[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2972 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 2972

  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.


_______________________________________________________________________


                    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 Program to individuals with end stage renal 
                    disease, and for other purposes.

    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 ``ESRD Continuous Quality Improvement 
Program Act of 1997''.

SEC. 2. ESTABLISHMENT OF CONTINUOUS QUALITY IMPROVEMENT PROGRAM FOR 
              ESRD FACILITIES 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 establish 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 consult 
with representatives of providers of services and renal dialysis 
facilities (including facility administrators, nephrologists, 
dietitians, social workers, and nurses), patients of such providers and 
facilities, and quality improvement experts.
    ``(B) Under the CQI Program--
            ``(i) the network administrative organizations (as defined 
        in paragraph (7)) shall provide information, 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 perform the 
following functions:
            ``(A) Provide for the routine and timely measurement and 
        statistical evaluation, and feedback to providers of services 
        and renal dialysis facilities, of the processes and outcomes of 
        care for kidney transplant, hemodialysis, and peritoneal 
        dialysis patients, using, among other data, the ESRD Core 
        Indicators established under paragraph (3).
            ``(B) Disseminate recommended clinical practices based on 
        practice guidelines or clinical algorithms.
            ``(C) Provide training in quality improvement to the staffs 
        of network administrative organizations to assist the 
        organizations in providing training and assistance 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 improvement activities to reflect 
        evolving needs of patients and facilities.
            ``(F) In consultation with the Work Group (as defined in 
        paragraph (7)), provide guidance to providers of services and 
        renal dialysis facilities on the collection and calculation of 
        the core indicator measures.
            ``(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 receive 
                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 enactment 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 periodically update 
        ESRD Core Indicators.
            ``(B) The ESRD Core Indicators defined under paragraph (A) 
        may include patient outcome measures based upon the following 
        types of indicators (subject to the establishment of unique 
        measures for kidney transplantation centers) and such other 
        indicators 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 established 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 providers of services 
        shall be encouraged to establish additional independent 
        patient-specific and physician-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 establish a standard 
information management system (hereafter 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 contribute 
        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 administrative 
organizations and to all facilities or providers of services.
    ``(B) The Secretary shall--
            ``(i) use the SIMS to collect with such frequency 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 relevant 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 measures 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 physician's combined and 
                adjusted data under this subparagraph to the physician;
                    ``(II) how that provider and facility compares in 
                various CQI indicators to other providers 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 administrative 
                organization for the network area in which the 
                provider, facility, or physician is located; 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 improve the quality of services 
        for renal patients.
    ``(5)(A) For each of three years beginning after December 31, 2001, 
the Secretary shall identify those dialysis 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 consecutive reporting periods (covering in the aggregate at least 
1 year), and shall designate such dialysis facilities and providers as 
`Medicare Dialysis Providers of Achievement'.
    ``(B) Upon request by the network administrative organization 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 monitoring 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 Secretary shall publish such list in 
the Federal Register. The appropriate network administrative 
organization shall publicly award such providers of achievement at an 
annual meeting.
    ``(6)(A) If the Secretary or the network administrative 
organizations for the network area in which a facility or physician is 
located determines that the dialysis facility or physician is 2 
standard deviations below the national norm for a preponderance of ESRD 
Core Indicators on a case severity adjusted basis for 2 consecutive 
reporting periods (covering in the aggregate at least 1 year), the 
Secretary or network administrative organization shall notify the 
facility or physician of such determination.
    ``(B) In the case of a facility notified under subparagraph (A), 
the network administrative organization for the network area in which 
the facility is located, in conjunction with the facility, shall 
develop strategies to improve the provision of services at the facility 
and shall provide appropriate training in CQI Program processes to the 
facility. Such network administrative organization shall review the 
quality of service provided by physicians at such facility for purposes 
of identifying those physicians that require training in CQI Program 
processes.
    ``(C) In the case of a physician notified under subparagraph (A), 
the network administrative organization for the network 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 appropriate training in CQI Program 
processes to the physician.
    ``(D) If the Secretary finds that the facility or physician has not 
made a good faith effort to improve its performance under this 
paragraph, the network administrative organization for the network area 
in which the facility or physician is located--
            ``(i) in the case of a facility, subject to subparagraph 
        (E), may recommend that the Secretary terminate or withhold 
        certification of the facility for purposes of payment for 
        services furnished to individuals with end stage renal disease; 
        and
            ``(ii) in the case of a physician, may recommend to the 
        Secretary--
                    ``(I) further investigation of the physician; or
                    ``(II) such other actions as the network determines 
                appropriate.
    ``(E) In the case of a facility for which the network 
administrative organization for the network area in which the facility 
is located proposes to recommend that the Secretary terminate or 
withhold certification of the facility under subparagraph (D), the 
network administrative organization shall profile physicians furnishing 
services at the facility to determine shared facility/physician 
responsibility for the termination.
    ``(7) As used in this subsection:
            ``(A) The term `network administrative organization' means 
        the organizations described in subsection (c)(1)(A).
            ``(B) The term `Work Group' means an ESRD Core Indicators 
        Work Group appointed by the Secretary and composed of 
        representatives of providers of renal services, patient 
        advocacy groups, the network administrative organizations, the 
        United States Renal Data System, patient vocational and 
        rehabilitation organizations, quality improvement 
        organizations, and the Secretary.''.

SEC. 3. RESPONSIBILITIES OF ESRD PROVIDERS, FACILITIES, AND NETWORKS.

    (a) Participation in CQI Program as Requirement 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 provider 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), including 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 improvement 
        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 Secretary or the 
        network administrative organization may require in the 
        administration of the CQI Program.
    ``(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 withhold 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 certification is 
terminated or withheld by the Secretary under subparagraph (A), if the 
Secretary determines that information 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, social 
        worker, dietitian, chief technician, together with 
        representatives of the provider's or facility's patients;
            ``(B) periodically hold meetings, which shall be open to 
        patients and personnel of the provider or facility, 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 director of 
        continuous quality improvement for the provider or facility and 
        coordinator with the Network on CQI issues;
            ``(D) consistent with the standards of the CQI Program 
        under subsection (h), promote clinical practice guidelines or 
        algorithms for the use of the provider or facility; and
            ``(E) take any other actions which may be required to 
        ensure the full participation of the provider or facility in 
        the CQI Program under subsection (h).''.
    (b) Responsibilities of ESRD Network Administrative 
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 
        Program)''.
            (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 subparagraph 
                (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 facilities and 
        providers generated under the CQI Program under subsection (h) 
        (in accordance with standards established by the Secretary in 
        consultation with representatives of providers, facilities, and 
        patients) and auditing samples of such data to ensure 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 ORGANIZATIONS.

    Not later than 2 years after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall--
            (1) analyze the financial impact of the establishment of 
        the ESRD Continuous Quality Improvement Program under section 
        1881(h) of the Social Security Act (as added by section 2) on 
        ESRD network 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.
                                 <all>