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 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 jurisdiction 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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare Chronic Kid5 ney Disease Management Act of 2003’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 
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1 (1) Clinical research indicates that in 2003, 

2 more than 300,000 Americans suffer from end-stage 

3 renal disease. 

4 (2) Clinical research also indicates that by 

5 2010, the number of Americans who will suffer from 

6 end-stage renal disease is expected to exceed 

7 600,000. 

8 (3) Clinical research also indicates that adult 

9 patients who are diagnosed as having advanced 

10 chronic kidney disease have a high likelihood of re11 quiring treatment for end-stage renal disease within 

12 6- to 18-month period after such diagnosis. 

13 (4) Clinical research also indicates that appro14 priate medical treatment, and education and coun15 seling services, furnished during the period referred 

16 to in paragraph (3) has been found to—

17 (A) decrease significantly both morbidity 

18 and mortality rates for such patients when 

19 treatment for end-stage renal disease is initi20 ated; and 

21 (B) slow down the progression from ad22 vanced kidney disease to end-stage renal dis23 ease. 
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1 SEC. 3. DELAYING ONSET OF AND DECREASING MORBIDITY 

2 AND MORTALITY RATES FOR END-STAGE 

3 RENAL DISEASE. 

4 (a) MEDICARE COVERAGE OF CHRONIC KIDNEY DIS5 EASE PATIENTS.—

6 (1) IN GENERAL.—Section 226A of the Social 

7 Security Act (42 U.S.C. 426–1) is amended—

8 (A) by redesignating the last subsection as 

9 subsection (e); and 

10 (B) by inserting after subsection (c) the 

11 following new subsection: 

12 ‘‘(d)(1)(A) Notwithstanding any provision to the con13 trary in section 226 of title XVIII, every qualified chronic 

14 kidney disease patient (as defined in paragraph (2)) shall, 

15 in accordance with the succeeding provisions of this sec16 tion, be entitled to benefits under part A and eligible to 

17 enroll under part B of title XVIII, subject to the deduct18 ible, premium, and coinsurance provisions of that title. 

19 ‘‘(B) No qualified chronic kidney disease patient may 

20 enroll under part C of title XVIII. 

21 ‘‘(2) For purposes of this subsection, the term ‘quali22 fied chronic kidney disease patient’ means an individual—

23 ‘‘(A) who would otherwise be described in sub24 section (a) but for paragraph (2) of that subsection; 

25 ‘‘(B) who has been diagnosed with chronic kid26 ney disease; 
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1 ‘‘(C) with respect to whom, a physician makes 

2 a certification that the individual—

3 ‘‘(i) has advanced chronic kidney disease 

4 (as defined in paragraph (3)), and, in the case 

5 of such an individual who is under 18 years of 

6 age, will likely need dialysis treatments or a 

7 kidney transplant within the 18-month period 

8 beginning on the date of the certification; and 

9 ‘‘(ii) may benefit from a program of pre10 ESRD services (as defined in section 

11 1861(ww)(1)); and 

12 ‘‘(D) who does not have health insurance cov13 erage, as certified by the individual, parent, or legal 

14 guardian, as the case may be. 

15 ‘‘(3) For purposes of this subsection, the term ‘ad16 vanced chronic kidney disease’ means with respect to kid17 ney disease a glomerular filtration rate of 30ml/min per 

18 1.73 m2 or less.’’. 

19 (2) CONFORMING AMENDMENT.—Section 1811 

20 of such Act (42 U.S.C. 1395c) is amended by insert21 ing before the period the following: ‘‘or who are 

22 qualified chronic kidney disease patients (as defined 

23 in section 226A(d)(2))’’.

24 (3) EFFECTIVE DATE.—The amendments made 

25 by this subsection shall take effect on the date that 
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1 is 6 months after the date of the enactment of this 

2 Act. 

3 (b) COVERAGE OF PRE-ESRD SERVICES.—

4 (1) IN GENERAL.—Section 1861(s)(2) of the 

5 Social Security Act (42 U.S.C. 1395x(s)(2)) is 

6 amended—

7 (A) by striking ‘‘and’’ at the end of sub8 paragraph (U); 

9 (B) by inserting ‘‘and’’ at the end of sub10 paragraph (V); and 

11 (C) by adding at the end the following new 

12 subparagraph: 

13 ‘‘(W) pre-ESRD services (as defined in sub14 section (ww)(1)) for an individual who has been di15 agnosed with chronic kidney disease and, with re16 spect to whom, a physician makes a certification de17 scribed in section 226A(d)(2)(C);’’. 

18 (2) SERVICES DESCRIBED.—Section 1861 of 

19 such Act (42 U.S.C. 1395x) is amended by adding 

20 at the end the following new subsection: 

21 ‘‘Pre-ESRD Services 

22 ‘‘(ww) The term ‘pre-ESRD Services’ means any or 

23 all of the following services: 

24 ‘‘(1) Individual and group nutritional coun25 seling services for the purpose of chronic kidney dis-
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1 ease management that are furnished by a registered 

2 dietitian or nutrition professional (as defined in sub3 section (vv)(2)) pursuant to a referral by a physician 

4 (as defined in subsection (r)(1)). 

5 ‘‘(2) Counseling furnished by qualified health 

6 care providers that—

7 ‘‘(A) provides comprehensive information 

8 regarding the management of comorbidities, 

9 and the prevention of uremic complications; 

10 ‘‘(B) ensures active participation of the in11 dividual in the choice of therapy or therapies; 

12 and 

13 ‘‘(C) provides comprehensive information 

14 regarding modalities of treatment for kidney 

15 disease and end-stage renal disease, including 

16 organ transplantation, hemodialysis, peritoneal 

17 dialysis, and home dialysis. 

18 ‘‘(3) Counseling, items and services, including 

19 tissue typing, furnished by qualified health care pro20 viders for preparation of possible organ transplan21 tation. 

22 ‘‘(4) Items and services furnished by qualified 

23 health care providers for the preparation of vascular 

24 access required for dialysis treatment. 
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1 ‘‘(5) Such other services as the Secretary deter2 mines appropriate, in consultation with national or3 ganizations representing individuals and entities who 

4 furnish pre-ESRD services and patients receiving 

5 such services.’’. 

6 (3) QUALIFICATION CRITERIA.—The Secretary 

7 of Health and Human Services shall establish such 

8 criteria as the Secretary determines appropriate for 

9 qualifications required for individuals to furnish pre10 ESRD services under section 1861(ww) of the Social 

11 Security Act, as added by paragraph (2), after con12 sulting with representatives of the following: 

13 (A) Physicians, including board certified 

14 nephrologists. 

15 (B) Certified nephrology nurses. 

16 (C) Certified nephrology dietitians. 

17 (D) Certified nephrology nutritionists. 

18 (E) Certified nephrology social workers. 

19 (F) Kidney patient organizations. 

20 (G) Health educators. 

21 (H) Dialysis facilities. 

22 (I) Transplant centers. 

23 (J) Network administrative organization 

24 designated under section 1881(c) of the Social 

25 Security Act (42 U.S.C. 1395rr(c)). 
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1 (K) Such other individuals with appro2 priate expertise as the Secretary may specify. 

3 (c) PAYMENT AMOUNT.—

4 (1) IN GENERAL.—Section 1833(a)(1) of the 

5 Social Security Act (42 U.S.C. 1395l(a)(1)) is 

6 amended—

7 (A) by striking ‘‘and’’ before ‘‘(U)’’; and 

8 (B) by inserting before the semicolon at 

9 the end the following: ‘‘, and (V) with respect 

10 to pre-ESRD services, the amount paid shall be 

11 80 percent of the amount determined under the 

12 fee schedule established under section 1834(e)’’. 

13 (2) ESTABLISHMENT OF FEE SCHEDULE.—Sec14 tion 1834 of such Act (42 U.S.C. 1395m) is amend15 ed by inserting after subsection (d) the following 

16 new subsection: 

17 ‘‘(e) FEE SCHEDULE FOR PRE-ESRD SERVICES.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall estab19 lish a fee schedule for payment for pre-ESRD serv20 ices in accordance with the requirements of this sub21 section. 

22 ‘‘(2) CONSIDERATIONS.—In establishing such 

23 fee schedule, the Secretary shall—

24 ‘‘(A) establish mechanisms to promote the 

25 efficient delivery of care; 
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1 ‘‘(B) establish definitions for pre-ESRD 

2 services which link payments to the type of 

3 services provided; 

4 ‘‘(C) consider appropriate regional and 

5 operational differences; and 

6 ‘‘(D) consider adjustments to payment 

7 rates to account for inflation and other relevant 

8 factors. 

9 ‘‘(3) CONSULTATION.—In establishing the fee 

10 schedule for pre-ESRD services under this sub11 section, the Secretary shall consult with various na12 tional organizations representing individuals and en13 tities who furnish pre-ESRD services and patients 

14 receiving such services. 

15 ‘‘(4) CODING SYSTEM.—The Secretary may re16 quire the claim for any services for which the 

17 amount of payment is determined under this sub18 section to include a code (or codes) under a uniform 

19 coding system specified by the Secretary that identi20 fies the services furnished.’’.

21 (3) PERMITTING DIALYSIS FACILITIES TO BILL

22 FOR PRE-ESRD SERVICES FURNISHED IN THE FACIL23 ITY.—Section 1881(b) is amended by adding at the 

24 end the following new paragraph: 
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1 ‘‘(12) A renal dialysis facility may provide for the fur2 nishing of some or all pre-ESRD services (as defined in 

3 section 1861(ww)(2). The facility may submit to the Sec4 retary a claim for payment for such services furnished in 

5 the facility, and the Secretary shall not require the facility, 

6 or the employee of the facility who is qualified to furnish 

7 such services, to apply for a separate provider number for 

8 purposes of payment under this title.’’. 

9 (d) ANNUAL REPORTS TO CONGRESS.—

10 (1) IN GENERAL.—Not later than 18 months 

11 after the date of the enactment of this Act, and an12 nually thereafter, the Secretary of Health and 

13 Human Services shall submit to Congress reports on 

14 the matters described in paragraph (2) with respect 

15 to pre-ESRD services (described in section 

16 1861(ww) of the Social Security Act) furnished dur17 ing the preceding year. 

18 (2) MATTERS DESCRIBED.—Reports under 

19 paragraph (1) shall include— 

20 (A) an assessment of the number of medi21 care beneficiaries who are entitled to pre-ESRD 

22 services; 

23 (B) an assessment of the number of medi24 care beneficiaries who are furnished such serv25 ices under the medicare program; 
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1 (C) an analysis of the patient outcomes 

2 and costs of furnishing care to the medicare 

3 beneficiaries who are furnished such pre-ESRD 

4 services as compared to such outcomes and 

5 costs with respect to other beneficiaries for the 

6 same health conditions; 

7 (D) an evaluation of patient satisfaction; 

8 and 

9 (E) such recommendations for legislative 

10 and administrative action as the Secretary de11 termines appropriate. 

12 SEC. 4. DEMONSTRATION PROJECT FOR HOME DIALYSIS 

13 PEER EDUCATION. 

14 (a) ESTABLISHMENT.—Subject to the succeeding 

15 provisions of this section, the Secretary shall establish 

16 demonstration projects to evaluate methods through which 

17 peer education may—

18 (1) slow down or prevent the progress of kidney 

19 disease to end-stage renal disease in medicare bene20 ficiaries; 

21 (2) improve the management of co-morbid con22 ditions associated with kidney disease; 

23 (3) improve choice in selection of renal replace24 ment therapies (including home dialysis); and 
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1 (4) improve other outcomes (such as employ2 ment). 

3 (b) CONDUCT THROUGH KIDNEY PATIENT ORGANI4 ZATIONS.—The Secretary shall carry out the demonstra5 tion projects in collaboration with kidney patient organiza6 tions with demonstrated expertise in kidney patient peer 

7 education programs. 

8 (c) PAYMENT.—Payment under the demonstration 

9 project shall be made by the Secretary in such amounts 

10 and using such methodology as the Secretary determines 

11 to be appropriate. 

12 (d) VOLUNTARY PARTICIPATION.—Participation of 

13 medicare beneficiaries in the demonstration projects shall 

14 be voluntary. 

15 (e) DEMONSTRATION PROJECTS SITES.—Not later 

16 than 1 years after the date of the enactment of this Act, 

17 the Secretary shall conduct no fewer than 2 demonstration 

18 projects established under this section. Of those dem19 onstration projects, the Secretary shall conduct at least 

20 one in an urban area and one in a rural area. 

21 (f) DURATION.—The Secretary shall carry out the 

22 demonstration projects over a period of three years. 

23 (g) EVALUATION AND REPORT.—
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1 (1) EVALUATIONS.—The Secretary shall con2 duct evaluations of the clinical and cost effectiveness 

3 of the demonstration projects. 

4 (2) REPORTS.—After the conclusion of the 

5 demonstration projects under this section, the Sec6 retary shall submit to Congress a report on the eval7 uation, and shall include in the report the following: 

8 (A) An analysis of the patient outcomes 

9 and costs of furnishing care to the medicare 

10 beneficiaries participating in the projects as 

11 compared to such outcomes and costs to other 

12 beneficiaries for the same health conditions. 

13 (B) Evaluation of patient satisfaction 

14 under the demonstration projects. 

15 (C) Such recommendations regarding the 

16 extension or expansion of the projects as the 

17 Secretary determines appropriate. 

18 (h) WAIVER AUTHORITY.—The Secretary may waive 

19 such requirements of title XVIII of the Social Security Act 

20 as may be necessary for the purposes of carrying out the 

21 demonstration project.

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