[Federal Register Volume 60, Number 180 (Monday, September 18, 1995)]
[Rules and Regulations]
[Pages 48039-48044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22859]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 405

[BPD-766-F]
RIN 0938-AG21


Medicare Program; Standards for Quality of Water Used in Dialysis 
and Revised Guidelines on Reuse of Hemodialysis Filters for End-Stage 
Renal Disease (ESRD) Patients

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule.

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SUMMARY: This final rule revises the Medicare conditions for coverage 
of suppliers of end-stage renal disease services. The revisions remove 
general language in the regulations regarding water quality; 
incorporate by reference standards for monitoring the quality of water 
used in dialysis as published by the Association for the Advancement of 
Medical Instrumentation (AAMI) in its document, ``Hemodialysis 
Systems'' (second edition); and update existing regulations to 
incorporate by reference the second edition of AAMI's voluntary 
guidelines on ``Reuse of Hemodialyzers.''

EFFECTIVE DATE: These regulations are effective on October 18, 1995. 
The incorporation by reference of certain publications listed in the 
regulations is approved by the Director of the Federal Register as of 
October 18, 1995.

FOR FURTHER INFORMATION CONTACT: Jackie Sheridan, (410) 966-4635.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1881 of the Social Security Act (the Act) authorizes 
Medicare coverage and payment for the treatment of end-stage renal 
disease (ESRD) in approved facilities that provide dialysis to ESRD 
patients. The Health Care Financing Administration (HCFA) grants 
approval of ESRD facilities after they have been surveyed by a State 
agency. The State survey agency determines the facility's compliance 
with the conditions specified in regulations at 42 CFR part 405, 
subpart U. Medicare payment is limited to ESRD services furnished by 
facilities meeting these conditions.

A. Water Quality

    The existing regulation governing the quality of water used in 
dialysis (Sec. 405.2140(a)(5)) requires that the water be analyzed 
periodically and treated as necessary to maintain a continuous supply 
that is biologically and chemically compatible with acceptable dialysis 
techniques. The lack of specificity of these requirements makes it 
difficult for State agency surveyors to measure facility compliance 
with the standard.
    Realizing that water quality is one of the most important aspects 
of health and safety in dialysis led us to consult with the Public 
Health Service and various other professionals in the dialysis industry 
to redefine the standards used by State surveyors in determining 
compliance with the regulations. As a result of these consultations, we 
concluded that there was a need to establish specific measurable 
standards regarding the quality of water used in dialysis. According to 
the Public Health Service's Center for Disease Control and Prevention, 
the Association for the Advancement of Medical Instrumentation (AAMI) 
standard on water quality is the only standard available, is accepted 
by the medical community and is currently used by most facilities.
    The 1992 AAMI standard, ``Hemodialysis Systems,'' reflects the 
collective expertise of a committee of health care professionals, in 
conjunction with device manufacturers and government representatives. 
This committee developed a standard of performance for manufacturers 
that will, at a minimum, promote the effective, safe performance of 
hemodialysis systems, devices, and related materials. The standard 
includes specific water quality requirements and has an appendix that 
provides a guideline for the device user with specific emphasis on 
water purity assurance and monitoring. This standard is outcome-
oriented in that it stipulates only specific biological and chemical 
water purity levels and does not restrict the methods used by 
facilities to attain and maintain the acceptable levels.
    Each AAMI standard or recommended practice is reviewed at least 
every 5 years because of constant changes in medical technology and to 
clarify or improve existing guidelines. The standard was originally 
published in 1982. In 1986, the AAMI Renal Disease and Detoxification 
Committee appointed task groups to carefully review specific areas of 
the standard. After review by the task groups and the full committee, a 
proposed revision was drafted. This document, ``Hemodialysis Systems'' 
(second edition), was voted on by the committee, reviewed by the 
public, and was approved on March 16, 1992. 

[[Page 48040]]


B. Reuse of Hemodialyzers

    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. Reuse can be accomplished 
through a variety of techniques that involve the cleaning, 
disinfecting, and preparing of disposable hemodialysis devices for 
subsequent use by the same patient. Although the potential exists for 
adverse patient outcomes from reuse, reprocessing and reuse of 
dialyzers are safe when done properly.
    Existing regulations at Sec. 405.2150 require ESRD facilities 
reusing hemodialyzers to meet the voluntary guidelines and standards 
adopted by AAMI and issued in July 1986 as ``Reuse of Hemodialyzers.'' 
The AAMI guidelines on reuse of hemodialyzers are based on the national 
consensus of physicians, other health care professionals, government 
representatives, patients, and industry. These guidelines (directed to 
health professionals) describe the details of reprocessing dialyzers 
and address various areas such as personnel qualifications and 
training, patient considerations, equipment, reprocessing supplies, 
monitoring during dialysis, quality assurance and quality control.
    After review by the AAMI Renal Disease and Detoxification Committee 
and the public, the second edition of the ``Reuse of Hemodialyzers'' 
was approved. The second edition is directed to the physician in charge 
of hemodialyzer reprocessing (using a manual or automated method) and 
describes the essential elements of good practices for reprocessing 
dialyzers to help assure safety and effectiveness.
II. Provisions of the Proposed Regulations

    We published in the Federal Register (59 FR 6937) on February 14, 
1994, a proposed rule to amend the Medicare regulations to incorporate 
by reference the AAMI standard for water quality and the AAMI 
guidelines for monitoring purity of water for hemodialysis found in the 
following sections of ``Hemodialysis Systems'' (second edition):
     3.2.1--Water Bacteriology
     3.2.2-- Maximum Level of Chemical Contaminants
     Appendix B, section B1 through B5-- Guidelines for 
Monitoring Purity of Water Used for Hemodialysis.
    We proposed that this incorporation by reference would replace the 
existing general language in Sec. 405.2140(a)(5) which requires that 
water used for dialysis must be analyzed periodically and treated as 
necessary to maintain a continuous supply that is biologically and 
chemically compatible with acceptable dialysis techniques.
    The February 14, 1994, proposed rule also specified the proposed 
incorporation by reference of the 1993 (second) edition of the AAMI 
guidelines on ``Reuse of Hemodialyzers'' to replace the previously 
incorporated 1986 edition. In addition, we proposed to amend 
Sec. 405.2150 to remove paragraph (a)(2) concerning staff exposure to 
chemical germicides, paragraph (a)(3)(iii) concerning reporting adverse 
patient reactions to the manufacturer, and paragraph (b) concerning the 
standard for dialyzer caps. These topics (included in the three 
paragraphs previously mentioned) are covered in the following sections 
of the revised 1993 AAMI guidelines that are now being incorporated by 
reference:
     Section 8--Physical plant and environmental safety 
considerations
     Section 11--Reprocessing
     Section 13--Monitoring
     Annex A--Section A11.4--Germicide.
    The proposed rule specified that copies of both AAMI publications 
may be purchased from AAMI and are available for inspection at the HCFA 
Information Resource Center or the Office of the Federal Register.

III. Analysis of and Responses to Public Comments

    We received five timely public comments on the February 1994 
proposed rule. All commenters were generally supportive of the proposed 
revisions. Their comments and our responses are discussed below.

A. General

    Comment: One commenter noted that the Government's regulatory 
process is slower than the private sector's in making changes. They 
recommended that we develop a mechanism to automatically incorporate 
the most recent revision of AAMI guidelines into the regulation rather 
than revise the regulations each time the AAMI guideline is updated.
    Response: We acknowledge that the process of issuing a revision to 
the regulations each time the AAMI guidelines are updated results in 
delay in giving the updated guidelines the force of law. It certainly 
would be simpler for us to merely adopt the most recent version of the 
AAMI guidelines automatically upon update as the commenter suggested. 
However, we have some concerns that such a system may not be consistent 
with our obligation to the ESRD facilities that would be affected.
    Under the current system, we carefully review and consider the 
changes made in the AAMI updates and make a determination as to whether 
it is appropriate and necessary to incorporate the AAMI provisions in 
our regulations. Then we offer the public an opportunity to participate 
in the regulation process through a comment period.
    If we were to adopt the commenter's suggestion, the industry would 
be required to comply with the AAMI guidelines regardless of whether 
changes are beneficial to Medicare beneficiaries or unduly burdensome 
to facilities.
    In this regard, we note that we received a comment, which is 
discussed later in this document, expressing concern with the level of 
influence afforded to the reuse manufacturers under the process of 
adopting the AAMI guidelines.
    We are in the process of preparing a proposed rule that would 
totally revise the conditions of coverage for ESRD facilities. We will 
solicit comment from the public on the merits of this proposal at that 
time. Until we have had an opportunity to hear form the facilities that 
would be impacted by this suggestion, we believe it is most appropriate 
to continue to pursue the rulemaking under the Administrative Procedure 
Act and provide an opportunity for participation by the affected 
entities.

B. Water Quality

    Comment: Two commenters recommended that we also incorporate the 
AAMI provisions relating to sampling and testing methodologies 
contained in sections 4.2.1 and 4.2.2 of ``Hemodialysis Systems.'' They 
noted that the sampling and testing protocols are essential to 
obtaining results that are meaningful and lead to the desired outcome 
of good patient health and safety. They presented examples of factors 
that can erroneously influence test results, such as leaving samples at 
room temperature, sampling only at one site, and shortened incubation 
periods.
    Response: We note the commenters' concern and fully endorse the 
provisions contained in sections 4.2.1 and 4.2.2. of the AAMI 
``Hemodialysis Systems'' document. However, we note that the subject 
provisions are exceedingly detailed and include not only point of water 
collection within the dialysis system, but also time of assay, storage 
temperatures, filter technique, and culture media. While we encourage 
facilities to utilize these guidelines, we 

[[Page 48041]]
believe that they are overly prescriptive. Moreover, the subject 
provisions are procedure-oriented as opposed to outcome-oriented and 
not necessary for ensuring Medicare beneficiary health and safety. We 
believe that we can meet the statutory mandate for beneficiary health 
and safety while permitting facilities some flexibility in sampling and 
testing procedures.
    In addition, the adopted provisions of AAMI water quality standard 
address specific bacteriological and chemical purity levels. We also 
adopted the AAMI Appendix guidelines with regard to monitoring 
frequency. The guidelines address monitoring practices similar to 
sections 4.2.1 and 4.2.2 but in a more general, less prescriptive 
nature. We feel confident that these provisions provide enough detail 
to permit surveyors to adequately determine appropriate water quality. 
Moreover, these new standards represent a significant improvement over 
the assurances contained in the existing regulation. We believe that it 
would be unnecessarily burdensome and prescriptive to specify minute 
details as to the sampling techniques. Further, such specificity would 
be inconsistent with the Administration's commitment to reduce Federal 
regulatory burden. Consequently, we are not adopting the commenters' 
suggestion at this time.
    We are, however, currently developing a complete revision of the 
ESRD conditions of coverage. One of the principal goals of this project 
is to make the conditions patient-centered and outcome-oriented. 
Ultimately, we may choose an outcome-oriented set of conditions 
regulating sampling methodology more explicitly. We will consider these 
comments as we develop the new conditions.
    Comment: One commenter recommended that we apply the water quality 
standards to water used for reprocessing as well as for dialysate, 
noting that contaminated water can adversely affect reprocessing 
through the water rinse phases.
    Response: The AAMI water standards that we have adopted were 
prepared, in collaboration with the industry, exclusively for water 
used during hemodialysis. The guidelines were not intended for adoption 
to the reuse process. We have incorporated water standards specifically 
for the reuse process from the AAMI reuse standards. The reuse 
standards contain water requirements in sections 7.1.2. and 11.4.1. We 
believe these standards are adequate to meet our need to ensure 
beneficiary health and safety.

C. Hemodialyzer Reuse

    Comment: One commenter took issue with the statement in the 
preamble of the proposed rule stating that, ``Although the potential 
exists for adverse patient outcomes from reuse, reprocessing and reuse 
of dialyzers are safe when done properly.'' This commenter referenced 
the recent research indicating an association between increased 
mortality and reuse with certain germicides. The commenter concluded 
that it may be premature to state unequivocally that reprocessing and 
reuse of dialyzers are safe.
    Response: We note that the sentence addressed by the commenter 
clearly includes the caveat that reprocessing is safe when done 
``properly''. We do not believe the statement is misleading or 
erroneous in light of research findings.
    Although the referenced research finds an association between 
increased mortality and reuse of certain germicides, it does not 
conclude that reuse is not safe. In addition, the Food and Drug 
Administration (FDA) has approved the product and its labelling, 
reviewed manufacturers' studies, and followed routine procedures that 
include product testing. Thus, we can conclude that the germicides 
currently marketed for reprocessing dialyzers do, in fact, work 
effectively to destroy bacteria.
    HCFA and the FDA believe the research in question supports a 
conclusion that proper technique is essential for effective use of the 
germicides. Consequently, the FDA has been working with one 
manufacturer to strengthen product user education. In this regard, the 
manufacturer in question has taken several voluntary actions to promote 
proper use of the product, including issuing revised detailed 
instructions. In addition, the manufacturer has held numerous training 
sessions all over the nation to educate its customers regarding proper 
use of the product. Further, the manufacturer in question requires its 
customers to sign commitments to verify that they understand and will 
comply with product user instructions before further merchandise will 
be distributed.
    Comment: Two commenters requested clarification of the requirement 
in Sec. 405.2150(a)(2) that states that facilities may use only one 
germicide in reprocessing. Specifically, the commenters were concerned 
about the use of bleach and another germicide during reprocessing. One 
commenter specifically asked if it was necessary to discard all 
dialyzers currently being reused if the facility changes germicides.
    Response: For purposes of reuse, bleach is considered a cleansing 
agent, not a germicide. Thus, many facilities use bleach as part of the 
reuse process to flush and clean blood deposits before the actual 
germicide soaking process is initiated. We do not intend to imply that 
this bleach cleansing process adversely affects the reprocessing. Since 
we do not consider bleach to be a germicide, the requirement to discard 
dialyzers treated with a different germicide does not apply to 
bleaching.
    We do intend that a facility that changes germicides discard all 
those dialyzers reprocessed with the old germicide. We are concerned 
that exposing dialyzers to different germicides may cause membrane 
leaks. While we recognize that it may be expensive and considered 
wasteful by some facilities to discard dialyzers with test values that 
indicate they are still effective, we believe that this precaution is a 
necessary safety measure. Facilities should take this added expense 
into consideration when analyzing their alternatives and making a 
determination regarding the changing of germicides.
    Comment: One commenter indicated that the prohibition against reuse 
of dialyzers for hepatitis B-positive patients that is contained in the 
AAMI guidelines is unjustified and costly to dialysis facilities. The 
commenter cited a report from the Centers for Disease Control that 
concluded that reuse of dialyzers was not associated with increased 
transmission of hepatitis B. Commenters supported measures other than a 
total ban against reuse for hepatitis B-positive patients, such as 
holding dedicated equipment in isolation areas, to eliminate the risk 
of cross-contamination of dialyzers.
    Response: Hepatitis B is a highly contagious disease that has the 
potential to be extremely damaging to an ESRD patient. Given the highly 
contagious nature of the disease, the CDC has for many years strongly 
recommended extreme precaution and isolation of those patients who are 
hepatitis B-positive. Many physicians, nurses, and other professionals 
involved in the ESRD field have similarly supported the position of 
extreme caution in treating the hepatitis B-positive patient.
    We want to point out that the AAMI provision related to banning 
reuse for hepatitis B-positive patients was developed in a public forum 
and reflects the views of many noted professionals. These guidelines 
were developed by a committee of national experts in a variety of ESRD-
related fields. The committee's recommendations were then distributed 
to the AAMI membership at large for comment. Thus, 

[[Page 48042]]
the prohibition against reuse of dialyzers for hepatitis B positive 
patients was developed by the medical community and reflects the 
general concern of most professionals that extreme caution is necessary 
in treating patients with the disease.
    While there may be no appreciable evidence to demonstrate that 
reuse would increase the spread of hepatitis B, there is no conclusive 
evidence that reuse in this population is safe. Given that hepatitis B 
is very contagious and that the industry generally supports the 
prohibition, we believe that permitting reuse for hepatitis B-positive 
patients would be an inappropriate risk to the health and safety of 
ESRD patients.
    Comment: One commenter expressed concern that the AAMI reuse 
guidelines provide too much latitude to device manufacturers in 
establishing operating parameters for their equipment. The commenter 
was concerned that ESRD facilities are a captive audience to 
manufacturers, who could design expensive equipment or procedures. 
Under the reuse regulations, which require compliance with the 
manufacturer's guidelines, facilities may be forced to bear financial 
burdens with little recourse. The commenter suggested that HCFA develop 
a process to allow ESRD facilities to appeal the application of 
excessively restrictive guidelines for equipment.
    Response: We do not support the commenter's recommendation for HCFA 
to develop an appeal process for application of equipment guidelines. 
It is not within the purview of the HCFA to become involved in 
manufacturers' guidelines. The FDA, not HCFA, is responsible for 
approval of devices, equipment, and labelling, including manufacturers' 
instructions.
    Manufacturers' product guidelines are very technical and are 
developed only after considerable research and deliberation with 
respect to complex technical and scientific matters. HCFA does not have 
the appropriate staffing or expertise to adjudicate facilities' appeals 
of these scientific matters. However, the FDA does offer recourse to 
facilities through its Office of Compliance. Facilities may contact the 
FDA by writing to: Food and Drug Administration, Office of Compliance, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20850.
    In addition, we note that the manufacture of reprocessing devices, 
germicides, and equipment takes place in the competitive market arena. 
ESRD facilities are free to choose among a number of alternative 
strategies for reprocessing dialyzers, or they may choose not to reuse 
at all. Thus, we do not believe that the facilities are a captive 
audience to the manufacturers given that there are a variety of 
dialyzer processing methods and reprocessing product manufacturers.

D. Impact on the Hemodialysis Community

    We specifically solicited input from the commenters on our 
assumption that the adoption of the AAMI water and reuse standards 
would not represent a burden on the provider community as most are 
voluntarily complying with the AAMI guidelines.
    Comment: Several commenters agreed with our conclusion that there 
would be little impact on facilities because most facilities already 
voluntarily comply with AAMI guidelines. Nonetheless, they voiced 
support for making the guidelines mandatory to force those few non-
compliant facilities into appropriate practices.
    Response: We appreciate the support for our proposal and are 
proceeding to publish the final regulations.
    Comment: One commenter challenged our statement that the AAMI water 
standards are supported by scientific literature. The commenter also 
disagreed with the statement that the standards are based on industry 
consensus, since Government representatives participated in the AAMI 
guideline development.
    Response: As noted earlier, the AAMI guidelines were developed by a 
committee of noted experts in hemodialysis. Once the committee 
formulated a draft document, it was circulated to AAMI membership for 
comment. The AAMI membership includes representatives of manufacturers, 
physicians, patients, technicians, and other fields. The committee 
seriously considered the comments and made appropriate revisions in the 
guidelines. Decisions reflected the majority of the committee members; 
no single member had authority to direct the decision or overrule the 
majority. While it is true that Government employees participated in 
the development of the guidelines, we do not believe that the fact that 
a Government representative participated in the process is an 
indication that the resulting guidelines are not representative of the 
industry consensus.
    The AAMI committee utilized empirical data regarding microbial 
limits and epidemiological findings (among other things) in developing 
the guidelines. We acknowledge that by using the term ``scientific 
literature'' we may have inadvertently implied that the AAMI had 
performed clinical trials and controlled experimentation. The intent of 
the statement was to indicate that the water quality limits established 
in the guidelines reflected reasonable assumptions and available 
empirical data.

IV. Provisions of the Final Regulations

    We are adopting the provisions of the February 14, 1994, proposed 
regulations as final regulations without change.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
VI. Regulatory Impact Statement

A. Introduction

    We generally prepare a regulatory flexibility analysis that is 
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
through 612) unless the Secretary certifies that a final rule will not 
have a significant economic impact on a substantial number of small 
entities. For purposes of the RFA, all ESRD facilities are considered 
to be small entities.
    Also, section 1102(b) of the Act requires the Secretary to prepare 
a regulatory impact analysis if a final rule will have a significant 
impact on the operations of a substantial number of small rural 
hospitals. This analysis must conform to the provisions of section 603 
of the RFA. For purposes of section 1102(b) of the Act, we define a 
small rural hospital as a hospital that is located outside of a 
Metropolitan Statistical Area and has fewer than 50 beds.

B. Water Quality Standards

    This final rule incorporates industry standards on the quality of 
water used in dialysis into existing regulations thereby, enabling 
surveyors to accurately assess a facility's compliance with the 
standards on water quality. The AAMI standards are the results of a 
collaborative effort by health professionals and industry 
representatives to respond to clinical needs and to help ensure patient 
health and safety. The AAMI's recommended maximum levels for water 
contaminants have been clearly defined, reflect reasonable assumptions 
and available empirical data, and were developed through industry 
consensus. Under the AAMI water standard, the supplier/manufacturer of 
dialysis water treatment 

[[Page 48043]]
equipment is responsible for ensuring that the water produced by the 
system routinely does not exceed the maximum allowable chemical 
contaminant levels. Because AAMI's acceptable contamination levels have 
been in effect since 1982 and are recognized as medically acceptable 
standards, we believe that manufacturers have been producing and 
facilities have been purchasing equipment capable of meeting these 
requirements. We understand that technology is in place for all 
facilities to meet the AAMI water standard. The public comments that we 
received on the proposed rule support this conclusion. Changes in water 
quality will be handled through consultation with State and local water 
authorities. Safe purity levels will be ensured through continued 
monitoring by the physician in charge of dialysis. Although 
contaminants in water used in dialysate may cause adverse patient 
reactions, actual documented adverse incidents are rare when the water 
is monitored properly. Because the AAMI water quality standard 
represents long-standing acceptable medical practice, we believe the 
vast majority of facilities already comply with this standard. 
Incorporation of the AAMI standard into the regulations will help 
ensure patient health and safety by providing surveyors with a 
measurable standard with which they may assess facility compliance, 
especially in the few facilities that do not voluntarily conform to the 
water quality guidelines adopted by the industry.

C. Reuse of Hemodialyzers

    The AAMI ``Reuse of Hemodialyzers'' does not promote either single 
use or reuse of dialyzers. The guidelines were developed to acknowledge 
the widespread practice of reprocessing and provide recommendations for 
optimal hemodialyzer reprocessing. In January 1993, HCFA's Health 
Standards and Quality Bureau canvassed the 2,345 Medicare-certified 
ESRD facilities to determine if they practiced reuse, and, if so, the 
disinfecting protocols used. Sixty-five percent (1,532) of the 
facilities reported practicing reuse. Of these facilities, 
approximately 51 percent use renalin as the germicide; two-thirds of 
these facilities use an automated disinfecting system. Approximately 40 
percent of the facilities reported using formalin/formaldehyde as the 
germicide, with manual and automated systems receiving equal use. 
Approximately 9 percent of the facilities practicing reuse reported 
using glutaraldehyde as the germicide, with the majority of these 
facilities using an automated disinfecting system. Less than 1 percent 
of the facilities use other disinfecting methods.
    Because the 1993 AAMI guidelines do not differ significantly from 
the 1986 guidelines (which all Medicare participating facilities 
practicing reuse already must meet) we believe that the great majority 
of the facilities practicing reuse will be in compliance with the new 
standards in this final regulation. The 1993 AAMI standards were 
developed through a public forum and their adoption was well 
publicized. They reflect the most up-to-date reuse procedures already 
practiced by many of the facilities. Moreover, we do not believe that 
incorporating the 1993 guidelines into our regulations, in and of 
itself, will prompt any facility to begin or discontinue reuse.
    We expect that each facility will respond to these new standards 
based on the relationship of these standards to its current reuse 
practices and to factors such as whether or not the facility can buy 
new filters in quantity less expensively than it can upgrade its reuse 
practices. As we indicated earlier, 65 percent of the facilities are 
already reusing dialyzers. The major effect of this final rule will be 
to ensure that Medicare standards for reuse reflect safe and effective 
practices.
D. Conclusion

    Because we are unable to predict the decisions facilities will make 
in response to this regulation, we are unable to quantify the potential 
effect it will have. All five public responses to the February 1994 
proposed rule were favorable.
    Beneficiaries may be reassured that HCFA has adopted specific water 
quality standards and updated its standards for reuse of hemodialyzers 
to ensure their health and safety. However, we expect that there will 
be a negligible effect on most beneficiaries and facilities since we 
believe these revisions will make no major changes in current facility 
operation or patient experience. This final rule is not expected to 
result directly in any increases or reductions in Medicare program 
expenditures.
    For these reasons, we have determined, and the Secretary certifies, 
that this final rule will not have a significant economic impact on a 
substantial number of small entities and will not have a significant 
economic impact on the operations of a substantial number of small 
rural hospitals. Therefore, we are not preparing analyses for either 
the RFA or section 1102(b) of the Act.
    In accordance with the provisions of Executive Order 12866, this 
final rule was not reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 405

    Administrative practice and procedure, Health facilities, Health 
professions, Incorporation by reference, Kidney diseases, Medicare, 
Reporting and recordkeeping requirements, Rural areas, X-rays.

    42 CFR Chapter IV, Part 405, Subpart U is amended as set forth 
below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

Subpart U--Conditions for Coverage of Suppliers of End-Stage Renal 
Disease (ESRD) Services

    A. The authority citation for part 405, Subpart U continues to read 
as follows:

    Authority: Secs. 1102, 1861, 1862(a), 1871, 1874, and 1881 of 
the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a), 1395hh, 
1395kk, and 1395rr), and sec. 353 of the Public Health Service Act 
(42 U.S.C. 263a), unless otherwise noted.

    B. In Sec. 405.2140, the heading of paragraph (a) is republished, 
and paragraph (a)(5) is revised to read as follows:


Sec. 405.2140  Condition: Physical environment.

* * * * *
    (a) Standard: building and equipment.* * *
    (5)(i) The ESRD facility must employ the water quality requirements 
listed in paragraph (a)(5)(ii) of this section developed by the 
Association for the Advancement of Medical Instrumentation (AAMI) and 
published in ``Hemodialysis Systems,'' second edition, which is 
incorporated by reference.
    (ii) Required water quality requirements are those listed in 
sections 3.2.1, Water Bacteriology; 3.2.2, Maximum Level of Chemical 
Contaminants; and in Appendix B: Guideline for Monitoring Purity of 
Water Used for Hemodialysis as B1 through B5.
    (iii) Incorporation by reference of the AAMI's ``Hemodialysis 
Systems,'' second edition, 1992, was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 
51.1 If any changes in 

[[Page 48044]]
``Hemodialysis Systems,'' second edition, are also to be incorporated 
by reference, a notice to that effect will be published in the Federal 
Register.

    \1\ The publication entitled ``Hemodialysis Systems,'' second 
edition, 1992, is available for inspection at the HCFA Information 
Resource Center, 7500 Security Boulevard, Baltimore, MD 21244-1850 
and the Office of the Federal Register, 800 North Capitol Street, 
NW., Suite 700, Washington, DC. Copies may be purchased from the 
Association for the Advancement of Medical Instrumentation, 3300 
Washington Boulevard, Suite 400, Arlington, VA 22201-4598.
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* * * * *
    C. In Sec. 405.2150, the undesignated introductory text and 
paragraph (a) are revised, paragraph (b) is removed, paragraphs (c) and 
(d) are redesignated as paragraphs (b) and (c), respectively, and 
redesignated paragraph (c)(1) is revised to read as follows:


Sec. 405.2150  Condition: Reuse of hemodialyzers and other dialysis 
supplies.

    An ESRD facility that reuses hemodialyzers and other dialysis 
supplies meets the requirements of this section. Failure to meet any of 
paragraphs (a) through (c) of this section constitutes grounds for 
denial of payment for the dialysis treatment affected and termination 
from participation in the Medicare program.
    (a) Standard: Hemodialyzers. If the ESRD facility reuses 
hemodialyzers, it conforms to the following:
    (1) Reuse guidelines. Voluntary guidelines adopted by the AAMI 
(``Reuse of Hemodialyzers,'' second edition). Incorporation by 
reference of the AAMI's ``Reuse of Hemodialyzers,'' second edition, 
1993, was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.2 If any changes 
in ``Reuse of Hemodialyzers,'' second edition, are also to be 
incorporated by reference, a notice to that effect will be published in 
the Federal Register.

    \2\ The publication entitled ``Reuse of Hemodialyzers,'' second 
edition, 1993, is available for inspection at the HCFA Information 
Resources Center, 7500 Security Boulevard, Baltimore, MD 21244-1850 
and the Office of the Federal Register, 800 North Capitol Street, 
NW., Suite 700, Washington, DC. Copies may be purchased from the 
Association for the Advancement of Medical Instrumentation, 3300 
Washington Boulevard, Suite 400, Arlington, VA 22201-4598.
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    (2) Procedure for chemical germicides. 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. If a dialyzer is exposed 
to a second germicide, the dialyzer must be discarded.
    (3) Surveillance of patient reactions. In order to detect 
bacteremia and to maintain patient safety when unexplained events 
occur, the facility--
    (i) Takes appropriate blood cultures at the time of a febrile 
response in a patient; and
    (ii) If pyrogenic reactions, bacteremia, or unexplained reactions 
associated with ineffective reprocessing are identified, terminates 
reuse of hemodialyzers in that setting and does not continue reuse 
until the entire reprocessing system has been evaluated.
    (b) * * *
    (c) * * *
    (1) Limit the reuse of bloodlines to the same patient;
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: June 30, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-22859 Filed 9-15-95; 8:45 am]
BILLING CODE 4120-01-P