NRAA Update Florida Renal Administrators Association July 2013

1. NRAA UpdateFlorida Renal Administrators AssociationJuly 2013 Katrina Russell, RN, CNN Dialysis Consulting Group, Inc. President, National Renal Administrators Association

2. NRAA • Non-profit, volunteer organization representing dialysis organizations, formed 36 years ago • Special emphasis on medium, small and independent organizations • Hospital-based & freestanding dialysis members • Key Areas of Focus: • Education • Advocacy • Services

3. NRAA • Education • Annual conference (September 25-27, 2013 Seattle, WA) • Spring Meeting & Day on The Hill • Renal Watch – weekly electronic newsletter • Webinars • Teleconferences • E-blasts • Advocacy • Day on the Hill • Cap Wiz • Monthly Advocacy Network Calls • Emails as needed • Services • NRAA GPO

4. NRAA GPO • Name Change-Renal Services Exchange • Renal Purchasing Group • Health Information Exchange • Oral Medication Pharmacy Options • Enterprise Risk Management Program • Disposable Supply Contracts

5. What’s Happening in ESRD? Overview

6. Medicare ESRD Program • Federal program specific to individuals with end stage renal disease (ESRD) • Dialysis providers heavily dependent on Medicare reimbursement • Many changes in recent years • Conditions for Coverage 2008 • New “Core survey” process • Composite rate to prospective payment system (“bundle”) • Quality Incentive Program (QIP) - Pay for Performance (“value based purchasing”)

7. Medicare ESRD Core survey process • Dialysis providers must be in compliance to participate in Medicare program • 2008 regulations cumbersome and time consuming • Focused approach to review most important aspects of facility operations and performance – drill down if problems are discovered • Pilot last quarter 2012 – now training State surveyors • Expect full implementation by end of 2013

8. Medicare ESRD PPS • 2013 • No change in Facility & Comorbid adjustors • 2.3% market basket update • Government Accountability Office (GAO) Report on Medicare ESRD PPS Drug Utilization • Significant decreases in ESA utilization • Estimated $650 - $880 Million in Overpayments • Used ASP + 6 data for pricing (15 month lag time) • Did not account for increases in price of ESA’a (three increases since implementation of PPS 1/2011) • Did not evaluate LDO’s separately

9. Medicare ESRD PPS • Fiscal Cliff – American Taxpayer Relief Act • Legislation passed by Congress 1/1/2013 • Includes Sustainable Growth Rate - SGR (“Doc Fix” – avoided a 27% cut) • Instructed CMS to delay inclusion of oral ESRD drugs in the ESRD PPS to 2016 • Required a rebasing of PPS to account for decreased ESA utilization for payment year 2014 • $4.9 billion over 10 years the projected savings • NRAA & other stakeholders communicated with CMS & Congress re: concerns • Delayed sequestration for two months

10. Medicare ESRD PPS • Sequestration – no deal reached by 3/1/13 deadline • Effective April 1 – 2% cuts to all Medicare providers • Continues indefinitely

11. ESRD Quality Incentive Program (QIP) • Section 1881(h) of the Social Security Act, amended by Section 153(c) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) • Program intent: • Promote patient health by encouraging renal dialysis facilities to deliver high-quality patient care • Section 1881(h): • Authorizes payment reductions if a facility does not meet or exceed the minimum Total Performance Score as set forth by CMS • Allows payment reductions of up to 2% • CMS/Medicare’s first value based purchasing program (now have hospital re-admissions) • Effective January 1, 2012

12. ESRD QIP – Process – Provider Actions • Annually: • Notice of Proposed Rulemaking (PPS and QIP) • Watch for the NPRM – Read • Comment Period • Review carefully and provide comments to CMS • Final Rule • Watch for it – review to understand implications • Implementation • Self-Monitor measures

13. Important Terminology • Measures - The high-level CMS definition of how quality of care is assessed.” • represent quality of care, evidence based, promote best clinical practice • Performance Standard - The rate against which a facility’s individual performance rate is compared. • Performance Period - Range of time for which a facility’s performance is assessed to determine their measure rates and scores. • Total Performance Score – Score which determines whether a payment reduction applies • Payment Reductions – Amount PPS rate will be decreased using applicable scale • Payment Year – Calendar Year in which payment reduction occurs

14. Quality Incentive Program • 2013 • Anemia measures - % HGB < 10; % HGB > 12 • Adequacy measure - % URR > 65% • Roughly 10% of providers received QIP payment reductions • 2014 – addition of reporting measures and achievement or performance scores • Anemia measures - % HGB < 10; % HGB > 12 • Adequacy measure - % URR > 65% • Vascular Access Measure - % AVF & % CVC • NHSN • ICH CAHPS • Mineral metabolism • Draft reports to be available 7/29. One month to review and query and/or provide comments • CMS predicting 31% of providers will have penalty in 2014

15. Achievement

16. Achievement or Improvement • If performance above the achievement & benchmark = 10 points • If performance below both achievement and improvement thresholds = 0 points • Scores calculated along the achievement range and improvement range are compared = points determined by actual score – best one applies

17. Quality Incentive Program Payment Year 2014

18. QIP 2015 – Measures

19. QIP 2015 Clinical Measures • Performance year -2013 • Anemia Management - % HGB > 12 • Kt/V Dialysis Adequacy measure topic • Adult Hemodialysis – % with Kt/V 1.2 or above • Adult Peritoneal Dialysis – % Kt/V 1.7 or above • Pediatric Dialysis – % Kt/V 1.2 or above • Vascular Access Type (VAT) measure topic • Access via arteriovenous fistula (AVF) - % in use • Access via catheter for 90+ days - % in use • Scores for applicable clinical measure topics will be weighted equally to comprise 75% of the TPS Proposed Clinical Measures • Apply achievement / performance ranges

20. QIP 2015 Clinical Measures

21. QIP 2015 Reporting Measures • Anemia Management – Report ESA dosage for 99% of patients with 2 or more treatments • Mineral Metabolism -Serum Calcium and Serum Phosphorus measure reported for 96% of patients with 7 or more txs per month • NHSN – 12 months of Dialysis Event data reported • ICH CAHPS – Administered to all ICH HD patients by a third party • 25% of Total Score

22. Proposed Rule 2014 PPS and 2016 QIP Released July 1,2013

23. NPRM 2014 ESRD PPS & 2016 QIP • Released July 1, 2013 • Proposed Rule – Comments due to CMS by 8/30/2013

24. NPRM 2014 ESRD PPS • 2014 – All providers paid under PPS (transition complete) • Propose base rate of $216.47 • Reduction of 12% based on ATRA, decrease in drug utilization under PPS • 2.9% market basket update • -.4% productivity adjustment • Net 9.5% cut • Varies for providers based on geography (wage index) and outlier calculation - Average 9.4%

25. NPRM 2014 ESRD PPS – Provider Impact File

26. NPRM 2014 ESRD PPS • Lowering outlier threshold in attempt to reach 1% outlier payments (currently only paying out 0.2%) • ICD9 to ICD10 crosswalk – dropping two ICD10 codes: • K52.81 Eosinophilic gastritis or gastroenteritis • Does not specify hemorrhage/bleeding • D89.2 Hypergammaglobulinemia, unspecified • Does not specify which immunoglobulin(s) are elevated

27. NPRM 2014 ESRD PPS • Home dialysis training adjustment • No change, but requesting comments on costs, number of sessions and duration for PD training and HHD training • Suggesting a “hold back”, partial training payments until patient completes training and starts home dialysis

28. NPRM - 2016 QIP • 14 measures proposed • 9 of 10 from 2015 • Revisions to three of these • Three new clinical measures • Two new reporting measures

29. NPRM - 2016 QIP – Continued • Hgb > 12 • Kt/V • Adult HD > 1.2 • Adult PD > 1.7 • Pediatric >1.2 • Vascular Access Type • % AVF • % Catheters > 90 days • Mineral Metabolism Reporting • Anemia Management Reporting

30. NPRM - 2016 QIP – Revised/Expanded • ICH CAHPS • Must use CMS certified vendor • Specifications per CMS (previously AHRQ) • https://ichcahps.org/ • Proposed administering twice a year starting in 2015 for 2017 score • Mineral Metabolism Reporting • Include PD patients • Anemia Management Reporting • Include PD patients

31. NPRM - 2016 QIP – New • Anemia Management • HGB > 12 • Informed Consent for ESA • Hypercalcemia - > 10.2 • Use of Iron for Pediatric Patients • NHSN – Bloodstream Infections (BSI)

32. NPRM - 2016 QIP – New • Comorbidity Reporting • Report/Update in CROWNWeb annually • May inform future SMR & SHR QIP measures

33. NPRM - 2016 QIP – New • Achievement & Improvement Scales continue as appropriate • Data Validation • Random sample of 300 patients from CW

34. Potential Future QIP Measures

35. Potential Future QIP Measures • Under Consideration • Kidney transplantation • Transfusions • Quality of life • Health information technology for quality improvement at the point of care & for care coordination • Residual renal function • Complications associated with ESRD • Frequent comorbid conditions (diabetes, heart disease)

36. Proposed Rule - Call To Action • Cuts as proposed are devastating to dialysis providers, especially small and independent clinics • Entire industry in process of reacting • NRAA • Conducting research and requesting data for 2012 Medicare Cost Reports • Seeking clarification on the Regulatory Flexibility Act – CMS notes some small facilities will be significantly impacted • Composing comment letter to CMS • Scheduling meetings with CMS and Congress

37. Call To Action – what you can do • Be Informed • Read the Proposed Rule • Find your facility on the provider impact file to determine proposed cut for your organization • Evaluate whether your organization is affected under the RFA ($35.5 million or less) • Determine what the reduced payment means for you – if finalized, how would you cope? • Educate your patients, physicians and staff

38. Call To Action – what you can do • Reach Out • Contact your Congressional Representatives and tell them how you and your patients will suffer if this proposed reduction goes forward • Visit Congressional office in DC or in your district • Write letters (use Cap Wiz for help with this) • Invite Congressional Representatives to tour your facility

39. Call To Action – what you can do • Inform your colleagues • Submit Comments to CMS by August 30, 2013 • Express your concerns and suggestions – this really works to shape the Final Rule

40. Medicare Comprehensive ESRD Care (CEC) model • This demonstration project to test and evaluate a new model for care delivery and payment for patients with end-stage renal disease (ESRD) • Seeking to improve care, achieve better patient outcomes and reduce expenditures for Medicare and Medicaid • CMMI accepting applications from ESRD Seamless Care Organizations (ESCO’s) • ESCO’s must have nephrologist(s), dialysis clinic and “other” providers

41. Medicare Comprehensive ESRD Care (CEC) model • Multiple providers can form ESCO but geographic restriction is not more than two contiguous CBSA’s (if rural & no CBSA, entire state may qualify) • ESCO’s must have minimum of 500 patients – decreased to 350 • Patients cannot be participating in any other Medicare shared savings model (ACO, dual eligible managed care program, etc) • Will accept 10-15 • LOI originally due by March 15, Applications by May 1; Extended to May 15 for LOI and July 1 for application; Latest extension – both LOI and applications now due by August 30, 2013

42. Medicare Comprehensive ESRD Care (CEC) model • Latest News • “Numerous suggestions & feedback” • 7/26/2013 revised RFA & Updated Fact Sheet • CMS Open Door Forum • August 1, 2013 4-5pm Eastern

43. Other Issues • Acute Kidney Injury (AKI) dialysis treatments • Requirements for hospitals to perform these for Medicare patients on hospital premises to be reimbursed • Often covered under acute contracts • Can continue to provide treatments at outpatient facilities for AKI for patients with Commercial insurance • ESRD Networks • Scope of work • Competed contracts • NRAA meeting in Seattle September 25-27

44. QUESTIONS?