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

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