Robert Hootkins MD PhD FASN An Assist from: Alex Rosenblum RN, AM & FM Jay Wish MD Steven Fishbane MD

USRDS: ESRD AS % OF MEDICARE ESRD Costs Continue to Rise

MEDICARE EXPENDITURES BY MODALITY

MEDICARE PAYMENT POLICIES  60% of what CMS paid for were dialysis treatments and included labs ($4.8 billion)  40% of what CMS paid was for separately billed items Parenteral drugs and biologicals ($2.8 billion) Additional lab services ($333 million) Major Drug is EPO Point # 1: EPO is expensive *

DRIVING FACTORS FOR REVISION OF MEDICARE REIMBURSEMENT High percentage of dialysis patients (50% in 2006) with Hb > 12 g/dL (upper limit per KDOQI guidelines) Previous payment policies did not provide financial incentive to constrain ESA use Point #2: EPO is over utilized.

USRDS: Hb LEVELS AND EPO DOSING (x1000u/wk)

DRIVING FACTORS FOR REVISION OF MEDICARE REIMBURSEMENT Randomized controlled trials failed to show improved outcomes when ESAs dosed to achieve higher Hb levels in patients with kidney disease.  CHOIR and CREATE - non-dialysis CKD patients  NORMAL HCT STUDY - hemodialysis patients Some studies suggest higher rates of cardiac events and strokes. Point #3: EPO use to Drive High Hb Levels High May Be Harmful

INCREASED ESA USE AND NO CHG IN MORTALITY

COMPOSITE RATE ENDS AND BUNDLING BEGINS The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) amended the Social Security Act to require CMS to develop a new, fully bundled prospective payment system for renal dialysis services to replace the existing composite rate payment methodology

COMPOSITE RATE ENDS AND BUNDLING BEGINS Specifically, CMS must develop a plan to bundle ESAs and other separately billable drugs into a single case-mix adjusted payment to dialysis facilities. What effect does/will this have? What potential “threat” will this have on outcomes?

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MATHEMATICS OF THE PAYMENT

AVG REIMBURSEMENT IN EARLY BUNDLING FRESENIUS DATA FOR 2011: AVG REIMBURSEMENT ABOUT $243

BUNDLE: MAXIMIZE REIMBURSEMENT Patient demographics and co-morbidity data is critical to know and document Process in place to capture this information and provide to provide and then upward to CMS [Process in place to provide oral medication in 2014]

BUNDLE: POTENTIAL THREATS TO ANEMIA ROLE OF THE QIP Largest Financial Impact in Bundling QIP important ?  50% Based on % of patients Hb < 10 g/dL  25% Based on % of patients Hb > 12 g/dL 75% of entire QIP is ANEMIA based !

QIP SPECIFICS

ANEMIA & THE QIP Might some small providers lower Hb to 10, use less ESA?  Lose 50% QIP= $3/tx  Gain lower ESA costs = $30/tx QIP may not be protective from inadequate ESA usage!

HOW CAN WE PROTECT QUALITY OUTCOMES? Avoid Hgb < 10 g/dL  Increased symptoms  Risk blood transfusions  Association with adverse cardiovascular outcomes How to stay in target range?  Utilize algorithms but keep option to individualize  Manage trends - not just absolute Hb  Frequent Hgb measurement (? weekly)  Look for and eliminate inflammatory causes (√ CRP)  Flexible protocols and don’t overreact to outlier values

HOW CAN WE PROTECT ANEMIA OUTCOMES AND BE COST EFFECTIVE?  Use of less expensive ESAs (when available in near future)  More aggressive IV iron use  Maintenance rather than “load and hold”  Higher targets for iron levels in blood - ?safety  Use of lower cost iron products?  More conservative ESA use in ESA-resistant patients  Get rid of dialysis catheters  Subcutaneous administration option?.

BUNDLE: MBD  Important financial impact  No QIP  Need to: maintain bone health avoid calcifications optimize mineral balance

BUNDLE: COSTS IN MBD  IV Vitamin D

BUNDLE: COST REDUCTION IN MBD  2014: Oral Vit D, Binders, Cinacalcet  Use of lower cost phosphate binders  Use of lower calcium dialysate  Use of lower cost oral / IV vitamin D agents  Abandonment of Cinacalcet Increased prevalence of parathyroidecomies?  Decreased testing and replacement of 25-OH Vit D

BUNDLE: “THREATS” TO DIALYSIS ADEQUACY  HD determined by:  Patient size  Blood flow  Dialyzer Size  Dialysate flow  Time  Access Pathology

BUNDLE: DIALYSIS ADEQUACY To Reduce Costs, “Incentive” to use:  Smaller Dialyzers  Decreased Dialysate Flows  Shorter Treatments  Makes sense to maintain access health

BUNDLE: DIALYSIS ADEQUACY QIP Begins 2012  96% patients > 65% URR  Contributes 25% of score QIP may protect patients from prescription changes ?

BUNDLE: VASCULAR ACCESS Dialysis patients from the 1999–2008 ESRD CPM data with Medicare as primary payor & vascular access data. Intent-to- treat model. Vascular access type in use in December prior to cost years 1999–2008. Costs include “pure” inpatient & outpatient claims & physician/ supplier access costs.

BUNDLE: VASCULAR ACCESS Catheters cost money and are bad for patients

BUNDLE: VASCULAR ACCESS  No QIP for access  Vascular access likely to become the next P4P indicator once CROWNWeb is able to capture those data  There is a financial impact Catheter patients use more ESAs and require TPA (Cathflo) and antibiotics and 2x times the number hospitalization days compared to AVFs  Desired outcomes require continued push for PD and AVF’s

BUNDLE: CV HEALTH  All CV oral meds outside of the bundle  Need for adequate BP and lipid management  Smoking cessation  Less Inflammation: fewer catheters/grafts

UNINTENTIONAL CONSEQUENCES OF THE BUNDLE  The following concerns were included in the CMS QIP final rule comments: “The QIP could lead to increased “cherry picking” in the practice of patient referrals, increased involuntary discharges, and other barriers to dialysis care for difficult-to-treat patients or those patients who might negatively affect provider/facility performance metrics.”

UNINTENTIONAL CONSEQUENCES OF THE BUNDLE  CMS plans to monitor:  In its March 2010 report, entitled “End-Stage Renal Disease: CMS Should Monitor Access to and Quality of Dialysis Care Promptly after Implementation of New Bundled Payment System” (GAO ).  GAO recommended that CMS monitor whether beneficiary access to, and the quality of, dialysis care is diminished or degraded following implementation of the newly expanded ESRD bundled payment system, especially for certain groups of Medicare ESRD beneficiaries who may be more vulnerable.  Specifically, the GAO report highlighted a concern that the new ESRD PPS might affect access to and quality of dialysis care for “certain groups of beneficiaries, such as those who receive above average doses of injectable ESRD drugs.

The goal in a bundled environment is to deliver the highest quality of care but now with emphasis in the most cost effective way.

 More permanent access placed before the need to start dialysis.  Increased efforts to encourage selection of home therapy  Ensure all co-morbid conditions are properly documented in the medical record and billing as one missing key co-morbidity will result is lower reimbursement.  Ensure facility has processes in place to ensure dialysis adequacy and optimal anemia management  Implement plan of care for each patient to maintain a Hgb of 10-12, while efficiently using EPO and generous iron dosing to achieve target. FINANCIALLY SURVIVING IN THE AGE OF THE BUNDLE

 Encourage patients with catheters to obtain a permanent access  Ensure all patients are aware of available resources to assist with medication and nutritional needs  Ensure all patients receive immediate nutritional counseling after admission and provided oral supplements for those not meeting goal. FINANCIALLY SURVIVING IN THE AGE OF THE BUNDLE

FINAL THOUGHTS / REVIEW  The ESRD bundled payment system began in January 2011  Since one of the goals of bundling was to decrease ESA use by making it a cost center, ESA use is likely to decrease by 15-25% (which is exactly what Congress intended)  Facilities are already testing algorithms for anemia management to decrease costs and maximize the number of patients within the hemoglobin target range of gm/dl  Additional dialysis industry consolidation is likely occur as some smaller providers may not be able to adapt