[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
