I
105TH CONGRESS
1ST SESSION
H. R. 2972
To direct the Secretary of Health and Human Services to establish a continu-
ous quality improvement 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
NOVEMBER 8, 1997
Mr. STARK introduced the following bill; which was referred to the Committee
on 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 jurisdiction of the
committee concerned
A BILL
To direct the Secretary of Health and Human Services to
establish a continuous quality improvement program for
providers that furnish services under the Medicare Pro-
gram 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 Continuous
Quality Improvement Program Act of 1997’’.
SEC. 2. ESTABLISHMENT OF CONTINUOUS QUALITY IM-
PROVEMENT PROGRAM FOR ESRD FACILI-
TIES UNDER MEDICARE.
Section 1881 of the Social Security Act (42 U.S.C.
1395rr) is amended by adding at the end the following
new subsection:
‘‘(h)(1)(A) Not later than 1 year after the date of
the enactment of this subsection, the Secretary shall es-
tablish a quality improvement program (hereafter in this
subsection referred to as the ‘CQI Program’) for providers
of services and renal dialysis facilities under this section.
In establishing the CQI Program, the Secretary shall con-
sult with representatives of providers of services and renal
dialysis 
facilities 
(including 
facility 
administrators,
nephrologists, dietitians, social workers, and nurses), pa-
tients of such providers and facilities, and quality improve-
ment experts.
‘‘(B) Under the CQI Program—
‘‘(i) the network administrative organizations
(as defined in paragraph (7)) shall provide informa-
tion, training, and technical assistance described in
paragraph (2);
‘‘(ii) the Secretary shall establish and publish in
ESRD Core Indicators as described in paragraph
(3);
‘‘(iii) the Secretary shall collect and analyze
data from providers and facilities as described in
paragraph (4);
‘‘(iv) the Secretary shall identify and reward
outstanding providers and facilities as described in
paragraph (5); and
‘‘(v) the Secretary shall identify and provide for
additional training to providers and facilities in need
of such training as described in paragraph (6).
‘‘(2) Network administrative organizations shall per-
form the following functions:
‘‘(A) Provide for the routine and timely meas-
urement and statistical evaluation, and feedback to
providers of services and renal dialysis facilities, of
the processes and outcomes of care for kidney trans-
plant, hemodialysis, and peritoneal dialysis patients,
using, among other data, the ESRD Core Indicators
established under paragraph (3).
‘‘(B) Disseminate recommended clinical prac-
tices based on practice guidelines or clinical algo-
rithms.
‘‘(C) Provide training in quality improvement to
the staffs of network administrative organizations to
assist the organizations in providing training and as-
sistance to providers of services and renal dialysis
facilities.
‘‘(D) Conduct regional and national peer review
of dialysis providers.
‘‘(E) Provide technical assistance for quality
improvement efforts and identify quality improve-
ment activities to reflect evolving needs of patients
and facilities.
‘‘(F) In consultation with the Work Group (as
defined in paragraph (7)), provide guidance to pro-
viders of services and renal dialysis facilities on the
collection and calculation of the core indicator meas-
ures.
‘‘(G) 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 re-
ceive payments under this title; and
‘‘(iii) private payers of services for end
stage renal disease patients.
‘‘(3) Not later than 1 year after the date of the enact-
ment of this subsection, the Secretary shall publish in the
Federal Register the ESRD Core Indicators established
as follows:
‘‘(A) The Work Group shall define and periodi-
cally update ESRD Core Indicators.
‘‘(B) The ESRD Core Indicators defined under
paragraph (A) may include patient outcome meas-
ures based upon the following types of indicators
(subject to the establishment of unique measures for
kidney transplantation centers) and such other indi-
cators as the Work Group considers appropriate:
‘‘(i) Adequacy of dialysis.
‘‘(ii) Adequacy of nutrition.
‘‘(iii) Correction of anemia and average per
patient dosage of anti-anemia medications.
‘‘(iv) Case-adjusted standardized mortality.
‘‘(v) Case-adjusted hospitalization ratios
and average length of hospital stay.
‘‘(vi) Adequacy of blood pressure control.
‘‘(vii) Successful vocational maintenance or
rehabilitation.
‘‘(viii) Referral for transplantation or self-
treatment at home.
‘‘(ix) Appropriate administration of clinical
lab tests.
‘‘(C) To the greatest extent possible, the ESRD
Core Indicators shall be developed in conjunction
with any relevant quality improvement goals estab-
lished by the Secretary or by network administrative
organizations which are in effect as of the date of
the enactment of this paragraph.
‘‘(D) The network administrative organizations,
individual renal dialysis facilities, and individual pro-
viders of services shall be encouraged to establish
additional independent patient-specific and physi-
cian-specific or facility-specific core indicators.
‘‘(4)(A)(i) Not later than 2 years after the date of
the enactment of this subsection, the Secretary shall es-
tablish a standard information management system (here-
after in this paragraph referred to as ‘‘SIMS’’) to promote
the electronic transfer of data obtained under the CQI
Program among providers, facilities, the Secretary, and
network administrative organizations. The Secretary shall
provide for technical assistance in the use of the SIMS
and for the development (or purchase) and distribution of
appropriate electronic software for access to the SIMS.
‘‘(ii) Under the SIMS—
‘‘(I) a facility or provider of services shall con-
tribute data to support the CQI Program; and
‘‘(II) network administrative organizations shall
use data entered into the SIMS to generate clinical
profiles on the performance of facilities, based on
the ESRD Core Indicators, and shall monitor trends
relevant to performance of facilities.
‘‘(iii) The SIMS shall be available to all network ad-
ministrative organizations and to all facilities or providers
of services.
‘‘(B) The Secretary shall—
‘‘(i) use the SIMS to collect with such fre-
quency as the Work Group determines appropriate
(but not less frequently than bi-annually) unadjusted
data on all patient outcomes required to compute
ESRD Core Indicators—
‘‘(I) from each provider of services and
renal dialysis facility; and
‘‘(II) from physicians providing services to
individuals determined to have end stage renal
disease under this section;
‘‘(ii) combine the data collected under clause (i)
on individual patients into aggregate data for each
provider of services and renal dialysis facility and for
each such physician, after taking into account rel-
evant factors (including age, gender, race, income,
severity of illness, and other morbidities);
‘‘(iii) adjust the data combined under clause (ii)
to establish comparisons of the core indicator meas-
ures of—
‘‘(I) each provider and facility with other
providers and facilities ; and
‘‘(II) each such physician with other such
physicians in the network area and the nation;
‘‘(iv) create a national core indicator measures
database from the data combined and adjusted
under this subparagraph;
‘‘(v) using unique identifiers to preserve patient
confidentiality and confidentiality between providers
and facilities, report—
‘‘(I) each provider’s and facility’s combined
and adjusted data under this subparagraph to
the provider or facility and each such physi-
cian’s combined and adjusted data under this
subparagraph to the physician;
‘‘(II) how that provider and facility com-
pares in various CQI indicators to other provid-
ers or facilities in the same network and in all
networks and how that physician compares in
various CQI indicators to other physicians; and
‘‘(III) such data to the network adminis-
trative organization for the network area in
which the provider, facility, or physician is lo-
cated; and
‘‘(vi) provide the data collected under clauses
(i), (ii), and (iii) to the United States Renal Dialysis
System and other entities engaged in efforts to im-
prove the quality of services for renal patients.
‘‘(5)(A) For each of three years beginning after De-
cember 31, 2001, the Secretary shall identify those dialy-
sis facilities and physicians that are 2 standard deviations
above the national norm for a preponderance of ESRD
Core Indicators on a case severity adjusted basis for 2 con-
secutive reporting periods (covering in the aggregate at
least 1 year), and shall designate such dialysis facilities
and providers as ‘Medicare Dialysis Providers of Achieve-
ment’.
‘‘(B) Upon request by the network administrative or-
ganization for the end stage renal disease network area
in which the facility is located, each Medicare Dialysis
Provider of Achievement designated under subparagraph
(A) shall provide a report on the clinical process and mon-
itoring techniques which in the facility’s opinion are most
responsible for the facility’s successful outcomes to the
network administrative organization for use as a model for
other facilities and physicians in the network area.
‘‘(C) The Secretary shall maintain and update a list
of Medicare Dialysis Providers of Achievement. Not later
than March 1 of each of the three years after 2001, the
under subparagraph (D), the network administrative orga-
nization shall profile physicians furnishing services at the
facility to determine shared facility/physician responsibil-
ity for the termination.
‘‘(7) As used in this subsection:
‘‘(A) The term ‘network administrative organi-
zation’ means the organizations described in sub-
section (c)(1)(A).
‘‘(B) The term ‘Work Group’ means an ESRD
Core Indicators Work Group appointed by the Sec-
retary and composed of representatives of providers
of renal services, patient advocacy groups, the net-
work administrative organizations, the United States
Renal Data System, patient vocational and rehabili-
tation organizations, quality improvement organiza-
tions, and the Secretary.’’.
SEC. 3. RESPONSIBILITIES OF ESRD PROVIDERS, FACILI-
TIES, AND NETWORKS.
(a) PARTICIPATION IN CQI PROGRAM AS REQUIRE-
MENT FOR MEDICARE PAYMENT FOR PROVIDERS AND
FACILITIES.—
(1) IN GENERAL.—Section 1881(b)(1) of the
Social Security Act (42 U.S.C. 1395rr(b)(1)) is
amended by striking the period at the end of the
second sentence and inserting the following: ‘‘, and
a requirement that the provider of services or renal
dialysis facility meet the requirements of subsection
(i) with respect to participation in the CQI Program
under subsection (h).’’.
(2) SPECIFIC
REQUIREMENTS
DESCRIBED.—
Section 1881 of such Act (42 U.S.C. 1395rr), as
amended by section 2, is amended by adding at the
end the following new subsection:
‘‘(i)(1) For purposes of subsection (b)(1), each pro-
vider of services or renal dialysis facility shall take such
actions as may be required for the provider or facility to
participate in the CQI Program under subsection (h), in-
cluding the following:
‘‘(A) Establishing a CQI team described in
paragraph (3) which will have primary responsibility
for ensuring that the provider or facility meets the
requirements of this paragraph.
‘‘(B) Developing and operating a quality im-
provement program consistent with the requirements
of the CQI Program under subsection (h).
‘‘(C) Furnishing information required for the
collection and reporting of data under subsection
(h)(4).
‘‘(D) Posting in a prominent location the data
for a provider or facility described in subsection
(h)(4)(B) and distributing a copy of the data to each
patient.
‘‘(E) Taking any other actions which the Sec-
retary or the network administrative organization
may require in the administration of the CQI Pro-
gram.
‘‘(2)(A) If the Secretary determines that a facility or
provider has failed to report data under the CQI Program
or has knowingly and willfully reported false data under
the CQI Program, the Secretary may terminate or with-
hold certification of the facility or provider for purposes
of payment for services furnished to individuals with end
stage renal disease.
‘‘(B) In the case of a facility or provider whose cer-
tification is terminated or withheld by the Secretary under
subparagraph (A), if the Secretary determines that infor-
mation submitted by such facility or provider is not false,
the bar to certification under such subparagraph shall not
apply.
‘‘(3) The CQI team of a provider of services or renal
dialysis facility shall—
‘‘(A) consist (at a minimum) of the provider’s
or facility’s medical director, director of nursing, so-
cial worker, dietitian, chief technician, together with
representatives of the provider’s or facility’s pa-
tients;
‘‘(B) periodically hold meetings, which shall be
open to patients and personnel of the provider or fa-
cility, and make minutes of the meetings available to
patients and personnel for a reasonable period of
time;
‘‘(C) designate one of its members as the direc-
tor of continuous quality improvement for the pro-
vider or facility and coordinator with the Network
on CQI issues;
‘‘(D) consistent with the standards of the CQI
Program under subsection (h), promote clinical prac-
tice guidelines or algorithms for the use of the pro-
vider or facility; and
‘‘(E) take any other actions which may be re-
quired to ensure the full participation of the pro-
vider or facility in the CQI Program under sub-
section (h).’’.
(b) RESPONSIBILITIES OF ESRD NETWORK ADMIN-
ISTRATIVE ORGANIZATIONS.—
(1) ASSISTANCE IN OPERATION OF PROGRAM.—
Section 1881(c)(2)(B) of such Act (42 U.S.C.
1395rr(c)(2)(B)) is amended by inserting after
‘‘(B)’’ the following: ‘‘assisting the Secretary in the
administration of the CQI Program under subsection
(h) and (consistent with the operation of such Pro-
gram)’’.
(2) COLLECTION AND DISSEMINATION OF CQI
DATA.—Section 1881(c)(2) of such Act (42 U.S.C.
1395rr(c)(2)) is amended—
(A) by striking ‘‘and’’ at the end of sub-
paragraph (G);
(B) by redesignating subparagraph (H) as
subparagraph (I); and
(C) 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; and’’.
(c) EFFECTIVE DATE.—The amendments made by
this section shall apply to services furnished 1 year on or
after the date of the enactment of this Act.
SEC. 4. STUDY OF FINANCIAL IMPACT OF CQI PROGRAM ON
ESRD NETWORK ADMINISTRATIVE ORGANI-
ZATIONS.
Not later than 2 years after the date of the enact-
ment of this Act, the Secretary of Health and Human
Services shall—
(1) analyze the financial impact of the estab-
lishment of the ESRD Continuous Quality Improve-
ment Program under section 1881(h) of the Social
Security Act (as added by section 2) on ESRD net-
work administrative organizations under section
1881(c) of such Act, and
(2) submit to Congress such recommendations
as the Secretary considers appropriate to assist the
organizations with meeting their responsibilities
under such Program.
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