Friday,

February 4, 2005

Part IV

Department of 

Health and Human 

Services

Centers for Medicare & Medicaid Services 

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

Medicare Program; Conditions for 

Coverage for End Stage Renal Disease 

Facilities; Proposed Rule

6184 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

42 CFR Parts 400, 405, 410, 412, 413, 

414, 488, and 494 

[CMS–3818–P] 

RIN 0938–AG82 

Medicare Program; Conditions for 

Coverage for End Stage Renal Disease 

Facilities

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule would 

revise the requirements that end stage 

renal disease (ESRD) dialysis facilities 

must meet to be certified under the 

Medicare program. The revised 

requirements focus on the patient and 

the results of the care provided to the 

patient, establish performance 

expectations for facilities, encourage 

patients to participate in their care plan 

and treatment, eliminate many 

procedural requirements from the 

current conditions for coverage, and 

preserve strong process measures when 

necessary to promote patient well being 

and continuous quality improvement. 

These changes are necessary to reflect 

the advances in dialysis technology and 

standard care practices since the 

requirements were last revised in their 

entirety in 1976.

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on May 5, 2005.

ADDRESSES: In commenting, please refer 

to file code CMS–3818–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (fax) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments. (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By mail. You may mail written 

comments (one original and two copies) 

to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3818–

P, PO Box 8012, Baltimore, MD 21244–

8012. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

9994 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by mailing 

your comments to the addresses 

provided at the end of the ‘‘Collection 

of Information Requirements’’ section in 

this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Robert Miller (410) 786–6797, Teresa 

Casey (410) 786–7215, and Rachael 

Weinstein (410) 786–6775 (Conditions 

for Coverage and Quality Standards). Jan 

Tarantino, (410) 786–0905 (Survey and 

Certification).

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–3818–P 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. After the close of the 

comment period, CMS posts all 

electronic comments received before the 

close of the comment period on its 

public website. Comments received 

timely will be available for public 

inspection as they are received, 

generally beginning approximately 3 

weeks after publication of a document, 

at the headquarters of the Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Baltimore, 

Maryland 21244, Monday through 

Friday of each week from 8:30 a.m. to 

4 p.m. To schedule an appointment to 

view public comments, phone 1–800–

743–3951. 

Copies: To order copies of the Federal 

Register containing this document, send 

your request to: New Orders, 

Superintendent of Documents, P.O. Box 

371954, Pittsburgh, PA 15250–7954. 

Specify the date of the issue requested 

and enclose a check or money order 

payable to the Superintendent of 

Documents, or enclose your Visa or 

Master Card number and expiration 

date. Credit card orders can also be 

placed by calling the order desk at (202) 

512–1800 (or toll-free at 1–888–293–

6498) or by faxing to (202) 512–2250. As 

an alternative, you can view and 

photocopy the Federal Register

document at most libraries designated 

as Federal Depository Libraries and at 

many other public and academic 

libraries throughout the country that 

receive the Federal Register. 

This Federal Register document is 

also available from the Federal Register

online database through GPO Access, a 

service of the U.S. Government Printing 

Office. The Web site address is: http://

www.gpoaccess.gov/fr/index.html.

Table of Contents 

I. Introduction and the Provision of Reference 

Materials 

II. Background 

A.History 

B. Existing ESRD Regulations 

C. Overview 

D. Establishment of Central Requirements 

E. Development of Outcome-Based 

Performance Quality Measures 

1. Dialysis Facility Compare 

2. Dialysis Facility Data Reporting 

Requirements 

3. Facility Specific Reports 

4. The National Kidney Foundation Kidney 

Disease Outcomes Quality Initiative 

(NKF-K/DOQI) Clinical Practice 

Guidelines 

5. CMS ESRD Clinical Performance 

Measures Project 

6. CPM Data Reporting 

7. Updating Existing ESRD Patient-Specific 

Performance Measures and Developing 

Future ESRD Facility Performance 

Standards 

F. Summary of the Contents of the 

Proposed Rule 

III. Provisions of Proposed Part 494 Subpart 

A (General Provisions) 

A. Basis and Scope (Proposed § 494.1) 

B. Definitions (Proposed § 494.10) 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6185

C. Compliance with Federal, State, and 

Local Laws and Regulations (Proposed 

§ 494.20) 

IV. Provisions of Proposed Part 494 Subpart 

B (Patient Safety) 

A. Infection Control (Proposed § 494.30) 

B. Water Quality (Proposed § 494.40) 

C. Reuse of Hemodialyzers and Bloodlines 

(Proposed § 494.50) 

D. Physical Environment (Proposed 

§ 494.60) 

V. Provisions of Proposed Part 494 Subpart 

C (Patient Care) 

A. Patients’ Rights (Proposed § 494.70) 

B. Patient Assessment (Proposed § 494.80) 

C. Patient Plan of Care (Proposed § 494.90) 

1. Development of the Patient Plan of Care 

(Proposed § 494.90(a)) 

a. Dose of Dialysis (Proposed 

§ 494.90(a)(1)) 

b. Nutritional Status (Proposed 

§ 494.90(a)(2)) 

c. Anemia (Proposed § 494.90(a)(3)) 

d. Vascular Access (Proposed 

§ 494.90(a)(4)) 

e. Transplantation Status (Proposed 

§ 494.90(a)(5)) 

f. Rehabilitation Status (Proposed 

§ 494.90(a)(6)) 

g. Social Services 

2. Implementation of the Patient Plan of 

Care (Proposed § 494.90(b)) 

3. Transplantation Referral (Proposed 

§ 494.90(c)) 

4. Patient Education and Training 

(Proposed § 494.90(d)) 

D. Care at Home (Proposed § 494.100) 

1. Dialysis of ESRD Patient in the Home 

Setting 

2. Dialysis of ESRD Patients in Nursing 

Facilities and Skilled Nursing Facilities 

a. Delineation of Responsibility 

b. Applicable ESRD Conditions for 

Coverage 

c. Nursing Coverage 

d. Training 

e. Monitoring 

E. Quality Assessment and Performance 

Improvement (Proposed § 494.110) 

1. Program Scope (Proposed § 494.110(a)) 

2. Monitoring Performance Improvement 

(Proposed § 494.110(b)) 

3. Prioritizing Improvement Activities 

(Proposed § 494.110(c)) 

4. Facility Specific Standards of 

Enforcement 

F. Special Purpose Renal Dialysis Facilities 

(Proposed § 494.120) 

G. Laboratory Services (Proposed 

§ 494.130) 

VI. Provisions of Proposed Part 494 Subpart 

D (Administration) 

A. Personnel Qualifications (Proposed 

§ 494.140) 

1. Medical Director (Proposed § 494.140(a)) 

2. Nursing Services (Proposed § 494.140(b)) 

3. Dietitian (Proposed § 494.140(c)) 

4. Social Worker (Proposed § 494.140(d)) 

5. Patient Care Dialysis Technicians 

(Proposed § 494.140(e)) 

6. Other Personnel Issues 

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) 

1. Existing Requirements for Governing 

Bodies 

2. Overview of the Proposed Governance 

Requirements 

3. Governance Condition (Proposed 

§ 494.180) 

4. Designating a Chief Executive Officer or 

Administrator (Proposed § 494.180(a)) 

5. Adequate Number of Qualified and 

Trained Staff (§ 494.180(b)) 

6. Medical Staff Appointments (Proposed 

§ 494.180(c)) 

7. Furnishing Services (Proposed 

§ 494.180(d)) 

8. Internal Grievance Process (Proposed 

§ 494.180(e)) 

9. Discharge and Transfer Policies and 

Procedures (Proposed § 494.180(f)) 

10. Emergency Coverage (Proposed 

§ 494.180(g)) 

11. Furnishing Data and Information for 

ESRD Program Administration (Proposed 

§ 494.180(h)) 

12. Disclosure of Ownership (Proposed 

§ 494.180(i)) 

VII. Other Proposed Changes 

A. Proposed Cross-Reference Changes 

B. Proposed Additions to Part 488 

VIII. Reference Materials 

A. New Provisions in Part 494 

B. ESRD Crosswalk 

C. Bibliography 

IX. Collection of Information Requirements 

and Public Comments 

A. Collection of Information Requirements 

B. Response to Comments 

X. Regulatory Impact Analysis 

Regulations Text 

Acronyms 

AKF American Kidney Fund 

AAMI Association for the Advancement of 

Medical Instrumentation 

ANNA American Nephrology Nurses 

Association 

AHRQ Agency for Healthcare Research and 

Quality 

AED Automatic external defibrillator 

AIA American Institute of Architects 

ANSI American National Standards 

Institute 

BBA Balanced Budget Act of 1997 

BONENT Board of Nephrology Nursing 

Examiners Nursing and Technology 

BUN Blood urea nitrogen 

CAHPS Consumer Assessment of Health 

Plans Survey 

CBC Center for Beneficiary Choices 

CDC Centers for Disease Control and 

Prevention 

CHI Consolidated Health Informatics 

CEO Chief executive officer 

CLIA Clinical Laboratory Improvement 

Amendments 

CMS Centers for Medicare and Medicaid 

Services 

CPG Clinical practice guidelines 

CPM Clinical performance measures 

CPR Cardiopulmonary resuscitation 

CROWN Consolidated Renal Operations in 

a Web-enabled Network 

DHHS Department of Health and Human 

Services 

DME Durable medical equipment 

DOQI Disease Outcomes Quality Initiative 

DSN Dialysis Surveillance Network 

EMS Emergency medical system 

ESRD End stage renal disease 

FDA Food and Drug Administration 

HHA Home health agency 

HIPAA Health Insurance Portability and 

Accountability Act of 1996 

ICH In-center hemodialysis 

IOM Institute of Medicine 

IT Information technology 

LSC Life Safety Code 

MedPAC Medicare Payment Advisory 

Commission 

MSW Master’s degree social worker 

NANT National Association of Nephrology 

Technicians 

NF Nursing facility 

NFPA National Fire Protection Association 

NIH National Institutes of Health 

NISTA National Institute of Standards and 

Technology Act 

NKF National Kidney Foundation 

NKF-K/DOQI National Kidney 

Foundation’s Kidney Disease Outcomes 

Quality Initiatives 

NNCC Nephrology Nursing Certification 

Commission 

NNCO National Nephrology Certification 

Organization 

NQF National Quality Forum 

NTTAA National Technology Transfer and 

Advancement Act of 1995 

OBRA 1990 Omnibus Reconciliation Act 

1990 

OIG Office of the Inspector General 

OMB Office of Management and Budget 

QAPI Quality assessment and performance 

improvement 

RPA Renal Physicians Association 

RRG Rapid response group 

SNF Skilled nursing facility 

VISION Vital Information System to 

Improve Outcomes in Nephrology 

URR Urea reduction rate 

USRDS United States Renal Data System

I. Introduction and the Provision of 

Reference Materials 

A. Introduction 

The Centers for Medicare and 

Medicaid Services (CMS) is committed 

to modernizing the existing regulations 

that are based on largely procedural 

standards. One of our key initiatives is 

to revise many of the health and safety 

conditions to focus on the patient’s 

experience with care in the delivery 

setting, patient outcomes of care, and 

the elimination of unnecessary 

procedural requirements. 

In concert with the Administration’s 

regulatory reform initiative, we believe 

that new ESRD regulations should—

• Be founded on evidence; 

• Be patient-centered;

• Promote outcomes desired for 

Medicaid and Medicare beneficiaries as 

well as others served by participating 

ESRD suppliers of services; 

• Establish a framework for the 

collection and reporting of consensusdriven performance standards; 

6186 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

• Set clear expectations for dialysis 

facility accountability; and 

• Stimulate improvements in 

processes, outcomes of care, and 

beneficiary satisfaction. 

In addition, the new ESRD conditions 

for coverage must comport with our 

national performance measurement 

strategy, which consists of three 

principles: (1) Performance measures 

should be consumer and purchaserdriven; (2) performance measures 

should be in general, commonly-used 

terms, and their associated collection 

tools should be generally available at 

little or no cost to dialysis facilities; and 

(3) the content and collection of data 

and performance measures derived from 

that data should be standardized. 

B. Provision of Informational and 

Review Aids 

In our development of the proposed 

rule, we have included references to a 

number of reports, articles, and other 

documents in the preamble. To indicate 

the source of this information, we have 

provided a brief parenthetical 

acknowledgement at the end of 

referenced statement and have provided 

a full citation for the reference in the 

bibliography (see section of VIII.C. of 

this preamble). Other informational and 

review aids incorporated in this 

proposed rule include—

• A table of contents; 

• A list of acronyms; 

• A chart listing the new provisions 

(see section VIII.A. of this preamble); 

and 

• A crosswalk of the existing 

requirements to the proposed 

requirements (see section VIII.B. of this 

preamble). 

II. Background 

A. History 

ESRD is a kidney impairment that is 

irreversible and permanent and requires 

a regular course of dialysis or kidney 

transplantation to maintain life. Dialysis 

is the process of cleaning the blood 

artificially with special equipment 

when the kidneys have failed. 

Section 299I of the Social Security 

Amendments of 1972 (Pub. L. 92–603) 

originally extended Medicare coverage 

to insured individuals, their spouses, 

and their dependent children with 

ESRD who require dialysis or 

transplantation. The ESRD program 

became effective July 1, 1973, and 

initially operated under interim 

regulations published in the Federal 

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

In the July 1, 1975 Federal Register (40 

FR 27782), we published a proposed 

rule that revised sections of the 

regulations relating to: 

• The Medicare conditions for 

coverage for suppliers of ESRD services; 

• Certification procedures; 

• Establishment of minimal 

utilization rates; 

• Designation of ESRD network areas; 

• Establishment of Network 

Coordination Councils; and 

• The provision of a Medical Review 

Board. 

A comment period lasting 60 days 

followed and comments were carefully 

considered. On June 3, 1976 the final 

rule was published in the Federal 

Register (41 FR 22501). Subsequently, 

the ESRD Amendments of 1978 (Pub. L. 

95–292), amended title XVIII of the 

Social Security Act (the Act) by adding 

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

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

the Secretary to prescribe health and 

safety requirements (known as 

conditions for coverage) that a facility 

providing dialysis and transplantation 

services to dialysis patients must meet 

to qualify for Medicare reimbursement. 

In addition, section 1881(c) of the Act 

establishes ESRD network areas and 

network organizations to assure that 

dialysis patients are provided 

appropriate care. 

B. Existing ESRD Regulations 

The requirements from section 

1881(b), (c), and (f)(7) are implemented 

in regulations at 42 CFR 405, subpart U, 

Conditions for Coverage of Suppliers of 

End-Stage Renal Disease (ESRD) 

Services. 

The existing regulations describe the 

health and safety requirements that 

dialysis facilities and renal 

transplantation centers must meet to 

furnish care to Medicare beneficiaries. 

The regulations in subpart U also 

include the provision that dialysis 

facilities be organized into Network 

areas and describe the role that 

Networks play in the ESRD program. 

The purpose of the existing 

conditions for coverage (also known as 

conditions) is to protect dialysis 

patients’ health and safety and to ensure 

that quality care is furnished to all 

patients in Medicare-approved dialysis 

and kidney transplantation facilities. To 

determine if a facility meets these 

conditions, the State survey agency 

performs on-site surveys of the facility. 

If a survey indicates that a facility is in 

compliance with the conditions, and all 

other Federal requirements are met, we 

then certify the facility as qualifying for 

Medicare payment. Medicare payment 

for outpatient maintenance dialysis and 

kidney transplantation is limited to 

facilities meeting these conditions. 

Our decision to propose major 

changes to the existing conditions is 

based on several considerations. As 

discussed above, revising the ESRD 

requirements is part of our effort to 

modernize regulations and move toward 

a patient outcome-based system that 

focuses on quality assessment and 

performance improvement. We believe 

that revising the conditions for coverage 

will encourage improvement in 

outcomes of care for beneficiaries. 

Secondly, the existing ESRD conditions 

were originally adopted in 1976 and 

although some amendments have been 

made they have not been 

comprehensively revised since that 

time. The existing requirements for 

dialysis facilities emphasize the policies 

and procedures that must be in place to 

support good patient care, and they 

focus on a facility’s capacity to furnish 

quality care, rather than on the actual 

provision of quality care to patients and 

the outcomes of that care. Third, we 

wish to incorporate the most recent 

medical and scientific guidelines and 

recommendations for dialysis facilities 

from the Centers for Disease Control and 

Prevention (CDC), the Association for 

the Advancement of Medical 

Instrumentation (AAMI), and recognize 

current practice guidelines and 

standards of practice such as the 

National Kidney Foundation’s Kidney 

Disease Outcomes Quality Initiative 

(NKF-K/DOQI) clinical practice 

guidelines (CPGs). 

The existing ESRD conditions do not 

require the facility to operate a patientcentered, outcome-oriented quality 

assessment and performance 

improvement program. Moreover, 

changes have taken place in the delivery 

of services to dialysis patients, and 

these advances are not reflected in the 

existing requirements. Thus, we have 

concluded that significant revisions to 

the conditions for coverage for ESRD 

facilities are essential. The proposed 

changes reflect improvements in 

standard care practices, the use of more 

advanced technology and equipment, 

and, most notably, a framework to 

incorporate performance measures 

viewed by the scientific and medical 

community to be related to the quality 

of care provided to dialysis patients. 

C. Overview 

Since 1994, we have received 

comments from the renal community at 

large and we have used the 

contributions provided by the 

community in developing the revised 

conditions contained in this proposed 

rule. Several renal organizations have 

offered recommendations regarding the 

conditions for coverage during the 

bimonthly public 2001 and 2002 CMS 

meetings on ESRD topics. Notices of 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6187

these were announced on the CMS Web 

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

schedule.asp). We believe that many in 

the community support the overall shift 

in the proposed conditions from an 

emphasis on process-oriented 

requirements to a more patient-centered, 

outcome-oriented approach. Further, we 

believe that virtually all members of the 

community support a quality 

assessment and performance 

improvement requirement and the 

development of a comprehensive data 

set that will contain information on the 

characteristics of ESRD facilities, its 

patient population, as well as outcome 

measures of patient care. 

The fundamental principles that 

guided us during this collaborative 

effort to develop new conditions were as 

follows: 

• Ensure that patients’ rights and 

physical safety are protected. 

• Stress continuous quality 

assessment and performance 

improvement, incorporating, to the 

greatest extent possible, outcomeoriented, data-driven measures. Thus, 

the new conditions would invest a 

major expectation for performance in a 

requirement that each facility 

participate in its own quality 

assessment and performance 

improvement program. This allows the 

facility flexibility to create its own selftailored program of continuous quality 

improvement. Facilities could be 

flexible and creative in their approach 

to patient care and delivery of services 

as they use their own information to 

assess and improve patient services, 

outcomes, and satisfaction. 

• Facilitate flexibility in how dialysis 

facilities meet our performance 

requirements; 

• Eliminate unnecessary 

administrative policies. 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 to move from a 

process and structure orientation toward 

a more patient-centered, outcomeoriented approach, individual patient 

and facility specific outcome measures 

must be identified and evaluated or in 

the absence of existing measures, they 

must be developed and validated with 

community input to ensure they are 

clinically meaningful and reflect current 

scientific knowledge. 

D. The Establishment of Central 

Requirements

We are proposing new conditions for 

coverage for ESRD facilities that revise 

or eliminate many of the existing 

requirements and establish critical 

central requirements. The central 

requirements of the proposed rule are 

grouped into three broad categories: (1) 

Patient safety; (2) patient care (which 

includes quality assessment and 

performance improvement); and (3) 

administration. Subpart A contains 

general provisions, for example, 

statutory authority, definitions, and 

requirements for compliance with 

Federal, State and local laws and 

regulations. Subparts B (patient safety) 

and C (patient care) of the proposed 

conditions for coverage would focus the 

facility’s efforts on the actual care 

delivered to the patients, the 

performance of the dialysis facility, and 

the impact of the treatment furnished by 

the dialysis facility on the health status 

of its patients. 

In Subpart B (patient safety), we are 

proposing to retain and strengthen some 

process-oriented patient safety 

provisions that we believe remain 

highly predictive of ensuring desired 

outcomes and preventing harmful 

outcomes. Accordingly, the patient 

safety requirements incorporate current 

CDC infection control procedures, retain 

and update our incorporation by 

reference of the AAMI standards and 

guidelines for water quality and dialyzer 

reuse practices, and incorporate by 

reference applicable current Life Safety 

Code (LSC) provisions. 

Subpart C (patient care) includes: (1) 

Requirements that emphasize a dialysis 

facility’s fundamental responsibility to 

respect and promote the rights of each 

patient (patient rights); (2) the critical 

nature of a comprehensive assessment 

in determining appropriate treatments 

and achieving desired health outcomes 

(patient assessment); (3) the 

interdisciplinary team approach of 

providing dialysis services to patients 

and the process by which the 

interdisciplinary team will achieve 

effective patient health outcomes 

(patient plan of care); (4) the quality 

assessment and performance 

improvement program which would 

charge each dialysis facility with the 

responsibility for carrying out a 

performance improvement program of 

its own design to affect continuing 

improvement in quality outcomes and 

patient satisfaction; and (5) the 

consolidation of the various aspects of 

home dialysis care into a single 

condition (care at home). 

Subpart D (administration) covers the 

operation of the dialysis facility in a 

patient outcome-oriented environment, 

including: (1) Minimum personnel 

qualifications; (2) the role of the medical 

director; (3) the facility’s relationship 

with its servicing ESRD network; (4) 

medical recordkeeping; and (5) 

minimum operating responsibilities of 

the facility, including data collection 

and reporting requirements 

(governance). 

We recognize that there are some who 

believe that regulations—particularly 

those that directly affect the health and 

safety of patients—should be very 

prescriptive in their detail to ensure that 

providers do not engage in practices that 

threaten patient health and safety. 

Therefore, we invite public comment on 

this fundamental shift in our regulatory 

approach, especially in terms of: (1) 

How we could improve on this 

approach; (2) what additional 

requirements could be removed or 

added to provide greater flexibility; and 

(3) which existing and new 

requirements are critical to patient care 

and safety. 

E. Development of Outcome-Based 

Performance Quality Measures 

Sections 1881(b)(5)(B) through (D) of 

the Act provide authority for us to 

obtain the data we need from ESRD 

suppliers. In accordance with these 

goals, we envision an information 

system that protects patients’ privacy in 

compliance with the new privacy 

protections afforded by the 

Department’s health information 

privacy regulations at 45 CFR Parts 160 

and 164. These regulations were 

developed under the authority of the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA). 

The data could be accessed by us as 

well as dialysis patients, the public, 

dialysis facilities, State survey agencies, 

ESRD networks, researchers, policy 

makers, renal physicians, and other 

professionals providing care to dialysis 

patients (where permitted by the 

privacy regulations). This system would 

provide information to meet the needs 

of the entire renal community, 

particularly the patients, to make better 

choices about care, and to help dialysis 

providers identify opportunities for 

continuous improvement in patient care 

processes. 

This proposal is in keeping with our 

strategic plan to help patients and the 

public become better informed about the 

health care services they need and 

receive so they can make better health 

6188 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

care choices and participate more fully 

in their care. The availability of 

information will permit patients to 

become more active and effective 

participants in their own care and in 

their facility’s quality improvement 

process. 

1. Dialysis Facility Compare 

One of the first steps to make 

information more available to the public 

is the CMS Dialysis Facility Compare 

website at: http://www.Medicare.gov/

Dialysis/Home.asp. Dialysis Facility 

Compare contains various dialysis 

facility characteristics and specific 

quality measures including the 

percentage of in-center hemodialysis 

patients with a urea reduction rate 

(URR) (a measure of the adequacy of 

dialysis) equal to or greater than 65, the 

percentage of patients treated with 

Epogen who have hematocrits of 33 

percent or greater (reflecting adequately 

managed anemia), and patient data 

categories on every dialysis facility 

approved to participate in the Medicare 

program.

2. Dialysis Facility Data Reporting 

Requirements 

Sections 1881(b)(5)(B) through (D) of 

the Act require ESRD suppliers to 

furnish all necessary information to 

CMS, the ESRD networks, and State 

survey agencies. Moreover, existing 

regulations at § 405.2133 require that 

each ESRD facility furnish data and 

information in a manner and frequency 

specified by the Secretary. This 

proposed regulation would continue to 

require facilities to provide data and 

other information, but in electronic 

format, including clinical performance 

measures (CPM) data, necessary for the 

administration of the ESRD program. 

3. Facility Specific Reports 

In 1996, CMS first distributed facilityspecific reports to Networks and 

facilities. These reports were compiled 

by the University of Michigan, using 

data from the CMS forms used for 

patient eligibility and patient death 

purposes; the CMS claims forms; the 

certification forms; and facility-specific 

data on infection control practices 

collected by the CDC. 

The initial reports presented 

comparative data on patient 

characteristics, patient outcomes, and 

facility practice patterns. A common 

CMS database and common data 

formulations were used to create these 

reports. Each year since 1996, these 

reports have been distributed to ESRD 

Networks and ESRD facilities. The 

reports have formed a basis for 

implementing and understanding 

quality improvement activities. The data 

that form the basis for these facilityspecific reports are used to report 

patient outcomes and to develop 

additional reports. 

CMS has expanded the Facility 

Specific Reports to include a broader 

array of information, including facilityspecific reports for the use of State 

survey agencies, state-specific reports, 

and region-specific reports. The facilityspecific reports have been improved by 

the expansion of facility practice pattern 

information, explanatory text with each 

report, table and graph modifications, 

and the inclusion of additional riskadjusters in the calculations of the 

standardized mortality ratio. 

4. The National Kidney Foundation 

Kidney Disease Outcomes Quality 

Initiative (NKF–K/DOQI) Clinical 

Practice Guidelines 

In March 1995, the National Kidney 

Foundation (NKF) initiated the National 

Kidney Foundation-Dialysis Outcomes 

Quality Initiative (NKF–DOQI), the first 

comprehensive effort in nephrology 

designed to provide evidence-based 

guidance to clinical care in nephrology. 

Development of the NKF–DOQI clinical 

practice guidelines involved a 2-year 

effort in which independent 

interdisciplinary workgroups reviewed 

the available body of scientific literature 

on hemodialysis and peritoneal dialysis 

adequacy, vascular access, and anemia. 

Each workgroup was composed of renal 

experts from diverse clinical disciplines 

and renal patients. The workgroups 

were tasked with developing and 

promulgating clinical practice 

guidelines for the treatments of patients 

with ESRD. Four principles guided the 

project’s decision-making: (1) Use of a 

high level of scientific and 

methodological rigor in the guideline 

development process; (2) commitment 

to an interdisciplinary approach; (3) 

independence of the workgroups; and 

(4) openness of the guideline 

development process. To that end, the 

workgroups developed draft guidelines 

with supporting rationales that included 

the evidentiary basis for the 

recommendations. 

Draft guidelines were subject to an 

unprecedented three-stage review 

process: (1) An advisory council, 

comprised of 25 experts, provided 

comments on the initial draft of the 

guidelines; (2) a variety of organizations 

(that is, ESRD networks, professional 

and patient associations, dialysis 

providers, government agencies, 

product manufacturers, and managed 

care groups) were invited by NKF to 

review and comment on a revised draft 

of the guidelines; and (3) a final draft of 

the guidelines was made available for 

public review by all interested 

individuals or parties. 

Four sets of DOQI clinical practice 

guidelines were published by the NKF 

in 1997, including recommended 

practices for management of anemia, 

adequacy of hemodialysis, adequacy of 

peritoneal dialysis, and vascular access. 

In 2000, the scope of DOQI expanded to 

encompass the spectrum of chronic 

kidney disease prior to the need for 

dialysis services. To reflect this 

expansion, DOQI became K/DOQI. A 

total of 114 chronic kidney disease 

clinical practice guidelines were 

developed by the workgroups and 

reviewed by numerous professionals 

and patients. The NKF has published 

Bone Metabolism and Disease in 

Chronic Kidney Disease clinical practice 

guidelines and Hypertension and 

Antihypertensive Agents in Chronic 

Kidney Disease as well as Managing 

Dyslipidemias guidelines. The latest set 

of clinical practice guidelines being 

developed under the K/DOQI umbrella 

are the CPGs for Cardiovascular Disease 

in Dialysis patients. 

5. CMS ESRD Clinical Performance 

Measures Project 

In 1999, we merged our ongoing ESRD 

Core Indicators Project, a quality 

improvement project, originally started 

in 1994, into a new ESRD Clinical 

Performance Measures Project (ESRD 

CPM Project). The ESRD CPM Project is 

an ongoing effort between us, the ESRD 

networks, and dialysis facilities to 

collect performance measures on a 

representative sample of dialysis 

patients in the areas of adequacy of 

dialysis, anemia management, nutrition 

(that is, serum albumin), and more 

recently, vascular access (DHHS/CMS/

CBC, pp. 1–104). The ESRD CPM Project 

was developed to implement section 

4558(b) of the Balanced Budget Act 

(BBA) of 1997 (Pub. L. 105–33). This 

provision required the Secretary to 

develop and implement a method to 

measure and report on the quality of 

renal dialysis services provided under 

Medicare no later than January 1, 2000. 

The goal of the CPM Project was to 

identify NKF DOQI guidelines that were 

suitable for the agency’s quality 

improvement initiatives and to meet the 

BBA requirement. The ultimate purpose 

of the project is to assist suppliers of 

ESRD services in improving the care 

provided to ESRD patients. 

In 1998, we contracted with PROWest (now named Qualis Health), a 

Seattle-based private nonprofit 

healthcare quality improvement 

organization, to facilitate the process of 

developing dialysis clinical 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6189

performance measures (CPMs) based on 

the NKF’s DOQI (now K/DOQI) 

guidelines. 

The process included several 

components. The first was to develop a 

mechanism to assure appropriate 

participation from the community in 

order to facilitate the acceptability and 

utility of the CPMs. The second was to 

prioritize the NKF DOQI guidelines 

based on the strength of the evidence 

supporting the guidelines, the feasibility 

of developing performance measures, 

and the significance of the areas 

addressed to the quality of care 

delivered to dialysis patients. The third 

was to identify a limited set of CPMs 

that could be used to support quality 

improvement activities as well as assist 

us in assessing nationally the quality of 

care delivered to Medicare beneficiaries. 

The fourth was to develop sampling and 

data specifications for the CPMs to 

facilitate measurement. Finally, we 

requested the development of data 

collection and analysis strategies to be 

used to augment the existing national 

performance measurement system. 

The CPM Project was conducted in 

collaboration with a broad range of 

stakeholders in the community. In order 

to facilitate this involvement, 

participation was solicited through 

contacts with professional and 

voluntary associations, presentations at 

national meetings, and invitations to 

individuals identified through a variety 

of sources. 

Four expert groups were convened to 

address each of the topic areas covered 

by the NKF DOQI guidelines: (1) 

Hemodialysis adequacy; (2) peritoneal 

dialysis adequacy; (3) vascular access; 

and (4) anemia management. The NKF 

DOQI guidelines were ranked via a 

survey of renal experts for their 

suitability as candidates for 

development of CPMs. All 114 NKF 

DOQI guidelines were included on a 

survey tool developed by CMS that was 

distributed to the rapid response group 

(RRG) and other expert consultants. 

Suitability of guidelines was based on 

clinical importance, feasibility of 

measurement, and the respondent’s 

assessment of the strength of the 

evidence supporting the guideline. 

We accepted 36 proposed guidelines 

for further evaluation and the 4 expert 

groups developed specific review 

criteria, algorithms, and CPMs selected 

through the prioritization process 

described above. The CPM development 

process was a modification of a 

methodology described by the Agency 

for Healthcare Research and Quality 

(AHRQ) (formerly the Agency for Health 

Care Policy and Research (AHCPR)). 

Candidate guidelines that did not have 

a strong evidence basis were eliminated 

from further consideration. Sixteen 

CPMs were developed based on 22 of 36 

candidate NKF DOQI clinical practice 

guidelines.

Data collection instruments were 

subsequently developed and submitted 

to us for field testing. Three data 

collection tools were developed and 

pilot tested. The first instrument was 

intended to collect data for the 

hemodialysis adequacy, anemia 

management, and vascular access CPMs 

from hemodialysis patient records. The 

second instrument was designed to 

collect adequacy and anemia 

management data for peritoneal dialysis 

patients. The third instrument focused 

on information about facility policies, 

procedures, and practices related to 

selected hemodialysis adequacy CPMs. 

In the summer of 1999, after fieldtesting, the CPMs were applied to a 

sample of 8,853 randomly selected adult 

hemodialysis patients and 1,650 

randomly selected adult peritoneal 

dialysis patients. 

In summary, the NKF DOQI process 

resulted in a broad set of guidelines 

amenable to prioritization based on 

strength of evidence, clinical 

importance and feasibility. The current 

NKF K/DOQI guidelines are widely 

accepted among the renal community 

and increase the likelihood that future 

CPMs can be developed and supported 

by a broad cross-section of stakeholders, 

including clinical practitioners, 

industry representatives, professional 

associations, and others interested in 

assessment and improvement of the care 

provided to dialysis patients. 

We have been working closely with 

the ESRD networks and information 

technology contractors to develop the 

Vital Information System to Improve 

Outcomes in Nephrology (VISION) 

database. VISION is a patient-specific, 

facility-based, outcome-oriented 

information system that will enable 

dialysis facilities to electronically 

collect and report both demographic 

and clinical data that can be profiled to 

assist efforts to improve outcomes of 

care. VISION will capture, among other 

things, data from the CMS ESRD CPM 

Project. VISION will be designed so that 

Consolidated Health Informatics (CHI) 

standards will be met. 

The CHI establishes health messaging 

and vocabulary standards that enable 

data sharing across all Federal systems. 

Implementation of the CHI standards is 

prospective (that is, applicable to new 

systems and systems undergoing major 

upgrades). Current plans are to upgrade 

the ESRD Information System within 

the next 2 to 3 years. Since the CHI 

standards are prospectively applied, the 

CHI standards will be incorporated 

when we upgrade the ESRD information 

system. 

Following the upgrade to the ESRD 

information system, ESRD facilities will 

be required to submit data using the 

new information technology (IT) system. 

They can accomplish submission of data 

that is consistent with the CHI standards 

by either modifying their internal 

systems or by using mapping tools that 

are provided by the National Library of 

Medicine (NLM) at no cost. The CHI 

standards are posted on the egov.gov

Web site located at http://

www.whitehouse.gov/omb/egov/gtob/

health_informatics.htm.

6. CPM Data Reporting 

ESRD CPM Project data have been 

collected for 1999, 2000, 2001, and 2002 

and published in annual reports. The 

2001 ESRD CPM report can be found on 

the Internet at http://www.cms.gov/esrd/

l.asp. The data for each year include a 

random sample, stratified by ESRD 

network, of adult in-center hemodialysis 

patients and a random peritoneal 

dialysis patient sample of 5 percent of 

adult peritoneal dialysis patients in the 

nation. The sample size of adult incenter hemodialysis patients was 

selected to allow us to be 95 percent 

confident that Network-specific 

estimates for selected clinical measures 

are accurate within plus or minus 5 

percent. The sample also included a 30 

percent ‘‘over sample’’ for in-center 

hemodialysis patients and a 10 percent 

‘‘over sample’’ for peritoneal dialysis 

patients to compensate for anticipated 

nonresponse rates. In 2002, the in-center 

hemodialysis sample included 8,863 

patients and the peritoneal dialysis 

sample included 1,451 patients. Also, a 

5 percent national sample of 

hemodialysis facilities was drawn, 

consisting over 200 hemodialysis 

facilities. 

Three data collection tools were used, 

an in-center hemodialysis form (Form 

CMS–820), a peritoneal dialysis form 

(Form CMS–821), and a hemodialysis 

facility-specific form. 

We believe that the ESRD CPM Project 

is an effective tool to facilitate ESRD 

quality improvement, and this project 

has successfully tracked positive 

improvements in patient outcomes of 

care in several areas. The 2001 Annual 

Report for the ESRD CPM Project 

contains additional Outcomes 

Comparison Tools (for hemodialysis and 

peritoneal dialysis). Outcomes 

Comparison Tools are practical quality 

improvement instruments that can be 

used by ESRD facilities to benchmark 

their performance outcomes against 

rates at the ESRD network’s level 

6190 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

(hemodialysis only) and the nation. 

Therefore, we are proposing in the 

Governance condition for coverage 

(§ 494.180(h)), that all ESRD facilities 

collect and provide us with ESRD CPM 

Project data electronically. This 

proposal applies only to the current 

CPMs and is discussed in more detail 

later in this preamble. We will carefully 

evaluate any revisions to the CPMs as 

well as any future CPMs, developed in 

accordance with the National 

Technology Transfer and Advancement 

Act of 1995 process (described in the 

next section of this preamble) for 

possible inclusion as electronic 

reporting requirements. The Secretary 

will provide notice and an opportunity 

for comment in the Federal Register

before the CPMs are updated or new 

measures are adopted. 

7. Updating Existing ESRD PatientSpecific Performance Measures and 

Developing Future ESRD Facility 

Performance Standards 

We would like to propose ESRD 

performance standards that dialysis 

facilities would be required to meet as 

well as propose a method to recognize 

updates in existing consensus-based 

patient-specific performance measures. 

We are proposing to adopt a framework 

that will utilize existing Federal 

legislation and operational guidelines. 

The National Technology Transfer and 

Advancement Act of 1995 ((NTTAA) 

Pub. L. 104–113) and OMB Circular A–

119 specify circumstances in which 

Federal agencies should use technical 

standards developed by voluntary 

consensus bodies. The phrase 

‘‘technical standards’’ is defined in the 

NTTAA at section 12(d)(4) as 

‘‘performance-based or design-specific 

technical specifications and related 

management systems practices.’’

The NTTAA has been implemented 

by, among other things, the provisions 

of the Office of Management and Budget 

(OMB) Circular No. A–119 (63 FR 8546, 

February 19, 1998). OMB Circular No. 

A–119 was published to: (1) Revise and 

clarify policies on Federal use and 

development of voluntary consensus 

standards; (2) set policy for conformity 

assessment activities; and (3) improve 

the clarity and effectiveness of the 

previously published (October 20, 1993) 

circular. By implementing the policies 

in this circular, we intend to reduce to 

a minimum our reliance on governmentspecific standards.

Definitions of terms and phrases 

within the circular are designed for very 

broad application, but are meant to be 

applicable to any specific and 

appropriate subject matter, including 

health care performance measures. 

The circular defines a ‘‘performance 

standard’’ as a standard that states 

requirements in terms of required 

results with criteria for verifying 

compliance but without stating the 

methods for achieving required results. 

‘‘Voluntary consensus standards’’ are 

defined as standards developed or 

adopted by voluntary consensus 

standards bodies, both domestic and 

international. ‘‘Voluntary consensus 

standards bodies’’ are organizations that 

plan, develop, establish, or coordinate 

voluntary consensus standards using 

agreed-upon procedures. One example 

of a voluntary consensus standards body 

is the National Forum for Health Care 

Quality Measurement and Reporting, 

also known as the National Quality 

Forum (NQF), which is currently 

engaged in various projects such as 

standardizing measures of hospital 

quality and developing diabetes 

mellitus treatment performance 

measures. 

The expected products of a voluntary 

consensus body would include the 

measures or indicators and standards, as 

well as explanatory text and other 

supporting documentation, such as 

guidelines for reporting the indicators. 

A voluntary consensus body would 

make a draft product available for 

general public review during the 

development of the measures. When the 

performance standards are complete, we 

would evaluate them and then 

promulgate the standards following the 

requirements of the Administrative 

Procedures Act. 

We are not advocating the NQF as the 

voluntary consensus body that is most 

appropriate to develop ESRD 

performance standards. We have only 

provided an illustration of the manner 

in which performance standards are 

being developed. Other organizations, 

for example, the NKF–K/DOQI, also 

function in a manner consistent with 

voluntary consensus bodies. Once ESRD 

facility performance measures are 

developed by a voluntary consensus 

body, the Secretary would evaluate 

those facility performance measures and 

adopt those that meet our needs for the 

effective administration of the ESRD 

program after notice and comment 

rulemaking required by the 

Administrative Procedures Act. 

We will also reference the NTTAA 

later in this preamble under our 

discussion of the Governance condition 

for coverage (see § 494.180(h)). 

F. Summary of the Contents of the 

Proposed Rule 

We are proposing to revise both the 

content and the organization of the 

existing regulations. The ESRD Network 

conditions for coverage will remain in 

part 405, subpart U. Through a separate 

proposed rule regarding conditions of 

participation for transplant hospitals, 

we are proposing to move the renal 

transplant center conditions to part 482. 

The ESRD conditions for coverage 

(health and safety provisions for dialysis 

facilities) would be moved from existing 

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

CFR part 494, where they would follow 

regulations establishing standards for 

other Medicare providers, such as the 

conditions of participation for hospitals 

(42 CFR part 482), long-term care 

facilities (42 CFR part 483), and home 

health agencies (42 CFR part 484). The 

termination of Medicare coverage and 

alternative sanctions conditions at 

§ 405.2180 through § 405.2184 will be 

recodified to § 488.604 through 

§ 488.610. Since many of the existing 

ESRD conditions would be revised, 

consolidated with other conditions, or 

deleted, we also propose to completely 

renumber and reorganize the 

requirements. The format for the 

dialysis facility conditions for coverage 

represents a dramatic change from the 

organization of the existing regulations, 

which contain nearly 20 conditions 

addressing organizational structure, 

utilization rate requirements, and other 

process-intensive requirements. The 

proposed regulations are divided into 

four subparts: general provisions, 

patient safety, patient care, and 

administration. 

The proposed organization of Part 494 

is as follows:

Subpart A—General Provisions 

§ 494.1 Basis and scope. 

§ 494.10 Definitions. 

§ 494.20 Compliance with Federal, State, 

and local laws and regulations. 

Subpart B—Patient Safety 

§ 494.30 Condition: Infection control. 

§ 494.40 Condition: Water quality. 

§ 494.50 Condition: Reuse of hemodialyzers 

and other dialysis supplies. 

§ 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 Condition: Relationship with 

ESRD network. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6191

§ 494.170 Condition: Medical 

recordkeeping. 

§ 494.180 Condition: Governance.

The following provides a detailed 

discussion of each new requirement and 

a discussion of the existing ESRD 

requirements that have been revised or 

deleted in this proposed rule. 

III. Provisions of Proposed Part 494 

Subpart A (General Provisions) 

A. Basis and Scope (Proposed § 494.1) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Basis’’ at the beginning of your 

comment.] 

Proposed § 494.1, identifies the 

statutory authority for the regulations. 

Proposed § 494.1 also states that 

provisions of part 494 serve as the basis 

for survey activities for determining 

whether a dialysis facility meets the 

conditions for coverage under the 

Medicare program. We note that the 

organizational format of the proposed 

conditions permits the elimination of 

almost all of the material in existing 

§ 405.2100, Scope of subpart, which 

consists largely of a description of the 

contents of the existing ESRD 

conditions for coverage. 

B. Definitions (Proposed § 494.10) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Definitions’’ at the beginning of your 

comment.]

Under proposed § 494.10, we set forth 

definitions for terms used in the ESRD 

conditions. Existing § 405.2102 provides 

a list of 32 definitions. We are proposing 

to eliminate the definitions of several 

terms for which we believe the meaning 

is self-evident, as well as terms that are 

not used in the revised conditions. We 

do not believe it is appropriate to have 

substantive requirements contained in 

those definitions. Thus, we would move 

definitions that contain qualification 

requirements to the appropriate 

conditions in the proposed rule. We 

have proposed to retain the definition of 

‘‘furnishes on the premises’’ and add it 

to proposed § 494.180 (Governance). We 

are proposing a modification of the 

definition of ‘‘home dialysis’’ to 

recognize the assisting role that a family 

member/caregiver may play. We have 

previously received questions about 

whether the definition of ‘‘home’’

includes institutional settings such as 

nursing facilities (NFs) and skilled 

nursing facilities (SNFs). Please refer to 

section V.D. of this preamble in which 

we discuss the unique needs of the NF/

SNF dialysis patient and the overall 

issue. We are soliciting comment on 

whether the definition of ‘‘home’’ for 

‘‘home dialysis’’ should also include 

these institutional settings. 

We propose to include the following 

definitions in § 494.10: 

• Dialysis facility means an entity 

that provides (1) outpatient 

maintenance dialysis services; or (2) 

home dialysis training and support 

services; or (3) both. A dialysis facility 

may be an independent or hospitalbased unit (as described in § 413.174(b) 

and (c) of this chapter), or a self-care 

dialysis unit, which furnishes only selfdialysis services. 

• Discharge means the termination of 

patient care services by a dialysis 

facility. 

• Furnishes directly means the ESRD 

facility provides the service through its 

own staff and employees or through 

individuals who are under contract with 

the facility to furnish these services 

personally for the facility. We note that 

furnishes directly does not apply to 

companies providing services under 

contract or arrangement. 

• Home dialysis means outpatient 

dialysis performed at home by an ESRD 

patient (or caregiver) if the individual 

performing such dialysis has completed 

the course of training required in 

§ 494.100(a) of this part. 

• Interdisciplinary team (as required 

in § 494.80 (Patient assessment)) means 

the group of persons responsible for 

providing patient care to each dialysis 

patient. 

• Self-dialysis means dialysis 

performed with little or no professional 

assistance by an ESRD patient (or 

caregiver) if the individual performing 

such dialysis has completed an 

appropriate course of training as 

required in § 494.100(a) (Care at Home). 

• Transfer means a temporary or 

permanent move of a patient from one 

dialysis facility to another that requires 

the transmission of the patient’s medical 

record information to the facility 

receiving the patient. 

C. Compliance With Federal, State, and 

Local Laws and Regulations (Proposed 

§ 494.20) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Compliance with Laws and 

Regulations’’ at the beginning of your 

comment.] 

Existing § 405.2135 requires that a 

dialysis facility be in compliance with 

applicable Federal laws and that a 

dialysis facility be licensed or approved 

as meeting applicable standards by the 

agency of the State or locality 

responsible for approval. Section 

405.2135 further requires a facility to 

comply with all relevant laws (for 

example, laws relating to licensure of 

staff) and requires conformity with other 

laws (for example, fire safety, 

equipment maintenance). 

We propose to retain the requirement 

that dialysis facilities must be in 

compliance with applicable Federal, 

State, and local laws and regulations 

pertaining to fire safety, equipment, and 

any other relevant health and safety 

issues. We are also proposing that 

dialysis facilities must be in compliance 

with the appropriate Federal, State, and 

local laws and regulations regarding 

drug and medical device usage. An 

example of meeting applicable Federal 

regulations is that the dialysis facility 

must use FDA-approved/cleared 

medical devices and adhere to the 

devices’ labelling instructions. We have 

added these examples because drugs 

and medical devices are major 

components of dialysis facilities and 

compliance with existing laws and 

regulations in this area is important in 

ensuring patient safety. 

We may find a facility to be in 

violation of these conditions for 

coverage if the facility is found out of 

compliance with any Federal, State, and 

local law or regulation pertaining to 

health and safety requirements. 

IV. Provisions of Proposed Part 494 

Subpart B (Patient Safety) 

A. Infection Control (Proposed § 494.30) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Infection Control’’ at the beginning of 

your comment.] 

Patients with ESRD have impaired 

immunological systems and are more at 

risk of developing serious infections 

than similarly situated non-ESRD 

patients. During hemodialysis therapy, 

there is a potential for patients to be 

exposed to a variety of microbial 

pathogens (including blood-borne 

pathogens) if proper procedures are not 

meticulously followed. Likewise, 

peritoneal dialysis patients are at risk of 

contamination leading to peritonitis if 

proper procedures are not followed. 

This proposed rule stipulates that the 

dialysis facility must provide and 

monitor conditions to ensure a sanitary 

environment that prevents the 

transmission of infectious agents. 

The existing standards relating to 

infection control are contained in 

§ 405.2140(b)(1) and (c). Section 

405.2140(b)(1) requires written 

procedures for controlling hepatitis and 

other infections. It further specifies that 

the procedures include surveillance and 

reporting of infections, housekeeping, 

handling of waste and contaminants, 

and sterilization and disinfection. 

Section 405.2140(c) requires the facility 

6192 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

to employ appropriate techniques to 

prevent cross-contamination between 

the unit and adjacent hospital or public 

areas. 

We believe infection control is vital to 

the health and safety of dialysis patients 

and others; and therefore, we propose to 

establish infection control as a separate 

condition for coverage (§ 494.30). The 

proposed infection control requirement 

states that each dialysis facility must 

provide and monitor a sanitary 

environment that prevents and controls 

the transmission of infectious agents, 

within and between the unit and any 

adjacent hospital, or other public areas. 

The proposed requirement sets forth the 

basic guidelines or procedures that 

facilities must follow to prevent and 

control infections. 

Proposed § 494.30(a)(1) requires that 

the facility demonstrate that it follows 

standard infection control precautions, 

including the ‘‘Recommended Infection 

Control Practices for Hemodialysis 

Units At a Glance’’ with the exception 

of screening for Hepatitis C as explained 

below. The ‘‘At a Glance’’ section is in 

the publication, ‘‘Recommendations for 

Preventing Transmission of Infections 

Among Chronic Hemodialysis Patients’’

developed by the Centers for Disease 

Control and Prevention (CDC) (DHHS/

CDC, 20–21). We propose to incorporate 

these guidelines to prevent and control 

cross contamination and the spread of 

infectious agents. These CDC infection 

control recommendations specific to the 

hemodialysis setting were developed in 

consultation with other Federal agencies 

and specialists and are based on 

available knowledge regarding 

transmission of infectious agents.

Recommended Infection Control 

Practices for Hemodialysis Units at a 

Glance 

Infection Control Precautions for All 

Patients 

• Wear disposable gloves when caring 

for the patient or touching the patient’s 

equipment at the dialysis station; 

remove gloves and wash hands between 

each patient or station. 

• Items taken into the dialysis station 

should either be disposed of, dedicated 

for use only on a single patient, or 

cleaned and disinfected before taken to 

a common clean area or used on another 

patient.

—Nondisposable items that cannot be 

cleaned and disinfected (e.g., adhesive 

tape, cloth covered blood pressure cuffs) 

should be dedicated for use only on a 

single patient. 

—Unused medications (including 

multiple dose vials containing diluents) 

or supplies (syringes, alcohol swabs, 

etc.) taken to the patient’s station should 

be used only for that patient and should 

not be returned to a common clean area 

or used on other patients.

• When multiple dose medication 

vials are used (including vials 

containing diluents), prepare individual 

patient doses in a clean (centralized) 

area away from dialysis stations and 

deliver separately to each patient. Do 

not carry multiple dose medication vials 

from station to station. 

• Do not use common medication 

carts to deliver medications to patients. 

Do not carry medication vials, syringes, 

alcohol swabs or supplies in pockets. If 

trays are used to deliver medications to 

individual patients, they must be 

cleaned between patients. 

• Clean areas should be clearly 

designated for the preparation, handling 

and storage of medications and unused 

supplies and equipment. Clean areas 

should be clearly separated from 

contaminated areas where used supplies 

and equipment are handled. Do not 

handle and store medications or clean 

supplies in the same or an adjacent area 

to that where used equipment or blood 

samples are handled. 

• Use external venous and arterial 

pressure transducer filters/protectors for 

each patient treatment to prevent blood 

contamination of the dialysis machines 

pressure monitors. Change filters/

protectors between each patient 

treatment, and do not reuse them. 

Internal transducer filters do not need to 

be changed routinely between patients. 

• Clean and disinfect the dialysis 

station (chairs, beds, tables, machines, 

etc.) between patients.

—Give special attention to cleaning 

control panels on the dialysis 

machines and other surfaces that are 

frequently touched and potentially 

contaminated with patients’ blood. 

—Discard all fluid and clean and 

disinfect all surfaces and containers 

associated with the prime waste 

(including buckets attached to the 

machines).

• For dialyzers and blood tubing that 

will be reprocessed, cap dialyzer ports 

and clamp tubing. Place all used 

dialyzers and tubing in leak-proof 

containers for transport from station to 

reprocessing or disposal area.

SCHEDULE FOR ROUTINE TESTING FOR HEPATITIS B VIRUS (HBV) AND HEPATITIS C VIRUS (HCV) INFECTIONS

Patient status On admission Monthly Semi-annual Annual 

All patients HBsAg*, Anti-HBc (total)* Anti-HBs*, 

Anti-HCV, ALT† 

HBV susceptible, including non-responders to vaccine HBsAg 

Anti-HBs positive(>10 mIU/mL), antiHBc negative Anti-HBs 

Anti-HBs and anti-HBc positive No additional HBV testing needed 

Anti-HCV negative ALT Anti-HCV 

Hepatitis B Vaccination 

• Vaccinate all susceptible patients 

against hepatitis B. 

• Test for anti-HBs 1–2 months after 

last dose.

—If anti-HBs is <10 mIU/mL, consider 

patient susceptible, revaccinate with 

an additional three doses, and retest 

for anti-HBs. 

—If anti-HBs is >10 mIU/mL, consider 

immune, and retest annually. 

—Give booster dose of vaccine if antiHBs declines to <10 mIU/mL and 

continue to retest annually. 

Management of HBsAg-Positive Patients 

• Follow infection control practices 

for hemodialysis units for all patients. 

• Dialyze HBsAg-positive patients in 

a separate room using separate 

machines, equipment, instruments, and 

supplies. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6193

• Staff members caring for HBsAgpositive patients should not care for 

HBV susceptible patients at the same 

time (e.g., during the same shift or 

during patient change-over).

We are proposing an exception to the 

CDC recommendation for monthly and 

semiannual screening for all 

hemodialysis patients for hepatitis C. 

Patients with clinical indicators or risk 

factors for hepatitis C should receive 

diagnostic testing as deemed necessary 

by the attending physician. Medicare 

covers diagnostic testing for hepatitis C 

on a case-by-case basis, but does not 

cover blanket hepatitis C screening at 

this time. According to the CDC, 

transmission of hepatitis C can be 

prevented by strict adherence to 

infection control precautions 

recommended for all hemodialysis 

patients. 

The ‘‘At a Glance’’ page highlights the 

crucial CDC recommendations that 

serve as the minimum acceptable 

infection control practices. This 

document reproduced above is currently 

available on the CDC Web site at http:

//www.cdc.gov/mmwr/preview/

mmwrhtml/rr5005a1.htm. 

There is substantial evidence that the 

CDC guidelines work in preventing the 

transmission of bloodborne infections. 

Recommendations for the control of 

hepatitis B in hemodialysis centers were 

first published in 1977 and within 3 

years there was a sharp reduction in 

incidence of hepatitis B infection among 

both patients and staff members in 

hemodialysis centers (Alter, pp. 860–

865). 

The entire CDC RR05 report contains 

recommendations for infection control 

precautions in greater detail than the 

‘‘At a Glance’’ highlights. We 

considered proposing that the entire 

CDC RR05 document be incorporated by 

reference. However, we want to be less 

prescriptive and burdensome in our 

requirements while protecting patient 

safety. Dialysis facilities are encouraged 

to utilize the more comprehensive 

document when developing their 

infection control programs. For 

example, the CDC infection control 

precautions for all patients identify 

procedures for cleaning up a blood spill; 

and detail information on glove use, 

protective gear, and handwashing. The 

CDC has issued additional guidance 

regarding hand hygiene and 

environmental infection control in the 

October 25, 2002 and June 6, 2003 

issues of the Morbidity and Mortality 

Weekly Report that dialysis facilities 

may want to reference in their infection 

control policies (DHHS/CDC, pp.1–45 

and DHHS/CDC, pp. 1–44, respectively). 

Existing § 405.2140(b)(1) requires that 

written policies and procedures must be 

in effect for preventing and controlling 

hepatitis and other infections. There is 

no current requirement in the 

conditions for coverage addressing 

patient isolation. However, many 

facilities have adopted the 1977 CDC 

guidelines that recommend use of a 

separate dialysis area, preferably a 

separate isolation room, for dialyzing 

hepatitis B surface antigen positive 

patients. Newly opened hemodialysis 

units would be required to have 

isolation rooms for hepatitis B positive 

patients as described in the ‘‘At a 

Glance’’ section. For existing units in 

which a separate room is not possible, 

there would be required to be a separate 

area removed from the mainstream of 

activity that also allows for dedicated 

staff and dedicated dialysis machines. 

When the facility determines that a 

patient is infectious (from admission or 

at least annual testing) the guidelines 

state that the facility would be required 

to isolate the infected patient from 

susceptible patients to prevent the 

transmission of the disease. We propose 

to require at § 494.30(a)(2) that a facility 

implement and maintain patient 

isolation procedures that prevent and 

control the spread of infectious agents 

and communicable diseases. 

We also propose at § 494.30(a)(3) that 

facilities implement appropriate 

procedures for the handling, storage, 

and disposal of waste, and for 

disinfection. Appropriate waste storage 

and disposal procedures are important 

not only for the control of infections 

within the units, but also for the welfare 

of the unit staff and the community. 

Since local policies vary, we do not 

believe it is appropriate to specify the 

minimum requirements for waste 

storage and disposal. Rather, facilities 

should continue to operate in 

accordance with applicable local laws 

and accepted public health procedures. 

We also propose to require that facilities 

implement protocols for cleaning and 

disinfection because we believe that 

adequate disinfection of surfaces, 

medical devices, and equipment is an 

important part of a facility’s efforts to 

control and prevent crosscontamination. We propose to add a 

requirement for the implementation and 

maintenance of procedures regarding 

cleaning of surfaces and devices 

potentially contaminated with blood to 

prevent patients from coming into 

contact with a blood-borne pathogen. 

The CDC RR05 recommendations and 

dialysis equipment manufacturers’

instructions provide valuable 

information on procedures a facility 

may adopt to meet this requirement. 

We considered proposing to include 

the American Institute of Architects 

(AIA) Guidelines for Design and 

Construction of Hospitals and Health 

Care Facilities, which outline building 

requirements pertinent to dialysis 

facilities. The AIA standards provide 

guidance to facilities regarding unit 

design and parts of the guidance relate 

to infection control. While we believe it 

is desirable for new units to follow AIA 

standards, and many States have 

adopted these as minimum standards, 

we recognize it may be overly 

burdensome to require existing dialysis 

units to adhere to these standards. 

We also considered including in the 

proposed rule the Healthcare Infection 

Control Practices Advisory Committee’s 

(HICPAC) guidelines entitled ‘‘Hand 

Hygiene in Healthcare Settings’’ and 

‘‘Guideline for Preventing Intravascular 

Device-Related Infections.’’ We are 

inviting comments on whether we 

should require new dialysis facilities to 

adhere to AIA design standards or 

HICPAC guidelines. 

We propose requirements for 

oversight of facility infection control in 

§ 494.30(b). The facility must implement 

and monitor biohazard and infection 

control policies and activities within the 

dialysis unit. Any infection control 

policies adopted by the facility are only 

effective when put into action. We 

propose that facilities must designate a 

registered nurse as the infection control 

or safety officer who maintains current 

infection control information, and 

reports to the facility’s chief executive 

officer or administrator and quality 

improvement committee. The infection 

control nurse must maintain current 

infection control information including 

the most current CDC guidelines for the 

proper techniques in the use of vials 

and ampules containing medication. For 

example, facilities should not pool vials 

of any medications. An outbreak of 

serratia liquefacies from contamination 

of erythropoietin at a hemodialysis 

center serves as a reminder of the 

importance of the proper handling of 

medications in protecting the dialysis 

patient. (Grohskopf, pp. 1491–1497.) 

The infection control or safety officer 

is also responsible for making 

recommendations regarding infection 

control training and improvements. The 

designation of an infection control 

officer provides a structure for infection 

control, encourages the maintenance of 

up-to-date information, and increases 

accountability for infection control. 

We propose to maintain the essence of 

the existing requirement for surveillance 

and reporting of the incidence of 

6194 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

infection (§ 405.2140(b)(1)). The facility 

must analyze and document the 

incidence of infections to identify 

trends and establish baseline 

information on infection incidence as 

proposed in § 494.30(c). By conducting 

a trend analysis of infections, the 

facility will be able to identify 

opportunities for improvement to 

prevent or eliminate the spread of 

infection or communicable disease 

between patients. By tracking the 

number and types of infections, the 

facility can identify areas that require 

improvement, indicate areas that have 

improved, define measures to improve 

outcomes, review implementation of 

improvement measures, and determine 

the success of the improvement 

measures implemented. 

In August 1999, the CDC initiated the 

CDC Dialysis Surveillance Network 

(DSN), a voluntary national surveillance 

system monitoring bloodstream and 

vascular infections by individual 

hemodialysis centers. The purposes of 

the DSN are to provide a method for 

individual hemodialysis centers to 

record and track rates of vascular access 

infections, other bacterial infections, 

and intravenous antimicrobial starts, 

and to provide rates for comparisons 

among various dialysis centers. The 

infection control or safety officer should 

look toward the CDC surveillance 

system as a resource. Information on the 

DSN may be found on the following 

Web site: http://www.cdc.gov/ncidod/

hip/Dialysis/dsn.htm. 

The existing standard governing 

infection control (§ 405.2140(b)(1)) 

contains a requirement governing reuse 

of dialyzers which states that when 

dialysis supplies are reused, records are 

maintained that can be used to 

determine whether established 

procedures covering the rinsing, 

cleaning, disinfection, preparation, and 

storage of reused items conform to the 

requirements for reuse. This standard is 

redundant with the reuse requirements 

included in the AAMI guidelines that 

are incorporated by reference in both 

the existing and proposed regulations. 

Therefore, we are proposing to delete 

the requirement in § 405.2140(b).

Existing § 405.2140(c) requires that 

written patient care policies specify the 

functions of facility personnel and selfdialysis patients with respect to 

contamination prevention. We are 

proposing to delete the ‘‘written policy’’

requirement because it is processoriented and a paperwork burden. 

As noted above, the existing 

conditions for coverage require policies 

for surveillance and reporting of 

infections at § 405.2140(b)(1). In this 

proposed rule, reporting requirements 

for communicable diseases are listed at 

§ 494.30(d). The facility must maintain 

a current list of the communicable 

diseases that must be reported according 

to Federal, State, and local 

requirements, and have a procedure for 

reporting these communicable diseases, 

which allows the facility to accurately 

report incidences of communicable 

diseases. These requirements are in 

concert with the present standard 

operating practices in dialysis facilities. 

B. Water Quality (Proposed § 494.40) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Water Quality’’ at the beginning of 

your comment.] 

Water quality is of vital importance to 

a dialysis facility and to the patient. 

Because we believe water quality is an 

essential health and safety issue for 

ESRD patients, we are proposing a 

condition for coverage for water quality 

in this proposed rule. 

The hemodialysis patient’s blood has 

the potential to be exposed to toxic 

contaminants present in water. Some 

chemical contaminants are not normally 

harmful when present in small amounts 

in usual physiological fluids. However, 

since hemodialysis patients are exposed 

to the large volume of water that is used 

to make dialysate, chemical 

contaminants can be dangerous to them. 

If water supplies are biologically or 

chemically contaminated, the patient 

may experience infection or other 

adverse consequences. Limits on 

bacterial growth in water and dialysate 

are necessary to prevent high bacterial 

counts associated with pyrogenic 

reactions (fevers, chills, nausea). 

The patient’s exposure to 

contaminated water can be through 

water mixed with dialysate, water 

mixed with reprocessing germicides, or 

water used to flush out dialyzers. 

Contamination of the water system with 

organic and inorganic chemicals, 

bacteria, and endotoxins can result in 

adverse patient reactions, such as 

hemolysis, bacteremia, pyrogenic 

reactions, or death. Exposure to some 

contaminants such as aluminum can 

cause chronic health problems, while 

exposure to other contaminants such as 

fluoride can be fatal. Therefore, a 

dialysis facility must monitor the 

quality of the water used in treatments, 

as well as monitor the equipment used 

in water treatment. 

In the September 18, 1995 Federal 

Register (60 FR 48039), we published a 

final rule that incorporated by reference 

the 1992 AAMI standard for water 

quality and the AAMI recommended 

guidelines for monitoring purity of 

water as published in the 

‘‘Hemodialysis Systems,’’ ANSI/AAMI 

RD5: 1992, sections 3.2.1, 3.2.2, and 

Appendix B, sections B1–B5 (American 

National Standards Institute 1992). Each 

AAMI standard or recommended 

practice reflects the collective expertise 

of a committee of health care 

professionals and industrial 

representatives, whose work has been 

reviewed nationally. AAMI standards 

and guidelines undergo a regular 5-year 

review process that allows updates and 

revisions. These consensus 

recommendations are intended to help 

ensure patient safety. 

The AAMI guidelines referenced in 

the existing conditions for coverage 

have been replaced by more recent 

AAMI guidelines, and therefore, we are 

proposing to incorporate new AAMI 

references. The ANSI/AAMI RD5: 1992 

document has been replaced by 

‘‘Concentrates for Hemodialysis’’ ANSI/

AAMI RD61: 2000, ‘‘Water Treatment 

Equipment for Hemodialysis 

Applications’’ ANSI/AAMI RD62: 2001, 

and ‘‘Dialysate for Hemodialysis’’ ANSI/

AAMI RD 52:2004. These publications 

update the information on monitoring of 

water quality currently incorporated by 

reference in § 405.2140(a)(5) and 

provide additional recommended 

practices. 

We are proposing to incorporate by 

reference the following revised AAMI 

water quality standards, published in 

‘‘Water Treatment Equipment for 

Hemodialysis Applications,’’ 4.2.1 and 

5.2.1, Water Bacteriology; 4.2.2 and 

5.2.2, Maximum Level of Chemical 

Contaminants; and 4.3, Water Treatment 

Equipment requirements (American 

National Standards Institute, 2001). The 

updated water purity standards, section 

4.2.1, now include bacteria and 

endotoxin action levels that identify the 

concentration at which steps (such as 

system disinfection and retesting) 

should be taken to reduce the levels to 

an acceptable range. Facilities must take 

corrective action when these action 

levels are met or exceeded. 

The AAMI list of contaminants for 

which water must be tested has been 

expanded to include antimony, 

beryllium, and thallium. These 

chemicals were added based on changes 

in the United States Environmental 

Protection Agency Safe Drinking Water 

Act 1996 (Pub. L. 104–182). AAMI’s 

rationale for testing water for these 

contaminants may be found in the 

appendix of the ANSI/AAMI RD62: 

2001 document at A.4.2.2 (American 

National Standards Institute, 2001). 

We have also included the updated 

AAMI requirements for water treatment 

equipment. This inclusion provides 

clarity by defining the minimum 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6195

standards for water treatment 

equipment needed to protect patient 

safety. Proper hemodialysis is 

dependent on the quality of the 

dialysate. A water system consisting of 

the proper components and maintained 

in accordance with the manufacturers’

instructions, can be expected to produce 

dialysate that meets the AAMI standards 

and produces acceptable patient 

outcomes. The minimum safety 

requirements are specified in the AAMI 

standards referenced in proposed 

§ 494.40(a)(1)(iii) for each component of 

the water treatment system (that is, 

deionization, reverse osmosis, monitors, 

sediment filters, carbon absorption 

media, automatically regenerated water 

softeners, storage tanks, piping systems; 

and when used, ultrafilters, ultraviolet 

irradiators, hot water disinfection 

systems, ozone disinfection systems, 

and tempering valves). A water 

treatment system consisting of the 

proper equipment components as 

identified by AAMI (and the Food and 

Drug Administration (FDA)) is standard 

practice in dialysis facilities. 

We are proposing state of the art water 

purity monitoring guidelines outlined in 

ANSI/AAMI RD52: 2004 ‘‘Dialysate for 

Hemodialyzers’’ section 7.2.1 document. 

Proposed § 494.40(a)(2) incorporates by 

reference the section that specifies the 

frequency of water purity testing to 

insure meeting the AAMI limits 

specified in § 494.40(a)(1)(i) and (ii) as 

follows: 

• Bacteria and bacterial endotoxin 

levels of water must be measured—

++ In established systems at least 

monthly;

++ In newly-installed systems at least 

weekly until an established pattern of 

compliance can be demonstrated. 

• At least monthly in samples drawn 

from—

++ The first and last outlets of the 

water distribution loop; 

++ Where water enters the dialyzer 

reprocessing equipment; 

++ Outlet of the water storage tanks, 

if used; 

++ Concentrate or from the 

bicarbonate concentrate mixing tank. 

• Bacteria levels must be measured at 

least monthly from a sample of two or 

more dialysis machines, this sampling 

must ensure that all machines are tested 

at least once a year. 

• Chemical analysis of water purity 

must be done at least once a year and 

when—

++ The system is installed; 

++ Membranes are replaced if using a 

reverse osmosis system; 

++ Seasonal variations in source 

water suggest worsening water quality; 

and 

++ Reverse osmosis rejection rates, 

which are monitored daily using 

continuous-reading monitors that 

measure product water conductivity, 

fall below 90 percent. 

Ultrapure dialysate has received 

attention in the clinical literature and 

the working draft AAMI standards 

‘‘Dialysate for Hemodialysis’’ RD52 

contains guidelines pertaining to 

ultrapure dialysate. We are not 

proposing a requirement for ultrapure 

dialysate at this time but we do invite 

comment on this topic. We also 

welcome comment on the requirements 

for the frequency of water purity testing. 

In addition, we are proposing further 

evidence-based requirements consistent 

with AAMI guidelines within the 

proposed water quality condition. The 

existing conditions for coverage do not 

address requirements for the water 

treatment equipment, although the 

interpretive guidelines for 

§ 405.2140(a)(5)(ii) do advise that water 

treatment systems must include a 

carbon tank and either a reverse osmosis 

or deionization system (DHHS/CMS, 

1995). We are proposing that the water 

treatment system must include a reverse 

osmosis or deionization component that 

conforms to the referenced water 

treatment equipment for hemodialysis 

applications AAMI guidelines 4.3.5 and 

4.3.6. This is in keeping with current 

standards of practice, which are widely 

adhered to by dialysis facilities. The 

reverse osmosis process serves to 

remove dissolved salts, bacteria, viruses, 

pyrogens, and organic molecules. 

Deionization serves to remove ions. A 

reverse osmosis system along with 

pretreatment is used in the vast majority 

of all dialysis centers and this 

requirement should not present an 

additional burden to hemodialysis 

centers. 

A consequence of patient exposure to 

high levels of chloramine via dialysis is 

hemolytic anemia, which may be lifethreatening. The 1992 AAMI guidelines 

specified at least once daily testing of 

purified water for chlorine/chloramine 

levels. It is now widely recognized that 

testing before each shift of hemodialysis 

sessions, which is the current standard 

in many dialysis units, provides greater 

patient safety. Therefore, we are 

proposing at § 494.40(c)(2) to require 

chlorine/chloramine testing of water 

samples that must be taken from the exit 

port of the initial chlorine/chloramine 

removal component (or carbon tank) 

prior to each patient shift or every 4 

hours, whichever is shorter, during 

operation of the water system, unless 

the facility ensures on a daily basis that 

the source water is chlorine/chloramine 

free by way of testing. In addition, 

proposed § 494.40(c)(2)(i) would require 

subsequent testing from the backup 

component (or second carbon tank) if 

the test shows greater than 0.50 parts 

per million (ppm) for free chlorine or 

0.10 ppm for chloramine. Due to the 

dangers of chlorine/chloramine 

exposure, each water purification 

system must provide for the adequate 

removal of chlorine/chloramine and this 

is standard operating practice in 

hemodialysis facilities. In conformity 

with the referenced AAMI guidelines at 

4.3.9, carbon tanks used for the removal 

of chlorine/chloramine must contain 

granulated activated carbon and provide 

adequate empty bed contact time to be 

effective. A backup component or 

second carbon tank must be in place for 

failure of the first line component for 

chlorine/chloramine removal (or first 

carbon tank), in order to protect patients 

during a hemodialysis session. 

Dialysis facilities would be required 

to follow the applicable FDA 

recommendations in ‘‘Guidance for the 

Content of Premarket Notifications for 

Water Purification Components and 

Systems for Hemodialysis’’ that 2 

carbon tanks be installed in series with 

empty bed contact time of 10 minutes 

(DHHS/FDA, 1997). The second carbon 

tank provides the backup safety 

measure. Some dialysis facilities have 

three or four carbon tanks that provide 

even more assurance there will not be 

chloramine breakthrough. We invite 

comment as to whether our proposed 

conditions for coverage that include 

expanded water equipment 

requirements are still too minimal. In 

addition, we are requesting comments 

on whether the current AAMI guidance 

regarding carbon tanks is adequate to 

address all potential health and safety 

problems associated with chlorine, 

chloramines, and unannounced 

variations in source water. Specifically, 

we seek comments regarding where 

there is sufficient evidence to require 

Medicare-participating dialysis facilities 

to maintain at least two carbon tanks 

(that is, primary and backup) as part of 

their water treatment system, regardless 

of the current composition of its source 

water. 

We are proposing in § 494.40(e) to 

require active surveillance of 

hemodialysis patient reactions during 

and following dialysis, particularly 

when there are adverse reactions that 

might be associated with a problem with 

the water purification system. The 

facility must take steps to protect 

patient safety and obtain the appropriate 

blood and dialysate cultures. Evaluation 

of the water purification system must be 

undertaken as well as any necessary 

corrective action (§ 494.40(d)). 

6196 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

If chlorine/chloramine levels in 

treated water from the last backup 

component (or carbon tank) are above 

the AAMI standards as required in 

proposed § 494.40(a)(1)(ii), dialysis 

treatments must be immediately 

stopped to protect patients from 

exposure to chlorine/chloramine as 

proposed in § 494.40(c)(2)(ii). The 

medical director, who is ultimately 

responsible for water quality, must be 

notified immediately and corrective 

action taken. A corrective action plan is 

also required (see § 494.40(d)) whenever 

any of the water purity action levels or 

standards, including but not limited to, 

chemical, microbial, and endotoxin, are 

detected. 

We propose to add a requirement, 

consistent with in the AAMI document 

RD52:2004, that specifies that once 

mixed, bicarbonate concentrate must be 

used within the time specified by the 

manufacturer of the concentrate and 

may not be mixed with fresh 

concentrate. The holding of the 

bicarbonate concentrate presents the 

risk of bacterial growth and should be 

avoided. 

We considered addressing water 

quality for home dialysis patients in this 

condition, but we decided instead to 

include a requirement that the facility 

monitor water used by its home dialysis 

patients to ensure that the water meets 

the AAMI standards under the proposed 

‘‘care at home’’ condition for coverage 

(§ 494.100). Addressing all home 

dialysis issues under a single condition 

simplifies the organization of the 

regulations and eliminates the need for 

readers to refer to separate sections for 

the requirements for home dialysis 

services. 

C. Reuse of Hemodialyzers and 

Bloodlines (Proposed § 494.50) 

Section 1881(f)(7) of the Act requires 

the Secretary to establish protocols for 

reuse of hemodialyzers for those 

facilities that voluntarily elect to reuse 

the filters. The Act further states that 

dialysis facilities that fail to follow the 

reuse protocol will be subject to denial 

of participation in the Medicare 

program and denial of payment for 

dialysis treatment not furnished in 

compliance with the reuse protocol. 

In hemodialysis the patient’s blood is 

cleansed of impurities when it passes 

through the filter (hemodialyzer) of a 

hemodialysis machine. There are 

various techniques that allow some of 

these filters to be reused under certain 

conditions. Reuse involves cleaning, 

disinfecting, and preparing such 

hemodialysis devices for subsequent use 

for the same patient. Although the 

potential exists for adverse patient 

outcomes from reuse, reprocessing and 

reuse of dialyzers are safe when proper 

techniques are utilized. 

The existing regulation at § 405.2150 

requires ESRD facilities reusing 

hemodialyzers to meet the guidelines 

and standards adopted by AAMI and 

issued in July 1993, as ‘‘Reuse of 

Hemodialyzers’’ (American National 

Standards Institute, 1993). We are 

proposing to retain this requirement in 

the proposed rule but to incorporate by 

reference the newly revised version and 

associated amendment (ANSI/AAMI 

RD47: 2002 and ANSI/AAMI RD47: 

2002/A1: 2003) which replaces the 1993 

version. This document received final 

AAMI approval on November 7, 2002.

Some in the renal community believe 

that we should not incorporate the CDC 

guideline that prohibits reuse for 

hepatitis B patients. They believe there 

is no documentation that reuse 

contributes to the spread of hepatitis or 

that it negatively affects the patient with 

hepatitis. In addition, they indicated 

that this prohibition is costly to 

facilities because a new dialyzer must 

be used for each session. 

Hepatitis B is a highly contagious and 

potentially damaging illness, especially 

for a dialysis patient. Thus, the CDC has 

for many years recommended extreme 

caution and isolation for those patients 

who are Hepatitis B positive. Many 

physicians, nurses and other 

professionals involved in the dialysis 

field have similarly supported the 

position of extreme caution in treating 

the hepatitis B positive patient. The 

2001 CDC guidelines advise against the 

reprocessing of dialyzers used for 

patients who have Hepatitis B because 

of the risk to facility staff. The hepatitis 

virus is relatively stable in the 

environment and has been shown to 

remain viable for several days on 

surfaces (via blood spills). While there 

may be no appreciable evidence to 

demonstrate that reuse would increase 

the spread of hepatitis B, there is not 

conclusive evidence that reuse in this 

population is safe. At this time we 

propose to maintain the CDC guidelines 

prohibiting reuse for hepatitis B patients 

to minimize the incidence of this mode 

of transmission. 

We are also proposing at 

§ 494.50(b)(2) that the hemodialyzer 

manufacturer recommendations be 

followed, or if an alternate method for 

reprocessing hemodialyzers is used, that 

the facility have documented evidence 

that the method is safe and effective. 

According to FDA guidance, 

hemodialyzer labeling should reflect the 

clinical use of a hemodialyzer, and 

whether it is intended for single or 

multiple usage (DHHS/FDA, 1995). 

Only hemodialyzers and bloodlines 

labeled for multiple use may be reused. 

In addition, manufacturers of reusable 

hemodialyzers are required to provide 

adequate instructions for safe and 

effective reuse in accordance with 21 

CFR 801.5. If the facility chooses to use 

an alternate method for reprocessing 

hemodialyzers there must be sufficient 

scientific evidence that the method is 

safe and effective. This flexibility is 

provided to allow for the use of newer 

and improved technologies that are 

proven safe in scientific studies which 

may become available in the future. The 

FDA approved label recommendations 

for the proper use of the device must be 

adhered to by dialysis facilities. 

Existing § 405.2150(a)(2) states that to 

prevent any risk of dialyzer membrane 

leaks due to the combined action of 

different chemical germicides, dialyzers 

are exposed to only one chemical 

germicide during the reprocessing 

procedure. We have received informal 

suggestions that we alter the current 

language because many facilities use 

bleach as part of the reuse process to 

flush and clean blood deposits before 

the actual germicide soaking process is 

initiated. However, for purposes of 

reuse, we consider bleach to be a 

cleansing agent, not a germicide. The 

requirement to discard dialyzers treated 

with a different germicide does not 

apply to bleaching. Nonetheless, since 

the language appears to be confusing to 

some, we are proposing to clarify the 

provision in proposed § 494.50(b)(3) by 

inserting the phrase ‘‘other than 

bleach.’’

Some in the renal community and on 

the AAMI RD47 workgroup stated that 

discarding dialyzers exposed to a 

second germicide was expensive and 

unnecessary if air pressure leak test 

results indicated the dialyzer was still 

effective. However, we are proposing to 

retain the requirement in existing 

§ 405.2150 that if a dialyzer is exposed 

to a second germicide it must be 

discarded because we are concerned 

that exposure to different germicides 

may cause membrane leaks. While we 

recognize that it may be considered 

wasteful by some to discard dialyzers 

with test values that indicate they are 

still effective, we believe this is a 

necessary safety measure. We do not 

have sufficient evidence that clearly 

supports the safety of using multiple 

germicides on hemodialyzers. We 

welcome comment on the issue of 

multiple germicide use in reused 

hemodialyzers. 

Existing § 405.2150(a)(3) requires that 

facilities take appropriate blood cultures 

at the time a patient has a febrile 

response and discontinue reuse of 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6197

hemodialyzers in the case of pyrogenic 

reactions, bacteremia, or unexplained 

reactions possibly associated with 

ineffective reprocessing, until the entire 

reprocessing system is evaluated. We 

have been advised that a single febrile 

response in one patient can be the 

consequence of many different 

etiologies not related to reuse, including 

an infected access, a current infection, 

or contamination of the water 

purification system. Members of the 

renal community suggested that a febrile 

reaction in a single patient is rarely 

attributed to dialyzer reuse. Facilities do 

not believe it is necessary to terminate 

reuse or order blood cultures when a 

febrile reaction occurs in only a single 

patient. It was suggested that a facility 

need only respond through aggressive 

evaluation of its water purification 

system, dialysis concentrates, and reuse 

system when the surveillance of febrile 

events reveals a cluster of febrile 

patients. Based on this evaluation, the 

facility can make an appropriate clinical 

decision concerning termination of 

reuse. As a result, we are proposing in 

§ 494.50(c) to revise the regulations to 

state that a facility need only obtain 

blood and dialysate cultures and 

evaluate its reprocessing and water 

purification systems in response to an 

adverse reaction when clinically 

indicated. If the evaluation indicates 

that the facility should discontinue 

reuse, we expect facilities to have 

established contingency plans, suspend 

the reuse of hemodialyzers until the 

problem has been corrected, and report 

the adverse outcomes to the FDA and 

other agencies as required by Federal, 

State or local laws and regulations. 

Existing § 405.2150(c) lists 4 

requirements applicable to a facility that 

reuses bloodlines. Facilities must: (1) 

Limit the reuse of bloodlines to the 

same patient; (2) not reuse bloodlines 

labeled for ‘‘single use only’’; (3) reuse 

only bloodlines for which the 

manufacturer’s protocol for reuse has 

been accepted by the FDA in accordance 

with the premarket notification (see 

section 510(k) of the Food, Drug, and 

Cosmetic Act and 21 CFR 876.5860 of 

the regulations); and (4) follow the FDAaccepted manufacturer’s protocol for 

reuse of that bloodline. We propose to 

maintain the first requirement to limit 

the reuse of bloodlines to the same 

patient because the risk of transmitting 

blood-borne pathogens is so high, and 

reusing for the same patient limits the 

risk of cross-contamination. We also 

propose to maintain the third and fourth 

requirements, that is, a facility may 

reuse only bloodlines for which the 

manufacturer’s protocol for reuse has 

been accepted by the FDA; and that the 

facility must follow the FDA-accepted 

manufacturer’s protocol for reuse of the 

bloodline. With these requirements, the 

facility must follow any specific 

instructions listed by the FDA, as well 

as any guidelines by the manufacturer 

that may not be discussed in the FDA 

regulations. We are proposing to delete 

the second existing requirement that 

facilities not reuse bloodlines labeled 

for ‘‘single use only’’ because it is 

redundant with the existing third and 

fourth requirements. Since the FDA 

would not recommend reuse on 

bloodlines labeled ‘‘single use only,’’

there is no need to maintain the 

requirement.

D. Physical Environment (Proposed 

§ 494.60) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Physical Environment’’ at the 

beginning of your comment.] 

The existing physical environment 

condition (§ 405.2140) stipulates that 

the physical environment in which 

dialysis services are furnished afford a 

functional, sanitary, safe, and 

comfortable setting for patients, staff, 

and the public. The existing regulation 

consists of four separate standards 

concerning building and equipment, 

favorable environment for patients, 

contamination prevention, and 

emergency preparedness. We propose to 

refine the physical environment section 

to include only those elements that 

relate directly to the physical 

surroundings of the dialysis facility and 

to relocate the remaining elements to 

other sections in the proposed rule that 

relate more closely to those subject 

areas. 

The existing building and equipment 

requirements in § 405.2140(a), include 

fire safety procedures, equipment 

maintenance, facility maintenance, and 

water treatment. Based on the 

experience and suggestions of our 

surveyors, we propose to establish 

separate standards for the building itself 

in proposed § 494.60(a) and equipment 

in proposed § 494.60(b). We propose to 

maintain the existing requirement 

(described in § 405.2140(a)) that the 

building in which dialysis services are 

furnished be constructed and 

maintained to ensure the safety of 

patients, the staff, and the public. The 

dialysis facility should be free from 

hazards that may bring harm to the 

patients, the staff, and the public. 

The existing language of 

§ 405.2140(a)(2) stipulates that all 

electrical and other equipment used in 

the facility be maintained free of defects 

that could present a potential hazard to 

patients or personnel and that there is 

a planned program of preventive 

maintenance of equipment used in 

dialysis and related procedures in the 

facility. We propose at § 494.60(b) to 

maintain the essence of this requirement 

but to clarify that all equipment is 

maintained in accordance with the 

manufacturer’s recommendations. Based 

on their experience with the equipment, 

we believe manufacturers have the most 

knowledge about routine maintenance 

and recommended repair. 

Existing § 405.2140(b) requires each 

facility to maintain a favorable 

environment for patients; and the 

facility must be maintained and 

equipped to provide a functional, 

sanitary, and comfortable environment 

with an adequate amount of well-lighted 

space for the services provided. The 

existing language in this standard 

combines several different concepts, 

including sanitary environment and 

infection control, and we propose to 

address each subject in separate sections 

of the regulation. As a result, we are 

proposing at § 494.60(c) to include only 

those standards regarding the safety and 

comfort of each patient. 

Since the proposed conditions are 

outcome-oriented, we believe that we do 

not need to specify all the process 

requirements that a facility must meet to 

provide a dialysis environment in 

which the patient can receive quality 

care. Each facility can develop its own 

strategies and techniques as long as the 

space for treating each patient is 

sufficient to provide needed care and 

services, prevent cross-contamination, 

and accommodate medically needed 

emergency equipment and staff. Existing 

§ 405.2140(b) also requires the facility to 

provide a well-lit space. We propose to 

delete this requirement because it is too 

subjective to be meaningful, and we 

believe this detail is better left to the 

judgment of the facility staff. 

We expect the dialysis facility to 

provide patients with a comfortable 

environment. Existing § 405.2140(b)(4) 

requires that heating and ventilation 

systems be capable of maintaining 

adequate and comfortable temperatures. 

We recognize that not all patients are 

comfortable at the same temperature; 

and therefore, proposed § 494.60(c)(2) 

specifies that the facility maintain a 

temperature that is comfortable for the 

majority of patients. The dialysis facility 

must make reasonable accommodations 

for patients who are not comfortable at 

the temperature setting determined by 

the majority of patients. The facility has 

the option of allowing patients to bring 

a blanket to dialysis or providing freshly 

laundered blankets to the patients. 

Infection control procedures must be 

6198 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

adhered to in either case. Often patients 

need a warm environment because of 

lowered body temperature during the 

dialysis process, and therefore, facilities 

should look to patients rather than staff 

to ascertain comfortable building 

temperatures. 

In the emergency preparedness 

standard (proposed § 494.60(d)), we 

have proposed requirements that we 

believe are fundamental for a dialysis 

facility to prepare effectively for 

emergency situations. These 

requirements include: (1) Procedures for 

medical and non-medical emergencies; 

(2) staff and patient training; (3) facility 

emergency equipment; and (4) periodic 

evaluation of emergency plans. Existing 

§ 405.2140(d) requires the facility to 

have written policies and procedures 

that specifically define the handling of 

emergencies that may threaten the 

health and safety of patients. The 

existing regulations also stipulate that 

facility staff should be trained for any 

emergency or disaster, as part of their 

employment orientation. 

We propose to clarify at § 494.60(d) 

that each dialysis facility must 

implement emergency preparedness 

procedures to manage potential medical 

and nonmedical emergencies that are 

likely to threaten the health or safety of 

facility patients, the staff, and the 

public. These emergencies include, but 

are not limited to, fire, equipment or 

power failures, care-related 

emergencies, water supply interruption, 

and natural disasters likely to occur in 

the facility’s geographic area. The 

facility will need to identify which 

hazards are most likely to effect their 

facility, evaluate how to minimize risks, 

and plan how to best protect patients in 

the event of an emergency, using an 

emergency management approach. We 

do not expect individual facilities to 

develop emergency plans for natural 

disasters that typically do not affect 

their geographic location. For example, 

facilities located in the Southeast would 

not typically need to develop emergency 

procedures for earthquakes. Facilities 

located in the central plains States, on 

the other hand, would need to be 

prepared for tornadoes. All facilities 

must plan for fire, care related 

emergencies, equipment and power 

failures, and interruption of the water 

supply, because these emergencies may 

occur regardless of a facility’s 

geographic location. 

In addition to having emergency 

procedures, a facility will need to plan 

ahead so that necessary information and 

tools are available to staff and patients. 

For example, a facility would need to 

have current patient telephone numbers, 

addresses, and transportation 

information available before an 

emergency happens rather then 

scrambling to update this kind of 

information during an emergency. As a 

resource in their movement toward an 

emergency management approach, 

dialysis facilities may want to use the 

ESRD facility emergency preparedness 

guidelines available from the ESRD 

Networks. 

We propose to maintain the existing 

requirement that a facility train each 

staff member on the actions required for 

different medical and nonmedical 

emergencies. The existing conditions for 

coverage require that emergency 

preparedness procedures be reviewed 

and tested at least annually and revised 

as necessary. Also, all personnel must 

be knowledgeable and trained in their 

respective roles in emergency situations. 

We are proposing that staff training 

must be evaluated at least annually and 

that staff must demonstrate knowledge 

of emergency procedures. This 

requirement is designed to ensure the 

safety and security of both the patients 

and the staff. We propose also to require 

that the facility provide periodic 

training to patients and staff. Patients 

routinely treated in dialysis units are at 

risk for medical emergencies. As a 

result, standard medical practice 

dictates that the facility must have 

trained personnel, drugs, and 

emergency equipment available to 

adequately support patients until an 

Emergency Medical System (EMS) unit 

responds to the facility. 

We are proposing at § 494.60(d)(1)(ii) 

that staff must maintain current 

cardiopulmonary resuscitation (CPR) 

certification. This is the standard 

practice in United States dialysis 

facilities. We have not prescribed the 

type or number of staff who must 

maintain CPR certification but at a 

minimum, the patient care staff must 

maintain current CPR certification. In 

this instance, patient care staff are staff 

who routinely provide direct medical 

care to patients in the dialysis unit. 

We would maintain the standard in 

the existing regulation (§ 405.2140(d)(5)) 

that the facility provides appropriate 

training to patients, so that they know 

the facility’s emergency procedures, 

since they may need to take steps to 

protect themselves during an 

emergency. Dialysis patients need to be 

informed on what to do, where to go, 

whom to contact from home, and how 

to disconnect themselves from dialysis 

equipment if an emergency occurs.

The existing text in § 405.2140(d)(3) 

requires that the facility have available 

at all times on the premises a fully 

equipped emergency tray, including 

emergency drugs, medical supplies, and 

equipment. We propose to maintain this 

requirement, but we want to eliminate 

the confusion regarding the meaning of 

‘‘fully equipped.’’ We propose to define 

the minimum emergency equipment 

that must be on the premises and 

immediately available as ‘‘oxygen, 

airways, suction, artificial resuscitator 

ventilation bag, defibrillator, and 

emergency drugs.’’ We propose to 

specifically require defibrillators. 

Automated external defibrillators 

(AEDs), in particular, have been shown 

to save lives in a variety of settings, 

most notably aboard airlines and in 

airports. One Seattle study (Arch Intern 

Med. 2001;161:1509–1512 available at 

http://www.ARCHINTERNMED.com) 

identified dialysis centers as having a 

relatively high incidence of cardiac 

arrest (≥ 0.746 per practice annually). In 

the 9 dialysis facilities studied there 

were 47 cardiac arrests over a 7-year 

period. Approximately 56 percent, or 26 

patients, had ventricular fibrillation and 

may have benefited from use of an AED. 

The authors of this study presented 

their findings to the nine dialysis 

centers and all nine agreed to equip 

their centers with AEDs and to train 

their staff in the use of AEDs. 

The key to saving a life is getting the 

defibrillator on the patient as soon as 

possible. The AED allows dialysis 

facility staff to defibrillate a patient 

without requiring the immediate 

presence of a physician. According to 

the American College of Emergency 

Physicians (www.acep.org/

1,2891,0.html), when a person suffers a 

sudden cardiac arrest, the chance of 

survival decreases by 7 to 10 percent for 

each minute that passes without 

defibrillation. The very real potential for 

saved lives supports the financial 

investment in an AED. The cost of an 

AED is approximately $2,000 to $3,000. 

Some units have already voluntarily 

purchased AEDs. Very small units (for 

example, units with two hemodialysis 

stations) may find the purchase of an 

AED to be a heavy financial burden. We 

are soliciting comments on whether 

small, predominantly rural dialysis 

facilities should receive special 

consideration and possibly an 

exemption from the defibrillator 

requirement. We propose that the 

dialysis nursing staff must be trained on 

the proper use of emergency equipment 

and emergency drugs. Staff could be 

trained on the use of an AED in 

conjunction with the CPR training. 

Having the right equipment at the time 

of an emergency is only useful when 

staff is well versed in how to effectively 

use it. In addition, the facility must have 

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a plan to obtain EMS assistance when 

needed. 

We are proposing to require a 

defibrillator without specifying an AED 

due to the fact that some dialysis units 

already have access to a defibrillator. 

Hospital-based dialysis units, in 

particular, may have immediate 

physician availability built into the 

hospital-wide cardiac resuscitation 

plan. This reduces the financial burden 

of the proposed defibrillator 

requirement. 

We are proposing to maintain the 

requirement that facilities conduct 

reviews of their emergency and disaster 

plans to ensure that facilities 

appropriately respond to the situations 

and needs that may arise from a variety 

of emergencies, medical and 

nonmedical. We are proposing in 

§ 494.60(d)(3)(ii) that facilities review 

their emergency and disaster plans at 

least annually. Drill and emergency 

episodes often reveal a weakness or flaw 

in the design of the emergency plan. An 

annual update will allow such flaws or 

potential problems to be identified and 

corrected. 

Existing § 405.2140(b)(3) specifies that 

the facility have a nursing/monitoring 

station from which adequate 

surveillance of patients receiving 

dialysis services can be made. We 

propose to delete this requirement 

because we believe this is not a physical 

environment issue. It is important that 

patients are appropriately monitored 

during the dialysis session. However, 

monitoring is most effectively done 

through interaction between the patients 

and the staff in the dialysis area and not 

from a monitoring station. 

We believe that existing 

§ 405.2140(b)(5) is another processoriented requirement, and we propose 

to delete this requirement. This 

requirement states that facilities using 

central batch processing must make 

arrangements to meet the needs of 

patients with special dialysis solutions. 

The Patient plan of care condition, 

proposed § 494.90, would require the 

dialysis facility to implement the care 

plan and make arrangements to meet the 

individual requirements of each patient 

regardless of whether those needs are 

related to special dialysis solutions or 

other medically necessary supplies or 

equipment. 

The existing emergency preparedness 

standard (§ 405.2140(d)) enumerates the 

facility physical emergency 

management procedures but provides 

minimal standards for the procedures 

that must be followed during a fire. We 

propose to strengthen the section 

governing fire safety to provide greater 

detail regarding the appropriate 

procedures that must be followed. 

We are proposing at § 494.60(e) to 

adopt the 2000 edition of the National 

Fire Protection Association’s (NFPA) 

Life Safety Code (LSC). The LSC is a 

compilation of fire safety requirements 

for new and existing buildings and is 

updated and published every 3 years by 

the NPFA, a private, non-profit 

organization dedicated to reducing loss 

of life due to fire.

The Medicare and Medicaid 

conditions of participation have 

historically incorporated by reference 

these requirements along with 

Secretarial waiver authority. The 

statutory basis for incorporating NFPA’s 

LSC for ESRD facilities falls under the 

Secretary’s general rulemaking 

authority. 

The 2000 edition of the LSC is 

divided into several occupancy chapters 

including a business chapter, 

educational chapters, ambulatory health 

care occupancy chapters, and health 

care occupancy chapters. The business 

occupancy chapter pertains to clinics 

and offices. The educational occupancy 

chapters pertain to schools and day care 

centers. The health care occupancy 

chapters pertain to inpatient health care 

facilities (for example, hospitals, 

nursing homes). Finally, the ambulatory 

health care occupancy chapters pertain 

to facilities that provide outpatient 

medical treatment that may render the 

patient temporarily incapable of selfpreservation (for example, critical 

access hospitals, dialysis centers). 

The NFPA LSC Handbook specifically 

designates Chapter 20 and Chapter 21 

for outpatient dialysis services. We 

propose to adopt, as recommended by 

the NFPA LSC, Chapter 20 (that is, new 

ambulatory health care occupancy 

buildings) and Chapter 21 (that is, 

existing ambulatory health care 

occupancy buildings) of the 2000 

edition of the LSC for all outpatient 

dialysis facilities regardless of size. 

The LSC classifies dialysis facilities as 

ambulatory health care occupancies 

because the treatment is not a routine 

medical visit to a doctor’s office but 

rather a procedure that may hinder the 

patient from self-preservation in the 

event of an emergency or fire. 

Incapability of self-preservation might 

be the result of the use of general 

anesthesia or a treatment such as 

dialysis. Dialysis patients are not as 

mobile as a person working or visiting 

an office building or health clinic but 

more mobile than patients being treated 

in an inpatient health care facility, such 

as a hospital or nursing home. Chapters 

20 and 21 give a level of safety from fire 

that is greater than the typical business 

occupancy but less than a health care 

occupancy such as a hospital or nursing 

home. 

Under our proposal, an outpatient 

dialysis facility would comply with the 

business occupancy provisions in 

Chapters 38 (that is, the new business 

occupancies) and 39 (that is, existing 

business occupancies) with the 

additional provisions contained within 

Chapters 20 and 21. Where there may be 

a conflict between the business 

occupancy chapter and the ambulatory 

health care occupancy chapter, the more 

stringent requirements would apply 

(LSC sections 20.1.1.1.2 and 21.1.1.1.2). 

The requirements of Chapters 20 and 21 

are described below. 

Chapter 20.1.2.1 and Chapter 21.1.2.1 

require 1-hour fire separation between 

different occupancies or tenants in a 

multi-tenant building. We believe most 

dialysis facilities currently meet this 

requirement because most State 

building codes already require this 

provision. 

Chapters 20.2.4 and 21.2.4 require 

that there be at least two emergency 

exits. Emergency lighting is required by 

Chapters 20.2.9.1 and 21.2.9.1 to ensure 

that the center is lighted and that egress 

paths are illuminated to allow 

movement during an emergency. 

Chapters 20.2.9.2 and 21.2.9.2 require 

an essential electrical system. This 

provision does not apply to dialysis 

facilities because dialysis equipment is 

not life-support equipment under the 

Life Safety Code. 

Chapters 20.3.4.4 and 21.3.4.4 require 

the fire alarm system to provide 

automatic notification of a fire to 

emergency forces. This is of great 

importance for the protection of 

patients. Any delay in the notification of 

fire and rescue personnel could 

adversely impact the health and safety 

of patients and expose them to a fire, 

smoke, or toxic gases created by the fire. 

Chapters 20.3.7 and 21.3.7 pertain to 

smoke compartmentation, otherwise 

known as subdivision of building space. 

Section 3.7 of Chapters 20 and 21 apply 

to any dialysis facility that is larger than 

5,000 square feet (or 10,000 square feet 

for facilities with sprinklers). We 

believe most dialysis facilities will fall 

within the exceptions outlined in this 

provision. If a dialysis facility is smaller 

that 5,000 square feet and protected by 

an approved, supervised sprinkler 

system, then section 3.7 of Chapters 20 

and 21 do not apply. 

Section 7 of Chapters 20 and 21 

specify procedures to assist outpatient 

dialysis facilities in providing fire 

safety. Section 7.1 of Chapters 20 and 21 

propose evacuation plans and fire exit 

drills and require staff to practice the 

6200 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

procedures outlined in the dialysis 

facilities written emergency plans. 

Section 7.1 of Chapters 20 and 21 are 

appropriate for outpatient dialysis 

facilities because there is a possibility a 

dialysis patient could lose blood or 

suffer unnecessary risks if the patient 

were removed from the dialysis 

machine during a fire drill. We believe 

that requiring a dialysis facility to stop 

dialysis treatment and evacuate all 

dialysis patients during a fire drill is an 

unnecessary procedure that could 

jeopardize the dialysis patient’s health 

and safety. Annex A, Explanatory 

Material to the 2000 NFPA LSC 

provides guidance for conducting fire 

drills when it is inexpedient and 

impractical to move patients during a 

fire drill. Many health care occupancies 

conduct fire drills by choosing the 

location of the simulated emergency in 

advance; practicing the movement of 

simulated patients or empty 

wheelchairs to adjacent safe areas, and 

ensuring that staff have the efficiency, 

knowledge, and response capability to 

implement the facility’s fire emergency 

plan. Surveyors may determine whether 

this standard was met by checking a 

dialysis facility’s records and 

interviewing staff to verify that the 

emergency and fire drills were 

conducted not less than once in each 3-

month period and that staff are very 

familiar with the procedures. 

Section 7.1.1 in Chapters 20 and 21 

also require that the dialysis facility 

prominently post its emergency plan. 

We expect the plan to include 

continuity of essential building 

operations in the event of an emergency. 

Electrical, water, fire protection, 

ventilation, and communications 

systems are some, but not all, areas a 

dialysis facility should consider in its 

disaster plan. A good reference, but not 

a requirement for developing an 

emergency plan for a dialysis facility, is 

the NFPA 99—Standard for Health Care 

Facilities, Chapter 11, Health Care 

Emergency Preparedness (NFPA, 

November 2001). Our intent in 

proposing the posting requirement is to 

ensure patients, staff and the public 

have the proper information to quickly 

evacuate in the event of an emergency. 

The remaining provisions in section 7 

of Chapters 20 and 21 include 

requirements for the procedures in case 

of fire (20.7.2 and 21.7.2); maintenance 

of exits (20.7.3 and 21.7.3); smoking 

regulations (20.7.4 and 21.7.4); 

furnishings, beddings, decorations 

(20.7.5 and 21.7.5); maintenance and 

testing of life safety-related equipment 

(20.7.6 and 21.7.6); portable space 

heating devices (20.7.7 and 21.7.7); and 

construction, repair and improvement 

operation (20.7.9 and 21.7.9).

We recognize that for some dialysis 

facilities it would be extremely 

burdensome to adhere strictly to all of 

the LSC requirements. For example, 

older dialysis facilities or facilities 

leasing space in an office building may 

not be able to add sprinkler systems. We 

are proposing to retain our existing 

authority to waive specific provisions of 

the LSC on a case-by-case basis, further 

reducing the exposure to additional cost 

and burden for facilities with unique 

situations that can justify the 

application of waivers which we 

determine will not endanger the health 

and safety of patients. We propose that 

a waiver may be granted for a specific 

LSC requirement if: (1) We determine 

that the waiver would not adversely 

affect the patient/staff health and safety; 

and (2) we determine that it would 

impose an unreasonable hardship on the 

facility to meet a specific LSC 

requirement. A provider may request a 

waiver from its State Agency. The State 

Agency will review the request and 

make a recommendation to the 

appropriate CMS Regional Office. The 

CMS Regional Office will review the 

waiver request and the State Agency’s 

recommendation and make a final 

decision on the waiver request. A 

waiver cannot be granted if patient 

safety is compromised in any way. 

A State may also request that a State 

fire and safety code, imposed by State 

law, be applicable to all dialysis 

facilities rather than the LSC proposed 

in this rule. The State must submit the 

request to its CMS Regional Office and 

the Regional Office will forward the 

State’s request to CMS Central office for 

a final determination. 

V. Proposed Part 494 Subpart C (Patient 

Care) 

A. Patients’ Rights (§ 494.70) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Patients’ Rights’’ at the beginning of 

your comment.] 

The existing patients’ rights 

condition, § 405.2138, requires that the 

facility’s governing body adopt written 

patients’ rights policies that are 

administered by the facility’s chief 

executive officer (CEO). Sections 

405.2138(a)(1) through (5) state that 

patients must be informed regarding the 

following: (1) Their rights and 

responsibilities; (2) services available at 

the facility and charges not covered; (3) 

their medical condition (by a 

physician); (4) the facility’s reuse 

policies; and (5) their suitability for 

transplantation or home dialysis. 

Sections 405.2138(b)(1) and (2) afford 

patients the right to participate in 

planning their medical treatment; 

require that a patient may be transferred 

or discharged for only medical reasons 

or for the patient’s or other patient’s 

welfare or nonpayment of fees; and 

require that patients must be given 

advance notice to ensure an orderly 

transfer or discharge. Section 

405.2138(c) states that patients must be 

treated with respect and dignity; 

§ 405.2138(d) protects patient 

confidentiality of personal and medical 

records; and § 405.2138(e) states 

patients must be advised, encouraged, 

and assisted in exercising their rights to 

bring grievances (through a 

representative, if desired) without fear 

of discrimination or reprisal. 

We are proposing to revise the 

provisions of this condition to include 

a number of changes, in keeping with 

our goals to reduce the Federal 

regulatory burden on dialysis facilities, 

eliminate unnecessary procedural 

requirements, and revise the conditions 

for coverage to be more outcomeoriented while protecting the basic 

rights of ESRD patients. 

First, we are proposing at § 494.70 

that the facility must inform patients (or 

their representatives) of their rights and 

responsibilities when they begin their 

treatment at the facility, and must also 

protect and provide for the exercise of 

those rights. We believe it is important 

to take steps to ensure that patients are 

fully and promptly informed of their 

rights. The existing regulatory language 

permits a facility an unspecified period 

of time to complete this activity. 

However, we believe that all dialysis 

patients must be informed of their rights 

and responsibilities when they begin 

their treatment, which is the standard 

practice in dialysis facilities, so they 

may exercise them from the beginning 

of their relationship with the facility. 

Existing § 405.2138 provides a list of 

numerous persons to whom these 

written patient rights policies must be 

‘‘made available.’’ The list includes 

patients and guardians, next of kin, 

sponsoring agencies, representative 

payees, and the public. Essentially, the 

facility must provide the list of patient 

rights to anyone who asks to see them. 

Rather than specifying a list of people 

to whom the patients’ rights policies 

must be made available, we are 

proposing at § 494.70 that facilities 

inform the patients (or their 

representatives), and at § 494.70(c) that 

facilities post a copy of the patients’

rights in a prominent location where it 

can easily be seen and read. This not 

only meets the objectives of the current 

list of disclosures, it also allows patients 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6201

to review their rights at any time during 

the course of their care at the dialysis 

facility. 

Section 405.2138 also states that the 

CEO is responsible for the development 

of, and adherence to, procedures 

implementing the patients’ rights 

policies. In § 494.70, we are proposing 

to change this requirement by holding 

the facility accountable for the outcome, 

which is to ensure that each patient’s 

rights and the ability to exercise them 

are protected. 

We are proposing to retain the 

patients’ rights enumerated in 

§ 405.2138(a)(1) through (a)(5) and 

include them in the proposed 

§ 494.70(a). 

Proposed § 494.70(a)(1) requires the 

dialysis facility to inform patients of 

their right to be treated with respect, 

dignity, and recognition of their 

individuality and personal needs as 

well as sensitivity to the patients’

psychosocial needs and ability to cope 

with ESRD. 

Proposed § 494.70(a)(2) requires a 

dialysis facility to provide information 

to patients in an understandable 

manner. The existing requirement at 

§ 405.2138(c) requires dialysis facilities 

to provide translators ‘‘where a 

significant number of patients exhibit 

language barriers.’’ Presumably, under 

this existing requirement, if a single 

patient has language difficulty, the 

facility does not need to act to address 

this patient’s needs. We are proposing to 

modify this requirement. Since written 

information is not required, the dialysis 

facility has the flexibility to decide the 

best vehicle for providing information to 

patients. We believe this more outcomeoriented requirement provides a facility 

with the latitude to devise its own 

means to ensure the outcome is met. 

Proposed §§ 494.70(a)(3) and (4) 

would require a dialysis facility to 

inform patients regarding privacy and 

confidentiality, and also expands those 

rights to include specific references to 

privacy and confidentiality in all 

aspects of the patient’s treatment as well 

as the patient’s medical records. These 

requirements include existing 

provisions from § 405.2138(c) and (d). 

Staff should be instructed that any 

discussions with dialysis patients or 

relatives regarding treatment, the patient 

care plan, and medical conditions 

should be held in private and kept 

confidential. There should be 

reasonable precautions to keep both 

written and verbal patient information 

private. Staff should be aware of the 

need to speak at a volume and at a 

proximity to patients such that privacy 

is reasonably protected. Facility staff 

must make efforts to protect patient 

information and physical privacy. While 

recognizing the patient’s right to privacy 

and confidentiality, we are not 

necessarily advocating physical barriers 

in the dialysis clinical area that provide 

patient privacy because patients should 

be in view of staff at all times during 

treatment to ensure safety. However, in 

situations when there is patient body 

exposure during therapy, the staff 

should be instructed to provide 

temporary screens, curtains, or blankets. 

We are proposing at § 494.70(a)(5) to 

retain the existing requirement under 

§ 405.2138(b)(1) that describes the right 

of patients to participate in the planning 

of their medical treatment and to refuse 

to participate in experimental research 

(or any part of their care). Section 

494.70(a)(5) requires a facility to inform 

patients regarding their right to 

participate in all aspects of their care. 

Although we recognize that a facility 

cannot require its patients to participate 

in the care process, we expect the 

facility to work closely with patients 

and encourage patient participation to 

ensure that a care plan is developed that 

is suitable to the needs and concerns of 

both the patient and staff. The facility 

should notify patients in advance, if 

possible, of any changes in the 

treatment plan recommended by the 

physician and the basis for the changes. 

The facility should also encourage 

patients to disclose any concerns they 

may have with the proposed changes. 

Proposed § 494.70(a)(5) would also 

require the facility to inform patients of 

the right to establish an advance 

directive. Advance directives establish 

in writing an individual’s preference 

with respect to the degree of medical 

care and treatment desired or who 

should make treatment decisions if the 

individual should become incapacitated 

and lose the ability to make or 

communicate medical decisions. 

Advance directives include written 

documents including living wills and 

durable powers of attorney for health 

care, as recognized by State law.

Congress passed section 4206 of the 

Omnibus Budget Reconciliation Act of 

1990 (OBRA 1990) (Pub. L. 101–508) to 

ensure that patients receive information 

regarding their right to execute or not to 

execute advance directives. While the 

OBRA 1990 requires hospitals, skilled 

nursing facilities, HHAs, managed care 

plans, and hospice programs 

participating in the Medicare program to 

establish and maintain written policies 

and procedures regarding advance 

directives, it does not specifically 

mention dialysis facilities. 

In proposing to add advance 

directives to the patients’ rights 

condition for coverage we took several 

factors into consideration. First is the 

chronic nature of ESRD. Kidney 

impairment is irreversible and 

permanent, and a regular course of 

dialysis or transplantation is essential to 

maintain life. In addition, we 

considered the amount of time a patient 

spends in the dialysis unit, and also the 

rapidly changing demographics of the 

ESRD patient population. The average 

age of the ESRD patient population is 

increasing annually. Elderly ESRD 

patients now comprise a large 

percentage of the total ESRD patient 

population. Data compiled by the 

United States Renal Data System, from 

1990 to 2001, shows the following rate 

of new cases of ESRD for patients 65 

years of age and older:

Age

(in years) 

Year 

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 

65–69 ............................... 7,177 7,982 8,597 8,895 9,852 9,643 10,390 10,829 11,078 11,225 11,415 11,545 

70–74 ............................... 6,159 7,260 8,093 8,533 9,664 9,678 10,753 11,248 11,648 12,005 12,276 12,367 

75–79 ............................... 4,587 5,367 5,997 6,293 7,243 7,404 8,481 9,339 10,133 11,170 11,407 11,408 

80–84 ............................... 2,386 2,754 3,228 3,427 4,051 4,290 4,959 5,725 6,125 6,785 7,349 7,477 

85+ ................................... 961 1,113 1,277 1,481 1,659 1,833 2,248 2,598 3,110 3,587 3,870 4,146 

The emergence of an older, sicker 

ESRD patient population has motivated 

the Renal Physicians Association (RPA) 

and the NKF to develop guidelines for 

implementation of advance directives in 

dialysis facilities, and we are 

encouraging dialysis facilities to adopt 

voluntary consensus guidelines for 

advance directives. The guidelines can 

be obtained through the NKF’s Web site 

at: http://www.kidneyva.org/public_ed/

orderforms.pdf and through the RPA 

6202 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

Web site at http://www.renalmd.org/

publications/index.cfm.

After taking these factors into 

account, we believe it is prudent to 

consider adding advance directives as a 

requirement in the patients’ rights 

condition of this proposed rule. 

Existing § 405.2138(a)(5) requires that 

patients be informed of their suitability 

for transplantation or home dialysis. We 

have strengthened this requirement at 

§ 494.70(a)(6) by proposing that patients 

be informed about alternative treatment 

modalities by requiring dialysis 

facilities to address all treatment 

choices. The treatment modality 

selected may directly affect the quality 

of life for dialysis patients. This choice 

is a very personal one, with important 

implications for how likely the patient 

is to be rehabilitated to the highest 

possible level. To assist dialysis patients 

in achieving the optimal quality of life, 

patients need education about each 

modality and must have access to the 

widest array of treatment choices 

possible. 

For example, a successful kidney 

transplant is the most desirable 

treatment for many ESRD patients and 

facilities should make every effort to 

both educate and inform patients 

regarding the transplantation option. 

Also, forms of dialysis that can be 

performed at home have been shown to 

have a positive influence on the 

patient’s quality of life. Home dialysis 

affords patients’ control over scheduling 

and setting, and it can be done in 

comfortable, familiar surroundings. 

Also, home dialysis is generally 

perceived to be less disruptive to family 

life and employment. We propose to 

require that a facility inform patients 

about all available treatment modalities 

and settings, so patients can make an 

informed decision regarding the most 

appropriate course of treatment that 

meets their needs. 

Open communication between the 

facility staff and the patient and patient 

access to treatment information are vital 

tools for enhancing the patient’s 

participation in his or her coordinated 

care planning. Proposed § 494.70(a)(7) 

requires that patients be informed of the 

facility’s patient care policies, including 

its patient isolation policies. 

Proposed §§ 494.70(a)(8) through (10) 

retain existing requirements in 

§ 405.2138(a)(2) through (4) that patients 

be fully informed regarding the facility’s 

reuse of dialysis supplies, including 

hemodialyzers; be informed by a 

physician regarding his or her own 

medical condition unless 

contraindicated; and be informed of 

services available in the facility and 

charges not covered by Medicare. 

Proposed § 494.70(a)(11) would 

require that patients be informed of the 

right to receive the necessary services 

outlined in the patient plan of care in 

proposed § 494.90. The importance of 

the patient plan of care is discussed in 

section V.C. of this preamble. 

Proposed § 494.70(a)(12) would retain 

the existing requirement at 

§ 405.2138(a)(1) that patients be 

informed of the rules and expectations 

of the facility regarding patient conduct 

and responsibilities. The success of the 

dialysis treatment is as contingent upon 

patients adhering to their 

responsibilities as it is upon other 

important factors. There is a discussion 

of the dialysis facility’s responsibility 

regarding disruptive and difficult 

patients in section VI.E.9. of this 

preamble. 

Proposed § 494.70(a)(13) would 

require facilities to inform patients 

regarding the facility’s internal 

grievance process and their right to 

express grievances against the facility 

using the internal grievance process 

through a representative chosen by the 

patient (if so desired). 

Proposed § 494.70(a)(14) strengthens 

the existing requirement for facilities to 

inform patients regarding the various 

external grievance mechanisms 

available to them, including how to 

contact the ESRD network and the State 

survey agency, and how to file external 

grievances without reprisal or denial of 

services, through a representative 

chosen by the patient or anonymously 

(if so desired). We believe that patients 

must be made aware of every grievance 

option available to them, including, at a 

minimum, contacting the two entities 

with the statutory responsibility under 

Federal law for addressing patient 

grievances (that is, the ESRD networks 

and the State survey agencies). 

In proposed §§ 494.70(b)(1) and (2), 

we would require a facility to inform 

patients regarding its transfer and 

discharge policies and provide 30 days 

notice in advance of reducing or 

terminating patient care services 

following the discharge and transfer 

procedure outlined in § 494.180(f). The 

facility would be exempt from the 30-

day notification requirement in cases 

when there was an immediate threat to 

the health and safety of others. Proposed 

§§ 494.70(b)(1) and (b)(2) and the 

procedure outlined at § 494.180(f) have 

been proposed, in part, in response to 

the ‘‘disruptive’’ or ‘‘challenging’’

patient issue. Increasing numbers of 

staff and patient grievances presented to 

the ESRD networks and the State survey 

agencies involve allegations of 

disruptive behavior by patients and 

allegations of inappropriate patient 

discharges from facilities for 

noncompliance or disruptive behavior. 

We would not expect a patient to be 

involuntarily discharged from a dialysis 

facility for failure to follow the 

instructions of a facility staff member. 

However, it may be necessary to 

discharge a disruptive patient in order 

to protect the rights and safety of other 

patients in the facility, or to protect the 

safety of facility staff.

We believe that a dialysis facility has 

both the resources and a responsibility 

to make a good faith effort to work with 

every patient, including patients 

perceived to be disruptive or 

challenging, to provide the necessary 

assessment, training, knowledge, and 

motivation to facilitate good outcomes 

of care. This process begins when the 

facility interdisciplinary team performs 

the comprehensive patient assessment 

described in proposed § 494.80, with 

periodic reassessments as needed; 

continues through the care planning 

process described in proposed § 494.90; 

as well as the facility’s quality 

assessment and performance 

improvement (QAPI) program described 

in proposed § 494.110. We believe the 

disruptive or challenging patient 

problem is multifaceted, and even 

conscientious assessments, care 

planning, and QAPI programs by a 

facility will not always be successful in 

mitigating the disruptive behavior of 

some patients. In those instances when 

good faith efforts by a facility have been 

unsuccessful and the facility has 

determined that it wants to discharge or 

transfer the patient, facilities must 

follow the procedure outlined in 

proposed § 494.180(f), and arrange to 

transfer or discharge the patient, as 

appropriate. 

We also recognize there will be rare 

instances when a facility must act 

immediately to discharge a patient. 

Such instances could be, for example, 

when a patient physically harms or 

threatens other patients and staff, a 

patient who brings weapons or illegal 

drugs into a facility, or a patient who is 

verbally abusive and disruptive to such 

an extreme degree that the facility is 

unable to operate effectively. In those 

and comparable circumstances, we 

would propose to shorten the 30-day 

notification requirement. We are 

soliciting comments on the proposed 

§§ 494.70(b)(1) and (b)(2), as well as 

suggestions for addressing the 

disruptive or challenging patient issue 

in the proposed ESRD conditions. 

If a patient chooses not to use a 

facility’s internal grievance process, or 

when grievances cannot be resolved at 

the facility level, the patient may elect 

to register a grievance with the 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6203

appropriate ESRD network or make a 

complaint directly to the State survey 

agency at any time. We believe it is 

essential that we require that patients be 

informed of every grievance and 

complaint option currently available to 

them under the law. 

Proposed § 494.70(c) would require 

dialysis facilities to prominently display 

a copy of the patients’ rights as well as 

the telephone numbers for the 

appropriate ESRD network and State 

survey agency in order to afford patients 

the opportunity to contact either entity, 

if desired. Dialysis patients have the 

right to be advised of and to use 

grievance processes developed by the 

facility, the ESRD network and the State 

survey agency. 

B. Patient Assessment (Proposed 

§ 494.80) 

The proposed patient assessment 

condition at § 494.80 underscores our 

belief that systematic patient assessment 

is essential to improving quality of care 

and patient outcomes. The information 

generated from the patient assessment is 

a vital tool for developing a patient’s 

care plan and subsequent treatment. A 

comprehensive patient assessment 

allows the dialysis facility to monitor 

the patient’s progress toward achieving 

the desired care outcomes and adjust 

the plan of care and treatment 

prescription as necessary. 

The existing regulations in part 405 

subpart U do not state that a patient will 

receive a comprehensive assessment. 

However, two sections of the existing 

regulations, §§ 405.2136(g)(1) and 

405.2137(b)(1), provide a basis for a 

patient assessment. For example, 

§ 405.2136(g)(1) holds the patient’s 

physician responsible to prescribe a 

planned regimen of care, ‘‘which covers 

indicated dialysis and other ESRD 

treatments, services, medications, diet, 

special procedures recommended for 

the health and safety of the patient, and 

plans for continuing care and 

discharge.’’ That section also states that 

such plans are made with the input of 

the professional personnel providing 

care to the patient. Existing 

§ 405.2137(b)(1) states that a patient care 

plan ‘‘reflects the psychological, social, 

and functional needs of the patient,’’

and indicates ESRD and other care 

needed to achieve the long- and shortterm treatment goals. 

Therefore, while the existing 

regulations indicate that a specialized 

care plan must be developed based 

upon the nature of the patient’s illness, 

the treatment prescribed, and an 

assessment of the patient’s needs, it 

does not specify the criteria that a 

facility must include in a patient 

assessment. Over the past 25 years, 

research has improved our knowledge of 

the components important to assessing 

and treating the dialysis patient so that 

improvements in quality of life and 

morbidity and mortality rates have been 

achieved. 

We believe that a comprehensive 

patient assessment that includes clinical 

interaction with the patient is a 

prerequisite for the delivery of quality 

care and is the basis for determining a 

patient’s functional status and 

identifying the services necessary to 

address the patient’s needs. Accurate 

and accessible patient information 

generated from the comprehensive 

assessment is critical to the 

development of a successful patient care 

plan and the achievement of desired 

patient outcomes. 

We do not believe that expanding the 

existing requirements in this proposed 

condition will impose any additional 

burden on facilities. Rather, we believe 

quality-oriented facilities already 

routinely perform comprehensive 

patient assessments upon initiating 

treatment. Further, we believe most 

facilities already have this information 

in different parts of the medical record 

since an appropriate and effective 

treatment plan cannot be developed 

without an initial assessment. 

We are proposing at § 494.80 to add 

a patient assessment condition for 

coverage that would make the ESRD 

facility, through the patient’s 

interdisciplinary team, responsible for 

providing each of its patients with an 

individualized and comprehensive 

assessment of his or her needs. The 

members of the interdisciplinary team 

(see proposed § 494.10) would include 

the patient (if he or she chooses), a 

registered nurse, a physician, a social 

worker, and a registered dietitian. With 

the team concept, the goal is to obtain 

input from each designated health 

professional as well as from the patient 

to develop an assessment that identifies 

the patient’s needs and allows for 

planning for necessary services. The 

proposed team members represent vital 

components of the patient’s medical 

treatment and psychosocial 

development. These professionals are 

also key to a successful transition to 

dialysis as well as to maintaining the 

patient’s quality of life. An assessment 

that involves the patient as a key 

member of the interdisciplinary team is 

important to the successful delivery of 

service and the patient’s adherence to 

the program. 

In proposed § 494.80(a), we list the 

assessment criteria. The minimum 

proposed elements of a patient’s 

assessment include the following:

• Evaluation of current health status, 

including comorbid conditions and 

medical condition. 

• Evaluation of the appropriateness of 

the dialysis prescription, blood pressure 

control, and fluid management needs. 

• Laboratory profile and medication 

history. 

• Evaluation of factors associated 

with anemia, such as hematocrit, 

hemoglobin, iron stores, and potential 

treatment plans for anemia, including 

administration of recombinant 

erythropoietin. 

• Evaluation of factors associated 

with renal bone disease. 

• Evaluation of nutritional status. 

• Evaluation of psychosocial needs. 

• Evaluation of dialysis access type 

and maintenance. 

• Evaluation of the patient’s ability, 

interests, preferences, and goals, 

including level of participation in the 

dialysis care process; modality and 

setting (for example, home dialysis, 

including home hemodialysis or 

peritoneal dialysis); and expectations 

for care outcomes. 

• Evaluation of suitability for 

transplantation referral, based on 

criteria developed by the transplant 

surgeon at the transplant center that 

would receive such transplantation 

referral including the basis for referral 

or nonreferral. 

• Evaluation of family and other 

support systems. 

• Evaluation of current physical 

activity level. 

• Evaluation of vocational and 

physical rehabilitation status and 

potential. 

Other information to be included in 

the initial assessment would be 

determined by the interdisciplinary 

team based on the specific 

characteristics and needs of the patient. 

We recognize that inclusion of a 

minimum set of assessment criteria may 

appear to be inconsistent with our goal 

of eliminating unnecessarily 

prescriptive and process-oriented 

requirements. However, we believe it is 

appropriate and necessary for every 

patient assessment to focus not only on 

the patient’s medical needs, but also on 

his or her psychosocial and 

rehabilitation needs. Further, these 

assessment criteria would assure that 

needed information would be available 

for the patient plan of care and the 

facility’s quality assurance and 

performance improvement program. 

We propose criteria for the frequency 

of assessment and reassessment of new 

patients in §§ 494.80(b)(1) and (2). A 

timely, comprehensive assessment is 

critical for planning patient care and 

achieving desired patient outcomes. We 

6204 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

believe this requirement, though 

process-oriented, is necessary to prevent 

harm to the patient. By permitting 

facilities 20 calendar days to complete 

assessments, we are providing a 

reasonable timeframe for every member 

of the team to assess the patient prior to 

development of the treatment plan. 

We also recognize that patients who 

are new to dialysis need time to adjust 

and adapt to the treatment. Initially, 

patients may experience a great deal of 

anxiety while learning self-care skills, 

modifying their diet, changing their 

behavior, and perhaps dealing with 

access issues. The level of compliance 

with the renal regimen may be set by the 

time the person has been on dialysis for 

4 to 6 months (Sciarini, pp. 299–305). 

Because of this period of adjustment, 

and the opportunity to establish the 

patient’s adherence to the renal 

regimen, proposed § 494.80(b)(2) would 

require a follow-up comprehensive 

reassessment for new patients within 3 

months after the completion of the 

initial comprehensive assessment. Three 

months was chosen so that the window 

of opportunity for establishing 

adherence to the renal regimen by a new 

patient is not missed. We recognize the 

additional burden this 3-month 

reassessment will place on the 

interdisciplinary team. However, an 

updated plan of care and the attention 

to the patient’s adjustment to the renal 

regimen may prevent problems in the 

coming months. The reassessment also 

ensures the continued accuracy and 

effectiveness of the treatment regimen. 

Existing § 405.2136(g) states that the 

physician responsible for the patient’s 

medical supervision evaluates the 

patient’s needs and prescribes a planned 

regimen of care for dialysis. Sections 

494.80(c)(1) and (2) propose a schedule 

for the assessment of the treatment 

prescription for hemodialysis and 

peritoneal dialysis patients. Studies 

indicate that ESRD patient mortality is 

lower when patients receive sufficient 

dialysis treatments. There has been 

considerable research recently 

indicating that the dose of dialysis is an 

important determinant of survival and 

morbidity of patients on hemodialysis 

((Held, pp.871–875); (Owen, pp.1001–

1006); (Parker, pp.981–989); and 

(Parker, pp.670–680)). The delivered 

dose of dialysis (Kt/V or an equivalent 

measure) indicates how well the 

dialysis treatment is working. Kt/V is 

the dialyzer clearance of urea (K) times 

the time of treatment (t), divided by the 

volume of distribution of urea (V), 

which yields a dimensionless value. 

Adequacy of dialysis clinical practice 

guidelines are available in the National 

Kidney Foundation’s Kidney Disease 

Quality Initiative (NKF–K/DOQI). As 

previously discussed in this preamble, 

the NKF–K/DOQI has established 

clinical practice guidelines for ESRD 

patients. This systematic, evidencebased approach to developing 

guidelines used focus workgroups to 

identify target issues and conducted 

extensive literature searches to extract 

relevant clinical study reports for each 

target issue. Clinical practice guidelines 

were derived from this information. The 

guidelines are available for public 

review and comment, and they continue 

to be reviewed. Health care 

professionals and providers, ESRD 

networks, managed care groups, 

industry, government, patient 

associations and individuals are invited 

to provide comments to the NKF–K/

DOQI workgroups. These comments are 

reviewed and when appropriate, 

incorporated in future editions. 

An important initiative of this project 

is the development of guidelines for the 

dose of dialysis, including standard 

methodology(ies) for measuring the 

dialysis dosage. 

To ensure that ESRD patients receive 

sufficient dialysis, the delivered dose of 

dialysis needs to be measured. 

Therefore, in keeping with the NKF’s K/

DOQI clinical practice guidelines, we 

propose in § 494.80(c) to specify that the 

delivered dose of dialysis for the 

patient’s hemodialysis treatment 

prescription must be measured at least 

monthly, and the patient’s peritoneal 

dialysis treatment prescription should 

be assessed at least every 4 months. 

More frequent monitoring may be 

necessary for new dialysis patients or 

when the dialysis prescription is 

changed. Less frequent monitoring of 

the adequacy of dialysis may 

compromise the timeliness with which 

deficiencies in the delivered dose of 

dialysis are identified and hence may 

delay implementation of corrective 

action.

In §§ 494.80(d)(1) and (2) we propose 

patient reassessment timeframes for 

both stable and unstable patients with 

respect to the standards specified in 

§§ 494.80(a)(1) through (a)(13). The 

comprehensive assessment process can 

be seen as part of a cycle. Through the 

use of the patient assessment, accurate 

and timely patient information is 

reflected in the plan of care. As the 

assessment changes, the plan of care 

must be revised accordingly. If the 

patient’s condition is stable, we propose 

in § 494.80(d)(1) that the facility must 

perform comprehensive reassessments 

at least annually, which assures that 

patients are receiving a continuing 

program of care that meets their needs. 

This proposed timeframe minimizes the 

facility burden because the existing 

§ 405.2137(b)(4) requires care plan 

review every 6 months for stable 

patients. If the patient is unstable, we 

are proposing in § 494.80(d)(2) to 

require a monthly reassessment, to 

allow for the update of the plan of care. 

Existing § 405.2137(b)(4) also requires a 

monthly review of the care plan for 

patients whose medical condition has 

not become stabilized. In proposed 

§§ 494.80 (d)(2)(i) through (d)(2)(iv), we 

added criteria to specify at a minimum, 

which patients may be considered to be 

unstable patients. These criteria include 

extended or frequent hospitalizations, 

marked deterioration in health status, a 

significant change in psychosocial 

needs, or poor nutritional status, with 

unmanaged anemia and inadequate 

dialysis. Extremely frail patients may 

need monthly reassessments. However, 

we are not proposing a specific 

requirement for monthly reassessments 

for frail patients because we believe this 

type of requirement would be too 

prescriptive and limit the flexibility of 

dialysis facilities to make clinical 

determinations on a case-by-case basis. 

The renal community has been unable 

to reach a consensus regarding the 

optimum frequency of assessments. 

Some believe that the proposed time 

periods create a strain on facilities, 

while others have encouraged us to 

propose more stringent timeframes. 

Because of the wide range of opinion in 

this matter, we are specifically soliciting 

public comments on whether the 

proposed 3-month timeframe for 

reassessment of new patients is 

reasonable and consistent with meeting 

the patient’s needs. 

C. Patient Plan of Care (Proposed 

§ 494.90) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Plan of Care’’ at the beginning of your 

comments.] 

The patient assessment serves as the 

basis for the patient plan of care. 

Existing § 405.2137 contains a large 

number of prescriptive requirements for 

the development of patient care plans. 

These requirements specify that there 

needs to be a patient long-term program 

and a patient care plan. 

The patient long-term program 

described in existing §§ 405.2137(a)(1) 

through (a)(4) relates to the selection of 

a suitable treatment modality and 

treatment setting by the treatment team. 

It also requires active participation by 

the physician director in the unit where 

the patient is being treated, a formal 

review of the written long-term plan by 

the team every 12 months, patient 

involvement in the plan’s development, 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6205

and a requirement to send the plan to 

the receiving facility within 1 day of an 

interfacility transfer. 

The patient care plan in existing 

§ 405.2137(b) requires a written care 

plan based on the nature of the patient’s 

illness, the treatment prescribed, and an 

assessment of the patient’s needs. 

Additional requirements in existing 

§§ 405.2137(b)(1) through (b)(7) include 

a personalized care plan reflecting the 

patient’s needs, a care plan developed 

by a professional team (including the 

physician responsible for the patient’s 

care), the involvement of the patient (or 

the patient’s parent or legal guardian), a 

monthly review for unstable patients, a 

6 month review for stable patients, 

sending the plan to the receiving facility 

within one day for interfacility transfers, 

periodic monitoring of home dialysis 

patients, and monitoring for home 

dialysis patients who use 

erythropoietin. 

In accordance with our goal of 

reducing Federal regulatory burden, we 

have simplified the proposed patient 

care plan condition (§ 494.90) by 

eliminating the separate requirement for 

a patient long-term program. 

We propose to retain some of the 

existing requirements of § 405.2137 in 

the patient assessment condition 

(proposed § 494.80). We believe that the 

patient assessment and patient care 

planning processes are inextricably 

linked. That is, each patient assessment 

must be followed with a review and 

revision, if necessary, of the patient’s 

plan of care. 

The comprehensive plan of care is an 

individualized program that ensures 

that each dialysis patient receives 

personalized and appropriate patient 

care within the selected modality and 

setting of treatment. In proposed 

§ 494.90 we would specify that the 

patient’s plan of care must include 

measurable and expected outcomes and 

estimated timetables to meet the 

patient’s medical and psychosocial 

needs as identified in the initial and 

subsequent comprehensive assessments. 

This section would also specify that the 

patient’s plan of care must address all 

the services that are to be furnished to 

achieve and maintain the expected 

outcomes of care. 

Existing §§ 405.2137(a)(1) and 

405.2137(b)(2) specify the composition 

of the professional team responsible for 

the preparation of the long-term and the 

patient care plans. The facility’s 

professional team currently writes a 

patient long-term program and a shortterm care plan. However, proposed 

§ 494.90 would require that a single 

patient plan of care be developed and 

this plan would address all of the 

patient’s needs. We are proposing in 

§ 494.90 to retain the existing 

requirement that the patient plan of care 

to be developed by the interdisciplinary 

team. Although we would retain the 

existing §§ 405.2137 (a)(1) and (2), we 

have chosen to use the term 

‘‘interdisciplinary team.’’ The term 

‘‘interdisciplinary team’’ is defined 

§ 494.10 and described in § 494.80. In 

§ 494.80, we are proposing that the 

interdisciplinary team consist of, at a 

minimum, the patient (if he or she 

desires) or his/her designee, a registered 

nurse, a nephrologist or physician 

treating the patient for ESRD, a social 

worker, and a dietitian. We are using the 

term ‘‘interdisciplinary team’’ instead of 

‘‘professional team’’ because the term 

‘‘interdisciplinary team’’ is commonly 

used in health care settings, including 

dialysis facilities. 

Although existing § 405.2137(a)(1) 

specifies a transplant surgeon as a 

member of the professional team, we 

did not include a transplant surgeon as 

a member of the interdisciplinary team 

as defined in proposed § 494.10 and 

described in proposed § 494.80. We 

believe all eligible ESRD patients must 

be referred for transplantation. 

However, it may not be reasonable to 

have transplant surgeons sign every care 

plan. The existing interpretive 

guidelines for surveyors (Survey 

Procedures and Interpretive Guidelines 

for End-Stage Renal Disease Facilities, 

Appendix H, State Operations Manual) 

allow a transplant surgeon’s designee, 

who could be a transplant coordinator 

or the treating nephrologist, to screen 

patients in the long-term care plan 

process (DHHS/CMS, April 1995). The 

designee would have to use screening 

criteria developed by the transplant 

surgeon. Because not every patient is 

medically suited for a transplant, we 

believe the transplant surgeon need not 

be involved with the team unless a 

possible candidate has been identified. 

We are proposing that the dialysis 

facility must have inclusion/exclusion 

criteria, defined by the transplant 

surgeon based at the transplant center 

that would receive the transplantation 

referral, to use in the evaluation of 

patients for transplant referral. 

Therefore, we propose to delete the 

requirement that a transplant surgeon 

directly sign the care plan. We believe 

transplant referral tracking must be part 

of the comprehensive plan of care 

condition (see § 494.90(c)), and we have 

also proposed to strengthen this 

requirement in the patient assessment 

(§ 494.80) and patient’s rights (§ 494.70) 

conditions. We are soliciting comment 

on the appropriate role of the transplant 

surgeon in developing the patient plan 

of care. 

Existing § 405.2137(a)(1) also requires 

that the facility medical director and a 

physician from a facility that offers 

home dialysis (if the patient’s present 

facility does not) be included in the 

team that develops the patient’s longterm program. While we believe the 

involvement of these physicians would 

be valuable in most cases, we recognize 

that there are situations when the 

services of these physicians may not be 

needed. Thus, in keeping with our goal 

of eliminating unnecessary process 

requirements, proposed § 494.10 

specifies the definition of 

‘‘interdisciplinary team’’ without 

including the facility medical director 

and the home dialysis physician. 

Nonetheless, we encourage facilities to 

expand the interdisciplinary team to 

include as many health professionals as 

necessary to furnish the best care 

possible to their patients. 

As required in existing § 405.2137 and 

in proposed § 494.10, a physician is part 

of the interdisciplinary team. We 

propose retention of this requirement 

because we believe the physician must 

play an integral role on the 

interdisciplinary team. The physician 

responsible for the patient’s dialysis 

treatment works with the other team 

members to ensure the development of 

an appropriate care plan for the patient. 

We also expect the physician to see the 

patients and monitor their care.

Existing § 405.2137(b)(3) specifies that 

the patient may be involved in the 

development of the care plan and 

consideration is given to the patient’s 

preferences. The patient’s right to be 

informed about and participate within 

the interdisciplinary team is 

encompassed in proposed § 494.70(a)(5). 

The patient or his/her designee, if he or 

she desires, as a member of the 

interdisciplinary team, must collaborate 

to design a plan of care that enables the 

patient to reach his or her desired level 

of general health, activity, and quality of 

care. When a patient communicates his 

or her goals regarding their medical 

treatment, he or she plays a more active 

role in improving their quality of life. 

We have eliminated the phrase ‘‘due 

consideration is given to [the patient’s] 

preferences’’ because we believe it 

implies the patient (or the patient’s 

designee) is not an equal member of the 

team. Each patient must be given the 

opportunity to participate with the 

interdisciplinary team. However, we 

would not require them to do so in the 

proposed requirements because we 

recognize that some patients may not 

wish to participate in the team process. 

We are proposing that the patient or 

6206 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

designee must sign the plan of care to 

assure the patient is aware of treatment 

plans and goals regardless of whether 

the patient has opted to participate in 

the care planning team process. 

The patient plan of care must include 

measurable and expected outcome 

targets or goals for each patient based on 

the individual patient’s assessment. 

These outcome targets must allow the 

patient to achieve current evidencebased community-accepted standards. 

Currently, the K/DOQI clinical practice 

guidelines are the community-accepted 

standards for individual patient care 

and we expect ESRD facilities to reflect 

the current standards of care for dialysis 

adequacy and anemia management in 

the patient plan of care. As additional 

evidence-based community-accepted 

standards become evident, they could 

be targeted in the patient plan of care as 

well. 

We propose that allowing the patient 

to achieve current evidence-based 

community-accepted standards for 

dialysis adequacy and anemia means (at 

§ 494.90(a)(1)), that the patient plan of 

care should specify a minimum 

delivered threshold for Kt/V of at least 

1.2 (single pool) for hemodialysis 

patients (NKF, Guideline 4); 1.7 

(weekly) for continuous ambulatory 

peritoneal dialysis (NKF, Guideline 15); 

2.1 (weekly) for continuous cycling 

peritoneal dialysis patients (NKF, 

Guideline 16); and 2.2 (quarterly) for 

intermittent peritoneal dialysis patients 

(NKF, Guideline 16). For anemia 

management (proposed § 494.90(a)(3)), 

the minimum specified threshold levels 

in the patient plan of care are: a 

hemoglobin level of 11 gm/dL or 

comparable hematocrit of at least 33 

percent (NKF, Guideline 4). 

There is significant correlation 

between achieving recommended NKFK/DOQI values for the adequacy of 

dialysis and anemia management 

measures with positive outcomes in 

mortality, hospitalization, and/or 

quality of life. Thus, the advantages of 

assigning patient-level minimum targets 

and thresholds is that we would 

establish a process when patients whose 

values do not meet the criteria are 

evaluated for possible further 

intervention so that they can achieve 

values that are associated with better 

outcomes. It is understood that 

guidelines and standards, although 

evidence-based, are not appropriate for 

all patients in all situations. Thus these 

minimum thresholds serve as indicators 

for potential quality improvement 

activity. 

We are proposing that outcomes 

specified in the patient plan of care 

must allow the patient to achieve 

current evidence-based communityaccepted standards. 

However, we are soliciting public 

comments on this issue, and we will be 

guided by those comments in reaching 

a final determination on whether to 

require minimum threshold values for 

the patient plan of care as we develop 

the final rule for new ESRD conditions 

for coverage. 

1. Development of the Patient Plan Of 

Care (Proposed § 494.90(a)) 

In developing this proposed rule, we 

determined that there is sufficient 

evidence to support the inclusion of 

minimum set of evaluative categories in 

the patient plan of care that have been 

shown by independent medical research 

to be important in achieving desirable 

patient outcomes. We are proposing (in 

§ 494.90) that the patient plan of care 

must, at a minimum, address: (1) Dose 

of dialysis; (2) nutritional status; (3) 

anemia; (4) vascular access; (5) 

transplantation status; and (6) 

rehabilitation status. Each of these 

elements is discussed below. 

a. Dose of Dialysis (Proposed 

§ 494.90(a)(1)) 

There is a consensus in the renal 

community that adequacy of dialysis in 

terms of a Kt/V is an important clinical 

performance measure and the vast 

majority of dialysis facilities do use 

minimal target levels or goal levels or 

both to ensure delivery of quality care. 

We are proposing in § 494.90(a)(1) that 

the patient’s interdisciplinary team 

assist and support the hemodialysis and 

peritoneal dialysis patient in achieving 

and maintaining an adequate dose of 

dialysis that meets evidence-based 

community-accepted standards as 

specified by the Secretary. We are 

soliciting comments on the possible use 

and appropriate minimum threshold 

values for the adequacy of dialysis.

b. Nutritional Status (Proposed 

§ 494.90(a)(2)) 

Existing § 405.2163(d) states that the 

dietitian, in consultation with the 

attending physician, is responsible for 

assessing the nutritional and dietetic 

needs of each patient, recommending 

therapeutic diets, counseling on 

prescribed diets, and monitoring 

adherence and response to diets. 

Our proposed requirement on 

nutrition at § 494.90(a)(2) would require 

the interdisciplinary team to provide the 

necessary care and services to achieve 

and sustain an effective nutritional 

status. Effective nutritional status 

encompasses acceptable levels of 

protein, calorie, and fluid intake as well 

as acceptable levels of nutrients in the 

blood. We did specify that one patient 

plan of care nutritional measure, the 

serum albumin (a marker of visceral 

protein stores), must be monitored on a 

monthly basis to reflect current 

standards of practice. 

The National Institutes of Health 

(NIH), in its Consensus Conference 

Report entitled ‘‘Morbidity and 

Mortality of Dialysis,’’ identified 

nutritional status as an important 

indication of the renal patient’s health 

(DHHS/NIH, pp.1–33). We recognize 

that nutrition plays an important role in 

the management of renal disease. 

However, we have found diverse 

opinions about using an objective 

measure as a clinical outcome measure 

for nutritional status. Potential clinical 

outcome measures of nutritional status 

include anthropometric measures, 

clinical signs of nutrient deficiency, 

urea kinetic modeling, prognostic 

nutrition indexing, and measurement of 

biochemical parameters. The NKF–K/

DOQI clinical practice guidelines for 

Nutrition of Chronic Renal Failure 

(Guideline 1) state that, ‘‘there is no 

single measure that provides a 

comprehensive indication of proteinenergy nutritional status.’’ (NKF, pp. 

S17.) NKF–K/DOQI guideline 3 further 

states that, ‘‘serum albumin is a valid 

and clinically useful measure of proteinenergy nutritional status in maintenance 

dialysis patients.’’ (NKF, pp. S20.) 

We invite comments on whether any 

additional specific nutritional outcome 

measures, such as other biochemical 

parameters of serum protein (total 

protein, transferrin, or prealbumin), or 

the protein catabolic rate or protein 

equivalent of total nitrogen appearance 

measure should be used as a patient 

plan of care outcome measure. 

c. Anemia (Proposed § 494.90(a)(3)) 

Proposed § 494.90(a)(3) uses anemia, 

as measured by the hematocrit (or 

comparable hemoglobin) level, as a 

specified patient outcome. There is a 

consensus in the community that the 

use of hemoglobin, hematocrit or both to 

monitor anemia management are 

important clinical performance 

measures and the vast majority of 

dialysis facilities do use minimal target 

levels or goal levels or both for these 

measures to manage anemia in the 

dialysis patient. In § 494.90(a)(3) we 

propose that the patient’s 

interdisciplinary team assist and 

support the hemodialysis and peritoneal 

dialysis patient in achieving and 

maintaining the expected hemoglobin/

hematocrit level. The hemoglobin or 

hematocrit level must be measured at 

least monthly, as is the current standard 

practice. We are soliciting comments on 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6207

the possible use and appropriate 

minimum threshold values for anemia 

management. 

Existing § 405.2163(g) address the 

patient’s hematocrit or comparable 

hemoglobin level as a marker for the 

necessity for administering 

erythropoietin at home. The assessment 

criteria include: (1) Preselection 

monitoring (lab values and blood 

pressure); (2) hematocrit or comparable 

hemoglobin level less than 30 percent or 

medical justification for a higher 

hematocrit or comparable hemoglobin 

level; (3) a target hematocrit or 

comparable hemoglobin range for a 

patient receiving erythropoietin of 30 to 

33 percent; and (4) the patient is under 

the care of a physician responsible for 

dialysis-related services. There are also 

additional process requirements. We are 

eliminating some of these process 

requirements and proposing that each 

patient be evaluated for anemia as 

specified in the patient assessment 

condition at § 494.80(a)(4). We are also 

proposing that any patient with a 

hematocrit of less than 33 percent or a 

hemoglobin of less than 11 gm/dL must 

be evaluated as a candidate for 

erythropoietin use. For home dialysis 

patients, we are proposing that the 

facility evaluate whether the patient can 

be trained to safely, aseptically and 

effectively administer erythropoietin, 

and store erythropoietin under 

refrigeration. The patient’s response to 

erythropoietin, including blood pressure 

levels and the patient’s utilization of 

iron stores, must be monitored on a 

routine basis. 

Section 1881(b)(1)(C) of the Act 

specifies that the patient selfadministering erythropoietin must be 

able to safely and effectively administer 

the drug in accordance with the 

applicable methods and standards 

established by the Secretary. Section 

1861(s)(2)(O) of the Act states that 

Medicare will pay for erythropoietin as 

‘‘medical and other services’’ if the 

patient self-administers the drug 

‘‘subject to methods and standards 

established by the Secretary by 

regulation for the safe and effective use 

of such drug. * * *’’ Section 

405.2163(g)(2) and (3) of the existing 

regulations specify the applicable 

methods as established by the Secretary. 

In keeping with our outcome-oriented 

focus, we are proposing to retain only 

those specific evaluation criteria that are 

clinically necessary and supported by 

the NKF–K/DOQI Clinical Practice 

Guidelines for Anemia of Chronic 

Kidney Disease, 2000 Update. Also, we 

are not proposing to retain all of the 

requirements in existing 

§ 405.2137(b)(7) relating to the plan 

providing for monitoring home use of 

erythropoietin. We believe these 

requirements are unduly prescriptive 

and may not reflect the most 

appropriate items to monitor for each 

individual patient. We want to provide 

flexibility to a facility to develop its 

own criteria to monitor all patients who 

are using erythropoietin. 

In § 494.90(a)(3) we are proposing to 

provide the facility with the flexibility 

to develop their own assessment and 

patient plan of care criteria for patients 

for whom the use of erythropoietin 

would be appropriate. In addition, we 

are proposing in § 494.90(a)(3) that a 

dialysis patient’s response, including 

blood pressure and utilization of iron 

stores, to erythropoietin must be 

monitored on a routine basis. The 

patient plan of care should ensure that 

the patient is trained and is competent 

to safely, aseptically, and effectively 

administer the drug; provide for 

monitoring and safe refrigerated storage 

for home use of erythropoietin; and 

target appropriate hematocrit or 

hemoglobin levels. 

d. Vascular Access (Proposed 

§ 494.90(a)(4)) 

Our existing regulations do not 

contain any specific requirements 

pertaining to hemodialysis vascular 

access. We note that the hemodialysis 

procedure is dependent on the 

availability of a patent vascular access. 

According to data from the United 

States Renal Data System access failure 

is the second most frequent cause of 

hospitalization among ESRD patients. 

Access failure is also one of the 

significant contributors to hemodialysis 

patient morbidity. The costs of vascular 

access failure are also significant. In 

1999 the total Medicare ESRD program 

expenditure for vascular graft failure 

was more than $97 million. Dialysis 

facilities may not have complete control 

over the type and placement of the 

access. However, it has been 

demonstrated that efforts to improve 

access patency can help to extend the 

life of an access. The NKF–K/DOQI 

provides vascular access clinical 

practice guidelines that address the 

importance of access monitoring and 

methods for improving the quality of 

patient care in this area (NKF, pp. S137–

S181). 

Therefore, we are proposing in 

§ 494.90(a)(4) to include vascular access 

as a component of the patient plan of 

care with the following requirements for 

the interdisciplinary team: 

• Evaluation of the hemodialysis 

patient for the appropriate vascular 

access type, taking into consideration 

co-morbid conditions and other risk 

factors. 

• Support and assist the patient in 

achieving and maintaining vascular 

access patency. 

• Routinely monitor the hemodialysis 

patient’s vascular access to prevent 

access failure, including routine 

monitoring of artiovenous grafts and 

fistulae for stenosis. 

e. Transplantation Status (Proposed 

§ 494.90(a)(5)) 

Although we are proposing to remove 

the existing requirements for a separate 

long-term program from the conditions 

(see § 405.2137), we are proposing in 

§ 494.90(a)(5) to retain the concept of 

transplant planning. Within the plan of 

care, the interdisciplinary team must 

address whether the patient is a 

transplant candidate and identify the 

plan for obtaining a transplant. The plan 

and the actions necessary to make the 

transplant a reality must be addressed in 

the plan of care. Necessary actions 

would include, for example, patient 

transplant referral for evaluation by a 

transplant center, communication with 

the transplant center, and monthly 

blood draws for antigen/antibody 

testing. We are soliciting public 

comment on whether the ‘‘necessary 

actions’’ listed above should be a 

requirement for dialysis facilities.

When the patient is not suitable for 

transplantation referral evaluation, the 

reason for nonreferral must be written in 

the patient’s assessment and notated in 

the patient plan of care. The reason(s) 

for nonreferral must be consistent with 

the criteria developed by the 

prospective transplantation center and 

surgeon. In cases when the patient 

meets the transplantation criteria but 

declines referral, there must be 

documentation in the patient plan of 

care that the patient has made an 

informed decision to decline renal 

transplantation. 

f. Rehabilitation Status (Proposed 

§ 494.90(a)(6)) 

Existing § 405.2163 includes 

rehabilitation-related activities under 

the minimal service requirements for 

social services. Advances in technology 

and pharmacology have offered the 

possibility of significant improvements 

in the well-being of dialysis patients. 

More efficient dialysis equipment, the 

development of the synthetic hormone 

erythropoietin and active vitamin D, for 

example, represent important 

breakthroughs in quality-of-life areas. 

However, despite this improved 

potential for restoration, it is generally 

acknowledged that renal rehabilitation 

has not yet been addressed nationally in 

6208 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

a consistent, integrated fashion. 

Therefore, we are proposing to focus on 

rehabilitation outcomes through this 

requirement. 

For dialysis patients, rehabilitation 

means restoring the mind and body to 

encourage the individual to maintain as 

full and active a life as possible. The 

Life Options Rehabilitation Advisory 

Council has defined the ideal process of 

rehabilitation for a dialysis patient as a 

coordinated program of adequate 

dialysis, education, counseling, and 

dietary regimens designed to maximize 

the vocational potential, functional 

status, and quality of life of dialysis 

patients (The Life Options 

Rehabilitation Advisory Council, p. 20). 

The ultimate goals of renal 

rehabilitation include employment for 

those who can work, enhanced physical 

fitness, increased individual control 

over the effects of kidney disease and 

dialysis, and the ability to maintain as 

active a lifestyle as possible. Many renal 

professionals equate successful renal 

rehabilitation with employment, in part 

because employment can be readily 

measured and documented, but factors 

other than employment must be 

examined in a complete discussion of 

rehabilitation or functional status of 

dialysis patients. 

Comprehensive rehabilitation efforts 

can make the difference between an 

acceptable quality of life and mere 

existence. The improved overall health 

and outlook of successfully rehabilitated 

patients may have positive cost 

implications as well (Stewart, pp. 907–

913). Patients who are rehabilitated to 

the point of employment may be able to 

offset Medicare costs, subject to Part 

411, Subpart F, of our rules, if they have 

health insurance through their 

employment that would cover the costs 

of ESRD treatment in place of Medicare. 

Patients whose physical health 

improves to the point when they can 

manage self-care activities may allow an 

adult caregiver to re-enter the 

workforce. Even patients who cannot 

care for themselves, but whose outlook 

and quality of life are improved, can 

experience positive health 

consequences that reduce costs; thus 

keeping patients at home rather than in 

nursing homes decreases the costs of 

care as well. And costs notwithstanding, 

the achievement of these improvements 

in the patient’s condition is inherently 

invaluable. (The Life Options 

Rehabilitation Advisory Council, p. 20). 

Rehabilitation cannot be ‘‘done to’’

the patient. Active patient participation 

in rehabilitation is key to the success of 

any rehabilitation effort. Facility staff 

must inform and educate patients that 

their participation in rehabilitation 

programs is critical to their well being, 

ongoing treatment, and attainment of a 

successful adjustment to their 

condition. The patient’s responsibility 

to participate in rehabilitation efforts is 

no less essential than her or his 

compliance with any aspect of the 

management of her or his care. 

In this proposed rule, we are 

separating the rehabilitation 

requirements (proposed § 494.90(a)(6)) 

into a distinct plan of care category, and 

we are implicitly extending the 

definition of rehabilitation to include 

education. We have chosen to include 

rehabilitation as a specific category 

because we want the interdisciplinary 

team to focus on providing patients with 

the opportunity and the education for 

rehabilitation. In addition, staff attitudes 

about rehabilitation may have a 

correlation to patients’ own attitudes 

about their potential to regain functional 

status. 

It is not sufficient for facility staff to 

merely provide information about 

rehabilitation to patients. Rather, the 

essential role of rehabilitation in the 

treatment and recovery process must be 

continuously conveyed to patients and 

their families. To that end, the proposed 

requirement for rehabilitation status 

requires that the interdisciplinary team 

play a critical role in supporting the 

patient and advising the patient on his 

or her rehabilitative efforts. Specifically, 

the interdisciplinary team must provide 

the necessary care and services for the 

patient to achieve and maintain an 

appropriate level of productive activity, 

including vocational, that permits the 

patient to resume, to the extent feasible, 

activities engaged in prior to kidney 

failure. As part of this requirement, 

rehabilitation should be included in the 

patient’s treatment prescription; the 

patient’s involvement in rehabilitation 

activities should be incorporated in 

patient education materials; and facility 

patient support groups focusing on 

rehabilitation activities could be offered. 

Under this condition, facility staff 

should encourage and educate patients 

on the benefits of rehabilitation. The 

importance of rehabilitation as part of 

the treatment and recovery process must 

be conveyed, so patients come to 

recognize it as a benefit to themselves. 

The team must reinforce activities that 

lead to successful rehabilitation. The 

interdisciplinary team must provide 

care and services to younger patients to 

enhance the possibility of a successful 

transition to adult life and 

responsibilities. Although rehabilitation 

services may not be needed by pediatric 

patients, there may be educational 

needs and developmental needs that the 

interdisciplinary team must consider 

when writing and implementing the 

patient plan of care. 

This proposed condition does not 

hold facilities accountable for 

rehabilitative outcomes that are beyond 

their control; instead, this proposed 

standard requires that interdisciplinary 

team staff use a combination of medical 

treatment, education, counseling, and 

dietary regimens to maximize dialysis 

patients’ rehabilitation activity. Patients 

may be able to lead more active and 

productive lives if other rehabilitation 

interventions such as physical, 

occupational, and recreational therapy, 

counseling, and education are made 

available to them on a regular basis. 

Joint goal-setting by informed patients 

and the facility staff assists this process. 

We believe the interdisciplinary team 

should refer patients to appropriate 

agencies and health professionals for 

additional services that the facility 

cannot provide.

This proposed rule does not 

incorporate the use of any particular 

measure of rehabilitation status because 

we do not believe there is consensus in 

the renal community about a specific 

measurement at this time. 

g. Social Services 

We would like to specify social 

service outcomes that must be included 

in the patient plan of care. However, we 

believe the social worker should 

identify social service outcomes based 

on the patient assessment (described at 

§ 494.80(a)) as part of the plan of care 

goals for each patient. 

Complex emotional and social factors 

affect the dialysis patient, including, but 

not limited to, changes in self-image, 

loss of independence, changes in 

financial security, loss of physical 

integrity, problems with sexual 

functioning, changes in roles, and 

coping with the anxiety and discomfort 

associated with treatment. We believe 

that the interdisciplinary team could 

influence many of these factors. We are 

soliciting comment regarding the most 

effective way to address these factors 

within a patient plan of care 

requirement that supports an effective 

level of emotional and social well-being 

for the patient. 

Work is being done on a variety of 

assessment instruments that could 

measure the emotional and social wellbeing of patients. We considered the 

current experiences with such 

instruments as the Kidney Dialysis 

Quality of Life instrument, the RAND 

Short Form-36, and the Duke Health 

Profile ((Hays, pp. 329–338); (Rand 

Corporation, (1997)); and (Parkerson, 

pp. 1056–1069), respectively). However, 

at this time we do not believe that there 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6209

is a consensus on a single instrument or 

a level of psychosocial achievement for 

dialysis patients that could be included 

as a specific measure for a patient plan 

of care requirement. 

As specified in existing § 405.2163(c), 

the social worker is responsible for 

counseling the patient and the patient’s 

family, assisting the patient with the 

emotional adjustment to ESRD and 

dialysis treatment, performing crisis 

intervention, coordinating referrals and 

other community services, and 

arranging other benefits. Social workers 

can, in some instances, provide some of 

the necessary care and services for the 

patient to achieve and sustain an 

effective level of emotional and social 

well-being. For example, a necessary 

care and services component of social 

services is facility staff counseling and 

educating the patient and providing 

necessary information for the patient to 

have a smooth transition to life on 

dialysis. The social worker has an 

important role in addressing patient 

behavior that may be challenging or 

disruptive. The social worker is 

uniquely qualified to provide 

counseling, anger management, and 

emotional support services to patients 

with ESRD. In cases in which the social 

worker is not able to provide the 

necessary services for the patient to 

adapt to dialysis treatment, the social 

worker should refer patients to 

appropriate agencies and health 

professionals for additional services. We 

are soliciting comments regarding the 

potential for an outcome-based 

requirement for social services in the 

patient plan of care. 

2. Implementation of the Patient Plan of 

Care (Proposed § 494.90(b)) 

The patient plan of care stems from 

the patient comprehensive assessment 

that identifies patient care needs. 

Proposed § 494.90(b)(1) would require 

that the patient’s plan of care be 

completed by the interdisciplinary 

team, signed by the patient or the 

patient’s designee, and implementation 

must begin within 10 calendar days 

after an assessment is completed. As 

stated in the patient assessment 

condition, the facility interdisciplinary 

team has 20 days from the initiation of 

dialysis treatment to complete the 

comprehensive assessment. After the 

assessment has been completed, the 

interdisciplinary team has 10 days to 

develop the patient’s plan of care. This 

gives the dialysis facility a maximum of 

30 days to complete the comprehensive 

assessment and the patient plan of care. 

We selected 10 days for completion of 

the patient care plan because the plan 

directs the patient’s treatment, and 

therefore, the plan of care should be 

initiated as soon as possible. Clearly, we 

are limiting a facility’s flexibility when 

we identify a timeframe for 

development of the plan of care. 

However, we believe that a timely, 

accurate, comprehensive plan of care is 

critical for planning patient care and 

achieving desired health care outcomes. 

We believe that a maximum of 30 days 

to complete the assessment and patient 

plan of care is ample time, considering 

the seriousness of the condition that 

necessitates the dialysis. We are 

soliciting comments on both the 

appropriateness of prescribing a 

timeframe as well as the suitability of 

the proposed timeframe. 

We propose at § 494.80(d) that 

patients be reassessed as needed but no 

less frequently than annually. The 

patient plan of care would also be 

reviewed at least annually since we are 

proposing that every comprehensive 

assessment must be followed by 

completion and implementation of the 

plan of care. Existing § 405.2137(b)(4) 

states that care planning is conducted 

monthly for unstable patients and every 

6 months for those patients who have 

become stabilized. While we have 

retained patient plan of care monthly 

timeframes for unstable patients 

(proposed at § 494.80(d)(2)), we believe 

that the 6-month review requirement for 

stable patients may be unnecessarily 

burdensome.

The individualized patient plan of 

care is not static and will require 

adjustments as the needs of the patient 

change, particularly if the patient is not 

stable. We propose at § 494.90(b)(3) that 

the interdisciplinary team must adjust 

the patient plan of care to achieve and 

sustain the specified patient outcomes 

goals. New strategies may need to be 

implemented as assessment, response, 

and patient preference information 

requires. If the targeted plan of care goal 

is achievable but is not being attained, 

the facility must implement an 

improvement plan to reach the goal. 

We recognize that patient outcomes 

are determined in part by factors outside 

of the dialysis facility’s control, such as 

demographics, the systemic effects of 

the underlying renal disease, and 

patient preferences and compliance. 

Further, we recognize that health care 

delivery is dynamic and that all patients 

may not be achieving for example, the 

expected delivered dose of dialysis at 

any specific point in time. If the patient 

is unable to achieve the desired health 

outcomes, the plan of care should be 

adjusted to reflect the patient’s 

condition along with an explanation, 

and any opportunities for improvement 

in the patient’s health should be 

identified. The explanation for not 

achieving the specific level of care may 

include patient preferences and patient 

noncompliance. 

Proposed § 494.90(b)(4) would specify 

that the facility must ensure every 

patient is seen at least monthly by a 

physician providing the ESRD care as 

evidenced by a monthly progress note 

that is either written in the beneficiary’s 

medical record by the physician or 

communicated from the physician’s 

office and placed in the beneficiary’s 

medical record. We are proposing this 

requirement based on a continuing 

concern of beneficiaries regarding the 

amount of interaction between patients 

and their physicians. We chose the time 

period of at least once a month because 

physicians have traditionally been paid 

for their services to renal patients on a 

monthly basis through the monthly 

capitation payment. Patients who are 

not stable will need to see the physician 

more frequently than our proposed 

minimal timeframe. According to 

preliminary information from the 

Dialysis Outcomes and Practice Patterns 

Study (DOPPS), better patient outcomes 

are associated with high levels of 

patient contact from the physician. 

Almost 70 percent of the dialysis 

patients sampled in the United States, 

as part of the DOPPS, see their 

physician once per week or more 

frequently, as reported by the nurse. 

However, we are concerned about the 

suggestion that as many as 5 percent of 

the dialysis patients may see their 

physician less often than once a month. 

While we are proposing a minimum 

monthly physician visit (without 

specifying any duration for the visit 

itself), we do not want to discourage 

more frequent visits. On November 7, 

2003, we published a final rule (68 FR 

63196, 63216) regarding the revisions to 

the payment policies under the 

physician fee schedule for calendar year 

2004. This rule aligns payment 

incentives with the frequency of the 

physician’s evaluation of the dialysis 

patient. In addition, the rule assigned 

new G codes that associate a higher 

payment to a physician who provides 

more visits within each month to an 

ESRD patient. Physicians should see 

patients and monitor their care as often 

as is medically necessary to ensure that 

they are progressing towards the 

specified outcomes. 

We believe it is important for 

physicians to see in-center hemodialysis 

patients periodically while they are 

undergoing dialysis in order to monitor 

the quality of care they are receiving 

and to address the patient’s particular 

clinical concerns and needs while in the 

treatment environment. We believe 

6210 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

periodic in-center monitoring by the 

patient’s hemodialysis physician is an 

accepted medical practice and would 

not impose any additional burden on 

dialysis facilities. We are soliciting 

comments regarding whether physicians 

should be required to see their in-center 

patients periodically while those 

patients are being dialyzed in the 

dialysis facility. Such in-center visits 

would not be in addition to the monthly 

requirement proposed in § 494.90(b)(4). 

3. Transplantation Referral Tracking 

(Proposed § 494.90(c)) 

We are proposing at § 494.90(c) that 

the interdisciplinary team track the 

results of each kidney transplant center 

referral and monitor the status of any 

facility patients who are on the 

transplant wait list. The routine 

exchange of information between the 

dialysis facility and the transplant 

center is important so that both facilities 

know who is active on the transplant 

wait list, who is temporarily or 

permanently inactive, and who is under 

evaluation. In addition, there may be a 

need to coordinate histocompatibility 

testing, which must be completed on a 

monthly basis. We invite comment on 

the coordination of the transplant 

process and the method and frequency 

of communication with the 

transplantation center. 

4. Patient Education and Training 

(Proposed § 494.90(d)) 

The existing regulations do not 

specifically address patient education 

and training for in-center patients. 

However, in § 494.90(d), we are 

proposing to stipulate that the patient 

plan of care must include, as applicable, 

education and training for patients and 

families in all relevant aspects of the 

dialysis experience, dialysis 

management, quality of life, 

rehabilitation, and education regarding 

renal transplantation. When kidneys 

fail, the resulting physical changes 

stimulate a chain of psychological and 

physiological events that alter the lives 

of the affected individuals and their 

families. The education of patients and 

their families goes beyond providing the 

necessary information for patients to 

make an informed choice regarding 

treatment modality. Because the life 

changes associated with beginning 

dialysis are so profound, patients and 

their families need to be educated and 

trained about strategies for successful 

adaptation to dialysis, optimizing 

functional status, employment options, 

and many other issues. Patients and 

their families must learn about the 

disease and the possibilities of life 

beyond it and then assume 

responsibility for their own health by 

complying with the treatment plan and 

participating actively in rehabilitation 

activities. Educating and training 

patients and their families is key to a 

successful transition to a life with 

dialysis. 

However, not all elements of the 

existing § 405.2137 will be retained in 

proposed § 494.90. In accordance with 

our approach to consolidate all similar 

standards, we propose to move the 

requirements in existing 

§ 405.2137(b)(5) regarding the transfer of 

the patient’s medical records to the 

proposed medical records condition for 

coverage (§ 494.170), and move the 

requirements in existing 

§ 405.2137(b)(6) regarding the 

monitoring of home dialysis patients to 

the proposed Care at Home condition 

for coverage (§ 494.100). We believe that 

this reclassification will improve the 

proposed regulation’s organization. 

D. Condition: Care at Home (Proposed 

§ 494.100) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Care at Home’’ at the beginning of your 

comments.] 

1. Dialysis of the ESRD Patient in the 

Home Setting 

Home dialysis has been shown to 

have a positive effect on a patient’s 

quality of life. Home dialysis affords the 

patient control over the scheduling and 

setting; it can be done in comfortable, 

familiar surroundings; and it is less 

disruptive to family life and 

employment than in-center dialysis. 

The existing requirements for home 

dialysis are located in four sections: (1) 

Definitions (§ 405.2102); (2) patient care 

plan (§ 405.2137(b)); (3) medical records 

(§ 405.2139); and (4) minimal service 

requirements (§ 405.2163(e) and (g)). 

Existing § 405.2102 defines home 

dialysis as dialysis performed by an 

appropriately trained patient at home. 

Existing § 405.2137(b) states that 

home dialysis patients will receive a 

written care plan with the same criteria 

that are specified for in-center patients. 

Section 405.2137(b)(6) requires the 

ESRD facility to conduct periodic 

monitoring of the patient’s home 

adaptation, including visits to the home 

by ‘‘qualified facility personnel’’ as 

appropriate. Section 405.2137(b)(7) 

contains patient care plan requirements 

that apply to home dialysis patients 

who use erythropoietin, including: (1) 

Monitoring diet and fluid intake; (2) 

medication usage; (3) hematocrit and 

iron stores; (4) reevaluations of the 

dialysis prescription; (5) a method for 

physician follow-up on blood tests and 

a mechanism to inform the physician of 

the results; (6) training the patient to 

identify signs of hypotension and 

hypertension; and (7) decreasing or 

discontinuing erythropoietin usage if 

hypertension is uncontrolled. 

Existing § 405.2139 requires facility to 

maintain ‘‘complete medical records’’

on all patients, including its home 

patients. Section 405.2139(d) contains 

requirements regarding medical records 

information generated by self-dialysis 

patients and entries of medical records 

information by trained self-dialysis 

patients, or ‘‘trained assistants,’’

countersigned by facility staff.

Existing §§ 405.2163(e)(1) through (6) 

list a facility’s home dialysis support 

services including: (1) Surveillance of 

the patient’s home, including periodic 

visits; (2) consultation for the patient 

with a qualified social worker and 

qualified dietitian; (3) a record keeping 

system that assures continuity of care; 

(4) installation and maintenance of 

equipment; (5) testing and appropriate 

treatment of the water; and (6) ordering 

supplies on an ongoing basis. 

Existing § 405.2163(g)(1) through (4) 

requires the facility or physician 

responsible to make a comprehensive 

patient assessment that includes the 

following: (1) Preselection monitoring, 

including the patient’s hematocrit (or 

hemoglobin), serum iron, transferrin 

saturation, serum ferritin, and blood 

pressure; (2) conditions the patient must 

meet, including a hematocrit (or 

comparable hemoglobin) hematocrit 

level of 30 percent (for patients 

initiating erythropoietin treatment), or a 

level of 30 to 33 percent (for patients 

already under the care of a dialysis 

facility or physician); (3) a requirement 

that patients or caregivers must be 

trained to inject erythropoietin, read 

and understand drug labeling, and 

observe aseptic techniques; and (4) the 

assessment must find that 

erythropoietin can be refrigerated in the 

patient’s residence and potential risks 

and hazards related to the drug and 

syringes are understood by the patient. 

In § 494.100, we proposed 

requirements that are only applicable to 

home dialysis. Since not every facility 

chooses to provide home dialysis, this 

condition would apply only to a facility 

that provides these services. 

We propose in the opening paragraph 

of § 494.100 to retain the implicit 

requirement in existing § 405.2163 that 

services to home patients are at least 

equivalent to those provided to incenter patients. Home dialysis patients 

are patients of the ESRD facility; and 

therefore, they are entitled to the same 

rights, services, and efforts to achieve 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6211

expected patient outcomes as any other 

patient of the facility. 

We are proposing to address home 

dialysis training in § 494.100(a). In our 

deliberations regarding home dialysis 

training requirements, we took into 

account the considerable lifestyle 

changes associated with initiating home 

dialysis and the unique needs of 

patients and caregivers engaged in home 

dialysis. Patients and their caregivers 

need to be trained and educated about 

strategies for successfully adapting to 

dialysis at home, ways to optimize 

functional status, proper self-dialysis 

procedures, and many other issues. 

Therefore, the processes of educating 

and training patients and their 

caregivers are crucial to a successful 

transition to a life with dialysis and to 

achieving good patient care outcomes. 

In the opening paragraph of 

§ 494.100(a), we are proposing that 

before the initiation of home dialysis, 

when the caregiver changes, or when 

the home modality changes, that the 

facility’s interdisciplinary team is 

responsible for providing self-dialysis 

training to the home patient, the 

patient’s designated caregiver, or both. 

Self-dialysis (as defined in existing 

§ 405.2102(b)(2)(ii) and proposed 

§ 494.10) means dialysis performed with 

little or no professional assistance by an 

ESRD patient who has completed an 

appropriate course of training. Home 

dialysis training may be only be 

provided by a dialysis facility certified 

to provide home dialysis services. 

Durable medical equipment (DME) 

companies cannot provide home 

dialysis training. We are proposing in 

§ 494.100(a)(1) to modify the existing 

requirement at § 405.2102(d)(3) that selfdialysis training must be conducted by 

a registered nurse with 18 months of 

clinical experience and at least 3 

months of specialized experience in 

training dialysis patients in self-care. 

We are proposing to modify these 

requirements to state that self-care 

training must be conducted by a 

registered nurse who meets the 

personnel qualifications specified in 

§ 494.140(b)(2) (that is, 12 months 

clinical experience and an additional 3 

months of clinical experience in the 

specific modality for which the 

registered nurse will provide training). 

As previously stated, home dialysis 

training is crucial to achieving desired 

patient outcomes; and therefore, we 

believe the initial training a patient 

receives must be provided by an 

experienced health care professional. 

Existing § 405.2102 requires that a 

facility provide a training program for 

self-dialysis and home dialysis patients, 

if it chooses to provide this service, but 

it does not specify the content of that 

training program. Therefore, we are 

proposing the following subject areas for 

home dialysis training programs in 

§§ 494.100(a)(3)(i) through (a)(3)(x). 

These types of programs would, at a 

minimum, be required to provide 

training in the following: 

• The nature and management of 

ESRD. 

• The full range of techniques 

associated with the applicable type of 

home dialysis, including effective use of 

dialysis supplies and equipment in 

achieving the physician’s prescription 

of Kt/V or URR, and effective 

erythropoietin administration (if 

prescribed) to achieve a hematocrit level 

of at least 33 percent or a hemoglobin 

level of 11 gm/dl. 

• Nutritional care planning. 

• Achieving and maintaining 

emotional and social well-being. 

• How to detect, report, and manage 

potential complications.

• Availability of support services and 

how to access and use available support 

services. 

• How to self-monitor health status 

and record and report health status 

information. 

• How to handle medical and nonmedical emergencies. 

• Infection control precautions. 

• Proper waste storage and disposal 

procedures. 

While we recognize that specifying 

the topics for a training program appears 

to be inconsistent with our goal of 

reducing process-oriented requirements, 

we believe it is critical and necessary 

that the items listed above be required, 

so that patients and caregivers are fully 

informed regarding the health and safety 

procedures that must be followed and 

precautions that must be taken when 

providing dialysis at home. 

Home patients are not seen 3 times a 

week by facility staff like in-center 

patients; and therefore, the quality and 

content of home training given to 

patients and their caregivers is an 

extension of the care and monitoring 

that would normally be provided in the 

dialysis facility. In addition, the facility 

is responsible for ensuring that home 

dialysis patients are achieving the 

desired outcomes, and this training will 

inform home care patients or their 

caregivers or both of the plan of care 

that must be followed (see proposed 

§ 494.90) to achieve the expected 

results. 

We propose in §§ 494.100(b)(1) 

through (3) that the dialysis facility: (1) 

Record who received the training 

described in § 494.100(a)(3) and indicate 

that the patient or caregiver 

demonstrated adequate comprehension; 

(2) retrieve and review self-monitoring 

data from patients or caregivers at least 

every 2 months; and (3) maintain this 

information in the patient’s medical 

record. The goal of the proposed 

standards is that facilities effectively 

coordinate the care of all patients, 

including home dialysis patients, to 

achieve the desired outcomes. As 

previously stated, we recognize that 

home patients do not see facility staff as 

frequently as in-facility patients, so the 

purpose of this proposed requirement is 

to ensure that the facility’s 

interdisciplinary team periodically 

monitors the care of home dialysis 

patients’ plans of care. 

Existing § 405.2139(d) requires 

dialysis facilities to collect medical 

information generated by self-dialysis 

patients, but it does not specify the 

frequency of the data collection. By 

proposing at § 494.100(b)(2) that the 

home patient’s facility collect and 

review information at least every 2 

months, we ensure the interdisciplinary 

team can determine if the patient is 

having problems with any aspect of the 

dialysis therapy at regular intervals. We 

would recommend that the facility 

collect data that will enable it to 

determine if home patients are adhering 

to the plan of care and achieving 

expected outcomes. Based on the data 

received, the facility staff can determine 

if the patient or caregiver needs to be 

retrained or, in some cases, determine 

that the patient is no longer a suitable 

candidate for self-care dialysis. As with 

in-facility patients, the goal of collecting 

data on home dialysis patients is to 

ensure that they are achieving the 

expected outcomes. 

We propose to retain many of the 

existing support services requirements 

at § 405.2163(e) in proposed 

§ 494.100(c). We have always taken the 

view that the law and the regulations 

require that the facility provide all of 

these support services, regardless of 

whether the dialysis supplies are 

provided by the dialysis facility or a 

durable medical equipment (DME) 

company, to the extent that they are 

medically necessary for a beneficiary’s 

care. In addition to meeting other 

requirements, the proposed Care at 

Home condition is intended to assure 

that home dialysis patients, including 

those residing in nursing facilities (NFs) 

or skilled nursing facilities (SNFs), are 

receiving care that is comparable to the 

care provided to in-facility patients. 

Thus, the support services provided to 

home dialysis patients should parallel 

the treatment provided to patients in a 

dialysis facility. 

We are proposing in § 494.100(c)(1)(i) 

to retain the existing requirements at 

6212 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

§ 405.2137(b)(6) regarding periodic 

surveillance of the patient’s home 

adaptation, including provisions for 

visits to the home by facility personnel. 

In addition, we are proposing in 

§§ 494.100(c)(1)(ii) through (iv) to retain 

existing requirements in §§ 405.2137(b) 

and 405.2163(e) to: (1) Coordinate the 

home patient’s care by a member of the 

facility interdisciplinary team; (2) 

develop and periodically review the 

patient’s plan of care (see § 494.90) to 

address the patient’s needs and achieve 

expected outcomes of care; and (3) 

consult with the members of the 

interdisciplinary team as needed. 

Existing § 405.2163(e)(2) requires 

consultation with a qualified social 

worker and dietitian. We are proposing 

in § 494.100(c)(1)(iv) to strengthen this 

requirement by including any member 

of the patient’s interdisciplinary team 

because some home dialysis patients 

may experience problems or have needs 

that require consultation with several 

members of the interdisciplinary team, 

and we do not want to limit their access 

to appropriate care. In addition, we 

recognize that patients who are new to 

dialysis therapy need a period to adjust 

and adapt to their treatment. Initially 

patients may experience anxiety while 

learning self-care skills, how to perform 

the dialysis treatment, how to modify 

their diet, and how to change their 

behavior. 

We also believe the interdisciplinary 

team must be responsible for the 

development and periodic review of the 

patient’s individualized, comprehensive 

care plan based on the comprehensive 

assessment (see § 494.80) that specifies 

the services necessary to address the 

patient’s needs and includes measurable 

and expected outcomes. We are 

proposing in § 494.100(c)(1)(iii) to 

expand the existing requirements by 

including a statement that the patient’s 

comprehensive plan of care will be 

developed and reviewed by the 

interdisciplinary team to address the 

patient’s needs and to achieve the 

expected outcomes of care. To that end 

we are encouraging and recommending 

that dialysis facilities adopt the same 

clinical performance measures for home 

patients as those that are used for incenter patients. As previously stated in 

the discussion of the patient plan of care 

condition for coverage (§ 494.90), the 

goal is to obtain input from each 

member of the interdisciplinary team as 

well as from the home patient so as to 

develop a comprehensive plan of care 

that indicates the services necessary to 

address the home patient’s needs. The 

home dialysis patient’s plan of care 

should stipulate the services that are to 

be furnished to achieve and maintain 

the expected outcomes of care. 

We are proposing in § 494.100(c)(1)(v) 

to retain and expand the existing 

requirement at § 405.2163(e)(5) to 

monitor the quality of the water used by 

home hemodialysis patients. We are 

specifically including onsite evaluation 

of the water system. Since we have 

incorporated by reference the AAMI 

standards regarding water quality at 

§ 494.40(a)(1)(i) and (ii), we are also 

proposing that a facility adhere to the 

applicable AAMI guidelines in 

determining whether the home dialysis 

patient’s water system meets acceptable 

standards. If water supplies are 

biologically or chemically 

contaminated, contaminants may be 

passed to the patient during the dialysis 

session, leading to infection or other 

adverse consequences. Therefore, a 

dialysis facility must monitor the 

quality of water used in treatments, as 

well as monitor the equipment used in 

water treatment. Because water is one of 

the most important aspects of health 

and safety, we are proposing in 

§ 494.100(c)(l)(v) to require that the 

facility conduct onsite evaluation of the 

patient’s water system if the AAMIspecified analysis of the water quality 

indicates contamination or if the home 

patient demonstrates clinical symptoms 

associated with water contamination. 

The dialysis facility must ensure that 

any problems with the water treatment 

system are corrected. If the problem 

cannot be corrected immediately, the 

dialysis facility must arrange for backup 

dialysis until the water quality at the 

patient’s home can be adequately 

restored. 

We are proposing in 

§ 494.100(c)(1)(vi) to retain the existing 

requirements of section 1881(b)(9) of the 

Act and §§ 405.2163(e)(4) and (e)(6) of 

the regulations that require the facility 

to install and maintain medically 

necessary home dialysis supplies and 

equipment prescribed by the attending 

physician. In addition, for those home 

patients not receiving equipment and 

supplies from a DME company the 

dialysis facility must also purchase and 

deliver the necessary home dialysis 

supplies and equipment. 

Furthermore, we propose in 

§ 494.100(c)(1)(vii) to require the facility 

to plan for and arrange for emergency 

backup dialysis services. This plan 

should address how emergency 

situations will be dealt with, and should 

hemodialysis be required, include a 

plan for obtaining this service.

We are proposing in § 494.100(c)(2) to 

retain the requirement at 

§ 405.2163(e)(3) that a facility maintain 

a record keeping system that promotes 

continuity of care. The medical record 

is used for diagnosing, treating, and 

caring for the patient. We believe this 

requirement is vital to the effective 

coordination of services provided to 

home dialysis patients because the 

medical record indicates what care has 

actually been provided and what 

outcomes have been achieved. The 

medical record documents the services 

provided by the interdisciplinary team 

members and provides an accurate 

picture of the patient’s progress in 

achieving care goals. Further, it 

provides the data for evaluation and 

documentation of the quality and 

appropriateness of care delivered. 

Adequate record keeping is vital to 

ensure continuity of care and to ensure 

that the home dialysis patient is 

receiving quality care. 

In addition, the patient’s supplier is 

often not part of the facility staff; and 

therefore, it may be difficult to ascertain 

the services they provide the home 

patient. In some instances, the services 

of home patients are not effectively 

coordinated. As a result, the facility staff 

is often not able to provide 

comprehensive care to home patients, 

and the quality of care suffers. In an 

effort to encourage facilities to 

coordinate services effectively, 

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

the patient’s supplier report to the 

facility, every 30 days, all services and 

items furnished to the beneficiary so 

that the information can be documented 

in the patient’s medical record. One of 

our primary goals is to have the care of 

home patients parallel the care of infacility patients, and this can only be 

accomplished if all information on 

patient care is reported to the facility. 

We selected 30 days because monthly 

reporting and billing is commonly used 

by dialysis facilities and by suppliers 

and we believe that this will not 

produce additional burden. All patient 

data are necessary to effectively evaluate 

the patient’s dialysis prescription and 

make changes to the patient plan of 

care. A less frequent reporting 

timeframe would compromise efforts to 

correct deficiencies in the patient’s plan 

of care (for example, adjustments to the 

dialysis prescription) by the patient’s 

physician and other necessary 

corrective actions by the patient’s 

interdisciplinary team. We welcome 

comments on the proposed timeframe 

for the patient’s supplier to report to the 

facility. 

2. Dialysis of ESRD Patients in Nursing 

Facilities and Skilled Nursing Facilities 

The existing regulations allow 

hemodialysis to be provided within NFs 

and SNFs when there is a certified 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6213

hemodialysis facility on-site or 

adjoining the NF or SNF and when the 

patient is a home dialysis patient who 

has been appropriately trained. In a 

March 19, 2004 letter to State survey 

agency directors entitled, ‘‘Clarification 

of Certification Requirements and 

Coordination of Care for Residents of 

Long-term (LTC) Facilities Who Receive 

End Stage Renal Disease (ESRD) 

Services’’ (Reference: S&C–04–24), we 

clarified certification requirements and 

coordination of care expectations for 

residents of LTCs who receive dialysis. 

On July 8, 2004, we sent State survey 

agency directors and addendum to the 

March 19, 2004 letter that included as 

an attachment follow-up questions and 

answers regarding the scope of the 

guidance and the responsibilities of the 

providers (Reference: S&C–04–37). In 

this proposed rule, we are soliciting 

comments on a wide range of issues 

affecting the population of patients who 

are nursing home residents and who 

desire to be dialyzed in the nursing 

home. We have received inquiries as to 

whether an institutionalized setting 

such as a long-term care facility may be 

considered to be a beneficiary’s ‘‘home’’

for self-dialysis purposes. In the past we 

have provided guidance in response to 

these inquiries. Home dialysis is 

currently only an option for NF or SNF 

patients when certain conditions are 

satisfied: (1) The NF or SNF must be 

considered to be the patient’s home (for 

short NF or SNF stays, such as 

rehabilitation or brief recovery time 

admissions, the nursing home would 

not be considered the patient’s home 

since the expectation is that the patient 

would soon be discharged and return to 

their own home); (2) the patient (and his 

or her family member or caregiver) must 

complete the home dialysis training; (3) 

all home dialysis patients must have 

their own dialysis machine, equipment, 

and supplies; and (4) home dialysis 

patients must receive their support 

services from a certified dialysis facility. 

Currently the NF or SNF patient who 

requires hemodialysis may be 

transported to a certified outpatient 

hemodialysis facility or may receive 

treatment from a certified hemodialysis 

facility available within or adjoining the 

NF or SNF. We recognize the hardship 

placed on long-term care patients who 

must be transported to offsite dialysis 

facilities 3 times per week. Since there 

is potential growth for home dialysis in 

NFs and SNFs because of changing 

demographics in both the ESRD 

population and the general population, 

it may be appropriate for us to provide 

further guidance regarding the 

regulatory expectations for the provision 

of dialysis in the NF or SNF. 

Dialyzing patients in NFs or SNFs 

without a certified ESRD facility within 

or adjoining the NF or SNF may present 

both opportunities and risks. Dialysis 

patients who remain in the NF or SNF 

are less likely to miss medication 

administration, treatment regimens, 

meals or planned activities during time 

that would otherwise be spent in 

waiting and transportation to and from 

a dialysis facility. We know that some 

patients would prefer to stay in their 

residence and dialyze while others 

would prefer to be transported to a 

certified dialysis facility for care. We 

believe that both choices should be 

available for NF or SNF residents, and 

we believe that both choices should 

provide patient protections for health 

and safety. In addition, we believe that 

patients receiving dialysis in a NF or 

SNF should not be deprived of essential 

services that they would normally 

receive in an outpatient dialysis facility. 

Finally, we need to assure that, in 

providing hemodialysis treatments in a 

NF or SNF, the care of other residents 

in the NF or SNF not requiring dialysis 

is not negatively impacted. We are 

soliciting comments on whether the 

current home dialysis regulations need 

to be modified to protect this vulnerable 

population, and if so, in what ways and 

under what particular set of 

circumstances. 

In the current ESRD regulations, the 

home dialysis training requirement 

presents a significant barrier in 

providing home dialysis to NF or SNF 

residents as the patient may be 

untrainable and may not have a ready 

caregiver who could be co-trained to 

assist the resident in performing 

dialysis. The patient’s role in home 

dialysis is defined at § 405.2102 under 

the definitions section of the 

requirements. The regulations require 

the patient to take part in the training. 

We have received correspondence 

requesting that the home-dialysis 

training requirement be waived for NF 

or SNF residents. It has been our longstanding policy to encourage home 

dialysis. We are also aware of the 

current limitations relative to severely 

debilitated patients who are ineligible 

for home dialysis based on the training 

requirement. Given the relative acuity of 

nursing home patients, there are safety 

concerns associated with allowing 

patients in nursing homes to be home 

dialysis patients. These patients may be 

less able to voice symptoms/problems 

then the typical ESRD home patient. In 

addition, the dialysis care of a patient 

who requires nursing home services 

may be more complex than the dialysis 

care of an independent home dialysis 

patient, and given their frailty, these 

patients may be more vulnerable than 

an independent home dialysis patient. 

Because of this, we have significant 

safety concerns about encouraging home 

dialysis, provided by multiple 

caregivers, who may not have any 

dialysis experience, in this setting. 

Home dialysis patients may choose to 

obtain their dialysis supplies and 

equipment from either the dialysis 

facility that provides the home training 

and support services (Method I 

payment) or from a DME company 

(Method II payment). The dialysis 

facility may have more patient contact 

and be more able to determine that 

necessary supplies are provided at the 

right time and in the right amounts to 

meet the needs of home patients due to 

the enhanced patient contact. If 

hemodialysis were provided to NF or 

SNF residents within the home dialysis 

model, these patients would continue to 

be able to choose between Method I and 

Method II. 

In order to address the issue of home 

dialysis in the NF or SNF, we believe 

there needs to be clarity about the 

various roles and responsibilities of the 

certified ESRD facility providing 

dialysis care and the responsibilities of 

the NF or SNF when there is no certified 

ESRD facility onsite or adjoining the NF 

or SNF. While we have addressed many 

of these concerns relative to the existing 

regulations through guidance to the 

State survey agency directors, the 

important issues that we would have to 

address through new rulemaking and 

the issues on which we request 

comment are discussed below. 

a. Delineation of Responsibility 

We believe the home hemodialysis 

services provided in a NF or SNF 

should be provided under the direction 

of a certified dialysis facility that is 

responsible for the dialysis care 

provided to the ESRD patients, for 

assuring that the NF or SNF is capable 

of providing appropriate pre- and postdialysis care, and for assuring that there 

is coordination of care between the two 

entities, that is, the nursing home and 

the ESRD facility. In order to assure that 

roles and responsibilities are clearly 

delineated prior to the initiation of care, 

we believe there should be a written 

agreement (specifying responsibilities 

and the coordination of care) between 

all parties providing the care, including 

the NF or SNF (and the DME supplier, 

if applicable). 

6214 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

b. Applicable ESRD Conditions for 

Coverage 

Consideration must be given as to 

whether home dialysis care provided in 

a NF or SNF must comply with all of the 

proposed conditions for coverage, 

except § 494.120, that governs special 

purpose dialysis facilities and the 

specification at § 494.180(d) that 

services must be provided on or 

contiguous with the premises. 

c. Nursing Coverage 

The existing regulations 

(§ 405.2162(b)) require that a licensed 

health professional (for example, 

physician, registered nurse, or licensed 

practical nurse) experienced in 

rendering ESRD care is on duty to 

oversee ESRD patient care whenever 

patients are being dialyzed. This 

proposed rule would require (proposed 

§ 494.180(b)(2)) that a registered nurse 

be on the premises whenever in-center 

patients are being treated. We believe 

that there would be a comparable risk to 

patient health and safety if a licensed 

nurse was not on the premises of the NF 

or SNF and available during multiple 

simultaneous home NF or SNF dialysis 

treatments. Consideration must be given 

as to whether this registered nurse could 

be a NF or SNF registered nurse trained 

by the ESRD facility, or a registered 

nurse provided by the ESRD facility to 

be available during NF or SNF 

hemodialysis treatments.

If the NF or SNF were allowed to 

provide this registered nurse to be 

available during hemodialysis 

treatments then the implications for care 

(requiring registered nurse attention) 

provided to other NF or SNF residents 

must be considered. We are considering 

whether a limitation of the NF or SNF 

registered nurse’s duties is necessary, so 

that the nurse is available to meet 

dialysis needs while another nurse 

tends to the NF or SNF residents (for 

example, such as the absence of direct 

NF or SNF resident care responsibilities 

and allowance of only administrative 

duties). When considering whether the 

NF or SNF registered nurse may be the 

licensed individual responsible for 

overseeing resident care when residents 

are being dialyzed, the provision of 

training by the ESRD facility for this 

individual also must be addressed. 

While the registered nurse would 

oversee the dialysis, a trained caregiver 

would administer the dialysis treatment. 

In a typical home dialysis patient 

situation, the ratio of patient to 

caregiver is one-to-one. We solicit 

comments on whether we should 

address patient to caregiver ratios in a 

situation when the NF or SNF is 

considered the patient’s residence. 

d. Training 

We believe that training provided by 

the certified ESRD facility should be 

specified and the ESRD facility should 

be responsible for providing training to 

NF or SNF staff and to all caregivers 

who will be working with the ESRD 

patients. These caregivers could 

possibly include the nursing and 

support staff of the residential 

institution, dialysis facility nurses and 

patient care technicians, and the 

caretaker that may be provided by the 

DME supplier, if available and the 

patient is a Method II home dialysis 

patient. We note that Medicare does not 

provide additional reimbursement for 

caregiver services within the current 

payment system. We believe that 

caregiver-training requirements that are 

similar to the training specifications for 

home dialysis patients may be 

appropriate. 

e. Monitoring 

If we were to propose requirements on 

this topic, we believe that the certified 

ESRD facility should be responsible for 

monitoring the care of the ESRD patient 

in the NF or SNF. We also believe that 

the dialysis facility should assure that 

trained caregivers be present in the 

room with the patient at all times while 

the hemodialysis is being provided. 

This ensures that a knowledgeable 

individual is available to assist the 

patient if any problems arise. 

We believe that the ESRD facility 

should—(1) periodically assess the 

ability of the staff (NF or SNF staff and 

caregiver) responsible for care of the 

ESRD patient to assure that they are 

competent in their tasks; (2) retrieve and 

review complete data, including 

laboratory data, clinical data, outcome 

data, and interdisciplinary team notes to 

assure that adequate care is being 

provided; (3) monitor the care of the 

patients, using appropriate clinical 

standards; and (4) work with the NF or 

SNF staff to monitor whether dialysis 

treatments being provided in the 

nursing home negatively impact the care 

of other NF or SNF residents and correct 

such impact as appropriate. 

We believe that the dialysis facility 

should ensure that care being provided 

to patients receiving dialysis in a NF or 

SNF is comparable to the care provided 

to facility patients. Thus, the support 

services provided to NF or SNF 

residents should parallel the treatment 

provided to patients in a dialysis 

facility. Therefore, we believe that the 

dialysis facility providing dialysis in a 

NF or SNF must also: (1) Provide 

periodic monitoring of the institutional 

residence to assure that appropriate care 

is being provided; (2) provide 

monitoring of supplies and equipment; 

(3) maintain medical records in both the 

NF or SNF and at the certified ESRD 

facility; and (4) assure that patient rights 

are protected as they would be in a 

dialysis facility, including access to a 

formal grievance process by the patient 

or the patient’s guardian or advocate. 

We want to ensure that the health and 

safety of NF or SNF hemodialysis 

patients is protected and so we are 

soliciting comment on the provision of 

hemodialysis in the NF or SNF on the 

issues discussed above. Specifically, we 

solicit comment on what competency 

requirements and experience/

qualifications should be proposed for 

the caregiver (who is not a patient’s 

family member) and for the registered 

nurse, what restrictions should be 

placed on the caregiver or the registered 

nurse or both, and whether caregiver to 

patient ratio limits should be proposed. 

We are interested in any suggestions 

regarding this issue to provide for the 

specific needs of this vulnerable 

population, and on how we can make 

these requirements more flexible to 

meet the needs of the providers, while 

providing appropriate patient 

protections. 

E. Condition: Quality Assessment and 

Performance Improvement (Proposed 

§ 494.110) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘QAPI’’ at the beginning of your 

comment.] 

An integral part of our effort to move 

toward a patient outcome-based system 

is the facility level quality assessment 

and performance improvement (QAPI) 

program. We propose to require that a 

dialysis facility create its own tailored 

program for quality improvement based 

on the framework provided in this 

condition. Existing §§ 405.2112(c) and 

405.2113(a) address quality standards 

for patient care in the context of the 

ESRD network organization’s role. 

Although § 405.2134 requires each 

dialysis facility to participate in 

network activities and to pursue 

network goals, there is currently no 

clear Federal requirement for an 

ongoing facility-specific, patientcentered continuous quality 

improvement program. The focus on 

outcomes in this proposed rule is a 

result of the fundamental shift in 

approach to performance expectations 

within the health care industry and 

efforts within the renal community to 

define and examine outcomes. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6215

In 2000, the Office of the Inspector 

General (OIG) of the Department of 

Health and Human Services (DHHS) 

conducted an extensive review to 

ascertain the effectiveness of our 

monitoring of the ESRD program. Their 

subsequent report was entitled 

‘‘External Quality Review of Dialysis 

Facilities: A Call for Greater 

Accountability’’ (DHHS/OIG, June 

2000). The purpose of this review was 

to ‘‘assess external mechanisms HCFA 

relies upon to monitor the quality of 

care provided by dialysis facilities to 

Medicare beneficiaries with ESRD.’’

This OIG report provides a thorough 

review of the external quality oversight 

of dialysis facilities in the United States 

and the roles played by CMS, the State 

survey agencies, and the ESRD 

networks. The OIG recommended that 

dialysis facilities be required to conduct 

their own quality improvement 

programs. The OIG also recommended 

that facilities be required to establish 

internal systems for identifying and 

analyzing the causes of medical injuries 

and medical errors. Another 

recommendation was to require 

facilities to monitor patient satisfaction. 

The Institute of Medicine’s (IOM) 1991 

report, ‘‘Report on Kidney Failure and 

the Federal Government’’ suggests that 

relating the conditions for coverage to 

patient outcomes would assist the 

quality assurance efforts of the ESRD 

program (IOM, 1991).

The 2001 IOM report, ‘‘Crossing the 

Quality Chasm: A New Health System 

for the 21st Century’’ addresses the need 

to narrow the quality chasm between 

the potential benefits of medical science 

and technology and the actual level of 

health care provided in the United 

States (IOM, 2001). The report offers a 

strategy and action plan for building a 

stronger health system over the coming 

decade. The report presents multiple 

challenges to health care leaders and 

points out that all organizations can 

improve their performance by 

incorporating care process and outcome 

measures into their daily work. In 

addition, many renal groups (including 

the RPA, the American Nephrology 

Nurses Association, the NKF, and the 

American Association of Kidney 

Patients) have developed similar 

positions. We believe that the quality 

improvement activities in this proposed 

rule and the data systems of the future 

will provide an opportunity to focus 

more closely on patient outcomes. We 

believe that it is critically important that 

dialysis facilities examine the adequacy 

of their information technology and 

identify opportunities to improve and 

expand the use of such technologies to 

prevent medical errors and improve the 

quality of care. This Administration is 

committed to working with other public 

and private stakeholders to develop 

means for improving and expanding the 

use of information technologies (such as 

bar coding and computerized physician 

order entry systems) in health care 

settings. 

Proposed § 494.110 would require 

that a facility develop, implement, 

maintain, and evaluate an effective, 

data-driven, quality assessment and 

performance improvement program that 

reflects the complexity of the dialysis 

facility’s patient population and its 

processes of care. The dialysis facility 

must take actions that result in 

performance improvements in the 

quality of patient care. We believe that 

dialysis facilities need to have a 

continuous quality improvement system 

in place to continually assess and 

improve health care delivery. The 

facility’s quality improvement program 

should monitor the systems and 

processes of care that are used to 

achieve the targeted patient outcomes. 

This approach calls for facilities to 

systematically collect and analyze 

clinical data about the components of 

their care processes. The majority of 

facilities already collect clinical 

performance measures as described in 

the 2002 OIG report, which describes 

the quality improvement programs of 

large dialysis corporations (DHHS/OIG, 

January 2002). The 5 largest dialysis 

corporations (representing 67 percent of 

the total number of dialysis facilities) 

routinely collect data on at least 14 

clinical performance measures; and 

therefore, requiring collection of those 

clinical performance data would not 

impose an additional data collection 

burden on most dialysis facilities. These 

types of data can be used to assess 

facility care processes and to identify 

opportunities for improvement. Once 

the opportunity has been identified, the 

facility should develop and implement 

an intervention strategy that focuses on 

the processes that need improvement, 

and then evaluate whether the 

improvement strategy achieved the 

desired results. The facility should 

reexamine goals that have been 

achieved and, if applicable, undertake 

new interventions to further increase 

the quality of care processes, outcomes, 

and patient satisfaction. The facility 

must continue to track its performance 

to assure that improvements in patient 

outcomes and patient satisfaction are 

sustained. This is what is meant by the 

cycle of continuous quality 

improvement. 

This QAPI approach demands an 

evaluation of organizational 

performance and a patient-centered 

focus. The evaluation includes 

measuring actual performance, as well 

as the impact of the performance on 

patient outcomes and satisfaction. The 

evaluation answers the question: ‘‘Did 

that process, treatment or procedure 

produce the targeted outcomes?’’ The 

approach gives the facility the ability to 

analyze interdependent processes of 

care and adjust them to optimize the 

system for providing care. 

1. Program Scope (§ 494.110(a)) 

We are proposing in § 494.110(a) to 

require that the dialysis facility’s QAPI 

program address at least the following 

areas: (1) Adequacy of dialysis; (2) 

nutritional status; (3) anemia 

management; (4) vascular access; (5) 

medical injuries and medical errors 

identification; (6) hemodialyzer reuse 

program (if applicable); and (7) patient 

satisfaction and grievances. We believe 

that these areas are reflective of: (1) the 

degree to which the facility achieves 

desirable patient outcomes; the extent of 

patient safety within the facility; and (2) 

the level of satisfaction attained as the 

patient experiences the continuum of 

care. 

Adequacy of dialysis has become an 

important clinical performance measure 

for benchmarking the quality of dialysis 

care. We believe that it is appropriate 

and necessary to consider using 

consensus performance measures in our 

health and safety standards for facilities. 

The NKF–K/DOQI guidelines for 

hemodialysis adequacy (guideline 4) 

provide minimal adequacy of 

hemodialysis levels of Kt/V of 1.2 and 

URR of 65, but do not suggest optimal 

dialysis target levels, based on their 

conclusion, after a literature review, that 

there is not sufficient data to make that 

determination (NKF, 2000). 

The Hemodialysis Study sponsored 

by the National Institutes of Health 

began in 1995 and was a comprehensive 

randomized clinical trial of dose and 

flux interventions to identify 

improvements in therapy that will 

reduce hemodialysis mortality. The 

study entitled ‘‘Effect of Dialysis Dose 

and Membrane Flux in Maintenance 

Hemodialysis,’’ confirmed that the 

minimum dosage of thrice weekly 

hemodialysis as stated in the NKF–K/

DOQI Guideline 4 (that is, Kt/V of 1.2 

and URR of 65) is adequate and that, in 

general, a high dosage and special highflux filters provide no added benefit in 

terms of survival, rate of hospitalization, 

and albumin levels to patients 

(Eknoyan, pp. 2010–2019). The 

Hemodialysis Study also found 

statistically nonsignificant data 

suggesting that higher dialysis dosage 

6216 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

appeared to reduce mortality and 

hospitalization for women in those who 

had been receiving hemodialysis longer 

than 3.5 years when they joined the 

study (DHHS/NIH, 2002). 

A recent retrospective study suggests 

that the recommended minimal urea 

reduction ratio of 65 percent may be too 

low to provide for an optimal mortality 

benefit (Szczech, pages 738 through 

745). Also, we recognize that there are 

several possible methods for calculating 

Kt/V. In addition, a major concern for 

accurate measurement of either URR or 

Kt/V is that small differences in the 

method and timing of the blood draw 

used for the postdialysis blood urea 

nitrogen (BUN) blood sample can make 

clinically important differences in the 

resulting hemodialysis adequacy 

estimates. 

We acknowledge the need for 

consistency in the techniques used for 

blood withdrawal as well as the method 

or formula used to calculate the Kt/V 

value. We considered proposing 

requirements that specified pre and 

postdialysis blood draw methods and 

Kt/V calculation methods that might 

allow for more accurate benchmarking. 

However, we are not proposing a 

specific methodology at this time, 

because we believe it would be more 

appropriate to recommend and 

encourage dialysis facilities to adopt the 

methodology(ies) recommended by a 

consensus process such as the NKF–K/

DOQI.

Despite these difficulties, dialysis 

facilities do use adequacy of dialysis as 

one of their benchmarks when 

evaluating the quality of peritoneal and 

hemodialysis patient care. The CMS 

ESRD CPM Project calculates the 

adequacy of dialysis measures for 

hemodialysis and peritoneal dialysis 

patients (that is, URR and Kt/V) that can 

be used by facilities and ESRD networks 

for benchmarking and comparison 

purposes. The CMS ‘‘Dialysis Facility 

Compare’’ website provides facilityspecific adequacy-of-dialysis 

information in terms of what percentage 

of patients are receiving at least the 

minimal dose of dialysis (defined as a 

URR ≥ 65 percent). The use of minimal 

performance levels for adequate dialysis 

is widely used to allow for comparisons. 

However, facilities are encouraged to 

evaluate the needs of individual 

patients and to deliver the amount of 

dialysis that will promote optimal 

health outcomes for that patient. 

In addition, we are proposing in 

§ 494.110(a)(2)(ii) that the dialysis 

facility’s QAPI program must also 

address nutrition. The nutritional status 

of the dialysis patient impacts the 

patient’s morbidity, mortality, and 

overall quality of life. The nutritional 

status of the patient may be affected by 

medical symptoms, physiological 

responses to ESRD, the dialysis process 

itself, anemia, endocrine disorders, etc. 

The importance of nutritional status in 

dialysis patients is recognized in the K/

DOQI clinical practice guidelines for 

nutrition of chronic renal failure and in 

the ESRD CPM Project’s inclusion of 

serum albumin levels. Under the plan of 

care condition (proposed § 494.90) we 

are proposing that the serum albumin 

level be monitored on a monthly basis. 

The facility may track the serum 

albumin levels or any other pertinent 

markers of nutritional status as part of 

its QAPI program. The goal is to identify 

care system opportunities for improving 

patient nutritional outcomes and then 

develop and implement interventions 

that will potentially achieve the targeted 

outcomes. 

We are also proposing in 

§ 494.110(a)(2)(iii) that the QAPI 

program must include anemia 

management. Existing §§ 405.2137(b) 

and 405.2163(g) address the patient’s 

hematocrit level as the indicator for the 

necessity for administering 

erythropoietin. In 1996, anemia was the 

subject of the first National Cooperative 

Project conducted by the ESRD 

networks. The reasons for selecting 

anemia both for the study and as an 

outcome measure included: (1) The 

prevalence of anemia among the 

Medicare population; (2) a consensus 

among the renal community that anemia 

is a major quality-of-life problem for 

dialysis patients and that proper drug 

manipulation can improve this 

condition; (3) the fact that commonly 

used measures of anemia (hematocrit 

and hemoglobin levels) are routinely 

collected by us when facilities bill 

Medicare for erythropoietin on the 

outpatient billing form; and (4) the 

relatively straightforward and easily 

accomplished process for monitoring 

hematocrit (or hemoglobin) levels. 

The United States Renal Data System 

(USRDS) Annual Data Report and the 

ESRD CPM Project provides regional 

and national anemia data that allow for 

facility benchmarking. The NKF–K/

DOQI clinical practice guidelines for 

Anemia of Chronic Kidney Disease 

(Guideline 4) recommend an evidencebased target for hemoglobin of 11–12 g/

dL (and hematocrit of 33 to 36 percent) 

for erythropoietin therapy. In May 2000, 

according to the 2001 Atlas of ESRD in 

the United States (USRDS), 12 percent 

of prevalent dialysis patients (that is, 

patients who have received chronic 

renal replacement therapy for at least 90 

days) with erythropoietin claims had 

hematocrits less then 30 percent and the 

risk of hospitalization is increased with 

hematocrit levels less than 30 percent. 

The 2001 ESRD Clinical Performance 

Measures (CPM) Project Annual Report 

revealed that 74 percent of in-center 

hemodialysis patients who were 

prescribed erythropoietin during the last 

3 months of 2000 had a mean 

hemoglobin of equal to or greater than 

11gm/dL (which is approximately equal 

to a hematocrit of 33 percent). This 

same report reveals that 63 percent of 

peritoneal dialysis patients prescribed 

Erythropoietin during the study period 

had a mean hemoglobin of equal to or 

greater than 11 gm/dL. This proposed 

rule uses anemia, as measured by the 

hematocrit or hemoglobin level, as an 

element of patient outcomes for both 

hemodialysis and peritoneal dialysis 

patients. 

Vascular access insertions and 

complications (for example, infection) 

have received increasing attention over 

the past few years. The current ESRD 

network quality improvement project, 

Fistula First, is focused on vascular 

access. Complications associated with 

vascular access account for about 18.3 

percent of ESRD patient hospitalizations 

(USRDS data from 2000) and is 

associated with high financial costs and 

diminished quality of life for the 

hemodialysis patient. Therefore, we are 

proposing in § 494.110(a)(2)(iv) that 

vascular access management be 

included in the facility’s QAPI program. 

Facilities should look for opportunities 

to improve patient outcomes related to 

vascular access by reviewing ESRD 

Fistula First data and ESRD CPM Project 

data in conjunction with the NFK-K/

DOQI clinical practice guidelines for 

vascular access. The ESRD CPM Project 

and the USRDS Annual Data Report 

provide regional and national data 

pertaining to vascular access. The NKF–

K/DOQI clinical practice guidelines for 

vascular access provide valuable 

information useful to a facility QAPI 

program regarding vascular access 

management.

We are proposing in § 449.110(a)(2)(v) 

to require a patient safety component 

specific to medical injuries and medical 

errors identification as part of each 

facility’s QAPI program. The IOM 

published a report entitled ‘‘To Err is 

Human: Building a Safer Health 

System,’’ that focused on the magnitude 

of medical errors, serious adverse events 

and the risks of medical care in the 

United States (IOM, 2000). Medical 

injuries and medical errors were also 

identified by the OIG as areas in which 

we should facilitate the development of 

publicly accountable means for 

identifying serious medical injuries and 

analyzing their causes. The OIG found 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6217

that medical injuries are not 

systematically monitored in dialysis 

facilities. 

The Renal Physicians Association 

(RPA), in partnership with the Forum of 

ESRD networks and the Patient Safety 

Foundation, has formed a Patient Safety 

Committee to address patient safety in 

dialysis facilities. The Committee’s 

report describes the work of 42 

stakeholder representatives from 34 

organizations as they engage in 

collaborative action planning (The 

Renal Physicians Association, 2001). 

The group identified challenges in 

improving patient safety, action options, 

and priorities. These participants have 

expressed their commitment to 

interorganizational collaboration on 

selected actions in the launch of the 

next phase of this initiative. The Phase 

I Report supports for the incorporation 

of patient safety activities into the 

conditions for coverage for ESRD, to 

encourage universal engagement in 

patient safety participation. This 

initiative provides resource information 

that may be useful to facilities as they 

develop their QAPI program to reduce 

medical errors and injuries. 

We propose in § 494.110(a)(2)(vi) that 

if a dialysis facility reprocesses 

hemodialyzers they must include reuse 

systems in their QAPI program. The 

AAMI Reuse of hemodialyzers RD47 

chapter (incorporated by reference in 

both the existing and the proposed 

conditions) includes guidelines for a 

reuse quality assurance program under 

section 14. Section 14 outlines quality 

assurance program areas that include: 

(1) Records that serve as the quality 

assurance foundation; (2) schedule of 

quality assurance activities; (3) patient 

considerations; (4) equipment; (5) 

physical plant; (6) supplies; (7) dialyzer 

labeling; and (8) reprocessing and 

preparation for dialysis. Since these 

activities are the same in the proposed 

conditions for coverage as in the 

existing conditions for coverage, there is 

no additional regulatory burden. 

Continuous quality management in the 

reuse area is important to ensuring 

patient safety. 

Assessment of patient satisfaction was 

identified by the OIG as a means of 

identifying patient concerns often 

missed by the complaint process. The 

OIG recognized that patients play an 

increasingly important role in their own 

health care, and that techniques of 

assessing patient satisfaction have 

become increasingly sophisticated. We 

concurred with the OIG’s 

recommendation. Therefore in 

§ 494.110(a)(2)(vii), we are proposing 

that dialysis facilities include patient 

satisfaction in their QAPI programs. The 

OIG further recommended that we exert 

leadership to facilitate the development 

of a common instrument that facilities 

and others could use to assess patient 

satisfaction. Many facilities do currently 

use a patient survey as a means to assess 

patient satisfaction and some have 

experience in utilizing the results for 

quality improvement efforts. 

We are proposing that facilities 

monitor patient satisfaction and 

grievances as part of the QAPI program 

and have the flexibility to use the 

method of their choice to meet this 

requirement. Tracking patient 

satisfaction and grievances allow the 

facility to identify any areas in which 

patients have expressed concerns. The 

facility can analyze this information and 

determine what aspect of facility 

operations needs improvement. CMS 

has an Intra-agency Agreement with 

AHRQ to develop a standardized patient 

experience of care instrument and 

survey protocol. In 2003, AHRQ 

conducted a feasibility study to assess 

the feasibility and applications (that is, 

quality improvement and public 

reporting) of a survey that measures 

dialysis patients’ experience of care in 

renal dialysis facilities. In the August 

25, 2003 Federal Register (68 FR 

51017), AHRQ published a notice that 

identified and cataloged existing 

surveys and survey results made 

available to the team and presented the 

exhaustive literature review that was 

performed. In addition, a Technical 

Expert Panel consisting of ESRD 

patients and professionals was 

consulted. AHRQ’s ESRD Consumer 

Assessment of Health Plan Survey 

(CAHPS) Feasibility Final Report and 

the CMS response can be found on 

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

the ESRD link to the CAHPS link). 

In the Feasibility Report, AHRQ 

recommended that a standardized 

survey for measuring in-center 

hemodialysis (ICH) patients’ experience 

and ratings of their care be developed 

that could serve several important and 

distinct purposes. An ICH CAHPS 

survey would provide information for 

consumer choice, reports that facilities 

can use for internal quality 

improvement and external 

benchmarking against other facilities, 

and finally, information that we can use 

for public reporting and monitoring 

purposes. The survey would be in the 

public domain and consist of a core set 

of questions that could be used in 

conjunction with existing surveys. 

In a January 30, 2004 Federal Register

notice (69 FR 4520) published as part of 

the Paperwork Reduction Act (PRA) 

process, a draft survey and pilot test 

plan were issued. On July 23, 2004, a 

second Federal Register notice (69 FR 

44012) was published and the package 

including the draft survey and pilot test 

plan was submitted to OMB at that time. 

We will take into consideration the 

practical difficulties and potential 

burden on facilities that may result from 

requiring the use of a common 

instrument for assessing patients’

experience of care. However, we invite 

comment on the value of utilizing one 

common survey that can yield 

information permitting comparisons of 

facilities across the nation. 

We are also interested in how 

facilities will assess the effectiveness of 

their internal grievance adjudication 

process, track the outcomes of patient 

grievances, and identify meaningful 

criteria for evaluation and tracking 

purposes. We are soliciting comment on 

how evaluating and tracking grievances 

can be used to improve patient 

outcomes of care. 

2. Monitoring Performance 

Improvement (Proposed 494.110(b)) 

We will specifically expect a facility 

whose treatment outcomes vary 

significantly from accepted standards to 

identify the reasons for poor outcomes 

and implement improvement projects to 

achieve expected outcomes. Therefore, 

we are proposing in § 494.110(b) that 

the dialysis facility must take actions 

that result in performance 

improvements and must track 

performance to assure standards are met 

and that improvements are sustained 

over time. This action stimulates the 

provider to continuously examine and 

improve performance. In addition, we 

are retaining the requirement in existing 

§ 405.2134 that requires a dialysis 

facility to participate in ESRD network 

activities and pursue Network goals. 

3. Prioritizing Improvement Activities 

(Proposed 494.110(c))

The principal focus of the facility’s 

continuous quality improvement 

program should be to establish a 

strategy to prioritize improvements in 

facility services so that performance 

improvements lead to better outcomes 

of care and increased satisfaction for 

patients. To this end, the proposed 

§ 494.110(c) requires the dialysis facility 

to set priorities for performance 

improvement, considering prevalence 

and severity of identified problems and 

giving priority to improvement activities 

that affect clinical outcomes. The 

facility must immediately correct any 

identified problems that directly or 

potentially threaten the health and 

safety of patients. Under the continuous 

quality improvement system, facilities 

should be analyzing care processes that 

6218 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

determine how the facility’s 

performance has affected—positively 

and negatively—patients, especially in 

terms of what the patient actually 

experiences. This proposed requirement 

emphasizes the need for the facility to 

focus on the areas of performance where 

problems have been specifically 

identified, especially in areas relating to 

outcomes of patient care. By prioritizing 

areas of improvement, facilities can: (1) 

Identify areas where outcomes indicate 

a need for improvement; (2) define 

measures to improve outcomes; (3) 

review implementation of improvement 

actions; and (4) determine the success of 

the actions implemented to improve the 

performance measures. 

With an effective QAPI program, the 

dialysis facility can identify and 

reinforce the activities that it is 

performing well and seek and respond 

to opportunities for improvement on a 

continuous basis. We intend that as a 

result of this proposed requirement the 

facility itself will be the catalyst that 

precipitates continuous improvements. 

The dialysis facility may choose to 

inform their patients of facility’s quality 

improvement activities and may want to 

engage patients who are dialyzing in 

their facility of these activities. The 

patient’s role in achieving quality 

improvement goals in areas such as 

adequacy of dialysis and vascular access 

should be acknowledged. Partnering 

with the patients to make improvements 

may be an important aspect of a 

successful QAPI program. 

The proposed QAPI Condition 

discussed in this section of the 

preamble encompasses a facility’s 

internal approach to improving the 

quality of dialysis care. We are 

considering putting into place, within 

these conditions, minimum clinical 

standards that would serve as external 

stimuli for further improvements in the 

quality of dialysis services. The 

following is a discussion of how 

minimum clinical standards could be 

implemented and specific areas for 

which we are soliciting public 

comment. 

4. Facility Specific Standards for 

Enforcement 

In this proposed rule, we have 

discussed and taken an approach to 

quality assurance that relies exclusively 

upon the facility’s own process for 

setting, monitoring, and maintaining 

clinical standards as the basis for 

evaluating its performance. This 

approach is consistent with our overall 

approach to quality improvement. 

However, dialysis care is provided in as 

homogeneous a medical context as any 

service and may well be susceptible to 

measurement against baseline clinical 

expectations. 

The OIG’s Report of 2000 on External 

Quality Review of Dialysis Facilities: A 

Call for Greater Accountability

encourages the use of standardized 

performance measures to hold 

individual facilities accountable for 

quality of care. OIG also recommends an 

approach that reflects a balance between 

collegial and regulatory modes of 

oversight. Their report addresses the use 

of standardized performance measures 

both to engage in quality improvement 

activities and to enforce minimum 

standards. 

Supporters of an approach requiring 

adherence to clinical standards for 

ESRD facilities argue that: (1) There is 

specificity and relative homogeneity in 

the services delivered; (2) there are 

significant risks to patient safety if care 

is not delivered appropriately; (3) the 

renal community has been proactive in 

defining and using clinical standards; 

(4) there are correlations between 

having acceptable NKF–K/DOQIderived measures for adequacy of 

dialysis and anemia and positive 

outcomes for individual patients; and 

(5) the data systems supporting ESRD 

program operations are comprehensive 

and unique. 

We are soliciting comments on the 

feasibility of using commonly agreedupon clinical standards in our 

requirements and enforcement efforts. 

In setting the minimum clinical 

standards for performance, we would 

use selected clinical practice guidelines 

developed by the NKF–K/DOQI, which 

were developed with broad community 

input and consensus, and have gained 

extensive national and international 

acceptance. We would initially establish 

minimal expectations about adequacy of 

dialysis rates and anemia levels, but we 

would continuously look to science for 

updated standards. 

The method for applying these 

standards would be to require that a 

dialysis facility must maintain 

minimum clinical standards (that is, 

adequacy of dialysis and anemia levels) 

for all patients. If the patient’s outcomes 

did not meet the clinical expectations, 

the interdisciplinary team would be 

required to make adjustments. If the 

patient is unable to achieve the 

minimum expected clinical outcomes, a 

member of the interdisciplinary team 

would need to enter an explanation in 

the patient’s medical records. If the 

minimum expected clinical outcome is 

achievable but is not being achieved, the 

interdisciplinary team would be 

expected to develop and implement an 

improvement program to achieve and 

maintain the expected outcome. 

We would periodically establish our 

requirements and publish them in the 

Federal Register. The standards that we 

would use if this approach were 

adopted are as follows: 

• The minimum delivered threshold 

for Kt/V is—

—1.2 (single pool) for hemodialysis 

patients (as specified in the NKF–K/

DOQI Clinical Practice Guidelines For 

Hemodialysis Adequacy: Update 

2000, Guideline 4); 

—1.7 (weekly) for continuous 

ambulatory peritoneal dialysis 

patients (as specified in the NKF–K/

DOQI Clinical Practice Guidelines for 

Peritoneal Dialysis Adequacy: Update 

2000, Guideline 15); 

—2.1 (weekly) for continuous cycling 

peritoneal dialysis patients (as 

specified in the Peritoneal Dialysis 

Adequacy: Update 2000, Guideline 

16); and 

—2.2 (weekly) for intermittent 

peritoneal dialysis patients (as 

specified in the Peritoneal Dialysis 

Adequacy: Update 2000, Guideline 

16).

• For anemia management, the 

minimum required levels would be—

—A hemoglobin level of 11 gm/dL (as 

specified in the NKF–K/DOQI Clinical 

Practice Guidelines for Anemia of 

Chronic Kidney Disease: Update 2000, 

Guideline 4); or 

—A comparable hematocrit of at least 33 

percent (as specified in the NKF–K/

DOQI Clinical Practice Guidelines for 

Anemia of Chronic Kidney Disease: 

Update 2000, Guideline 4).

To make this approach work, we 

would need to address and mitigate the 

disadvantages that arise from assigning 

minimum numerical target values. We 

would be required to go through a 

rulemaking process each time we 

wanted to update the numerical values 

to correspond with any scientific 

advances. NKF–K/DOQI clinical 

practice guidelines for adequacy of 

dialysis and anemia are designed for 

assessing individual patient care based 

on individual patient characteristics. 

We would need to address the issue of 

using these as measures for facility-wide 

performance. Can this effectively be 

done or would a risk adjustor need to 

be developed to avoid disadvantaging 

facilities that have a different case mix? 

We are also soliciting comments on 

methods for using current NKF–K/DOQI 

clinical practice guidelines as facilitywide measures. For example, comments 

on the use of the statistically based 

threshold measures of performance 

would be especially helpful. Under such 

an approach, facilities in which a 

predetermined portion of patients fail to 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6219

meet the selected clinical standards over 

some period of time, using a standard 

deviation, percentile-based, or some 

other method, need to develop a 

corrective action plan. We are 

specifically soliciting comments on this 

issue. 

If we were to codify a clinical 

standards condition, the text would read 

as follows: 

Condition: Clinical Standards 

The dialysis facility must maintain 

minimum clinical standards for all 

patients. If the patient’s care does not 

meet such standards, the 

interdisciplinary team must make 

adjustments. If the patient is unable to 

achieve the minimum expected clinical 

outcomes, a member of the 

interdisciplinary team must provide an 

explanation in the patient’s medical 

records. If the minimum expected 

clinical outcome is achievable but is not 

being achieved, the interdisciplinary 

team must develop and implement an 

improvement program to achieve and 

maintain the patient’s expected level of 

general health. 

Standard: Performance Expectations 

(a) Dose of dialysis. The 

interdisciplinary team must assist and 

support facility patients in achieving 

and maintaining the expected dose of 

dialysis as specified by the Secretary 

and published in accordance with the 

notification requirements in paragraph 

(d)(i) of this section. 

(b) Anemia. The interdisciplinary 

team must assist and support facility 

patients in achieving and maintaining 

the expected hematocrit/hemoglobin 

level as specified by the Secretary and 

published in accordance with the 

notification requirements in paragraph 

(d)(i) of this section. The patient’s 

hematocrit/hemoglobin levels must be 

measured at least monthly. 

(c) Additional clinical standards.

Facilities are responsible for assuring 

that their patients achieve at least a 

minimum performance level on 

additional clinical standards that may 

be selected by the Secretary. The 

methodology and minimum 

performance expectations will be 

determined in accordance with the 

NTTAA guidelines. 

(d) Notification. CMS will publish a 

Federal Register document that 

proposes or finalizes—

(i) The current minimum expected 

outcomes for dose of dialysis and 

anemia referenced in paragraphs (a) and 

(b) of this section. 

(ii) Other standards upon 

development and acceptance of the 

standards by the Secretary. 

F. Condition: Special Purpose Renal 

Dialysis Facilities (Proposed § 494.120) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Special Purpose Renal Dialysis 

Facilities’’ at the beginning of your 

comment.] 

Special purpose renal dialysis 

facilities are dialysis units approved on 

a short-term basis (currently, for no 

more than 8 months) to provide dialysis 

services to a group of patients otherwise 

unable to obtain treatment in the 

geographic area served by the facility. 

The existing requirements for special 

purpose renal dialysis units are in 

§ 405.2164. That section states that 

special purpose units must comply with 

the conditions specified at §§ 405.2130 

through 404.2164, with the exception of 

§§ 405.2134 to 405.2137 (that is, 

conditions relating to participation in 

network activities and the patient longterm care program). Existing 

§ 405.2164(b) requires a special purpose 

facility to consult with the patient’s 

physician to ensure that care provided 

is consistent with the care plan and 

long-term care plan required in existing 

§ 405.2137. Existing § 405.2164(c) 

requires the ‘‘period of approval’’ (that 

is, Medicare certification), not to exceed 

8 calendar months. 

In the May 11, 1983 Federal Register

(48 FR 21254), we published a final rule 

that provided for time-limited approval 

of special purpose renal dialysis 

facilities. These facilities were 

established for two purposes: (1) To 

serve ESRD patients in a vacation area 

(such as a vacation camp) when the area 

is too remote from existing approved 

facilities to allow convenient access by 

patients; or when a convenient 

approved facility does not have 

sufficient available capacity to serve a 

number of vacationing patients; and (2) 

to serve ESRD patients on an emergency 

basis when approved permanent 

facilities close due to natural disasters, 

strikes, or bankruptcies, and the backup 

facilities in the area cannot 

accommodate the patients of the closed 

facilities. In the May 11, 1983 final rule, 

the last provision was added 

specifically, ‘‘to ensure continuous 

access to care in the event that an 

approved permanent facility is closed 

because it cannot achieve adequate 

revenues under the prospective 

reimbursement system.’’ The 

certification period of 8 months was 

determined to be appropriate in 

response to public comments urging 

that the original temporary certification 

proposal (of 6 months) be extended. 

Following the publication of the May 

11, 1983 final rule, we developed a 

certification and approval process and a 

separate series of provider numbers for 

ESRD facilities approved as special 

purpose renal dialysis facilities. 

In our deliberations regarding any 

possible revisions to this condition, we 

found that very few vacation camps 

have requested approval for certification 

as special purpose renal dialysis 

facilities. In March 2001, for example, 

Medicare records indicated that only 

one vacation camp in the United States 

was certified as a special purpose renal 

dialysis facility. We now question 

whether the requirements for vacation 

camp renal facilities to be certified as a 

special purpose renal dialysis facility 

are too onerous. 

A search on the web lists 36 camps for 

ESRD patients throughout the United 

States. Some of the camps do not accept 

hemodialysis patients or accept 

hemodialysis patients for weekend only 

camps. These camps do not have a need 

for hemodialysis services. Other camps 

provide transportation to a certified 

hemodialysis facility off the 

campgrounds. Since the number of 

United States certified hemodialysis 

facilities has doubled in the last decade 

to approximately 4,000, transporting 

campers to a nearby dialysis facility 

may be feasible in many locations. It is 

not clear whether there remains a need 

to continue to establish vacation camp 

special purpose renal dialysis facilities 

in the conditions for coverage.

However, we are proposing to retain 

this condition in order to address the 

possible needs of patients who, as a 

result of the emergency conditions 

listed above, or participation in a remote 

vacation camp, need dialysis services on 

a short-term basis, and to ensure that 

facilities providing this type of care are 

properly certified for participation in 

the Medicare program. We are also 

proposing to reduce the burden of the 

requirements that a vacation camp must 

meet in order to be certified as a special 

purpose renal facility. Vacation camps 

generally operate during the summer 

months, when schools are closed, and 

usually offer sessions lasting up to 2 

weeks. The task of meeting the ESRD 

conditions for coverage in order to offer 

a few camp sessions each year (with the 

exception of the conditions relating to 

participation in network activities and 

the patient long-term care program), 

may deter vacation camps from 

providing hemodialysis services and 

seeking Medicare certification. 

Therefore, we are proposing in 

§ 494.120 that a special purpose renal 

dialysis facility would be approved to 

furnish dialysis at special locations, that 

is, vacation camps that serve ESRD 

patients in a temporary residence, or 

6220 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

facilities established to serve ESRD 

patients under emergency 

circumstances. A vacation camp must 

be operated under the direction of a 

certified renal dialysis facility that 

assumes full responsibility for the care 

provided to patients. 

Proposed § 494.120(a) maintains the 

8-month approval period in the existing 

§ 405.2164(c). In view of the history of 

the few Medicare-certified special 

purpose dialysis facilities, we believe a 

8-month approval period is adequate. 

Proposed § 494.120(b) would retain 

the existing service limitation 

requirement (specified in § 405.2164(d)) 

that limits the special purpose unit to 

providing services only to those patients 

who would otherwise be unable to 

obtain treatments in the geographic 

locality served by the facility. 

In addition, we are proposing in 

§ 494.120(c)(1) that a special purpose 

renal dialysis facility would be 

approved as a vacation camp by 

demonstrating compliance with the 

following standards and conditions for 

coverage: 

• Infection control (§ 494.30)). 

• Water quality (§ 494.40); if the 

facility uses home portable water 

treatment systems, the facility would 

instead comply with the provision 

regulating home monitoring of water 

quality (§ 494.100(c)(1)–(v)). 

• Reuse of hemodialyzers and other 

dialysis supplies if reuse is performed 

(§ 494.50). 

• Patients’ rights (§§ 494.70(a) and 

(c)). 

• Laboratory services (§ 494.130); a 

facility would be required to have a plan 

for obtaining laboratory services for 

cases when it is necessary for patient 

safety. 

• Medical director responsibilities for 

patient care policies and procedures 

(§ 494.150(c) and (d)). 

• Medical records (§ 494.170). 

We are proposing in § 494.120(c)(2) to 

specify that a special purpose renal 

dialysis facility certified due to 

emergency circumstances may provide 

services only to those patients who 

would otherwise be unable to obtain 

treatments in the geographical areas 

served by the facility and is approved by 

demonstrating compliance with 

§ 494.120(c)(1) and the following 

additional conditions: 

• Compliance with Federal, State, 

and local laws and regulations 

(§ 494.20). 

• Physical environment (§ 494.60). 

• Patients’ rights (§§ 494.70(a) 

through (c)). 

• Personnel qualifications 

(§ 494.140). 

• Medical director (§ 494.150). 

• Governance (§ 494.180). 

While the certification of a special 

purpose unit is time-limited and the 

patient’s treatment in the unit will be 

limited, we believe that every effort 

must be made to ensure that the quality 

of care provided is comparable to that 

provided to any dialysis patient in a 

Medicare-approved unit. However, we 

believe requiring compliance with any 

additional requirements would be too 

burdensome for a special purpose unit. 

We are proposing in § 494.120(d) to 

retain the existing requirement that a 

special purpose unit consult with the 

patient’s physician, with an added 

provision that this consultation must 

occur before the initiation of dialysis in 

the special purpose unit. This provision 

is added to ensure that the special 

purpose unit is fully aware of the 

patient’s current medical condition and 

that the special purpose unit can 

provide dialysis services consistent with 

the patient’s plan of care described at 

§ 494.90. 

In addition, we are proposing in 

§ 494.120(e) to require the special 

purpose unit to document care provided 

to the patient and forward that 

documentation to the patient’s regular 

dialysis facility within 30 days of the 

last scheduled treatment in the special 

purpose unit. 

We are soliciting comments on 

whether vacation camps should 

continue to be included under the 

special purpose renal dialysis facility 

condition for coverage. 

G. Laboratory Services (Proposed 

§ 494.130) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Laboratory Services’’ at the beginning 

of your comment.] 

In 1994, we revised existing 

§ 405.2163 to stipulate that the dialysis 

facility must make available laboratory 

services (other than tissue pathology 

and histocompatibility) and that all 

laboratory services must be performed 

by an appropriately certified laboratory 

in accordance with the Clinical 

Laboratory Improvement Amendments 

(CLIA) regulations at 42 CFR 493. 

Existing § 405.2163(b) also requires a 

dialysis facility that furnishes laboratory 

services to furnish these services in 

accordance with applicable 

requirements established for 

certification of laboratories under the 

CLIA. Independent dialysis facilities 

must be certified under CLIA to perform 

and bill most laboratory tests to the 

Medicare program. This section also 

allows a dialysis facility that does not 

provide laboratory services to make 

arrangements to obtain these services 

with a laboratory certified under CLIA. 

We are proposing in § 494.130 to 

retain the existing requirements 

governing laboratory services in 

§ 405.2163(b) without change. 

VI. Provisions of Proposed Subpart D: 

Administration 

A. Personnel Qualifications (Proposed 

§ 494.140) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Personnel Qualifications’’ at the 

beginning of your comment.] 

The existing personnel qualifications 

of dialysis facility staff can be found in 

§ 405.2102. Those requirements list the 

education and experiential requirements 

for chief executive officers, physiciandirectors, nurses responsible for nursing 

services, dietitians, medical records 

practitioners, transplantation surgeons, 

and social workers.

In existing § 405.2102(e), a physiciandirector must be board eligible or board 

certified in internal medicine or 

pediatrics with at least 12 months of 

experience or training in the care of 

patients at ESRD facilities. 

Existing § 405.2102(d) defines the 

nurse ‘‘responsible for nursing service’’

as a person who is licensed as a 

registered nurse by the State in which 

practicing, with at least 12 months 

experience in clinical nursing, with at 

least 6 months experience in nursing 

care of patients with permanent kidney 

failure or patients undergoing kidney 

transplantation, or 18 months of 

experience in nursing care of the patient 

on maintenance dialysis. This section 

also states that if the same individual is 

assigned responsibility for self-care 

dialysis training, that individual must 

have at least 3 months experience in 

training ESRD patients for self-care. 

Existing § 405.2102(b) defines a 

dietitian as a person who—

• Is eligible for registration by the 

American Dietetic Association under its 

requirements in effect on June 3, 1976 

and has at least 1 year of experience in 

clinical nutrition; or 

• Has a baccalaureate or advanced 

degree with major studies in food and 

nutrition or dietetics and at least 1 year 

of experience in clinical nutrition. 

Existing § 405.2102(f) defines a social 

worker as a person who is licensed in 

the State in which practicing, has 

completed a course of study with 

specialization in clinical practice at, and 

holds a masters degree from, a graduate 

school accredited by the Council on 

Social Work Education, or has served 

for at least 2 years as a social worker 

with at least 1 year in a dialysis or 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6221

transplantation program before 

September 1, 1976 and consults with a 

social worker holding a masters degree. 

ESRD is an extremely complex 

disease requiring highly technical and 

complex treatment, and patients with 

this disease have special needs that 

require highly specialized care that can 

only be provided by qualified 

personnel. As the demographics of the 

dialysis population continue to change, 

producing a more elderly patient 

population with more co-morbid 

conditions, direct patient care needs 

and the skill needed to meet those needs 

will continue to increase. Also, as we 

move away from unnecessary process 

and procedural requirements in the 

conditions for coverage towards better 

patient outcomes, it becomes even more 

important to have qualified, 

experienced, and well-trained staff to 

achieve the targeted clinical outcomes 

for each patient. 

In the past, industry representatives 

have supported the retention of 

minimum personnel qualifications in 

the conditions, and we are proposing to 

retain most of the existing personnel 

qualifications requirements in this 

proposed rule. We are also proposing 

changes where we believe they are 

needed, and those changes are 

discussed in the preamble discussion 

that follows. 

In § 494.140, we are proposing to 

consolidate all of the personnel 

qualifications requirements into a single 

condition, entitled ‘‘Personnel 

qualifications.’’ In addition, proposed 

§ 494.140 would require that a dialysis 

facility’s staff (whether employees or 

contractors) meet the personnel 

qualifications and demonstrated 

competencies necessary to serve the 

general needs of its patients. We also 

propose that the dialysis facility’s staff 

must have the ability to sustain and 

demonstrate the skills needed to 

perform the specific duties of their 

positions. 

We recognize that facilities are not 

always able to directly employ 

individuals to perform all required 

services; and therefore, facilities may 

continue to furnish services through 

qualified personnel by arrangement. 

Any position in a facility may be filled 

by a contracted employee, but the 

contracted employees must meet the 

personnel requirements as well as the 

demonstrated skills and competencies 

in proposed § 494.140 to ensure that 

patients receive quality care from all 

personnel. 

The expected outcome is the 

coordinated, comprehensive 

interdisciplinary delivery of appropriate 

and effective services provided by 

skilled professionals. These 

professionals would meet the 

requirements in this proposed rule and 

would adhere to the facility’s policies 

and procedures. The dialysis facility has 

the flexibility to assign specific duties to 

each staff member (either employee or 

contractor) who provides services in the 

facility, as long as the required 

outcomes required are being met. 

1. Medical Director (Proposed 

§ 494.140(a)) 

In proposed § 494.140(a) we would 

maintain some of the qualification 

requirements for a physician director. 

However, we propose to change the 

word ‘‘physician’’ to ‘‘medical’’ to be 

consistent with current standards of 

practice in the industry. The medical 

director of a facility is responsible for 

the development of patient care policies 

and the delivery of services. For this 

reason, we chose to require that the 

medical director be trained in 

nephrology and have experience in the 

care of dialysis patients to emphasize 

the need for experience in managing 

dialysis care and associated medical 

conditions. The medical director of a 

dialysis unit must have a thorough 

knowledge and understanding of the 

complexity of ESRD and its effects on 

the dialysis patient.

The existing regulation at § 405.2102 

requires that the director of the facility 

be either board certified or board 

eligible. There has been considerable 

disagreement within the medical 

community as to whether board 

certification or eligibility is an 

important indicator of professional 

competence. In view of the diversity of 

opinion in the industry and the absence 

of any indication that the quality of care 

would decline if this requirement were 

deleted, we are proposing to eliminate 

the requirement that the medical 

director be either board certified or 

board eligible. Thus, we propose to 

require only that the medical director be 

a physician who has completed a boardapproved training program in 

nephrology and has at least 12 months 

experience providing care to patients 

receiving dialysis. We are retaining the 

alternate option for situations when a 

physician who meets this criterion is 

not available that allows another 

physician to direct the facility, subject 

to the approval of the Secretary. In the 

absence of a compelling reason for 

maintaining the grandfathering 

provision for the physician director 

under § 405.2102(e)(2), we have not 

incorporated this provision in our 

proposed personnel qualifications for 

the medical director at § 494.140(a). 

2. Nursing Services (Proposed 

§ 494.140(b)) 

In § 494.140(b) we propose a Nursing 

Services standard that would include 

the necessary qualifications for 4 nurse 

categories: (1) The nurse responsible for 

nursing services in the facility; (2) the 

nurse responsible for training in selfcare; (3) the charge nurse with 

responsibility for each patient shift; and 

(4) any nurse who provides care and 

treatment in the unit. 

We are proposing in § 494.140(b)(1)(i) 

to retain the existing requirement at 

§ 405.2162(a) that each facility employ 

at least 1 full time qualified nurse 

responsible for nursing service in the 

unit. In proposed § 494.140(b)(1)(ii) and 

(iii) we would maintain the existing 

requirements that the nurse responsible 

for nursing services in the unit be a 

registered nurse who meets the practice 

requirements of the State in which he or 

she is employed, and has at least 12 

months of experience in clinical nursing 

with an additional 6 months of 

experience in providing nursing care to 

patients on maintenance dialysis. 

We are proposing in § 494.140(b)(2) to 

specify the requirements for the nurse 

responsible for training in self-care. For 

a detailed discussion of these nursing 

requirements see section V.D.1. of this 

preamble. 

We are proposing in § 494.140(b)(3)(i) 

to retain with minor modifications the 

existing requirement at § 405.2162(b)(1) 

that the individual responsible for each 

shift be a licensed health professional 

such as a registered nurse (RN) or a 

licensed practical nurse (LPN) who 

meets the practice requirements of the 

State in which he or she is employed. 

We recognize that in some instances, a 

licensed practical nurse is able to 

demonstrate the knowledge, training, 

and experience to serve as the charge 

nurse in a dialysis unit and this is 

currently the practice in some units. In 

proposed § 494.140(b)(3)(ii) we would 

specify that the charge nurse must have 

at least 12 months experience in nursing 

care, including 3 months of specialized 

experience in providing clinical nursing 

care to patients on maintenance 

dialysis. 

We are proposing in § 494.140(b)(4) 

that each nurse who provides care and 

treatment to patients must be either a 

registered nurse or a licensed practical 

nurse who meets the practice 

requirements of the State in which he or 

she is employed. 

3. Dietitian (Proposed § 494.140(c)) 

Renal dietitians are important and 

necessary members of the patient’s 

interdisciplinary care team. Some of the 

6222 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

responsibilities of the renal dietitian are: 

(1) Counseling patients on management 

of protein, sodium, potassium, 

phosphorus, and fluid controlled diets, 

translating the chemistry of these limits 

into meals for patients; (2) monitoring 

vitamin and mineral supplementation, 

including iron levels and their effect on 

erythropoietin; (3) managing glycemic 

control of diabetic patients by 

manipulation of diet; and (4) assessing 

nutritional status by using clinical and 

biochemical measures. 

We believe that these kinds of 

activities will require a dietitian with 

specialized experience in clinical 

nutrition. The specialized training and 

experience would ensure that dialysis 

facilities have a dietitian knowledgeable 

about medical nutrition therapy, 

physiology, and food composition. This 

specialized knowledge is critical if a 

dietitian is to effectively manage the 

complex tasks necessary in treating a 

dialysis patient, so the patient is able to 

manage his or her own disease. 

We are proposing in § 494.140(c) to 

retain requirements comparable to the 

existing requirements laid out under the 

definition of ‘‘qualified personnel’’ at 

§ 405.2102(b). We propose that the 

dialysis facility dietitian be a registered 

dietitian with the Commission on 

Dietetic Registration, the official 

credentialing agent for the American 

Dietetic Association. We also propose 

that the dietitian meet the practice 

requirements of the State in which he or 

she is employed and have a minimum 

of 1 year of professional work 

experience in clinical nutrition as a 

registered dietitian in order to qualify to 

perform the special responsibilities of 

renal dietitians discussed above. 

4. Social Worker (Proposed 

§ 494.140(d)) 

We are proposing in § 494.140(d) to 

retain the existing requirements for 

social workers at § 405.2102(f), except 

for the ‘‘grandfather clause’’ which 

exempted individuals hired prior to the 

effective date of the existing regulations 

(that is, September 1, 1976) from the 

social work master’s degree requirement 

and substituted an experience criterion, 

which is 1 year in a dialysis setting; and 

a criterion requiring including a 

consultative relationship with a social 

worker with a master’s degree. Since 

this clause only applied to social 

workers without a master’s degree, 

already employed in a dialysis or 

transplantation setting as of 1975, we 

question whether there is any need to 

retain it. 

We recognize the importance of the 

professional social worker, and we 

believe there is a need for the 

requirement that the social worker have 

a master’s degree. Since the extension of 

Medicare coverage to individuals with 

ESRD, the ESRD patient population has 

become increasingly more complex from 

both medical and psychosocial 

perspectives. In order to meet the many 

and varied psychosocial needs of this 

patient population, we believe qualified 

master’s degree social workers (MSW) 

trained to function autonomously are 

essential. Social workers must have 

knowledge of individual behavior, 

family dynamics, and the psychosocial 

impact of chronic illness and treatment 

on the patient and family. The dialysis 

patient needs psychosocial evaluations, 

a treatment plan based on the patient’s 

current psychosocial needs, and direct 

social work interventions. Facility social 

worker services include counseling 

services, long-term behavioral and 

adaptation therapy, and grieving 

therapy. We believe that MSW training 

provides the necessary education and 

experience in these areas. We have 

removed the requirement for 

specialization in clinical practice, 

because this designation is not available 

in all States and may prove to be a 

barrier to social workers entering 

practice in the dialysis arena. 

While nonprofessional personnel may 

serve in a supportive capacity, we do 

not believe they can be employed in 

place of a fully-credentialed MSW. We 

recognize that dialysis patients also 

need other essential services including 

transportation and information on 

Medicare benefits, eligibility for 

Medicaid, housing, and medications, 

but these tasks should be handled by 

other facility staff in order for the MSW 

to participate fully with the patient’s 

interdisciplinary teams so that optimal 

outcomes of care may be achieved. 

5. Dialysis Technicians (Proposed 

§ 494.140(e)) 

There are no Federal requirements for 

dialysis technicians in the existing 

ESRD conditions for coverage with the 

single exception of reuse technicians, 

who are covered by the AAMI 

guidelines. When the existing 

conditions for coverage were published 

in 1976, dialysis technicians were an 

emerging occupation. At that time it was 

common for one nurse to provide 

dialysis care to two dialysis patients at 

a time. Currently, dialysis patient care 

technicians are the primary caregivers 

in most facilities and it is not unusual 

for a single technician to provide 

dialysis care to three or four patients at 

a time. 

The discussion that follows applies 

primarily to dialysis technicians who 

provide direct patient care. Training and 

other requirements for reuse technicians 

are described in specific sections of the 

AAMI guidelines, which have been 

incorporated by reference in existing 

§ 405.2150(a)(1) and in this proposed 

rule (see § 494.50). 

As we researched this issue, we 

reviewed past and current efforts by the 

States to regulate dialysis technicians. 

The States are currently using a variety 

of approaches and methodologies to 

regulate dialysis technicians, including 

minimum qualification requirements, 

mandatory competency testing, 

registration, licensure, and certification. 

We also looked at the typical scope of 

practice for this occupation in dialysis 

facilities, and took into account the 

public policy positions and statements 

from national associations and 

organizations that advocate uniform 

Federal guidelines for dialysis 

technicians.

Arizona, Ohio, and Oregon now 

require dialysis technician certification 

via a nationally standardized 

examination. California and Texas 

require specific training and testing, but 

allow a nationally standardized 

certification examination to be 

substituted for their training and testing 

requirements. Georgia identifies a 

standardized training program for 

hemodialysis patient care technicians 

(PCTs), but does not require technicians 

to pass a national certification test 

unless a facility’s training program fails 

to provide adequate training. The three 

organizations that provide nationally 

recognized standardized certification 

examinations are listed later in this 

section of the preamble. 

Other States including Connecticut, 

South Dakota, Kentucky, Utah, Virginia, 

Washington, New Mexico, and the 

District of Columbia require certain 

training and competencies for dialysis 

technicians. States with past or ongoing 

efforts to regulate the practice of 

unlicensed dialysis technicians and 

technical staff include Colorado, 

Illinois, Louisiana, Maryland, New York 

and Oklahoma. 

Some national associations (for 

example, the American Nephrology 

Nurses Association (ANNA) and the 

National Association of Nephrology 

Technicians (NANT)) have advocated 

uniform training and certification 

requirements for dialysis technicians for 

several years and continue to advocate 

for these measures at the State and 

national level. Their primary concern is 

to ensure that care is provided by 

qualified and trained health care 

workers who are able to demonstrate the 

necessary competencies to perform the 

assigned duties of their positions. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6223

Since 1990, NKF’s Public Policy 

Board has been interested in evaluating 

and defining the proper role of, and 

training needed by, dialysis technicians. 

In 1992, NKF’s Dialysis Technician Task 

Force published an extensive list of 

tasks that define the ‘‘patient care role 

description’’ as well as the appropriate 

areas of required training (NKF, pp. 

229–232). The authors of that article 

advocated, among other things, that 

technicians should have at least a high 

school diploma or equivalency; take 

training courses in the basic sciences; 

report directly to a registered nurse; and 

be able to effectively perform specific 

tasks, subject to individual State 

licensure and scope of practice laws and 

regulations. The article also 

recommended a basic training course 

curriculum for renal technicians which 

included, among other things: (1) An 

introduction to dialytic therapies; (2) 

principles of hemodialysis; (3) the 

effects on the patient of kidney failure; 

(4) dialysis procedures; (5) hemodialysis 

devices; (6) water treatment; (7) 

reprocessing (if applicable); (8) patient 

education; (9) infection control; and (10) 

the techniques used in quality assurance 

and continuous quality improvement. 

The adverse outcomes for dialysis 

patients of improper care from 

inadequately trained dialysis 

technicians could include blood leaks, 

access damage, incorrect dialysis 

concentrate, infection, and hypotension. 

Increased numbers of patient 

hospitalizations, which in turn result in 

higher costs to both public and private 

payers, could also be a direct outcome 

of poor patient care from dialysis 

technicians. 

In most dialysis facilities, renal 

technicians now provide a large 

percentage of direct patient care 

services. In most instances, care is 

provided under the supervision of a 

registered nurse. However, the degree of 

supervision and the technician-topatient ratio will often vary from facility 

to facility. 

A wide variety of tasks are performed 

by dialysis technicians, depending on 

the limitations of State law. These tasks 

include, but are not limited to the 

following: 

• Preparing dialysis apparatus. 

• Performing equipment safety 

checks. 

• Initiating dialysis (including 

cannulation and venipucture with large 

gauge needles). 

• Intravenous administration of 

heparin and sodium chloride solutions. 

• Subcutaneous or topical 

administration of local anesthetics in 

conjunction with placement of fistula 

needles. 

• Intraperitoneal administration of 

sterile electrolyte solutions and heparin 

for peritoneal dialysis. 

• Monitoring patients during dialysis. 

• Taking vital signs. 

• Documenting tasks and patient 

observations. 

• Equipment maintenance and repair. 

• Water systems monitoring and 

maintenance. 

• Quality control measures. 

• Inventory. 

One of the options we considered was 

requiring certification for dialysis 

technicians. Certification is a voluntary 

process by which recognition is granted 

to an individual who has met certain 

qualifications. Certification is typically 

awarded upon the successful 

completion of an approved competency 

examination. The goal would be a 

national, standardized requirement for 

education, training, and competency 

testing for dialysis technicians. In 

considering this option, we noted that 

some States have chosen to develop 

their own competency examinations or 

to recognize competency examinations 

prepared and administered by one of the 

three national organizations that 

provide competency testing and 

certification for dialysis technicians. 

Those organizations are the Nephrology 

Nursing Certification Commission 

(NNCC), the Board of Nephrology 

Examiners Nursing and Technology 

(BONENT), and the National 

Nephrology Certification Organization 

(NNCO). The common goal of these 

organizations is to administer an 

effective test that serves as a basis to 

certify technicians for initial or more 

advanced competencies in knowledge, 

skill and abilities. 

In our deliberations on whether to 

propose Federal requirements for 

dialysis technicians engaged in direct 

patient care, we are reminded that 

Medicare has had a longstanding policy 

of respecting State control and oversight 

of health professionals. The Congress 

has left this licensure function to the 

States and Medicare recognizes Statedefined scope-of-practice laws under 

which health care professionals are 

licensed in the United States. 

After careful consideration, we do not 

believe it would be prudent to propose 

a national certification requirement for 

dialysis technicians at this time. We 

take this position for several reasons. 

First, there is no consensus within the 

renal community regarding the efficacy 

of technician certification to produce 

improved patient outcomes of care. 

Second, there is no standardized 

national certification test at this time, 

and the individuals and organizations, 

including the States, who advocate or 

have adopted certification are not in 

agreement regarding which certification 

test is the most effective. Some States 

have designed, or are in the process of 

designing, their own competency 

examinations, while others have 

recognized one or more of the existing 

examinations as evidence of compliance 

with their requirements. Finally, a 

Federal certification requirement 

entailing mandatory competency 

examinations would necessitate 

additional costs for transportation, 

lodging, fees, and preparatory materials 

associated with the examination. Those 

costs would have to be borne by either 

the individuals seeking certification, the 

dialysis facilities, or both. Without clear 

evidence that certification would 

produce better patient outcomes, we are 

reluctant to propose any new 

requirements that would drive up costs 

for technicians in current practice, 

dialysis facilities, or both. Therefore, for 

these reasons, we believe it is more 

prudent at this time, not to propose a 

national certification requirement for 

dialysis technicians. Instead, we are 

proposing in § 494.140(e) a set of 

minimum qualifications for dialysis 

technicians that will include a 

minimum education requirement, 

minimum requirements for on-the-job 

training and experience, and proposals 

for the composition of an effective 

technician-training program. 

We are proposing in § 494.140(e)(1) to 

specify that dialysis technicians meet all 

applicable State requirements (for 

example, credentialing, certification, 

and licensure) in the State in which 

they are employed. As stated above, we 

believe technicians in any Medicareapproved facility should comply with 

any existing State requirements for their 

profession. 

In proposed § 494.140(e)(2) we would 

require dialysis technicians to have at 

least a high school diploma or 

equivalency. We are proposing this 

criterion for two reasons. First, some of 

the States that regulate dialysis 

technicians (for example, Connecticut 

and Ohio) require dialysis technicians 

to have a high school education or 

equivalency.

Second, other States (for example, 

Texas, California, Oregon, and New 

Mexico) that require (among other 

options) certification by one of the 

national certification organizations (that 

is, NNCC, NNCO, BONENT) also require 

a high school diploma or equivalency 

because that is a prerequisite for taking 

the certification examination. We 

concur with the position taken by States 

that regulate dialysis technicians and 

the national technician certification 

organizations because we believe a 

6224 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

minimal education requirement is 

appropriate and necessary to enable an 

individual to complete the wide variety 

of patient care functions. 

We are proposing in § 494.140(e)(3) to 

require that each technician complete at 

least 3 months experience, following the 

facility’s training program (also required 

by § 494.180(b)(5)). This experience 

must be gained under the direct 

supervision of a registered nurse with a 

focus on the operation of kidney 

dialysis equipment and machines and 

providing direct patient care with 

particular sensitivity to the management 

of difficult patients. We see dialysis 

technician training as a cycle that 

proceeds from written instruction that 

would provide a basic foundation of 

knowledge, to a necessary period of onthe-job training under the supervision of 

a knowledgeable professional trained in 

all aspects of patient care, including 

medical emergencies. 

While written instruction is essential, 

we also believe properly supervised onthe-job training must follow to allow the 

technician to take maximum advantage 

of the information provided in the 

training program before the dialysis 

technician is allowed to provide direct 

patient care with minimal supervision. 

We believe 3 months of effective on-thejob, supervised training is necessary 

before a technician is permitted to care 

for patients without close and direct 

supervision. 

We have made this proposal for 

several reasons. As discussed in section 

VI.A.2 of this preamble, a registered 

nurse has the necessary professional 

training and expertise to coordinate care 

in the unit, perform patient assessments, 

respond to clinical questions from staff 

and patients, and coordinate ongoing 

care. Dialysis technicians, as the 

primary caregivers in most dialysis 

units, function as extensions of the 

unit’s professional nursing staff. We 

believe it is essential that a unit’s 

registered nurse provide the ‘‘hands-on’’

direct supervision to impart this 

training to new dialysis technicians. For 

example, in the patient outcomes 

environment these regulations are 

designed to encourage, it is essential 

that technicians understand the 

significance of continuous quality 

improvement (that is, collecting data, 

keeping logs, the clinical importance 

and meaning of target patient outcome 

measures, and recognizing and reporting 

medical errors). We also believe a 

registered nurse can be very effective in 

instructing new dialysis technicians in 

necessary aspects of patient care, such 

as ensuring patient privacy and 

confidentiality, and demonstrating good 

interpersonal skills when dealing with 

patients, including disruptive or 

challenging patients. In addition, a 

registered nurse is best equipped, 

through training and experience, to 

ensure that every technician can 

demonstrate the basic skills needed to 

provide routine patient care (for 

example, initiating, monitoring, and 

terminating dialysis; proper aseptic 

techniques; recognizing and reporting 

medical errors; and dealing with 

medical emergencies). For all of these 

reasons, we believe a 3-month period of 

direct supervision by a registered nurse 

is essential to ensure patient health and 

safety and to ensure that dialysis 

technicians that provide direct patient 

care can do their part to ensure that the 

unit meets its patient outcomes goals. 

We invite comments on the 3-month 

training proposal. 

We are proposing implementation of 

a training program that is specific to 

technicians who monitor the water 

treatment system. Water purity is 

important to protecting patient safety 

and the water must be adequately 

monitored and properly collected for 

testing as specified at proposed 

§ 494.40. The technician who carries out 

water testing and monitoring of the 

water treatment system must be 

appropriately trained following a 

program that has been approved by the 

medical director and governing body. 

Typically, facility patient care 

technician training programs contain a 

water treatment system training module. 

This module may form the basis of a 

training program that could be used to 

train a water treatment technician. 

6. Other Personnel Issues 

Existing § 405.2136(f)(1)(vi) requires 

the facility have patient care policies 

that cover pharmaceutical services. 

There is currently no Federal 

requirement for a pharmacist to play a 

role on the multidisciplinary team 

within the dialysis facility. The dialysis 

facility generally has some access to the 

pharmacist who is dispensing 

outpatient medications to the dialysis 

patient. A hospital-based dialysis unit 

might be able to use the hospital 

pharmacist as a resource. There may 

also be limited pharmacy resources 

available to the average dialysis facility 

that is administering intravenous drugs 

and making adjustments to a patient’s 

medication regimen. It has been 

suggested by some in the renal 

community that there should be a 

requirement within the proposed 

conditions for coverage for each dialysis 

facility to ensure a routine assessment of 

patient medications by a pharmacist. 

The reasons for this recommendation 

are: (1) Most dialysis patients take an 

average of 12 medications, which 

increases the risk of adverse drug 

events; and (2) the patients’ have 

complex pathophysiology, which affects 

how medications can be used safely 

(Kaplan, pp. 316–319). There are a 

number of publications that describe the 

contributions of pharmacists to the 

improved care of various patient 

populations while simultaneously 

reducing medication-related costs. 

Therefore, we have proposed, as part 

of the new patient assessment condition 

at § 494.80(a)(3), that facilities conduct 

a laboratory profile and medication 

history on each patient as part of their 

comprehensive patient assessment. 

However, we have not proposed a 

specific requirement for pharmaceutical 

services. We invite comments regarding 

what role, if any, the pharmacist should 

play within the dialysis facility as well 

as the facility’s appropriate 

responsibility for pharmaceutical 

services and the efficient use of 

medications in the new conditions for 

coverage. 

B. Condition: Responsibilities of the 

Medical Director (Proposed § 494.150) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Responsibilities of the Medical 

Director’’ at the beginning of your 

comment.] 

The requirements for the director of a 

renal dialysis facility are found in 

existing § 405.2161. Section 405.2161 

requires the director to be a physician 

who devotes sufficient time to his or her 

director responsibilities to plan, 

organize, conduct, and direct the 

professional ESRD services of the 

facility. Existing § 405.2161 also states 

that the physician-director may also 

serve as the chief executive officer 

(CEO) of the unit. 

Existing § 405.2161(a) states that the 

director must meet the qualifications 

described in § 405.2102 (that is, be 

board eligible or board certified and 

have at least 12 months of experience or 

training in the care of patients in ESRD 

facilities). Existing § 405.2161(b) 

requires the physician-director to: (1) 

Participate in the selection of a suitable 

treatment modality for all patients 

treated in the unit; (2) assure adequate 

training of nurses and technicians in 

dialysis techniques; (3) assure adequate 

monitoring of the patient and the 

dialysis process, including periodic 

monitoring of self-dialysis patients; (4) 

assure the development of a patient care 

policy and procedures manual and its 

implementation; and (5) assure that 

patient teaching materials are made 

available for self-dialysis and home 

dialysis patients. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6225

The June 2000 OIG Report was an 

extensive review to ascertain our 

effectiveness in monitoring the ESRD 

program. The report contained several 

recommendations regarding ways we 

should revise the ESRD conditions for 

coverage in order to strengthen the 

accountability of dialysis facilities that 

participate in the Medicare program. 

One of those recommendations was to 

reinforce the accountability of the 

dialysis facility’s medical director for 

the provision of patient care. 

Specifically, the report stated the 

following: ‘‘While the governing body of 

the facility is the basic source of 

accountability, the medical director 

should clearly be empowered as the onsite agent most directly responsible for 

the quality of care being delivered. In 

this capacity, the medical director 

should clearly have the authority to 

develop and monitor quality 

improvement efforts, to serve as an 

educational resource for medical and 

nursing staff, and, when individual staff 

are not performing adequately, to bring 

that to the attention of the facility’s 

designated governing authority.’’

In response to the OIG’s 

recommendations, we are proposing in 

§ 494.150 to retain medical director as a 

separate condition for coverage and 

strengthen the medical director’s role. 

Section § 494.150 would require each 

dialysis facility to have a medical 

director who meets the qualifications for 

that position at § 494.140(a) and who is 

responsible for the delivery of patient 

care and patient outcomes in the 

facility.

We are proposing in § 494.150(a) to 

assign the operational responsibility for 

the facility’s quality assessment and 

performance improvement (QAPI) 

program (§ 494.110) to the medical 

director. While the facility’s governing 

body is ultimately responsible for 

allocating the necessary resources (for 

example, dedicated staff and computers) 

to establish a QAPI program, we believe 

the medical director is best qualified to 

ensure that the facility’s QAPI program 

is effectively developed, implemented, 

maintained, and periodically evaluated. 

We are also proposing that the medical 

director ensure that all clinical staff in 

the facility, including attending 

physicians, actively participate in 

achieving the performance goals and 

objectives specified in the facility’s 

QAPI program. It is essential for an 

effective QAPI program that the 

attending physician and nonphysician 

staff, who treat patients in the facility, 

‘‘buy-in’’ to the facility’s quality 

improvement initiatives and actively 

participate in achieving the facility’s 

QAPI goals. In order for this to happen, 

we believe the medical director should 

be given the responsibility to ensure 

that all staff that treat patients actively 

participate in the facility’s QAPI 

program. In that capacity we would 

expect the medical director to make a 

special effort to educate and encourage 

facility staff, including attending 

physician and nonphysician staff, who 

have not actively participated in the 

facility’s QAPI program. In those rare 

instances when in-house or attending 

physician or nonphysician staff will not 

actively participate in the facility’s 

QAPI program, we would expect the 

medical director to refer those 

individuals to the facility’s governing 

body through its CEO or administrator. 

The governing body (see § 494.180) has 

the final legal responsibility and 

authority for the operation of the facility 

and the ultimate responsibility for the 

facility’s compliance with Federal 

Medicare regulations. 

In assuming operational responsibility 

for QAPI, this requirement emphasizes 

the importance of the medical director 

utilizing the best practices within a 

strong QAPI program. Under this 

requirement, we would expect the 

facility’s medical director to seek and 

use comparative data with other 

facilities when available and use the 

facility’s historical data to demonstrate 

internal improvements in outcomes over 

time. This standard also underscores the 

medical director’s ongoing 

responsibility to ensure that each 

patient treated in the facility achieves 

the best possible outcomes of care. 

We propose in § 494.150(b) to retain 

the existing requirement at 

§ 405.2161(b)(2) for the medical director 

to ensure that staff in the unit are 

adequately trained. We believe that all 

patient care personnel in the facility 

should receive the necessary education 

and ongoing training to furnish services 

effectively, efficiently, and completely. 

We are proposing in § 494.150(c)(1) to 

retain the existing requirement 

§ 405.2161(b)(4) for the medical director 

to assure the development of a ‘‘patient 

care policies and procedures manual’’

for the facility. While our goal 

throughout this proposed rule has been 

to eliminate unnecessary process 

requirements, we believe that a 

comprehensive patient care policies and 

procedures manual within a dialysis 

unit is an essential reference for clinical 

staff within the unit. The manual is also 

an opportunity for the medical director 

to incorporate improved treatment 

methodologies and current medical 

practices into day-to-day patient care 

within the facility in order to ensure 

better outcomes of care. 

We are proposing in § 494.150(c)(1) 

that the medical director participate in 

the development, periodic review, and 

approval of the patient care policies and 

procedures manual. We are also 

proposing in § 494.150(c)(2) that the 

medical director, as the individual with 

direct responsibility for the manner in 

which patient care is administered 

within the facility, be responsible to 

ensure that these patient care policies 

and procedures are adhered to by staff 

who treat patients in the dialysis 

facility, including attending physician 

and nonphysician staff. In those 

instances when facility staff or attending 

physicians or nonphysicians have not, 

or will not, follow the facility’s written 

patient care policies and procedures, we 

would expect the medical director to 

educate and encourage those 

individuals to follow facility policies 

and procedures. In those rare instances 

when the medical director has been 

unsuccessful in achieving compliance, 

we would expect the medical director to 

refer the matter to the facility’s 

governing body (see § 494.180). 

We are proposing in § 494.150(c)(2)(ii) 

that the medical director ensure that the 

interdisciplinary team follows the 

facility’s patient discharge and transfer 

policies and procedures described in 

§ 494.180(f). In section VI.E9 of this 

preamble, we proposed that all patients 

be informed of a facility’s transfer and 

discharge policies and be given 30 days 

notice in advance of a facility reducing 

or terminating on-going care. In 

addition, we are proposing that the 

medical director monitor and review 

each involuntary patient discharge to 

ensure that the patient’s 

interdisciplinary team has performed 

the tasks required in § 494.180(f). 

In a January 2002 report (Building on 

the Experiences of Dialysis 

Corporations, OEI–01–99–0052), the 

OIG recommended that the ESRD 

conditions for coverage specify the 

responsibilities of the Medical Director 

in situations when there is a quality 

problem related to an ESRD facility 

physician. The OIG recommendation 

follows:

CMS should also address in the Conditions 

what medical directors are expected to do 

when a quality problem is attributable to an 

attending physician who is not performing 

adequately. It should make clear that: (1) 

Medical directors have the authority to 

conduct or initiate peer review and to 

address performance problems through 

directed education, and (2) for more serious 

situations, the medical director’s 

responsibility to report a physician to an 

authoritative body, such as the End-Stage 

Renal Disease Network and/or the State 

Medical Board.

6226 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

We are soliciting comments on adding 

language to this regulation under the 

Medical Director condition to more 

specifically state Medical Director 

responsibilities in regard to ESRD 

facility attending physicians. 

C. Relationship With ESRD Network 

(§ 494.160) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘ESRD Network’’ at the beginning of 

your comment.] 

Existing §§ 405.2110 through 

405.2113 contain provisions that relate 

to the designation of the ESRD 

networks, the functions of the ESRD 

networks, and the role of the medical 

review boards. These provisions focus 

primarily on the role and 

responsibilities of the ESRD networks, 

rather than establishing conditions for 

Medicare coverage that must be met by 

dialysis facilities. Therefore, we are not 

incorporating these requirements in the 

proposed ESRD conditions for coverage. 

These regulations will remain in part 

405 and any revisions will be addressed 

in a separate notice of proposed 

rulemaking. 

While we believe that the role and 

responsibilities of the networks do not 

need to be included in the proposed 

conditions for coverage, we believe that 

dialysis facilities must continue to share 

information with the networks. Thus, 

we propose to require at § 494.160 that 

each facility cooperate with the ESRD 

network serving its designated area in 

fulfilling the terms of the Network’s 

scope of work contract with CMS, 

similar to the requirement under 

existing § 405.2134 concerning 

participation in network activities. In 

addition, we believe that this proposed 

condition pertains directly to the 

dialysis facility rather than the network 

and is a condition that a dialysis facility 

must meet in order to qualify for 

Medicare approval. 

D. Condition: Medical Records 

(§ 494.170) 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Medical Records’’ at the beginning of 

your comment.] 

The patient’s medical record presents 

a total picture of the care provided by 

the dialysis facility. The medical 

record—

• Serves as an organized plan for 

treatment and is used for diagnosing, 

treating, and caring for the patient; 

• Facilitates communication among 

the various health care professionals 

providing services to the patient; 

• Provides a focal point for 

coordinating the actions of the 

interdisciplinary team; 

• Provides an accurate picture of the 

patient’s progress in achieving care 

goals; 

• Provides the team interdisciplinary 

members with data for evaluating and 

documenting the quality and 

appropriateness of care delivered; and 

• Provides evidence of the facility’s 

implementation of policies and 

procedures relating to patient care. 

The existing Medical records 

requirements at § 405.2139 contain a 

large number of prescriptive 

requirements. These requirements 

include the following: 

• Requires that each medical record 

contain sufficient information to 

identify the patient, justify the diagnosis 

and treatment, and document the results 

accurately.

• Prescribes the content of the 

medical record to include, for example, 

patient assessment information, 

evidence the patient was informed of 

the assessment, identification and social 

data, consent forms, medical and 

nursing history, diagnostic and 

therapeutic orders, observations and 

progress notes, laboratory results, and, if 

necessary, a discharge summary. 

• Requires written policies and 

procedures to protect medical records 

information. 

• Requires the facility to designate a 

medical records supervisor and includes 

a list of duties and responsibilities for 

that individual. 

• Requires medical records to be 

completed promptly and states that all 

clinical information pertaining to the 

patient be maintained in a centralized 

location. 

• Requires facilities to maintain 

medical records in compliance with 

State laws, or for 5 years in the absence 

of State requirements. 

• Requires a facility to maintain 

adequate facilities, equipment, and 

space conveniently located, to provide 

efficient processing, viewing, filing, and 

prompt retrieval of medical records. 

• Requires that a facility provide for 

the interchange of medical and other 

information ‘‘necessary or useful’’ in the 

care and treatment of patients 

transferred between treating facilities. 

In keeping with our goals to eliminate 

unnecessary requirements and to reduce 

burden on dialysis facilities, we are 

retaining only those minimum facility 

requirements that we believe would be 

necessary in a patient outcome-oriented 

environment. 

In the proposed medical records 

condition for coverage (§ 494.170), we 

would state that the facility must 

maintain complete, accurate, and 

accessible medical records on all 

patients, including home dialysis 

patients for whom the facility has 

signed a backup agreement with a DME 

supplier to provide support services to 

the patient or whose care is under their 

supervision. The proposed rule 

emphasizes that a facility must maintain 

complete medical records for all 

patients under its supervision, 

including home patients. 

We propose to no longer prescribe the 

elements that facilities must include in 

the patient medical record. Instead, we 

believe that facilities should have the 

flexibility to decide what information 

must be included in the medical record 

as long as the services provided are 

consistent with the patient’s diagnosed 

condition. We believe facilities will 

document patient outcomes (such as

Kt/V and hematocrit levels), results of 

assessments and reassessments (see

§ 494.80), changes in the care plan (see

§ 494.90), and other pertinent 

information even though the elements 

are not prescribed, because this 

information is necessary to track patient 

progress, implement the patient care 

plan, record information needed to 

comply with the patient discharge or 

transfer procedure (see § 494.150(e)), 

and effectively manage a facility quality 

assessment and performance 

improvement program (see § 494.110). 

The patient’s plan of care condition (see

§ 494.90(b)) would require the facility to 

monitor and track patient progress 

toward the desired outcomes, and 

inherent in these requirements is the 

need to document patient results in 

some form. 

We are proposing at § 494.170(a)(1) to 

retain the existing § 405.2139(b) that 

requires a facility to protect its patients’

medical records against loss, 

destruction, or unauthorized use 

because the records are crucial to the 

patient’s care. 

However, we propose to eliminate the 

requirement at § 405.2139(b) that the 

facility must have written policies and 

procedures for recordkeeping. We 

believe this existing requirement is too 

restrictive and inflexible. The facilities 

must protect medical record information 

and keep all patient records 

confidential. Therefore, as long as there 

is a system in place to achieve the 

outcome, we believe that it is not 

necessary to require the facility to have 

written policies. However, facilities may 

find it necessary to have written 

procedures to ensure that they achieve 

the expected outcome. 

The existing requirement at 

§ 405.2139(b) mandates confidentiality 

in the handling of patient information

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6227

and requires facilities to safeguard 

patients’ records by making them 

available only to authorized individuals. 

Under this requirement, a patient may 

refuse release of records to any 

individual outside the facility, except in 

specific situations such as a patient’s 

transfer to another health facility or the 

release of information required by law. 

We are proposing in § 494.170(a)(2) 

that the patient’s medical record be 

released only under the following 

circumstances: (1) The transfer of the 

dialysis patient to another facility; (2) 

certain exceptions provided for in law; 

(3) provisions allowed under a third 

party payment contract; (4) approval by 

the patient; or (5) inspection by 

authorized agents of the Secretary as 

required for the administration of the 

Medicare program. 

We are proposing in § 494.170(a)(3) to 

maintain the existing requirement at 

§ 405.2139(b) that the facility obtain 

written authorization of the patient or 

legal representative for release of 

information not required or authorized 

to be released by law. 

We are proposing in § 494.170(b)(1) to 

retain the existing requirement at 

§ 405.2139(d) that current medical 

records and those of discharged patients 

are completed promptly. In a dialysis 

unit, it is essential that each clinical 

event be documented as soon as 

possible after its occurrence. 

Documentation must be current so that 

the medical records provide an up-todate picture of the status of the patient 

at all times. We recognize that stating 

that medical records should be 

completed promptly is somewhat vague 

and subject to interpretation. We invite 

comments on the addition of a specific 

timeframe for the completion of patient 

medical records. 

In proposed § 494.170(b)(2) we would 

maintain the existing requirement at 

§ 405.2139(d) that all clinical 

information pertaining to a patient is 

centralized. Regardless of how the 

medical record is completed and 

maintained (on paper or electronically), 

each member of the interdisciplinary 

team has access to the most recent 

information on the patient’s condition 

and prescribed treatment. 

We are also proposing, in 

§ 494.170(b)(3), that the dialysis facility 

is responsible for completing, 

maintaining and monitoring medical 

records for its Method II home dialysis 

patients and its other home patients. 

Under Method II, home dialysis patients 

elect to receive all equipment and 

supplies from a DME company. The 

DME supplier must have a backup 

agreement with a dialysis facility that 

provides support services to the patient. 

We have mentioned Method II 

specifically in this proposed 

requirement because Method II requires 

that the patient’s ESRD facility is fully 

aware of the equipment and supplies 

being used by the patient in order to 

accurately update the patient’s medical 

record. Our new focus on achieving 

better patient outcomes is contingent 

upon accurate and current medical 

records for Method II and all other home 

dialysis patients. 

In proposed § 494.170(c), we would 

make minor revisions to the existing 

requirement at § 405.2139(e) that 

medical records be retained for a period 

of time not less than that determined by 

State statute governing records retention 

or statute of limitations; or in the 

absence of a State statute, 5 years from 

the date of discharge; or, in the case of 

a minor, 3 years or until the patient 

becomes of age under State law, 

whichever is longer. The facility’s 

policy for the retention and preservation 

of records must conform to the 

requirements of State law or regulations. 

In this case, the date of discharge means 

the latest date the patient was 

discharged from any type of service 

provided by the dialysis facility.

As previously stated, existing 

§ 405.2139(f) requires the dialysis 

facility to maintain adequate facilities, 

equipment, and space conveniently 

located, to provide efficient processing 

of medical records (for example, 

reviewing, filing, and prompt retrieval) 

and statistical medical information (for 

example, required abstracts, reports). 

The rationale for this requirement was 

that patient records should be easily 

retrievable and available to all facility 

staff and that medical records of 

patients undergoing treatment should be 

located close to the treatment area so 

that no time is lost in obtaining records 

for review and documentation. 

Although we agree that patient medical 

records should be accessible, we do not 

believe the prescriptive requirements in 

existing § 405.2139(f) are necessary. As 

a result, we are proposing to eliminate 

this requirement. We believe that 

facilities already provide easy access to 

all patient medical records to ensure 

that all staff can promptly retrieve and 

review patient information. 

In § 494.170(d) we are proposing to 

retain the requirement in existing 

§ 405.2139(g) that requires the facility to 

provide for prompt transfer of medical 

information between treatment 

facilities. The intent of this requirement 

is to facilitate continuation of care 

whenever a patient has to either 

temporarily leave the facility (for 

example, for vacation or hospitalization) 

or transfer permanently to a new 

facility. We believe that it is essential to 

the continuation of care that a patient’s 

medical history and plan of treatment 

follow the patient. In addition, we are 

proposing to require that the facility 

exchange all medical records within 1 

working day. The requirement that 

information be transferred within 1 

working day is in existing 

§ 405.2137(b)(5) (Patient long-term 

program and patient care plan), which 

states that if the patient is transferred to 

another facility, the care plan is sent 

with the patient or within 1 working 

day of the transfer. However, we believe 

the requirement should apply not only 

to the care plan, but to any medical 

record information, including, but not 

limited to, nutritional information, 

social work services, and rehabilitation 

status. 

Because dialysis patients must receive 

frequent treatments at prescribed 

intervals, this proposed requirement 

would minimize disruption in care. 

Without the medical information, the 

patient might receive inappropriate 

treatment. Requiring that the facility 

transfer information within 1 working 

day would minimize the possibility of a 

breakdown in communication between 

facilities. It would also ensure that the 

patient continues to receive care in 

accordance with his or her designed 

plan of treatment. 

Finally, we are proposing to eliminate 

the requirement at existing § 405.2139(c) 

that the facility designate a staff member 

to serve as the medical records 

supervisor to facilitate the 

recordkeeping process. The current 

functions of the medical record 

supervisor include, but are not limited 

to: (1) Ensuring that the medical records 

are documented, completed, and 

maintained in accordance with accepted 

professional standards and practices; (2) 

safeguarding the confidentiality of the 

records in accordance with established 

policy and legal requirements; (3) 

ensuring that the records contain 

pertinent medical information and are 

filed for easy retrieval; and (4) obtaining 

the services of a qualified medical 

records practitioner when necessary. In 

keeping with our goal of eliminating 

process requirements that are not 

predictive of good outcomes for patients 

or necessary to prevent harmful 

outcomes for patients, we are proposing 

to eliminate the requirement that a 

facility designate a medical records 

supervisor. 

E. Condition: Governance (Proposed 

§ 494.180) 

[If you choose to comment on issues in 

this section please include the caption 

6228 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

‘‘Governance’’ at the beginning of your 

comment.] 

1. Existing Requirements for Governing 

Bodies 

The existing requirements for the 

dialysis facility’s governing body are 

found at § 405.2136. Section 405.2136 

states that the facility governing body or 

designated person(s) so functioning has 

the full legal authority and 

responsibility for the governance and 

operation of the facility. The governing 

body adopts and enforces rules relative 

to its own governance and to the health 

and safety of patients, acts upon 

recommendations from the Networks, 

and appoints a CEO who is responsible 

for the overall management of the 

facility. 

Existing § 405.2136(a) covers the full 

disclosure of ownership for facilities 

that are independently owned, 

controlled by a partnership, or wholly 

or partially owned by corporate entities. 

Existing § 405.2136(b) requires the 

governing body to develop, delineate, 

and review annually written operational 

objectives for the facility. These 

objectives apply to, among other things, 

services provided and admission 

criteria. 

Existing § 405.2136(c) requires the 

appointment of a full-time or part-time 

CEO who acts as the facility’s 

administrator. The CEO’s 

responsibilities for the operation of the 

facility include the following: 

• Implementing facility policies. 

• Coordinating administrative 

functions. 

• Authorizing expenditures. 

• Familiarizing staff with facility 

policies, rules and regulations and 

applicable Federal, State and local laws 

and regulations. 

• Maintaining and submitting 

required records and reports. 

• Developing, negotiating and 

implementing contracts. 

• Developing and implementing 

accounting and reporting systems, an 

annual budget, tracking expenses and 

revenues, submitting reports; 

• Ensuring the facility employs the 

necessary number of qualified 

personnel, that those personnel are 

assigned appropriate duties, and have 

opportunities for continuing education 

and related developmental activities. 

Existing § 405.2136(d) requires the 

governing body, through the CEO, to 

develop and implement personnel 

policies and procedures, covering, for 

example, assigned duties, health and 

safety hazards, supervising trainees, 

maintaining personnel records for staff, 

maintaining written personnel policies, 

orientation and in-service education, 

and maintaining written personnel 

manuals. 

Existing § 405.2136(e) requires the 

facility to develop detailed, written 

arrangements for the use of outside 

resources, as needed, through its CEO 

who will serve as a consultant with the 

responsibility to continually assess 

performance and use documentation 

(that is, dated, signed reports). 

Existing § 405.2136(f) specifies that 

the ESRD facility must have written 

patient care policies, and that policies 

are—

• Developed by the physician 

responsible for supervising or directing 

the provision of ESRD services or the 

facility’s organized medical staff (if 

there is one) with the advice of (and 

with provision for review of such 

policies from time to time, but at least 

annually, by) a group of professional 

personnel associated with the facility, 

including but not limited to, one or 

more physicians and one or more 

registered nurses experienced in 

rendering ESRD care; and 

• Approved by the governing body. 

The governing body is also responsible 

for periodic review of the 

implementation of policies to ensure 

that the intent of the policies is carried 

out. 

Under this section patient care 

policies must include the following: (1) 

Scope of services; (2) admission and 

discharge policies; (3) medical 

supervision and physician services; (4) 

patient long-term programs and care 

plans; (5) medical and other 

emergencies; (6) pharmaceutical 

services; (7) medical records; (8) 

administrative records; (9) maintenance 

of the physical plant; (10) consultant 

qualifications and activities; and (11) 

home dialysis support services. This 

standard also requires the medical 

director to execute these patient care 

policies, schedule hours of operation 

(when feasible) that are convenient to 

patients, and evaluate patients’ progress 

toward goals in their long-term 

programs and care plans. 

Existing § 405.2136(g) requires the 

governing body to ensure that every 

patient is under the continuing care of 

a physician and that a physician is 

available in emergency situations. This 

standard requires the physician 

responsible for the patient’s care to 

evaluate the patient’s immediate and 

long-term needs and prescribe a 

planned regimen of care. The standard 

also requires the governing body to 

ensure that there is always medical care 

available for emergencies with a list of 

physicians to contact posted at the 

nursing/monitoring station. 

Existing § 405.2136(h) requires the 

governing body to designate a qualified 

physician as director of the ESRD 

facility and establish written policies 

regarding how medical appointments 

should be developed, maintained, and if 

necessary, terminated. 

2. Overview of the Proposed 

Governance Requirements 

Consistent with the shift from 

process-oriented requirements to a more 

patient-centered, outcome-oriented 

approach, we are proposing significant 

revisions to the governance condition. 

In developing these proposed revisions 

for the Governance condition we sought 

to identify requirements that are 

covered in other parts of this proposed 

rule, as well as any other redundant, 

unnecessary or overly burdensome 

requirements that are unrelated to better 

patient outcomes. At the same time, we 

want to retain those structural 

requirements that might be indicative of 

better patient outcomes or offer 

necessary protections to patient health 

and safety. We also want to be 

responsive to a recommendation from 

the OIG (in its June 2000 report) to 

‘‘strengthen the accountability of the 

dialysis facility governing body’’

(DHHS/OIG, June 2000). In that report, 

the OIG made the following 

recommendation: ‘‘The governing body 

should be held clearly accountable for 

the overall quality outcomes provided 

by the facility. Moreover, since most 

dialysis facilities are now part of 

national or multi-national corporations, 

the governing bodies should ensure that 

authoritative representatives are readily 

available to respond to queries and/or 

visits by State survey agencies or 

Networks.’’ (DHHS/OIG, June 2000.) 

We believe that the performance of 

certain basic organizational functions is 

a minimum condition for an 

environment in which appropriate 

patient-centered care can occur. 

Therefore, the proposed Governance 

condition, § 494.180, requires the 

necessary minimum administrative 

features to allow the governing body to 

safely and effectively run a facility in an 

outcomes environment while being 

responsive to the patients and to the 

OIG’s recommendation to strengthen the 

accountability of the governing body. 

3. Governance Condition (Proposed 

§ 494.180) 

In proposed § 494.180 we state the 

dialysis facility must be under the 

control of an identifiable governing 

body, or designated person(s) so 

functioning, with full legal authority 

and responsibility for the governance 

and operation of the facility. The 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6229

Medicare program requires that each 

dialysis facility be independently 

certified, and therefore, each facility 

must independently achieve compliance 

with the conditions for coverage. It is 

essential that surveyors and networks be 

able to identify the group or individual 

with legal responsibility and 

accountability for managing patient 

health care, safety, and protection of 

patient rights and for the operation of 

each dialysis facility. 

4. Designating of a Chief Executive 

Officer or Administrator (Proposed 

§ 494.180(a)) 

Proposed § 494.180(a) retains the 

existing requirement for the governing 

body or responsible party(ies) to appoint 

an individual who will serve as the 

facility’s CEO or administrator. We are 

proposing to use these terms 

interchangably (that is, CEO and 

administrator) because the duties would 

be the same regardless of the title 

assigned. We have previously proposed 

that the facility’s medical director (see

§ 494.150) assume certain clinical 

responsibilities for the care provided 

within the unit. We recognize that in 

smaller units it would be possible for 

the same individual to perform the 

duties of both medical director and 

CEO/administrator and these 

regulations do not preclude that. 

However, in a typical unit we believe 

the volume, scope, and complexity of 

administrative, financial, and 

operational responsibilities requires the 

day-to-day attention of a separate CEO/

administrator position. Therefore, we 

are proposing to retain this position and 

the performance of certain duties and 

responsibilities by the occupant of this 

position in these proposed conditions. 

We are proposing in § 494.180(a) that 

the CEO/administrator exercise overall 

management responsibility for the 

facility and oversee staff appointments, 

fiscal operations, the relationship with 

the ESRD network, and the allocation of 

necessary staff and other resources for 

the facility’s QAPI program (see

§ 494.110). 

5. Adequate Number of Qualified and 

Trained Staff (§ 494.180(b)) 

Proposed § 494.180(b) would retain 

and consolidate some of the existing 

requirements at §§ 405.2136(c)(3)(viii) 

and 405.2162(b)(2). 

We propose at § 494.180(b)(1) to 

retain the existing requirement at 

§ 405.2162(b)(2) that a dialysis facility 

ensure an adequate number of qualified 

personnel are present whenever patients 

are undergoing dialysis. Under the 

existing requirement, every approved 

dialysis facility must maintain staff-topatient ratios that are appropriate to the 

level of dialysis care being given in 

order to meet the needs of its patients. 

The determination and allocation of 

appropriate staff-to-patient ratios is left 

to each dialysis facility. State agency 

surveyors would assess facility 

compliance with this requirement by 

evaluating whether routine care is being 

delivered, assessments are conducted as 

the patient’s condition changes, routine 

monitoring adheres to facility policy, 

and patients care provided by staff 

during surveys (for example, equipment 

alarms are responded to promptly). In 

our deliberations regarding ‘‘adequate 

staff’’, we noted that there is no national 

consensus within the dialysis industry 

regarding the appropriate staff-to-patient 

ratios. We also noted the wide variety of 

State staff-to-patient ratio requirements. 

For example, some States have staff-topatient ratio requirements for registered 

nurses. Connecticut requires that 50 

percent of a dialysis unit’s patient care 

staff be registered nurses. New Jersey 

requires a registered nurse for the first 

nine patients in the unit. Georgia and 

South Carolina mandate a registered 

nurse for every 10 patients, while Texas 

requires a registered nurse for every 12 

patients. Washington requires two 

registered nurses per shift. Oregon 

requires that a written staff plan for 

registered nurses be on file with the 

State. 

Some States have staff-to-patient 

ratios for patient care technicians. 

Maryland, Massachusetts, New Jersey, 

Washington, Puerto Rico, and the Virgin 

Islands require a three-to-one patient-tostaff care technician ratio. Georgia, 

South Carolina, and Texas require a 

four-to-one patient-to-patient care 

technician ratio. Nevada has a 100 to 1 

patient-to-staff ratio for social workers 

and renal dietitians. Further 

complicating the wide variation in State 

regulations are decisions involving 

scope of practice and the various nurse 

practice acts administered by the State 

boards of nursing. For the reasons cited 

above, we are not proposing any Federal 

staff-to-patient ratios. 

However, we are interested in 

strengthening the existing requirement 

while at the same time preserving the 

facility’s flexibility in determining the 

appropriate staff-to-patient ratio.

One alternative to mandated staff-topatient ratios is an acuity-based staffing 

system developed by each dialysis 

facility. This type of system would take 

into account the number of patients 

treated on each shift, individual patient 

characteristics, patient needs, the 

expertise and experience levels of 

facility staff, the physical layout of the 

facility, available technology, and the 

availability of support services. An 

acuity-based staffing plan, including 

some or all of the criteria listed above, 

could be developed by the nurse 

responsible for nursing services in the 

facility and approved by the medical 

director. It could also be incorporated 

into the facility’s QAPI program (see

§ 494.110) as a means of achieving 

desired outcomes of care specified in 

the facility’s individual patient plans of 

care (see § 494.90). We are soliciting 

public comment on whether we should 

include a requirement for an acuitybased staffing plan in § 494.180(b)(1) to 

ensure that every dialysis facility has 

‘‘adequate staffing’’ and appropriate 

staff-to-patient ratios to meet the needs 

of its patients. 

We are proposing in § 494.180(b)(2) 

that a registered nurse must be present 

in the facility at all times that patients 

are being treated. We have made this 

proposal for several reasons. As 

previously discussed in this preamble, 

the rapidly changing demographics of 

the dialysis patient population has 

resulted in an older, sicker patient 

population. An older patient population 

with more serious co-morbid conditions 

elevates the potential for medical 

emergencies (for example, heart attack, 

stroke, severe reactions to chemicals). A 

registered nurse has the professional 

training and expertise to properly react 

to these types of emergencies. Properly 

trained dialysis technicians and 

licensed practical nurses may be 

effective in providing day-to-day patient 

care, but may lack the training and 

expertise to react to critical medical 

emergencies. Therefore, we believe that 

having a registered nurse on the 

premises when treatment is being 

provided is a necessary health and 

safety measure for dialysis patients. 

Registered nurses, by training and 

professional expertise, are also needed 

to provide other important patient care 

functions that occur routinely while 

patients are being dialyzed. Those 

functions include: (1) Assessing patient 

needs; (2) developing treatment plans; 

(3) coordinating ongoing care in the 

unit; (4) continually evaluating the 

ability of the other nursing and 

technical staff to use the most current 

skills and techniques; (5) answering 

clinical questions from patients and 

staff; (6) and providing direct 

supervision for dialysis technicians 

during their 3-month training period 

(see proposed § 494.140(e)(3)). 

At § 494.180(b)(3), we are proposing 

to retain the existing requirement that 

all employees have appropriate 

orientation to the facility and their work 

responsibilities upon employment. In 

addition, at § 494.180(b)(4), we are 

6230 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

proposing to retain the existing 

requirement that all employees have an 

opportunity for continuing education 

and related development activities. 

At § 494.180(b)(5), we are proposing a 

new requirement for a written approved 

training program, designed by the 

facilities, that is specific to dialysis 

technicians. As discussed earlier in this 

preamble, dialysis technicians are now 

the primary caregivers in many dialysis 

units, and we have proposed minimum 

Federal requirements for this 

occupation because we believe properly 

trained dialysis technicians are essential 

in achieving good patient outcomes of 

care (see § 494.140(e)). Many States that 

regulate dialysis technicians require 

training programs that include: (1) The 

initiation of dialysis; (2) monitoring and 

termination of dialysis; (3) possible 

complications of dialysis; (4) water 

treatment; and (5) infection control 

procedures. 

We are proposing that every dialysis 

patient care technician-training program 

contain criteria that would provide at 

least a minimal set of skills. When State 

requirements meet or exceed these 

proposed patient care techniciantraining requirements, the State 

requirements would have to be met. The 

criteria we are proposing include the 

following competencies: (1) Principles 

of dialysis; (2) care of the patient with 

kidney failure, including interpersonal 

skills; (3) dialysis procedures and 

documentation, including initiation, 

monitoring, and termination of dialysis; 

(4) possible complications of dialysis; 

(5) water treatment; (6) infection 

control; (7) safety; and (8) dialyzer 

reprocessing, if applicable. We invite 

public comment on the basic criteria 

proposed for § 494.180(b)(5)(i) through 

(viii). 

6. Medical Staff Appointments 

(Proposed § 494.180(c)) 

In § 494.180(c) we propose to retain 

some of the existing requirements at 

§ 405.2136(h) that the governing body be 

responsible to oversee appointments to 

medical staff. We propose to expand 

this requirement to include all medical 

staff appointments, including 

appointments and credentialing for 

attending physicians, physician 

assistants, and nurse practitioners. 

However, consistent with our goal to 

reduce unnecessary process-oriented 

requirements and regulatory burden, we 

are not proposing to retain the existing 

requirement in § 405.2136(h) for the 

governing body to establish written 

policies regarding the development, 

negotiation, consummation, evaluation, 

and termination of appointments to the 

medical staff (if the facility has a 

medical staff). Consistent with the new 

patient outcomes in this regulation, we 

are proposing to add a new requirement 

at § 494.180(c)(2) that the governing 

body be responsible for ensuring that all 

attending physicians, physicians 

assistants, and nurse practitioners who 

provide care in the facility are informed 

regarding all patient care policies and 

procedures as well as the QAPI 

program. We believe adding this new 

requirement will assist the facility 

medical director in achieving better 

patient outcomes through direct care 

and through the QAPI program without 

adding any unnecessary burden to a 

dialysis facility. We are soliciting 

comments on our proposal to delete 

process requirements for medical staff 

appointments and add a new governing 

body requirement to inform the facility’s 

medical staff regarding the facility’s 

patient care policies and the facility’s 

quality assurance and performance 

improvement program. 

7. Furnishing Services (Proposed 

§ 494.180(d)) 

Proposed § 494.180(d) would retain 

the existing requirement § 405.2102 for 

the governing body to ensure that 

(except for home care services provided 

pursuant to § 494.100) services are 

furnished directly (see § 494.10) on its 

main premises or on other premises that 

are contiguous with the main premises 

under the direction of the same 

professional staff and governing body as 

the main premises. We believe this 

requirement is essential to ensure that 

dialysis services are not provided in 

uncertified locations. 

8. Internal Grievance Process (Proposed 

§ 494.180(e)) 

In § 494.180(e), we are proposing to 

require that facilities have an internal 

grievance process. We believe a good 

internal grievance process is an 

invaluable tool in resolving patient 

grievances in a positive and expeditious 

manner for both the patient and the 

facility. The grievance process must 

include a clearly explained procedure 

for the submission of grievances, 

timeframes for reviewing the grievance, 

and a description of how the patient or 

the patient’s designated representative 

will be informed of steps taken to 

resolve the grievance. The grievance 

process must be implemented so that 

the patient may file a grievance with the 

facility without reprisal or denial of 

services. 

9. Discharge and Transfer Policies and 

Procedures (Proposed § 494.180(f))

We are also proposing that the 

facility’s discharge and transfer policy 

be designed to ensure that no patient, 

including disruptive or noncompliant 

patients, is discharged or transferred 

from the facility unless one of the 

following situations applies: 

• The patient or payor will no longer 

reimburse the facility for covered 

services; 

• The facility ceases to operate; 

• The transfer is necessary for the 

patient’s welfare because the facility can 

no longer meet the patient’s 

documented medical needs; 

• The facility has determined the 

patient’s behavior is so disruptive or 

abusive that the facility is unable to 

deliver care to the patient or to operate 

effectively. 

We are proposing that the governing 

body assign the medical director the 

responsibility to monitor and review 

every patient discharge of an abusive or 

disruptive patient to ensure that the 

patient’s interdisciplinary team has 

reassessed the patient and documented 

the ongoing problem(s) and efforts to 

resolve the problem(s); obtained a 

written physician’s order which must be 

signed by the medical director and (if 

applicable) the patient’s attending 

physician; and that a documented 

attempt has been made to place the 

patient in another facility. The State 

survey agency and the ESRD network 

must be notified of the involuntary 

discharge of any patient. We believe, as 

the individual in charge of patient care 

in the facility, the medical director (see

proposed § 494.150(c)(2)(ii)) is the 

appropriate individual to ensure that a 

patient’s interdisciplinary team has 

followed the procedure described in 

§ 494.180(f) before any transfers or 

discharges from the facility. We also 

believe it is important to allow facilities 

the flexibility to make these 

determinations on a case-by-case basis 

without the imposition of prescriptive 

criteria that would define disruptive or 

abusive behavior. However, the facility’s 

interventions and reasons for 

involuntary discharge of a disruptive or 

abusive patient must be clearly 

documented in the patient’s medical 

record. We invite comments on our 

proposal to hold the dialysis facility 

accountable for their staff adherence to 

facility’s patient discharge or transfer 

policies and procedures. 

10. Emergency Coverage (Proposed 

§ 494.180(g) 

Proposed § 494.180(g) would require 

the governing body to be responsible for 

emergency coverage. Emergency 

coverage is not the same thing as 

emergency preparedness (see

§ 494.60(d) in the proposed physical 

environment condition). As previously 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6231

discussed, emergency preparedness 

applies to medical and nonmedical 

emergencies related to fire, equipment 

or power failures, care-related 

emergencies, water supply 

interruptions, and natural disasters. The 

emphasis in emergency preparedness is 

on the facility staff’s ability to manage 

and respond appropriately to these 

facility-wide problems. Emergency 

coverage, as proposed in § 494.180(g), 

relates only to patient medical 

emergencies. Specifically, proposed 

§ 494.180(g)(1) would require the 

governing body to ensure that patients 

and staff have written instructions for 

obtaining emergency medical care. We 

believe giving patients and staff written 

instructions is both prudent and 

necessary to ensure that every patient 

has the necessary information if and 

when a medical emergency should arise. 

Proposed § 494.180(g)(2) would retain 

the existing provision at § 405.2136(g)(2) 

that requires the dialysis facility to post, 

at the nursing/monitoring station, a 

roster of physician names to be called 

for emergencies, when they can be 

reached, and how they can be reached. 

Proposed § 494.180(g)(3) retains and 

combines existing provision at 

§ 405.2136(g)(2) which requires the 

governing body to ensure emergency 

care is always available, and existing 

§ 405.2160 which requires the facility to 

have an agreement with a hospital to 

provide inpatient care and other 

services to patients at all times. 

However, our proposed agreement 

requirement at § 494.180(g)(3) is much 

less prescriptive than the existing 

requirement at § 405.2160, which is a 

condition-level requirement. For 

example, § 405.2160 requires a dialysis 

facility to have an agreement with a 

renal dialysis center, which is defined 

in existing § 405.2102 as a hospital that 

is qualified to provide the full spectrum 

of diagnostic, therapeutic, and 

rehabilitative services required for the 

care of ESRD dialysis patients. Existing 

§ 405.2160 also contains explicit 

requirements for the affiliation 

agreement, that is, the agreement must 

(1) include the basis for working 

relationships between staff of both 

facilities to ensure that services are 

available promptly; (2) specify transfers 

for only medically appropriate 

circumstances as determined by the 

medical director or attending physician; 

(3) prescribe an interchange (within 1 

working day) between facilities of the 

patient’s long-term plan and patient care 

plans; and (4) specify security and 

accountability for patients’ personal 

effects. Our proposal, at § 494.180(g)(3) 

states simply that the dialysis facility 

must have an arrangement with a 

hospital that can provide inpatient care, 

other hospital services, and emergency 

services which are available 24 hours a 

day, 7 days a week; services will be 

made available promptly; and there are 

reasonable assurances in the agreement 

that patients from the dialysis facility 

will be accepted and treated in 

emergencies. This is consistent with our 

goal of transitioning from unnecessary 

procedural and process requirements to 

a patient-outcomes environment in 

which a dialysis facility will have more 

flexibility in determining how necessary 

services, including emergency services, 

are provided to its patients. 

11. Furnishing Data and Information for 

ESRD Program Administration 

(Proposed § 494.180(h) 

We propose in § 494.180(h) that 

dialysis facilities furnish data and 

information electronically and in 

intervals that conform to specifications 

established by the Secretary. While 

reporting data and information is an 

existing requirement in § 405.2133, the 

proposal to require the ESRD CPM data 

and to require electronic data reporting 

are new requirements. The CPM project, 

a quality improvement initiative 

between CMS, the ESRD networks, and 

ESRD facilities was discussed in section 

II.E.4.1 of this proposed rule. Currently, 

dialysis facilities participate in this 

project voluntarily. We are proposing 

full participation in reporting the 

existing CPMs by all dialysis facilities. 

We have received recommendations 

from the OIG ‘‘External Quality Review 

of Dialysis Facilities/A Call For Greater 

Accountability,’’ the IOM ‘‘Crossing the 

Quality Chasm, 2001’’, and Medicare 

Payment Advisory Commission 

(MedPAC) ‘‘Improving Quality 

Assurance for Institutional Providers’’ to 

require facilities participating in 

Medicare to report on performance 

measures to stimulate improvements in 

the quality of care and to achieve a 

degree of accountability for performance 

((DHHS/OIG, 1999), (IOM, 2001), and 

(MedPAC, 2000) respectively). The 

requirement for full CPM reporting is an 

important step in moving in that 

direction. 

Section 4558(b) of Pub. L. 105–33 

requires us to develop a method to 

measure and report the quality of 

dialysis services provided in the 

Medicare program. To comply with this 

requirement, we developed the CPMs 

from the NKF–DOQI (now NKF–K/

DOQI) clinical practice guidelines. The 

CPM project assists providers in the 

assessment of care provided to ESRD 

patients and stimulates improvement in 

that care. The processes used to develop 

the CPMs and the DOQI guidelines were 

also discussed in section II.E.3 and 4 of 

this preamble. 

Dialysis facilities and ESRD networks 

have used the ESRD CPM project annual 

reports for benchmarking purposes and 

as a means of identifying opportunities 

to improve care. The approach of this 

proposed rule is to decrease process 

requirements and instead look to 

outcomes of patient care so that quality 

may be assessed and reported. The 

CPMs will be a part of the vehicle by 

which we measure and report on the 

quality of dialysis services provided in 

the Medicare program. 

The CPM data collection tools were 

briefly described in section II.E.5 of this 

preamble. Data elements included on 

these forms are intermediate outcome 

measures and process markers for 

adequacy of hemodialysis and 

peritoneal dialysis, anemia 

management, nutrition (albumin), and 

vascular access management. 

The CMS VISION software will 

provide the electronic means for 

collection of the ESRD administrative 

forms (that is, CMS–2728, CMS–2746, 

and CMS–2744) as well as the CPM data 

(CMS–820 and CMS–821). In the future, 

CMS VISION software may also collect 

other information such as patient 

experience of care survey data. The 

VISION program will utilize an 

encryption technology that assures 

privacy, confidentiality, and security for 

electronic communications. The 

requirement for full CPM reporting on 

all patients by all facilities will be 

implemented only when the VISION 

software is fully operational. Vision 

software will be provided to 

independent dialysis facilities and small 

to medium size corporate dialysis 

facilities at no cost. Specifications are 

being provided for developing an 

interface between the major corporate 

dialysis facilities’ databases and the 

CMS database to enable ESRD 

administrative data and CPM data to be 

transmitted electronically with minimal 

effort from dialysis facility staff. There 

are initial costs for major corporate 

dialysis facilities as they develop the 

software interface and for initial 

training. For a more detailed discussion 

of these costs see section IX. of this 

preamble.

The Secretary will determine the 

frequency of CPM data collection. 

Facilities currently report (via billing 

submissions) monthly URR values for 

all hemodialysis patients and monthly 

hematocrit levels for all patients 

receiving erythropoietin. 

The CPM data collection would 

provide a means for the reporting of 

facility-specific performance measures 

capturing information related to the 

6232 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

quality of care delivered. This kind of 

information is especially important if a 

fully-bundled payment system for the 

ESRD program expands the composite 

rate structure to include all outpatient 

routine dialysis payments. We are 

concerned that this change in the 

payment structure could provide 

financial incentives to reduce services 

provided to ESRD beneficiaries; thereby 

compromising quality of care. Any shift 

in payment policy necessitates a strong 

external monitoring process to ensure 

that an acceptable level of care 

continues. The reporting of facilityspecific performance measures and the 

development of standards would 

provide us with the means externally to 

evaluate and monitor dialysis facilities 

to ensure that the necessary services 

have been provided and to assist 

patients to reach optimal outcomes. 

We are looking at the feasibility of 

developing minimum performance 

standards. There are widely accepted 

(K/DOQI) clinical practice guidelines 

and clinical performance measures 

(CPMs) in existence. However, there is 

no consensus for minimum performance 

standards. Dialysis facility performance 

is generally compared to performance of 

other facilities in the network or to 

national performance data. Facilities 

whose performance measures fall well 

below the comparison group are 

generally identified as needing 

improvement. However, we do not have 

defined thresholds that tell us, for 

example, that if a dialysis facility 

provided a KT/V of 1.2 or higher to at 

least 85 percent of its hemodialysis 

patients, that facility is providing an 

acceptable level of care. 

An additional problem in using 

minimum standards for accountability 

purposes is the possibility of ‘‘cherry 

picking’’ and decreased access to 

dialysis for some patients. Dialysis 

facilities may have a disincentive to 

accept patients likely to be more 

difficult to manage as well as patients 

that are more resource-intensive and 

who are less likely to achieve acceptable 

levels on the performance measures. 

This raises the issue of the necessity of 

risk adjusters to be used in developing 

the bundled payment rate, as well as 

developing performance standards for 

accountability. We are looking at these 

difficult issues and considering the 

implications of any changes in payment 

and performance accountability. We are 

soliciting comments on how the 

incentives to ‘‘cherry pick’’ could be 

minimized. Any performance standards 

that we may use for dialysis facilities 

would be developed in conjunction 

with the NTTAA process discussed in 

section II.E.6 of this preamble. 

This proposal, which requires CPM 

reporting, is specific to the CPMs as 

they currently exist. The process for 

updating, revising, and expanding the 

CPMs will be done in conjunction with 

the NTTAA process. A voluntary 

consensus standards body, which as yet 

has not been identified, would likely 

plan, develop, establish, or coordinate 

voluntary consensus standards using 

agreed upon procedures in conjunction 

with the NTTAA. 

In the February 19, 1998 Federal 

Register (63 FR 8546), the Office of 

Management and Budget published a 

notice regarding the Federal 

participation in the development and 

use of voluntary consensus standards. 

We will use the policies established in 

this publication and the Administrative 

Procedure Act (APA) when adopting 

voluntary consensus standards. If we 

adopt voluntary consensus standards 

that are not legally binding, we would 

publish them as a notice in the Federal 

Register. 

The ESRD CPM project data, which 

would provide the use patterns of 100 

percent of dialysis patients, would 

provide an array of possibilities for 

facilities to compare performance and 

practice patterns at facility, State, 

network, and national levels in order to 

identify opportunities for improvement 

in the care of dialysis patients. 

This information would provide 

independent dialysis facilities with the 

same type of information that some 

dialysis chain corporations have been 

able to collect on their own dialysis 

facilities across the nation. These CPM 

data would expand the breadth of data 

that have been previously available even 

to the large dialysis corporations. 

The ESRD networks would use the 

CPM data elements and calculated 

measures in order to assist dialysis 

facilities with quality improvement 

activities and as a benchmark to look at 

their own performance. 

The State survey agencies would 

receive facility profiles as well as data 

for dialysis adequacy, vascular access, 

anemia management, and nutrition for 

use in their survey activities.

At a minimum, we would use the 

following facility-specific information 

for public reporting on our Dialysis 

Facility Compare Web site: 

• Number of patients included in 

each calculation. 

• Percent of patients treated in the 

facility with a Kt/V ≥ 1.2. 

• Percent of patients treated in the 

facility with a hemoglobin ≥ 11 gms/dL. 

Public reporting of performance 

measures provides an important 

resource to dialysis patients and their 

families. The Dialysis Facility Compare 

website provides detailed information 

about Medicare-certified dialysis 

facilities and allows for comparison of 

facility characteristics and quality 

measures. We are evaluating the 

information reported on the Dialysis 

Facility Compare website for usability 

and to ensure that the publicly reported 

information meets the needs of the 

beneficiary. The availability of 

information will permit patients to 

become more active participants in their 

facilities’ quality improvement process. 

Informed patients make better health 

care choices and are more active 

participants in their medical care. 

12. Disclosure of Ownership (Proposed 

§ 494.180(i)) 

In § 494.180(i) we are proposing to 

retain the existing § 405.2136(a) that the 

dialysis facility must provide complete 

information to the State survey agency 

regarding persons who have any direct 

or indirect ownership of the facility in 

whole or in part in compliance with the 

requirements of §§ 420.200 through 

420.406. This requirement, reporting 

ownership interests of 5 percent or 

more, is a conforming change to 

comport with the existing requirements 

in § 420.201, which have been in effect 

since 1992. 

VII. Other Proposed Changes and Issues 

A. Proposed Cross-Reference Changes 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Cross-Reference Changes’’ at the 

beginning of your comment.] 

We are proposing to make technical 

changes in the following sections of the 

regulations to correct cross-references to 

the sections in part 405, subpart U that 

are proposed to be relocated or deleted: 

§§ 410.5, 410.50, 410.52, 410.152, 

410.170, 413.170, 413.172, 413.198, and 

414.330. 

B. Proposed Additions to Part 488 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Part 488’’ at the beginning of your 

comment.] 

We are proposing to add a new 

subpart H to part 488. Proposed subpart 

H would consist of the existing sanction 

provisions in part 405 subpart U. The 

existing sanction provisions are in 

§§ 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 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6233

of any patients accepted for care after 

the effective date of the sanction, and 

gradual reduction of payments for all 

patients) and the circumstances under 

which they might be imposed. 

• Section 405.2182 specifies the 

notice procedures that we will follow 

and the appeal rights of sanctioned 

suppliers. 

• Section 405.2184 specifies (in 

greater detail) the rights of suppliers 

that appeal proposed imposition of an 

alternative sanction. 

We propose to redesignate these 

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

488.606, 488.608, and 488.610 

respectively. 

VIII. Reference Materials 

A. New Provisions of Part 494 

This proposed rule contains a number 

of requirements that are not included in 

the existing regulations. For information 

and ease of reference, outlined below is 

a list of the new provisions, grouped by 

condition:

Condition New provisions 

Infection control (§ 494.30) .................................. § 494.30(a)—Infection control procedures (including the Recommended Infection Control Practices for Hemodialysis Units At a Glance CDC guidelines). 

§ 494.30(a)(2)—Patient isolation procedures. 

Water quality (§ 494.40) ...................................... § 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)(5)—Advance directives. 

§ 494.70(a)(14)—Complaint systems. 

§ 494.70(b)—Discharge and transfer policies. 

§ 494.70(d)—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. 

§ 494.80(a)(10)—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. 

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

§ 494.90(a)(2)—Nutritional status. 

§ 494.90(a)(3)—Anemia. 

§ 494.90(a)(4)—Vascular access. 

§ 494.90(a)(5)—Transplantation status. 

§ 494.90(a)(7)—Rehabilitation status. 

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

§ 494.90(b)(3)—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)—Anemia management. 

§ 494.110(a)(2)(iv)—Vascular access. 

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

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

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

§ 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).

§ 494.150(a)—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)—Discharge and transfer policies and procedures. 

§ 494.180(g)—Emergency coverage. 

§ 494.180(h)—Furnishing data and information for ESRD program administration. 

B. ESRD Crosswalk (Cross Refers 

Existing Requirements to Proposed 

Requirements)

6234 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

Existing conditions (part 405, subpart U) Existing citation Proposed conditions (part 

494) Proposed citation 

Scope of subpart ............................................................. 405.2100(a) ....................... Basis and scope ................ 494.1 

405.2100(b) ....................... Deleted.

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

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

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

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

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

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

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

(a) Renal transplantation center ....................... ............................................ Retained in 405, Subpart U 494.10 

(b) Renal dialysis center ................................... ............................................ Deleted ..............................

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

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

(e) Special purpose renal dialysis facility ......... ............................................ Special purpose renal dialysis facilities.494.120 

ESRD service (introductory text) .............................. ............................................ Retained in 405, Subpart U 

(a) Transplantation service ............................... ............................................ Deleted ..............................

(b) Dialysis service ............................................ ............................................ Deleted ..............................

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

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

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

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

(3) Home dialysis ....................................... ............................................ Care at home ....................

(c) Self-dialysis and home dialysis ................... ............................................ Deleted .............................. 494.100 

Furnishes directly ..................................................... ............................................ Governance .......................

Furnishes on the premises ....................................... ............................................ Retained in 405, Subpart U 494.180(d) 

Histocompatibility testing .......................................... ............................................ Deleted ..............................

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

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

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

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

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

Network organization ................................................ ............................................ Retained in 405, Subpart U 

Organ procurement (introductory text) ..................... ............................................ Deleted ..............................

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

(a) Chief executive officer ................................. ............................................ Personnel qualifications .... 494.190(a) 

(b) Dietitian ........................................................ ............................................ Deleted .............................. 494.150(c) 

(c) Medical record practitioner .......................... ............................................ Personnel qualifications ....

(d) Nurse responsible for nursing services ....... ............................................ Personnel qualifications .... 494.150(b) 

(e) Physician-director ........................................ ............................................ Personnel qualifications .... 494.150(a) 

(f) Social worker ................................................ ............................................ Retained in 405, Subpart U 494.150(d) 

(g) Transplantation surgeon .............................. ............................................ ............................................

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

[Reserved] ....................................................................... 405.2111 ............................ Deleted ..............................

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

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

[Reserved] ....................................................................... 405.2114 ............................ Deleted ..............................

Minimum utilization rates: General .................................. 405.2120 ............................ Retained in Subpart U .......

Basis for determining minimum utilization rates ............. 405.2121 ............................ Retained in Subpart U .......

Types and duration of classification according to utilization rates.405.2122 ............................ Retained in Subpart U .......

Reporting of utilization rates for classification ................. 405.2123 ............................ Retained in Subpart U .......

Calculation of utilization rates for comparison with minimum utilization rate(s) and notification of status.405.2124 ............................ Retained in Subpart U .......

Minimum utilization rates ................................................. 405.2130 ............................ Retained in Subpart U .......

Provider status: renal transplantation center or renal dialysis center.405.2131 ............................ Retained in 405, Subpart U 

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

Furnishing data and information for ESRD program administration.405.2133 ............................ Governance ....................... 494.190(f) 

Participation in network activities .................................... 405.2134 ............................ Relationship with ESRD 

network.

494.170 

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

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

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

(c) Chief executive officer ........................................ 405.2136(c) ....................... Governance ....................... 494.180(a) 

(d) Personnel policies and procedures .................... 405.2136(d)(1,3–5,7) ......... Deleted ..............................

(d)(2) Infection control/Incident reports .................... 405.2136(d)(2) ................... Infection control and Quality assessment and performance improvement.494.30(a) & 494.110(a)(5) 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6235

Existing conditions (part 405, subpart U) Existing citation Proposed conditions (part 

494) Proposed citation 

(d)(6) Facility personnel educational programs ....... 405.2136(d)(6) ................... Personnel qualifications .... 494.140(e) 

(e) Use of outside resources .................................... ............................................ Medical Director ................ 494.150(c) 

(f) Patient care policies ............................................ 405.2136(e) ....................... Deleted ..............................

(g) Medical supervision and emergency coverage .. 405.2136(f) ........................

405.2136(g)(1) ...................

Medical Director ................

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

494.150(d) 

494.90 (introductory text) 

(h) Medical staff ........................................................ ............................................ Care at home and Governance.494.100(c) & 494.180(b) 

494.2136(g)(2) ................... Governance ....................... 494.180(e) 

405.2136(h) ....................... Governance ....................... 494.180(c) 

Patient long-term program and patient care plan ........... 405.2137 (introductory 

text).

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

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

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

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

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

(b)(3) The patient is involved ................................... 405.2137(b)(3) ................... Patient rights ..................... 494.70(a)(5) 

(b)(4) Frequency of care plan review ....................... 405.2137(b)(4) ................... Patient plan of care ........... 494.90(b), (1) 

(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) ................... Care at home .................... 494.100 (introductory text) 

(b)(7) Erythropoietin for the home dialysis patient ... 405.2137(b)(7) ................... Patient plan of care ........... 494.90(a)(3) 

Patient’s rights and responsibilities ................................. 405.2138(a)–(d) ................. Patient rights and medical 

records.

494.70(a) and 494.170(a) 

405.2138(e) ....................... Patient rights ..................... 494.70(c) (13 and 14) 

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

(a) Medical record contents ..................................... 405.2139(a) ....................... Deleted ..............................

(b) Protection of medical record information ............ 405.2139(b) ....................... Recordkeeping .................. 494.170(a) 

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

(d) Completion and centralization ............................ 405.2139(d) ....................... Recordkeeping .................. 494.170(b) 

(e) Retention and preservation ................................ 405.2139(e) ....................... Recordkeeping .................. 494.170(c) 

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

(g) Transfer of medical information .......................... 405.2139(g) ....................... Recordkeeping .................. 494.170(d) 

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

text).

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

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

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

(a)(2), (3) Equipment and areas are hazard free .... ............................................ Physical environment ........ 494.60(a), (b) 

(a)(5) Water quality requirements ............................ 405.2140(a)(5) ................... ............................................

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

text).

Water quality ..................... 494.40 

(b)(1) Infection prevention ........................................ ............................................ Physical environment ........ 494.60(c) 

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

ventilation systems.

405.2140(b)(1) ...................

405.2140(b)(2)(4) ..............

Infection control .................

Physical environment ........

494.60(c) 

494.60(c) 

(b)(3) Nursing station ............................................... ............................................ ............................................

(b)(5) Special dialysis solutions ............................... 405.2140(b)(3) ................... Deleted ..............................

(c) Contamination prevention ................................... 405.2140(b)(5) ................... Deleted ..............................

405.2140(c) ....................... Infection control and 

Reuse of.

494.30(a) and 494.40 

(d) Emergency preparedness ................................... 405.2140(d) ....................... Hemodialyzers ................... (introductory text), (a) 

Physical environment ........ 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)(1–3) ............... Reuse of hemodialyzers 

and Bloodlines.

494.50 (introduction), (a), 

(b) 

(b) Transducer filters ................................................ 405.2150(b) ....................... Infection Control ................ 494.30(a)(1) 

(c) Bloodlines ............................................................ 405.2150(c) ....................... Resuse of hemodialyzers 

and Bloodlines.

494.50(c) 

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

405.2160(b)(2) ................... Medical records ................. 494.170(d) 

Director of a renal dialysis facility or renal dialysis center.405.2161 ............................ Personnel qualifications .... 494.140(a) 

Medical Director ................ 494.150 

Staff of a renal dialysis facility or renal dialysis center ... 405.2162 (stem statement) Governance ....................... 494.180(b) 

Adequate numbers of personnel are present to meet 

patient needs.

405.2162(a) ....................... Governance ....................... 494.180(b) 

(a) Registered nurse ................................................ 405.2162(b) ....................... Personnel qualifications .... 494.140(b) & (e) 

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

(c) Self-care dialysis training personnel ................... 405.2162(c) ....................... Care at home .................... 494.100(a) 

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) ....................... Patient plan of care ........... 494.90 

Care at home .................... 494.100 

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

(c) Social services .................................................... 405.2163(c) ....................... Patient Assessment ........... 494.80(a) 

6236 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

Existing conditions (part 405, subpart U) Existing citation Proposed conditions (part 

494) Proposed citation 

Patient plan of care ........... 494.90(a) 

Care at home .................... 494.100(a) 

(d) Dietetic services .................................................. 405.2163(d) ....................... Patient Assessment ........... 494.80(a) 

Patient plan of care ........... 494.90 

(e) Self-dialysis support services ............................. 405.2163(e) ....................... Care at home .................... 494.100(c) 

(f) Participation in recipient registry ......................... 405.2163(f) ........................ Patient plan of care ........... 494.90(c) 

(g) Use of erythropoietin at home ............................ 405.2163(g) ....................... Patient Assessment ........... 494.80(a)(4) 

Patient plan of care ........... 494.90(a)(3) 

Care at home .................... 494.100(a)(2) 

(h) Responsibilities of the physician/facility for use 

of erythropoietin at home.

405.2163(h) ....................... Care at home .................... 494.100(b)(2) 

Conditions for coverage of special purpose renal dialysis facilities.405.2164 ............................ Special purpose renal dialysis facilities.494.120 

Director of a renal transplantation center ........................ 405.2170 ............................ Retained in 405, Subpart U 

Minimal service requirements for a transplantation center.405.2171 (introductory 

text).

Retained in 405, Subpart U.

405.2171(a)–(e) ................. ............................................

Termination of Medicare coverage .................................. 405.2180 ............................ Termination of Medicare 

coverage.

488.604 

Alternative sanctions ....................................................... 405.2181 ............................ Alternative sanctions ......... 488.606 

Notice of sanction and appear 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 

C. Bibliography

Alter, M.J., et al. ‘‘Dialysis & 

Transplantation.’’ Annals of Internal 

Medicine 12 (1983): 860–865. 

American National Standards Institute. 

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Medical Instrumentation. Hemodialysis 

Systems. (RD5) 1992. Sections 3.2.1, 3.2.2 

and Appendix B, Sections B1–B5. 

—Reuse of Hemodialyzers. 1993. 

—Reuse of Hemodialyzers. (RD47) 2002. 

—Reuse of Hemodialyzers (Corrected Copy). 

(RD47) 2003. 

—Concentrates for Hemodialysis. (RD61) 

2000. 

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Hemodialysis Applications. (RD62) 2001. 

—Dialysate for Hemodialysis. (RD52) 2004. 

Becker, Linda, M.A. et al. ‘‘Cardiac Arrest in 

Medical and 

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‘‘Recommendations for Preventing 

Transmission of Infections Among Chronic 

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Mortality Weekly Report 50 (RR05) (April 

27, 2001): 20–21. (Available at 

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for Hemodialysis Units At a Glance.’’ 50 

(RR05) (April 27, 2001): 20–21. (Available 

at www.cdc.govmmwr/preview/mmwrhtml/

rr5005al.htm.) 

—‘‘Guidelines for Hand Hygiene in HealthCare Settings: Recommendations of the 

Healthcare Infection Control Practice 

Advisory Committee and the HCIPAC/

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Force.’’ Morbidity and Mortality Weekly 

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rr5210al.htm.) 

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Interpretive Guidelines for Surveyors of 

End-Stage Renal Disease Facilities.’’ State 

Operations Manual. April 1995: Tag V–

188. 

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Hemodialysis, Adult Peritoneal Dialysis, 

and Pediatric In-Center Hemodialysis 

Patients.’’ December 2002: 1–104. 

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for Hemodialyzer Reuse Labeling.’’ 1995. 

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Notification for Water Purification 

Components and Systems for 

Hemodialysis.’’ 1997. 

—National Institutes of Health. ‘‘Morbidity 

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Conference Report, 11.2 (1993): 1–33. 

—‘‘Study Confirms Recommended Dialysis 

Dose’’. National Institute of Diabetes and 

Digestive and Kidney Diseases (April 23, 

2002). (Available at www.nih.gov/news/pr/

apr2002/niddk-23.htm) 

—Office of the Inspector General. ‘‘External 

Quality Review of Dialysis Facilities: A 

Call for Greater Accountability.’’ Report, 

1999. (p. 131, 189) 

—‘‘Clinical Performance Measures for 

Dialysis Corporations, Practices of Major 

Dialysis Corporations.’’ Report, OEI–01–

99–00053, January 2002. 

—‘‘Clinical Performance Measures for 

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Experiences of the Corporations.’’ Report, 

2002. 

Ekoyan, Garabed, M.D., Beck, Gerald J., 

Ph.D., Cheung, Alfred K., M.D. et al.

‘‘Effect of Dialysis Dose and Membrane 

Flux in Maintenance Hemodialysis,’’ New 

England Journal of Medicine 347.25 

(December 19, 2002): 2010–2019. 

(Available at www.nejm.org) 

Grohskopf, Lisa A., M.D. et al. ‘‘Serratia 

Liquefaciens Bloodstream Infections From 

Contamination of Erythropoietin Alfa At A 

Hemodialysis Center.’’ New England 

Journal of Medicine 344.20 (May 17, 2001): 

1491–1497. (Available at www.nejm.org) 

Hays, R.D., Kallich, J.D., Mapes, D.L., Coons, 

S.J., Carter, W.B. ‘‘Development of the 

Kidney Disease Quality of Life (KDQOL) 

Instrument.’’ Quality of Life Research 3.5 

(October 1994): 329–338. 

Held, P.J., Levin, N.W., Bovbjerg, R.R., et al.

‘‘Mortality and Duration of Hemodialysis 

Treatment.’’ Journal of the American 

Medical Association 265 (1991): 871–875. 

Institute of Medicine. ‘‘Report on Kidney 

Failure and the Federal Government.’’

Report, 1991. 

—‘‘To Err is Human: Building a Safer Health 

System.’’ Report, 2000. 

—‘‘Crossing the Quality Chasm: A New 

Health System for the 21st Century.’’

Report, 2001. (Available at 

www.books.nap.edu/books/0309072808/

html/indes.html.) 

Kaplan, B., et al. ‘‘Chronic Hemodialysis 

Patients. Part I: Characterization and DrugRelated Problems.’’ The Annals of 

Pharmacotherapy. 28 (1994): 316–319. 

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Council. Renal Rehabilitation, Bridging the 

Barriers. 1994. Madison, Wisconsin: 

Medical Education Institute, Incorporated. 

(Available at www.lifeoptions.org.) 

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for Institutional Providers,’’ Report to 

Congress: Selected Medicare Issues. June 

2000. 81–103.

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6237

National Fire Protection Association. NFPA 

101, Life Safety Code Handbook. Chapters 

20 and 21. January 12, 2000. 

—Standard for Health Care Facilities.

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Preparedness. November 2001. 

National Kidney Foundation. ‘‘Kidney/

Disease Outcomes Quality Initiative 

Clinical Practice Guidelines for Nutrition 

in Chronic Renal Failure.’’ American 

Journal of Kidney Diseases. 35 (2000): S1–

S140. 

—Hemodialysis Adequacy Guidelines. 1997 

(updated June 2000). Guideline 4. 

—Peritoneal Dialysis Adequacy Guidelines.

1997 (updated June 2000). Guidelines 15 

and 16. 

—Guidelines for Advance Directives. 2000. 

(Available at www.kidneyva.org/public ed/

orderforms.pdf.) 

—‘‘Kidney/Disease Outcomes Quality 

Initiative Clinical Practice Guidelines for 

Vascular Access.’’ American Journal of 

Kidney Diseases 37 (supplement 1) (2001): 

S137–S181. 

—‘‘Disease Outcome Quality Initiative 

Clinical Practice Guidelines for 

Hemodialysis Adequacy, Peritoneal 

Dialysis Adequacy, Vascular Access, and 

Anemia for Chronic Kidney Disease.’’

American Journal of Kidney Diseases 37 

(supplement 1) (January 2001): S182-S238. 

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Technician Task Force.’’ American Journal 

of Kidney Diseases. 21 (1993): 2. 

Owen, W.F., Jr., Lew, N.L., Lui, Y., et al.

‘‘The Urea Reduction Ratio and Serum 

Albumin Concentration as Predictors of 

Mortality in Patients Undergoing 

Hemodialysis.’’ New England Journal of 

Medicine 329 (1993): 1001–1006. 

Parker, T.F., III. ‘‘Role of Dialysis Dose on 

Morbidity and Mortality in Maintenance 

Hemodialysis Patients.’’ American Journal 

of Kidney Diseases 24 (1994): 981–989.

Parker, T.F., III, Husni, L., Haugn, W., et al.

‘‘Survival of Hemodialysis Patients in the 

United States is Improved with a Greater 

Quantity of Dialysis.’’ American Journal of 

Kidney Diseases 23 (1994): 670–680. 

Parkerson, G.R. et al. ‘‘The Duke Health 

Profile: A 17-Item Measure of Health and 

Dysfunction.’’ Medical Care 28.11 (1990): 

1056–1069. 

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of Life Short Form, Version 1.3: A Manual 

for Scoring.’’ 1997. 

The Renal Physicians Association. The 

Collaborative Leadership for ESRD Patient 

Safety, Phase I Report of the National 

Patient Safety Consensus for the 

Community of Stakeholders in End Stage 

Renal Disease. Patient Safety Committee 

Report. 2001. 

Sciarini, P. and Dungan, J.M. ‘‘A Holistic 

Protocol for Management of Fluid Volume 

Excess in Hemodialysis Patients’’

Nephrology Nursing Journal 23.3 (1996): 

299–305. 

Stewart, A.L. et al. ‘‘Functional Status and 

Well-Being of Patients with Chronic 

Conditions.’’ Journal of the American 

Medical Association 262.7 (1989): 907–

913. 

Szczech, L.A. ‘‘Changing Hemodialysis 

Thresholds for Optimal Survival.’’ Kidney 

International 59 (2001): 738–745.

VIII. Collection of Information 

Requirements and Response to 

Comments 

A. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 60-

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements: 

Section 414.330 Payment for home 

dialysis equipment, supplies and 

support services. Suppliers must report 

to the ESRD facility providing support 

services, every 30 days, all data for each 

patient regarding services and items 

furnished to the patient in accordance 

with § 494.100(c)(2) of this chapter. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, exempts the burden associated 

with this requirement from the PRA as 

stipulated under 5 CFR 1320.3(b)(2). 

Section 488.60 Special procedures 

for approving end stage renal disease 

facilities. An ESRD facility that wishes 

to be approved or that wishes an 

expansion of dialysis services to be 

approved for coverage, in accordance 

with part 494, must submit the 

documents and data as outlined in 

§ 488.60(a)(1) through (a)(4). 

We estimate that it will take 250 

facilities on an annual basis 40 hours 

each to gather and submit the necessary 

documentation for consideration of 

approval. 

Section 494.30 Condition: Infection 

control. The dialysis facility must 

maintain current infection control 

information including the most current 

CDC guidelines for the proper 

techniques in the use of vials and 

ampules containing medication. In 

addition, facilities must report infection 

control issues to the dialysis facility’s 

chief executive officer or administrator 

(see § 494.180(a)) and the quality 

improvement committee. 

While these requirements are subject 

to the PRA, the fact that they are usual 

and customary business practices, 

exempts the burden associated with 

these requirements from the PRA as 

stipulated under 5 CFR 1320.3(b)(2). 

The facility must document the 

incidence of infection to identify trends 

and establish baseline information on 

infection incidence, develop 

recommendations to prevent infection 

transmission and take corrective actions 

to reduce future incidents, and report 

incidences of communicable diseases as 

required by Federal, State and local 

laws. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice and may be required under 

State or local law, exempts the burden 

associated with this requirement from 

the PRA as stipulated under 5 CFR 

1320.3(b)(2) or (b)(3) or both. 

Section 494.40 Condition: Water 

quality. If the test results from the last 

component or carbon tank are greater 

than the parameters for chlorine or 

chloramine described at § 494.30(c)(2)(i) 

the facility must immediately notify the 

medical director. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, exempts the burden associated 

with this requirement from the PRA as 

stipulated under 5 CFR 1320.3(b)(2). 

Section 494.50 Condition: Reuse of 

hemodialyzers and bloodlines. The 

dialysis facility must monitor patient 

reactions, undertake evaluation of its 

dialyzer reprocessing and water 

purification system, and report any 

adverse outcomes to FDA and other 

Federal, State, or local governments 

agencies as required by law. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice and is required under other 

Federal, State, and local laws, exempts 

the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

Section 494.70 Condition: Patients’

rights. The dialysis facility must inform 

patients (or their representatives) of 

their rights and responsibilities when 

they begin their treatment. The facility 

must also inform patients of the 

facility’s policies for transfer, discharge, 

and discontinuation of services to 

patients.

6238 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

We estimate that 4,317 facilities will 

need 8 hours each on an annual basis to 

disclose the necessary information. This 

is based on the belief that the materials 

will be standardized and incorporated 

into the facility’s entrance materials. 

In addition, the dialysis facility must 

prominently display a copy of the 

patients’ rights in the facility. These 

rights must include the current State 

agency and ESRD network telephone 

compliant numbers and it must be 

posted in a place where it can be easily 

seen and read by patients. 

We estimate that 4,317 facilities will 

need 1 hour each on an annual basis to 

comply with this requirement. 

Section 494.90 Condition: Patient 

plan of care. The interdisciplinary team 

must develop and implement a written, 

individualized comprehensive plan of 

care that meets the requirements of 

§ 494.90. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

Section 494.100 Condition: Care at 

home. The dialysis facility must 

document in the patient’s medical 

record, that the patient, the caregiver, or 

both received and comprehended 

required training. In addition, the 

facility must document, in the patient’s 

medical record, that the self-monitoring 

data and other information from selfcare were reviewed, at least every 2 

months. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

Section 494.110 Condition: Quality 

assessment and performance 

improvement. The dialysis facility must 

develop, implement, maintain, and 

evaluate an effective, data-driven 

interdisciplinary quality assessment and 

performance improvement program that 

reflects the complexity of the dialysis 

facility’s organization and services. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

Section 494.120 Condition: Special 

purpose renal dialysis facilities.

Facilities must contact the patient’s 

physician prior to initiating dialysis in 

the special purpose renal dialysis 

facility, to discuss the patient’s current 

condition to assure care provided in the 

special purpose renal dialysis facility is 

consistent with the plan of care 

(specified in § 494.90). 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

Facilities must document all care 

provided in the special purpose facility 

and forward the documentation to the 

patient’s dialysis facility within 30 days 

of the last scheduled treatment in the 

special purpose renal dialysis facility. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

Section 494.170 Condition: Medical 

records. The dialysis facility must 

maintain complete, accurate, and 

accessible records on all patients, 

including home patients who elect to 

receive dialysis supplies and equipment 

from a supplier that is not a provider of 

ESRD services and all other home 

dialysis patients whose care is under the 

supervision of the facility. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

The dialysis facility must obtain 

written authorization from the patient or 

legal representative before releasing 

information that is not compelled by 

law. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, exempts the burden associated 

with this requirement from the PRA as 

stipulated under 5 CFR 1320.3(b)(2). 

Patient records must be retained for a 

period of time not less than that 

required by State law, or in the absence 

of State law, 5 years from the date of 

discharge, including death for adults 

and 3 years for minors or until the 

patient reaches legal age under State 

law, whichever is longer. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

When a dialysis patient is transferred, 

the transferring facility must provide the 

receiving facility with all medical 

records and other information necessary 

or useful in the patient’s care or 

treatment. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

Section 494.180 Condition: 

Governance. The dialysis facility must 

have available at the nursing/monitoring 

station, a roster with the names of 

physicians to be called for emergencies, 

when they can be called, and how they 

can be reached. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

The dialysis facility must have a 

written agreement, that meets the 

requirements in § 494.180, with a 

hospital that can provide inpatient care, 

other hospital services, and emergency 

medical care that is available 24 hours 

a day, 7 days a week. 

While this requirement is subject to 

the PRA, the fact that this requirement 

is a usual and customary business 

practice, or is required under other 

Federal, State, and local laws, or both, 

exempts the burden associated with this 

requirement from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) or (b)(3) or 

both. 

The facility must provide each patient 

with written notice 30 days in advance 

of the facility reducing or terminating 

ongoing care after following the 

procedure specified in § 494.180(f). 

We estimate that 500 facilities will 

need 1 hour on an annual basis to 

provide the required disclosure. This is 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6239

based on the assumption that the 

disclosure will be standardized and will 

not be required by the majority of 

facilities. 

The dialysis facility must furnish data 

information electronically to CMS at 

intervals specified by the Secretary, 

which meet the requirements referenced 

in this section. 

While these requirements are subject 

to the PRA, they are currently approved 

under the following OMB approval 

numbers: 0938–0046, 0938–0360, 0938–

0386, 0938–0657, and 0938–0658.

In accordance with §§ 420.200 

through 420.206 of this chapter, the 

governing body must report ownership 

interests of 5 percent or more to its State 

survey agency. 

While these requirements are subject 

to the PRA, it is currently approved 

under OMB approval number 0938–

0086. 

We have submitted a copy of this 

proposed rule to OMB for its review of 

the information collection requirements 

in §§ 414.330, 488.60, 494.40, 494.50, 

494.70, 494.80, 494.90, 494.100, 

494.110, 494.120, 494.170, and 494.180. 

These requirements are not effective 

until they have been approved by OMB. 

If you comment on these information 

collection and recordkeeping 

requirements, please mail copies 

directly to the following:

Centers for Medicare & Medicaid 

Services, Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development and 

Issuances Group, Attn: Dawn 

Willinghan, Room C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850; and 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 

20503, Attn: Christopher J. Martin, 

CMS Desk Officer, 

Christopher_J._Martin@omb.eop.gov.

Fax: (202) 395–6974. 

B. Response to Comments 

Because of the large number of items 

of correspondence we normally receive 

on Federal Register documents 

published for comment, we are not able 

to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, if we proceed with 

a subsequent document, we will 

respond to the major comments in the 

preamble to that document. 

X. Regulatory Impact Analysis 

[If you choose to comment on issues in 

this section please include the caption 

‘‘Impact Analysis’’ at the beginning of 

your comment.] 

A. Overall Impact 

We have examined the impact of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Public Law 96–354), section 

1102(b) of the Social Security Act, the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4), and Executive Order 

13132. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in any 1 year). This rule is a proposed 

revision of the Medicare conditions for 

coverage for end-stage renal disease 

(ESRD) facilities. The conditions for 

coverage are the basic health and safety 

requirements that an ESRD supplier of 

services must meet in order to receive 

payment from the Medicare program. 

This proposed rule would incorporate 

new scientific advances and current 

medical practices in treating ESRD 

while removing numerous burdensome 

process and procedural requirements 

contained in the existing conditions for 

coverage. While it is not possible at this 

point to determine definitively the 

additional costs to the Medicare 

program resulting from this rule, we 

believe that the impact will be below 

the $100 million threshold; and 

therefore, believe that this proposed rule 

is not a major rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations and government 

agencies. Individuals and States are not 

included in the definition of small 

entity. According to the latest numbers 

from the Small Business 

Administration’s North American 

Industrial Classification System, 37 

percent (1,751) of dialysis facilities have 

revenues of $29 million or less 

annually; and therefore, are considered 

to be small entities. Thirty of these 

facilities have annual revenue less than 

$100,000. It is possible that this 

proposed regulation could cost some of 

these small facilities an additional 

$6,545 (about 6.5 percent of $100,000). 

However, this is an essential upgrading 

necessary to bring these facilities into 

conformity with what is becoming 

standard practice in the renal field and 

to provide essential quality in health 

care, potentially saving lives. For these 

reasons, we are not preparing analyses 

for either the RFA or section 1102(b) of 

the Act because we have determined, 

and we certify, that this rule will not 

have a significant economic impact on 

a substantial number of small entities or 

a significant impact on the operations of 

a substantial number of small rural 

facilities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. Since this rule applies only to 

dialysis facilities, it has no impact on 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule that may result in expenditures in 

any one year by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $110 million. This rule 

has no impact on the expenditures of 

State, local or tribal governments, and 

the impact on the private sector is 

estimated to be less than $110 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This rule will not have any effect on 

State and local governments. The costs 

associated with treating ESRD are 

currently a Medicare-covered benefit for 

individuals with ESRD. This rule will 

not increase the costs of the Medicare 

program. 

B. Impact of the Proposed Policy 

Changes 

1. Retained Requirements

We note that we have retained a 

number of requirements from the 

existing regulations in this proposed 

rule. Therefore, these requirements do 

not add any new financial burden for 

dialysis facilities. These requirements 

include the following: 

• Special procedures for approving 

end stage renal disease facilities. 

• Infection control. 

• Water quality. 

• Reuse of hemodialyzers. 

• Patient plan of care. 

6240 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

2. Physical Environment and Emergency 

Preparedness 

The existing regulations require 

dialysis facilities to have written 

policies and procedures for handling 

emergencies with annual reviews, 

testing, and revisions, and staff training 

to handle any emergency or disaster. 

Facilities are now expending resources 

to develop procedures and train staff for 

natural disasters that had never been 

known to occur in their region. The 

proposed rule requires only that the 

staff be able to demonstrate the ability 

to manage emergencies that are likely to 

occur in the facility’s geographic area. 

Although an annual review would still 

be required, the proposed rule does not 

require the involvement of the CEO in 

this activity. We estimate a typical 

facility will expend 4 hours less of staff 

time for this activity at $50 per hour, 

with a net savings of $200 per year for 

an overall savings of $947,000. 

The proposed rule requires that the 

facility meet the 2000 edition of Life 

Safety Code (LSC) requirements of the 

National Fire Protection Association. 

Most dialysis facilities currently meet 

most of the provisions required in 

Chapter 21 of the LSC because of State 

and local building codes as well as 

facilities’ own liability purposes. 

However, there may be some burden for 

existing facilities in regard to the 

installation and maintenance of the fire 

department alarm connection. We 

estimate that approximately 1,136 

facilities will need to be upgraded to 

meet this requirement. The one-time 

cost to install a fire department or 

central monitoring station connection is 

estimated to be $1,000 per facility. The 

monthly fee for the monitoring station 

and telephone cost is estimated to be 

about $80. Thus, we estimate the 

additional overall cost of compliance for 

facilities in the first year will be 

$2,226,500, with the annual cost 

thereafter being $1,090,560 ($80 month 

X 12 months X 1,136 facilities). 

This estimate does not take into 

account any specific waivers or 

acceptance of a State code in lieu of the 

LSC that may decrease the burden. If the 

health and safety of patients and staff 

are not adversely affected, the proposed 

rule would permit us to waive specific 

provisions of the LSC, which, if rigidly 

applied, would result in an 

unreasonable hardship on the facility. In 

addition, the proposed rule specifies 

that the Secretary, may accept a State 

code in lieu of the LSC, if it adequately 

protects patients. 

The proposed rule requires that every 

dialysis facility have access to a 

defibrillator. As discussed earlier in this 

preamble, USRDS data on causes of 

death among hemodialysis patients 

between 1997 and 1999 indicates that 

nearly half (49 percent) of the deaths 

were attributable to cardiovascular 

conditions, with cardiac arrest ranking 

first among the specified causes. 

One study found that the typical 

dialysis facility faces one cardiac arrest 

each year (Becker, pp. 1509–1512). The 

study estimated the cost of AEDs at 

$3,000, with a useful life of 10 years, 

that is, $300 annually for each life 

potentially saved. Currently, AEDs can 

be purchased for $2,000 with a useful 

life of 10 years (that is, an AED can be 

use at a cost of $200 each year for 10 

years). 

Since 19 percent of dialysis facilities 

are hospital-based, it is presumed that 

these facilities have already met the 

requirement, since they have access to 

an in-hospital defibrillator. However, 

we assume that all of the remaining 81 

percent of facilities would have to 

acquire this piece of equipment. The 

only ongoing annual costs for 

maintaining the equipment are those for 

testing and replacing batteries, and 

these costs are negligible. The cost of 

AEDs in 81 percent of dialysis facilities 

is estimated to be $7,670,700. We have 

requested public comment regarding the 

AED proposal as well as comments 

regarding the appropriateness of waivers 

or a phase-in period or both for small 

rural dialysis facilities. 

3. Patients’ Rights 

The existing regulations require 

dialysis facilities to have written 

patients’ rights policies and procedures 

and a list of numerous persons to whom 

the patient rights policies must be made 

available. The proposed rule details 

basic information that must be provided 

to patients (for example, advance 

directives and how to contact entities in 

regard to complaints) but only requires 

that patient rights be prominently 

displayed. Proposing minimum contents 

in the patients’ rights condition, and 

proposing only that these rights be 

posted, will limit the administrative 

burden. We estimate that this will save 

the typical facility about 2 hours of staff 

time at $15 per hour, that is, $30 

annually, for an overall savings of 

$142,050.

The existing regulations require 

translators when a significant number of 

patients exhibit language barriers. The 

proposed rule would delete this 

requirement and specify information be 

given to patients in a manner that 

assures their understanding. However, 

translators could still be used and 

facilities would have more flexibility in 

overcoming language barriers in lieu of 

hiring translators. This results in a net 

reduction in facility costs. 

The existing regulations require that 

advance notice be given to patients who 

are being terminated from a dialysis 

facility. The proposed rule is more 

specific and requires that written notice 

be given 30 days in advance. However, 

since involuntary terminations are a 

relatively infrequent occurrence, we 

consider the financial impact on 

dialysis facilities to be negligible. 

We estimate that 569 facilities will 

need 1 hour at $15 an hour on an annual 

basis to provide the required disclosure 

for a total annual cost of $8,535 (569 ×

1 × 15). This is based on the assumption 

that the disclosure will be standardized 

and will not be required by the majority 

of facilities. 

4. Quality Assessment and Performance 

Improvement 

Existing regulations are not 

comparable to the proposed rule’s 

requirement that the facility develop, 

implement, maintain, and evaluate a 

data-driven QAPI program. However, 

quality improvement efforts are 

considered part of the professional 

staff’s job and the renal community has 

developed considerable consensus in 

recent years in regard to clinical 

performance data. The top 5 dialysis 

chains, representing two-thirds of all 

dialysis facilities are already collecting 

and reporting standardized data on 14 

data elements, some of which are 

reported to the USRDS. 

This proposed rule simply requires 

the facilities to use this data internally, 

in a formal QAPI program that each 

facility has the flexibility to develop to 

suit its own purposes. The two-thirds of 

dialysis facilities in the top five chains 

are already complying with this 

requirement and many others also 

consider use of this data as part of their 

standard practice. We estimate that the 

QAPI requirements would impose a 

burden on no more than 10 percent of 

the dialysis facilities (that is, 473 

facilities). 

Assuming that a facility were 

initiating a QAPI program only as a 

result of this proposed rule, this may 

entail a 1-hour meeting of 4 staff 

persons quarterly, with each staff person 

having an additional hour of work each 

month beyond the meeting (that is, 16 

staff hours of meeting time + 48 staff 

hours beyond meetings = 64 hours 

annually). Assuming that the average 

staff cost is $25, the total additional cost 

to the facility would be $1,600 annually. 

The total cost for 473 facilities would be 

$756,800. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6241

5. Medical Records 

In the proposed rule, essential 

requirements in regard to retention, 

preservation, and transfer of medical 

records would be retained. However, the 

existing regulations are highly 

prescriptive in not only requiring the 

designation of a medical records 

supervisor, but in detailing that person’s 

duties, specifying categories of 

information to be included in the 

medical record, requiring written 

policies and procedures to protect 

medical records information, and even 

addressing spatial issues in regard to the 

maintenance and processing of medical 

records. The proposed rule would delete 

many of these requirements, giving the 

facility flexibility in deciding how the 

medical records are to be maintained 

and what is to be in them, as long as 

they facilitate positive patient outcomes. 

This reduces burden on the dialysis 

facilities. We estimate that this will save 

the typical facility about 40 hours of a 

medical records professional’s time, at 

$15 per hour, that is, $600 annually for 

an overall savings of $2,841,000. 

6. Governance 

The existing regulations specify the 

minimum requirements for CEO 

education and experience, whereas the 

proposed rule would delete these 

requirements. 

However, the proposed rule would 

add new requirements, for a training 

program for water treatment system 

technicians and a written training 

program for dialysis patient care 

technicians, in regard to the operation of 

kidney dialysis equipment and 

machines and the provision of patient 

care. This training program would be 

developed or adopted by the facility and 

must be approved by the medical 

director and the governing body of the 

facility. The water system training 

program may be written, audiovisual, or 

computer based. Since the major 

dialysis chains all have training 

programs for their dialysis patient care 

technicians and water treatment 

technicians, and the majority of dialysis 

facilities are affiliated with these chains, 

a large portion of facilities already meet 

this requirement. In addition, at least 11 

States already have some form of 

credentialing (training; competency 

exam; certification) requirements for 

dialysis patient care technicians, so 

dialysis facilities in these States, if they 

are unaffiliated with a major chain, may 

simply declare that meeting the State 

credentialing requirement is equivalent 

to completion of their training program. 

Even facilities that are not affiliated 

with a major dialysis chain and are in 

a State where there are no credentialing 

requirements for dialysis technicians, 

are not likely to be burdened with the 

requirement to develop a dialysis 

training program, since they can request 

medical director and governing body 

approval to use a packaged curriculum 

that includes a water treatment system 

module, which has been developed by 

organizations in the renal field and is 

available to any dialysis facility without 

cost. 

7. Clinical Performance Measures 

The proposed rule would add a 

requirement that all dialysis facilities 

electronically collect and report ESRD 

CPM Project data on all patients. The 

data include several measures of 

dialysis adequacy, vascular access, 

anemia management and nutrition. 

Any potential burden added by this 

requirement is mitigated by the 

following: 

• More than half the dialysis facilities 

already collect data on at least 14 

clinical performance measures, 

including measures that evaluate 

adequacy of dialysis treatment, anemia, 

nutritional level, vascular access, bone 

disease, and hypertension. Many units 

affiliated with the major dialysis chains 

have integrated their electronic data 

systems for quality management with 

their data systems for patient 

management, to minimize the data 

reporting burden. These facilities 

understand that it is important to collect 

and to use the data to allow an accurate 

comparison of the facility’s performance 

relative to that of its peers, since these 

comparisons can serve to identify 

significant opportunities for 

improvement.

• CPM data is already reported to 

CMS on a voluntary basis for a 5 percent 

national sample of patients, so many 

facilities are already familiar with the 

data reporting and collection process. 

• The CPM data set will become a 

part of the Consolidated Renal 

Operations in a Web-enabled Network 

(CROWN) data system, and CMS will 

supply VISION software free to dialysis 

facilities to permit them to enter CPM 

data electronically directly into the 

system. VISION is available for general 

use and is currently being used by 138 

independent dialysis facilities. Any 

dialysis facility that chooses to 

voluntarily participate in the CPM 

Project will be allowed to do so before 

the publication of a final rule. This 

could substantially reduce the number 

of facilities that need to be brought on 

line before the effective date of the final 

rule. 

• Training for purposes of 

implementing the CPM requirement will 

be provided by CMS and its ESRD 

Networks without cost to the dialysis 

industry, and some of the training will 

be done using an Internet Web tool. 

However, we do estimate that there 

will be some additional costs involved 

in: (1) Travel costs to training sites for 

some dialysis facility or chain 

representatives; (2) computer hardware 

and Internet Service Provider (ISP) 

connections for some facilities; and (3) 

collecting and transmitting data on the 

residual patients who are not served by 

the major dialysis chains and who are 

not part of the 5 percent sample of 

patients in the current CPM project. The 

detail in these estimates is as follows: 

• Estimated costs for travel to training 

sites will be approximately $200 for 

each facility/chain representative and 

we estimate that 2,000 persons will be 

sent for training, most representing 

chains of dialysis facilities. The total 

cost of travel to training would, then, be 

$400,000, and this would be only for the 

initial year of implementation; 

• Very few dialysis facilities would 

have to purchase computer hardware to 

implement this requirement, possibly 

no more than 142 (3 percent of total 

facilities). We estimate the cost of this 

purchase to be $1,000. Thus, the total 

cost for purchasing hardware would be 

$142,000, and this would be only in the 

initial year of implementation. We 

estimate ISP costs to be $150 annually 

($150 × 142 facilities = $21,300); 

• The estimated 5 percent annual 

growth rate in the ESRD population 

would mean that in 2005 there will be 

approximately 337,839 ESRD 

beneficiaries. We believe that the larger 

chains are already collecting CPM data 

on approximately 65 percent of these 

patients. Since the CPM project requires 

submission of this data on a 5 percent 

sample, we assume that the burden is 

only in regard to 95 percent of the 

remaining 35 percent of patients. Thus, 

we estimate that additional CPM data 

collection and reporting will be required 

for 112,331 patients annually (337,839 ×

.35 × .95). Based on current CPM project 

norms, we assume: One-half hour to 

abstract the data from the medical 

record by staff who are typically paid 

$25 per hour, for a cost of $1,404,142 

(112,331 × .5 × $25) annually; and keyentry at the rate of 12 patients per hour 

by staff who are typically paid $12 per 

hour, for a cost of $112,331 annually. 

Thus, in the first year of 

implementation, the total financial 

impact on the dialysis facilities of 

implementing the CPM requirement is 

estimated to be $2,079,774; thereafter, 

the cost would be approximately 

$1,537,774 ($1,404,142 + $112,331 + 

$21,300) annually for collecting and 

6242 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

transmitting the data and paying the 

ISP.

COST ESTIMATE FOR THE COLLECTION OF CPM DATA

$400,000 for travel to training (first year). 

$142,000 for computer hardware (first year). 

$1,537,474 for abstracting & key-entry of CPM data and ISP annually. 

$2,079,774 Total 

The following chart provides an 

overall estimate of the impact of the 

proposed rule:

OVERALL IMPACT OF THE PROPOSED RULE ON THE ECONOMY

4,735 facilities disaster planning burden @ $200 ................................................................................................................... = ¥$947,000 

1,136 facilities (24%) LSC upgrades @ $1,960 ...................................................................................................................... = +2,226,560 

3,835 facilities (81%) purchasing AEDs @ $3,000 ................................................................................................................. = +7,670,700 

4,735 facilities (patient rights distribution) @ $30 ................................................................................................................... = ¥142,050 

473 facilities (QAPI) @ $1,600 ................................................................................................................................................ = +756,800 

4,735 facilities (medical records burden) @ $600 ................................................................................................................... = ¥2,841,000 

569 facilities (30-day discharge notice) @ $15 ....................................................................................................................... = +8,535 

CPM reporting requirement (detailed above) ........................................................................................................................... = 2,079,774 

Total impact on the economy ........................................................................................................................................... = +8,812,319 

C. Anticipated Effects of the Revised 

ESRD Conditions on Suppliers of ESRD 

Services 

The Medicare conditions for coverage 

for ESRD facilities have not been revised 

in their entirety since their original 

publication in 1976. The revisions in 

this proposed rule reflect, for the most 

part, advances in dialysis technology 

and standard care practices. Transplant 

centers will not be affected because they 

are not included in this rule. One of the 

major purposes of this revision is to be 

responsive to regulatory reform 

initiatives, eliminating unnecessary 

procedural requirements and focusing 

on better patient outcomes of care. 

D. Alternatives Considered 

1. Maintenance of Existing Regulations 

One alternative would be to keep the 

existing regulations. However, the 

current regulations inhibit our ability to 

ensure better outcomes of patient care, 

collect electronic data for quality 

assurance and quality improvement, 

incorporate new CDC and AAMI 

guidelines and fire safety standards and 

reduce current facility burden by 

eliminating numerous process and 

procedural requirements. 

2. Infection Control 

One alternative was not proposing an 

exception to the CDC recommendation 

for monthly and semiannual screening 

for hepatitis C. We retained the 

exception because blanket screening for 

hepatitis C is not a Medicare-covered 

service. 

Another alternative was to propose 

compliance with all of the CDC 

guidelines in the RR05 report rather 

than just the crucial ‘‘Recommended 

Infection Control Practices for 

Hemodialysis Units At a Glance’’ (At a 

Glance) requirements. However, 

although we encourage compliance with 

the entire report, we decided against 

proposing compliance with the entire 

report. Our rationale was compliance 

with guidelines in the entire report 

would reduce flexibility and add 

unnecessary burden for dialysis 

facilities since some of the guidelines 

exceed the scope of these health and 

safety requirements. 

A third alternative was to propose 

compliance with AIA Guidelines for 

Design and Construction of Hospitals 

and Health Care Facilities. The AIA 

guidelines provide instructions 

regarding dialysis unit design as it 

relates to infection control. While some 

states have adopted specific AIA 

guidelines as minimal standards, we 

believe it would be too burdensome on 

dialysis facilities to propose to 

incorporate AIA guidelines as federal 

requirements. 

3. Water Quality 

One alternative was to propose to 

continue to require compliance with 

portions of the current AAMI 

guidelines,—ANSI/AAMI RD5: 1992 

Appendix B5. However, we decided to 

propose compliance with portions of the 

newer AAMI document—RD62: 2001 

and additional requirements that are 

compatible with ANSI/AAMI RD52: 

2004 because RD62 and RD52, are the 

state-of-the-art water quality guidelines. 

We have asked for comments on this 

proposal. 

4. Reuse of Hemodialyzers and 

Bloodlines 

One potential cost-saving alternative 

was to remove the proposal that 

dialyzers exposed to more than one 

germicide were acceptable for reuse. We 

decided against this proposal because 

exposure to different germicides may 

cause membrane leaks and we have no 

scientific evidence to support the safety 

of using dialyzers exposed to more than 

one germicide. 

5. Physical Environment and Emergency 

Preparedness 

One alternative was to remove the 

proposal that every dialysis facility have 

a defibrillator. We retained this proposal 

because a Seattle study (Becker, pp. 

1509–1512) identified dialysis centers 

as having a relatively high incidence of 

cardiac arrests over a 7-year period. 

Also, automated external defibrillators 

are now required on airliners and in 

other public places because the 

technology is simple to use, staff can be 

trained on the use of such equipment, 

and the technology has been proven to 

save lives.

A second alternative was to propose 

a waiver or phase-in period for 

defibrillators in small rural satellite 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6243

dialysis facilities with very low 

utilization. We are considering this 

alternative and have requested public 

comments on the defibrillator proposal. 

6. Patients’ Rights 

One alternative was to remove the 

proposal for advance directives. We 

retained this proposal because of the 

nature of ESRD and the aging dialysis 

population. 

Another alternative considered was 

not proposing that dialysis facilities 

have an internal grievance procedure. 

We did not adopt this alternative 

because we believe an internal 

grievance process is essential to allow 

patients to express their concerns 

directly to the facility in which they 

receive dialysis. 

7. Patient Assessment 

One alternative was to include 

‘‘extremely frail patients’’ in the 

proposal to reassess unstable patients 

monthly. This proposal was not adopted 

in order to ensure that dialysis facilities 

retain the flexibility to make clinical 

determinations on a case-by-case basis. 

Another alternative was to remove the 

proposal for a 3-month timeframe to 

reassess new patients. We are aware that 

the dialysis industry has not reached 

consensus regarding the appropriate 

frequency for reassessments, and 

therefore, we have requested comments 

on the current proposal to reassess new 

patients 3 months after starting dialysis. 

8. Patient Plan of Care 

One alternative was to retain the 

existing requirement for an 

individualized care plan with a 6-month 

review and a long-term program with an 

annual review. We did not adopt this 

approach because it was less 

burdensome to propose a single 

individualized plan of care (without a 

long-term program) to be reviewed 

annually. 

Another alternative was to propose to 

adopt specific evidence-based NKF–K/

DOQI clinical practice guidelines as 

numerical minimum target values 

within the patient plan of care condition 

(that is, adequacy of dialysis and anemia 

management). This issue is discussed in 

detail in the preamble and we are 

requesting public comments on the 

issue. 

9. Quality Assessment and Performance 

Improvement 

One alternative was to propose a 

QAPI program without specific 

threshold criteria. We determined, 

based on the work of the NFK–K/DOQI 

committees (adequacy, nutrition, 

anemia, and vascular access), AAMI 

guidelines (reuse), and specific 

recommendations from the OIG 

(medical error identification and patient 

satisfaction) that there was sufficient 

basis to include 7 basic criteria. We 

have requested public comment on 

QAPI. 

10. Special Purpose Renal Dialysis 

Facilities 

One alternative was to remove this 

condition entirely based on historically 

low levels of participation. We 

determined that eliminating this 

condition would be detrimental to the 

small number of vacation camps that 

choose to participate and it would also 

inhibit access to care during natural 

disasters. 

Another alternative was to retain the 

current 8-month certification period and 

the current certification requirements. 

We believe that the current certification 

requirements are onerous; we believe 

that this is demonstrated by the lack of 

participation in Medicare by vacation 

camps. We believe proposing to reduce 

the number of certification requirements 

addresses this issue. The existing 8-

month certification period is also 

excessive (that is, vacation camps are 

typically not open for 8 months and 

natural emergencies are of shorter 

duration). The current proposal 

represents a significant reduction in 

administrative burden for special 

purpose units. 

11. Personnel Qualifications 

One alternative was to retain the 

existing requirement that at least a 

licensed practical nurse must be on the 

premises during dialysis. We decided to 

propose that a registered nurse be on the 

premises during dialysis to protect 

patient health and safety and because 

this did not represent an increase in 

burden for dialysis units. 

Other options were to propose no 

Federal requirements for dialysis 

technicians, or, to propose minimal 

Federal requirements for dialysis 

technicians and include proposals for 

competency testing and certification. A 

detailed discussion of this issue is in 

section VI.A.5 of this preamble. We 

determined that minimal Federal 

requirements are needed at this time 

because dialysis technicians are the 

primary caregivers in most dialysis 

facilities. However, we did not propose 

competency testing or certification and 

have requested public comment. 

12. Medical Director 

One alternative was to propose to 

eliminate the medical director condition 

and propose that other health care 

professionals run dialysis facilities. 

However, a June 2000 OIG report 

strongly recommended that we 

strengthen the role of the facility’s 

medical director. In response to that 

recommendation, we proposed to retain 

the condition with a clarification of the 

medical director’s responsibilities to 

include overseeing both the QAPI 

program and all involuntary patient 

transfers or discharges. We do not 

believe that this approach would 

impose an additional cost burden on 

dialysis facilities. We have requested 

public comments on these proposals. 

13. Governance 

One alternative considered was to 

remove the proposal for a 30-day 

advanced notice before involuntary 

patient discharge or transfer and retain 

the existing requirement (see

§ 405.2138(b)(2)) for patients to be 

‘‘given advance notice to ensure orderly 

transfer or discharge.’’ We did not adopt 

this alternative because: (1) A 30-day 

advance notice for discharge and 

transfer has been consistent with the 

existing requirements in NFs, SNFs, and 

hospital swing-beds for over 12 years; 

(2) the dialysis patient population is 

increasingly older and many are nursing 

home residents with co-morbid 

conditions; and (3) large dialysis chains 

have emerged that can offer more 

flexibility and options for a patient 

involuntarily discharged from a facility 

by providing numerous units nearby or 

within commuting distance of that 

patient’s place of residence. We have 

added a proposal to waive the 30-day 

notice under unusual circumstances. 

This proposed rule contains a 

requirement for every dialysis facility to 

report ESRD CPM Project data to CMS. 

One option considered was to propose 

that less than 100 percent of facilities be 

required to participate. However, 

section 4558(b) of Pub. L. 105–33 

requires CMS to monitor the quality of 

care delivered to dialysis patients. To 

date, CMS has been collecting a 5 

percent CPM patient sample on a 

voluntary basis. CPM electronic data 

collection has been pilot-tested and is 

expected to be ready for general use in 

2005. A gradual voluntary phase-in will 

be undertaken for facilities that want to 

participate before full implementation. 

We believe that 100 percent CPM data 

collection is necessary to comply with 

the intent of the statute. The large chain 

dialysis facilities and many other 

dialysis facilities already collect this 

data for benchmarking and quality 

improvement purposes, and therefore, 

this will not create a significant new 

burden for the industry. However, small 

rural facilities may have a difficult time 

coming into compliance, and therefore, 

6244 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

we are considering a phase-in period for 

these facilities. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget.

List of Subjects 

42 CFR Part 405 

Administrative practice and 

procedure, Health facilities, Health 

professions, Kidney diseases, Medical 

devices, Medicare, Reporting and 

recordkeeping requirements, Rural 

areas, X-rays. 

42 CFR Part 410 

Health facilities, Health professions, 

Kidney diseases, Laboratories, 

Medicare, Reporting and recordkeeping 

requirements, Rural areas, X-rays. 

42 CFR Part 413 

Health facilities, Kidney diseases, 

Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 414 

Administrative practice and 

procedure, Health facilities, Health 

professions, Kidney diseases, Medicare, 

Reporting and recordkeeping 

requirements. 

42 CFR Part 488 

Administrative practice and 

procedure, Health facilities, Medicare, 

and Reporting and recordkeeping 

requirements. 

42 CFR Part 494 

Health facilities, Kidney diseases, 

Medicare, Reporting and recordkeeping 

requirements.

For the reasons stated in the preamble 

of this proposed rule, the Centers for 

Medicare & Medicaid Services proposes 

to amend 42 CFR chapter IV as follows:

PART 405—FEDERAL HEALTH 

INSURANCE FOR THE AGED AND 

DISABLED

Subpart U—Conditions for Coverage of 

End-Stage Renal Disease (ESRD) 

Services 

1. The authority citation for part 405, 

subpart U continues to read as follows:

Authority: Secs. 1102, 1138, 1861, 1862(a), 

1871, 1874, and 1881 of the Social Security 

Act (42 U.S.C. 1302, 1320b-8, 1395x, 

1395y(a), 1395hh, 1395kk, and 1395rr), 

unless otherwise noted. 

2. The title of the subpart is revised 

to read as follows:

Subpart U—Conditions for Coverage 

for Suppliers of Renal Transplantation 

Services and Requirements for ESRD 

Networks

§§ 405.2100, 405.2101, 405.2135 through 

405.2164, and 405.2180 through 405.2184

[Removed and Reserved] 

3. Sections 405.2100, 405.2101, 

405.2135 through 405.2164, and 

405.2180 through 405.2184 are removed 

and reserved. 

4. Section 405.2102 is revised to read 

as follows:

§ 405.2102 Definitions. 

As used in this subpart, the following 

definitions apply:

ESRD Network organization. The 

administrative governing body to the 

network and liaison to the Federal 

government. 

Histocompatibility testing. Laboratory 

test procedures which determine 

compatibility between an organ donor 

and a potential organ transplant 

recipient. 

Network, ESRD. All Medicareapproved ESRD facilities in a designated 

geographic area specified by CMS. 

Organ procurement. The process of 

acquiring donor organs. (See definition 

of Organ procurement organization in 

§ 486.302 of this chapter.) 

Renal transplantation center. A 

hospital unit which is approved to 

furnish directly transplantation and 

other medical and surgical specialty 

services required for the care of the 

ESRD transplant patients, including 

inpatient dialysis furnished directly or 

under arrangement. A Renal 

Transplantation Center may also be a 

Renal Dialysis Center. 

Transplantation service. A process by 

which (1) a kidney is excised from a live 

or cadaveric donor, (2) that kidney is 

implanted in an ESRD patient, and (3) 

supportive care is furnished to the 

living donor and to the recipient 

following implantation. 

Transplantation surgeon. A person 

who—

(1) Is board eligible or board certified 

in general surgery or urology by a 

professional board; and 

(2) Has at least 12 months training or 

experience in the performance of renal 

transplantation and the care of patients 

with renal transplants.

PART 410—SUPPLEMENTARY 

MEDICAL INSURANCE (SMI) 

BENEFITS 

1. The authority citation for part 410 

continues to read as follows:

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh).

§ 410.5 [Amended] 

2. In § 410.5(a), the reference ‘‘Part 

405, subpart U’’ is revised to read ‘‘Part 

494’’.

§ 410.50 [Amended] 

3. 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] 

4. Section 410.52 is amended as 

follows: 

a. In paragraph (a)(4), the reference to 

‘‘§ 405.2163’’ is revised to read 

‘‘§ 494.90(a)(3)’’. 

b. In paragraph (b), the parenthetical 

statement ‘‘(Section 405.2137 of this 

chapter contains specific details.)’’ is 

revised to read ‘‘(Section 494.90 of this 

chapter contains details on patient plans 

of care.)’’

§ 410.152 [Amended] 

5. In § 410.152(e)(1), ‘‘subpart U of 

part 405’’ is revised to read ‘‘part 494’’.

§ 410.170 [Amended] 

6. 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; OPTIONAL 

PROSPECTIVELY DETERMINED 

PAYMENT RATES FOR SKILLED 

NURSING FACILITIES 

1. The authority citation for part 413 

continues to read as follows:

Authority: Secs. 1102, 1812(d), 1814(b), 

1815, 1833(a), (i), (n), 1861(v), 1871, 1881, 

1883, and 1886 of the Social Security Act (42 

U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 

1395l(a), (i), and (n), 1395x(v), 1395hh, 

1395rr, 1395tt, and 1395ww).

2. In § 413.170, paragraph (a) is 

revised to read as follows:

§ 413.170 Scope. 

This subpart implements sections 

1881(b)(2) and (b)(7) of the Act by—

(a) Setting forth the principles and 

authorities under which CMS is 

authorized to establish a prospective 

payment system for outpatient 

maintenance dialysis furnished in or 

under the supervision of a dialysis 

facility under part 494 of this chapter 

(referred to as ‘‘facility’’). For purposes 

of this section and §§ 413.172 through 

413.198, ‘‘outpatient maintenance 

dialysis’’ means outpatient dialysis 

provided by a dialysis facility, home 

dialysis or self-dialysis as defined in 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6245

§ 494.10 of this chapter and includes all 

items and services specified in 

§§ 410.50 and 410.52 of this chapter.

* * * * *

3. In § 413.172, paragraph (b) is 

revised to read as follows:

§ 4l3.172 Principles of prospective 

payment.

* * * * *

(b) All approved ESRD facilities must 

accept the prospective payment rates 

established by CMS as payment in full 

for covered outpatient maintenance 

dialysis. Approved ESRD facility 

means—

(1) Any independent or hospitalbased facility (as defined in accordance 

with § 413.174(b) and (c) of this part) 

that has been approved by CMS to 

participate in Medicare as an ESRD 

supplier; or 

(2) Any approved independent facility 

with a written agreement with the 

Secretary. Under the agreement, the 

independent ESRD facility agrees—

(i) To maintain compliance with the 

conditions for coverage set forth in part 

494 of this chapter and to report 

promptly to CMS any failure to do so; 

and 

(ii) Not to charge the beneficiary or 

any other person for items and services 

for which the beneficiary is entitled to 

have payment made under the 

provisions of this part.

* * * * *

§ 413.198 [Amended] 

4. 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 

1. Part 414 is amended as follows: 

1a. The authority citation for part 414 

continues to read as follows:

Authority: Secs. 1102, 1871, and 1881(b)(1) 

of the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr(b)(1)).

§ 414.330 [Amended] 

2. In § 414.330(a)(2)(iii)(B), the 

reference ‘‘subpart U of part 405’’ is 

revised to read ‘‘part 494’’; and in 

§ 414.330(a)(2)(iii)(B)(l), the reference to 

‘‘subpart U’’ is changed to read ‘‘part 

494’’. 

3. In § 414.330(a)(2)(iii)(B)(1) the 

references ‘‘subpart U’’ are revised to 

read ‘‘part 494’. 

4. In § 414.330(a)(2)(iii)(B)(7) the 

references ‘‘subpart U’’ are revised to 

read ‘‘part 494’. 

5. Section 414.330(a)(2)(iii)(C) is 

added to read as follows:

§ 414.330 Payment for home dialysis 

equipment, supplies, and support services. 

(a) * * * 

(2) * * * 

(iii) * * * 

(C) Agrees to report to the ESRD 

facility providing support services, 

every 30 days, all data for each patient 

regarding services and items furnished 

to the patient in accordance with 

§ 494.100(c)(2) of this chapter.

* * * * *

PART 488—SURVEY, CERTIFICATION, 

AND ENFORCEMENT PROCEDURES 

1. The authority citation for part 488 

continues to read as follows:

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1895hh). 

2. In § 488.60 paragraph (a) is revised 

to read as follows:

§ 488.60 Special procedures for approving 

end stage renal disease facilities. 

(a) Consideration for approval. An 

ESRD facility that wishes to be 

approved or that wishes an expansion of 

dialysis services to be approved for 

coverage, in accordance with part 494 of 

this subchapter, must secure a 

determination by the Secretary. To 

secure a determination, the facility must 

submit the following documents and 

data for consideration by the Secretary: 

(1) Certification by the State agency 

referred to in § 488.12 of this part. 

(2) Data furnished by ESRD network 

organizations and recommendations of 

the Public Health Service concerning 

the facility’s contribution to the ESRD 

services of the network. 

(3) Data concerning the facility’s 

compliance with professional norms 

and standards. 

(4) Data pertaining to the facility’s 

qualifications for approval or for any 

expansion of services.

* * * * *

3. A new subpart H, consisting of 

§§ 488.604, 488.606, 488.608, and 

488.610, is added to read as follows:

Subpart H—Termination of Medicare 

Coverage and Alternative Sanctions for End 

Stage Renal Disease (ESRD) Facilities 

Sec. 

488.604 Termination of Medicare coverage. 

488.606 Alternative sanctions. 

488.608 Notice of alternative sanction and 

appeal rights: Termination of coverage. 

488.610 Notice of appeal rights: Alternative 

sanctions.

Subpart H—Termination of Medicare 

Coverage and Alternative Sanctions 

for End Stage Renal Disease (ESRD) 

Facilities

§ 488.604 Termination of Medicare 

coverage. 

(a) Except as otherwise provided in 

this subpart, failure of a supplier of 

ESRD services to meet one or more of 

the conditions for coverage set forth in 

part 494 of this subchapter will result in 

termination of Medicare coverage of the 

services furnished by the supplier. 

(b) If termination of coverage is based 

solely on a supplier’s failure to 

participate in network activities and 

pursue network goals, as required at 

§ 494.160 of this subchapter, coverage 

may be reinstated when CMS 

determines that the supplier is making 

reasonable and appropriate efforts to 

meet that condition. 

(c) If termination of coverage is based 

on failure to meet any of the other 

conditions specified in part 494 of this 

subchapter, coverage will not be 

reinstated until CMS finds that the 

reason for termination has been 

removed and there is reasonable 

assurance that it will not recur.

§ 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 

6246 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

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 

subchapter.

§ 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. 

1. Part 494 is added to read as follows:

PART 494—CONDITIONS FOR COVERAGE 

FOR END STAGE RENAL DISEASE 

FACILITIES

Subpart A—General Provisions 

Sec. 

494.1 Basis and scope. 

494.10 Definitions. 

494.20 Condition: Compliance with 

Federal, State, and local laws and 

regulations.

Subpart B—Patient Safety 

494.30 Condition: Infection control. 

494.40 Condition: Water quality. 

494.50 Condition: Reuse of hemodialyzers 

and bloodlines. 

494.60 Condition: Physical environment.

Subpart C—Patient Care 

494.70 Condition: Patient rights. 

494.80 Condition: Patient assessment. 

494.90 Condition: Patient plan of care. 

494.100 Condition: Care at home. 

494.110 Condition: Quality assessment and 

performance improvement. 

494.120 Condition: Special purpose renal 

dialysis facilities. 

494.130 Condition: Laboratory services.

Subpart D—Administration 

494.140 Condition: Personnel 

qualifications. 

494.150 Condition: Medical director. 

494.160 Condition: Relationship with the 

ESRD network. 

494.170 Condition: Medical records. 

494.180 Condition: Governance.

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh).

Subpart A—General Provisions

§ 494.1 Basis and scope. 

(a) Statutory basis. This part is based 

on the following provisions: 

(1) Section 299I of the Social Security 

Amendments of 1972 (Pub. L. 92–603), 

which extended Medicare coverage to 

insured individuals, their spouses, and 

their dependent children with ESRD 

who require dialysis or transplantation. 

(2) Section 1138(a)(1)(B) of the Act, 

which requires hospitals to be members 

and abide by the rules and requirements 

of the Organ Procurement and 

Transplantation Network. 

(3) Section 1861(e)(9) of the Act, 

which requires hospitals to meet such 

other requirements as the Secretary 

finds necessary in the interest of health 

and safety of individuals who are 

furnished services in the institution. 

(4) Section 1861(s)(2)(F) of the Act, 

which describes ‘‘medical and other 

health services’’ covered under 

Medicare to include home dialysis 

supplies and equipment, self-care home 

dialysis support services, and 

institutional dialysis services and 

supplies. 

(5) Section 1862(a) of the Act, which 

specifies exclusions from coverage. 

(6) Section 1881 of the Act, which 

authorizes Medicare coverage and 

payment for the treatment of ESRD in 

approved facilities, including 

institutional dialysis services, 

transplantation services, self-care home 

dialysis services, and the administration 

of recombinant epoetin alpha (EPO). 

(7) Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (Pub. L. 104–113), which 

requires Federal agencies to achieve 

greater reliance on voluntary standards 

and emphasize, where possible, the use 

of standards developed by private, 

consensus organizations. 

(b) Scope. The provisions of this part 

establish the conditions for coverage of 

services under Medicare and are the 

basis for survey activities for the 

purpose of determining whether an 

ESRD facility’s services may be covered.

§ 494.10 Definitions. 

As used in this part—

Dialysis facility means an entity that 

provides (1) outpatient maintenance 

dialysis services; or (2) home dialysis 

training and support services; or (3) 

both. A dialysis facility may be an 

independent or hospital-based unit (as 

described in § 413.174(b) and (c) of this 

chapter), or a self-care dialysis unit that 

furnishes only self-dialysis services. 

Discharge means the termination of 

patient care services by a dialysis 

facility. 

Furnishes directly means the ESRD 

facility provides the service through its 

own staff and employees or through 

individuals who are under direct 

contract to furnish these services 

personally for the facility. 

Home dialysis means dialysis 

performed at home by an ESRD patient 

or caregiver who has completed an 

appropriate course of training as 

described in § 494.100(a) of this part. 

Interdisciplinary team means the 

group of persons, specified § 494.80 of 

this part, responsible for providing 

patient care to each dialysis patient.

Self-dialysis means dialysis 

performed with little or no professional 

assistance by an ESRD patient or 

caregiver who has completed an 

appropriate course of training as 

specified in § 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, 

staff licensure and other personnel staff 

qualifications, fire safety, equipment, 

building codes, drugs, medical device 

usage, and any other relevant health and 

safety requirements.

Subpart B—Patient Safety

§ 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 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6247

1This publication is available for inspection at 

the CMS Information Resource Center, 7500 

Security Boulevard, Central Building, Baltimore, 

MD and at the National Archives and Records 

Administration (NARA). For availability of this 

material at NARA, call 202–741–6030, or got to 

http://www.archives.gov./federal_register/code

lowbar;of_federal_regulations/ibr_locations.html.

2This publication is available for inspection at 

the CMS Information Resource Center, 7500 

Security Boulevard, Central Building, Baltimore, 

MD and at the National Archives and Records 

Administration (NARA). For availability of this 

material at NARA, call 202–741–6030, or go to 

http://www.archives.gov./federal_register/

code_of_federal_regulations/ibr_locations.html. 

Copies may be purchased from the Association for 

the Advancement of Medical Instrumentation, 3300 

Washington Boulevard, Suite 400, Arlington, VA 

22201–4598.

3This publication is available for inspection at 

the CMS Information Resource Center, 7500 

Security Boulevard, Central Building, Baltimore, 

MD and at the National Archives and Records 

Administration (NARA). For availability of this 

material at NARA, call 202–741–6030, or got to 

http://www.archives.gov./federal_register/

code_of_federal_regulations/ibr_locations.html. 

Copies may be purchased from the Association for 

the Advancement of Medical Instrumentation, 3300 

Washington Boulevard, Suite 400, Arlington, VA 

22201–4598.

any adjacent hospital or other public 

areas. 

(a) Standard: Procedures for infection 

control. The facility must demonstrate 

that it follows standard infection control 

precautions by implementing—

(1) The ‘‘Recommended Infection 

Control Practices for Hemodialysis 

Units at a Glance,’’ with the exception 

of screening for Hepatitis C, found in 

‘‘Recommendations for Preventing 

Transmission of Infections Among 

Chronic Hemodialysis Patients’

Morbidity and Mortality Weekly Report, 

volume 50 number RR05, April 27, 

2001, pages 20 and 21, developed by the 

Centers for Disease Control and 

Prevention, which are incorporated by 

reference, to prevent and control crosscontamination and the spread of 

infectious agents. Incorporation by 

reference of the CDC ‘‘Recommended 

Infection Control Practices for 

Hemodialysis Units at a Glance,’’ was 

approved by the Director of the Federal 

Register in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51.1

(2) Patient isolation procedures to 

minimize the spread of infectious agents 

and communicable diseases; and 

(3) Maintaining procedures, in 

accordance with applicable State and 

local laws and accepted public health 

procedures, for the—

(i) Handling, storage, and disposal of 

potentially infectious waste; and 

(ii) Cleaning and disinfection of 

contaminated surfaces, medical devices, 

and equipment. 

(b) Standard: Oversight. The facility 

must—

(1) Monitor and implement biohazard 

and infection control policies and 

activities within the dialysis unit; and 

(2) Designate a registered nurse as the 

infection control or safety officer, 

responsible for—

(i) Maintaining current infection 

control information including the most 

current Centers for Disease Control and 

Prevention guidelines for the proper 

techniques in the use of vials and 

ampules containing medication; 

(ii) Reporting infection control issues 

to the dialysis facility’s chief executive 

officer or administrator (see § 494.180(a) 

of this part) and the quality 

improvement committee; and 

(iii) Making recommendations 

regarding infection control training and 

improvements. 

(c) Standard: Monitoring. The facility 

must—

(1) Analyze and document the 

incidence of infection to identify trends 

and establish baseline information on 

infection incidence; and 

(2) Develop recommendations to 

minimize infection transmission and 

take actions to reduce future incidents. 

(d) Standard: Reporting. The facility 

must report incidences of 

communicable diseases as required by 

Federal, State, and local regulations.

§ 494.40 Condition: Water quality. 

The facility must be able to 

demonstrate the following: 

(a) Standard: Water purity. Water 

used for dialysis meets the following 

water quality standards and equipment 

requirements of the Association for the 

Advancement of Medical 

Instrumentation (AAMI) published in 

‘‘Water Treatment Equipment for 

Hemodialysis Applications,’’ ANSI/

AAMI RD62: 2001, which are 

incorporated by reference. Incorporation 

by reference of the AAMI Water 

Treatment Equipment for Hemodialysis 

Applications, was approved by the 

Director of the Federal Register in 

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

CFR part 51.2

(1) Incorporated water quality 

requirements are those listed in 

sections—

(i) 4.2.1 and 5.2.1, Water Bacteriology; 

(ii) 4.2.2 and 5.2.2 Maximum Level of 

Chemical Contaminants; and 

(iii) 4.3, Water Treatment Equipment 

requirements. 

(2) The requirements for frequency of 

water purity testing to insure meeting 

the AAMI limits specified in paragraphs 

(a)(1)(i) and (ii) of this section are as 

follows: 

(i) Bacteria and bacterial endotoxin 

levels of water/dialysate must be 

monitored—

(A) In established systems at least 

monthly; 

(B) In newly-installed systems at least 

weekly until an established pattern of 

compliance can be demonstrated; 

(C) In accordance with the 

requirements of AAMI published in 

‘‘Dialysate for Hemodialysis,’’ ANSI/

AAMI RD52:2004 section 7.2.1, which 

are incorporated by reference. 

Incorporation by reference of the AAMI 

Dialysate for Hemodialysis was 

approved by the Director of the Federal 

Register in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51.3

(ii) Chemical analysis of water purity 

must be done at least once a year and 

when—

(A) The system is installed; 

(B) Membranes are replaced, if using 

a reverse osmosis system; 

(C) Seasonal variations in source 

water suggest worsening water quality; 

(D) Reverse osmosis rejection rates, 

which are monitored daily using 

continuous-reading monitors that 

measure product water conductivity, 

fall below 90 percent. 

(b) Standard: Reverse osmosis or 

deionization. Each water treatment 

system must include reverse osmosis 

membranes or a deionization 

component with resistivity monitors. 

(c) Standard: Chlorine/chloramines. 

The facility must ensure, on a daily 

basis, that the source water does not 

contain chlorine/chloramines or the 

facility must ensure that—

(1) The water treatment system 

includes a component or carbon tank 

which removes chlorine/chloramine 

along with a backup component or 

second carbon tank for chlorine/

chloramine removal; and 

(2) The water from the exit port of the 

first component or carbon tank which 

removes chlorine/chloramine is tested 

for chlorine/chloramine levels, at a 

minimum, before each patient shift or 

every 4 hours, whichever is shorter, 

during operation of the water treatment 

system. 

(i) If the test results are greater than 

0.50 mg/L for free chlorine or 0.10 mg/

L for chloramines from the port of the 

initial component or carbon tank then 

the second component or carbon tank 

which removes chlorine/chloramine 

must be tested; and 

(ii) If the test results from the last 

component or carbon tank are greater 

than the parameters for chlorine or 

chloramine specified in paragraph 

(c)(2)(i) of this section the facility 

must—

(A) Immediately terminate dialysis 

treatment to protect patients from 

exposure to chlorine/chloramine; 

6248 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

4This publication is available for inspection at 

the CMS Information Resource Center, 7500 

Security Boulevard, Central Building, Baltimore, 

MD and at the National Archives and Records 

Administration (NARA). For availability of this 

material at NARA, call 202–741–6030, or got to: 

http://www.archives.gov./federal_register/

code_of_federal_regulations/ibr_locations.html. 

Copies may be purchased from the Association for 

the Advancement of Medical Instrumentation, 3300 

Washington Boulevard, Suite 400, Arlington, VA 

22201–4598.

(B) Immediately notify the medical 

director; and 

(C) Take corrective action. 

(d) Standard: Corrective action plan. 

Water testing results including, but not 

limited to, chemical, microbial, and 

endotoxin levels which meet AAMI 

action levels or deviate from the AAMI 

standards must be addressed with a 

corrective action plan that ensures 

patient safety. 

(e) Standard: Adverse events. A 

dialysis facility must maintain active 

surveillance of patient reactions during 

and following dialysis. When clinically 

indicated (for example, after adverse 

patient reactions) the facility must —

(1) Obtain blood and dialysate 

cultures; 

(2) Undertake evaluation of the water 

purification system; and 

(3) Take corrective action. 

(f) Standard: Unused bicarbonate. 

Once mixed, bicarbonate concentrate 

must be used within the timeframe 

specified by the manufacturer of the 

concentrate.

§ 494.50 Condition: Reuse of 

hemodialyzers and bloodlines. 

The dialysis facility that reuses 

hemodialyzers or bloodlines must meet 

the requirements of this section. Failure 

to meet any of these requirements 

constitutes grounds for denial of 

payment for the dialysis treatment 

affected and termination from 

participation in the Medicare program. 

(a) Standard: General requirements 

for the reuse of hemodialyzers and 

bloodlines. Certain hemodialyzers and 

bloodlines—

(1) May be reused for certain patients 

with the exception of Hepatitis B 

positive patients; 

(2) Must be reused only for the same 

patient; and 

(3) Must be labeled for multiple reuse 

in accordance with the premarket 

notification provisions of section 501(k) 

of the Food, Drug, and Cosmetics Act 

and 21 CFR 876.5860. 

(b) Standard: Reprocessing 

requirements for the reuse of 

hemodialyzers and bloodlines. A 

dialysis facility that reuses 

hemodialyzers and bloodlines must 

adhere to the following reprocessing 

guidelines: 

(1) Meet the requirements of AAMI 

published in ‘‘Reuse of Hemodialyzers,’’

third edition, ANSI/AAMI RD47:2002/

A1:2003, which is incorporated by 

reference. Incorporation by reference of 

the ‘‘Reuse of Hemodialyzers, third 

edition, RD47:2002/A1:2003’’ was 

approved by the Director of the Federal 

Register in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51.4

(2) Reprocess hemodialyzers and 

bloodlines—(i) By following the 

manufacturer’s recommendations; or 

(ii) Using an alternate method and 

maintaining documented evidence that 

the method is safe and effective. 

(3) Not expose hemodialyzers to more 

than one chemical germicide, other than 

bleach, during the life of the dialyzer. 

All hemodialyzers must be discarded 

before a different chemical germicide is 

used in the facility. 

(c) Standard: Monitoring, evaluation, 

and reporting requirements for the reuse 

of hemodialyzers and bloodlines. In 

addition to the requirements for 

hemodialyzer and bloodline reuse 

specified in paragraphs (a) and (b) of 

this section, the dialysis facility must 

adhere to the following: 

(1) Monitor patient reactions during 

and following dialysis. 

(2) When clinically indicated (for 

example, after adverse patient 

reactions), the facility must—

(i) Obtain blood and dialysate 

cultures; and 

(ii) Undertake evaluation of its 

dialyzer reprocessing and water 

purification system. When this 

evaluation suggests a cluster of adverse 

patient reactions is associated with 

hemodialyzer reuse, the facility must 

suspend reuse of hemodialyzers until it 

is satisfied the problem has been 

corrected. 

(iii) Report the adverse outcomes to 

the FDA and other Federal, State or 

local government agencies as required 

by law.

§ 494.60 Condition: Physical environment.

The dialysis facility must be designed, 

constructed, equipped, and maintained 

to provide dialysis patients, staff, and 

the public a safe, functional, and 

comfortable treatment environment. 

(a) Standard: Building. The building 

in which dialysis services are furnished 

must be constructed and maintained to 

ensure the safety of the patients, the 

staff, and the public. 

(b) Standard: Equipment 

maintenance. The dialysis facility must 

implement and maintain a program to 

ensure that all equipment (including 

emergency equipment, dialysis 

machines and equipment, and the water 

treatment system) are maintained and 

operated in accordance with the 

manufacturer’s recommendations. 

(c) Standard: Patient care 

environment. (1) The space for treating 

each patient must be sufficient to 

provide needed care and services, 

prevent cross-contamination, and to 

accommodate medical emergency 

equipment and staff. 

(2) The dialysis facility must—

(i) Maintain a temperature within the 

facility that is comfortable for the 

majority of its patients; and 

(ii) Make reasonable accommodations 

for the patients who are not comfortable 

at the temperature that is comfortable 

for the majority. 

(d) Standard: Emergency 

preparedness. The dialysis facility must 

implement processes and procedures to 

manage medical and nonmedical 

emergencies that are likely to threaten 

the health or safety of the patients, the 

staff, or the public. These emergencies 

include, but are not limited to, fire, 

equipment or power failures, 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; 

(C) Whom to contact if an emergency 

occurs while the patient is not in the 

dialysis facility; and 

(D) How to disconnect themselves 

from the dialysis machine if an 

emergency occurs. 

(ii) Ensuring that, at a minimum, 

patient care staff maintain current CPR 

certification; and 

(iii) Ensuring that nursing staff are 

properly trained in the use of emergency 

equipment and emergency drugs; 

(2) Emergency preparedness patient 

training. The facility must provide 

appropriate orientation and training to 

patients, including the areas specified in 

paragraph (d)(1)(i) of this section. 

(3) Emergency equipment and plans.

Emergency equipment, including, but 

not limited to, oxygen, airways, suction, 

defibrillator, artificial resuscitator, and 

emergency drugs, must be on the 

premises at all times and immediately 

available. The facility must—

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(i) Have a plan to obtain emergency 

medical system assistance when 

needed; and 

(ii) Evaluate at least annually the 

effectiveness of emergency and disaster 

plans and update them as necessary. 

(e) Standard: Fire safety. (1) The 

dialysis facility must meet applicable 

provisions of the 2000 edition of the 

Life Safety Code of the National Fire 

Protection Association (which is 

incorporated by reference in 

§ 403.744(a)(1)(i) of this chapter). 

(2) Chapter 5 of the 2000 edition of 

the Life Safety Code does not apply to 

a dialysis facility. 

(3) If CMS finds that a State has a fire 

and safety code imposed by State law 

that adequately protects a dialysis 

facility’s patients, CMS may allow the 

State survey agency to apply the State’s 

fire and safety code instead of the Life 

Safety Code. 

(4) After consideration of State survey 

agency recommendations, CMS may 

waive, for appropriate periods, specific 

provisions of the Life Safety Code if the 

following requirements are met: 

(i) The waiver would not adversely 

affect the health and safety of the 

dialysis facility’s patients; and 

(ii) Rigid application of specific 

provisions of the Life Safety Code 

would result in an unreasonable 

hardship for the dialysis facility.

Subpart C—Patient Care

§ 494.70 Condition: Patients’ rights. 

The dialysis facility must inform 

patients (or their representatives) of 

their rights (including their privacy 

rights) and responsibilities when they 

begin their treatment and must protect 

and provide for the exercise of those 

rights. 

(a) Standard: Patients’ rights. The 

patient has the right to—

(1) Respect, dignity, and recognition 

of his or her individuality and personal 

needs, and sensitivity to his or her 

psychological needs and ability to cope 

with ESRD; 

(2) Receive all information in a way 

that he or she can understand; 

(3) Privacy and confidentiality in all 

aspects of treatment; 

(4) Privacy and confidentiality in 

personal medical records; 

(5) Be informed about and participate, 

if desired, in all aspects of his or her 

care, including advance directives, and 

be informed of the right to refuse 

treatment and to refuse to participate in 

experimental research; 

(6) Be informed about all treatment 

modalities and settings, including but 

not limited to, transplantation, home 

dialysis modalities (home hemodialysis, 

intermittent peritoneal dialysis, 

continuous ambulatory peritoneal 

dialysis, continuous cycling peritoneal 

dialysis), and in-facility hemodialysis; 

(7) Be informed of facility policies 

regarding patient care, including, but 

not limited to, isolation of patients; 

(8) Be informed of facility policies 

regarding the reuse of dialysis supplies, 

including hemodialyzers;

(9) Be informed by a physician of his 

or her own medical status as 

documented in the patient’s medical 

record unless the medical record 

contains a documented contraindication 

to do so; 

(10) Be informed of services available 

in the facility and charges for services 

not covered under Medicare; 

(11) Receive the necessary services 

outlined in the patient plan of care 

described in § 494.90 of this part; 

(12) Be informed of the rules and 

expectations of the facility regarding 

patient conduct and responsibilities; 

(13) Be informed of the facility’s 

internal grievance process; 

(14) Be informed of external grievance 

mechanisms and processes, including 

how to contact the ESRD Network and 

the State survey agency; 

(15) Be informed of his or her right to 

file internal grievances or external 

grievances or both without reprisal or 

denial of services; and 

(16) Be informed that he or she may 

file internal or external grievances, 

personally, anonymously or through a 

representative of the patient’s choosing. 

(b) Standard: Right to be informed 

regarding the facility’s discharge and 

transfer policies. The patient has the 

right to—

(1) Be informed of the facility’s 

policies for transfer, discharge, and 

discontinuation of services to patients; 

and 

(2) Receive written notice 30 days in 

advance of the facility reducing or 

terminating ongoing care after following 

the procedure described in § 494.180(f) 

of this part. In the case of immediate 

threats to the health and safety of others, 

a shortened discharge procedure may be 

allowed. 

(c) Standard: Posting of rights. The 

dialysis facility must prominently 

display a copy of the patient’s rights in 

the facility, including the current State 

agency and ESRD network telephone 

complaint numbers, where it can be 

easily seen and read by patients.

§ 494.80 Condition: Patient assessment. 

The facility’s interdisciplinary team, 

consisting of, at a minimum, the patient 

(if the patient chooses) or the patient’s 

designee, a registered nurse, a 

nephrologist or the physician treating 

the patient for ESRD, a social worker, 

and a dietitian, is responsible for 

providing each patient with an 

individualized and comprehensive 

assessment of his or her needs. The 

comprehensive assessment must be 

used to develop the patient’s treatment 

plan and expectations for care. 

(a) Standard: Assessment criteria. The 

patient’s comprehensive assessment 

must include, but is not limited to, the 

following: 

(1) Evaluation of current health status 

and medical condition, including comorbid conditions. 

(2) Evaluation of the appropriateness 

of the dialysis prescription, blood 

pressure, and fluid management needs. 

(3) Laboratory profile and medication 

history. 

(4) Evaluation of factors associated 

with anemia, such as hematocrit, 

hemoglobin, iron stores, and potential 

treatment plans for anemia, including 

administration of erythropoietin. 

(5) Evaluation of factors associated 

with renal bone disease. 

(6) Evaluation of nutritional status. 

(7) Evaluation of psychosocial needs. 

(8) Evaluation of dialysis access type 

and maintenance (for example, 

arteriovenous fistulas, arteriovenous 

grafts, and peritoneal catheters). 

(9) Evaluation of the patient’s ability, 

interests, preferences, and goals, 

including level of participation in the 

dialysis care process; modality and 

setting, for example, home dialysis, 

including hemodialysis or peritoneal 

dialysis; and expectations for care 

outcomes. 

(10) Evaluation of suitability for a 

transplantation referral, based on 

criteria developed by the prospective 

transplantation center and its 

surgeon(s). If the patient is not suitable 

for transplantation referral, the basis for 

nonreferral must be documented in the 

patient’s medical record. 

(11) Evaluation of family and other 

support systems. 

(12) Evaluation of current patient 

physical activity level. 

(13) Evaluation of vocational and 

physical rehabilitation status and 

potential. 

(b) Standard: Frequency of 

assessment for new patients.

(1) An initial comprehensive 

assessment must be conducted within 

20 calendar days after the first dialysis 

treatment. 

(2) A follow up comprehensive 

reassessment must occur within 3 

months after the completion of the 

initial assessment to provide 

information to adjust the patient’s plan 

of care specified in § 494.90 of this part. 

(c) Standard: Assessment of treatment 

prescription.

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The adequacy of the patient’s dialysis 

prescription, as described in 

§ 494.90(a)(1) of this part, must be 

assessed on an ongoing basis as follows: 

(1) Hemodialysis patients. At least 

monthly by calculating delivered Kt/V 

or an equivalent measure. 

(2) Peritoneal dialysis patients. At 

least every 4 months by calculating 

delivered weekly Kt/V or an equivalent 

measure. 

(d) Standard: Patient reassessment. In 

accordance with the standards specified 

in paragraphs (a)(1) through (a)(13) of 

this section, a comprehensive 

reassessment of each patient and a 

revision of the plan of care must be 

conducted—

(1) At least annually for stable 

patients; and 

(2) At least monthly for unstable 

patients including, but not limited to, 

patients with—

(i) Extended or frequent 

hospitalizations; 

(ii) Marked deterioration in health 

status; 

(iii) Significant change in 

psychosocial needs; or 

(iv) Poor nutritional status, with 

unmanaged anemia and inadequate 

dialysis.

§ 494.90 Condition: Patient plan of care.

The interdisciplinary team must 

develop and implement a written, 

individualized comprehensive plan of 

care that specifies the services necessary 

to address the patient’s needs, as 

identified by the comprehensive 

assessment and changes in the patient’s 

condition, and must include measurable 

and expected outcomes and estimated 

timetables to achieve these outcomes. 

The outcomes specified in the patient 

plan of care must allow the patient to 

achieve current evidence-based 

community-accepted standards. 

(a) Standard: Development of patient 

plan of care. The interdisciplinary team 

must develop a plan of care for each 

patient. The plan of care must address, 

but not be limited to, the following: 

(1) Dose of dialysis. The 

interdisciplinary team must provide the 

necessary care and services to achieve 

and sustain the prescribed dose of 

dialysis. 

(2) Nutritional status. The 

interdisciplinary team must provide the 

necessary care and services to achieve 

and sustain an effective nutritional 

status. A patient’s albumin level must 

be measured at least monthly. 

(3) Anemia. The interdisciplinary 

team must provide the necessary care 

and services to achieve and sustain the 

expected hemoglobin/hematocrit level. 

The patient’s hemoglobin/hematocrit 

must be measured at least monthly. If a 

patient has hemoglobin less than 11 gm/

dL or hematocrit of less than 33 percent, 

the dialysis facility must conduct an 

evaluation to determine whether the 

patient is an erythropoietin candidate. 

For a home dialysis patient, the facility 

must evaluate whether the patient can 

safely, aseptically, and effectively 

administer erythropoietin and store 

erythropoietin under refrigeration. The 

patient’s response to erythropoietin, 

including blood pressure levels and 

utilization of iron stores, must be 

monitored on a routine basis. 

(4) Vascular access. The 

interdisciplinary team must provide the 

necessary care and services to achieve 

and sustain vascular access. The 

hemodialysis patient must be evaluated 

for the appropriate vascular access type, 

taking into consideration co-morbid 

conditions and other risk factors. The 

patient’s vascular access must be 

monitored to prevent access failure, 

including monitoring of ateriovenous 

grafts and fistulae for stenosis. 

(5) Transplantation status. When the 

patient is a transplantation referral 

candidate, the interdisciplinary team 

must develop plans for pursuing 

transplantation. The patient’s plan of 

care must include documentation of 

the—

(i) Plan for transplantation, if the 

patient accepts to transplantation 

referral; 

(ii) Patient’s decision, if the patient is 

a transplantation referral candidate but 

declines the transplantation referral; or 

(iii) Reason(s) for the patient’s 

nonreferral as a transplantation 

candidate as documented in accordance 

with § 494.80(a)(10) of this part. 

(6) Rehabilitation status. The 

interdisciplinary team must provide the 

necessary care and services for the 

patient to achieve and sustain an 

appropriate level of productive activity, 

including vocational, as desired by the 

patient, including the educational needs 

of pediatric patients (patients under the 

age of 18 years). 

(b) Standard: Implementation of the 

patient plan of care.

(1) The patient’s plan of care—

(i) Must be completed by the 

interdisciplinary team; 

(ii) Must be signed by the patient or 

the patient’s designee. 

(2) Implementation of the plan of care 

must begin within 10 calendar days 

after completion the patient assessment 

as specified in § 494.80 of this part. 

(3) If the expected outcome is not 

achieved, the interdisciplinary team, 

must adjust the patient’s plan of care to 

achieve the specified goals. 

(4) The dialysis facility must ensure 

that all dialysis patients are seen by a 

physician providing the ESRD care at 

least monthly, as evidenced by a 

monthly progress note placed in the 

medical record, and periodically, while 

the hemodialysis patient is receiving infacility dialysis. 

(c) Standard: Transplantation referral 

tracking. The interdisciplinary team 

must track the results of each kidney 

transplant center referral and must 

monitor the status of any facility 

patients who are on the transplant wait 

list. The team must communicate with 

the transplant center regarding patient 

transplant status at least quarterly or 

more frequently if necessary. 

(d) Standard: Patient education and 

training. The patient care plan must 

include, as applicable, education and 

training for patients and family 

members or caregivers or both, in 

aspects of the dialysis experience, 

dialysis management, quality of life, 

rehabilitation, and transplantation.

§ 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. 

(a) Standard: Training. The 

interdisciplinary team must provide 

training to the home dialysis patient, the 

designated caregiver, or self-dialysis 

patient before the initiation of home 

dialysis or self-dialysis (as defined in 

§ 494.10 of this part) and when the 

home dialysis caregiver or home 

dialysis modality changes. The 

training—

(1) Must be provided by a dialysis 

facility that is approved to provide 

home dialysis services; 

(2) For self-care, must be conducted 

by a registered nurse who meets the 

requirements of § 494.140(b)(2) of this 

part; and 

(3) Must be conducted for each home 

patient and address the specific needs of 

the patient, in the following areas: 

(i) The nature and management of 

ESRD; 

(ii) The full range of techniques 

associated with treatment modality 

selected, including effective use of 

dialysis supplies and equipment in 

achieving and delivering the physician’s 

prescription of Kt/V or URR, and 

effective erythropoietin administration 

(if prescribed) to achieve and maintain 

a hematocrit level of at least 33 percent 

or a hemoglobin level of 11 gm/dL; 

(iii) Implementation of a nutritional 

care plan; 

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(iv) How to achieve and maintain 

emotional and social well-being; 

(v) How to detect, report, and manage 

potential dialysis complications;

(vi) Availability of support resources 

and how to access and use resources; 

(vii) How to self-monitor health status 

and record and report health status 

information; 

(viii) How to handle medical and nonmedical emergencies; 

(ix) Infection control precautions; and 

(x) Proper waste storage and disposal 

procedures. 

(b) Standard: Home dialysis 

monitoring. The dialysis facility must—

(1) Document in the medical record 

that the patient, the caregiver, or both 

received and demonstrated adequate 

comprehension of the training; 

(2) Retrieve and review complete 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 dialysis facility must furnish 

directly home dialysis support services 

regardless of whether dialysis supplies 

are provided by the dialysis facility or 

a durable medical equipment company, 

that include, but are not limited to, the 

following: 

(i) Periodic monitoring of the patient’s 

home adaptation, including visits to the 

patient’s home by facility personnel in 

accordance with the patient’s plan of 

care. 

(ii) Coordination of the home patient’s 

care by a member of the dialysis 

facility’s interdisciplinary team. 

(iii) Development and periodic review 

of the patient’s individualized 

comprehensive plan of care that 

specifies the services necessary to 

address the patient’s needs and meet the 

measurable and expected outcomes as 

specified in § 494.90 of this part. 

(iv) Patient consultation with 

members of the interdisciplinary team, 

as needed. 

(v) Monitoring of the quality of water 

used by home hemodialysis patients in 

accordance with the requirements 

specified in § 494.40(a)(1)(i) and (ii) of 

this part and conducting an onsite 

evaluation of the water system. The 

dialysis facility must correct the water 

quality of the home hemodialysis 

patient, and if necessary, arrange for 

backup dialysis until the problem is 

corrected if—

(A) Analysis of the water quality 

indicates contamination; or 

(B) The home hemodialysis patient 

demonstrates clinical symptoms 

associated with water contamination. 

(vi) Purchasing, delivering, installing, 

repairing and maintaining medically 

necessary home dialysis supplies and 

equipment (including supportive 

equipment) prescribed by the attending 

physician. 

(vii) Identifying a plan and arranging 

for emergency back-up dialysis services 

when needed. 

(2) The dialysis facility must maintain 

a recordkeeping system that ensures 

continuity of care and patient privacy. 

This includes items and services 

furnished by durable medical 

equipment (DME) suppliers referred to 

in § 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, interdisciplinary 

quality assessment and performance 

improvement program. The program 

must reflect the complexity of the 

dialysis facility’s organization and 

services (including those services 

provided under arrangement), and must 

focus on indicators related to improved 

health outcomes and the prevention and 

reduction of medical errors. The dialysis 

facility must maintain and demonstrate 

evidence of its quality improvement and 

performance improvement program for 

review by CMS. 

(a) Standard: Program scope. (1) The 

program must include, but not be 

limited to, an ongoing program that 

achieves measurable improvement in 

health outcomes and reduction of 

medical errors by using indicators or 

performance measures associated with 

improved health outcomes and with the 

identification and reduction of medical 

errors. 

(2) The dialysis facility must measure, 

analyze and track quality indicators or 

other aspects of performance that the 

facility adopts or develops that reflect 

processes of care and facility operations. 

These performance components must 

influence or relate to the desired 

outcomes or be the outcomes 

themselves. The program must include, 

but not be limited to, the following: 

(i) Adequacy of dialysis. 

(ii) Nutritional status. 

(iii) Anemia management. 

(iv) Vascular access. 

(v) Medical injuries and medical 

errors identification. 

(vi) Hemodialyzer reuse program, if 

the facility reuses hemodialyzers.

(vii) Patient satisfaction and 

grievances. 

(b) Standard: Monitoring performance 

improvement. The dialysis facility must 

continuously monitor its performance, 

take actions that result in performance 

improvements, and track performance to 

ensure that improvements are sustained 

over time. Each facility must participate 

in ESRD network activities and pursue 

network goals. 

(c) Standard: Prioritizing 

improvement activities. The dialysis 

facility must set priorities for 

performance improvement, considering 

prevalence and severity of identified 

problems and giving priority to 

improvement activities that affect 

clinical outcomes or patient safety. The 

facility must immediately correct any 

identified problems that threaten the 

health and safety of patients.

§ 494.120 Condition: Special purpose renal 

dialysis facilities. 

A special purpose renal dialysis 

facility is approved to furnish dialysis 

on a short-term basis at special 

locations. Special purpose dialysis 

facilities are divided into two categories: 

vacation camps (locations that serve 

ESRD patients while the patients are in 

a temporary residence) and facilities 

established to serve ESRD patients 

under emergency circumstances. 

(a) Standard: Approval period. The 

period of approval for a special purpose 

renal dialysis facility may not exceed 8 

months in any 12-month period. 

(b) Standard: Service limitation. 

Special purpose renal dialysis facilities 

are limited to areas in which there are 

limited dialysis resources or access-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 of this 

part; 

(ii) Water quality at § 494.40 of this 

part (except as provided in paragraph 

(c)(1)(viii) of this section; 

(iii) Reuse of hemodialyzers at 

§ 494.50 of this part (if reuse is 

performed); 

(iv) Patients’ rights and posting of 

patients’ rights) §§ 494.70(a) and (c) of 

this part; 

(v) Laboratory services at § 494.130 of 

this part; 

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(vi) Medical director responsibilities 

for staff education and patient care 

policies and procedures at § 494.150(c) 

and (d) of this part; 

(vii) Medical records at § 494.170 of 

this part; and 

(viii) When portable home water 

treatment systems are used in place of 

a central water treatment system, the 

facility may adhere to § 494.100(c)(1)(v) 

(home monitoring of water quality) of 

this part, in place of § 494.40 (water 

quality) of this part. 

(2) Scope of requirements for an 

emergency circumstance facility. A 

special purpose renal dialysis facility 

set up due to emergency circumstances 

may provide services only to those 

patients who would otherwise be unable 

to obtain treatments in the geographic 

areas served by the facility. These types 

of special purpose dialysis facilities 

must additionally comply with the 

following conditions: 

(i) § 494.20 (compliance with Federal, 

State, and local laws and regulations). 

(ii) § 494.60 (physical environment). 

(iii) § 494.70(a) through (c) (patient 

rights). 

(iv) § 494.140 (personnel 

qualifications). 

(v) § 494.150 (medical director). 

(vi) § 494.180 (governance). 

(d) Standard: Physician contact. The 

facility must contact the patient’s 

physician, prior to initiating dialysis in 

the special purpose renal dialysis 

facility, to discuss the patient’s current 

condition to assure care provided in the 

special purpose renal dialysis facility is 

consistent with the patient plan of care 

(described in § 494.90 of this part). 

(e) Standard: Documentation. All 

patient care provided in the special 

purpose facility is documented and 

forwarded to the patient’s dialysis 

facility within 30 days of the last 

scheduled treatment in the special 

purpose renal dialysis facility.

§ 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. 

The dialysis facility’s staff (employee 

or contractor) must meet the personnel 

qualifications and demonstrated 

competencies necessary to serve 

collectively the comprehensive needs of 

the patients. The dialysis facility’s staff 

must have the ability to demonstrate 

and sustain the skills needed to perform 

the specific duties of their positions. 

(a) Standard: Medical director. (l) The 

medical director must be a physician 

who has completed a board approved 

training program in nephrology and has 

at least 12 months of experience 

providing care to patients receiving 

dialysis. 

(2) If a physician, as specified in 

paragraph (a)(1) of this section, is not 

available to direct a certified dialysis 

facility, another physician may direct 

the facility, subject to the approval of 

the Secretary. 

(b) Standard: Nursing services. (1) 

Nurse manager. The facility must have 

a nurse manager responsible for nursing 

services in the facility who must—

(i) Be a full time employee of the 

facility; 

(ii) Be a registered nurse who meets 

the practice requirements of the State in 

which he or she is employed; and 

(iii) Have at least 12 months of 

experience in clinical nursing, and an 

additional 6 months of experience in 

providing nursing care to patients on 

maintenance dialysis. 

(2) Self-care training nurse. The nurse 

responsible for self-care training must—

(i) Be a registered nurse who meets 

the practice requirements of the State in 

which he or she is employed; and 

(ii) Have at least 12 months 

experience in providing nursing care 

and an additional 3 months of 

experience in the specific modality for 

which the nurse will provide self-care 

training. 

(3) Charge nurse. The charge nurse 

responsible for each shift must—

(i) Be a registered nurse or a practical 

nurse who meets the practice 

requirements in the State in which he or 

she is employed; and 

(ii) Have at least 12 months 

experience in providing nursing care, 

including 3 months of experience in 

providing nursing care to patients on 

maintenance dialysis. 

(4) Staff nurse. Each nurse who 

provides care and treatment to patients 

must be either a registered nurse or a 

practical nurse who meets the practice 

requirements in the State in which he or 

she is employed. 

(c) Standard: Dietitian. The facility 

must have a dietitian who must—

(1) Be a registered dietitian with the 

Commission on Dietetic Registration; 

(2) Meet the practice requirements in 

the State in which he or she is 

employed; and 

(3) Have a minimum of one year’s 

professional work experience in clinical 

nutrition as a registered dietitian. 

(d) Standard: Social worker. The 

facility must have a social worker 

who—

(1) Holds a master’s degree in social 

work from a school of social work 

accredited by the Council on Social 

Work Education; and 

(2) Meets the practice requirements 

for social work practice in the State in 

which he or she is employed. 

(e) Standard: Patient care dialysis 

technicians. Patient care dialysis 

technicians must—

(1) Meet all applicable State 

requirements for education, training, 

credentialing, competency, standards of 

practice, certification, and licensure in 

the State in which he or she is 

employed as a dialysis technician; and 

(2) Have a high school diploma or 

equivalency; 

(3) Have completed at least 3 months 

experience, following a training 

program that is approved by the medical 

director and governing body. This 

experience must be under the direct 

supervision of a registered nurse, and be 

focused on the operation of kidney 

dialysis equipment and machines, 

providing direct patient care, and 

communication and interpersonal skills 

including patient sensitivity training 

and care of difficult patients. 

(f) Standard: Water treatment system 

technicians. Technicians who perform 

monitoring and testing of the water 

treatment system must complete a 

training program that has been approved 

by the medical director and the 

governing body.

§ 494.150 Condition: Responsibilities of 

the medical director. 

The dialysis facility must have a 

medical director who meets the 

qualifications of § 494.140(a) of this part 

to be responsible for the delivery of 

patient care and outcomes in the 

facility. Responsibilities include, but are 

not limited to, the following: 

(a) Quality assessment and 

performance improvement program. 

(b) Staff education, training, and 

performance. 

(c) Policies and procedures. The 

medical director must—

(1) Participate in the development, 

periodic review and approval of a 

‘‘patient care policies and procedures 

manual’’ for the facility; and 

(2) Ensure that—

(i) All policies and procedures 

relative to patient care and safety are 

adhered to by all individuals who treat 

patients in the facility, including 

attending physicians and nonphysician 

providers; and 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6253

(ii) The interdisciplinary team 

adheres to the discharge and transfer 

policies and procedures specified in 

§ 494.180(f) of this part.

§ 494.160 Condition: Relationship with the 

ESRD network. 

The dialysis facility must cooperate 

with the ESRD network designated for 

its geographic area, in fulfilling the 

terms of the Network’s current 

statement of work.

§ 494.170 Condition: Medical records. 

The dialysis facility must maintain 

complete, accurate, and accessible 

records on all patients, including home 

patients who elect to receive dialysis 

supplies and equipment from a supplier 

that is not a provider of ESRD services 

and all other home dialysis patients 

whose care is under the supervision of 

the facility. 

(a) Standard: Protection of the 

patient’s record. The dialysis facility 

must—

(1) Safeguard patient records against 

loss, destruction, or unauthorized use. 

(2) Keep confidential all information 

contained in the patient’s record, except 

when release is authorized pursuant to 

one of the following: 

(i) The transfer of the patient to 

another facility. 

(ii) Certain exceptions provided for in 

the law. 

(iii) Provisions allowed under third 

party payment contracts. 

(iv) Approval by the patient. 

(v) Inspection by authorized agents of 

the Secretary, as required for the 

administration of the dialysis program. 

(3) Obtain written authorization from 

the patient or legal representative before 

releasing information that is not 

authorized by law. 

(b) Standard: Completion of patient 

records and centralization of clinical 

information. 

(1) Current medical records and those 

of discharged patients must be 

completed promptly. 

(2) All clinical information pertaining 

to a patient must be centralized in the 

patient’s record. These records must be 

maintained in a manner such that each 

member of the interdisciplinary team 

has access to current information 

regarding the patient’s condition and 

prescribed treatment. 

(3) The dialysis facility must 

complete, maintain, and monitor home 

care patients’ records, including the 

records of patients who receive supplies 

and equipment from a durable medical 

equipment supplier.

(c) Standard: Record retention and 

preservation. Patient records must be 

retained for a period of time not less 

than that required by State law or, in the 

absence of State law—

(1) Adults. 5 years from the date of the 

patient’s discharge, transfer or death; or 

(2) Minors. 3 years or until the patient 

reaches legal age under State law, 

whichever is longer, from the date of the 

patient’s discharge, transfer or death. 

(d) Standard: Transfer of patient 

record information. When a dialysis 

patient is transferred, the dialysis 

facility releasing the patient must send 

the patient’s medical record and other 

information necessary in the patient’s 

care or treatment to the receiving facility 

within 1 working day of the transfer.

§ 494.180 Condition: Governance. 

The ESRD facility is under the control 

of an identifiable governing body, or 

designated person(s), with full legal 

authority and responsibility for the 

governance and operation of the facility. 

The governing body adopts and enforces 

rules and regulations relative to its own 

governance and to the health care and 

safety of patients, to the protection of 

the patients’ personal and property 

rights, and to the general operation of 

the facility. The governing body receives 

and acts upon recommendations from 

the ESRD Network. 

(a) Standard: Designating a chief 

executive officer or administrator. The 

governing body or designated person 

responsible must appoint an individual 

who serves as the dialysis facility’s chief 

executive officer or administrator who 

exercises responsibility for the 

management of the facility and the 

provision of all dialysis services, 

including, but not limited to—

(1) Staff appointments; 

(2) Fiscal operations; 

(3) The relationship with the ESRD 

networks; and 

(4) Allocation of necessary staff and 

other resources for the facility’s quality 

assessment and performance 

improvement program described in 

§ 494.110 of this part. 

(b) Standard: Adequate number of 

qualified and trained staff. The 

governing body or designated person 

responsible must ensure that—

(1) An adequate number of qualified 

personnel are present whenever patients 

are undergoing dialysis so that the 

patient/staff ratio is appropriate to the 

level of dialysis care given and meets 

the needs of patients; 

(2) A registered nurse is present in the 

facility at all times that patients are 

being treated; 

(3) All employees have appropriate 

orientation to the facility and their work 

responsibilities upon employment; 

(4) All employees have an 

opportunity for continuing education 

and related development activities; and 

(5) There is an approved written 

training program specific to dialysis 

technicians that includes—

(i) Principles of dialysis; 

(ii) Care of patients with kidney 

failure, including interpersonal skills; 

(iii) Dialysis procedures and 

documentation, including the initiation, 

monitoring, and termination of dialysis; 

(iv) Possible complications of dialysis; 

(v) Water treatment; 

(vi) Infection control; and 

(vii) Safety; and 

(viii) Dialyzer reprocessing, if 

applicable. 

(6) When State requirements meet or 

exceed § 494.180(b)(5) the State 

requirements must be met. 

(c) Standard: Medical staff 

appointments. The governing body—

(1) Is responsible for all medical staff 

appointments and credentialing, 

including attending physicians, 

physician assistants, and nurse 

practitioners; and 

(2) Ensures that all medical staff who 

provide care in the facility are informed 

of all facility policies and procedures, 

including the facility’s quality 

assessment and performance 

improvement program specified in 

§ 494.110 of this part. 

(d) Standard: Furnishing services. The 

governing body is responsible for 

ensuring that the dialysis facility 

furnishes directly (see § 494.10 of this 

part) services on its main premises or on 

other premises that are contiguous with 

the main premises and are under the 

direction of the same professional staff 

and governing body as the main 

premises (except for services provided 

under § 494.100 of this part).

(e) Standard: Internal grievance 

process. The facility’s internal grievance 

process must be implemented so that 

the patient may file a grievance with the 

facility without reprisal or denial of 

services. The grievance process must 

include—

(1) A clearly explained procedure for 

the submission of grievances; 

(2) Timeframes for reviewing the 

grievance; 

(3) A description of how the patient 

or the patient’s designated 

representative will be informed of steps 

taken to resolve the grievance. 

(f) Standard: Discharge and transfer 

policies and procedures. The governing 

body must ensure that all staff follow 

the facility’s patient discharge and 

transfer policies and procedures. The 

medical director ensures that no patient 

is discharged or transferred from the 

facility unless—

(1) The patient or payer no longer 

reimburses the facility for the ordered 

services; 

6254 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

(2) The facility ceases to operate; 

(3) The transfer is necessary for the 

patient’s welfare because the facility can 

no longer meet the patient’s 

documented medical needs; or 

(4) The facility has reassessed the 

patient and determined that the 

patient’s behavior is disruptive and 

abusive to the extent that the delivery of 

care to the patient or the ability of the 

facility to operate effectively is seriously 

impaired, in which case the medical 

director ensures that the patient’s 

interdisciplinary team—

(i) Documents the reassessments, 

ongoing problem(s), and efforts made to 

resolve the problem(s) and enters this 

documentation into the patient’s 

medical record; 

(ii) Obtains a written physician’s 

order that must be signed by both the 

medical director and the patient’s 

attending physician concurring with the 

patient’s discharge or transfer from the 

facility; 

(iii) Attempts to place the patient in 

another facility and documents that 

effort; and 

(iv) Notifies the State survey agency 

and the ESRD Network that services the 

area (where the facility is located) of the 

involuntary transfer or discharge. 

(g) Standard: Emergency coverage. (1) 

The governing body is responsible for 

ensuring that the dialysis facility 

provides patients and staff with written 

instructions for obtaining emergency 

medical care. 

(2) The dialysis facility must have 

available at the nursing/monitoring 

station, a roster with the names of 

physicians to be called for emergencies, 

when they can be called, and how they 

can be reached. 

(3) The dialysis facility must have an 

agreement with a hospital that can 

provide inpatient care, other hospital 

services, and emergency medical care 

which is available 24 hours a day, 7 

days a week. The agreement must—

(i) Ensure that hospital services are 

available promptly to the dialysis 

facility’s patients when needed. 

(ii) Include reasonable assurances that 

patients from the dialysis facility are 

accepted and treated in emergencies. 

(h) Standard: Furnishing data and 

information for ESRD program 

administration. The dialysis facility 

must furnish data and information to 

CMS and at intervals as specified by the 

Secretary. This information is used in a 

national ESRD information system and 

in compilations relevant to program 

administration, including claims 

processing and reimbursement, quality 

improvement, and performance 

assessment. The data and information 

must—

(1) Be submitted at the intervals 

specified by the Secretary; 

(2) Be submitted electronically in the 

format specified by the Secretary; 

(3) Include, but not be limited to—

(i) Cost reports; 

(ii) ESRD administrative forms; 

(iii) Patient survival information; and 

(iv) Existing ESRD clinical 

performance measures and any future 

clinical performance standards 

developed in accordance with the 

National Technology Transfer and 

Advancement Act process adopted by 

the Secretary. 

(i) Standard: Disclosure of ownership.

In accordance with §§ 420.200 through 

420.206 of this chapter, the governing 

body must report ownership interests of 

5 percent or more to its State survey 

agency.

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Approved: July 19, 2004. 

Tommy G. Thompson, 

Secretary.

Note: This document was received at the 

Office of the Federal Register on January 25, 

2005.

[FR Doc. 05–1622 Filed 1–28–05; 8:45 am] 

BILLING CODE 4120–01–P