United States Department of Justice Investigation of Implantable Cardiac Defibrilators and it s impact on Hospitals and Physicians

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1 United States Department of Justice Investigation of Implantable Cardiac Defibrilators and it s impact on Hospitals and Physicians Kevin Cornish, National Director, Healthcare & Life Sciences, Navigant, Phoenix, AZ

2 What Will be Covered Overview of investigation to date Recent DOJ communications on ICD settlement approach How hospitals and Physicians are responding 1

3 Overview of Investigation CIDs, notice letters, voluntary requests Hospitals, device manufacturers What is the issue? DOJ endeavoring to enforce a CMS National Coverage Decision Implantable Cardioverter Defibrillators (ICDs) Part A hospital reimbursement Timing Violations and Secondary Prevention Rogue physicians 2

4 Requests Limited number of CIDs; hundreds of notice letters (based on volume) Tolling agreements Data spreadsheets Requests for information Some asked to provide medical records The intent requests are voluntary 3

5 Status Still in investigative stage Many months spent in attempting to develop a common ICD classification / settlement approach Advancement toward any settlements have been stalled while industry, DOJ, CMS and OIG try to agree on approach. No settlements to date. Highly collaborative approach by DOJ 4

6 How This Investigation is Different Hospital responses mostly voluntary Significant dialogue among defense counsel and DOJ attorneys Great amount of dialogue around actual ICD case reviews and how facts and information should inform interpretation of NCD for purposes of settlement. May be a new paradigm for DOJ 5

7 Medicare Coverage Rules National Coverage Decision (NCD) for ICDs Last updated 2005 What is an ICD, who needs one, and who implants it? Government assumes NCD is only basis for coverage Complex provisions that require a clinician to interpret Many gray areas 6

8 The Crux of the NCD Analysis 40 days 3 months MI, CABG, PTCA Primary vs. Secondary Prevention Sustained Associated With Transient and Reversible Cause 7

9 Challenges NCD is ambiguous Key terms not defined No language that it is the only way to get paid Terms defined inconsistently in Claims Processing Manual and NCDR Data Registry Patient history of cardiac disease is crucial to medical necessity Frequent lack of specificity of key clinical markers within medical record Inconsistent physician and hospital use of key clinical terms Professional standards vary 8

10 NCDR ICD Data Registry CMS requires data submission for primary prevention cases; most hospitals submit primary and secondary data Registry operated by ACC Foundation and HRS (DOJ consultants) CMS has access to registry data Nonetheless, CMS has not issued reports or conducted education re: any perceived problem with ICD implants 9

11 Challenges for DOJ CMS has placed DOJ in an untenable position If the NCD is so explicit, why have hundreds of hospitals around the country apparently had trouble interpreting and applying it? CMS has not educated on, or reported problems with, the NCD Hospitals should be able to rely on the clinical judgment of a multi-disciplinary team of physicians and other medical professionals Each case presents unique circumstances involving a sick patient who may die without an ICD 10

12 Challenges for DOJ NCD outdated, poorly worded NCD is inconsistent with Claims Processing Manual and Data Registry CMS has not enacted any coding edits to catch potentially erroneous claims CMS has not denied these claims since 2003 CMS has not conducted post-payment review Simply put, this is not an FCA case 11

13 FCA DOJ is proceeding as if this is an FCA matter for all of the involved hospitals DOJ would have to show that a hospital knowingly submitted false claims Against the background we have discussed, this is simply not tenable. At most, this should be a CMS repayment matter 12

14 DOJ Matrix DOJ distributed to target hospitals their ICD classification matrix and definition document in August Five broad categories that have different treatment and repayment potential. DOJ plan is to have hospitals review DOJ identified ICD cases using matrix and definitions to self assess number of ICD cases for which repayment may be do. 13

15 Recommendations for Hospitals If recipients of DOJ ICD letters Engage in active dialogue with DOJ Review claims per DOJ matrix and assess results 14

16 Recommendations for Hospitals Issues to consider in review; Significant complexity and subjectivity in review process Format and integrity of results, data and documents to be presented to DOJ Extent and inclusion of information available beyond episode medical record Involvement of implanting physicians in review process Importance to objectively define and substantiate medical necessity outside of DOJ categories The post review negotiation process Complexity of overpayment calculation False Claims Act Release and CIA 15

17 Recommendations for Hospitals If not recipients of DOJ ICD letters, but do ICD cases. Review claims and consider need for voluntary refunds Consider pre-procedure assessment policies and forms Consider parameters to determine when/ whether ICDs should be done OP or IP Prepare to submit no-bills or to notify payer that claim could be seen differently 16

18 Recommendations for Hospitals General Recommendations Become more aware of NCDs and LCDs and have enterprise wide monitoring, dissemination and education policies. Develop ICD policies, procedures and documentation guidelines and educate all implanting physicians. Consider ongoing monitoring of ICD Medical Necessity for each implanting physician. Educate physicians, staff, patients on the DOJ and CMS positions and how it might mean a life-saving ICD would not be covered 17

19 Larger Implications Can hospitals rely on the clinical judgment of physicians, or are they supposed to supplant it? What is the interplay with peer review, quality, monitoring and management of physician decision making? Where is the patient in all of this? Need to inform them that physician and hospital decision making may not mesh with CMS 18

20 Questions? Kevin Cornish, Navigant 19

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