 

including the facility’s quality 

assessment and performance 

improvement program specified in 

§ 494.110. 

(3) Communicates expectations to the 

medical staff regarding staff 

participation in improving the quality of 

medical care provided to facility 

patients. 

(d) Standard: Furnishing services. The 

governing body is responsible for 

ensuring that the dialysis facility 

furnishes services directly on its main 

premises or on other premises that are 

contiguous with the main premises and 

are under the direction of the same 

professional staff and governing body as 

the main premises (except for services 

provided under § 494.100). 

(e) Standard: Internal grievance 

process. The facility’s internal grievance 

process must be implemented so that 

the patient may file an oral or written 

grievance with the facility without 

reprisal or denial of services. The 

grievance process must include: 

(1) A clearly explained procedure for 

the submission of grievances. 

(2) Timeframes for reviewing the 

grievance. 

(3) A description of how the patient 

or the patient’s designated 

representative will be informed of steps 

taken to resolve the grievance. 

(f) Standard: Involuntary discharge 

and transfer policies and procedures. 

The governing body must ensure that all 

staff follow the facility’s patient 

discharge and transfer policies and 

procedures. The medical director 

ensures that no patient is discharged or 

transferred from the facility unless—

(1) The patient or payer no longer 

reimburses the facility for the ordered 

services; 

(2) The facility ceases to operate; 

(3) The transfer is necessary for the 

patient’s welfare because the facility can 

no longer meet the patient’s 

documented medical needs; or 

(4) The facility has reassessed the 

patient and determined that the 

patient’s behavior is disruptive and 

abusive to the extent that the delivery of 

care to the patient or the ability of the 

facility to operate effectively is seriously 

impaired, in which case the medical 

director ensures that the patient’s 

interdisciplinary team—

(i) Documents the reassessments, 

ongoing problem(s), and efforts made to 

resolve the problem(s), and enters this 

documentation into the patient’s 

medical record; 

(ii) Provides the patient and the local 

ESRD Network with a 30-day notice of 

the planned discharge; 

(iii) Obtains a written physician’s 

order that must be signed by both the 

medical director and the patient’s 

attending physician concurring with the 

patient’s discharge or transfer from the 

facility; 

(iv) Contacts another facility, attempts 

to place the patient there, and 

documents that effort; and 

(v) Notifies the State survey agency of 

the involuntary transfer or discharge. 

(5) In the case of immediate severe 

threats to the health and safety of others, 

the facility may utilize an abbreviated 

involuntary discharge procedure. 

(g) Standard: Emergency coverage. 

(1) The governing body is responsible 

for ensuring that the dialysis facility 

provides patients and staff with written 

instructions for obtaining emergency 

medical care. 

(2) The dialysis facility must have 

available at the nursing/monitoring 

station, a roster with the names of 

physicians to be called for emergencies, 

when they can be called, and how they 

can be reached. 

(3) The dialysis facility must have an 

agreement with a hospital that can 

provide inpatient care, routine and 

emergency dialysis and other hospital 

services, and emergency medical care 

which is available 24 hours a day, 7 

days a week. The agreement must: 

(i) Ensure that hospital services are 

available promptly to the dialysis 

facility’s patients when needed. 

(ii) Include reasonable assurances that 

patients from the dialysis facility are 

accepted and treated in emergencies. 

(h) Standard: Furnishing data and 

information for ESRD program 

administration. Effective February 1, 

2009, the dialysis facility must furnish 

data and information to CMS and at 

intervals as specified by the Secretary. 

This information is used in a national 

ESRD information system and in 

compilations relevant to program 

administration, including claims 

processing and reimbursement, quality 

improvement, and performance 

assessment. The data and information 

must—

(1) Be submitted at the intervals 

specified by the Secretary; 

(2) Be submitted electronically in the 

format specified by the Secretary; 

(3) Include, but not be limited to—

(i) Cost reports; 

(ii) ESRD administrative forms; 

(iii) Patient survival information; and 

(iv) Existing ESRD clinical 

performance measures, and any future 

clinical performance standards 

developed in accordance with a 

voluntary consensus standards process 

identified by the Secretary. 

(i) Standard: Relationship with the 

ESRD network. The governing body 

receives and acts upon 

recommendations from the ESRD 

network. The dialysis facility must 

cooperate with the ESRD network 

designated for its geographic area, in 

fulfilling the terms of the Network’s 

current statement of work. Each facility 

must participate in ESRD network 

activities and pursue network goals. 

(j) Standard: Disclosure of ownership. 

In accordance with § 420.200 through 

§ 420.206 of this chapter, the governing 

body must report ownership interests of 

5 percent or more to its State survey 

agency. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Approved: July 12, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: December 10, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 08–1102 Filed 4–3–08; 8:45 am] 

BILLING CODE 4120–01–P 


PWALKER on PROD1PC71 with RULES2