I 
108TH CONGRESS 
1ST SESSION H. R. 3635
To amend the Social Security Act to provide for coverage under the Medicare 
Program of chronic kidney disease patients who are not end-stage renal 
disease patients. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 21, 2003
Mr. STARK (for himself, Mr. MCDERMOTT, Mr. KENNEDY of Rhode Island, 
Mr. FROST, Mrs. CHRISTENSEN, Mr. JEFFERSON, and Mr. MCNULTY) 
introduced the following bill; which was referred to the Committee on En-
ergy 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 jurisdic-
tion of the committee concerned 
A BILL 
To amend the Social Security Act to provide for coverage 
under the Medicare Program of chronic kidney disease 
patients who are not end-stage renal disease patients.
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 ‘‘Medicare Chronic Kid-
ney Disease Management Act of 2003’’. 
SEC. 2. FINDINGS. 
Congress makes the following findings:
(1) Clinical research indicates that in 2003, 
more than 300,000 Americans suffer from end-stage 
renal disease. 
(2) Clinical research also indicates that by 
2010, the number of Americans who will suffer from 
end-stage renal disease is expected to exceed 
600,000. 
(3) Clinical research also indicates that adult 
patients who are diagnosed as having advanced 
chronic kidney disease have a high likelihood of re-
quiring treatment for end-stage renal disease within 
6- to 18-month period after such diagnosis. 
(4) Clinical research also indicates that appro-
priate medical treatment, and education and coun-
seling services, furnished during the period referred 
to in paragraph (3) has been found to—
(A) decrease significantly both morbidity 
and mortality rates for such patients when 
treatment for end-stage renal disease is initi-
ated; and 
(B) slow down the progression from ad-
vanced kidney disease to end-stage renal dis-
ease.
SEC. 3. DELAYING ONSET OF AND DECREASING MORBIDITY 
AND MORTALITY RATES FOR END-STAGE 
RENAL DISEASE. 
(a) MEDICARE COVERAGE OF CHRONIC KIDNEY DIS-
EASE PATIENTS.—
(1) IN GENERAL.—Section 226A of the Social 
Security Act (42 U.S.C. 426–1) is amended—
(A) by redesignating the last subsection as 
subsection (e); and 
(B) by inserting after subsection (c) the 
following new subsection: 
‘‘(d)(1)(A) Notwithstanding any provision to the con-
trary in section 226 of title XVIII, every qualified chronic 
kidney disease patient (as defined in paragraph (2)) shall, 
in accordance with the succeeding provisions of this sec-
tion, be entitled to benefits under part A and eligible to 
enroll under part B of title XVIII, subject to the deduct-
ible, premium, and coinsurance provisions of that title. 
‘‘(B) No qualified chronic kidney disease patient may 
enroll under part C of title XVIII. 
‘‘(2) For purposes of this subsection, the term ‘quali-
fied chronic kidney disease patient’ means an individual—
‘‘(A) who would otherwise be described in sub-
section (a) but for paragraph (2) of that subsection; 
‘‘(B) who has been diagnosed with chronic kid-
ney disease;
‘‘(C) with respect to whom, a physician makes 
a certification that the individual—
‘‘(i) has advanced chronic kidney disease 
(as defined in paragraph (3)), and, in the case 
of such an individual who is under 18 years of 
age, will likely need dialysis treatments or a 
kidney transplant within the 18-month period 
beginning on the date of the certification; and 
‘‘(ii) may benefit from a program of pre-
ESRD 
services 
(as 
defined 
in 
section 
1861(ww)(1)); and 
‘‘(D) who does not have health insurance cov-
erage, as certified by the individual, parent, or legal 
guardian, as the case may be. 
‘‘(3) For purposes of this subsection, the term ‘ad-
vanced chronic kidney disease’ means with respect to kid-
ney disease a glomerular filtration rate of 30ml/min per 
1.73 m2 or less.’’. 
(2) CONFORMING AMENDMENT.—Section 1811 
of such Act (42 U.S.C. 1395c) is amended by insert-
ing before the period the following: ‘‘or who are 
qualified chronic kidney disease patients (as defined 
in section 226A(d)(2))’’.
(3) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that
is 6 months after the date of the enactment of this 
Act. 
(b) COVERAGE OF PRE-ESRD SERVICES.—
(1) IN
GENERAL.—Section 1861(s)(2) of the 
Social Security Act (42 U.S.C. 1395x(s)(2)) is 
amended—
(A) by striking ‘‘and’’ at the end of sub-
paragraph (U); 
(B) by inserting ‘‘and’’ at the end of sub-
paragraph (V); and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(W) pre-ESRD services (as defined in sub-
section (ww)(1)) for an individual who has been di-
agnosed with chronic kidney disease and, with re-
spect to whom, a physician makes a certification de-
scribed in section 226A(d)(2)(C);’’. 
(2) SERVICES
DESCRIBED.—Section 1861 of 
such Act (42 U.S.C. 1395x) is amended by adding 
at the end the following new subsection: 
‘‘Pre-ESRD Services 
‘‘(ww) The term ‘pre-ESRD Services’ means any or 
all of the following services: 
‘‘(1) Individual and group nutritional coun-
seling services for the purpose of chronic kidney dis-
ease management that are furnished by a registered 
dietitian or nutrition professional (as defined in sub-
section (vv)(2)) pursuant to a referral by a physician 
(as defined in subsection (r)(1)). 
‘‘(2) Counseling furnished by qualified health 
care providers that—
‘‘(A) provides comprehensive information 
regarding the management of comorbidities, 
and the prevention of uremic complications; 
‘‘(B) ensures active participation of the in-
dividual in the choice of therapy or therapies; 
and 
‘‘(C) provides comprehensive information 
regarding modalities of treatment for kidney 
disease and end-stage renal disease, including 
organ transplantation, hemodialysis, peritoneal 
dialysis, and home dialysis. 
‘‘(3) Counseling, items and services, including 
tissue typing, furnished by qualified health care pro-
viders for preparation of possible organ transplan-
tation. 
‘‘(4) Items and services furnished by qualified 
health care providers for the preparation of vascular 
access required for dialysis treatment.
‘‘(5) Such other services as the Secretary deter-
mines appropriate, in consultation with national or-
ganizations representing individuals and entities who 
furnish pre-ESRD services and patients receiving 
such services.’’. 
(3) QUALIFICATION CRITERIA.—The Secretary 
of Health and Human Services shall establish such 
criteria as the Secretary determines appropriate for 
qualifications required for individuals to furnish pre-
ESRD services under section 1861(ww) of the Social 
Security Act, as added by paragraph (2), after con-
sulting with representatives of the following: 
(A) Physicians, including board certified 
nephrologists. 
(B) Certified nephrology nurses. 
(C) Certified nephrology dietitians. 
(D) Certified nephrology nutritionists. 
(E) Certified nephrology social workers. 
(F) Kidney patient organizations. 
(G) Health educators. 
(H) Dialysis facilities. 
(I) Transplant centers. 
(J) Network administrative organization 
designated under section 1881(c) of the Social 
Security Act (42 U.S.C. 1395rr(c)).
(K) Such other individuals with appro-
priate expertise as the Secretary may specify. 
(c) PAYMENT AMOUNT.—
(1) IN GENERAL.—Section 1833(a)(1) of the 
Social Security Act (42 U.S.C. 1395l(a)(1)) is 
amended—
(A) by striking ‘‘and’’ before ‘‘(U)’’; and 
(B) by inserting before the semicolon at 
the end the following: ‘‘, and (V) with respect 
to pre-ESRD services, the amount paid shall be 
80 percent of the amount determined under the 
fee schedule established under section 1834(e)’’. 
(2) ESTABLISHMENT OF FEE SCHEDULE.—Sec-
tion 1834 of such Act (42 U.S.C. 1395m) is amend-
ed by inserting after subsection (d) the following 
new subsection: 
‘‘(e) FEE SCHEDULE FOR PRE-ESRD SERVICES.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a fee schedule for payment for pre-ESRD serv-
ices in accordance with the requirements of this sub-
section. 
‘‘(2) CONSIDERATIONS.—In establishing such 
fee schedule, the Secretary shall—
‘‘(A) establish mechanisms to promote the 
efficient delivery of care;
‘‘(B) establish definitions for pre-ESRD 
services which link payments to the type of 
services provided; 
‘‘(C) consider appropriate regional and 
operational differences; and 
‘‘(D) consider adjustments to payment 
rates to account for inflation and other relevant 
factors. 
‘‘(3) CONSULTATION.—In establishing the fee 
schedule for pre-ESRD services under this sub-
section, the Secretary shall consult with various na-
tional organizations representing individuals and en-
tities who furnish pre-ESRD services and patients 
receiving such services. 
‘‘(4) CODING SYSTEM.—The Secretary may re-
quire the claim for any services for which the 
amount of payment is determined under this sub-
section to include a code (or codes) under a uniform 
coding system specified by the Secretary that identi-
fies the services furnished.’’.
(3) PERMITTING DIALYSIS FACILITIES TO BILL 
FOR PRE-ESRD SERVICES FURNISHED IN THE FACIL-
ITY.—Section 1881(b) is amended by adding at the 
end the following new paragraph:
‘‘(12) A renal dialysis facility may provide for the fur-
nishing of some or all pre-ESRD services (as defined in 
section 1861(ww)(2). The facility may submit to the Sec-
retary a claim for payment for such services furnished in 
the facility, and the Secretary shall not require the facility, 
or the employee of the facility who is qualified to furnish 
such services, to apply for a separate provider number for 
purposes of payment under this title.’’. 
(d) ANNUAL REPORTS TO CONGRESS.—
(1) IN GENERAL.—Not later than 18 months 
after the date of the enactment of this Act, and an-
nually thereafter, the Secretary of Health and 
Human Services shall submit to Congress reports on 
the matters described in paragraph (2) with respect 
to 
pre-ESRD 
services 
(described 
in 
section 
1861(ww) of the Social Security Act) furnished dur-
ing the preceding year. 
(2) 
MATTERS
DESCRIBED.—Reports 
under 
paragraph (1) shall include— 
(A) an assessment of the number of medi-
care beneficiaries who are entitled to pre-ESRD 
services; 
(B) an assessment of the number of medi-
care beneficiaries who are furnished such serv-
ices under the medicare program;
(C) an analysis of the patient outcomes 
and costs of furnishing care to the medicare 
beneficiaries who are furnished such pre-ESRD 
services as compared to such outcomes and 
costs with respect to other beneficiaries for the 
same health conditions; 
(D) an evaluation of patient satisfaction; 
and 
(E) such recommendations for legislative 
and administrative action as the Secretary de-
termines appropriate. 
SEC. 4. DEMONSTRATION PROJECT FOR HOME DIALYSIS 
PEER EDUCATION. 
(a) ESTABLISHMENT.—Subject to the succeeding 
provisions of this section, the Secretary shall establish 
demonstration projects to evaluate methods through which 
peer education may—
(1) slow down or prevent the progress of kidney 
disease to end-stage renal disease in medicare bene-
ficiaries; 
(2) improve the management of co-morbid con-
ditions associated with kidney disease; 
(3) improve choice in selection of renal replace-
ment therapies (including home dialysis); and
(4) improve other outcomes (such as employ-
ment). 
(b) CONDUCT THROUGH KIDNEY PATIENT ORGANI-
ZATIONS.—The Secretary shall carry out the demonstra-
tion projects in collaboration with kidney patient organiza-
tions with demonstrated expertise in kidney patient peer 
education programs. 
(c) PAYMENT.—Payment under the demonstration 
project shall be made by the Secretary in such amounts 
and using such methodology as the Secretary determines 
to be appropriate. 
(d) VOLUNTARY PARTICIPATION.—Participation of 
medicare beneficiaries in the demonstration projects shall 
be voluntary. 
(e) DEMONSTRATION PROJECTS SITES.—Not later 
than 1 years after the date of the enactment of this Act, 
the Secretary shall conduct no fewer than 2 demonstration 
projects established under this section. Of those dem-
onstration projects, the Secretary shall conduct at least 
one in an urban area and one in a rural area. 
(f) DURATION.—The Secretary shall carry out the 
demonstration projects over a period of three years. 
(g) EVALUATION AND REPORT.—
(1) EVALUATIONS.—The Secretary shall con-
duct evaluations of the clinical and cost effectiveness 
of the demonstration projects. 
(2) REPORTS.—After the conclusion of the 
demonstration projects under this section, the Sec-
retary shall submit to Congress a report on the eval-
uation, and shall include in the report the following: 
(A) An analysis of the patient outcomes 
and costs of furnishing care to the medicare 
beneficiaries participating in the projects as 
compared to such outcomes and costs to other 
beneficiaries for the same health conditions. 
(B) Evaluation of patient satisfaction 
under the demonstration projects. 
(C) Such recommendations regarding the 
extension or expansion of the projects as the 
Secretary determines appropriate. 
(h) WAIVER AUTHORITY.—The Secretary may waive 
such requirements of title XVIII of the Social Security Act 
as may be necessary for the purposes of carrying out the 
demonstration project.
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