RAC vs. Oncology A coalition-building Prototype to Quell onerous attacks

1. Dane J. Dickson MD President Idaho Society of Clinical Oncology RAC vs. Oncology A coalition-building Prototype to Quell onerous attacks

3. Sun Tzu 孫子 – The Art of War “If you know the enemy and know yourself, you need not fear the result of a hundred battles.”

4. Know yourself • Remember • FDA Labels • Guidelines (NCCN, ASCO, etc.) • Published Literature (not abstracts!!!!) • Standard of Care Payment for an issue doesn’t necessarily mean that the payer agrees with your medical decision

5. RAC Demonstration Program • 2003 Medicare Modernization Act (MMA) – Section 306 • 3-year demonstration program using Recovery Audit Contractors (RACs) to detect and correct improper payments in the Medicare FFS program • Initially started in states of New York, Massachusetts, Florida, South Carolina and California • Ended on March 27, 2008

6. Results of the 3 year project

7. Results of the 3 year project

8. Results of the 3 year project • Only 14% of audits appealed • (with a 33.3% chance you would win). • If you are a RAC you have a 95% success rate.

9. Results of the 3 Year Project • Lessons Learned: • “Claim RACs are able to find a large volume of improper payments.” • “Providers do not appeal every overpayment determination.” • “Overpayments collected were significantly greater than program costs.” • … • “It is possible to find companies willing to work on a contingency fee basis.”

10. Results of the 3 year Project • “The RAC demonstration had limited financial impact on most providers. . .those repayments were small in comparison with the providers’ overall income from Medicare.” “. . .the RAC . . .cost only 20 cents for each dollar collected”

11. Results of the 3 year Project

12. Updated Statement of WorkSept 1, 2011 • Added a 3rd audit category • Semi-automated Review • “To be used in [cases where] a clear CMS policy does not exist but in most instances the items and services as billed would be clinically unlikely or not consistent with evidence-based medical literature.” • Prior to this, only Automated and Complex Reviews

13. Updated Statement of WorkSept 1, 2011 RACK – Medieval Torture Device RA – Egyptian Sun Deity

14. RAC Regions • Follows the DME Regions for Medicare • Region A:  Performant Recovery https://www.dcsrac.com/Default.aspx • Region B:  CGI Federal, Inc.  https://racb.cgi.com/default.aspx • Region C:  Connolly, Inc.  http://www.connolly.com/healthcare/Pages/CMSRacProgram.aspx • Region D:  HealthDataInsights, Inc. http://www.healthdatainsights.com/rac.htm

15. CMS – RAC Regions

16. Semi-Automated Review 8/30/2012 “This letter is notify you that the Recovery Auditor HDI believes that Medicare has potentially made an overpayment to you. . . .Pegfilgrastim should not be administered during the 24 hours after chemotherapy.”

17. How RACs Determine Major Audits • “Low Hanging Fruit” • Proprietary Data Review RAC • CMS • Audit Item

18. Notification of Audit Item

19. Finding RAC Audit Items • Region A https://www.dcsrac.com/IssuesUnderReview.aspx • Region B https://racb.cgi.com/Issues.aspx • Region C http://www.connolly.com/healthcare/pages/ApprovedIssues.aspx • Region D https://racinfo.healthdatainsights.com/Public1/NewIssues.aspx

20. Simplifying the RAC Process MAC: Medicare Administrative Contractor QIC: Qualified Independent Contractor ALJ: Administrative Law Judge DAB: HHS – Departmental Appeals Board

21. Sun Tzu 孫子 – The Art of War “. . .in war the victorious . . .only seek battle after the victory has been won, whereas he who is destined to defeat fights first and then looks afterwards for victory.”

22. Objectives, Strategies, and Allies

23. Objectives/Strategies MAC “Overturn RAC” MAC to CMS to RAC “Stop Audit” 2 1 CMS 2 CMS “Stop Audit” 3 1 3 1 1 4 RAC “Unreasonable” 4

24. Escalated Strategies (If Needed) Congress “Bad Policy” 5 Patients Congress 5 5 CMS Corporate Leadership “Very bad PR” 6 6 5 Share Holders Performant: PFMT CGI: GIB Connolly: Private HDI: HMSY

25. Business of RAC • HDI Acquired by HMS Holdings • 11/7/2011 Announced • 3 month increase of 25% vs. 10% for Dow • Approx. increase in market value $670 Million

26. “Why bring a nuclear missile to a knife fight?” • Inherent conflict of interest of the RAC • Defining “not consistent with medical literature” • Personal Experience/Concerns with RAC • Loss of Records • Inability of RAC to find records • Faxed • Certified mail • Response not received = automatic denial, and no further work needed to be done by RAC (MAC now does the work) • Over 3 year look back on audit item • Surprising given complete access to billing and payment records

27. Unified Oncology Coalition COA Idaho Oregon Utah Montana Washington Alaska Nebraska S. California SAC State Societies PRIT MAC CMS RAC ASCO CPC

28. States/State Societies • Alaska - Denali Oncology Group • Southern California (MOASC) • Idaho Society of Clinical Oncology (ISCO) • Montana – Frontier Cancer • Nebraska Oncology Society (NOS) • Oregon Society of Medical Oncology (OSMO) • Society of Utah Medical Oncologists (SUMO) • Washington State Medical Oncology Society (WSMOS)

29. COA/Administrators • COA • Amazing communication and mobilization • Rapid response and focused perspective • Involved CMS/PRIT • State Administrators • Logistic support • Communication and direction THANK YOU!

30. American Society of Clinical Oncology Although physicians clearly do not like to receive letters from the RACs, the concerns described below are well beyond such general frustrations and involve very specific, significant flaws with this particular audit. Any one of these concerns warrant suspension of the audit. Especially given the implications when these issues are taken in combination, we urge CMS to intervene and suspend the ongoing RAC audit in Region D and to ensure that the same audit is not pursued in other regions of the United States.

31. CMS - PRIT • Physicians Regulatory Issues Team • Small group since 1999 “. . . working hard to identify issues, chase them down, and create solutions that are truly tangible to the practicing physician.” • CMS Position • Suffers from lack of funding and low visibility William D Rogers MD Medical Officer CMS and Director Physicians Regulatory Issues Team

32. MAC - Noridian • Medicare Administrative Contractor – Jurisdiction F and Minnesota • After receiving information from the State Societies • Contacted CMS – halted audit • “We are going to overturn them all on appeal any way. . .” • “GET INVOLVED!” Bernice Hecker MD Contract Medical Director Parts A&B Noridian Administrative Services

33. Noridian – Coverage Letter “Based on the evidence, the administration of same-day pegfilgrastim has become an accepted standard of care and in particular, in situations where patients are believed to be a higher risk of potential non-compliance with day 2 administration. “. . .the administration of pegfilgrastim before the traditional 14 day window has become an accepted standard of care to maintain dose-density or reduce neutropenic complications in regimens with substantial myelosuppression.”

34. ? Final Results of Audits • RAC contacted our practice saying that our appeal was accepted and no overpayment existed • This included the audit that they lost • Most practices had all same day pegfilgrastim audits overturned but . . . • Nebraska fights on – ? If RAC reviewed, ? If MAC reviewed, ? next steps

35. Why does one RAC Drug Audit Matter?

38. COA/ISCO National Post-Payment Review Survey (1 of 3) Informal, non-scientific survey written by ISCO and sent by COA (thank you Mary Jo Wichers and Bo Gamble) to practice administrators nation wide. Completely voluntary with no follow up. # of respondents         26 States Represented     19 How Frequent are Post Payment Reviews in the Following Areas:             Chemotherapy  62% WBC 31% RBC 15%  Anti-emetics 15% (Note: each area independent – some practices have received audits in multiple areas)

39. COA/ISCO National Post-Payment Review Survey (2 of 3) Who is conducting the audits? Medicare 70% Medicaid 3% Private Insurers 27% How often has the audit been performed even when a pre-authorization was obtained:     34% How often was the following successful in retaining payment: Provide Records 64% Showing guidelines or compendia 27% Providing clinical trial information 17% Talking to Medical Director 6% Legal Action 1%

40. COA/ISCO National Post-Payment Review Survey (3 of 3) When a claim had to be repaid, how often was the following the reason for the repayment: Lack of unbiased review by payer                     35% Mistake by Billing or Coding 28% Other                                                                         19% Use of therapy outside of guidelines or compendia14% Limited research                                                         5% Number of man hours spent on post payment review/month             20 hours Average days until resolution of a single review                                53 days

41. Where do we go from here?

42. Using an Unified Oncology Coalition to Drive Policy State Societies COA Patients and Advocates ASCO SAC National (CMS) Statewide (Private Insurers)

43. Possible Areas to Address • Pre-authorization • Develop a standardized method of authorization for all insurers • Simplify the process – especially with on-label drug usage • Quality Measures • Develop standard methodology of measuring quality • Simplify the process

44. Possible Areas to Address Establishing National Rules for Drug Audits Private Insurers: • If pre-authorization was given – then this claim shall never be subject to post-payment review.  • If pre-authorization becomes even more arduous, then there shall be an expectation that payers will reimburse this administrative burden. • Any disputed claim should be subjected to an independent review board. Medicare: • Any RAC audit item that deals with a “standard of care” issue – should be reviewed and agreed upon by an independent society before CMS approves it. Both: When dealing with the appropriate use of drug: • FDA Label trumps everything else, NCCN Drug Formulary/etc. next, NCCN/ASCO Guidelines next. • Sequencing of drug shall not be a look-back audit item.  If a payer wants to look at sequencing (i.e. pathway) it should be established and communicated up front.

45. Summary “If we don’t lead, we will concede.”