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H.R. 3636 (ih) To support sustainable and broad-based agricultural and rural development in sub-Saharan Africa, and for other purposes. ...


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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Chronic Kidney 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 requiring treatment for end-stage 
        renal disease within 6- to 18-month period after such 
        diagnosis.
            (4) Clinical research also indicates that appropriate 
        medical treatment, and education and counseling 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 initiated; and
                    (B) slow down the progression from advanced kidney 
                disease to end-stage renal disease.

SEC. 3. DELAYING ONSET OF AND DECREASING MORBIDITY AND MORTALITY RATES 
              FOR END-STAGE RENAL DISEASE.

    (a) Medicare Coverage of Chronic Kidney Disease 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 contrary 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 section, be entitled to benefits under 
part A and eligible to enroll under part B of title XVIII, subject to 
the deductible, 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 `qualified chronic 
kidney disease patient' means an individual--
            ``(A) who would otherwise be described in subsection (a) 
        but for paragraph (2) of that subsection;
            ``(B) who has been diagnosed with chronic kidney 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 coverage, as 
        certified by the individual, parent, or legal guardian, as the 
        case may be.
    ``(3) For purposes of this subsection, the term `advanced chronic 
kidney disease' means with respect to kidney 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 inserting 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 subparagraph 
                (U);
                    (B) by inserting ``and'' at the end of subparagraph 
                (V); and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(W) pre-ESRD services (as defined in subsection (ww)(1)) 
        for an individual who has been diagnosed with chronic kidney 
        disease and, with respect to whom, a physician makes a 
        certification described 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 counseling services 
        for the purpose of chronic kidney disease management that are 
        furnished by a registered dietitian or nutrition professional 
        (as defined in subsection (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 
                individual 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 providers for 
        preparation of possible organ transplantation.
            ``(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 determines 
        appropriate, in consultation with national organizations 
        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 
        consulting 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 appropriate 
                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.--Section 1834 of such 
        Act (42 U.S.C. 1395m) is amended by inserting after subsection 
        (d) the following new subsection:
    ``(e) Fee Schedule for Pre-ESRD Services.--
            ``(1) In general.--The Secretary shall establish a fee 
        schedule for payment for pre-ESRD services in accordance with 
        the requirements of this subsection.
            ``(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 subsection, the Secretary shall 
        consult with various national organizations representing 
        individuals and entities who furnish pre-ESRD services and 
        patients receiving such services.
            ``(4) Coding system.--The Secretary may require the claim 
        for any services for which the amount of payment is determined 
        under this subsection to include a code (or codes) under a 
        uniform coding system specified by the Secretary that 
        identifies the services furnished.''.
            (3) Permitting dialysis facilities to bill for pre-esrd 
        services furnished in the facility.--Section 1881(b) is amended 
        by adding at the end the following new paragraph:
    ``(12) A renal dialysis facility may provide for the furnishing of 
some or all pre-ESRD services (as defined in section 1861(ww)(2). The 
facility may submit to the Secretary 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 annually 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 during the preceding year.
            (2) Matters described.--Reports under paragraph (1) shall 
        include--
                    (A) an assessment of the number of medicare 
                beneficiaries who are entitled to pre-ESRD services;
                    (B) an assessment of the number of medicare 
                beneficiaries who are furnished such services 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 determines 
                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 beneficiaries;
            (2) improve the management of co-morbid conditions 
        associated with kidney disease;
            (3) improve choice in selection of renal replacement 
        therapies (including home dialysis); and
            (4) improve other outcomes (such as employment).
    (b) Conduct Through Kidney Patient Organizations.--The Secretary 
shall carry out the demonstration projects in collaboration with kidney 
patient organizations 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 
demonstration 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 conduct evaluations 
        of the clinical and cost effectiveness of the demonstration 
        projects.
            (2) Reports.--After the conclusion of the demonstration 
        projects under this section, the Secretary shall submit to 
        Congress a report on the evaluation, 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 

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