gao-10-295 end-stage renal disease: cms should monitor access

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  • GAO United States Government Accountability Office

    Report to Congressional Requesters

    END-STAGE RENAL DISEASE

    CMS Should Monitor Access to and Quality of Dialysis Care Promptly after Implementation of New Bundled Payment System

    March 2010

    GAO-10-295

  • What GAO Found

    United States Government Accountability Office

    Why GAO Did This Study

    HighlightsAccountability Integrity Reliability

    March 2010 END-STAGE RENAL DISEASE

    CMS Should Monitor Access to and Quality of Dialysis Care Promptly after Implementation of New Bundled Payment System Highlights of GAO-10-295, a report to

    congressional requesters

    Medicare covers dialysis for most individuals with end-stage renal disease (ESRD). Beginning in January 2011, the Centers for Medicare & Medicaid Services (CMS) is required to use a single payment to pay for dialysis and related services, which include injectable ESRD drugs. Questions have been raised about this new payment systems effects on the access to and quality of dialysis care for certain groups of beneficiaries, such as those who receive above average doses of injectable ESRD drugs. GAO examined (1) Medicare expenditures for injectable ESRD drugs, by demographic characteristics; (2) factors likely to result in above average doses of these drugs; (3) CMSs approach for addressing beneficiary differences in the cost of dialysis care under the new payment system; and (4) CMSs plans to monitor the new payment systems effects. GAO analyzed 2007 datathe most recent availableon Medicare ESRD expenditures and input from 73 nephrology clinicians and researchers collected using a Web-based data collection instrument. GAO also reviewed reports and CMSs proposed rule on the payment systems design and interviewed CMS officials.

    What GAO Recommends GAO recommends that CMS begin monitoring access to and quality of dialysis care for certain beneficiary groups as soon as possible after implementation of the new payment system. CMS agreed with this recommendation.

    Certain demographic groups had above average Medicare expenditures for injectable ESRD drugs in 2007. For example, Medicare spent $782 per month on injectable ESRD drugs per African American beneficiary, which was about 13 percent more than the average across all beneficiaries on dialysis and was also higher than for other racial groups. Similarly, monthly Medicare spending per beneficiary with additional coverage through Medicaid was about 6 percent higher than the average across all beneficiaries on dialysis. Although GAO did not identify the factors that led to the differences described above, it did obtain information from 73 nephrology clinicians and researchers, selected through referrals from dialysis-related professional organizations and a literature review, on the factors that they consider likely to result in above average doses of injectable ESRD drugs. A majority of these experts identified primarily clinical factors as likely to result in above average doses of these drugs. For example, at least 50 percent of the 73 clinicians and researchers from whom GAO obtained information identified 14 factors (including chronic blood loss and low iron stores) as likely to result in above average doses of erythropoiesis stimulating agents, which accounted for about 75 percent of expenditures on injectable ESRD drugs in 2007. CMSs proposed design for the new payment system for dialysis care includes, as required by law, two payment mechanisms to address differences across beneficiaries in their costs of dialysis care. Under the first payment mechanisma case-mix adjustmentCMS proposed to adjust payments based on characteristics such as age, sex, and certain clinical conditions that are associated with beneficiaries costs of dialysis care. The second proposed payment mechanisman outlier policyinvolves making additional payments to providers when they treat patients whose costs of care are substantially higher than would be expected. CMSs preliminary plans for monitoring the effects of the new payment system build on existing initiatives, but it is unclear whether CMS will monitor the effects on the quality of and access to dialysis care for groups of beneficiaries. In prior work, GAO and others have emphasized the importance of monitoring both the quality of and access to care to ensure that Medicare payment system changes do not result in certain groups of beneficiaries experiencing poor care quality or problems accessing services. CMS intends to monitor the quality of dialysis care under the new payment system, but the extent to which CMS will conduct such monitoring for various groups of beneficiaries is currently unclear because CMSs plans are preliminary. Furthermore, CMSs preliminary plans for monitoring access to dialysis care are limited. However, CMS has stated that it will have a comprehensive monitoring strategy in place by January 2011. GAO obtained comments on a draft of this report from CMS and from industry groups representing both large and small dialysis providers and nephrologists.

    View GAO-10-295 or key components. For more information, contact James C. Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.

  • Page i GAO-10-295

    Contents

    Letter 1

    Background 7 Certain Groups of Beneficiaries, Including African Americans and

    Those with Medicaid Coverage, Had Above Average Expenditures for Injectable ESRD Drugs in 2007 12

    A Majority of Selected Clinicians and Researchers Identified Primarily Clinical Factors as Likely to Result in Above Average Doses of Injectable ESRD Drugs 16

    CMS Proposed Several Case-Mix Adjustment Factors and an Outlier Policy to Address Cost Differences among Beneficiaries 24

    CMSs Preliminary Monitoring Plans Build on Existing Initiatives, but Whether CMS Will Monitor Quality of and Access to Care for Groups of Beneficiaries Is Unclear 27

    Conclusions 32 Recommendation for Executive Action 33 Agency and Industry Comments and Our Evaluation 33

    Appendix I Objectives, Scope, and Methodology 38

    Appendix II GAO Data Collection Instrument on Dose of Dialysis-Related Drugs 46

    Appendix III Medicare Expenditures for Injectable ESRD Drugs by Demographic Characteristics 54

    Appendix IV Detailed Results from Data Collection Instrument on Dose of Dialysis-Related Drugs 57

    Appendix V Comments from the Centers for Medicare & Medicaid Services 63

    End-Stage Renal Disease

  • Appendix VI GAO Contact and Staff Acknowledgments 66

    Tables

    Table 1: Factors Identified by Selected Clinicians and Researchers as Likely or Not Likely to Result in Above Average Doses of ESAs 17

    Table 2: Factors Identified by Selected Clinicians and Researchers as Likely or Not Likely to Result in Above Average Doses of IV Iron 20

    Table 3: Factors Identified by Selected Clinicians and Researchers as Likely or Not Likely to Result in Above Average Doses of IV Vitamin D 23

    Table 4: Current CMS Initiatives to Monitor the Quality of Dialysis Care 28

    Table 5: Average Monthly Medicare Expenditures per Beneficiary for Injectable ESRD Drugs by Demographic Characteristics, 2007 55

    Table 6: Percentage of Selected Clinicians and Researchers Indicating Whether a Factor Is Likely or Not Likely to Result in a Higher-Than-Average Dose of ESAs 57

    Table 7: Percentage of Selected Clinicians and Researchers Indicating Whether a Factor Is Likely or Not Likely to Result in a Higher-Than-Average Dose of IV Iron 59

    Table 8: Percentage of Selected Clinicians and Researchers Indicating Whether a Factor Is Likely or Not Likely to Result in a Higher-Than-Average Dose of IV Vitamin D 61

    Figures

    Figure 1: Average Monthly Medicare Expenditures on Injectable ESRD Drugs by Race, 2007 13

    Figure 2: Average Monthly Medicare Expenditures on Injectable ESRD Drugs by Age, 2007 15

    Figure 3: Crosswalk between Race and Ethnicity Categories on CMS Medical Evidence Forms and the Categories Used in This Report 41

    Page ii GAO-10-295 End-Stage Renal Disease

  • Abbreviations

    AV arteriovenous BMI body mass index CMS Centers for Medicare & Medicaid Services CPM clinical performance measure CROWNWeb Consolidated Renal Operations in a Web-Enabled Network EDB Enrollment Database ESA erythropoiesis stimulating agent ESRD end-stage renal disease FDA Food and Drug Administration HHS Department of Health and Human Services IV intravenous KCC Kidney Care Council MedPAC Medicare Payment Advisory Commission MIPPA Medicare Improvements for Patients and Providers Act of 2008 NRAA National Renal Administrators Association PTH parathyroid hormone QIP quality incentive program REMIS Renal Management Information System RPA Renal Physicians Association UM-KECC University of Michigan Kidney Epidemiology and Cost Center USRDS United States Renal Data System VA Department of Veterans Affairs

    This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately.

    Page iii GAO-10-295 End-Stage Renal Disease

  • Page 1 GAO-10-295

    United States Government Accountability OfficeWashington, DC 20548

    March 31, 2010

    The Honorable Pete Stark Chairman Subcommittee on Health Committee on Ways and Means House of Representatives

    The Honorable John Lewis Chairman Subcommittee on Oversight Committee on Ways and Means House of Representatives

    Medicare covers