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  1. 1. Healthcare Reform: Issues for the ESRD Community Barry M. Straube, M.D. Centers for Medicare & Medicaid Services NRAA Spring Meeting May 7, 2009
  2. 2. The US Economy <ul><li>“ The economy is in a crisis not seen since the Great Depression” (Congressional Conference Agreement on the ARRA, February 13, 2009) </li></ul><ul><ul><li>Credit is frozen </li></ul></ul><ul><ul><li>Consumer purchasing power in decline </li></ul></ul><ul><ul><li>In prior 4 months, 2.0 million jobs lost </li></ul></ul><ul><ul><li>Job loss projection: 3-5 million in the next year </li></ul></ul><ul><ul><li>Unemployment rate is 8.5% and still rising </li></ul></ul><ul><ul><li>Pundits: “The economy is shutting down” </li></ul></ul>
  3. 3. 2008 Medicare Trust Fund Report <ul><li>Income to the HI Trust Fund will soon become inadequate to fund the HI portion of Medicare benefits </li></ul><ul><ul><li>HI Trust Funds to be depleted by 2019 (CMS Actuary update in December, 2008 shortened to 2016-2017 due to economic downturn) </li></ul></ul><ul><ul><li>HI deficit over the next 75 years is $13 trillion. Eliminating the deficit would require: </li></ul></ul><ul><ul><ul><li>Immediate 120% increase in payroll tax, or </li></ul></ul></ul><ul><ul><ul><li>Immediate 51% reduction in benefits, or </li></ul></ul></ul><ul><ul><ul><li>Combination of both </li></ul></ul></ul><ul><ul><li>This dismal situation is in addition to the increased funding needs of Medicare Parts B & D that are funded out of the general fund and premium payments that are adjusted annually. </li></ul></ul>
  4. 4. The Healthcare Quality Challenge <ul><li>We spend more per capita on healthcare than any other country in the world </li></ul><ul><li>In spite of those expenditures, US Healthcare quality is often inferior to other nations and often doesn’t meet expected evidence-based guidelines </li></ul><ul><li>There are significant variations in quality and costs across the nation with increasing evidence that there may be an inverse relationship between the two </li></ul><ul><li>Adoption & use of interoperable HIT is felt critical to improving the quality of care, yet implementation lags </li></ul><ul><li>CMS is responsible for the healthcare of a growing number of persons </li></ul><ul><li>CMS, in partnership and collaboration with other healthcare leaders, must demonstrate leadership in addressing these issues </li></ul>
  5. 5. CKD/ESRD Value Imperative <ul><li>Growing number of patients needing renal replacement therapy </li></ul><ul><ul><li>Epidemic of CKD: 26 Million Americans </li></ul></ul><ul><ul><li>Increasing shortfall of donor kidneys </li></ul></ul><ul><ul><li>Unless we can mitigate progression of CKD, increasing need for dialytic services </li></ul></ul><ul><li>Overall costs of care continue to grow, particularly for injectable medications </li></ul><ul><li>We spend more per capita on ESRD care than any other country in the world, yet the quality measured is often no better or even inferior to other developed nations </li></ul>
  6. 6. CKD/ESRD Value Imperative <ul><li>Quality of care has improved for a number of clinical performance measures in ESRD </li></ul><ul><ul><li>Many of these have started to level off or reach a peak </li></ul></ul><ul><li>Many other metrics of quality have not improved in ESRD and there are many “opportunities for improvement” we’re not addressing </li></ul><ul><ul><li>Particularly true for compliance with medications, infections, nutrition, volume/fluid control, preventive services, mineral metabolism, disparities, etc. </li></ul></ul><ul><ul><li>Referrals to Transplant still low; Under-use of home Rx </li></ul></ul><ul><ul><li>We will not meet Health People 2010 Goals globally </li></ul></ul>
  7. 7. CKD/ESRD Value Imperative <ul><li>There are wide variations in treatment modality usage, outcomes, costs of ESRD care </li></ul><ul><ul><li>Regional, facility, organizational variations </li></ul></ul><ul><ul><li>Health disparities a very major variation </li></ul></ul><ul><li>Adherence to evidence-based guidelines is lower than expected </li></ul><ul><li>CMS, in collaboration with the renal community, needs to address these imperatives </li></ul>
  8. 8. President Obama’s Health Care Plan <ul><li>Make health insurance affordable to all </li></ul><ul><ul><li>Builds on the existing healthcare system </li></ul></ul><ul><ul><li>Uses existing providers, doctors and plans to implement </li></ul></ul><ul><ul><li>Affordability increases access </li></ul></ul><ul><li>Reduce Costs, Improve Quality, and save a typical family up to $2500 </li></ul><ul><ul><li>Investing in health information technology </li></ul></ul><ul><ul><li>Prevention </li></ul></ul><ul><ul><li>Care coordination and chronic disease management </li></ul></ul><ul><ul><li>Quality & cost transparency </li></ul></ul><ul><li>Promote public health </li></ul><ul><ul><li>Preventive services </li></ul></ul><ul><ul><li>State and local preparedness for terrorist attacks, natural disasters and epidemics </li></ul></ul><ul><ul><ul><ul><ul><li>Source: www. whitehouse . gov & www. barackobama .com </li></ul></ul></ul></ul></ul>
  9. 9. CMS Hospital Quality Initiative <ul><li>National Voluntary Hospital Reporting Initiative (NVHRI) public-private initiative </li></ul><ul><ul><li>Federation of American Hospitals </li></ul></ul><ul><ul><li>AHA </li></ul></ul><ul><ul><li>AAMC </li></ul></ul><ul><ul><li>CMS , JCAHO, others </li></ul></ul><ul><li>Hospital Quality Alliance </li></ul><ul><li>Medicare Modernization Act of 2003: Section 501b – Financial incentive of 0.4% </li></ul>
  10. 10. Hospital Quality Initiative <ul><li>“ Voluntary” participation went from 10% of hospitals reporting some of 10 measures to over 95% </li></ul><ul><li>Incentive increased from 0.4% to 2% of APU under DRA </li></ul><ul><li>Current year 96% of hospitals qualified </li></ul><ul><ul><li>44 measures (includes Hospital CAHPS) </li></ul></ul><ul><ul><li>Recent inclusion of mortality and readmission rates for AMI, CHF, Pneumonia </li></ul></ul><ul><ul><li>Plan to test EHR submission soon </li></ul></ul><ul><li>Pay-for-Reporting works, better than voluntarism </li></ul><ul><li>Quality reporting roadmap: Voluntary to P4R to P4P </li></ul>
  11. 11. MIPPA 2008 <ul><li>Section 131: Physician Quality Reporting Initiative (PQRI) </li></ul><ul><ul><li>Extended prior authorization for this program </li></ul></ul><ul><ul><li>153 quality measures across specialties (7 measures groups) </li></ul></ul><ul><ul><li>Alternatives for reporting periods </li></ul></ul><ul><ul><li>43 approved clinical registries to satisfy reporting requirements </li></ul></ul><ul><ul><ul><li>More approved registries in near-future </li></ul></ul></ul><ul><ul><li>EHR testing in near future and this is the end goal </li></ul></ul><ul><li>Section 132: E-Prescribing Initiative </li></ul><ul><ul><li>Physician 2% bonus, with phase out and then disincentive, for E-prescribing </li></ul></ul><ul><li>Section 153: ESRD Renal CROWNWeb system, Bundled Payment Reform, and ESRD Quality Incentive Program </li></ul><ul><ul><li>Some of quality measures impacted by pre-ESRD care </li></ul></ul><ul><ul><li>Withhold of % of bundled payment for not meeting benchmarks </li></ul></ul>
  12. 12. CHIPRA 2009 <ul><li>Signed into law by President Obama on February 4, 2009 </li></ul><ul><li>Expands coverage from 7 million to 11 million </li></ul><ul><li>$32.8 billion cost completely offset, primarily by increase of $0.62 in cigarette tax to $1.01 per pack </li></ul><ul><li>Reduced barriers to enrollment and premium assistance </li></ul><ul><li>Improved access to benefits: including dental, mental health, etc. </li></ul><ul><li>Strengthens pediatric health quality and outcomes </li></ul><ul><ul><li>Pediatric quality measures program </li></ul></ul><ul><ul><li>Grants for evidence-based quality measures and interventions development </li></ul></ul><ul><ul><li>Model EHR for pediatric patients and promotion of HIT adoption </li></ul></ul>
  13. 13. American Recovery & Reinvestment Act (ARRA) of 2009 <ul><li>Passed by Congress: February 13, 2009 </li></ul><ul><li>Signed by the President: February 17, 2009 </li></ul><ul><li>$787.2 billion of economic recovery tax cuts and carefully targeted priority investments with unprecedented accountability measures built in </li></ul><ul><ul><li>Clean, efficient energy </li></ul></ul><ul><ul><li>Transforming our Economy with Science & Technology </li></ul></ul><ul><ul><li>Modernizing Roads, Bridges, Transit & Waterways </li></ul></ul><ul><ul><li>Education for the 21 st Century </li></ul></ul><ul><ul><li>Tax Cuts to Make Work Pay and Create Jobs </li></ul></ul><ul><ul><li>Lowering Health Care Costs </li></ul></ul><ul><ul><li>Helping Workers Hurt by the Economy </li></ul></ul><ul><ul><li>Saving Public Sector Jobs and Protecting Vital Services </li></ul></ul>
  14. 14. American Recovery & Reinvestment Act (ARRA) of 2009 <ul><li>Quality Affordable Healthcare </li></ul><ul><li>Health Information Technology: $19 billion to jumpstart computerized health records </li></ul><ul><li>Prevention & Wellness Fund: $1 billion to fight preventable diseases </li></ul><ul><ul><li>Hospital infections & serious adverse events prevention </li></ul></ul><ul><ul><li>Immunization programs </li></ul></ul><ul><ul><li>Evidence-based disease prevention </li></ul></ul><ul><li>Healthcare Effectiveness Research: $1.1 billion </li></ul><ul><li>Community Health Centers: $2 billion to expand sites </li></ul><ul><li>Training Primary Care Providers: $500 million to address shortages in under-served areas </li></ul><ul><li>Indian Health Service: $500 million to modernize facilities </li></ul>
  15. 15. ARRA 2009: Medicare HIT <ul><li>Incentive payments for adoption and meaningful use of certified EHR adoption </li></ul><ul><ul><li>Physicians </li></ul></ul><ul><ul><ul><li>2013 (1 st Payment Year): $15,000 [$18,000 if 2011 or 2012] </li></ul></ul></ul><ul><ul><ul><li>2 nd Payment Year: $12,000 </li></ul></ul></ul><ul><ul><ul><li>3 rd Payment Year: $8,000 </li></ul></ul></ul><ul><ul><ul><li>4 th Payment Year: $4,000 </li></ul></ul></ul><ul><ul><ul><li>5 th Payment Year: $2,000 </li></ul></ul></ul><ul><ul><ul><li>Subsequent Years: $0 </li></ul></ul></ul><ul><ul><ul><li>Must adopt by 2014, otherwise no incentive payments </li></ul></ul></ul><ul><ul><ul><li>Increase in health professional shortage areas </li></ul></ul></ul><ul><ul><ul><li>Hospital-based physicians excluded from this incentive </li></ul></ul></ul><ul><ul><ul><li>Coordination with Medicaid to avoid duplicate payments from federal and state sources </li></ul></ul></ul>
  16. 16. ARRA 2009: Medicare HIT <ul><li>Physicians </li></ul><ul><ul><li>Meaningful use </li></ul></ul><ul><ul><ul><li>Meaningful use to be defined, but applies to multiple coordination elements in office or delivery site setting, includes electronic prescribing </li></ul></ul></ul><ul><ul><ul><li>Information exchange and care coordination with other entities </li></ul></ul></ul><ul><ul><ul><li>Reporting of measures using an EHR </li></ul></ul></ul><ul><ul><li>Meaningful users will be posted on a CMS website </li></ul></ul><ul><ul><li>Will also be required under Medicare Advantage, with need to avoid duplicate payments </li></ul></ul>
  17. 17. ARRA 2009: Medicare HIT <ul><li>Incentive payments for adoption and meaningful use of certified EHR adoption </li></ul><ul><ul><li>Hospitals </li></ul></ul><ul><ul><ul><li>Base amount of $2 million </li></ul></ul></ul><ul><ul><ul><li>Discharge-related amount of $200 per discharge for the 1150 th through 23,00 th discharge </li></ul></ul></ul><ul><ul><ul><li>Transition reduction over four years (100%, 75%, 50%, 25%) </li></ul></ul></ul><ul><ul><ul><li>Must start by 2013 for a full 4 year incentive </li></ul></ul></ul><ul><ul><ul><li>No incentives if not started by 2015 </li></ul></ul></ul><ul><ul><ul><li>Meaningful user definition similar to physicians </li></ul></ul></ul><ul><ul><ul><li>Meaningful users posted on CMS website </li></ul></ul></ul><ul><ul><ul><li>Coordination with Medicare Advantage plans also required </li></ul></ul></ul><ul><ul><ul><li>Critical Access Hospitals have additional incentives and exceptions </li></ul></ul></ul><ul><ul><ul><li>Market Basket increases after 2015 adjusted downward for those eligible hospitals that are not meaningful users </li></ul></ul></ul>
  18. 18. Some Conclusions <ul><li>The White House, Congress, HHS and many others are committed to reforming the U.S. healthcare system and some action is expected this year </li></ul><ul><li>Key issues: </li></ul><ul><ul><li>Accessibility to as many as possible </li></ul></ul><ul><ul><li>Affordability </li></ul></ul><ul><ul><li>Quality, reducing costs, achieving value and transparency </li></ul></ul><ul><ul><li>Public health + personalized medicine </li></ul></ul><ul><ul><li>Prevention, safety, care coordination, CDM, HAIs </li></ul></ul><ul><ul><li>HIT </li></ul></ul><ul><ul><li>Addressing disparities and variation </li></ul></ul>
  19. 19. The ESRD World: Observations <ul><li>Progress with some metrics, not with others </li></ul><ul><li>ESAs as a paradigm </li></ul><ul><ul><li>Increasing use: more is better </li></ul></ul><ul><ul><li>IV not SQ </li></ul></ul><ul><ul><li>Danger alerts via new literature, slow to respond </li></ul></ul><ul><ul><li>Misalignment of reimbursement with desired outcomes </li></ul></ul><ul><li>Number of facility-level metrics at a minimum </li></ul><ul><ul><li>Limits public reporting transparency </li></ul></ul><ul><ul><li>Limits national quality improvement focus </li></ul></ul><ul><ul><li>Impedes linking reimbursement to quality </li></ul></ul>
  20. 20. The ESRD World: MIPPA &MedPAC <ul><li>MedPAC has recommended an expanded bundled payment reimbursement system as well as a pay-for-performance system for the past decade </li></ul><ul><li>MMA of 2003 restricted some payments for separately billable drugs, but retained 2-part reimbursement structure </li></ul><ul><li>CMS Epo-monitoring policy also restricted over-use of ESAs due to reports of increased M/M </li></ul><ul><li>MIPPA expanded outpatient dialysis payment reform significantly </li></ul>
  21. 21. MIPPA: Section 153 <ul><li>153 (a) : Raised composite rate by 1% 1/1/2009, and another 1% in 2010 </li></ul><ul><li>153 (b) : Development of ESRD Bundled Payment System </li></ul><ul><li>153 (c) : Quality incentives in the ESRD Program </li></ul><ul><li>153 (d) : GAO report on ESRD Bundling System and Quality Incentive </li></ul>
  22. 22. Bundled Payment System <ul><li>Basic components </li></ul><ul><ul><li>Services in composite rate as of 2010 </li></ul></ul><ul><ul><li>ESAs and other drugs, separately billable under Part B, including oral equivalents </li></ul></ul><ul><ul><li>Laboratory tests and other items & services furnished to beneficiaries in ESRD Rx (vaccines excluded) </li></ul></ul><ul><li>Will not be budget neutral </li></ul><ul><ul><li>98% of estimated total payments had bundle not been implemented </li></ul></ul><ul><ul><li>Lowest Patient utilization data from 2007, 2008, 2009 </li></ul></ul>
  23. 23. Bundled Payment System <ul><li>Adjustments </li></ul><ul><ul><li>Patient case mix (height, weight, BMI, comorbidities, length of time on dialysis, age, race, ethnicity, “other” </li></ul></ul><ul><ul><li>High-cost outlier patients </li></ul></ul><ul><ul><li>Low-volume facilities that incur high costs </li></ul></ul><ul><ul><li>Geographic factors </li></ul></ul><ul><ul><li>Pediatric facilities </li></ul></ul><ul><ul><li>Rural areas </li></ul></ul><ul><li>In 2012, regular update of bundled rate by market basket minus 1% </li></ul><ul><li>4 year phase-in, by end of 2014 </li></ul>
  24. 24. ESRD Quality Incentive Program <ul><li>In 2012, bundled payment rate may be reduced by up to 2% for facilities that do not achieve or make progress toward specified quality measures </li></ul><ul><li>Mandated quality measures </li></ul><ul><ul><li>Anemia management </li></ul></ul><ul><ul><li>Dialysis adequacy </li></ul></ul><ul><ul><li>To extent feasible </li></ul></ul><ul><ul><ul><li>Patient satisfaction </li></ul></ul></ul><ul><ul><ul><li>Iron management </li></ul></ul></ul><ul><ul><ul><li>Bone mineral metabolism </li></ul></ul></ul><ul><ul><ul><li>Maximizing placement of recommended vascular access </li></ul></ul></ul>
  25. 25. ESRD Quality Incentive Program <ul><li>Quality measures must be endorsed by a national consensus process, with certain exceptions </li></ul><ul><li>A process for updating measures in consultation with interested parties shall be established </li></ul><ul><li>Measures may be weighted </li></ul><ul><li>Special rule for initial performance standards </li></ul><ul><li>Each facility’s performance scores will be publicly reported on the internet and posted at each facility </li></ul>
  26. 26. GAO Report <ul><li>Report to Congress no later than March 1, 2013 </li></ul><ul><li>Report shall provide information on: </li></ul><ul><ul><li>Changes in utilization rates for ESAs </li></ul></ul><ul><ul><li>Mode of ESA administration </li></ul></ul><ul><ul><li>Analysis of payment adjustments, including those for low-volume and rural providers and facilities </li></ul></ul><ul><ul><li>Changes in utilization of other drugs and biologicals and oral equivalents </li></ul></ul><ul><ul><li>Any other information deemed appropriate by the Comptroller </li></ul></ul>
  27. 27. CROWNWeb & ESRD Quality Initiatives <ul><li>ESRD facilities currently report 3 claims-based quality measures </li></ul><ul><ul><li>Survival </li></ul></ul><ul><ul><li>Anemia management </li></ul></ul><ul><ul><li>Dialysis adequacy </li></ul></ul><ul><li>CMS now has 26 clinical performance measures (CPMs) ready for use at facility-level plus CAHPS </li></ul><ul><ul><li>In addition, an ESRD CAHPS survey is ready to be tested </li></ul></ul><ul><li>CROWNWeb developed to </li></ul><ul><ul><li>Facilitate collection of facility-level administrative & quality data via single-user internet submission, then EHRs </li></ul></ul>
  28. 28. Quality Administrative Form 2728 Medicare Entitlement Form 2746 Death Notification Form 2744 Annual Facility Survey NPAR Network Patient Activity Report Forms 820/821 Clinical Data (5% Sample) Fistula First Vascular Access Reporting Clinical Performance Measures VISION Vital Information System to Improve Outcomes in Nephrology SIMS Standard Information Management System REMIS Renal Management Information System CROWNWeb Consolidated Renal Operations in a Web-Enable Network Medicare Claims Data Future Renal Administrative and Quality Reporting Future
  29. 29. CROWNWeb <ul><li>Has been under development for years </li></ul><ul><li>3 years ago, elevated to highest IT priority in the Office of Clinical Standards & Quality </li></ul><ul><li>Original full-implementation date was February 1, 2009 </li></ul><ul><ul><li>ESRD Conditions for Coverage (2007) required this </li></ul></ul><ul><ul><li>CfCs were finalized after public rulemaking with public comment </li></ul></ul><ul><li>Development of this system was strongly encouraged by some in Congress, patient advocates, and other stakeholders </li></ul>
  30. 30. CROWNWeb <ul><li>CROWNWeb basic platform was always based on a single-user web-based platform to replace </li></ul><ul><ul><li>Paper administrative data submission </li></ul></ul><ul><ul><li>Abstracted (from charts) or other source quality data </li></ul></ul><ul><li>In the development phase, CMS received input that some dialysis providers had the capability to submit some quality data via “Batch” submission </li></ul><ul><li>CMS added plans for a “Batch Submission Pilot” to test feasibility of Batch submission as an alternative to single-user interface submission </li></ul>
  31. 31. CROWNWeb <ul><li>Batch Submission Pilot </li></ul><ul><ul><li>3 LDOs chosen to test batch submission </li></ul></ul><ul><ul><ul><li>Large volume of data </li></ul></ul></ul><ul><ul><ul><li>History of testing with CMS </li></ul></ul></ul><ul><ul><ul><li>Apparent well-developed batch collection capabilities </li></ul></ul></ul><ul><ul><li>In a pilot format, batch submission isn’t just pushing a button </li></ul></ul><ul><ul><ul><li>Requires significant back and forth collaboration with CMS IT staff, problem-solving, significant administrative time and other organizational resources </li></ul></ul></ul><ul><ul><li>If batch doesn’t work, pilot submitters will be required to use single-user submission </li></ul></ul>
  32. 32. CROWNWeb <ul><li>Late 2008-January 2009 CMS performed final testing on CROWNWeb </li></ul><ul><li>In addition to normal application process functional tests </li></ul><ul><ul><li>Security testing: Must meet extra-rigid Federal standards that CMS is internally required to meet </li></ul></ul><ul><ul><li>2-point authentication clearance necessary </li></ul></ul><ul><ul><li>Validity of data submitted </li></ul></ul>
  33. 33. CROWNWeb <ul><li>For multiple reasons, a decision was made to implement CROWNWeb in a phased approach </li></ul><ul><ul><li>February 1, 2009: Four LDOs and four SDOs in four geographic areas </li></ul></ul><ul><ul><ul><li>Phase I proceeding well and evaluation being performed </li></ul></ul></ul><ul><ul><ul><li>Includes implementation results, including security and validation, plus burden analysis at facility and corporate level </li></ul></ul></ul><ul><ul><li>Late spring – late summer: Phase II planned, with all 18 ESRD Networks overseeing limited implementation </li></ul></ul><ul><ul><li>By end of 2009: National implementation </li></ul></ul><ul><ul><li>Contractor is working on planned updated versions of CROWNWeb </li></ul></ul><ul><ul><li>If Batch Submission Pilot is successful, will allow Batch Submission by others as appropriate as soon as feasible </li></ul></ul>
  34. 34. MedPAC Policy Considerations <ul><li>Defining the payment bundle </li></ul><ul><li>Unit of payment </li></ul><ul><li>Adjusting the payment rate for patient case-mix, high-cost cases, and other factors </li></ul><ul><li>Payment for different types of dialysis </li></ul><ul><li>Quality Incentive Program flexibility </li></ul>
  35. 35. Contact Information <ul><li>Barry M. Straube, M.D. </li></ul><ul><li>CMS Chief Medical Officer, & </li></ul><ul><li>Director, Office of Clinical Standards & Quality </li></ul><ul><li>Centers for Medicare & Medicaid Services </li></ul><ul><li>7500 Security Boulevard </li></ul><ul><li>Baltimore, MD 21244 </li></ul><ul><li>Email: </li></ul><ul><li>Phone: (410) 786-6841 </li></ul>