I
107TH CONGRESS
2D SESSION
H. R. 5141
To amend title XVIII of the Social Security Act to direct the Secretary
of Health and Human Services to establish a continuous quality improve-
ment program for providers that furnish services under the Medicare
Program to individuals with end stage renal disease, and for other
purposes.
IN THE HOUSE OF REPRESENTATIVES
JULY 16, 2002
Mr. STARK introduced the following bill; which was referred to the Committee
on Energy and Commerce, and in addition to the Committee on Ways
and Means, for a period to be subsequently determined by the Speaker,
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned
A BILL
To amend title XVIII of the Social Security Act to direct
the Secretary of Health and Human Services to establish
a continuous quality improvement program for providers
that furnish services under the Medicare Program to
individuals with end stage renal disease, and for other
purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘ESRD Quality Im-
provement Act of 2002’’.
SEC. 2. CONTINUOUS QUALITY IMPROVEMENT PROGRAM
FOR ESRD FACILITIES UNDER MEDICARE.
(a) IN GENERAL.—Section 1881 of the Social Secu-
rity Act (42 U.S.C. 1395rr) is amended by adding at the
end the following new subsection:
‘‘(h) CONTINUOUS
QUALITY
IMPROVEMENT
AND
QUALITY ASSURANCE PROGRAM.—
‘‘(1) CQI AND QA PROGRAMS.—
‘‘(A) IN GENERAL.—Not later than 1 year
after the date of the enactment of this sub-
section, the Secretary shall establish a manda-
tory continuous quality improvement program
(in this section referred to as the ‘CQI Pro-
gram’) and a mandatory quality assurance pro-
gram (in this section referred to as the ‘QA
Program’) for furnishing services to individuals
determined to have end stage renal disease
under this section. In establishing the CQI Pro-
gram and the QA Program, the Secretary shall
consult with representatives of patients, pro-
viders of services and renal dialysis facilities
(including facility administrators, physicians
(including 
nephrologists), 
dietitians, 
social
workers, and nurses), facilities, quality improve-
ment experts, and ESRD Network Administra-
tive Organizations (as defined in paragraph
(8)).
‘‘(B) PROVISIONS RELATING TO QA PRO-
GRAM ONLY.—The Secretary shall contract with
the ESRD Network Administrative Organiza-
tions and with State survey agencies to conduct
a coordinated quality assurance program (in
this section referred to as the ‘QA Program’)
that recognizes excellent ESRD clinical out-
comes and imposes sanctions for chronically
substandard care.
‘‘(C) COORDINATION
WITH
ESTABLISHED
DEPARTMENT OR ORGANIZATION PROGRAMS.—
The CQI Program required under this sub-
section, the ESRD Clinical Performance Meas-
ures required under paragraph (4), the infor-
mation management system required under
paragraph (5), the QA Program, and other
components of this subsection, as appropriate,
shall be established or developed in conjunction
with relevant quality improvement goals estab-
lished by the Secretary, or by ESRD Network
Administrative Organizations, which are in ef-
fect or in the process of development as of the
date of the enactment of this subsection.
‘‘(2) DUTIES OF THE SECRETARY.—Under the
CQI Program the Secretary—
‘‘(A) shall establish, and publish in the
Federal Register, the ESRD Clinical Perform-
ance Measures as described in paragraph (4);
‘‘(B) shall collect and analyze data from
providers and facilities as described in para-
graph (5);
‘‘(C) shall identify and reward outstanding
providers and facilities as described in para-
graph (6);
‘‘(D) shall identify and provide for addi-
tional training to providers and facilities in
need of such training as described in paragraph
(7) and shall institute such disciplinary actions
as deemed appropriate against those providers
and facilities that fail to improve;
‘‘(E) shall develop, in conjunction with the
Work Group, and implement a methodology to
identify serious medical errors and injuries in-
volving end-stage renal disease patients and to
analyze the causes for such injuries (such im-
plementation may first be initiated through a
demonstration project that is coordinated by
the ESRD Network Administrative Organiza-
tions);
‘‘(F) delineate the shared and distinctive
duties of the ESRD Network Administrative
Organizations and State survey agencies with
respect to facility or provider certification and
investigation;
‘‘(G) develop standards to evaluate the per-
formance of ESRD Network Administrative Or-
ganizations and State survey agencies; and
‘‘(H) determine an appropriate uniform
minimum frequency for on-site dialysis certifi-
cation and recertification surveys.
‘‘(3) DUTIES OF ESRD NETWORK ADMINIS-
TRATIVE ORGANIZATIONS.—ESRD Network Admin-
istrative Organizations shall perform the following
functions:
‘‘(A) COLLECTION AND ANALYSIS OF DATA
ON PROCESSES AND OUTCOMES OF CARE; USE
OF
ESRD
CLINICAL
PERFORMANCE
MEAS-
URES.—
‘‘(i) IN GENERAL.—The ESRD Net-
work Administrative Organizations shall
provide for the routine and timely data col-
lection, and statistical evaluation, of the
processes and outcomes of care for pa-
tients undergoing kidney transplant, hemo-
dialysis and other modalities requiring
blood access, and peritoneal dialysis.
‘‘(ii) DATA
USED.—In carrying out
such measurements and evaluations, the
ESRD Network Administrative Organiza-
tions shall use, among other data, the
ESRD Clinical Performance Measures es-
tablished under paragraph (4), and data
acquired under subparagraphs (F) and (H)
of subsection (c)(2), including medical in-
juries and their causes, medical errors, and
evidence of Hepatitis B and C serologic
conversion of patients or staff.
‘‘(iii) FEEDBACK TO PROVIDERS AND
FACILITIES.—The ESRD Network Admin-
istrative Organizations shall provide feed-
back to providers, facilities, and physi-
cians, from whom data has been collected
of their patterns of practice and ESRD
Clinical Performance Measures outcomes
as compared to the following:
‘‘(I) National averages of such
patterns and outcomes.
‘‘(II) State, Network, and where
statistically appropriate, local aver-
ages of such patterns and outcomes.
‘‘(III) Clinical goals established
by the Secretary of such patterns and
outcomes.
‘‘(B) DISSEMINATION
OF
RECOMMENDED
CLINICAL
PRACTICES.—The ESRD Network
Administrative Organizations shall disseminate
recommended clinical practices derived from
evidence based practice guidelines or clinical al-
gorithms to medical directors of dialysis facili-
ties and to such other providers of services as
the Secretary determines appropriate.
‘‘(C) MONITORING
PATIENT
AND
STAFF
SATISFACTION.—The ESRD Network Adminis-
trative Organizations, individual renal dialysis
facilities, and individual providers of services
shall 
collaborate 
to 
develop 
a 
uniform
mechanism—
‘‘(i) to monitor patient and staff satis-
faction and shall ensure an effective and
integrated complaint system; and
‘‘(ii) for the reporting of data by di-
alysis facility to the Network of the nurse
to patient ratio and the technician to pa-
tient ratio of the facility.
State survey agencies shall also collaborate in
the establishment of the mechanism with re-
spect to clause (i).
‘‘(D) PEER REVIEW.—The ESRD Network
Administrative Organizations shall conduct re-
gional and national peer review of renal dialysis
facilities and providers of services.
‘‘(E) 
TECHNICAL
ASSISTANCE.—The
ESRD Network Administrative Organizations
shall provide technical assistance for quality im-
provement efforts and identify quality improve-
ment activities to reflect evolving needs of facili-
ties and patients including rehabilitation, pa-
tient education, community outreach, grievance
resolution, and patient rights and responsibil-
ities.
‘‘(F) GUIDANCE ON COLLECTION AND CAL-
CULATION OF CLINICAL PERFORMANCE MEAS-
URES.—In consultation with the Work Group
(as defined in paragraph (8), the ESRD Net-
work Administrative Organizations shall provide
guidance to providers of services and renal di-
alysis facilities on the collection and measure-
ment of the ESRD Clinical Performance Meas-
ures.
‘‘(G) DISSEMINATION OF INFORMATION ON
CQI PROGRAM AND QA PROGRAM.—
‘‘(i) IN GENERAL.—The ESRD Net-
work Administrative Organizations shall
make information and materials under the
program available for the use of—
‘‘(I) facilities and providers in
Medicare+Choice organizations;
‘‘(II) facilities and providers that
do not receive payments under this
title;
‘‘(III) private payers of services
for end stage renal disease patients;
and
‘‘(IV) end stage renal disease pa-
tients and families.
‘‘(ii) REQUIREMENTS
RELATING
TO
PATIENT INFORMATION.—
‘‘(I) IN
GENERAL.—In making
available information under clause (i)
for patients and families, the ESRD
Network Administrative Organizations
shall make available the information
described in subclause (II) in printed
and electronic format. The content of
such information shall be determined
by the Work Group.
‘‘(II) 
INFORMATION
DE-
SCRIBED.—The information referred
to in subclause (I) is CQI Program in-
formation and facility-specific ESRD
Clinical Performance measures and
outcomes, including comparisons to
clinical goals established by the Sec-
retary 
under 
subparagraph
(A)(iii)(III) and national and appro-
priate State, Network, and local aver-
ages of such measures and outcomes.
‘‘(4) ESRD CLINICAL
PERFORMANCE
MEAS-
URES.—
‘‘(A) DEVELOPMENT OF INITIAL INDICA-
TORS.—Not later than 1 year after the date of
the enactment of this subsection, the Work
Group as defined in paragraph (8), shall define
a set of ESRD Clinical Performance Measures.
‘‘(B) UPDATING
OF
INDICATORS.—The
Work Group shall periodically update the
ESRD Clinical Performance Measures defined
in subparagraph (A).
‘‘(C) AUTHORITY TO CONSIDER CERTAIN
INDICATORS.—The ESRD Clinical Performance
Measures defined under subparagraph (A) and
updated under subparagraph (B) may include
patient outcome measures based upon the fol-
lowing types of indicators:
‘‘(i) Adequacy of hemodialysis and
peritoneal dialysis.
‘‘(ii) Adequacy of nutrition including
bone and mineral metabolism.
‘‘(iii) Vascular access.
‘‘(iv) Anemia management including
average per patient dosage of anti-anemia
medications.
‘‘(v) Standardized mortality ratios.
‘‘(vi) Standardized hospitalization ra-
tios and average length of hospital stay.
‘‘(vii) Standardized transplantation
ratios.
‘‘(viii) Adequacy of blood pressure
control.
‘‘(ix) Successful vocational mainte-
nance or rehabilitation.
‘‘(x) Referral for self-treatment at
home.
‘‘(xi) Appropriate administration of
clinical laboratory tests.
‘‘(xii) Such other indicators as the
Work Group considers appropriate, includ-
ing any appropriate unique measures for
kidney transplant centers.
‘‘(D) COORDINATION WITH ESTABLISHED
DEPARTMENT OR ORGANIZATION QUALITY IM-
PROVEMENT
GOALS.—To the greatest extent
possible, the ESRD Clinical Performance Meas-
ures shall be defined in conjunction with rel-
evant quality improvement goals established by
the Secretary, or by ESRD Network Adminis-
trative Organizations, which are in effect or in
the process of development as of the date of the
enactment of this paragraph, including informa-
tion system design and implementation, and en-
hanced data collection, analysis, and reporting
initiatives.
‘‘(E) AUTHORITY FOR ORGANIZATIONS TO
ESTABLISH
CERTAIN
SPECIFIC
INDICATORS.—
The ESRD Network Administrative Organiza-
tions, individual renal dialysis facilities, and in-
dividual providers of services may establish ad-
ditional independent patient-specific, physician-
specific or facility-specific performance meas-
ures.
‘‘(F) PUBLICATION IN THE FEDERAL REG-
ISTER.—The Secretary shall publish in the Fed-
eral Register the ESRD Clinical Performance
Measures as defined under subparagraph (A),
and as updated in subparagraph (B).
‘‘(5) ESRD CQI PROGRAM.—
‘‘(A) INFORMATION
MANAGEMENT
SYS-
TEM.—Not later than 2 years after the date of
the enactment of this subsection, the Secretary
shall establish an information management sys-
tem. The purpose of the information manage-
ment system is to provide for the electronic
transfer of data obtained under the CQI Pro-
gram and the QA Program among providers of
services, renal dialysis facilities, the Secretary,
ESRD Network Administrative Organizations,
and state agencies under contract with the Sec-
retary to conduct surveys of dialysis facilities.
The Secretary shall provide for technical assist-
ance in the use of the information management
system and for the development (or purchase)
and distribution of appropriate electronic soft-
ware for access to the information management
system.
‘‘(B) MANNER OF USE OF INFORMATION
MANAGEMENT SYSTEM.—
‘‘(i) PROVIDERS
OF
SERVICES
AND
FACILITIES.—Each provider of services
and each renal dialysis facility shall con-
tribute data obtained under the CQI Pro-
gram and the QA Program to the informa-
tion management system.
‘‘(ii) ESRD NETWORK ADMINISTRA-
TIVE ORGANIZATIONS.—Each ESRD Net-
work Administrative Organization shall
generate clinical profiles on the perform-
ance of renal dialysis facilities and indi-
vidual providers of services, and shall mon-
itor trends relevant to performance of fa-
cilities and providers.
‘‘(C) DUTIES OF THE SECRETARY.—With
respect to data contributed to the information
management system, the Secretary shall per-
form the following duties:
‘‘(i) COLLECTION
OF
UNADJUSTED
DATA.—The Secretary shall use the infor-
mation management system to collect, at
least biannually, the unadjusted data re-
quired to compute standards on all patient
outcomes—
‘‘(I) from each provider of serv-
ices and renal dialysis facility; and
‘‘(II) from physicians providing
services to individuals determined to
have end stage renal disease under
this section.
‘‘(ii) COMPILATION
OF
DATA.—The
Secretary shall combine the data collected
under clause (i) on individual patient out-
comes into aggregate data for each pro-
vider of services and renal dialysis facility
and for each such physician.
‘‘(iii) RISK-ADJUSTED
COMPARISONS
OF
PROVIDERS.—To the extent possible,
the Secretary shall adjust the data com-
bined under clause (ii) to establish risk ad-
justed comparisons of the ESRD Clinical
Performance Measures of—
‘‘(I) each provider of services and
renal dialysis facility with other such
providers and facilities;
‘‘(II) each such physician with
other such physicians in the network
area and the nation; and
‘‘(III) the current clinical out-
come goals established by the Sec-
retary (as periodically updated).
‘‘(iv) NATIONAL CLINICAL PERFORM-
ANCE
MEASURES
DATABASE.—The Sec-
retary shall administer a national clinical
performance measures database from the
data combined and adjusted under this
subparagraph.
‘‘(v) 
CONFIDENTIAL
REPORTS.—
Using CQI reports that preserve patient
confidentiality and confidentiality between
providers and facilities, the Secretary shall
report—
‘‘(I) each provider’s and facility’s
combined and adjusted data under
this subparagraph to the provider or
facility and each such physician’s
combined and adjusted data under
this subparagraph to the physician;
‘‘(II) how that provider, facility,
and physician (as the case may be)
compare in various CQI indicators to
other providers, facilities, or physi-
cians in the same network, in all net-
works, and to the ESRD Clinical Per-
formance Measures; and
‘‘(III) such data to the ESRD
Network Administrative Organization
for the network area in which the pro-
vider, facility or physician is located.
‘‘(vi) DISSEMINATION
OF
CERTAIN
DATA.—While protecting patient, provider,
and facility confidentiality, the Secretary
shall provide the data collected under
clauses (i), (ii), and (iii) to the United
States Renal Data System, State survey
agencies, and other public entities that the
Secretary determines is engaged in efforts
to improve the quality of services for renal
patients.
‘‘(D) REQUIREMENT TO REPORT DATA ON
PATIENTS
DISCHARGED
FOR
NONCOMPLIANCE
WITH TREATMENT PLAN.—In the case of an in-
dividual who is discharged from a facility or
provider by the facility, provider, or a physician,
for noncompliance with the treatment plan es-
tablished for the individual by the facility, pro-
vider, or physician, as the case may be, the fa-
cility, provider, or physician shall report such
discharge and reasons for the discharge to the
Secretary.
‘‘(E) PLAN
TO
IMPROVE
SERVICES.—In
the case of a facility notified under paragraph
(7)(B), the ESRD Network Administrative Or-
ganization for the network area in which the fa-
cility is located, in conjunction with the facility,
shall develop strategies to improve the provision
of services at the facility and shall provide ap-
propriate training in CQI Program processes to
the facility.
‘‘(F) PHYSICIAN
TRAINING.—The ESRD
Network Administrative Organization for the
network area in which the facility is located, in
conjunction with the facility, shall review the
quality of service provided by physicians noti-
fied under paragraph (7)(B) or identified under
subparagraph (E) at such facility for the pur-
poses of identifying those physicians that re-
quire training in CQI Program processes. In
the case of a physician notified under para-
graph (7)(B) or identified under subparagraph
(E), the ESRD Network Administrative Orga-
nization for the area in which the physician is
located, in conjunction with the physician, shall
develop strategies to improve the provision of
services by the physician, and shall provide ap-
propriate training in CQI Program processes to
the physician.
‘‘(6) AWARDS
FOR
OUTSTANDING
PROVIDERS
AND FACILITIES.—
‘‘(A) DESIGNATION OF FACILITY OR PHY-
SICIAN AS A MEDICARE DIALYSIS PROVIDER OF
ACHIEVEMENT.—For each of 2005, 2006, and
2007, the Secretary shall designate Medicare
Dialysis Providers of Achievement (as defined
in subparagraph (B)).
‘‘(B) DEFINITION OF MEDICARE DIALYSIS
PROVIDER OF ACHIEVEMENT.—A Medicare Di-
alysis Provider of Achievement is a renal dialy-
sis facility, or a physician, identified by the Sec-
retary as being 2 standard deviations above the
national norm for a preponderance of ESRD
Clinical Performance Measures on a case sever-
ity-risk adjusted basis for 2 consecutive report-
ing periods (covering in the aggregate a period
of at least 1 year).
‘‘(C) AUTHORITY
TO
MAKE
BONUS
PAY-
MENTS.—The Secretary may make a payment
to 
a 
Medicare 
Dialysis 
Provider 
of
Achievement—
‘‘(i) in a single monetary payment of
not less than $1,000 and not greater than
to $5,000; or
‘‘(ii) by increasing the reimbursement
rate otherwise applicable under this section
to the facility or physician by 1 to 3 per-
cent for a period of 1 year.
‘‘(D) REPORT ON SUCCESSFUL PROCESSES
AND
TECHNIQUES.—Upon request by any
ESRD Network Administrative Organization, a
Medicare Dialysis Provider of Achievement des-
ignated under subparagraph (A) shall submit to
such organization a report on the clinical proc-
ess and monitoring techniques which the facility
determines are most responsible for the facili-
ty’s or physician’s successful outcomes for use
as a model for other facilities and physicians.
‘‘(E) LIST OF MEDICARE DIALYSIS PRO-
VIDERS
OF
ACHIEVEMENT.—The 
Secretary
shall maintain and update a list of Medicare
Dialysis Providers of Achievement. Not later
than March 1 of each of 2006, 2007, and 2008,
the Secretary shall publish such list for the ap-
plicable preceding year in the Federal Register.
The appropriate ESRD Network Administrative
Organization shall publicly recognize such pro-
viders of achievement at an annual meeting.
‘‘(7) ESRD QA PROGRAM.—
‘‘(A) REVIEW OF CQI DATA TO IDENTIFY
CHRONICALLY SUBSTANDARD PROVIDERS.—
‘‘(i) IN GENERAL.—The ESRD Net-
work Administrative Organizations shall
review the quantitative, evidence-based
ESRD Clinical Performance Measures to
identify chronically substandard facilities,
providers, and physicians.
‘‘(ii) USE OF DATA.—Data identified
by the ESRD Network Administrative Or-
ganizations under clause (i) shall be sub-
mitted to the appropriate State survey
agency to initiate review and appropriate
subsequent actions. Such actions shall be
coordinated with the appropriate ESRD
Network Administrative Organization.
‘‘(B) NOTICE
OF
SUBSTANDARD
SERV-
ICES.—If the Secretary or the ESRD Network
Administrative Organization for the network
area in which a dialysis facility or physician is
located determines that the facility or physician
is 2 standard deviations below the national
norm for a preponderance of the ESRD Clinical
Performance Measures selected for this purpose
by the Work Group on a case severity-risk ad-
justed basis for 2 consecutive reporting periods
(covering in the aggregate a period of at least
1 year), the Secretary or ESRD Network Ad-
ministrative Organization shall notify the facili-
ty’s medical director and any affected attending
physicians of such determination.
‘‘(C) SANCTIONS FOR ESRD NETWORKS.—
If the Secretary finds that an ESRD Network
Administrative Organization has not made a
good faith effort to carry out all of the data col-
lection, CQI Program, QA Program, adminis-
trative and oversight activities assigned, the
Secretary may—
‘‘(i) require within a specified time
frame, a plan of correction; and
‘‘(ii) terminate any contracts with the
ESRD Network Administrative Organiza-
tion and reshape the networks by merging
or otherwise redefining the geographic
areas of responsibility.
‘‘(D) SANCTIONS FOR FACILITIES.—If the
Secretary finds that the facility or medical di-
rector has not made a good faith effort to im-
prove its performance under this paragraph, the
Secretary shall—
‘‘(i) subject to subparagraph (F)—
‘‘(I) assess a civil monetary pen-
alty of not less than $500 and not
more than $10,000;
‘‘(II) reduce reimbursement rates
under this section by not less than 1
and not more than 3 percent for a pe-
riod not to exceed one year, or
‘‘(III) in the event of life-threat-
ening or recurrent violations, termi-
nate or withhold certification of the
facility for purposes of payment under
this section; and
‘‘(ii) notify and work collaboratively
with the ESRD Network Administrative
Organization involved and appropriate
State survey agency to carry out (if appro-
priate) one or more of the following ac-
tions:
‘‘(I) Recommend that a sub-
stitute administrator or director be
appointed by the appropriate State
agency or officer with the authority to
hire, terminate and reassign staff, ob-
ligate funds, and alter facility proce-
dures as appropriate.
‘‘(II) Require corrective action
within specified time frames according
to a plan developed by the network,
the State, or the temporary manager
(if any is appointed).
‘‘(III) Place an on-site monitor to
ensure the facility achieves and main-
tains acceptable levels of quality in
furnishing services.
‘‘(IV) Carry out such other ac-
tions as the Secretary determines ap-
propriate.
‘‘(E) SANCTIONS FOR PHYSICIANS.—If the
Secretary finds that the attending physician has
not made a good faith effort to improve per-
formance under this paragraph, the Secretary
shall initiate—
‘‘(i) further investigation of the physi-
cian; or
‘‘(ii) such other actions as the Sec-
retary determines appropriate, after con-
sultation with the appropriate ESRD Net-
work Administrative Organization and
State survey agency.
‘‘(F) DETERMINATION OF RESPONSIBILITY
FOR
SUBSTANDARD
SERVICES.—If the Sec-
retary terminates or withholds the certification
of a facility under subparagraph (D)(i)(III), the
State survey organization and the ESRD Net-
work Administrative Organizations involved
shall submit to the Secretary a statement with
respect to the relative responsibility of the facil-
ity, the medical director, and attending physi-
cian for the deficiencies involved.
‘‘(8) DEFINITIONS.—As used in this subsection:
‘‘(A) ESRD NETWORK
ADMINISTRATIVE
ORGANIZATION.—The term ‘ESRD Network
Administrative Organization’ means a network
administrative organization designated under
subsection (c)(1)(A)(i)(II).
‘‘(B) WORK
GROUP.—The term ‘Work
Group’ means the ESRD Clinical Performance
Measures Work Group established under this
subparagraph as follows:
‘‘(i) COMPOSITION.—The Work Group
shall be composed of the Secretary and of
such representatives of patient advocacy
groups, providers of renal services, the net-
work administrative organizations, the
United States Renal Data System, patient
vocational and rehabilitation organizations,
and quality improvement organizations
that the Secretary appoints.
‘‘(ii) TERM.—Members of the Work
Group who are appointed by the Secretary
may not serve for more than three con-
secutive terms.
‘‘(iii) APPLICATION
OF
FACA.—The
provisions of the Federal Advisory Com-
mittee Act (5 U.S.C. App.), other than sec-
tion 14(a)(2)(B) of such Act (relating to
the termination of advisory committees),
shall apply to the Work Group.’’.
(b) RESPONSIBILITIES OF ESRD PROVIDERS, FA-
CILITIES, NETWORKS AND STATE SURVEY AGENCIES.—
(1) PARTICIPATION IN CQI PROGRAM AND QA
PROGRAM
AS
REQUIREMENT
FOR
MEDICARE
PAY-
MENT FOR PROVIDERS AND FACILITIES.—
(A) IN GENERAL.—The second sentence of
section 1881(b)(1) of the Social Security Act
(42 U.S.C. 1395rr(b)(1)) is amended by insert-
ing before the period the following: ‘‘, and a re-
quirement that the provider of services or renal
dialysis facility meet the requirements of sub-
section (i) with respect to participation in the
CQI Program and the QA Program under sub-
section (h)’’.
(B) 
SPECIFIC
REQUIREMENTS
DE-
SCRIBED.—Section 1881 of such Act (42
U.S.C. 1395rr), as amended by subsection a, is
amended by adding at the end the following
new subsection:
‘‘(i) MANDATORY
PARTICIPATION
IN
CQI PRO-
GRAM.—
‘‘(1) IN GENERAL.—For purposes of subsection
(b)(1), each provider of services or renal dialysis fa-
cility shall take such actions as may be required for
the provider or facility to participate in the CQI
Program and the QA Program under subsection (h),
including—
‘‘(A) establishing a CQI team (as defined
in paragraph (3));
‘‘(B) developing and operating a quality
improvement program consistent with the re-
quirements of the CQI Program under sub-
section (h);
‘‘(C) furnishing information required for
the collection and reporting of data under sub-
section (h)(4);
‘‘(D) posting in a prominent location of the
provider or facility the data described in sub-
section (h)(3)(A)(ii); and
‘‘(E) taking any other action which the
Secretary or the ESRD Network Administrative
Organizations may require in the administra-
tion of the CQI Program or the QA Program.
‘‘(2) 
SANCTIONS
FOR
REPORTING
FALSE
DATA.—If the Secretary determines that a facility or
provider has knowingly and willfully reported false
data under the CQI Program or the QA Program,
the Secretary shall terminate certification of the fa-
cility or provider for the purposes of payment for
services furnished to individuals with end stage renal
disease and shall ensure the placement of the facili-
ty’s patients with another qualified provider.
‘‘(3) DEFINITION
OF
CQI
TEAM.—The term
‘CQI team’ means a group established by a provider
of services or renal dialysis facility as follows:
‘‘(A) COMPOSITION.—
‘‘(i) IN
GENERAL.—The group shall
consist of the medical director, director of
nursing, social worker, dietitian, and chief
technician of the provider or facility, and
shall include representatives of the patients
of the provider or facility.
‘‘(ii) DIRECTOR.—The group shall
designate one of its members as the Direc-
tor of Continuous Quality Improvement for
the provider or facility who shall coordi-
nate with the ESRD Network Administra-
tive Organization for the network area in
which the provider or facility is located on
CQI Program issues.
‘‘(B) DUTIES.—The group shall—
‘‘(i) ensure that the provider or facil-
ity meets the requirements of this para-
graph;
‘‘(ii) consistent with the standards of
the CQI Program under subsection (h),
promote clinical practice guidelines or algo-
rithms for the use of the provider or facil-
ity; and
‘‘(iii) take any other actions which
may be required to ensure the full partici-
pation of the provider or facility in the
CQI Program under subsection (h).
‘‘(C) MEETINGS.—The group shall periodi-
cally hold meetings, which shall be open to pa-
tients and personnel of the provider or facility,
and make minutes of the meetings available to
patients and personnel for a reasonable period
of time.’’.
(2) RESPONSIBILITIES OF ESRD NETWORK AD-
MINISTRATIVE ORGANIZATIONS.—
(A) ASSISTANCE IN OPERATION OF PRO-
GRAM.—Section 1881(c)(2)(B) of such Act (42
U.S.C. 1395rr(c)(2)(B)) is amended by insert-
ing after ‘‘(B)’’ the following: ‘‘assisting the
Secretary in the administration of the CQI Pro-
gram under subsection (h) and (consistent with
the operation of such Program)’’.
(B) COLLECTION AND DISSEMINATION OF
CQI DATA.—Section 1881(c)(2) of such Act (42
U.S.C. 1395rr (c)(2)) is amended—
(i) by striking ‘‘and’’ at the end of
subparagraph (G);
(ii) by redesignating subparagraph
(H) as subparagraph (I); and
(iii) by inserting after subparagraph
(G) the following new subparagraph:
‘‘(H) collecting and making public data on fa-
cilities and providers generated under the CQI Pro-
gram under subsection (h) (in accordance with
standards established by the Secretary in consulta-
tion with representatives of providers, facilities, and
patients) and auditing samples of such data to en-
sure its accuracy.’’.
(3) RESPONSIBILITIES
OF
STATE
SURVEY
AGENCIES.—Section 1881, as amended by sub-
section (a) and paragraph (1)(B), is further amend-
ed by adding at the end the following new sub-
section:
‘‘(j) ASSISTANCE OF STATE SURVEY AGENCIES.—
Each State agency responsible for the licensing of a pro-
vider or facility shall provide the following assistance
under this section:
‘‘(1) ASSISTANCE
IN
OPERATION
OF
PRO-
GRAM.—The State agency shall provide such assist-
ance to the Secretary and the ESRD Network Ad-
ministrative Organizations in the administration of
the CQI Program and the QA Program under sub-
section (h) and (consistent with the operation of
such Program) as the Secretary requires.
‘‘(2) COLLECTION AND DISSEMINATION OF CQI
DATA.—The State agency shall forward copies of all
complaints, investigations and surveys of providers
or facilities to the appropriate ESRD Network Ad-
ministrative Organizations.’’.
(4) EFFECTIVE DATE.—The amendments made
by this subsection shall apply to services furnished
on or after the date that is one year after the date
of the enactment of this Act.
(c) PAYMENTS OF DIALYSIS USER FEES FOR ALL
DIALYSIS PERFORMED.—
(1) IN GENERAL.—The seventh sentence of sec-
tion 1881(b)(7) of the Social Security Act (42
U.S.C. 1395rr(b)(7)) is amended by inserting after
‘‘50 cents’’ the following: ‘‘(and in the case of each
treatment furnished to individuals during the 30-
month period during which section 1862(b)(1)(C)
applies, the Secretary shall pay 50 cents)’’.
(2) EFFECTIVE DATE.—The amendment made
by paragraph (1) shall apply to services furnished on
or after the date of the enactment of this Act.
Æ